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GEULEN & KLINGER

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Prof. Dr. Remo Klinger

Dr. Caroline Douhaire LL.M.

Dr. Karoline Borwieck

David Krebs

Lukas Rhiel

Mathea Schmitt LL.M.

Yannis Haug-Jurgan

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Legal Opinion

on

The Lawfulness of the Planned Amendments through the

„Food and Feed Safety Omnibus“

by

Dr. Caroline Douhaire LL.M.

Yannis Haug-Jurgan

GEULEN & KLINGER Rechtsanwälte

Prepared on behalf of

Aurelia Stiftung, ClientEarth gGmbH, Deutsche Umwelthilfe e.V., Deutscher Naturschutz-

ring (DNR) e.V., foodwatch e.V., Pestizid Aktions-Netzwerk e.V. (PAN Germany) and Um-

weltinstitut München e.V.

20 January 2026

Table of Contents

A. Background and questions presented .................................................................... 1

B. Executive summary ............................................................................................... 2

C. The Commission initiative and its legality ............................................................... 4

I. Classification of the key proposed amendments ................................................ 4

1. Removal of time limits on approvals of active substances ............................... 4

a. Abolition of the current periodic review ........................................................ 4

b. No compensation through Articles 18, 18a and 21 of Regulation (EC) No

1107/2009 .......................................................................................................... 6

c. Ad hoc review under Article 21 of Regulation (EC) No 1107/2009 ............... 9

d. Adjustment of the duration of national product authorisations .................... 10

2. Simplification of temporary approvals of active substances .......................... 11

3. Extended privileges and exemptions for certain substances ......................... 13

a. Biocontrol substances ............................................................................... 13

b. Privileges for low-risk active substances ................................................... 17

c. Privileges for basic substances ................................................................. 17

d. Privileges for plant protection products required to prevent the establishment

or spread of certain quarantine pests ............................................................... 19

4. Possibility for the RMS to seek EFSA support ............................................... 20

5. Extension of grace periods ........................................................................... 20

a. Rules on transitional periods at active substance level .............................. 20

b. Rules on transitional periods at national level ............................................ 21

6. Freezing the state of scientific knowledge ..................................................... 22

7. Adjustments to the procedure for mutual recognition .................................... 24

8. Treatment of treated seed and plant reproductive material ........................... 25

9. Easier market access for minor uses ............................................................ 26

II. Compatibility with higher-ranking law ............................................................... 27

1. Article 191 TFEU .......................................................................................... 27

2. Article 114 TFEU and Article 11 TFEU .......................................................... 29

3. Article 37 CFR, Article 168 TFEU and Article 35, second sentence, CFR ...... 29

4. Duty to protect under Articles 2(1), 3(1) and 7 CFR ...................................... 32

5. Application to the proposed amendments ..................................................... 34

a. Indefinite approval of active substances .................................................... 35

b. Freezing the state of scientific knowledge ................................................. 36

c. Waiving prior authorisation and approval for certain substances ............... 37

d. Temporary approval of active substances.................................................. 39

e. Extension of grace periods for disposal/use .............................................. 39

D. The Commission’s procedural approach and its lawfulness ................................. 40

I. Dispensing with an impact assessment ........................................................... 40

1. The Commission’s approach ......................................................................... 40

2. Infringement of the Interinstitutional Agreement and the Better Regulation

Guidelines............................................................................................................ 41

3. Legal consequences ..................................................................................... 43

a. Violation of the principle of proportionality ................................................. 43

b. Violations of the principles of equal treatment and the protection of legitimate

expectations ..................................................................................................... 45

c. Infringement of Article 168(1) TFEU .......................................................... 46

II. Insufficient stakeholder consultation ................................................................ 47

1. Approach of the Commission ........................................................................ 47

2. Infringement of procedural requirements as well as the Interinstitutional

Agreement and the Better Regulation Guidelines ................................................ 48

3. Legal consequence: violation of the principles of proportionality, equal treatment

and the protection of legitimate expectations ....................................................... 49

III. Statement of reasons of the proposal .............................................................. 50

E. Conclusion and outlook ........................................................................................ 50

1

A. Background and questions presented

For about a year, European Union policy has been dominated by the drive towards sim-

plification.

To that end, the Union has drawn up a total of ten ‘Omnibus’ packages, some of which

have already been adopted. Each package amends an entire bundle of regulations and

directives within a (at least loosely) related policy area.1

There is nothing fundamentally wrong with the goal of simplifying procedures and thereby

easing the administrative burden on the Union and the Member States, as well as on

businesses and consumers. However, experience with the Omnibus packages to date

suggests that minor progress in reducing bureaucracy has come at the cost of abandon-

ing key achievements in the areas of human rights, health, and environmental protection.

On December 16, the Commission proposed the tenth omnibus package – the so‑called

Food and Feed Safety Omnibus2. It consists of three proposed legislative acts and an

accompanying document, namely:

• Proposal for a regulation amending Regulation (EU) No 528/2012 as regards the

extension of certain data-protection periods3

• Proposal for a directive amending Council Directive 98/58/EC and Directive

2009/128/EC of the European Parliament and of the Council as regards simplify-

ing and strengthening requirements on food and feed safety and repealing Coun-

cil Directives 82/711/EEC and 85/572/EEC4

• Proposal for a regulation amending Regulations (EC) No 999/2001, (EC) No

1829/2003, (EC) No 1831/2003, (EC) No 852/2004, (EC) No 853/2004, (EC) No

396/2005, (EC) No 1099/2009, (EC) No 1107/2009, (EU) No 528/2012 and (EU)

1 An overview is provided by the European Commission at https://commission.eu- ropa.eu/law/law-making-process/better-regulation/simplification-and-implementation/simplifica- tion_en, last accessed on 13 January 2026. 2 European Commission, Food and Feed Safety Simplification Package – December 2025, available at https://food.ec.europa.eu/horizontal-topics/simplification-legislation_en, last ac- cessed on 6 January 2026. 3 COM(2025) 1020 final, available at https://food.ec.europa.eu/document/download/d8c35be0- ecc9-432b-a645-fd363681f5d3_en?filename=horiz_omnibus_reg_com-2025-1020-1-p1.pdf, last accessed on 6 January 2026. 4 COM(2025) 1021 final, available at https://food.ec.europa.eu/document/download/f08402e6- de66-4082-bf8d-ec3aff7787bb_en?filename=horiz_omnibus_dir_com-2025-1021-1part1.pdf, last accessed on 6 January 2026

2

2017/625 as regards simplifying and strengthening requirements on food and

feed safety5 (hereinafter “draft amending regulation”), together with the related

Commission Staff Working Document6

The third proposed legislative act contains proposals for far-reaching amendments to the

EU Plant Protection Products Regulation (EC) No 1107/2009, which would lower the

level of protection in this area.

This analysis is limited to this part of the Omnibus package.

The clients request an assessment of the effects of the proposed amendments to Regu-

lation (EC) No 1107/2009 on the level of protection under plant protection products law

and of their compatibility with higher-ranking law.

B. Executive summary

The amendments to Regulation (EC) No 1107/2009 proposed by the Commission would

lower the level of protection for the environment and human health.

Especially the proposed shift from time-limited approvals of active substances to pre-

dominantly unlimited approval duration represents a major step backwards in terms of

environmental and health protection. Already today, it is a problem that new scientific

findings on risks to health and the environment are not swiftly translated into regulatory

decisions. The implementation of the proposal would exacerbate the problem.

Active substances that do not meet the approval criteria would be allowed to be tempo-

rarily approved under simplified conditions pursuant to Article 4(7) of Regulation (EC)

No 1107/2009. According to the proposal, the absence of “reasonable” alternatives

should be sufficient for such a temporary approval of an active substance. This consti-

tutes a problematic watering down of the existing requirement that alternatives are not

available.

5 COM(2025) 1030 final, available at https://food.ec.europa.eu/document/download/b0817113- 6edc-4219-b638-8060fee037d5_en?filename=horiz_omnibus_reg-com-2025-1030_en.pdf and, in an editorially revised version, as COM(2025) 1030 final/3 at https://eur-lex.europa.eu/legal- content/DE/TXT/?uri=CELEX%3A52025PC1030%2802%29&qid=1767695026766, both last ac- cessed on 6 January 2026. 6 SWD(2025) 1030 final, available at https://food.ec.europa.eu/document/download/863722d6- 85d9-4273-b1f6-475b1bcde200_en?filename=horiz_omnibus_2025-1030_swd_en.pdf, last ac- cessed on 6 January 2026.

3

In addition, Member State authorities would no longer be permitted to consider new sci-

entific findings concerning the active substance when granting national product authori-

sations. This would be equivalent to freezing the state of knowledge at the time of the

last approval. This point in time can be far in the past, particularly in view of the planned

abolition of the periodic review of active substance approvals.

The requirement for prior authorisation of treated seed is to be removed entirely, provided

that the seed has been treated with a plant protection product authorised in another

Member State. Considering the risks to the environment and health associated with the

use of treated seed, this exemption would entail a critical lowering of the level of protec-

tion.

Moreover, various privileges are proposed for substances that the Commission expects

to be less harmful (including biocontrol substances, low‑risk active substances and basic

substances). In some cases, these exemptions lead to the waiver of the authorisation

requirement or to automatic authorisation upon expiry of the decision period. Since the

actual harmlessness of these privileged substances is not ensured by restrictive criteria

and definitions, this would create a problematic loophole for circumventing authorisation

control.

Transitional periods for the placing on the market and use of plant protection products

are to be extended – including for substances that are questionable from a safety per-

spective. This would prioritise economic interests over the protection of health and the

environment.

The proposed amendments raise serious doubts as to their compatibility with the pre-

cautionary principle and with the high level of protection for health and the environment

guaranteed by Article 191(2) of the Treaty on the Functioning of the European Union

(TFEU) and the obligations and rights set out in the Charter of Fundamental Rights of

the European Union (CFR).

The Commission’s approach in preparing the proposal is also not consistent with higher-

ranking law.

4

Contrary to the Interinstitutional agreements and the Better Regulation Guidelines, the

Commission refrained from carrying out an impact assessment and the associated public

stakeholder consultation. Instead, it merely quantified the expected cost savings and

sought feedback on an abstract description of its project in a targeted consultation.

The Commission had at its disposal numerous indications of the risks to the environment

and human health associated with a lowering of the level of protection. Nevertheless, it

proceeded on the assumption - without further substantiation - that the planned changes

would not pose any risk to health and environmental protection. It is not apparent that

the Commission sought information on the expected effects as an alternative to the im-

pact assessment that was not carried out.

This approach violates the principle of proportionality, as the information required to as-

sess proportionality was not available, even though significant environmental and health

impacts were to be expected. Furthermore, serious doubts arise as to whether this ap-

proach is compatible with the principles of equal treatment and the protection of legiti-

mate expectations. Finally, the omission of a health impact assessment and the lack of

a health-specific statement of reasons for the initiative would suggest a breach of Article

168(1) TFEU (in conjunction with Article 296(2) TFEU), if the legislative act were

adopted.

C. The Commission initiative and its legality

I. Classification of the key proposed amendments

The draft amending regulation proposed by the Commission provides for a series of

amendments to Regulation (EC) No 1107/2009 that would significantly lower the level of

protection in the fields of health and environmental protection.

1. Removal of time limits on approvals of active substances

a. Abolition of the current periodic review

At present, first approvals of active substances are limited to a period of no more than

ten years.7 On application, the approval of an active substance shall be renewed if it is

7 Article 5 of Regulation (EC) No 1107/2009.

5

established that the approval criteria set out in Article 4 are satisfied.8 For that purpose,

companies must submit a comprehensive and up-to-date dataset containing toxicologi-

cal, ecotoxicological and environmental information.9

The Commission proposal provides for a fundamental shift towards approvals of active

substances that are, as a rule, unlimited. Only for candidates for substitution, active sub-

stances within the meaning of Article 4(7) of Regulation (EC) No 1107/2009, and those

for which, pursuant to Article 6(j) of Regulation (EC) No 1107/2009, a limited approval

period has been set due to relevant uncertainties, approval duration would remain lim-

ited.10 All other active substances are to be approved without a time limit. Under the

transitional rule proposed by the Commission, this would in principle apply to all active

substances that are approved at the time the amendments enter into force.11 For active

substances that are already in a renewal procedure when the amendments enter into

force, that procedure is to be completed. The renewal of the active substance approval

would be, subject to the above exceptions, unlimited.12

This substantially lowers the level of protection.

The reason why approval duration is limited is to ensure that developments in science

and technology are taken into account.13 In practice, it is quite common that, in the course

of the periodic review of an active substance approval, new scientific evidence on harm

to the environment and human health leads to the finding that the conditions for approval

are not met.14

8 Article 14(1) of Regulation (EC) No 1107/2009. 9 Article 6 Commission Implementing Regulation (EU) 2020/1740 of 20 November 2020 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and repealing Commission Implementing Regulation (EU) No 844/2012. 10 Article 5 of Regulation (EC) No 1107/2009 (Draft). These rules are also to apply to active sub- stances that are approved at the time the draft amending regulation enters into force, see Article 27a of Regulation (EC) No 1107/2009 (Draft). 11 Cf. Article 27a(1) of Regulation (EC) No 1107/2009 (Draft) and the exceptions provided for there. 12 Cf. Article 2(1) of the draft amending regulation; recital 26 of the draft amending regulation. 13 Recital 15 of Regulation (EC) No 1107/2009. 14 Cf. for example, Commission Implementing Regulation (EU) 2024/20 of 12 December 2023 concerning the non-renewal of the approval of the active substance S-metolachlor; Commission Implementing Regulation (EU) 2025/910 of 20 May 2025 concerning the non-renewal of the ap- proval of the active substance flufenacet.

6

Without an obligation on companies to submit updated toxicity data at regular intervals,

significantly fewer new scientific data would be generated.15 The state of knowledge

could then evolve only through independent scientific literature, without the industry be-

ing obliged to contribute to it.

The exceptions, inter alia, for candidates for substitution or active substances pursuant

to Article 4(7) of Regulation (EC) No 1107/2009, are insufficient to ensure an acceptable

level of protection. They would concern only a small proportion of active substances.

According to PAN Europe 90% of active substances would receive an unlimited approval

under this proposal – including highly problematic substances such as acetamiprid and

PFAS active substances.16

The proposal of unlimited approval duration is officially justified with the intention to re-

duce the administrative workload and to facilitate the transition to more sustainable active

substances and plant protection products.17 It is questionable whether the proposed

move to open-ended approvals will contribute to the latter or, rather, will lead to problem-

atic active substances remaining on the market for a longer time.

b. No compensation through Articles 18, 18a and 21 of Regulation (EC) No

1107/2009

Although the proposal provides for mechanisms by which open-ended active substance

approvals can also be reviewed, these do not ensure that new scientific findings are

promptly translated into regulatory decisions.

aa. Periodical identification of active substances that must be reviewed

According to the Commission's proposal, Article 18 of Regulation (EC) No 1107/200918

should stipulate that the Commission shall “periodically” after consulting EFSA, adopt

implementing acts identifying active substances or groups of active substances with un-

limited approval periods for which a renewal procedure shall be conducted.19

15 PAN Europe, Briefing ‘Food and feed safety omnibus’ threatens pesticide rules, available at https://www.pan-europe.info/sites/pan-europe.info/files/public/resources/briefings/Briefing_Om- nibus%20threatens%20pesticide%20rules%20.pdf, last accessed on 16 January 2026.16 16 PAN Europe, fn. 15, p. 2. 17 Recital 14 of the draft amending regulation. 18 This provision currently governs the Commission’s power to establish a work programme set- ting priorities for the mandatory review of active substances. 19 Article 18(1) of Regulation (EC) No 1107/2009 (Draft).

7

This identification of the active substances concerned “shall take into account”, among

others, indications of safety concerns for human or animal health or the environment,

new scientific or technical knowledge and available monitoring data and “may” take into

account requests from Member States.20 Where relevant approval criteria set out in An-

nex II, data requirements or relevant guidance documents become applicable, the Com-

mission shall adopt an implementing act identifying all relevant active substances at the

latest within three years.

The implementing acts shall, among others set deadlines for the submission of applica-

tions for renewal of the approval of the active substances concerned that “allow sufficient

time for the generation of the necessary data and the submission of the said applications”

and set expiry dates for the approvals of the active substances concerned that “allow

sufficient time for the submission and evaluation of the applications and for the adoption

of decisions on the renewal” of the approval of the active substances concerned.

This mechanism set out in Article 18 of the Commission’s proposal cannot replace the

currently foreseen mandatory periodic review.

The proposed obligation on the Commission to decide “periodically” is too vague in terms

of time, because it leaves open the question of how often a decision on the need for

renewal procedure must be taken (annually, every five, ten or 20 years?). The timetable

for identifying the active substances to be reviewed is thus left to the Commission’s dis-

cretion. Only in the case of amended approval criteria, data requirements or guidance

documents there is a specific (but very long) three‑year deadline set for the identification

of the active substances to be reviewed.

Furthermore, the Commission is granted overly broad discretion in identifying the active

substances to be reviewed. The proposed Article 18 does not stipulate clearly enough

that a review must be initiated where there are indications of safety gaps, new scientific

findings and monitoring data. Nor is there a sufficiently clear obligation to respond to

review requests from Member States. It is therefore to be feared that the Commission

will claim broad discretion in assessing the available state of knowledge and the resulting

20Article 18(1), second subparagraph, of Regulation (EC) No 1107/2009 (Draft).

8

need for review. In addition, less data on health and environmental risks will be available

if companies are no longer obliged to generate them.

In addition, the implementing acts identifying the active substances that need to undergo

a renewal procedure are adopted with the participation of the Standing Committee on

Plants, Animals, Food and Feed (SCoPAFF), which is composed of representatives of

national ministries. This creates the risk of political influence.21

Furthermore, the duration of the review procedure is not clearly circumscribed: Already

today, review procedures often take far too long.22 The same problem is likely to happen

for substances chosen under Article 18 of the draft, because this provision leaves open

by when the renewal procedure must be completed. It provides only vague requirements

that the implementing regulation is to set deadlines for the submission of applications for

renewal of the approval of the active substances concerned, which allow “sufficient time”

for the generation of the necessary data and the submission of the said applications”.

Similarly, expiry dates for the active substance approvals are to be set which leave “suf-

ficient time” for the submission and evaluation of the applications and for the adoption of

decisions on the renewal of the active substances concerned.23 These vague formula-

tions, as well as the reference to Article 17 (technical prolongation), give rise to concerns

that problematic active substances could remain on the market for a very long period

without being reviewed.

bb. Targeted reassessment under Article 18a

Whereas the proposed Article 18 of Regulation (EC) No 1107/2009 (Draft) foresees a full

review of the approval of an active substance, a new Article 18a is intended to regulate

a selective reassessment of active substances approved for an indefinite or limited pe-

riod with regard to individual approval criteria.

The proposed provision stipulates that the Commission “may” at any time, based on the

criteria laid down in Article 18(1) initiate a targeted reassessment of the approval of active

substances to verify whether certain approval criteria, or specific aspects thereof, are still

21 PAN Europe, fn. 15, p. 2.16 22 Cf. in this context, the recent judgments of the General Court, judgments of 19 November 2025, Cases T-412/22, T-94/23 and T-565/23, concerning the need for a restrictive application of so- called technical extensions pursuant to Article 17 of Regulation (EC) No 1107/2009. 23 Article 18(2) of Regulation (EC) No 1107/2009 (Draft).

9

met in light of current scientific and technical knowledge. To that end, after consulting the

Authority, the Commission “may” adopt implementing acts under the committee proce-

dure identifying the active substances to be reassessed, the scope of the targeted reas-

sessment, data requirements, the guidance documents to be used, and deadlines for the

submission of required data. If the data are not submitted within the prescribed deadline,

or if the review concludes that the approval criteria are not met, the approval shall be

withdrawn.

This provision in Article 18a also does not ensure that active substance approvals are

swiftly adapted to the latest state of science and to monitoring data. It is designed as a

purely discretionary provision, empowering the Commission to initiate a partial review

but not obliging it to do so. In view of the way in which the existing review option under

Article 21 of Regulation (EC) No 1107/2009 (see below) has been handled to date, there

is reason to fear that the Commission will rarely exercise this discretion to initiate a tar-

geted review. Furthermore, the added value compared to the existing possibility of ad

hoc review under Article 21 of Regulation (EC) No 1107/2009 appears to be low. Finally,

the criticism raised above regarding Article 18 of the proposal, namely that the criteria

for identifying the active substances to be reviewed are not regulated clearly enough,

also applies here.

c. Ad hoc review under Article 21 of Regulation (EC) No 1107/2009

According to the Commission's proposal, the existing possibility of ad hoc review under

Article 21 of Regulation (EC) No 1107/2009 should remain in place.24

According to this provision, the Commission may review the approval of an active sub-

stance at any time. This includes both a targeted review and a full review. It “shall take

into account” a request of a Member State to review, in the light of new scientific and

technical knowledge and monitoring data, the approval of an active substance. Where,

in the light of new scientific and technical knowledge it considers that there are indica-

tions that the substance no longer satisfies the approval criteria provided for in Article 4,

or where requested data has not been provided, it review is initiated. Where the Com-

mission concludes that the approval criteria are not met or where requested information

has not been provided, a Regulation to withdraw or amend the approval shall be adopted.

24 Recital 14 of the draft amending regulation.

10

Article 21 of Regulation (EG) No 1107/2009 is an expression of the precautionary princi-

ple.25 Unfortunately,

it is currently being applied very restrictively by the Commission. There are only a few

cases documented in the case law in which the provision has been invoked by the Com-

mission to review an active substance approval.26 In response to calls by environmental

NGOs to apply this provision, the Commission invokes a very broad discretion to initiate

a review.27 Also Member State requests to apply Article 21 were not always followed by

the Commission.28

Given the Commission’s restrictive approach to the ad hoc review under Article 21 of

Regulation (EC) No 1107/2009, also this provision cannot compensate for the removal

of the current system of limited approval duration.

d. Adjustment of the duration of national product authorisations

As a consequence of the unlimited duration of active substance approvals, the time-

limitation of product authorisations is also to be redesigned.

Currently, the duration of an authorisation is linked to the duration of the active substance

approvals.29 Under the Commission proposal, the duration of authorisations for plant

protection products containing open-ended approved active substances may in future be

up to 15 years; otherwise, the maximum authorisation duration (as before) is a maximum

of one year after expiry of the active substance approval.30

In future, where the contained active substances are approved without a time limit, the

application for renewal of the authorisation is to be submitted at the latest nine months

before expiry of the authorisation. Otherwise, the existing rule is to remain, namely that

25 CJEU, judgment of 1 October 2019, C‑616/17, paras. 99 et seq. 26 General Court, judgment of 17 May 2018, T‑584/13, paras. 157 et seq.; CJEU, judgment of 6

May 2021, C‑499/18 P, paras. 81 et seq., 121. 27 Cf. for example, the Commission’s replies to the requests for internal review IR/2025/931238 and IR/2025/378391, available at https://environment.ec.europa.eu/law-and-governance/aar- hus/requests-internal-review_en, last accessed on 16 January 2026. 28 For example, the Commission has so far not acted on Member State requests to initiate an ad hoc review of several active substances regarding the formation of trifluoroacetate (TFA), see Standing Committee on Plants, Animals, Food and Feed Section Phytopharmaceuticals – Legis- lation, 1–2 October 2025, p. 12, available at https://food.ec.europa.eu/document/down- load/884895c3-94e2-45ad-8861-ba67b4615401_en?file- name=sc_phyto_20251001_ppl_sum.pdf, last accessed on 16 January 2026. 29 Approval period + 1 year, cf. Article 32(1) of Regulation (EC) No 1107/2009. 30 Article 32(1) of Regulation (EC) No 1107/2009 (Draft).

11

the application must be submitted within three months after renewal of the active sub-

stance approval.31 However, the processing time limit is to be 12 months after submission

of the application for renewal of the product authorisation, rather than – as previously –

12 months after renewal of the active substance approval.32

The possibility for Member States to review product authorisations ad hoc under Article

44 of Regulation (EC) No 1107/2009 and, where appropriate, to withdraw them is to re-

main – just like the parallel rule in Article 21 at active substance level. The provision is

also to be supplemented by an obligation to adapt authorisations following a targeted

review pursuant to Article 18a.33 For the reasons set out above, this cannot replace a full

review of the authorisation on the basis of the latest state of science and technology.

2. Simplification of temporary approvals of active substances

Under Article 4(7) of Regulation (EC) No 1107/2009, an active substance may, by way of

derogation, be approved on a temporary basis for a maximum of five years even though

it does not meet the approval criteria. To date, this requires "documented evidence in-

cluded in the application" demonstrating that the active substance is necessary to control

a "serious danger to plant health which cannot be contained by other available means

including non-chemical methods". Given the strict requirements, this provision has not

yet been used.34

According to the Commission proposal, these requirements are to be watered down.

The proposal provides that the derogation is also to apply in the event of a serious danger

to "plant production" (no longer only "plant health").35 The term "plant production" is nei-

ther used nor defined anywhere in Regulation (EC) No 1107/2009. Its inclusion tends to

extend the scope to problems that do not primarily concern the health of plants but rather

the quantity of production. .

In addition, the proposal shifts the focus to the lack of "reasonable" alternatives rather

than on the lack of objectively "available" other means. This softer standard threatens to

31 Article 43(2) of Regulation (EC) No 1107/2009 (Draft). 32 Article 43(5) of Regulation (EC) No 1107/2009 (Draft). 33 Article 44(1a) of Regulation (EC) No 1107/2009 (Draft). 34 PAN Europe, fn. 15, p. 3.16 35 Article 4(7) of Regulation (EC) No 1107/2009 (Draft).

12

be used to dismiss existing alternatives as "unreasonable" on the grounds that they re-

quire greater effort or entail higher costs. At least, this was the aim of demands made by

the agricultural industry.36 Making the assessment depend on the reasonableness of al-

ternatives would therefore be a gateway for an extensive interpretation of Article 4(7) of

Regulation (EC) No 1107/2009 and thus a weakening of the level of protection.

According to the proposal, it would be sufficient for temporary approval that the compel-

ling necessity of the active substance for plant health or plant production becomes ap-

parent during the authorisation procedure. It would no longer no longer be mandatory to

document and prove this in the application. The application of Article 4(7) of Regulation

(EC) No 1107/2009 could thus also be based on facts that only become known at a later

stage. This, too, broadens the scope of this derogation.

Mutagenic substances37, carcinogenic substances (Cat. 1A/B) 38, substances toxic to re-

production39 (only Cat. 1A) and substances classified as POP40, PBT41 or vPvB42 are not

to fall within the derogation in Article 4(7). However, endocrine-disrupting substances

(Annex II, 3.6.5) or reproductive toxic substances of category 1B (Annex II, 3.6.4), as

well as substances that do not meet the ecotoxicological criteria set out in Annex II, No.

3.8, and the groundwater-protection criterion in Annex II, No. 3.10 could potentially be

temporarily approved under the extended exemption.

Finally, the proposal suggests deleting the seventh subparagraph of Article 4(7) of Reg-

ulation (EC) No 1107/2009. This provision requires Member States, when authorizing a

plant protection products containing an active substance temporarily approved under Ar-

ticle 4(7), to simultaneously draw up a phasing out plan concerning the control of the

serious danger by other means, including non-chemical methods and submit it to the

Commission. The removal of this provision is detrimental from an environmental and

health protection perspective.

36 IVA, Simplification of food and feed safety legislation - The opinion of the Industrieverband Agrar e.V., October 2025, p. 6. 37 Cf. Annex II, point 3.6.2 of Regulation (EC) No 1107/2009. 38 Cf. Annex II, point 3.6.3 of Regulation (EC) No 1107/2009. 39 Cf. Annex II, point 3.6.4 of Regulation (EC) No 1107/2009. 40 Cf. Annex II, point 3.7.1 of Regulation (EC) No 1107/2009. 41 Cf. Annex II, point 3.7.2 of Regulation (EC) No 1107/2009. 42 Cf. Annex II, point 3.7.3 of Regulation (EC) No 1107/2009.

13

3. Extended privileges and exemptions for certain substances

The central objective of the proposal is to improve access to and availability of "sustain-

able plant protection products".43 The Commission proposal therefore contains several

provisions intended to facilitate market access for allegedly more sustainable sub-

stances. These proposed significant facilitations in the approval and authorisation pro-

cedure seem partly problematic, because there is a risk that also harmful substances

could benefit from them.

a. Biocontrol substances

The proposal would introduce far-reaching privileges in favor of biocontrol substances.

aa. Definition

Under the proposed legal definition, "biocontrol substances" encompass microorgan-

isms, “inorganic substances as occurring in nature, with the exception of heavy metals

and their salts” and “substances of biological origin or produced synthetically that are

functionally identical and structurally similar to them".44

This definition is too broad. The fact that it covers not only naturally occurring substances

used directly for plant protection, but also substances merely of biological origin and

synthetically produced substances, raise concerns that problematic substances could be

included in some cases.

The active substance Spinosad for example is obtained from a bacterium and is therefore

of natural origin,.45 but at the same time is a highly effective broad-spectrum insecticide

that is not unproblematic from an ecological perspective.46

Another problem is that the suggested definition covers synthetically produced sub-

stances that are functionally identical and structurally similar to naturally produced sub-

stances. There is a concern that even synthetic pyrethroids (insecticides), which are

43 Recital 4 of the draft amending regulation. 44 Article 3(35) of Regulation (EC) No 1107/2009 (Draft). 45 https://de.wikipedia.org/wiki/Spinosad. 46 The approval of the active substance Spinosad was granted subject to the condition that Member States pay particular attention to the protection of aquatic organisms and earthworms and, where appropriate, lay down risk mitigation measures; cf. the Annex to Commission Imple- menting Regulation (EU) No 540/2011.

14

based on the main active ingredients of the natural insecticide pyrethrum,47 could qualify

as a biocontrol substance. These substances cannot be assumed to be a low risk to the

environment and health. Some pyrethroids (e.g. cypermethrin) are even classified as

candidates for substitution due to their hazardousness.

The definition of biocontrol substances would therefore urgently need to be drafted more

narrowly and more concretely, so that only harmless substances are covered.48

bb. Privileges for biocontrol substances

The proposal allows for several regulatory privileges for biocontrol substances:

(1) Acceleration of the active substance approval procedure

Because some Member States currently do not have sufficient expertise to assess bio-

control substances, the Commission suggests that applications for the approval of these

substances may be submitted directly to EFSA.49 .

In addition, the approval process is to be accelerated by requiring the rapporteur Member

State to give priority to applications for the approval of biocontrol substances.50

Even if facilitating market access for less harmful products appears sensible in principle,

this must not lead to delays in the necessary review of approved synthetic active sub-

stances.

(2) Acceleration of product authorisation and mutual recognition

As regards the national authorisation of plant protection products that contain exclusively

biocontrol substances, the EU is to be treated as a single zone.51 In the zonal authorisa-

tion procedure, one Member State proposed by the applicant shall evaluate the applica-

tion taking into account all zones, 52 so that separate assessments for the three different

zones are no longer required. Similarly, mutual recognition under Article 40 should not

47 https://de.wikipedia.org/wiki/Pyrethroide. 48 See also PAN Europe, fn. 15, p. 5, with a concrete proposal for a narrower definition.16 49 Article 7(1) of Regulation (EC) No 1107/2009 (Draft), recital 8 of the draft amending regula- tion. 50 Article 11(1a) of Regulation (EC) No 1107/2009 (Draft). 51 Article 3(17) of Regulation (EC) No 1107/2009 (Draft). 52 Article 33(2) (b) of Regulation (EC) No 1107/2009 (Draft).

15

be limited to recognition within a zone but should be permitted regardless of which zone

the reference Member State belongs to.53

These privileges assume that plant protection products containing exclusively biocontrol

substances do not pose different risks in the individual Member States.54 However, given

the very broad definition, it cannot be assumed that only environmentally compatible

substances fall within the concept of biocontrol substances. Accordingly, it cannot be

assumed that these products are harmless throughout the European Union.

In order to speed up the authorisation process, plant protection products containing ex-

clusively biocontrol substances as active substances are suggested to have priority in

the authorisation procedure.55

Partly, the authorisation can even be assumed: according to the Commission proposal,

where a plant protection product contains only biocontrol substances as active sub-

stances and the Member States concerned have not adopted a decision after 120

days,authorisation shall be deemed as having been granted by the Member States.56

Similarly, mutual recognition is to be deemed to have taken place if no decision on the

recognition has been taken within 120 days.57 A "decision" within the meaning of these

proposals is likely to require not just any reaction by the authority, but a final authorisation

or refusal. In light of the staff shortages in Member State authorities,58 this amount to a

problematic partial waiver of the authorisation requirement.

This is highly concerning, because even natural substances, such as microbial organ-

isms, can entail risks,59 and the proposed definition of biocontrol substances encom-

passes too many problematic substances. It is therefore of great importance that these

substances are subject to a thorough risk assessment and can be subject to national risk

management.

53 Article 40(1) (c) of Regulation (EC) No 1107/2009 (Draft). 54 Recital 10 ofthe draft amending regulation. 55 Article 37(6) of Regulation (EC) No 1107/2009 (Draft), EEC 7 Draft amending regulation. 56 Article 37(5) of Regulation (EC) No 1107/2009 (Draft). 57 Article 42(3) of Regulation (EC) No 1107/2009 (Draft). 58 Which are highlighted by the Commission itself COM (2025) 1030 final, Explanatory Memoran- dum, pp. 1, 20. 59 In this regard, PAN Europe notes that microorganisms have the potential to survive, multiply, move and colonize new environments, with possible unintended impacts on biodiversity; see PAN Europe, fn. 15, pp. 5-6.16

16

(3) Provisional authorisations

For the same reasons, the proposal to enable provisional authorizations for plant protec-

tion products containing one or more biocontrol active substances that have not yet been

approved60 can be seen critically.

These provisional authorizations would only be possible if the draft assessment report of

the rapporteur Member State concludes that the substance can be approved. However,

given that the rapporteur Member State is proposed by the applicant itself,61 the peer

review procedure the EFSA62 is an important step that should not be waived.

In addition, the envisaged validity period of a provisional authorisation of up to five years

appears too long and unjustified, since it can be assumed that the peer-review procedure

can be completed within a shorter time frame.

(4) Exemption from the recording obligation

To reduce the administrative burden for farmers, it is suggested that biocontrol sub-

stances are to be exempted from the obligation imposed on professional users to keep

records for three years of the plant protection products used. As a result, farmers will no

longer be required to record the name of the plant protection product, the date of use,

the quantity used, the area treated and the crop for which the plant protection product

was used.63

From an environmental protection perspective, this exemption is problematic. As ex-

plained above, it cannot be assumed that all biocontrol substances that would fall under

the suggested definition are entirely harmless. In addition, without an obligation to record

all applications of plant protection products, it would not be possible to effectively verify

compliance with the mandatory principles of integrated pest management.64 Moreover,

where environmental damage occurs, it will become significantly more difficult to trace

which products were used and thereby caused the damage.

60 Article 30 of Regulation (EC) No 1107/2009 (Draft). 61 Article 7(1), third subparagraph, of Regulation (EC) No 1107/2009. 62 Cf. Article 12 of Regulation (EC) No 1107/2009. 63 Article 67 of Regulation (EC) No 1107/2009 (Draft). 64 Cf. Article 55 of Regulation (EC) No 1107/2009 in conjunction with Article 14 and Annex III to Directive 2009/128/EC.

17

b. Privileges for low-risk active substances

Further facilitations are envisaged for plant protection products containing low-risk active

substances. For these products, the obligation to accelerate the authorisation procedure

and the concept of tacit authorisation set out in Articles 37 and 42 of Regulation (EC) No

1107/2009 (Draft) would apply as well.

At present, classification as a low-risk active substance requires that the active sub-

stance meets the criteria in Article 4 and Annex II, point 5, of Regulation (EC) No

1107/2009, which sets out certain hazard-based cut-off criteria. These requirements are

to be maintained.

However, the additional requirement currently applicable under Article 22(1) of Regula-

tion (EC) No 1107/2009, according to which also the plant protection products containing

the substance of low-risk must be of low risk to human and animal health and the envi-

ronment, is to be deleted. This suggested removal is justified with the argument that, at

the time of approval or renewal of approval, it is not known whether the criteria for low-

risk products under Article 47 of Regulation (EC) No 1107/2009 are met or not.65 The

proposal therefore suggests to focus only on the intrinsic properties of the active sub-

stance.66

This removal of the product-related element is highly problematic, particularly in the light

of the fact that national authorisation controls for products containing low-risk active sub-

stances are to be relaxed and authorisation can be simulated.

In addition, the Commission suggests introducing the possibility of applying retrospec-

tively for low-risk status.67

c. Privileges for basic substances

Another category of privileged substances are so-called basic substances. These are

substances that are not primarily used for plant protection but are nevertheless useful

65 Recital 12 of the draft amending regulation. 66 Ibid. 67 Recital 12 of the draft amending regulation, Article 7 Regulation (EC) 1107/2009 (draft).

18

for plant protection. In the past, this category included, for example, baking powder,

sugar, fructose or vinegar.68

Already under the current regulatory framework, basic substances benefit from certain

privileges, in particular a simplified approval procedure and unlimited approval duration.69

Qualification as a basic substance currently requires, inter alia, that the substances are

not substances of concern70, that they cannot cause endocrine-disrupting, neurotoxic or

immunotoxic effects, and that they are not marketed as plant protection products.71

The Commission wants to amend these rules, claiming that the previous rules on basic

substances were unclear and made basic substances less available to farmers.72 A def-

inition of the term "basic substances" is proposed that would encompass active sub-

stances that are not predominantly used for plant protection purposes, including food-

stuffs and substances assessed under other Union legislation, but are still useful in plant

protection.73 Suggested is a specification, which uses are covered by qualification as a

basic substance (as distinct from an active substance for plant protection products). In

addition to direct use of the basic substance, also formulations that contain, as a simple

diluent, another basic substance or "substances necessary to stabilize the product".

Here, again, it must be doubted whether this wording ensures that no problematic sub-

stances are used in the formulation.

According to the Commission proposal, basic substances are to be further privileged by

exempting not only their use but also the placing on the market of basic substances from

the requirement of national authorisation; this exemption is also to apply to products

within the meaning of Article 23(1) of Regulation (EC) No 1107/2009 (Draft).74

From an environmental and public health perspective, the planned removal of the na-

tional authorisation requirement for the placing on the market of products containing

68 BVL, Genehmigung von Grundstoffen, available at https://www.bvl.bund.de/DE/Arbeits- bereiche/04_Pflanzenschutzmittel/03_Antragsteller/09_GenehmigungGrund- stoffe/psm_GenehmGrundstoffe_node.html, last accessed on 13 January 2026. 69 Article 23(1) of Regulation (EC) No 1107/2009. 70 Under Article 3(4) of Regulation (EC) No 1107/2009, a "substance of concern" means any substance which has an inherent capacity to cause an adverse effect on humans, animals or the environment and is present or is produced in a plant protection product in sufficient concen- tration to present risks of such an effect. 71 Article 23(1), second sentence, of Regulation (EC) No 1107/2009. 72 Cf. Recital 13 of the draft amending regulation. 73 Article 3 No 36 of draft amending regulation. 74 Article 28(2) (a) of Regulation (EC) No 1107/2009 (Draft).

19

basic substances entails risks. The approval of the individual basic substance does not

make a specific risk assessment for the product unnecessary, because the formulation

can be more harmful than the basic substance considered in isolation. Moreover, even

for basic substances, it must be noted that the dose makes the poison. It therefore cannot

be assumed that products containing basic substances are harmless in every conceiva-

ble application and thus not require risk management.

The Commission proposal includes product-related assessments partly at the basic sub-

stance approval- The suggested criteria for approval as a basic substance are the fol-

lowing: first, the basic substance must not be a substance of concern, or the product

must not fall under hazard classification pursuant to Regulation (EC) No 1272/2008. Sec-

ond, the basic substance, or the product containing it, must not have endocrine-disrupt-

ing, neurotoxic or immunotoxic effects. Third, it must not be an active substance ap-

proved for use in plant protection products, and no such approval procedure may be

pending. Fourth, the basic substance, or the product in which it is used, must not have

immediate or delayed harmful effects on human and animal health or unacceptable ef-

fects on the environment. 75 Moreover, under the Commission proposal an application for

classification as a basic substance must also contain information on intended uses and

proposed conditions of use.76

However, this product reference is then devalued again by the proposal, that approval of

a basic substance is to cover all approved uses and products and is not limited by the

uses applied for. 77 This would mean that only some uses and formulations are actually

subject to a risk assessment, while for the rest compliance with the substantive approval

criteria in Article 23 of Regulation (EC) No 1107/2009 would be presumed.

d. Privileges for plant protection products required to prevent the establishment

or spread of certain quarantine pests

The Commission proposal provides for simplifications for substances required to prevent

the introduction and spread of certain pests pursuant to Regulation (EU) 2016/2031. For

these substances, the European Union is to be treated as a single zone; authorisation is

75 Article 23(2) of Regulation (EC) No 1107/2009 (Draft). 76 Article 23a(1) of Regulation (EC) No 1107/2009 (Draft). 77 Article 23a(4) of Regulation (EC) No 1107/2009 (Draft).

20

to be carried out by one Member State for the entire zone. 78 In addition, an accelerated

procedure is also to apply here, under which the assessing Member State must endeavor

to take a decision as quickly as possible and, in any event, within six months.79

Here too, a restrictive formulation of the uses covered is necessary to ensure that the

derogation is not used to circumvent certain requirements of Regulation (EC) No

1107/2009.

4. Possibility for the RMS to seek EFSA support

To accelerate the initial approval procedure, the Commission proposal provides that the

rapporteur Member State may request EFSA to provide technical or scientific support in

assessing the application for approval.80 This provision is intended to support Member

States that do not have sufficient technical or scientific expertise.81

This proposal seems reasonable, provided that the independence of the experts is en-

sured and any conflicts of interest of the experts involved in the assessment are ex-

cluded.

5. Extension of grace periods

The proposal also provides for an extension of grace periods.

a. Rules on transitional periods at active substance level

At present, where the approval of an active substance is not renewed, the non-renewal

Regulation may provide for a grace period of up to 18 months (6 months for distribution

and sale, plus 12 months for disposal and use of existing stocks). However, according to

the clear wording of the legislation, this option exists only 'where the reasons for not

renewing the approval do not concern the protection of health and environment'.82 Con-

versely, where renewal is refused for reasons relating to environmental and health

78 Article 3(17), Article 33(2) (b); for mutual recognition, cf. Article 40(1) (c) of Regulation (EC) No 1107/2009 (Draft). 79 Article 37(7) of Regulation (EC) No 1107/2009 (Draft). 80 Article 11(2), fourth subparagraph, Regulation (EC) No 1107/2009 (Draft). 81 Recital 17 of the draft amending regulation. 82 Article 20(2), first subparagraph, Regulation (EC) No 1107/2009.

21

protection, no such transitional period may be set. This is currently disregarded by the

Commission.

Under the proposed amendment, the 18-month grace period would apply irrespective of

the reason for non-renewal or restriction, and thus also where there are concerns re-

garding environmental and health safety. The Commission's current practice (which is

not compliant with the Regulation) would therefore be legalised.83 In addition, transitional

periods of a total of three years would be permissible where no other available, 'reason-

able' alternatives to plant protection products containing the active substance concerned

exist. Given the vagueness and breadth of the concept of 'reasonable' alternatives, there

is a risk that the total transitional period of three years will become the rule rather than

the exception. Plant protection products could be used for a substantial period even

though their harmfulness to health and the environment has been proven. Compared to

the status quo, this would constitute a worrying extension of transitional periods.

Article 20(2), second subparagraph, of Regulation (EC) No 1107/2009 requires the im-

mediate cessation of placing plant protection products on the market (and use) where

there is an 'immediate concerns for human health or animal health'. The Commission

proposal would further restrict this possibility by requiring that the concern for health and

the environment must also be 'serious'. This further raises the legal threshold to the det-

riment of health and environmental protection.

b. Rules on transitional periods at national level

Article 46 of Regulation (EC) No 1107/2009 concerns the setting of transitional periods

by Member States in the event of the withdrawal or restriction of product authorisations.

To date, the first sentence of Article 46 of Regulation (EC) No 1107/2009 provides, in

very general terms, that Member States 'may' set transitional periods. This discretion is

limited by the rule in sentence 2, according to which the transitional period shall not ex-

ceed 6 months for sale and distribution and, in addition, no more than 1 year for disposal,

storage and use of existing stocks of the plant protection product concerned, 'where the

reasons for withdrawal, amendment or non-renewal of the authorisation are not related

to the protection of human and animal health or the environment'. This means that, con-

versely, where an authorisation is terminated for reasons of environmental or health

83 See also PAN Europe, fn. 15, p. 4.16

22

protection, transitional periods are not permissible. This provision, too, is incorrectly ap-

plied in the national enforcement practice.84

Under the Commission proposal, in cases where a Member State withdraws or amends

an authorisation or does not renew it, as a result of a non-renewal or withdrawal of the

active substance approval, Member States shall set a grace period within the limits of

the maximum grace period set by the Commission. Where an authorisation is terminated

for other reasons, Member States 'may' provide for a grace period of in total one year.

The current limitation of this option to reasons not relating to environmental and health

protection would thus be removed. As a result, transitional periods of up to 18 months

would also be permissible where health and environmental protection are affected. This

lowers the level of protection.

Member States would still be able to set shorter transitional periods or none at all. How-

ever, given the existing practice in implementing Article 46 of Regulation (EC) No

1107/2009, there is no guarantee that Member States will make use of this option.

6. Freezing the state of scientific knowledge

The proposal foresees a far-reaching adjustment of the legal standard against which

applications for product authorisation are to be assessed.

A new sentence in Article 36(1) dirst subparagraph of Regulation (EC) No 1107/2009 is

to provide that, for the active substances contained in the plant protection product, Mem-

ber States “shall rely on the last assessment conducted at EU level”.

This means that the state of knowledge to be taken into account is frozen at the time of

the last approval of the active substance. However, this point in time may lie far in the

past, particularly if the proposed abolition of the periodic renewal of active substance

approvals is implemented. National authorisation authorities would have to ignore scien-

tific findings known to them on harmful effects on health and the environment in the au-

thorisation procedure if these relate to the active substance.

84 Cf. Higher Administrative Court of Lower Saxony (OVG Lüneburg), order of 3 November 2025, 10 ME 124/25, not published: The court clarifies that the national authorities must exer- cise their discretion when setting sell-out and use-up periods.

23

The implementation of this proposal would result in a significant reduction in the level of

protection and would contradict the findings of the ECJ that the authorities of the Member

States are obliged to take into account the latest scientific and technical findings when

authorising plant protection products.85

Furthermore, it is unclear how findings on the active substance can be clearly distin-

guished from findings on individual products. Many of the effects of the active substance

on the environment and health can only be determined by considering formulations,

which is why representative formulations are also included in the assessment at the level

of active substance approval.

The proposed provision would also lead to a problematic divergence in the state of

knowledge to be taken into account: although the data requirements for active sub-

stances86 and for plant protection products87 are largely identical, an outdated state of

knowledge would have to be applied regarding the data for active substances, whereas

the latest state of knowledge would be relevant for plant protection products. This would

lead to inconsistencies in risk assessment.

While the proposal provides that updates of the state of knowledge may also be taken

into account with regard to active substances ('unless it considers an update is neces-

sary in the light of current scientific and technical knowledge'), in such a case the Member

State may only request the Commission to act under Articles 18, 18a or 21 of Regulation

(EC) No 1107/2009.88 The recitals explain that this adjustment is intended to ensure that

findings can be assessed in a 'harmonised manner'.89

This 'detour' via the review of the active substance approval would mean that new sci-

entific evidence on active substances could only be taken into account with a consider-

able time delay. For instance, if new scientific evidence on the endocrine-disrupting prop-

erties of an active substance approved for an unlimited period becomes available, the

Member State would first have to persuade the Commission to adopt an implementing

85 CJEU, judgment of 25 April 2024, Joined Cases C-309/22 and C-310/22, paras 81, 83 and 100. 86 Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Par- liament and of the Council concerning the placing of plant protection products on the market. 87 Commission Regulation (EU) No 284/2013 of 1 March 2013 setting out the data requirements for plant protection products, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market. 88 Article 36(1), first subparagraph, second sentence, Regulation (EC) No 1107/2009 (Draft). 89 Recital 18 of the draft amending regulation.

24

Regulation under Articles 18 and 18a of Regulation (EC) No 1107/2009, for which no

specific deadlines are provided, or to initiate a review under Article 21 of Regulation (EC)

No 1107/2009. The review would then still have to be carried out, which can take several

years. The incorporation of new scientific findings would be significantly delayed.

Irrespective of this delay, it must be feared that the Commission claims a very wide dis-

cretion with regard to the application of Articles 18 and 18a of Regulation (EC) No

1107/2009 (Draft) and Article 21 of Regulation (EC) No 1107/2009.

7. Adjustments to the procedure for mutual recognition

To be welcomed is the proposal that mutual recognition of an authorisation is made sub-

ject to the additional condition that the authorised product is actually placed on the mar-

ket in the reference Member State.90 This is intended to prevent abuse of the mutual

recognition system in view of the differing fees that Member States set for granting au-

thorisations for plant protection products.91

A further extension of the scope of mutual recognition would result from the proposal that

official or scientific bodies engaged in agricultural activities, or agricultural professional

organisations should in future be able to apply for the mutual recognition of an authori-

sation even without the company's consent92 and that the existing requirement to demon-

strate a public interest in the use is deleted.93

Particularly problematic is the deletion of the current requirement to attach to the appli-

cation a complete dossier or a summary dossier, as well as the assessment report of the

reference Member State and its authorisation decision.94 These documents are essential

for an assessment within the meaning of Article 41(1) of Regulation (EC) No 1107/2009,

which, inter alia, requires account to be taken of the conditions in the territory of the

Member State granting recognition. The explanatory memorandum to the proposal notes

that the authorities of the Member State granting recognition can obtain these documents

directly from the reference Member State.95 However, this increases the administrative

burden (which is supposed to be reduced) and is contrary to the principle that the

90 Article 40(1)(a) and (b), Regulation (EC) No 1107/2009 (Draft). 91 Recital 20 of the draft amending regulation. 92 Recital 21 of the draft amending regulation. 93 Article 40(2), Regulation (EC) No 1107/2009 (Draft). 94 Article 42(1), second sentence, Regulation (EC) No 1107/2009 (Draft). 95 Recital 21 of the draft amending regulation.

25

applicant must submit the necessary documents. In addition, this additional procedural

step, whereby the authority must first obtain the necessary documents, further shortens

the already tight recognition period of 120 days.96

There are also particular concerns regarding the planned legal fiction of authorisation for

plant protection products containing biological control agents and low-risk active sub-

stances (see above under C.I.3.a.bb.(2)).

8. Treatment of treated seed and plant reproductive material

The proposal suggests amending the provisions governing the treatment of treated

seeds.

At present, the placing on the market and use of plant protection products used for seed

treatment require a national authorisation decision under Article 28(1) of Regulation (EC)

No 1107/2009. Under the Commission proposal, the placing on the market and use of

treated seed and plant reproductive material would be exempted from this authorisation

requirement, provided that the treatment was carried out with plant protection products

authorised for that use in at least one Member State.97 This would potentially allowto

treat seed domestically with products that do not have a national authorisation but are

merely authorised in another Member State. In view of the considerable risks that may

arise from the use of treated seed,98 this cannot be justified. Plant protection products

used for seed treatment urgently require thorough national risk assessment and national

risk management.

Another problematic aspect is the proposal to further raise the requirements for on inter-

nal market trade under Article 49 of Regulation (EC) No 1107/2009 with respect to seed

treated abroad. At present, where there are serious concerns that seed treated abroad

is likely to present a serious risk to health or the environment, 'measures to restrict or

prohibit the use and/or sale of such treated seeds shall be taken immediately'.99 Under

the amending proposal, the adoption of such measures would be left to the Commission's

96 See Article 42(2), Regulation (EC) No 1107/2009 (Draft). 97 Article 28(2) (f), Regulation (EC) No 1107/2009 (Draft). It is not specified in the proposal whether this must be a Member State within the same zone; it must therefore be assumed that authorisations from Member States in other zones would also have to be taken into account. 98 By way of reminder, reference may be made, for example, to the toxicity to bees of seed treated with neonicotinoids. 99 Article 49(2), Regulation (EC) No 1107/2009.

26

discretion.100 Here, too, it is clear that the proposal would reduce the importance of pro-

tection concerns.

Furthermore, it is proposed that machines for sowing treated seed would not constitute

pesticide application equipment within the meaning of Article 8 of Directive

2009/128/EC.101 This would mean that the inspection obligations laid down there would

not apply. No technical reasons are given for this privilege; according to the recitals, it is

intended solely to reduce the administrative burden for farmers.102

9. Easier market access for minor uses

The authorisation of minor uses under Article 51 of Regulation (EC) 1107/2009 is also to

be facilitated.

The proposal suggests, inter alia, deleting the current requirement that extending the

scope of an authorisation to minor uses must be of public interest.103

In addition, Member States are to be obliged to take measures to simplify or promote the

submission of applications to extend the scope of an authorisation of plant protection

products already authorised to minor uses.104

Furthermore, the possibility of mutual recognition of a minor use should no longer be

subject to the requirement that the use is minor in the reference Member State.105

Such relaxations must be viewed critically, because authorisations of minor uses are

exempt from some authorisation criteria, such as sufficient efficacy, and therefore do not

rely on a comprehensive assessment.

.

100 See Article 49(4), Regulation (EC) No 1107/2009 (Draft). 101 Article 49(7), Regulation (EC) No 1107/2009 (Draft). 102 Recital 22 of the draft amending regulation. 103 Article 51(2), Regulation (EC) No 1107/2009 (Draft). 104 Art. 51(3) Regulation (EC) No 1107/2009 (Draft). 105 Article 51(7), Regulation (EC) No 1107/2009 (Draft).

27

II. Compatibility with higher-ranking law

In shaping EU plant protection product law, the requirements of Article 191(2) in conjunc-

tion with Articles 114, 11 and 168 TFEU and Articles 35, second sentence, and 37 CFR,

as well as state duties of protection derived from fundamental rights, must be observed.

The proposed amendments give rise to serious doubts as to their compatibility with the

precautionary principle based on these provisions and the high level of protection for

health and the environment that must be ensured.

1. Article 191 TFEU

The principles laid down in Article 191 are to be regarded as legally binding, fundamental

and formative principles of European environmental policy and European environmental

law.106 They must be taken into account not only when interpreting secondary law107 but

also have a binding effect on the Union legislator.108

When exercising its powers in the environmental field pursuant to Articles 191 and

192 TFEU, the EU legislature enjoys a broad discretion.109 Judicial review is limited to

determining whether the EU legislature committed a manifest error of assessment.110

Article 191(2), first sentence, TFEU imposes on the Union an obligation, in its environ-

mental policy, to aim at a high level of protection. The objective of protecting human and

animal health and the environment takes precedence when granting an authorisation for

a plant protection product, over the objective of improving plant production.111 The high

level of protection to be ensured in plant protection product law also takes precedence

106 See, on Article 174 EC: CJEU, judgment of 14 July 1998, C-284/95, para. 36; judgment of 15 June 2002, C-9/00, para. 23. 107 See in the context of plant protection product law, for example, CJEU, judgment of 6 May 2021, C-499/18 P. 108 CJEU, judgment of 13 November 1990, C-331/88; judgment of 5 May 1998, C-157/96; judg- ment of 1 October 2019, C-616/17; General Court, judgment of 11 September 2002, Case T- 13/99; judgment of 11 September 2002, Case T-70/99. 109 Kahl, in: Streinz, EUV/AEUV, 3rd ed. 2018, Article 191 TFEU, para. 74; General Court, judg- ment of 2 March 2010, T‑16/04, para. 143; judgment of 31 January 2024, T-745/20, para. 114. 110 CJEU, judgment of 1 October 2019, C-616/17, para. 50; judgment of 21 December 2016, C- 444/15, para. 46. 111 CJEU, judgment of 19 January 2023, C‑162/21, para. 48; judgment of 25 April 2024, joined

Cases C‑309/22 and C‑310/22, para. 90.

28

over economic considerations and may therefore justify substantial adverse economic

consequences for certain traders.112

Pursuant to Article 191(2), second sentence, TFEU, environmental policy is also based

on the precautionary and preventive principle. These requirements also give rise to du-

ties of protection on the part of the Union in the field of environmental protection and

public health.113

According to the case-law of the European Court of Justice concerning Regulation (EC)

No 1107/2009, the precautionary principle entails that, where there is uncertainty as to

the existence or extent of risks to human health, protective measures may be taken with-

out having to wait until the reality and seriousness of those risks become fully apparent.

Where it proves impossible to determine with certainty the existence or extent of the

alleged risk because the results of the studies carried out are inconclusive, but the like-

lihood of real harm to public health persists should the risk materialise, the precautionary

principle justifies the adoption of restrictive measures.114

A correct application of the precautionary principle in the field covered by Regulation

(EC) No 1107/2009 requires, first, identification of the potentially negative effects of the

use of active substances and plant protection products falling within its scope on health

and, second, a comprehensive assessment of the health risk on the basis of the most

reliable scientific data available and the most recent results of international research.115

The EU legislature is required to establish a normative framework enabling the compe-

tent authorities, when deciding on authorisations and approvals, to have sufficient infor-

mation to assess, in a satisfactory manner, the hazards to health arising from the use of

those active substances and those plant protection products, in accordance with the pre-

cautionary principle and on the basis of the most reliable scientific data available and the

most recent results of international research.116

112 General Court, judgment of 17 May 2018, T-429/13 and T-451/13, paras 323, 106, 289; judg- ment of 9 September 2011, T‑475/07, para. 143; judgment of 6 September 2013, T‑483/11, not

published, para. 85; judgment of 12 December 2014, T‑269/11, not published, para. 138. 113 CJEU, judgment of 26 June 2019, C-723/17, para. 33. 114 CJEU, judgment of 1 October 2019, C-616/17, para. 43; cf. to that effect, CJEU, judgment of 22 December 2010, C‑77/09, paras 73, 76; judgment of 17 December 2015, C‑157/14, para. 81

et seq.; judgment of 22 November 2018, C‑151/17, para. 38. 115 CJEU, judgment of 1 October 2019, C-616/17, para. 46; judgment of 8 July 2010, C-343/09, para. 60; judgment of 22 December 2010, C-77/09, para. 75. 116 CJEU, judgment of 1 October 2019, C-616/17, para. 47.

29

The precautionary and preventive principles also imply that environmental pollution must

be addressed as a matter of priority through preventive measures, so that environmental

damage is prevented rather than merely remedied - including in situations of scientific

uncertainty.117

2. Article 114 TFEU and Article 11 TFEU

The requirement, under Regulation (EC) No 1107/2009, to maintain a high level of envi-

ronmental protection is also implemented pursuant to Article 11 TFEU, under which en-

vironmental protection requirements must be integrated into the definition and implemen-

tation of Union policies and activities, in particular with a view to promoting sustainable

development.

Article 114(3) TFEU also provides that, in its proposals for the approximation of laws

which have as their object the establishment and functioning of the internal market, the

Commission shall take as a base a high level of protection, inter alia in the field of envi-

ronmental protection, taking account, in particular, of any new development based on

scientific facts, and that the Parliament and the Council shall also seek to achieve that

objective within the scope of their respective powers.

That protection takes precedence over economic considerations, so that it may even

justify substantial adverse economic effects for certain economic operators.118

3. Article 37 CFR, Article 168 TFEU and Article 35, second sentence, CFR

Pursuant to Article 37 CFR, a high level of environmental protection and the improvement

of the quality of the environment must be integrated into the policies of the Union and

ensured in accordance with the principle of sustainable development. The quality of the

environment must therefore not only be preserved but improved.119

117 Epiney, in: Landmann/Rohmer UmweltR, 108th update (August 2025), TFEU Article 191 para. 23. 118 General Court, judgment of 19 November 2025, T-94/23, juris para. 76 et seq., with further references. 119 Jarass, Charta der Grundrechte der EU, 4th ed. 2021, Article 37 para. 6.

30

Environmental protection and the protection of human health are closely linked in the

field of environmental policy.120 In this context, the European Court of Justice refers to a

right to live in an environment that is adequate for an individual's health and well-being.121

Regulation (EC) No 1107/2009 also aims to protect human health from plant protection

products and is based, inter alia, on the public health legal basis in Article 168(4)(b)

TFEU. Accordingly, Article 168(1) TFEU and the identically worded Article 35, second

sentence, CFR must also be taken into account, pursuant to which a high level of human

health protection shall be ensured in the definition and implementation of all Union poli-

cies and activities.

That principle is aimed primarily at the preventive safeguarding of the state of health.122

In view of the potential health effects of the use of plant protection products, the precau-

tionary principle must therefore also be observed. According to the case law of the Eu-

ropean Court of Justice, it must also be applied in public health policy, and likewise where

- as here - Union institutions, on the basis of the common agricultural policy or internal

market policy, adopt measures to protect human health.123

When applying the precautionary principle, it must be borne in mind that health protection

has particular weight. The wording of the cross-cutting clause in Article 168(1) ('shall be

ensured') goes further than the wording of other cross-cutting clauses, for example in

Articles 9, 11 or 12 TFEU, which merely provide for the integration or consideration of

the relevant interest.124 Article 168(1) TFEU and Article 35, second sentence, CFR must

therefore be understood as an optimisation requirement. The greatest possible level of

health protection must be realised; health protection interests are to prevail as far as

possible.125

Accordingly, the case law of the Court of Justice shows that the protection of health must

be given priority over economic considerations.126

120 CJEU, judgment of 25 June 2024, C-626/22, para. 68. 121 CJEU, judgment of 25 June 2024, C-626/22, para. 72. 122 Jarass, Charta der Grundrechte der EU, 4th ed. 2021, Article 35 para. 9. 123 CJEU, judgment of 1 October 2019, C-616/17, para. 41, with further references. 124 Schmidt am Busch, in: Grabitz/Hilf/Nettesheim, EUV/AEUV, 85th update (May 2025), Article 168 TFEU para. 95. 125 Cf. Schmidt am Busch, in: Grabitz/Hilf/Nettesheim, EUV/AEUV, 85th update (May 2025), Arti- cle 168 TFEU para. 95, with further references. 126 CJEU, judgment of 17 July 1997, C-183/75, para. 43, with further references.

31

Furthermore, the obligation, provided for in Article 168(1) TFEU and Article 35, second

sentence, CFR, to ensure a high level of health protection means that the institutions of

the European Union must ensure that their decisions are taken with full account taken of

the best available scientific data and are based on the most recent results of international

research.127

These principles arising from Article 37 CFR, Article 168(1) TFEU and Article 35, second

sentence, CFR must be taken into account when applying Article 191 TFEU. Article 52(2)

CFR provides that rights recognised by the Charter which are based on the Treaties shall

be exercised under the conditions and within the limits defined by those Treaties.128

Article 168(1) TFEU and Article 35, second sentence, CFR must also be taken into ac-

count when reviewing compliance with the principle of proportionality laid down in Article

5 (4) TEU.

According to settled case law, the principle of proportionality, which forms part of the

general principles of EU law, requires that acts of the institutions must not exceed the

limits of what is appropriate and necessary in order to attain the objectives legitimately

pursued by the measure in question. Where there is a choice between several appropri-

ate measures, the least onerous must be used, and the disadvantages caused must not

be disproportionate to the aims pursued.129

If, in that balancing exercise, interests of health protection are not taken into account at

all or are given incorrect weight, this constitutes a breach of the cross-cutting clause in

Article 168(1), first subparagraph, TFEU and/or the principle in Article 35, second sen-

tence, CFR, which goes hand in hand with a breach of the principle of proportionality.130

In this context, due account must be taken of the principle that the protection of public

health takes precedence over economic interests.131

127 General Court, judgment of 11 September 2002, T-13/99, para. 158. 128 Cf. CJEU, judgment of 13 March 2019, C‑128/17, para. 130 et seq., with further references. 129 Cf. CJEU, judgment of 8 July 2010, C-343/09, para. 45, with further references. 130 Cf. the discussion of Article 168(1), first subparagraph, TFEU in Schmidt am Busch, in: Grabitz/Hilf/Nettesheim, EUV/AEUV, 85th update (May 2025), Article 168 para. 103, and of Arti- cle 35, second sentence, CFR in Jarass, Charta der Grundrechte der EU, 4th ed. 2021, para. 13; CJEU, judgment of 4 May 2016, C-547/14, para. 156 et seq. 131 Cf. CJEU, judgment of 19 April 2012, C-221/10 P, para. 99.

32

4. Duty to protect under Articles 2(1), 3(1) and 7 CFR

In addition, the fundamental rights enshrined in the EU Charter of Fundamental Rights

give rise to obligations on the part of the Union to protect life and health, inter alia, from

the hazards arising from the use of plant protection products.

For the interpretation of fundamental rights under the Charter, recourse must be had to

the case law of the European Court of Human Rights (ECtHR). This is because, for Char-

ter rights, Article 52(3) first sentence CFR provides that they shall have the 'same mean-

ing and scope' as the corresponding rights under the European Convention on Human

Rights (ECHR).132 The ECHR therefore has particular significance where Charter rights

overlap with the guarantees of the Convention.133 The provisions of the ECHR constitute

a minimum standard of protection. The protection guaranteed by the Charter may never

be less than that afforded by the ECHR.134

Pursuant to Article 2(1) CFR, everyone has the right to life. Article 2(1) CFR - like the

corresponding Article 2 ECHR - requires those bound by fundamental rights to protect

life through active measures.135 Article 2 ECHR must also be relied upon for the shaping

of that fundamental right as a duty of protection in environmental law.136

Under Article 3(1) CFR, everyone has the right to respect for his or her physical and

mental integrity. Article 7 CFR guarantees everyone the right to respect for his or her

private and family life, home and communications. By reference to the corresponding

Article 8 ECHR, Articles 3(1) and 7 CFR are understood as imposing an obligation to

provide protective support for the legal interest of physical integrity and to promote that

legal interest - particularly with regard to environmental burdens.137

132 Jarass, Charta der Grundrechte der EU, 4th ed. 2021, Article 52 para. 56. 133 CJEU, judgment of 25 March 2004, C-71/02, para. 48; judgment of 3 September 2009, C- 402/05, para. 283. 134 Jarass, Charta der Grundrechte der EU, 4th ed. 2021, Article 52 para. 63, with further refe- rences. 135 Borowsky, in: Meyer/Hölscheidt, Kommentar zur Charta der Grundrechte der Europäischen Union, 5th ed. 2019, Article 2 para. 37; Jarass, Charta der Grundrechte der EU, 4th ed. 2021, Article 2 para. 8. 136 Borowsky, in: Meyer/Hölscheidt, Kommentar zur Charta der Grundrechte der Europäischen Union, 5th ed. 2019, Before Title I para. 9, Article 2 para. 38; Jarass, Charta der Grundrechte der EU, 4th ed. 2021, Article 2 para. 8. 137 Jarass, Charta der Grundrechte der EU, 4th ed. 2021, Article 3 para. 10; Callies, in: Cal- lies/Ruffert, 6th ed. 2022, EU-GrCH, Article 3 para. 11, Article 7 para. 32; Borowsky, in: Meyer/Hölscheidt, Kommentar zur Charta der Grundrechte der Europäischen Union, 5th ed. 2019, Article 3 para. 39.

33

For the purposes of specifying these duties of protection, recourse must be had to the

ECtHR’s case-law on the positive obligations arising from Articles 2 and 8 ECHR.

According to the case law of the ECtHR, Article 2 ECHR entails a positive obligation to

take appropriate steps to safeguard life - both in respect of acts of public authorities and

of private actors.138

According to the ECtHR, Article 8 ECHR gives rise to a duty to protect against environ-

mental pollution, which applies well below the threshold of a risk to life. The ECtHR jus-

tifies this on the basis that severe environmental pollution may affect individuals’ well-

being and may lead to such a serious impairment of the enjoyment of their homes that it

affects their private and family life, without necessarily endangering their health.139 That

duty applies both in cases where pollution is directly caused by the State and in cases

where its responsibility is the result of a failure to regulate private activities of third parties

adequately.140

With regard to climate change, the ECtHR has only recently held that Article 8 ECHR

encompasses an individual right to effective protection by the public authorities against

serious adverse effects of climate change on his or her life, health, well-being and quality

of life.141 The same applies in relation to environmental protection.

While the scope of the duties of protection depends on the circumstances of the individ-

ual case,142 the measures to protect life and health and private and family life must nev-

ertheless be effective.143

138 ECtHR, Öneryıldız, judgment of 30 November 2004, no. 48939/99, paras 71, 89 et seq.; Bu- dayeva and Others, judgment of 20 March 2008, nos. 15339/02 et al., para. 128 et seq.; Nicolae Virgiliu Tanase, judgment of 25 June 2019, no. 41720/13, paras 140 et seq. 139 Cf. ECtHR, Fadeyeva, judgment of 9 June 2005, no. 55723/00, para. 87; López Ostra, judg- ment of 9 December 1994, no. 16798/90, para. 51; Jugheli and Others, judgment of 13 July 2007, no. 38342/05, para. 71. 140 ECtHR, Frankowski and Others, decision of 20 September 2011, no. 25002/09. 141 ECtHR, Climate Seniors and Others, no. 53600/20, para. 519. 142 Settled case-law, ECtHR, Kolyadenko and Others, judgment of 28 February 2012, nos. 17423/05 et al., paras 160 et seq.; Budayeva and Others, judgment of 20 March 2008, no. 15339/02, paras 136-137; Vilnes and Others, judgment of 5 December 2013, nos. 52806/09 and 22703/10, para. 220. 143 See, on Article 2 ECHR: ECtHR, Brincat and Others, judgment of 24 July 2014, no. 60908/11, para. 79; likewise ECtHR, L.C.B., judgment of 9 June 1998, no. 14/1997/798/1001, para. 36. See, on Article 8 ECHR: ECtHR, Oluić, judgment of 20 May 2010, no. 61260/08, paras 48 et seq., 64 et seq.; Moreno Gómez, judgment of 16 November 2004, no. 4143/02, para. 55.

34

The establishment of an effective legal and administrative framework is of particular im-

portance. The ECtHR derives from the positive obligations under Articles 2 and 8 ECHR

a duty on the State to put in place a legislative and administrative framework ensuring

effective prevention of harm to the environment and to human health and life.144 Only

under certain specific circumstances may it be assumed that positive obligations are met

in practice even in the absence of relevant statutory provisions.145

Where environmental protection standards have been enacted, there is a violation of the

Convention if they fail to strike a fair balance between the competing interests.146

The European Union’s action or failure to act must also be assessed against that stand-

ard.

5. Application to the proposed amendments

Applying those principles to the amendments proposed by the Commission, there are

serious doubts as to their compatibility with higher ranking law.

In the Blaise case, the European Court of Justice already had to rule on the compatibility

with primary law of Regulation (EC) No 1107/2009. The Court emphasised that, when

adopting rules on the placing on the market of plant protection products, the EU legisla-

ture must comply with the precautionary principle and ensure a high level of health pro-

tection:

“There is therefore an obligation on the EU legislature, when it adopts rules gov-

erning the placing on the market of plant protection products, such as those laid

down in Regulation No 1107/2009, to comply with the precautionary principle, in

order to ensure, in particular, in accordance with Article 35 of the Charter of Fun-

damental Rights of the European Union and Article 9 and Article 168(1) TFEU, a

high level of -protection of human health (see, by analogy, judgment of 4 May

2016, Pillbox 38, C‑477/14, EU:C:2016:324, paragraph 116).”

CJEU, judgment of 1 October 2019, C‑616/17, para. 42; see also General Court,

judgment of 19 November 2025, T‑412/22, juris, para. 46

144 ECtHR, Brincat and Others, judgment of 24 July 2014, no. 60908/11, para. 112; Cordella and Others, judgment of 24 January 2019, no. 54414/13, para. 159; Moreno Gómez, judgment of 16 November 2004, no. 4143/02, para. 55; judgment of 9 April 2024, Climate Seniors and Others, no. 53600/20, para. 545; on Article 2: Öneryıldız, judgment of 30 November 2004, no. 48939/99, para. 89. 145 ECtHR, Brincat and Others, judgment of 24 July 2014, no. 60908/11, para. 112. 146 ECtHR, Fadeyeva, judgment of 9 June 2005, no. 55723/00, para. 132 et seq.

35

In that judgment, the Court interpreted the safeguards laid down in Regulation (EC) No

1107/2009 in a protection‑oriented manner and in accordance with the precautionary

principle, and, based on that restrictive interpretation, upheld the Regulation as compat-

ible with primary law.

The Commission proposal provides for a significant lowering of the level of protection

achieved by Regulation (EC) No 1107/2009. It is therefore questionable whether, if this

proposal were to be implemented, the Court would still conclude that the Regulation

complies with the principles of precaution and a high level of protection.

a. Indefinite approval of active substances

Significant legal concerns are raised by the proposal to grant approvals for plant protec-

tion product active substances with an unlimited duration.

In its current form, that proposal would mean that, the regular reevaluation of risks to the

environment and human health would be removed for the vast majority of active sub-

stances.

However, as the European Court of Justice has emphasized in the Blaise-ruling, the pre-

cautionary principle requires that potential adverse effects on health be identified and

subjected to a comprehensive assessment based on the most reliable scientific data

available and the most recent results of international research.147

Those requirements are not met if an active substance approval is assessed only once

and is then no longer updated in line with scientific and technical progress.

The high level of protection required under primary law pursuant to Articles 114(3), 168(1)

and 191(2) TFEU is also unlikely to be maintained if such a far-reaching waiver of adap-

tation to scientific progress is granted. These principles require measures ensuring that

existing approvals are reviewed regularly in the light of current scientific data.

No such safeguards are foreseen in the proposal. The provisions in Articles 18 and 18a

of Regulation (EC) No 1107/2009 (Draft) cannot ensure that new scientific findings on

147 CJEU, judgment of 1 October 2019, C‑616/17, para. 46 et seq.; judgment of 8 July 2010,

C‑343/09, para. 60; judgment of 22 December 2010, C‑77/09, para. 75.

36

health and environmental hazards are taken into account in a timely manner. A mere

possibility of review provided for in discretionary provisions is insufficient in situations

where scientifically proven risks to health and the environment arise. Article 21 of Regu-

lation (EC) No 1107/2009 as well cannot fully compensate for the loss of a regular, sys-

tematic full review. That would apply even if the Commission were to abandon its hitherto

restrictive approach to applying Article 21, because the possibility (and obligation) of ad

hoc review does not render regular comprehensive review, including the generation of

new data, dispensable.

The proposal for indefinite approvals also runs counter to the Court’s findings that, in the

field of plant protection products, the principle of legal certainty must be balanced against

the precautionary principle. The Court held that those placing plant protection products

on the market must at all times expect that circumstances may come to light showing

that an active substance or a plant protection product has harmful effects on the health

of humans or animals or unacceptable effects on the environment. The Commission

and/or the Member States are required to take such findings into account and, where

appropriate, to withdraw the active substance approval or the product authorisation.148

b. Freezing the state of scientific knowledge

Serious concerns under primary law are also raised by the proposal to prohibit Member

States from taking account of the latest state of science in relation to active‑substance

data.

As explained above, the proposed rule in Article 36(1) of Regulation (EC) 1107/2009

(Draft) would mean that the national authorities would have to ignore new scientific find-

ings or would only be able to take them into account many years later.

This is incompatible with the precautionary principle and the required high level of pro-

tection within the meaning of Article 191(2) TFEU, Article 168(1) TFEU, Article 35 and 37

CFR. The precautionary principle specifically enables and requires action in situations

where there are indications of risks to human health and the environment, but the risk

cannot yet be established with certainty. The proposal runs diametrically counter to this

principle, as it not only fails to provide that action is mandatory, but even prohibits action

148 CJEU, judgment of 25 April 2024, C‑308/22, paras 107–109.

37

and directs national authorities only to initiate a multi‑year review mechanism fraught

with uncertainty.

Moreover, the proposal contradicts the findings of the European Court of Justice in its

judgments of 25 April 2024 that, when examining authorisation applications, Member

States are not confined to particular categories of scientific evidence or to specific points

in time when that evidence became available, and that they must assess applications in

the light of current scientific knowledge.149 These findings are not a mere interpretation

of secondary law, because the Court also relied on the objective, enshrined in primary

law, of ensuring a high level of protection and on the precautionary principle.150

In addition, in the Blaise-ruling the Court of Justice explained that the obligation to take

account of the latest state of science follows from the precautionary principle anchored

in primary law. It therefore cannot be curtailed by an amendment to the Regulation.

c. Waiving prior authorisation and approval for certain substances

The insufficiently defined exemptions that provide for a complete waiver of an authorisa-

tion or approval decision are also questionable under primary law. These include, in par-

ticular, new exemptions from the authorisation requirement for treated seed and the au-

tomated authorisation/recognition for products containing biocontrol substances where

the 120‑day decision period is exceeded.

The precautionary principle and the principle of ensuring a high level of health protection

are aimed at preventive safeguarding of health.151 Against that background, the require-

ments in Regulation (EC) No 1107/2009 for prior approval of active substances and prior

authorisation of plant protection products give expression to the precautionary princi-

ple.152 Purely ex post control does not satisfy the requirements of the precautionary and

preventive principles.

149 CJEU, judgment of 25 April 2024, C‑309/22 and C‑310/22, para. 77; C‑308/22, para. 91. 150 CJEU, judgment of 25 April 2024, C‑308/22, paras 102 et seq. 151 Jarass, Charta der Grundrechte der EU, 4th ed. 2021, Article 35, para. 9. 152 General Court, judgment of 19 November 2025, T‑94/23, para. 45, juris; judgment of 17 -March 2021, T‑719/17, paras 60 and 61, and the case-law cited-; CJEU, judgment of 22 De-

cember 2010, C‑77/09, para. 74.

38

According to the European Court of Justice the harmlessness of plant protection prod-

ucts must not be presumed.153 That is also reflected in the fact that the applicant must

prove that the approval criteria are met.154

A waiver of the authorisation requirement, or an automated authorisation upon expiry of

the time limit, is not compatible with these findings an the principles of precaution and a

high level of protection.

The waiver of the authorisation requirement cannot be justified by the Commission’s as-

sertion that the substances are harmless. It cannot generally be assumed that, for ex-

ample, products containing biological control substances have no harmful effects what-

soever on health and the environment, or that any doubts in that regard are purely hypo-

thetical.

The waiver of the authorisation requirement triggered by the legal fiction in case of ex-

ceedance of the 120‑day deadline also raises doubts as to the proportionality of the pro-

posal. It is not even suitable for achieving the objectives of the amending regulation. The

objective of promoting the accessibility and availability of sustainable plant protection

products is not achieved, since the chosen definition does not ensure that only safe plant

protection products benefit from the intended privilege. The objective of reducing the

burden on national authorities and companies would likewise be promoted by the legal

fiction only if, given the short deadline, the national authorities simply “capitulated” and

did not even attempt an assessment. If, by contrast, the authorities attempt to process

applications within 120 days which must be expected in a state governed by the rule of

law - the pressure created by the proposed provision of tacit authorisation would mean

that the authorities would have to build up and maintain human resources in order to

issue legally secure approval or rejection decisions within the short time available. A

streamlining of the authorities is then not to be expected. Even if relieving effects were

to be expected and the proposal succeeded in paving the way for more sustainable plant

protection products to enter the market, these marginal positive developments would be

disproportionate to the significant risks to the environment and human health described

above.

153 CJEU, judgment of 1 October 2019, C-‑616/17, para. 80. 154 CJEU, judgment of 1 October 2019, C‑-616/17, para. 80; judgment of 9 December 2021,

C‑374/20 P, para. 128; judgment of 22 Jun-e 2023, C‑259/22 P, para. 73.

39

d. Temporary approval of active substances

Similar concerns regarding compatibility with the precautionary principle and the high

level of protection are raised by the proposed relaxation of the requirements for tempo-

rary approval of active substances in accordance with Article 4(7) of Regulation (EC) No

1107/2009.

As outlined above, the planned focus on the absence of “reasonable” alternatives and

on “plant production” creates the risk that this provision could be relied upon even where

less harmful alternatives exist but entail greater effort or higher costs.

As a result, even substances that are extremely harmful to health (e.g. endocrine disrup-

tors) could, despite the availability of alternatives, obtain an approval (albeit temporary)

on economic grounds.

This is difficult to reconcile with the requirements of primary law under Article 191(2)

TFEU, Article 168(1) TFEU, Article 35and 37 CFR. According to the case law of the EU

Courts, environmental and health protection must take precedence over economic con-

siderations and the improvement of plant production.155

e. Extension of grace periods for disposal/use

It is also questionable whether the provision of sales and use-up periods of up to 18 or

even 36 months in cases where the authorisation or approval has been terminated for

reasons of environmental and health protection is compatible with primary law.

These transitional periods, which tolerate continued exposure to substances harmful to

health and the environment, appear disproportionately long and are incompatible with

the high level of protection required by primary law. Furthermore, they are diametrically

opposed to the precautionary principle. As explained above, the precautionary principle

requires that active substances and plant protection products be withdrawn from the

market as soon as there are serious indications of harmful effects on health. This is all

the more true when a decision has already been taken not to renew authorisations and

approvals for reasons of environmental and health protection.

155 See CJEU, judgment of 19 April 2012, C‑221/10 P, para. 99; judgment of 25 April 2024,

C‑309/22, para. 90.

40

The transition periods also violate the principle of proportionality. It is not clear how they

contribute to reducing administrative burdens for authorities and companies. The with-

drawal of a plant protection product authorisation is a simple administrative act. Its ne-

cessity in practice becomes apparent many months in advance. It is therefore not clear

why administration would need several months to implement the withdrawal decision.

Ultimately, the proposal seems to serve solely economic interests and the objective of

improving plant production. That interest must be weighed against the interest in reme-

dying identified risks to human health or the environment. The latter takes precedence.

In light of the foregoing, there are serious doubts as to the conformity of several of the

Commission's proposals with primary law.

D. The Commission’s procedural approach and its lawfulness

Despite the expected significant environmental impacts and contrary to the Interinstitu-

tional Agreement and the Better Regulation Guidelines, the Commission did not conduct

an impact assessment. This constitutes an infringement of the principles of proportional-

ity, equal treatment and the protection of legitimate expectations (see I. below). That

infringement is exacerbated by the decision not to conduct a public consultation (see II.

below).

I. Dispensing with an impact assessment

1. The Commission’s approach

The Commission did not conduct an impact assessment of its initiative. By way of justi-

fication, it states that a full impact assessment would add no value because the proposed

simplification measures are highly technical in nature, there are no viable alternatives to

achieve the objectives, and the proposed measures would not alter core policy objec-

tives. In any event, significant cost savings for industry and the authorities are to be

expected.156

Potential impacts on health and the environment are not mentioned in the section on the

impact assessment. In the subsequent remarks on regulatory fitness and

156 See COM(2025) 1030 final, fn. 5, p. 18.

41

fundamental‑rights relevance, it is merely stated that the proposal would not undermine

the protection of human and animal health and the environment.

Under the heading “Ex‑post evaluations/fitness checks of existing legislation”, the Com-

mission refers to the accompanying Commission Staff Working Document, which alleg-

edly provides a detailed overview of the positive impacts of the proposed amendments.

That overview is said to be based on available data and on information obtained from

the “Call for Evidence” conducted from mid‑September to mid‑October, as well as previ-

ous analyses.157

The Commission Staff Working Document referred to contains an extensive analysis of

the expected cost savings for businesses and the administration. As further positive ef-

fects, it mentions a reduced workload for businesses, faster and simpler decision‑making

by the competent authorities, and greater legal certainty. As regards possible impacts on

health and the environment, it merely states that the protection of human and animal

health would be maintained or even strengthened. There is no indication that the Com-

mission expected any impacts on those legal interests.

2. Infringement of the Interinstitutional Agreement and the Better Regulation

Guidelines

In accordance with point 13 of the Interinstitutional Agreement on Better Law‑Making,158

the Commission will carry out impact assessments of its legislative initiatives that are

expected to have significant economic, environmental or social impacts. In doing so, it

will consult as widely as possible.

The Commission has set out these Better Regulation principles for its work in the Better

Regulation Guidelines159 (hereinafter: “Guidelines”) and the accompanying Toolbox.160

157 See COM(2025) 1030 final, fn. 5, p. 17. 158 Interinstitutional Agreement between the European Parliament, the Council of the European Union and the European Commission on Better Law‑Making of 13 April 2016, OJ L 123, p. 1, available at https://eur-lex.europa.eu/legal-con- tent/de/ALL/?uri=CELEX%3A32016Q0512%2801%29, last accessed on 8 January 2026. 159 European Commission, Better Regulation Guidelines, SWD(2021) 305 final, available at https://commission.europa.eu/document/download/d0bbd77f-bee5-4ee5-b5c4- 6110c7605476_en?filename=swd2021_305_en.pdf, last accessed on 8 January 2026. 160 European Commission, Better Regulation Toolbox, July 2023, available at https://commis- sion.europa.eu/document/download/9c8d2189-8abd-4f29-84e9-abc843cc68e0_en?file- name=BR%20toolbox%20-%20Jul%202023%20-%20FINAL.pdf, last accessed on 6 January 2026.

42

In Chapter 4 of the Guidelines, the Commission notes that an impact assessment is

required for Commission initiatives that are likely to have significant economic, environ-

mental or social impacts, or entail significant expenditure, and where the Commission

has a choice of different policy options.161

In exceptional cases, the Commission may depart from the Guidelines and therefore also

dispense with an impact assessment. The exceptions mentioned include political ur-

gency, emergencies, deadlines in the legislative procedure, as well as the need to protect

security-related or confidential information.162 Where such a derogation is granted, an

analytical document in the form of a Staff Working Document is to be prepared within

three months of the initiative’s adoption, presenting the evidence behind the proposal

and the cost estimates.163

In the present case, the Commission did not carry out an impact assessment and justified

this by stating that such an assessment would add no value due to the technical nature

of the proposed measures, that there were no viable alternatives for achieving the ob-

jective, and that the measures would not alter core policy objectives.

It remains unclear whether the Commission considered that an impact assessment was

not required in the first place because no significant economic, environmental or social

impacts, or significant expenditure, were expected, or whether it claimed a derogation

for itself. The former seems more likely, since in the past the Commission has expressly

mentioned reliance on derogations on grounds of urgency.164 Furthermore, in the present

case the Commission indicated in several places that no negative impacts were to be

expected.

In any event, its approach is not consistent with the Guidelines.

161 See European Commission, Better Regulation Guidelines, fn. 159, p. 30. 162 See European Commission, Better Regulation Toolbox, fn. 160, p. 10; Better Regulation Guidelines, fn. 159, p. 4. 163 See European Commission, Better Regulation Guidelines, fn. 159, p. 30. 164 See, for example, COM(2023) 754 final, p. 10; COM(2024) 139 final, p. 6; COM(2025) 80 final, p. 10; COM(2025) 81 final, p. 14.

43

The proposed amendments are expected to have significant environmental impacts (see

above). Both under the Interinstitutional Agreement and under the Guidelines, an impact

assessment should therefore in principle have been carried out.

Moreover, the reasons relied upon do not constitute a valid justification for dispensing

with an impact assessment by way of derogation. The technical nature of measures may

be relevant to the format of consultation, but not to the need for an impact assessment.

The consequences of measures do not depend on their technical character. The asser-

tion that there were no alternatives for achieving the objective is simply incorrect. The

objective of reducing administrative burdens for businesses and the administration could

have been pursued through a range of measures that ought to have been compared

precisely in terms of their potential social, economic and environmental effects. Finally,

whether the measures alter the core policy objectives could only be assessed after an

impact assessment.

Lastly, the Commission also failed to address the expected impacts on the environment

and health in its accompanying Staff Working Document, although this would have been

required had it relied on a derogation.

3. Legal consequences

a. Violation of the principle of proportionality

Although the rules on impact assessment presumably do not confer any individual

rights,165 the absence of an impact assessment may nevertheless render a legal act un-

lawful by reason of an infringement of the principle of proportionality.166

According to settled case-law, the principle of proportionality forms part of the general

principles of EU law and requires that the means employed by EU law provisions be

appropriate for attaining the legitimate objectives pursued by the legislation at and must

not go beyond what is necessary to achieve them.167

165 General Court, judgment of 31 January 2024, T‑745/20, para. 97. 166 See the legal opinion by Baldon Acovats, Potential legal challenges under EU law to the pro- posed omnibus directive amending the CRSD and CSDD, 23 June 2025, p. 8 et seq. 167 CJEU, judgment of 3 December 2019, C‑482/17, para. 76.

44

Despite the broad margin of discretion, the EU legislature is required to base its decision

on objective criteria and to examine whether the objectives pursued by the measure

chosen can justify the adverse consequences resulting from it.168 This dictum, formulated

with reference to Article 5 of the Protocol (No 2) on the application of the principles of

subsidiarity and proportionality in order to justify negative economic consequences, must

also apply to adverse consequences for health and environment protection, given that

these are enshrined in Art. 11 TFEU and Article 191 TFEU.

In the context of judicial review of the act by the Court of Justice, the EU legislature must

be able to show that it has actually exercised its discretion, which presupposes that all

relevant factors and circumstances of the situation intended to be regulated by that act

have been taken into account.169 This, in turn, requires a sufficient degree of information

to be available in order to assess the proportionality of the measure.170 If the EU legisla-

ture did not have that information, this results in an infringement of the principle of pro-

portionality.171

This is where the impact assessments becomes relevant: the Court of Justice has ex-

pressly held, with reference to points 12 to 15 of the Interinstitutional Agreement, that the

preparation of impact assessments is a step in the legislative process which must be

carried out as soon as a legislative initiative is liable to have significant economic, envi-

ronmental or social impacts.172 The absence of an impact assessment cannot be classi-

fied as an infringement of the principle of proportionality where the EU legislature is in a

specific situation requiring it to dispense with such an assessment and has a sufficient

degree of information enabling it to assess the proportionality of the measure adopted.173

A violation of the principle of proportionality therefore exists, at the very least, where the

EU legislature dispenses with an impact assessment despite expected economic, envi-

ronmental or social consequences and has also not obtained, by other means, the

168 CJEU, judgment of 3 December 2019, C‑482/17, para. 79; judgment of 4 October 2024,

C‑541/20 to C‑555/20, paras 243 and 721. 169 CJEU, judgment of 3 December 2019, C‑482/17, para. 81; judgment of 4 October 2024, C‑541/20 to C‑555/20, paras 244 and 722. 170 CJEU, judgment of 4 October 2024, C‑541/20 to C‑555/20, paras 244 and 722. 171 CJEU, judgment of 4 October 2024, C‑541/20 to C‑555/20, paras 244 and 722. 172 CJEU, judgment of 3 December 2019, C‑482/17, para. 82 et seq.; General Court, judgment of 27 November 2024, para. 270. 173 CJEU, judgment of 3 December 2019, C‑482/17, para. 85.

45

information required to review proportionality.174 Accordingly, the Court of Justice de-

clared an EU act void in an action for annulment brought by several Member States,

because the EU legislature had taken into account the information necessary to assess

the factual situation neither in the impact assessment nor by other means.175

In the present case, the Commission dispensed with an impact assessment and instead

referred to the accompanying Staff Working Document, which was said to set out the

positive effects of the Commission proposal. That document contains no indications of

possible adverse impacts on the environment and human health.

Nor is it apparent that the Commission identified such impacts outside of an impact as-

sessment to take them into account in the exercise of its discretion. The repeated asser-

tion that the high standards for the protection of human and animal health and the envi-

ronment is not substantiated at any point in the Commission’s proposal.

If the Council and the Parliament also refrain from conducting an impact assessment or

otherwise investigating possible environmental and health impacts, it would have to be

assumed that these impacts were simply not examined and therefore could not be taken

into account in the proportionality assessment. Correspondingly, the proportionality as-

sessment in the statement of reasons of the Commission proposal is very brief and is

limited to a single sentence.176

In view of the serious adverse effects on the environment and human health which are

to be expected, their non-consideration constitutes a misuse of discretion and is incom-

patible with the principle of proportionality.

b. Violations of the principles of equal treatment and the protection of legitimate

expectations

Dispensing with an impact assessment contrary to the Guidelines also gives rise to se-

rious doubts as to compliance with the principle of equal treatment.

174 See, on the possibility of relying on other information, among others CJEU, judgement of 13 march 2019, C-128/17, paras 31 et seq., 42; judgment of 3 December 2019, C‑482/17, para. 86 et seq. 175 See CJEU, judgment of 4 October 2024, C‑541/20 to C‑555/20, para. 738. 176 “The initiative does not go beyond what is necessary to achieve the objectives of simplifica- tion and burden reduction without lowering the protection of human health and environment.”, COM(2025) 1030 final, fn. 5, p. 17.

46

According to the case-law of the Court of Justice, internal measures may form rules of

practice from which the administration may not depart in an individual case without giving

reasons that are compatible with the principles of equal treatment or the protection of

legitimate expectations. Such measures therefore constitute a general and the officials

and other staff concerned may invoke their illegality in support of an action against indi-

vidual measures adopted on their basis.177

That case-law can likewise be applied to the Better Regulation Guidelines.178 As the Eu-

ropean Ombudsman correctly points out, stakeholders rely on the Commission’s Better

Regulation rules and plan their activities in accordance with them. They expect to have

access to the Commission’s impact assessments and to be able to submit their views on

those assessments as early as possible.179

Accordingly, with regard to the general legal principles of equal treatment and the pro-

tection of legitimate expectations, the failure to carry out an impact assessment, contrary

to the guidelines, calls into question the lawfulness of the Commission’s approach.

c. Infringement of Article 168(1) TFEU

By virtue of the horizontal clause in Article 168(1) TFEU, all measures must be subjected

to a health impact assessment which must take into account the above-mentioned stand-

ard of achieving a high level of health protection, for which all developments based on

scientific findings must be taken into account.180 A health impact assessment requires

that all measures and projects be evaluated with regard to their potential effects on the

health of the individual and/or of the population.181

It is not apparent that the Commission identified the effects of its proposal on human

health. Apart from the repeated assertion that the proposal would not lower the level of

177 CJEU, judgment of 28 June 2005, C‑189/02 et al., para. 209 et seq. 178 See also European Ombudsman, Recommendation on the European Commission’s compli- ance with ‘Better Regulation’ rules and other procedural requirements in preparing legislative proposals that it considered to be urgent (983/2025/MAS – the “Omnibus” case, 2031/2024/VB - the “migration” case, and 1379/2024/MIK - the “CAP” case, recommendation of 25 November 2025, point 38. 179 European Ombudsman, fn. 178, cited above. 180 Schmidt am Busch, in: Grabitz/Hilf/Nettesheim, EUV/AEUV, 85th update (May 2025), Article 168 TFEU, para. 93. 181 Schmidt am Busch, in: Grabitz/Hilf/Nettesheim, EUV/AEUV, 85th update (May 2025), Article 168 TFEU, para. 94.

47

protection of human or animal health or the environment, there are no comments on this

subject.

The failure to carry out an impact assessment despite the expected significant impacts

on human health, and thus contrary to the Guidelines, is therefore also contrary to EU

law because of the obligation arising from Article 168(1) TFEU.

II. Insufficient stakeholder consultation

1. Approach of the Commission

The Commission did not conduct a public consultation, arguing that that the initiative did

not aim to alter the objectives of the legislation and addresses technical adjustments

aimed at efficiency gains within the existing framework.182

Instead, the Commission stated that it had carried out a proportionate, targeted stake-

holder consultation. To that end, it relied on ongoing exchange formats with Member

States and stakeholders as well as recent evaluations. In addition, in July 2025 it con-

ducted a targeted Implementation Dialogue on biocides. Furthermore, a “Call for Evi-

dence” was carried out, which generated a total of around 6,500 responses, including

319 position papers with detailed technical input. All of this was said to have been incor-

porated into the problem definition, the prioritisation of options and the safeguards.183

The Commission sets out the positions of the various stakeholder groups, clustered by

topic, in the Commission proposal itself on approximately one page, concluding that

stakeholders advocate a risk-based simplification which maintains a high level of health,

environmental and consumer protection and is underpinned by transparency, independ-

ent science and strong enforcement.

The Staff Working Document contains a more detailed presentation of the stakeholders’

positions, noting at several points that citizens and NGOs expressed the concern that

the level of protection could be reduced.184

182 See SWD(2025) 1030 final, fn. 6, p. 56. 183 See COM(2025) 1030 final, fn. 5, p. 17; SWD(2025) 1030 final, fn. 6, p. 56. 184 See SWD(2025) 1030 final, fn. 6, p. 56 et seq.

48

It is not comprehensible whether and how that concern was taken into account and ad-

dressed in the drafting of the Commission’s proposal.

2. Infringement of procedural requirements as well as the Interinstitutional

Agreement and the Better Regulation Guidelines

Pursuant to Article 11 (3) TEU, the Commission is required to conduct borad consulta-

tions with the parties concerned.

Article 2 of Protocol (No 2) on the application of the principles of subsidiarity and propor-

tionality provides that the Commission consult widely before proposing a legislative act.

In cases of exceptional urgency, it shall not conduct such consultations and give reasons

for its decision in its proposal.

Similarly, point 19 of the Interinstitutional Agreement provides that, before adopting a

proposal, the Commission shall carry out public consultations in an open and transparent

way and ensure that the modalities and time limits of those public consultations allow for

the widest possible participation.

Under the Guidelines, a public consultation of at least 12 weeks is required where an

initiative is prepared which is accompanied by an impact assessment. For initiatives that

are not accompanied by a public consultation, a Call for Evidence is planned to give

stakeholders four weeks to provide their feedback.185

The Commission merely launched the Call for Evidence and otherwise asserted that it

has taken into account existing findings from its exchanges with interest groups.

The findings already available from the past cannot replace the consultations, as they

cannot relate to the Commission’s project due to the passage of time.

The Commission limited itself to obtaining feedback in the Call for Evidence. That is con-

sistent with the approach not to conduct an impact assessment. However, it illustrates

the effects of the failure to conduct an impact assessment for stakeholder participation:

instead of being able to comment on the initiative over a 12-week period and on the basis

of extensive material, stakeholders were confined to commenting within four weeks on

185 See European Commission, Better Regulation Guidelines, fn. 159, pp. 15-16.

49

the overall five-page Call for Evidence document. 186 That document contained only a

brief overview of the planned measures and of the thematic areas to be addressed. The

Call for Evidence did not provide any information on key measures such as the removal

of the time limit on the approval of active substances.

This made it impossible to submit a targeted statement on the planned project.

3. Legal consequence: violation of the principles of proportionality, equal treat-

ment and the protection of legitimate expectations

The General Court extends the case-law on the relevance of impact assessments to the

conduct of wide consultations which are provided for in Protocol (No 2) on the application

of the principles of subsidiarity and proportionality and in the Interinstitutional Agree-

ment.187

The above-mentioned violation of the principles of proportionality, equal treatment and

the protection of legitimate expectations by refraining from conducting an impact assess-

ment is therefore exacerbated by the subsequent failure to conduct a public consultation

which is actually provided for in the Guidelines prior to an initiative such as the present

one.

Furthermore, it cannot be ruled out that the absence of the consultations provided for in

the Guidelines can be challenged as an infringement of essential procedural require-

ments within the meaning of Article 263(2) TFEU.188

However, such an infringement is only to be assumed where the failure to conduct the

consultations and hearings results in the Commission not having the necessary infor-

mation at its disposal.189 The infringement therefore merges into the violation of the

186 Available at https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14824- Food-and-feed-safety-simplification-omnibus_en, last accessed on 9 January 2026. 187 General Court, judgment of 27 November 2024, T‑526/19, paras 287–288 and 322. 188 See the Court’s assessment in General Court, judgment of 27 November 2024...; see also the legal opinion by Baldon Acovats, Potential l...us directive amending the CRSD and CSDD, 23 June 2025, p. 20 et seq. 189 See the Court’s assessment in General Court, judgment of 27 November 2024, T‑526/19, para. 280.

50

principles of proportionality, equal treatment and the protection of legitimate expectations

already described above.190

III. Statement of reasons of the proposal

Article 168(1) TFEU gives rise to an obligation to reflect the health-policy considerations

to be undertaken, pursuant to Article 296(2) TFEU, in the statement of reasons. This

requires that the statement of reasons disclose the key considerations, so that it can be

reviewed whether the health-protection requirements were observed and correctly

weighed.191

This did not occur, since the identification of the possible consequences for health was

already omitted. The approach therefore also contravenes Article 296(2) TFEU in con-

junction with Article 168(1) TFEU.

E. Conclusion and outlook

The amendments provided for in the Commission proposal significantly weaken the pro-

tection of human health and the environment under the EU Legislation on Plant Protec-

tion Products.

In addition to the extensive removal of time limits on active substance approvals, the

freezing of the state of scientific knowledge at the time of approval of the active sub-

stance and the envisaged privileging of certain substances and substance groups, it is

in particular the extension of grace periods which leads to a lowering of the level of pro-

tection.

The Commission proposal violates higher-ranking EU law in several respects, both in

terms of its content and the procedure followed in its preparation. It is compatible neither

with the precautionary principle laid down in Article 191(2) TFEU, nor does the Union

fulfil its positive obligations guaranteed in the Charter of Fundamental Rights with the

amended Regulation (EC) No 1107/2009. From a procedural point of view, the failure to

carry out an impact assessment and the insufficient statement of reasons due to the lack

190 See CJEU, judgment of 3 December 2019, C‑482/17, para. 79; judgment of 4 October 2024, C‑541/20 to C‑555/20, para. 689. 191 Schmidt am Busch, in: Grabitz/Hilf/Nettesheim, EUV/AEUV, 85th update (May 2025), Article 168 TFEU, para. 98.

51

of considerations on the effects on health lead to a violation of the principle of propor-

tionality as well as of Article 168(1) TFEU and Article 296(2) TFEU.

Considering past experience with the so-called Omnibus packages, it is to be expected

that the ordinary legislative procedure under Article 294 TFEU will be further accelerated

by a whole series of measures, so that there can scarcely be any expectation of sub-

stantive debate in plenary of the European Parliament.

‘Food and feed safety omnibus’

threatens EU pesticide rules

Position paper- 27/01/2026

Overview The Commission’s proposal for a “food and feed safety omnibus” seriously weakens the EU's

current pesticide rules, which aim to protect health and the environment.

● It removes the limited approvals and the procedure for systematic, regular toxicity reviews

that incorporate new scientific evidence and instead makes the unlimited approval of

pesticides the default.

● It restricts Member States’ ability to use the most recent scientific evidence when

authorising pesticide products at the national level.

● It extends grace periods for harmful pesticides, allowing these substances to remain on the

market for much longer before they are banned.

● It broadens the possibility of approving harmful pesticides by derogation from the safety

approval criteria.

● It introduces a poor definition of biocontrol, which could include synthetically produced

substances that may have unknown or harmful effects.

● It broadens the possibility of using drones for pesticide application.

The proposal undermines the primary purpose of the EU pesticide regulation, which is to ensure a

high level of protection of human health and the environment. It was found to breach EU primary law, notably the precautionary principle and the principle of proportionality.

The proposal also contradicts the EU’s goal of moving away from a pesticide-dependent

agricultural model. Far from promoting biocontrols, it functions as a deregulation “Trojan horse”

for hazardous pesticides and disregards citizens’ repeated calls for stricter pesticide rules and

better protection of health and the environment.

We urge the European Parliament and Council to oppose and reject the proposal.

1

Position Paper- PAN Europe

Introduction

The European Commission’s proposal for a ‘food and feed safety omnibus’ would fundamentally

undermine the current system for approving and authorising pesticide active substances and

pesticide products, as established under the EU Pesticide Regulation (1107/2009).

In force since 2011, the Pesticide Regulation requires that pesticides must have no harmful effects on human or animal health, and no unacceptable effects on the environment. To meet

these requirements, pesticides are subject to a rigorous assessment and regular re-evaluation to

be placed or remain on the market. This is a crucial step as pesticides are intentionally designed to

be highly toxic to target organisms but are inevitably toxic to other non-target organisms, such as

bees, fish, amphibians, as well as mammals, including humans.

According to the Commission itself, the existing Regulation has been largely effective in protecting human health and the environment, and has improved protection thanks to the stringency of its approval criteria and the mandatory regular reviews of all active substances. It

is through these periodic reviews, based on the latest scientific evidence, that previously unknown

toxic effects on non-target species, including humans, have been identified, leading to the banning

of pesticides and their removal from the market. Indeed, some of the most toxic chemicals ever

intentionally released into the environment have been pesticides. Yet, the Commission’s proposal

to change the current system represents a serious step backwards for pesticide regulation in the

EU, potentially allowing hazardous substances to remain on the market indefinitely.

Indeed, the proposal is to make unlimited approval periods for active substances the norm, while limited approvals would become the exception, applicable only to a few active substances.

This shift is combined with measures that would:

● restrict Member States’ ability to rely on the latest scientific evidence in product

authorisation decisions,

● extend grace periods for substances that should no longer be approved, and

● make it easier to reapprove substances that do not meet safety criteria.

Taken together, these changes would hamper the identification of hazardous properties for a wide range of pesticides and delay, or even circumvent, their ban, even once risks are known.

The proposal undermines the primary objective of Regulation 1107/2009, namely to ensure a high

level of protection of human health and the environment from pesticides based on the

precautionary principle. Therefore, the Commission’s proposal was found to violate EU primary law in both substance and procedure in a legal opinion. It is considered incompatible with the

precautionary principle under Article 191(2) TFEU and fails to meet the Union’s positive

obligations under the Charter of Fundamental Rights as applied to Regulation (EC) No 1107/2009.

2

Position Paper- PAN Europe

Procedurally, the absence of an impact assessment and inadequate reasoning breach the

principles of proportionality and Articles 168(1) and 296(2) TFEU.

It also fundamentally contradicts the EU’s objective of transitioning away from an agricultural

model that is highly dependent on chemical pesticides. While the initial intention behind the

revision was to facilitate market access for biocontrol products, the current proposal acts as a

Trojan horse for deregulating all pesticides, including the hazardous ones. This is not a reform to

support safer alternatives, but a giveaway to the agro-industry, shaped by pesticide industry

demands1. Rather than accelerating the transition to sustainable farming, the proposal reinforces chemical dependency and locks the EU into a pesticide-driven agricultural model, jeopardising the resilience of farming systems and long-term food security. This reflects a

troubling lack of policy coherence. It contradicts the EU’s Green Deal and Farm to Fork objective

to reduce pesticide dependency, use and risks by 2030 and is at odds with the findings and

recommendations of the European Commission’s own REFIT evaluation, as well as repeated

reports of the European Court of Auditors. These have consistently concluded that the core

problem lies not in overly stringent pesticide rules, but in weak implementation, insufficient

enforcement, inadequate risk monitoring, and the failure to translate existing legal requirements

into measurable reductions in pesticide use and risks.

Moreover, the proposal runs counter to citizens’ long-standing and consistent demands for stricter pesticide regulation and the phase-out of synthetic pesticides. These demands are

echoed by civil society organisations representing children and youth, which warn that weakening

pesticide rules would expose children to serious and preventable health risks, violating the rights

and futures of our youngest citizens.

The proposal also blatantly disregards the recent call from the scientific community to strengthen the implementation of existing pesticide legislation to better protect the

environment, biodiversity and citizens from the harmful effects of pesticides.

Finally, the proposal has been put forward without an impact assessment and is wholly

disproportionate to the stated objective of the omnibus exercise, which is to ‘simplify’ regulation,

while at the same time maintaining a high level of protection.

1 Feedback from: Bayer AG (particularly “Data Call-In” p.4); Feedback from: BASF (cf particularly p.4).

3

Position Paper- PAN Europe

I. Main concerns

a) Unlimited approval as the default

Under the current rules, active substances are approved for a limited period: up to ten years for an

initial approval and up to fifteen years for renewals. Exceptions to this general rule are candidates

for substitution, i.e. more hazardous substances, which must be approved or renewed for no

longer than seven years, and substances approved by derogation to the safety criteria (Article

4(7)), which are limited to five years.2

The Commission proposes to make unlimited approval the default for active substances, with

limited approval becoming the exception. This exception would cover three categories:

● candidates for substitution, which represent only around 10% of approved substances;

● substances approved by derogation from the safety criteria under Article 4(7) due to a

serious danger to plant health, of which none are currently approved;

● and substances subject to limited approvals/renewals due to uncertainties or data gaps.

The scope of this third exception is particularly unclear and would grant the Commission broad

discretion in determining which substances fall within it. Moreover, unlike candidates for

substitution and substances approved by derogation, which would be approved for seven and five

years respectively, there is no time limit for substances subject to limited approvals or renewals

due to uncertainties or data gaps. This leaves the decision at the discretion of the Commission and

Member States, both in determining which substances are concerned and in deciding the duration

of approval, within the context of comitology discussions.

Practically, if the proposal were adopted as it stands, substances subject to an ongoing renewal

procedure, or for which a renewal application has been submitted, would complete the renewal

process before any decision is taken on whether approval is limited or unlimited. By contrast, for

substances for which no renewal procedure is ongoing, unlimited approval would be granted automatically. According to our network’s estimates, this would cover more than 50 synthetic active substances, among them certain PFAS substances, the suspected neurotoxic and

carcinogenic fungicide folpet, and captan, suspected to be carcinogenic and highly toxic to wildlife.

Importantly, by making unlimited approval the default, the proposal reverses the burden of proof. Under the current system, companies must periodically demonstrate the safety of their

active substances through renewal procedures and the submission of new scientific data. Where

the available evidence does not sufficiently demonstrate the safety of a pesticide active substance,

approval cannot be granted or renewed. Moreover, the applications for approvals submitted by

the companies have to include scientific peer-reviewed literature of the last ten years on the

2 Exceptions also apply to low-risk substances, which receive direct approval for 15 years, and to basic substances, which are approved indefinitely.

4

Position Paper- PAN Europe

effects of the active substance and its metabolites on health, environment and non-target species.

This system has led to the identification and banning of 54 harmful pesticide substances since 20113. These include the brain-harming chlorpyrifos, the bee-toxic neonicotinoids, the reprotoxic,

endocrine disruptor mancozeb and the PFAS endocrine disruptor flufenacet. Under the proposal,

the burden of proof would shift from industry to regulators to identify and assess potentially

harmful substances based on existing suspicions of harm. This process would depend largely on

publicly available literature and monitoring, shifting the costs to the public rather than the

industry.

Under the proposal, indeed, the Commission is required, periodically, to determine which other

substances (not falling under one of these three categories) should be subject to a renewal

procedure. It should take into account health or environmental concerns, new scientific or

technical knowledge, available monitoring data, and requests from Member States. While this

identification process must take place within three years following the adoption of new criteria or

data requirements, the Commission would retain discretion over the deadline for the submission

of data, the designation of the rapporteur Member State, and the expiry date of the approval.

Moreover, the Commission would not be obliged to respond to review requests from Member

States. Despite the Commission’s claim that this would increase agility and improve resource

allocation, the proposal once again affords the Commission broad discretion. It risks resulting in

very lengthy assessment procedures for substances for which concerns have already been

identified. Last, the implementing acts identifying the active substances that need to undergo a

renewal procedure are to be adopted by Member States, creating a risk of political influence.

One argument put forward by the Commission to justify this new system is that new active

substances are expected to have improved toxicological and ecotoxicological properties. However,

reality presents a different picture. Among the new active substances currently under assessment and awaiting approval, several exhibit harmful properties, such as the PFAS and

potential TFA precursor fluazaindolizine or the suspected carcinogenic metyltetraprole. Likewise,

‘new' substances recently put on the market, such as the bee-toxic sulfloxaflor, have been found to

be harmful and restricted quickly after their first approval.

b) Restrictions on Member States’ use of the latest science

For national authorisations of products containing substances with unlimited approval, the

maximum duration would be fifteen years. However, the proposal introduces a highly restrictive

interpretation of what constitutes the “latest scientific and technical knowledge” for the purposes of

product authorisation, directly contradicting recent EU case law. A recent preliminary ruling by

the Court of Justice of the European Union clarified that Member States are obliged to consider

the most up-to-date scientific evidence when assessing the authorisation of pesticide products.

3The figure of 54 included 19 CfS and 35 non-CfS, including one prohibited under Article 21 (see annex, Générations Futures, PAN Europe).

5

Position Paper- PAN Europe

This implies that the latest scientific evidence must be taken into account, even in the absence of

any guidance document. In another recent ruling, the French State was recently held accountable

for ecological harm resulting from outdated and inadequate pesticide environmental risk

assessments, and obliged to review authorisation in light of the latest science. Under the amended

text, however, Member States would be required to rely exclusively on “the last assessment conducted at EU level” for the active substance, even if that assessment is already decades old.

In other words, instead of strengthening protection and aligning the Regulation with EU case law

by ensuring pesticide products are evaluated against the most recent science, the Commission is

proposing a deliberate weakening of the law. This is unacceptable.

In practice, this would severely limit the ability of Member States to respond to emerging science.

Because active substances would be granted unlimited approval, EU-level assessments may be

decades old by the time a national product authorisation is granted. By freezing the scientific basis

of evaluations at the date of the most recent EU assessment, even if this was done over a decade

ago, Member States would be prevented from taking into account new peer-reviewed studies or

other emerging evidence of risks. In cases where concerns arise, Member States would be

required to notify the Commission so that an EU-level assessment can be initiated.

c) Extended grace periods for harmful substances

The proposal extends grace periods for substances that risk assessments indicate should no longer

be approved. Currently, these substances may remain on the market for up to eighteen months

when non-renewal does not concern health or environmental protection. However, in practice,

harmful substances such as endocrine disruptors have still been granted grace periods of 9 to 18

months (e.g., the recent case of flufenacet), in clear violation of the Regulation.

Under the new proposed rules, the Commission’s proposal would legalise these 18 months for substances banned due to health and environmental concerns, and even extend the grace period up to three years “when there are no alternatives” (one year allowed for sale and distribution and

two more years for disposal, storage, or use). This contradicts Recital 24 of the Regulation and

established case law, which state that the protection of human health and the environment must

always take precedence over plant production. Moreover, applicants are not required to submit

information on available alternatives in the context of renewal procedures, unless they apply for

approval by derogation under Article 4(7). As a result, the decision to grant an extended grace

period of up to three years would be largely arbitrary and politically driven. Immediate withdrawal

of substances would only occur in cases of “immediate and serious concerns” for human health or the

environment, but this concept is not defined. It therefore appears that the standard would be to

grant a long grace period to substances that are prohibited because they are hazardous.

6

Position Paper- PAN Europe

d) Easier derogations from safety criteria

Under the current Regulation, Article 4(7) allows for a very narrow and exceptional derogation: an

active substance that does not meet the safety approval criteria may still be approved for a strictly

limited period of five years, but only if it can be demonstrated, based on documented evidence that

there is a serious danger to plant health which cannot be contained by any other available means,

including non-chemical alternatives. In practice, this derogation has never been used, because in

no case has it been proven that an active substance was truly essential and that no alternative

solution existed.

The proposal “clarifies” that Article 4(7) cannot apply to certain highly hazardous pesticides:

Carcinogenic (Categories 1A & 1B but only those with “no threshold”), Mutagenic (Categories

1A/1B) and Toxic for reproduction (Category 1A, based on data on humans), Persistent Organic

Pollutant (POP), Persistent, Bioaccumulative and Toxic (PBT), or very Persistent and very

Bioaccumulative (vPvB) substances. This restriction, however, does not cover

endocrine-disrupting substances, some carcinogenic category B and toxic to reproduction

category 1B (presumed to be toxic for human health based on animal studies), which fall under the

cut-off criteria in the same way as substances classified under Carcinogens and Mutagens 1A/1B,

POP, PBT, or vPvB. Moreover, there is currently no scientific evidence that can be relied upon to

set a safe threshold value for endocrine disruptors, nor toxic to reproduction according to animal

studies4. The Commission is “normalising” a long-standing industry claim that carcinogenic or

reprotoxic pesticides can be assigned safe exposure thresholds, rather than being removed from

the market altogether.

Moreover, while this scope’s restriction appears positive at first glance, the drafting

simultaneously broadens the scope of Article 4(7) by introducing the concept of substances

necessary not only for plant health but also for plant production. This means the derogation could be invoked to approve harmful substances when production (yield) levels for a specific crop are at risk. This amendment runs directly against Recital 24, which states that the objective of

ensuring a high level of protection for human and animal health and the environment must take

priority over the objective of improving plant production. Moreover, how this would be assessed in

practice remains unclear. Farmers are expected to transition from intensive synthetic pesticide

use to integrated pest management practices, which, while agriculturally environmentally

beneficial, require long-term evaluation and may not provide immediate yield benefits. The

assessment of “necessity” for derogations should not rely on narrow yield comparisons that focus

only on immediate output, without considering the broader context of long-term soil health,

biodiversity, and overall farm resilience and food security.

4 Zoeller RT, Brown TR, Doan LL, Gore AC, Skakkebaek NE, Soto AM, Woodruff TJ, Vom Saal FS.

Endocrine-disrupting chemicals and public health protection: a statement of principles from The Endocrine

Society. Endocrinology. 2012 Sep;153(9):4097-110. doi: 10.1210/en.2012-1422.

7

Position Paper- PAN Europe

Last, the proposal waives the obligation on the Member States authorising plant protection

products containing active substances approved under Article 4(7) to draw up a phasing-out plan.

e) Biocontrol substances

The proposal includes several measures aimed at facilitating market access for biocontrol

products. This objective is welcome, as biocontrol plays a key role in Integrated Pest Management

and is essential for phasing out synthetic pesticides5. At the same time, several elements of the

proposed changes risk compromising safety and data transparency. Accelerated access for

biocontrol products should be pursued through strengthening assessment capacity, maintaining

robust risk evaluation, and ensuring comprehensive monitoring.

The proposal introduces a problematic definition of biocontrol active substances. It describes

them as micro-organisms, inorganic substances occurring in nature (excluding heavy metals and

their salts), or substances of biological origin or produced synthetically that are functionally

identical and structurally similar to natural substances. However, it is necessary to ensure that

biocontrol remains restricted to substances that are truly natural, and therefore, “identical” must

be clearly defined. It should require that the substance contains only naturally occurring amino

acids, that its three-dimensional molecular structure is identical to the natural substance, that its

function is identical, and that it is biologically degraded through predictable, natural pathways.

Without these clarifications, there is a risk of widening the category to synthetically produced

substances that may have unknown or harmful effects.

The Commission also proposes requiring Member States to prioritise the assessment of biocontrol

substances. This should not result in further delays in the evaluation of synthetic substances.

Moreover, the Commission proposes provisional authorisation for products containing an active

biocontrol substance not yet approved. While faster access to biocontrol products is desirable,

natural substances, particularly microbial organisms, can present risks. Microbials have the

potential to survive, multiply, move, and colonise new environments, with possible unintended

impacts on biodiversity. These characteristics make a robust risk assessment essential prior to

authorising their use.

Finally, the text removes the obligation to keep records of biocontrol product use. Such records

are critical to monitor trends, assess environmental and health impacts, and inform policy

decisions. Even natural substances can have unexpected harmful effects, and comprehensive data

collection is essential for timely detection and management of any risks.

5 Will the Commission’s plan to fast-track biocontrol miss the mark for pesticide reductions? (Oct. 2025)

8

Position Paper- PAN Europe

f) Low-risk substances

The criteria for identifying low-risk substances are being relaxed. While hazard-based criteria,

such as classification as carcinogenic, mutagenic, or toxic to reproduction (CMR), or the presence

of neurotoxic effects, must still be met, other requirements are being removed. These include the

obligation to provide information on co-formulants and the requirement to apply for maximum

residue levels (MRLs). Moreover, the proposal introduces the possibility of requesting a change in

the status of an already approved active substance to low-risk.

g) Mutual recognition

The system of mutual recognition implies that authorisations to a pesticide product granted by

one Member State should, in principle, be accepted by the other Member States of the same

geographical area. This is unless there are concerns relating to human health or the environment.

The proposal introduces several changes to the system to improve its implementation. Positively,

the proposal requires that a product must actually be placed on the market in the reference

Member State, helping prevent abuse of the system to circumvent higher fees, by placing the

product authorisation application in one Member State while selling the product in another.

However, the proposal also makes it easier for official or scientific bodies and professional agricultural organisations to apply for mutual recognition without demonstrating public interest, while it expands the types of eligible uses, and reduces documentation and assessment requirements for certain applications (for biocontrol, submitted by official or scientific bodies

involved in agricultural activities or professional agricultural organisations or submitted for minor

uses). Lastly, the proposal introduces the possibility for detailed implementation rules to be

adopted by the EU Commission via an implementing regulation. It remains unclear what these

rules would entail.

h) Minor uses

A minor use is defined as a use on a crop that is either not widely grown in a Member State or

widely grown but addressing an exceptional plant protection need. Under the current pesticide

regulation, uses meeting this definition benefit from a simplified authorisation procedure: an

existing pesticide authorisation may be extended to cover minor uses if certain conditions are met,

including a demonstrated public interest, without requiring a full comprehensive assessment.

However, this system is increasingly misused due to the lack of a clear and harmonised definition

of minor uses, leading to inconsistent application across Member States and enabling some

applicants to circumvent standard authorisation requirements by falsely claiming a minor use. The Commission proposal aims to increase the availability of pesticides for minor uses, namely by removing the public interest requirement and obliging Member States to facilitate or encourage

9

Position Paper- PAN Europe

extensions for minor uses. These changes raise concerns that they would weaken the

requirements for minor uses without addressing the underlying problem of an inconsistent,

non-harmonised definition and the ongoing misuse of minor-uses.

i) Application of drones

Under Directive 2009/128/EC on the sustainable use of pesticides, aerial spraying of pesticides by

aircraft is currently prohibited because of its devastating impacts to local communities and

ecosystems. Derogation is only possible on an individual basis and under certain conditions, for

professional users who have submitted a formal request. The Commission proposes allowing the use of certain drones without needing individual derogations, provided the pesticide has been explicitly authorised for drone applications under the Pesticide Regulation (1107/2009).

The use of drones for pesticide application requires a comprehensive scientific assessment. Aerial

spraying by drones increases the risk of pesticide drift, leading to higher exposure of the

environment and nearby populations. Small load capacities may result in pesticides being applied

at higher concentrations, which can have more serious impacts on soil biodiversity, food safety,

and operator and citizen health. Risk levels are further influenced by weather conditions, flight

height, speed, and crop type. Therefore, drones should only be considered for targeted application

of natural, low-risk pesticides as a last resort, after all preventive Integrated Pest Management

(IPM) measures have been implemented. Any derogations must be strictly recorded by Member

States, and the public should be informed in advance, in line with the Directive.

j) Residues of pesticides in food

When pesticides are banned in the EU due to their harmful effects on human health or the

environment, their residues are not automatically prohibited in all food products. In many cases,

residues continue to be allowed in certain imported products to accommodate trade demands.

Currently, residues of 67 EU-banned (PIC) pesticides are permitted in specific imported products6.

The omnibus proposal introduces a timid change to this practice, but it remains wholly insufficient.

The proposal would remove the term “import tolerance” and replace it with “Good Agricultural

Practices (GAPs) implemented in a third country” (i.e., recommended, authorised, or registered use

of a pesticide). However, this cosmetic change does little in practice, as the possibility to apply for

authorisation to import products containing residues of EU-banned pesticides would still remain.

The notable change is that the Commission would now be empowered to reject such applications or revoke existing Maximum Residue Levels (MRLs) for EU-banned pesticides when the active

6 Report, Double Standards, Double Risks, Annex II (p. 58).

10

Position Paper- PAN Europe

substance meets one of the “cut-off” criteria of the Pesticide Regulation (1107/2009)7. However,

this measure remains very limited and insufficient. First, it is framed as a derogation, which must

be interpreted narrowly, i.e., the general practice would still allow residues in imported food.

Second, the proposal conditions revocation on the outcome of an impact assessment. Finally, the

measure would apply only to a small proportion of EU-banned pesticides since ‘cut-off’ pesticides

represent just a small fraction8 of the EU-banned pesticides. As a result, through trade, the EU will

continue to allow the use of hazardous pesticides in the production of food imported into the EU,

turning a blind eye to the impacts on local communities, water resources, and biodiversity where

these chemicals are used. European farmers face unfair competition, as products grown with these

toxic substances can be imported at lower costs, while European consumers are exposed to

residues of dangerous pesticides.

Moreover, these trade-related changes should not obscure other problematic aspects of the proposal. In particular, the proposal allows for transitional measures to keep products on the

market with MRLs that are to be deleted, even when the reason for deletion is related to human

health. The obligation to review temporary MRLs every ten years based on monitoring data is

being removed from the regulation.

II. Recommendations PAN Europe calls on the European Parliament and the Council to oppose and reject the “Food and Feed Safety Omnibus” proposal. Rather than deregulating pesticides, the EU must urgently

implement the existing Regulation effectively. The current legal framework already provides a

robust system for identifying and banning toxic pesticides, but it has been undermined by weak

implementation.

In its 2020 report on the assessment of the implementation of the Pesticide Regulation (REFIT),

the European Commission provided recommendations which we consider the way forward today

to address procedural delays and inefficiencies.

1. Member States should only accept complete, high-quality dossiers as admissible for both

first-time and renewal approvals of active substances, as well as product authorisations.

2. Member States should review and adjust fees to fully cover costs and ensure they directly

fund the authorities performing the work. Some Member States charge fees that do not

fully cover their costs, and often the fees are not ring-fenced for the responsible

authorities, resulting in insufficient resources.

8Report, Double Standards, Double Risks, Annex II (p. 58).

7 These are substances that are Carcinogenic, Mutagenic and Toxic for reproduction (CMR) Categories

1A/1B, Endocrine Disruptors for humans or non-target organism, Persistent Organic Pollutant (POP),

Persistent, Bioaccumulative and Toxic (PBT), or very Persistent and very Bioaccumulative (vPvB).

11

Position Paper- PAN Europe

3. The Commission should open infringement proceedings against Member States that fail to

enforce the regulation.

4. Risk assessment should only continue if active substances do not meet the cut-off criteria

or if at least one derogation option is invoked.

PAN Europe has also identified urgent priorities that must be addressed within the current

regulatory framework to improve the protection of human health and the environment from

pesticides.

Contact details:

Dr Angeliki Lysimachou, Head of Science and Policy, [email protected], +32 2 318 62 55

Salomé Roynel, Policy Officer, [email protected], +32 451 02 31 33 PAN Europe, Rue de la Pacification 67, 1000, Brussels, Belgium Who we are | PAN Europe

Pesticide Action Network (PAN Europe) is a network of NGOs working to reduce the use of

hazardous pesticides and have them replaced with ecologically sound alternatives. We work to

eliminate dependency on chemical pesticides and to support safe sustainable pest control

methods. Our network brings together over 45 consumer, public health and environmental

organisations and women’s groups from across Europe.

Co-funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the

European Union or CINEA. Neither the European Union nor the granting authority can be held responsible for them.

12

GEULEN & KLINGER

Rechtsanwälte

IBAN: DE97 1604 0000 0570 6163 00 BIC: COBADEFFXXX Kontoinhaber: Prof. Dr. Remo Klinger

USt-ID Nummer: DE 454 992 784

Prof. Dr. Remo Klinger

Dr. Caroline Douhaire LL.M.

Dr. Karoline Borwieck

David Krebs

Lukas Rhiel

Mathea Schmitt LL.M.

Yannis Haug-Jurgan

10719 Berlin, Fasanenstraße 42

Telefon +49/ 30 / 88 47 28-0

Telefax +49/ 30 / 88 47 28-10

E-Mail [email protected]

[email protected]

www.geulenklinger.com

Legal Opinion

on

The Lawfulness of the Planned Amendments through the

„Food and Feed Safety Omnibus“

by

Dr. Caroline Douhaire LL.M.

Yannis Haug-Jurgan

GEULEN & KLINGER Rechtsanwälte

Prepared on behalf of

Aurelia Stiftung, ClientEarth gGmbH, Deutsche Umwelthilfe e.V., Deutscher Naturschutz-

ring (DNR) e.V., foodwatch e.V., Pestizid Aktions-Netzwerk e.V. (PAN Germany) and Um-

weltinstitut München e.V.

20 January 2026

Table of Contents

A. Background and questions presented .................................................................... 1

B. Executive summary ............................................................................................... 2

C. The Commission initiative and its legality ............................................................... 4

I. Classification of the key proposed amendments ................................................ 4

1. Removal of time limits on approvals of active substances ............................... 4

a. Abolition of the current periodic review ........................................................ 4

b. No compensation through Articles 18, 18a and 21 of Regulation (EC) No

1107/2009 .......................................................................................................... 6

c. Ad hoc review under Article 21 of Regulation (EC) No 1107/2009 ............... 9

d. Adjustment of the duration of national product authorisations .................... 10

2. Simplification of temporary approvals of active substances .......................... 11

3. Extended privileges and exemptions for certain substances ......................... 13

a. Biocontrol substances ............................................................................... 13

b. Privileges for low-risk active substances ................................................... 17

c. Privileges for basic substances ................................................................. 17

d. Privileges for plant protection products required to prevent the establishment

or spread of certain quarantine pests ............................................................... 19

4. Possibility for the RMS to seek EFSA support ............................................... 20

5. Extension of grace periods ........................................................................... 20

a. Rules on transitional periods at active substance level .............................. 20

b. Rules on transitional periods at national level ............................................ 21

6. Freezing the state of scientific knowledge ..................................................... 22

7. Adjustments to the procedure for mutual recognition .................................... 24

8. Treatment of treated seed and plant reproductive material ........................... 25

9. Easier market access for minor uses ............................................................ 26

II. Compatibility with higher-ranking law ............................................................... 27

1. Article 191 TFEU .......................................................................................... 27

2. Article 114 TFEU and Article 11 TFEU .......................................................... 29

3. Article 37 CFR, Article 168 TFEU and Article 35, second sentence, CFR ...... 29

4. Duty to protect under Articles 2(1), 3(1) and 7 CFR ...................................... 32

5. Application to the proposed amendments ..................................................... 34

a. Indefinite approval of active substances .................................................... 35

b. Freezing the state of scientific knowledge ................................................. 36

c. Waiving prior authorisation and approval for certain substances ............... 37

d. Temporary approval of active substances.................................................. 39

e. Extension of grace periods for disposal/use .............................................. 39

D. The Commission’s procedural approach and its lawfulness ................................. 40

I. Dispensing with an impact assessment ........................................................... 40

1. The Commission’s approach ......................................................................... 40

2. Infringement of the Interinstitutional Agreement and the Better Regulation

Guidelines............................................................................................................ 41

3. Legal consequences ..................................................................................... 43

a. Violation of the principle of proportionality ................................................. 43

b. Violations of the principles of equal treatment and the protection of legitimate

expectations ..................................................................................................... 45

c. Infringement of Article 168(1) TFEU .......................................................... 46

II. Insufficient stakeholder consultation ................................................................ 47

1. Approach of the Commission ........................................................................ 47

2. Infringement of procedural requirements as well as the Interinstitutional

Agreement and the Better Regulation Guidelines ................................................ 48

3. Legal consequence: violation of the principles of proportionality, equal treatment

and the protection of legitimate expectations ....................................................... 49

III. Statement of reasons of the proposal .............................................................. 50

E. Conclusion and outlook ........................................................................................ 50

1

A. Background and questions presented

For about a year, European Union policy has been dominated by the drive towards sim-

plification.

To that end, the Union has drawn up a total of ten ‘Omnibus’ packages, some of which

have already been adopted. Each package amends an entire bundle of regulations and

directives within a (at least loosely) related policy area.1

There is nothing fundamentally wrong with the goal of simplifying procedures and thereby

easing the administrative burden on the Union and the Member States, as well as on

businesses and consumers. However, experience with the Omnibus packages to date

suggests that minor progress in reducing bureaucracy has come at the cost of abandon-

ing key achievements in the areas of human rights, health, and environmental protection.

On December 16, the Commission proposed the tenth omnibus package – the so‑called

Food and Feed Safety Omnibus2. It consists of three proposed legislative acts and an

accompanying document, namely:

• Proposal for a regulation amending Regulation (EU) No 528/2012 as regards the

extension of certain data-protection periods3

• Proposal for a directive amending Council Directive 98/58/EC and Directive

2009/128/EC of the European Parliament and of the Council as regards simplify-

ing and strengthening requirements on food and feed safety and repealing Coun-

cil Directives 82/711/EEC and 85/572/EEC4

• Proposal for a regulation amending Regulations (EC) No 999/2001, (EC) No

1829/2003, (EC) No 1831/2003, (EC) No 852/2004, (EC) No 853/2004, (EC) No

396/2005, (EC) No 1099/2009, (EC) No 1107/2009, (EU) No 528/2012 and (EU)

1 An overview is provided by the European Commission at https://commission.eu- ropa.eu/law/law-making-process/better-regulation/simplification-and-implementation/simplifica- tion_en, last accessed on 13 January 2026. 2 European Commission, Food and Feed Safety Simplification Package – December 2025, available at https://food.ec.europa.eu/horizontal-topics/simplification-legislation_en, last ac- cessed on 6 January 2026. 3 COM(2025) 1020 final, available at https://food.ec.europa.eu/document/download/d8c35be0- ecc9-432b-a645-fd363681f5d3_en?filename=horiz_omnibus_reg_com-2025-1020-1-p1.pdf, last accessed on 6 January 2026. 4 COM(2025) 1021 final, available at https://food.ec.europa.eu/document/download/f08402e6- de66-4082-bf8d-ec3aff7787bb_en?filename=horiz_omnibus_dir_com-2025-1021-1part1.pdf, last accessed on 6 January 2026

2

2017/625 as regards simplifying and strengthening requirements on food and

feed safety5 (hereinafter “draft amending regulation”), together with the related

Commission Staff Working Document6

The third proposed legislative act contains proposals for far-reaching amendments to the

EU Plant Protection Products Regulation (EC) No 1107/2009, which would lower the

level of protection in this area.

This analysis is limited to this part of the Omnibus package.

The clients request an assessment of the effects of the proposed amendments to Regu-

lation (EC) No 1107/2009 on the level of protection under plant protection products law

and of their compatibility with higher-ranking law.

B. Executive summary

The amendments to Regulation (EC) No 1107/2009 proposed by the Commission would

lower the level of protection for the environment and human health.

Especially the proposed shift from time-limited approvals of active substances to pre-

dominantly unlimited approval duration represents a major step backwards in terms of

environmental and health protection. Already today, it is a problem that new scientific

findings on risks to health and the environment are not swiftly translated into regulatory

decisions. The implementation of the proposal would exacerbate the problem.

Active substances that do not meet the approval criteria would be allowed to be tempo-

rarily approved under simplified conditions pursuant to Article 4(7) of Regulation (EC)

No 1107/2009. According to the proposal, the absence of “reasonable” alternatives

should be sufficient for such a temporary approval of an active substance. This consti-

tutes a problematic watering down of the existing requirement that alternatives are not

available.

5 COM(2025) 1030 final, available at https://food.ec.europa.eu/document/download/b0817113- 6edc-4219-b638-8060fee037d5_en?filename=horiz_omnibus_reg-com-2025-1030_en.pdf and, in an editorially revised version, as COM(2025) 1030 final/3 at https://eur-lex.europa.eu/legal- content/DE/TXT/?uri=CELEX%3A52025PC1030%2802%29&qid=1767695026766, both last ac- cessed on 6 January 2026. 6 SWD(2025) 1030 final, available at https://food.ec.europa.eu/document/download/863722d6- 85d9-4273-b1f6-475b1bcde200_en?filename=horiz_omnibus_2025-1030_swd_en.pdf, last ac- cessed on 6 January 2026.

3

In addition, Member State authorities would no longer be permitted to consider new sci-

entific findings concerning the active substance when granting national product authori-

sations. This would be equivalent to freezing the state of knowledge at the time of the

last approval. This point in time can be far in the past, particularly in view of the planned

abolition of the periodic review of active substance approvals.

The requirement for prior authorisation of treated seed is to be removed entirely, provided

that the seed has been treated with a plant protection product authorised in another

Member State. Considering the risks to the environment and health associated with the

use of treated seed, this exemption would entail a critical lowering of the level of protec-

tion.

Moreover, various privileges are proposed for substances that the Commission expects

to be less harmful (including biocontrol substances, low‑risk active substances and basic

substances). In some cases, these exemptions lead to the waiver of the authorisation

requirement or to automatic authorisation upon expiry of the decision period. Since the

actual harmlessness of these privileged substances is not ensured by restrictive criteria

and definitions, this would create a problematic loophole for circumventing authorisation

control.

Transitional periods for the placing on the market and use of plant protection products

are to be extended – including for substances that are questionable from a safety per-

spective. This would prioritise economic interests over the protection of health and the

environment.

The proposed amendments raise serious doubts as to their compatibility with the pre-

cautionary principle and with the high level of protection for health and the environment

guaranteed by Article 191(2) of the Treaty on the Functioning of the European Union

(TFEU) and the obligations and rights set out in the Charter of Fundamental Rights of

the European Union (CFR).

The Commission’s approach in preparing the proposal is also not consistent with higher-

ranking law.

4

Contrary to the Interinstitutional agreements and the Better Regulation Guidelines, the

Commission refrained from carrying out an impact assessment and the associated public

stakeholder consultation. Instead, it merely quantified the expected cost savings and

sought feedback on an abstract description of its project in a targeted consultation.

The Commission had at its disposal numerous indications of the risks to the environment

and human health associated with a lowering of the level of protection. Nevertheless, it

proceeded on the assumption - without further substantiation - that the planned changes

would not pose any risk to health and environmental protection. It is not apparent that

the Commission sought information on the expected effects as an alternative to the im-

pact assessment that was not carried out.

This approach violates the principle of proportionality, as the information required to as-

sess proportionality was not available, even though significant environmental and health

impacts were to be expected. Furthermore, serious doubts arise as to whether this ap-

proach is compatible with the principles of equal treatment and the protection of legiti-

mate expectations. Finally, the omission of a health impact assessment and the lack of

a health-specific statement of reasons for the initiative would suggest a breach of Article

168(1) TFEU (in conjunction with Article 296(2) TFEU), if the legislative act were

adopted.

C. The Commission initiative and its legality

I. Classification of the key proposed amendments

The draft amending regulation proposed by the Commission provides for a series of

amendments to Regulation (EC) No 1107/2009 that would significantly lower the level of

protection in the fields of health and environmental protection.

1. Removal of time limits on approvals of active substances

a. Abolition of the current periodic review

At present, first approvals of active substances are limited to a period of no more than

ten years.7 On application, the approval of an active substance shall be renewed if it is

7 Article 5 of Regulation (EC) No 1107/2009.

5

established that the approval criteria set out in Article 4 are satisfied.8 For that purpose,

companies must submit a comprehensive and up-to-date dataset containing toxicologi-

cal, ecotoxicological and environmental information.9

The Commission proposal provides for a fundamental shift towards approvals of active

substances that are, as a rule, unlimited. Only for candidates for substitution, active sub-

stances within the meaning of Article 4(7) of Regulation (EC) No 1107/2009, and those

for which, pursuant to Article 6(j) of Regulation (EC) No 1107/2009, a limited approval

period has been set due to relevant uncertainties, approval duration would remain lim-

ited.10 All other active substances are to be approved without a time limit. Under the

transitional rule proposed by the Commission, this would in principle apply to all active

substances that are approved at the time the amendments enter into force.11 For active

substances that are already in a renewal procedure when the amendments enter into

force, that procedure is to be completed. The renewal of the active substance approval

would be, subject to the above exceptions, unlimited.12

This substantially lowers the level of protection.

The reason why approval duration is limited is to ensure that developments in science

and technology are taken into account.13 In practice, it is quite common that, in the course

of the periodic review of an active substance approval, new scientific evidence on harm

to the environment and human health leads to the finding that the conditions for approval

are not met.14

8 Article 14(1) of Regulation (EC) No 1107/2009. 9 Article 6 Commission Implementing Regulation (EU) 2020/1740 of 20 November 2020 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and repealing Commission Implementing Regulation (EU) No 844/2012. 10 Article 5 of Regulation (EC) No 1107/2009 (Draft). These rules are also to apply to active sub- stances that are approved at the time the draft amending regulation enters into force, see Article 27a of Regulation (EC) No 1107/2009 (Draft). 11 Cf. Article 27a(1) of Regulation (EC) No 1107/2009 (Draft) and the exceptions provided for there. 12 Cf. Article 2(1) of the draft amending regulation; recital 26 of the draft amending regulation. 13 Recital 15 of Regulation (EC) No 1107/2009. 14 Cf. for example, Commission Implementing Regulation (EU) 2024/20 of 12 December 2023 concerning the non-renewal of the approval of the active substance S-metolachlor; Commission Implementing Regulation (EU) 2025/910 of 20 May 2025 concerning the non-renewal of the ap- proval of the active substance flufenacet.

6

Without an obligation on companies to submit updated toxicity data at regular intervals,

significantly fewer new scientific data would be generated.15 The state of knowledge

could then evolve only through independent scientific literature, without the industry be-

ing obliged to contribute to it.

The exceptions, inter alia, for candidates for substitution or active substances pursuant

to Article 4(7) of Regulation (EC) No 1107/2009, are insufficient to ensure an acceptable

level of protection. They would concern only a small proportion of active substances.

According to PAN Europe 90% of active substances would receive an unlimited approval

under this proposal – including highly problematic substances such as acetamiprid and

PFAS active substances.16

The proposal of unlimited approval duration is officially justified with the intention to re-

duce the administrative workload and to facilitate the transition to more sustainable active

substances and plant protection products.17 It is questionable whether the proposed

move to open-ended approvals will contribute to the latter or, rather, will lead to problem-

atic active substances remaining on the market for a longer time.

b. No compensation through Articles 18, 18a and 21 of Regulation (EC) No

1107/2009

Although the proposal provides for mechanisms by which open-ended active substance

approvals can also be reviewed, these do not ensure that new scientific findings are

promptly translated into regulatory decisions.

aa. Periodical identification of active substances that must be reviewed

According to the Commission's proposal, Article 18 of Regulation (EC) No 1107/200918

should stipulate that the Commission shall “periodically” after consulting EFSA, adopt

implementing acts identifying active substances or groups of active substances with un-

limited approval periods for which a renewal procedure shall be conducted.19

15 PAN Europe, Briefing ‘Food and feed safety omnibus’ threatens pesticide rules, available at https://www.pan-europe.info/sites/pan-europe.info/files/public/resources/briefings/Briefing_Om- nibus%20threatens%20pesticide%20rules%20.pdf, last accessed on 16 January 2026.16 16 PAN Europe, fn. 15, p. 2. 17 Recital 14 of the draft amending regulation. 18 This provision currently governs the Commission’s power to establish a work programme set- ting priorities for the mandatory review of active substances. 19 Article 18(1) of Regulation (EC) No 1107/2009 (Draft).

7

This identification of the active substances concerned “shall take into account”, among

others, indications of safety concerns for human or animal health or the environment,

new scientific or technical knowledge and available monitoring data and “may” take into

account requests from Member States.20 Where relevant approval criteria set out in An-

nex II, data requirements or relevant guidance documents become applicable, the Com-

mission shall adopt an implementing act identifying all relevant active substances at the

latest within three years.

The implementing acts shall, among others set deadlines for the submission of applica-

tions for renewal of the approval of the active substances concerned that “allow sufficient

time for the generation of the necessary data and the submission of the said applications”

and set expiry dates for the approvals of the active substances concerned that “allow

sufficient time for the submission and evaluation of the applications and for the adoption

of decisions on the renewal” of the approval of the active substances concerned.

This mechanism set out in Article 18 of the Commission’s proposal cannot replace the

currently foreseen mandatory periodic review.

The proposed obligation on the Commission to decide “periodically” is too vague in terms

of time, because it leaves open the question of how often a decision on the need for

renewal procedure must be taken (annually, every five, ten or 20 years?). The timetable

for identifying the active substances to be reviewed is thus left to the Commission’s dis-

cretion. Only in the case of amended approval criteria, data requirements or guidance

documents there is a specific (but very long) three‑year deadline set for the identification

of the active substances to be reviewed.

Furthermore, the Commission is granted overly broad discretion in identifying the active

substances to be reviewed. The proposed Article 18 does not stipulate clearly enough

that a review must be initiated where there are indications of safety gaps, new scientific

findings and monitoring data. Nor is there a sufficiently clear obligation to respond to

review requests from Member States. It is therefore to be feared that the Commission

will claim broad discretion in assessing the available state of knowledge and the resulting

20Article 18(1), second subparagraph, of Regulation (EC) No 1107/2009 (Draft).

8

need for review. In addition, less data on health and environmental risks will be available

if companies are no longer obliged to generate them.

In addition, the implementing acts identifying the active substances that need to undergo

a renewal procedure are adopted with the participation of the Standing Committee on

Plants, Animals, Food and Feed (SCoPAFF), which is composed of representatives of

national ministries. This creates the risk of political influence.21

Furthermore, the duration of the review procedure is not clearly circumscribed: Already

today, review procedures often take far too long.22 The same problem is likely to happen

for substances chosen under Article 18 of the draft, because this provision leaves open

by when the renewal procedure must be completed. It provides only vague requirements

that the implementing regulation is to set deadlines for the submission of applications for

renewal of the approval of the active substances concerned, which allow “sufficient time”

for the generation of the necessary data and the submission of the said applications”.

Similarly, expiry dates for the active substance approvals are to be set which leave “suf-

ficient time” for the submission and evaluation of the applications and for the adoption of

decisions on the renewal of the active substances concerned.23 These vague formula-

tions, as well as the reference to Article 17 (technical prolongation), give rise to concerns

that problematic active substances could remain on the market for a very long period

without being reviewed.

bb. Targeted reassessment under Article 18a

Whereas the proposed Article 18 of Regulation (EC) No 1107/2009 (Draft) foresees a full

review of the approval of an active substance, a new Article 18a is intended to regulate

a selective reassessment of active substances approved for an indefinite or limited pe-

riod with regard to individual approval criteria.

The proposed provision stipulates that the Commission “may” at any time, based on the

criteria laid down in Article 18(1) initiate a targeted reassessment of the approval of active

substances to verify whether certain approval criteria, or specific aspects thereof, are still

21 PAN Europe, fn. 15, p. 2.16 22 Cf. in this context, the recent judgments of the General Court, judgments of 19 November 2025, Cases T-412/22, T-94/23 and T-565/23, concerning the need for a restrictive application of so- called technical extensions pursuant to Article 17 of Regulation (EC) No 1107/2009. 23 Article 18(2) of Regulation (EC) No 1107/2009 (Draft).

9

met in light of current scientific and technical knowledge. To that end, after consulting the

Authority, the Commission “may” adopt implementing acts under the committee proce-

dure identifying the active substances to be reassessed, the scope of the targeted reas-

sessment, data requirements, the guidance documents to be used, and deadlines for the

submission of required data. If the data are not submitted within the prescribed deadline,

or if the review concludes that the approval criteria are not met, the approval shall be

withdrawn.

This provision in Article 18a also does not ensure that active substance approvals are

swiftly adapted to the latest state of science and to monitoring data. It is designed as a

purely discretionary provision, empowering the Commission to initiate a partial review

but not obliging it to do so. In view of the way in which the existing review option under

Article 21 of Regulation (EC) No 1107/2009 (see below) has been handled to date, there

is reason to fear that the Commission will rarely exercise this discretion to initiate a tar-

geted review. Furthermore, the added value compared to the existing possibility of ad

hoc review under Article 21 of Regulation (EC) No 1107/2009 appears to be low. Finally,

the criticism raised above regarding Article 18 of the proposal, namely that the criteria

for identifying the active substances to be reviewed are not regulated clearly enough,

also applies here.

c. Ad hoc review under Article 21 of Regulation (EC) No 1107/2009

According to the Commission's proposal, the existing possibility of ad hoc review under

Article 21 of Regulation (EC) No 1107/2009 should remain in place.24

According to this provision, the Commission may review the approval of an active sub-

stance at any time. This includes both a targeted review and a full review. It “shall take

into account” a request of a Member State to review, in the light of new scientific and

technical knowledge and monitoring data, the approval of an active substance. Where,

in the light of new scientific and technical knowledge it considers that there are indica-

tions that the substance no longer satisfies the approval criteria provided for in Article 4,

or where requested data has not been provided, it review is initiated. Where the Com-

mission concludes that the approval criteria are not met or where requested information

has not been provided, a Regulation to withdraw or amend the approval shall be adopted.

24 Recital 14 of the draft amending regulation.

10

Article 21 of Regulation (EG) No 1107/2009 is an expression of the precautionary princi-

ple.25 Unfortunately,

it is currently being applied very restrictively by the Commission. There are only a few

cases documented in the case law in which the provision has been invoked by the Com-

mission to review an active substance approval.26 In response to calls by environmental

NGOs to apply this provision, the Commission invokes a very broad discretion to initiate

a review.27 Also Member State requests to apply Article 21 were not always followed by

the Commission.28

Given the Commission’s restrictive approach to the ad hoc review under Article 21 of

Regulation (EC) No 1107/2009, also this provision cannot compensate for the removal

of the current system of limited approval duration.

d. Adjustment of the duration of national product authorisations

As a consequence of the unlimited duration of active substance approvals, the time-

limitation of product authorisations is also to be redesigned.

Currently, the duration of an authorisation is linked to the duration of the active substance

approvals.29 Under the Commission proposal, the duration of authorisations for plant

protection products containing open-ended approved active substances may in future be

up to 15 years; otherwise, the maximum authorisation duration (as before) is a maximum

of one year after expiry of the active substance approval.30

In future, where the contained active substances are approved without a time limit, the

application for renewal of the authorisation is to be submitted at the latest nine months

before expiry of the authorisation. Otherwise, the existing rule is to remain, namely that

25 CJEU, judgment of 1 October 2019, C‑616/17, paras. 99 et seq. 26 General Court, judgment of 17 May 2018, T‑584/13, paras. 157 et seq.; CJEU, judgment of 6

May 2021, C‑499/18 P, paras. 81 et seq., 121. 27 Cf. for example, the Commission’s replies to the requests for internal review IR/2025/931238 and IR/2025/378391, available at https://environment.ec.europa.eu/law-and-governance/aar- hus/requests-internal-review_en, last accessed on 16 January 2026. 28 For example, the Commission has so far not acted on Member State requests to initiate an ad hoc review of several active substances regarding the formation of trifluoroacetate (TFA), see Standing Committee on Plants, Animals, Food and Feed Section Phytopharmaceuticals – Legis- lation, 1–2 October 2025, p. 12, available at https://food.ec.europa.eu/document/down- load/884895c3-94e2-45ad-8861-ba67b4615401_en?file- name=sc_phyto_20251001_ppl_sum.pdf, last accessed on 16 January 2026. 29 Approval period + 1 year, cf. Article 32(1) of Regulation (EC) No 1107/2009. 30 Article 32(1) of Regulation (EC) No 1107/2009 (Draft).

11

the application must be submitted within three months after renewal of the active sub-

stance approval.31 However, the processing time limit is to be 12 months after submission

of the application for renewal of the product authorisation, rather than – as previously –

12 months after renewal of the active substance approval.32

The possibility for Member States to review product authorisations ad hoc under Article

44 of Regulation (EC) No 1107/2009 and, where appropriate, to withdraw them is to re-

main – just like the parallel rule in Article 21 at active substance level. The provision is

also to be supplemented by an obligation to adapt authorisations following a targeted

review pursuant to Article 18a.33 For the reasons set out above, this cannot replace a full

review of the authorisation on the basis of the latest state of science and technology.

2. Simplification of temporary approvals of active substances

Under Article 4(7) of Regulation (EC) No 1107/2009, an active substance may, by way of

derogation, be approved on a temporary basis for a maximum of five years even though

it does not meet the approval criteria. To date, this requires "documented evidence in-

cluded in the application" demonstrating that the active substance is necessary to control

a "serious danger to plant health which cannot be contained by other available means

including non-chemical methods". Given the strict requirements, this provision has not

yet been used.34

According to the Commission proposal, these requirements are to be watered down.

The proposal provides that the derogation is also to apply in the event of a serious danger

to "plant production" (no longer only "plant health").35 The term "plant production" is nei-

ther used nor defined anywhere in Regulation (EC) No 1107/2009. Its inclusion tends to

extend the scope to problems that do not primarily concern the health of plants but rather

the quantity of production. .

In addition, the proposal shifts the focus to the lack of "reasonable" alternatives rather

than on the lack of objectively "available" other means. This softer standard threatens to

31 Article 43(2) of Regulation (EC) No 1107/2009 (Draft). 32 Article 43(5) of Regulation (EC) No 1107/2009 (Draft). 33 Article 44(1a) of Regulation (EC) No 1107/2009 (Draft). 34 PAN Europe, fn. 15, p. 3.16 35 Article 4(7) of Regulation (EC) No 1107/2009 (Draft).

12

be used to dismiss existing alternatives as "unreasonable" on the grounds that they re-

quire greater effort or entail higher costs. At least, this was the aim of demands made by

the agricultural industry.36 Making the assessment depend on the reasonableness of al-

ternatives would therefore be a gateway for an extensive interpretation of Article 4(7) of

Regulation (EC) No 1107/2009 and thus a weakening of the level of protection.

According to the proposal, it would be sufficient for temporary approval that the compel-

ling necessity of the active substance for plant health or plant production becomes ap-

parent during the authorisation procedure. It would no longer no longer be mandatory to

document and prove this in the application. The application of Article 4(7) of Regulation

(EC) No 1107/2009 could thus also be based on facts that only become known at a later

stage. This, too, broadens the scope of this derogation.

Mutagenic substances37, carcinogenic substances (Cat. 1A/B) 38, substances toxic to re-

production39 (only Cat. 1A) and substances classified as POP40, PBT41 or vPvB42 are not

to fall within the derogation in Article 4(7). However, endocrine-disrupting substances

(Annex II, 3.6.5) or reproductive toxic substances of category 1B (Annex II, 3.6.4), as

well as substances that do not meet the ecotoxicological criteria set out in Annex II, No.

3.8, and the groundwater-protection criterion in Annex II, No. 3.10 could potentially be

temporarily approved under the extended exemption.

Finally, the proposal suggests deleting the seventh subparagraph of Article 4(7) of Reg-

ulation (EC) No 1107/2009. This provision requires Member States, when authorizing a

plant protection products containing an active substance temporarily approved under Ar-

ticle 4(7), to simultaneously draw up a phasing out plan concerning the control of the

serious danger by other means, including non-chemical methods and submit it to the

Commission. The removal of this provision is detrimental from an environmental and

health protection perspective.

36 IVA, Simplification of food and feed safety legislation - The opinion of the Industrieverband Agrar e.V., October 2025, p. 6. 37 Cf. Annex II, point 3.6.2 of Regulation (EC) No 1107/2009. 38 Cf. Annex II, point 3.6.3 of Regulation (EC) No 1107/2009. 39 Cf. Annex II, point 3.6.4 of Regulation (EC) No 1107/2009. 40 Cf. Annex II, point 3.7.1 of Regulation (EC) No 1107/2009. 41 Cf. Annex II, point 3.7.2 of Regulation (EC) No 1107/2009. 42 Cf. Annex II, point 3.7.3 of Regulation (EC) No 1107/2009.

13

3. Extended privileges and exemptions for certain substances

The central objective of the proposal is to improve access to and availability of "sustain-

able plant protection products".43 The Commission proposal therefore contains several

provisions intended to facilitate market access for allegedly more sustainable sub-

stances. These proposed significant facilitations in the approval and authorisation pro-

cedure seem partly problematic, because there is a risk that also harmful substances

could benefit from them.

a. Biocontrol substances

The proposal would introduce far-reaching privileges in favor of biocontrol substances.

aa. Definition

Under the proposed legal definition, "biocontrol substances" encompass microorgan-

isms, “inorganic substances as occurring in nature, with the exception of heavy metals

and their salts” and “substances of biological origin or produced synthetically that are

functionally identical and structurally similar to them".44

This definition is too broad. The fact that it covers not only naturally occurring substances

used directly for plant protection, but also substances merely of biological origin and

synthetically produced substances, raise concerns that problematic substances could be

included in some cases.

The active substance Spinosad for example is obtained from a bacterium and is therefore

of natural origin,.45 but at the same time is a highly effective broad-spectrum insecticide

that is not unproblematic from an ecological perspective.46

Another problem is that the suggested definition covers synthetically produced sub-

stances that are functionally identical and structurally similar to naturally produced sub-

stances. There is a concern that even synthetic pyrethroids (insecticides), which are

43 Recital 4 of the draft amending regulation. 44 Article 3(35) of Regulation (EC) No 1107/2009 (Draft). 45 https://de.wikipedia.org/wiki/Spinosad. 46 The approval of the active substance Spinosad was granted subject to the condition that Member States pay particular attention to the protection of aquatic organisms and earthworms and, where appropriate, lay down risk mitigation measures; cf. the Annex to Commission Imple- menting Regulation (EU) No 540/2011.

14

based on the main active ingredients of the natural insecticide pyrethrum,47 could qualify

as a biocontrol substance. These substances cannot be assumed to be a low risk to the

environment and health. Some pyrethroids (e.g. cypermethrin) are even classified as

candidates for substitution due to their hazardousness.

The definition of biocontrol substances would therefore urgently need to be drafted more

narrowly and more concretely, so that only harmless substances are covered.48

bb. Privileges for biocontrol substances

The proposal allows for several regulatory privileges for biocontrol substances:

(1) Acceleration of the active substance approval procedure

Because some Member States currently do not have sufficient expertise to assess bio-

control substances, the Commission suggests that applications for the approval of these

substances may be submitted directly to EFSA.49 .

In addition, the approval process is to be accelerated by requiring the rapporteur Member

State to give priority to applications for the approval of biocontrol substances.50

Even if facilitating market access for less harmful products appears sensible in principle,

this must not lead to delays in the necessary review of approved synthetic active sub-

stances.

(2) Acceleration of product authorisation and mutual recognition

As regards the national authorisation of plant protection products that contain exclusively

biocontrol substances, the EU is to be treated as a single zone.51 In the zonal authorisa-

tion procedure, one Member State proposed by the applicant shall evaluate the applica-

tion taking into account all zones, 52 so that separate assessments for the three different

zones are no longer required. Similarly, mutual recognition under Article 40 should not

47 https://de.wikipedia.org/wiki/Pyrethroide. 48 See also PAN Europe, fn. 15, p. 5, with a concrete proposal for a narrower definition.16 49 Article 7(1) of Regulation (EC) No 1107/2009 (Draft), recital 8 of the draft amending regula- tion. 50 Article 11(1a) of Regulation (EC) No 1107/2009 (Draft). 51 Article 3(17) of Regulation (EC) No 1107/2009 (Draft). 52 Article 33(2) (b) of Regulation (EC) No 1107/2009 (Draft).

15

be limited to recognition within a zone but should be permitted regardless of which zone

the reference Member State belongs to.53

These privileges assume that plant protection products containing exclusively biocontrol

substances do not pose different risks in the individual Member States.54 However, given

the very broad definition, it cannot be assumed that only environmentally compatible

substances fall within the concept of biocontrol substances. Accordingly, it cannot be

assumed that these products are harmless throughout the European Union.

In order to speed up the authorisation process, plant protection products containing ex-

clusively biocontrol substances as active substances are suggested to have priority in

the authorisation procedure.55

Partly, the authorisation can even be assumed: according to the Commission proposal,

where a plant protection product contains only biocontrol substances as active sub-

stances and the Member States concerned have not adopted a decision after 120

days,authorisation shall be deemed as having been granted by the Member States.56

Similarly, mutual recognition is to be deemed to have taken place if no decision on the

recognition has been taken within 120 days.57 A "decision" within the meaning of these

proposals is likely to require not just any reaction by the authority, but a final authorisation

or refusal. In light of the staff shortages in Member State authorities,58 this amount to a

problematic partial waiver of the authorisation requirement.

This is highly concerning, because even natural substances, such as microbial organ-

isms, can entail risks,59 and the proposed definition of biocontrol substances encom-

passes too many problematic substances. It is therefore of great importance that these

substances are subject to a thorough risk assessment and can be subject to national risk

management.

53 Article 40(1) (c) of Regulation (EC) No 1107/2009 (Draft). 54 Recital 10 ofthe draft amending regulation. 55 Article 37(6) of Regulation (EC) No 1107/2009 (Draft), EEC 7 Draft amending regulation. 56 Article 37(5) of Regulation (EC) No 1107/2009 (Draft). 57 Article 42(3) of Regulation (EC) No 1107/2009 (Draft). 58 Which are highlighted by the Commission itself COM (2025) 1030 final, Explanatory Memoran- dum, pp. 1, 20. 59 In this regard, PAN Europe notes that microorganisms have the potential to survive, multiply, move and colonize new environments, with possible unintended impacts on biodiversity; see PAN Europe, fn. 15, pp. 5-6.16

16

(3) Provisional authorisations

For the same reasons, the proposal to enable provisional authorizations for plant protec-

tion products containing one or more biocontrol active substances that have not yet been

approved60 can be seen critically.

These provisional authorizations would only be possible if the draft assessment report of

the rapporteur Member State concludes that the substance can be approved. However,

given that the rapporteur Member State is proposed by the applicant itself,61 the peer

review procedure the EFSA62 is an important step that should not be waived.

In addition, the envisaged validity period of a provisional authorisation of up to five years

appears too long and unjustified, since it can be assumed that the peer-review procedure

can be completed within a shorter time frame.

(4) Exemption from the recording obligation

To reduce the administrative burden for farmers, it is suggested that biocontrol sub-

stances are to be exempted from the obligation imposed on professional users to keep

records for three years of the plant protection products used. As a result, farmers will no

longer be required to record the name of the plant protection product, the date of use,

the quantity used, the area treated and the crop for which the plant protection product

was used.63

From an environmental protection perspective, this exemption is problematic. As ex-

plained above, it cannot be assumed that all biocontrol substances that would fall under

the suggested definition are entirely harmless. In addition, without an obligation to record

all applications of plant protection products, it would not be possible to effectively verify

compliance with the mandatory principles of integrated pest management.64 Moreover,

where environmental damage occurs, it will become significantly more difficult to trace

which products were used and thereby caused the damage.

60 Article 30 of Regulation (EC) No 1107/2009 (Draft). 61 Article 7(1), third subparagraph, of Regulation (EC) No 1107/2009. 62 Cf. Article 12 of Regulation (EC) No 1107/2009. 63 Article 67 of Regulation (EC) No 1107/2009 (Draft). 64 Cf. Article 55 of Regulation (EC) No 1107/2009 in conjunction with Article 14 and Annex III to Directive 2009/128/EC.

17

b. Privileges for low-risk active substances

Further facilitations are envisaged for plant protection products containing low-risk active

substances. For these products, the obligation to accelerate the authorisation procedure

and the concept of tacit authorisation set out in Articles 37 and 42 of Regulation (EC) No

1107/2009 (Draft) would apply as well.

At present, classification as a low-risk active substance requires that the active sub-

stance meets the criteria in Article 4 and Annex II, point 5, of Regulation (EC) No

1107/2009, which sets out certain hazard-based cut-off criteria. These requirements are

to be maintained.

However, the additional requirement currently applicable under Article 22(1) of Regula-

tion (EC) No 1107/2009, according to which also the plant protection products containing

the substance of low-risk must be of low risk to human and animal health and the envi-

ronment, is to be deleted. This suggested removal is justified with the argument that, at

the time of approval or renewal of approval, it is not known whether the criteria for low-

risk products under Article 47 of Regulation (EC) No 1107/2009 are met or not.65 The

proposal therefore suggests to focus only on the intrinsic properties of the active sub-

stance.66

This removal of the product-related element is highly problematic, particularly in the light

of the fact that national authorisation controls for products containing low-risk active sub-

stances are to be relaxed and authorisation can be simulated.

In addition, the Commission suggests introducing the possibility of applying retrospec-

tively for low-risk status.67

c. Privileges for basic substances

Another category of privileged substances are so-called basic substances. These are

substances that are not primarily used for plant protection but are nevertheless useful

65 Recital 12 of the draft amending regulation. 66 Ibid. 67 Recital 12 of the draft amending regulation, Article 7 Regulation (EC) 1107/2009 (draft).

18

for plant protection. In the past, this category included, for example, baking powder,

sugar, fructose or vinegar.68

Already under the current regulatory framework, basic substances benefit from certain

privileges, in particular a simplified approval procedure and unlimited approval duration.69

Qualification as a basic substance currently requires, inter alia, that the substances are

not substances of concern70, that they cannot cause endocrine-disrupting, neurotoxic or

immunotoxic effects, and that they are not marketed as plant protection products.71

The Commission wants to amend these rules, claiming that the previous rules on basic

substances were unclear and made basic substances less available to farmers.72 A def-

inition of the term "basic substances" is proposed that would encompass active sub-

stances that are not predominantly used for plant protection purposes, including food-

stuffs and substances assessed under other Union legislation, but are still useful in plant

protection.73 Suggested is a specification, which uses are covered by qualification as a

basic substance (as distinct from an active substance for plant protection products). In

addition to direct use of the basic substance, also formulations that contain, as a simple

diluent, another basic substance or "substances necessary to stabilize the product".

Here, again, it must be doubted whether this wording ensures that no problematic sub-

stances are used in the formulation.

According to the Commission proposal, basic substances are to be further privileged by

exempting not only their use but also the placing on the market of basic substances from

the requirement of national authorisation; this exemption is also to apply to products

within the meaning of Article 23(1) of Regulation (EC) No 1107/2009 (Draft).74

From an environmental and public health perspective, the planned removal of the na-

tional authorisation requirement for the placing on the market of products containing

68 BVL, Genehmigung von Grundstoffen, available at https://www.bvl.bund.de/DE/Arbeits- bereiche/04_Pflanzenschutzmittel/03_Antragsteller/09_GenehmigungGrund- stoffe/psm_GenehmGrundstoffe_node.html, last accessed on 13 January 2026. 69 Article 23(1) of Regulation (EC) No 1107/2009. 70 Under Article 3(4) of Regulation (EC) No 1107/2009, a "substance of concern" means any substance which has an inherent capacity to cause an adverse effect on humans, animals or the environment and is present or is produced in a plant protection product in sufficient concen- tration to present risks of such an effect. 71 Article 23(1), second sentence, of Regulation (EC) No 1107/2009. 72 Cf. Recital 13 of the draft amending regulation. 73 Article 3 No 36 of draft amending regulation. 74 Article 28(2) (a) of Regulation (EC) No 1107/2009 (Draft).

19

basic substances entails risks. The approval of the individual basic substance does not

make a specific risk assessment for the product unnecessary, because the formulation

can be more harmful than the basic substance considered in isolation. Moreover, even

for basic substances, it must be noted that the dose makes the poison. It therefore cannot

be assumed that products containing basic substances are harmless in every conceiva-

ble application and thus not require risk management.

The Commission proposal includes product-related assessments partly at the basic sub-

stance approval- The suggested criteria for approval as a basic substance are the fol-

lowing: first, the basic substance must not be a substance of concern, or the product

must not fall under hazard classification pursuant to Regulation (EC) No 1272/2008. Sec-

ond, the basic substance, or the product containing it, must not have endocrine-disrupt-

ing, neurotoxic or immunotoxic effects. Third, it must not be an active substance ap-

proved for use in plant protection products, and no such approval procedure may be

pending. Fourth, the basic substance, or the product in which it is used, must not have

immediate or delayed harmful effects on human and animal health or unacceptable ef-

fects on the environment. 75 Moreover, under the Commission proposal an application for

classification as a basic substance must also contain information on intended uses and

proposed conditions of use.76

However, this product reference is then devalued again by the proposal, that approval of

a basic substance is to cover all approved uses and products and is not limited by the

uses applied for. 77 This would mean that only some uses and formulations are actually

subject to a risk assessment, while for the rest compliance with the substantive approval

criteria in Article 23 of Regulation (EC) No 1107/2009 would be presumed.

d. Privileges for plant protection products required to prevent the establishment

or spread of certain quarantine pests

The Commission proposal provides for simplifications for substances required to prevent

the introduction and spread of certain pests pursuant to Regulation (EU) 2016/2031. For

these substances, the European Union is to be treated as a single zone; authorisation is

75 Article 23(2) of Regulation (EC) No 1107/2009 (Draft). 76 Article 23a(1) of Regulation (EC) No 1107/2009 (Draft). 77 Article 23a(4) of Regulation (EC) No 1107/2009 (Draft).

20

to be carried out by one Member State for the entire zone. 78 In addition, an accelerated

procedure is also to apply here, under which the assessing Member State must endeavor

to take a decision as quickly as possible and, in any event, within six months.79

Here too, a restrictive formulation of the uses covered is necessary to ensure that the

derogation is not used to circumvent certain requirements of Regulation (EC) No

1107/2009.

4. Possibility for the RMS to seek EFSA support

To accelerate the initial approval procedure, the Commission proposal provides that the

rapporteur Member State may request EFSA to provide technical or scientific support in

assessing the application for approval.80 This provision is intended to support Member

States that do not have sufficient technical or scientific expertise.81

This proposal seems reasonable, provided that the independence of the experts is en-

sured and any conflicts of interest of the experts involved in the assessment are ex-

cluded.

5. Extension of grace periods

The proposal also provides for an extension of grace periods.

a. Rules on transitional periods at active substance level

At present, where the approval of an active substance is not renewed, the non-renewal

Regulation may provide for a grace period of up to 18 months (6 months for distribution

and sale, plus 12 months for disposal and use of existing stocks). However, according to

the clear wording of the legislation, this option exists only 'where the reasons for not

renewing the approval do not concern the protection of health and environment'.82 Con-

versely, where renewal is refused for reasons relating to environmental and health

78 Article 3(17), Article 33(2) (b); for mutual recognition, cf. Article 40(1) (c) of Regulation (EC) No 1107/2009 (Draft). 79 Article 37(7) of Regulation (EC) No 1107/2009 (Draft). 80 Article 11(2), fourth subparagraph, Regulation (EC) No 1107/2009 (Draft). 81 Recital 17 of the draft amending regulation. 82 Article 20(2), first subparagraph, Regulation (EC) No 1107/2009.

21

protection, no such transitional period may be set. This is currently disregarded by the

Commission.

Under the proposed amendment, the 18-month grace period would apply irrespective of

the reason for non-renewal or restriction, and thus also where there are concerns re-

garding environmental and health safety. The Commission's current practice (which is

not compliant with the Regulation) would therefore be legalised.83 In addition, transitional

periods of a total of three years would be permissible where no other available, 'reason-

able' alternatives to plant protection products containing the active substance concerned

exist. Given the vagueness and breadth of the concept of 'reasonable' alternatives, there

is a risk that the total transitional period of three years will become the rule rather than

the exception. Plant protection products could be used for a substantial period even

though their harmfulness to health and the environment has been proven. Compared to

the status quo, this would constitute a worrying extension of transitional periods.

Article 20(2), second subparagraph, of Regulation (EC) No 1107/2009 requires the im-

mediate cessation of placing plant protection products on the market (and use) where

there is an 'immediate concerns for human health or animal health'. The Commission

proposal would further restrict this possibility by requiring that the concern for health and

the environment must also be 'serious'. This further raises the legal threshold to the det-

riment of health and environmental protection.

b. Rules on transitional periods at national level

Article 46 of Regulation (EC) No 1107/2009 concerns the setting of transitional periods

by Member States in the event of the withdrawal or restriction of product authorisations.

To date, the first sentence of Article 46 of Regulation (EC) No 1107/2009 provides, in

very general terms, that Member States 'may' set transitional periods. This discretion is

limited by the rule in sentence 2, according to which the transitional period shall not ex-

ceed 6 months for sale and distribution and, in addition, no more than 1 year for disposal,

storage and use of existing stocks of the plant protection product concerned, 'where the

reasons for withdrawal, amendment or non-renewal of the authorisation are not related

to the protection of human and animal health or the environment'. This means that, con-

versely, where an authorisation is terminated for reasons of environmental or health

83 See also PAN Europe, fn. 15, p. 4.16

22

protection, transitional periods are not permissible. This provision, too, is incorrectly ap-

plied in the national enforcement practice.84

Under the Commission proposal, in cases where a Member State withdraws or amends

an authorisation or does not renew it, as a result of a non-renewal or withdrawal of the

active substance approval, Member States shall set a grace period within the limits of

the maximum grace period set by the Commission. Where an authorisation is terminated

for other reasons, Member States 'may' provide for a grace period of in total one year.

The current limitation of this option to reasons not relating to environmental and health

protection would thus be removed. As a result, transitional periods of up to 18 months

would also be permissible where health and environmental protection are affected. This

lowers the level of protection.

Member States would still be able to set shorter transitional periods or none at all. How-

ever, given the existing practice in implementing Article 46 of Regulation (EC) No

1107/2009, there is no guarantee that Member States will make use of this option.

6. Freezing the state of scientific knowledge

The proposal foresees a far-reaching adjustment of the legal standard against which

applications for product authorisation are to be assessed.

A new sentence in Article 36(1) dirst subparagraph of Regulation (EC) No 1107/2009 is

to provide that, for the active substances contained in the plant protection product, Mem-

ber States “shall rely on the last assessment conducted at EU level”.

This means that the state of knowledge to be taken into account is frozen at the time of

the last approval of the active substance. However, this point in time may lie far in the

past, particularly if the proposed abolition of the periodic renewal of active substance

approvals is implemented. National authorisation authorities would have to ignore scien-

tific findings known to them on harmful effects on health and the environment in the au-

thorisation procedure if these relate to the active substance.

84 Cf. Higher Administrative Court of Lower Saxony (OVG Lüneburg), order of 3 November 2025, 10 ME 124/25, not published: The court clarifies that the national authorities must exer- cise their discretion when setting sell-out and use-up periods.

23

The implementation of this proposal would result in a significant reduction in the level of

protection and would contradict the findings of the ECJ that the authorities of the Member

States are obliged to take into account the latest scientific and technical findings when

authorising plant protection products.85

Furthermore, it is unclear how findings on the active substance can be clearly distin-

guished from findings on individual products. Many of the effects of the active substance

on the environment and health can only be determined by considering formulations,

which is why representative formulations are also included in the assessment at the level

of active substance approval.

The proposed provision would also lead to a problematic divergence in the state of

knowledge to be taken into account: although the data requirements for active sub-

stances86 and for plant protection products87 are largely identical, an outdated state of

knowledge would have to be applied regarding the data for active substances, whereas

the latest state of knowledge would be relevant for plant protection products. This would

lead to inconsistencies in risk assessment.

While the proposal provides that updates of the state of knowledge may also be taken

into account with regard to active substances ('unless it considers an update is neces-

sary in the light of current scientific and technical knowledge'), in such a case the Member

State may only request the Commission to act under Articles 18, 18a or 21 of Regulation

(EC) No 1107/2009.88 The recitals explain that this adjustment is intended to ensure that

findings can be assessed in a 'harmonised manner'.89

This 'detour' via the review of the active substance approval would mean that new sci-

entific evidence on active substances could only be taken into account with a consider-

able time delay. For instance, if new scientific evidence on the endocrine-disrupting prop-

erties of an active substance approved for an unlimited period becomes available, the

Member State would first have to persuade the Commission to adopt an implementing

85 CJEU, judgment of 25 April 2024, Joined Cases C-309/22 and C-310/22, paras 81, 83 and 100. 86 Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Par- liament and of the Council concerning the placing of plant protection products on the market. 87 Commission Regulation (EU) No 284/2013 of 1 March 2013 setting out the data requirements for plant protection products, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market. 88 Article 36(1), first subparagraph, second sentence, Regulation (EC) No 1107/2009 (Draft). 89 Recital 18 of the draft amending regulation.

24

Regulation under Articles 18 and 18a of Regulation (EC) No 1107/2009, for which no

specific deadlines are provided, or to initiate a review under Article 21 of Regulation (EC)

No 1107/2009. The review would then still have to be carried out, which can take several

years. The incorporation of new scientific findings would be significantly delayed.

Irrespective of this delay, it must be feared that the Commission claims a very wide dis-

cretion with regard to the application of Articles 18 and 18a of Regulation (EC) No

1107/2009 (Draft) and Article 21 of Regulation (EC) No 1107/2009.

7. Adjustments to the procedure for mutual recognition

To be welcomed is the proposal that mutual recognition of an authorisation is made sub-

ject to the additional condition that the authorised product is actually placed on the mar-

ket in the reference Member State.90 This is intended to prevent abuse of the mutual

recognition system in view of the differing fees that Member States set for granting au-

thorisations for plant protection products.91

A further extension of the scope of mutual recognition would result from the proposal that

official or scientific bodies engaged in agricultural activities, or agricultural professional

organisations should in future be able to apply for the mutual recognition of an authori-

sation even without the company's consent92 and that the existing requirement to demon-

strate a public interest in the use is deleted.93

Particularly problematic is the deletion of the current requirement to attach to the appli-

cation a complete dossier or a summary dossier, as well as the assessment report of the

reference Member State and its authorisation decision.94 These documents are essential

for an assessment within the meaning of Article 41(1) of Regulation (EC) No 1107/2009,

which, inter alia, requires account to be taken of the conditions in the territory of the

Member State granting recognition. The explanatory memorandum to the proposal notes

that the authorities of the Member State granting recognition can obtain these documents

directly from the reference Member State.95 However, this increases the administrative

burden (which is supposed to be reduced) and is contrary to the principle that the

90 Article 40(1)(a) and (b), Regulation (EC) No 1107/2009 (Draft). 91 Recital 20 of the draft amending regulation. 92 Recital 21 of the draft amending regulation. 93 Article 40(2), Regulation (EC) No 1107/2009 (Draft). 94 Article 42(1), second sentence, Regulation (EC) No 1107/2009 (Draft). 95 Recital 21 of the draft amending regulation.

25

applicant must submit the necessary documents. In addition, this additional procedural

step, whereby the authority must first obtain the necessary documents, further shortens

the already tight recognition period of 120 days.96

There are also particular concerns regarding the planned legal fiction of authorisation for

plant protection products containing biological control agents and low-risk active sub-

stances (see above under C.I.3.a.bb.(2)).

8. Treatment of treated seed and plant reproductive material

The proposal suggests amending the provisions governing the treatment of treated

seeds.

At present, the placing on the market and use of plant protection products used for seed

treatment require a national authorisation decision under Article 28(1) of Regulation (EC)

No 1107/2009. Under the Commission proposal, the placing on the market and use of

treated seed and plant reproductive material would be exempted from this authorisation

requirement, provided that the treatment was carried out with plant protection products

authorised for that use in at least one Member State.97 This would potentially allowto

treat seed domestically with products that do not have a national authorisation but are

merely authorised in another Member State. In view of the considerable risks that may

arise from the use of treated seed,98 this cannot be justified. Plant protection products

used for seed treatment urgently require thorough national risk assessment and national

risk management.

Another problematic aspect is the proposal to further raise the requirements for on inter-

nal market trade under Article 49 of Regulation (EC) No 1107/2009 with respect to seed

treated abroad. At present, where there are serious concerns that seed treated abroad

is likely to present a serious risk to health or the environment, 'measures to restrict or

prohibit the use and/or sale of such treated seeds shall be taken immediately'.99 Under

the amending proposal, the adoption of such measures would be left to the Commission's

96 See Article 42(2), Regulation (EC) No 1107/2009 (Draft). 97 Article 28(2) (f), Regulation (EC) No 1107/2009 (Draft). It is not specified in the proposal whether this must be a Member State within the same zone; it must therefore be assumed that authorisations from Member States in other zones would also have to be taken into account. 98 By way of reminder, reference may be made, for example, to the toxicity to bees of seed treated with neonicotinoids. 99 Article 49(2), Regulation (EC) No 1107/2009.

26

discretion.100 Here, too, it is clear that the proposal would reduce the importance of pro-

tection concerns.

Furthermore, it is proposed that machines for sowing treated seed would not constitute

pesticide application equipment within the meaning of Article 8 of Directive

2009/128/EC.101 This would mean that the inspection obligations laid down there would

not apply. No technical reasons are given for this privilege; according to the recitals, it is

intended solely to reduce the administrative burden for farmers.102

9. Easier market access for minor uses

The authorisation of minor uses under Article 51 of Regulation (EC) 1107/2009 is also to

be facilitated.

The proposal suggests, inter alia, deleting the current requirement that extending the

scope of an authorisation to minor uses must be of public interest.103

In addition, Member States are to be obliged to take measures to simplify or promote the

submission of applications to extend the scope of an authorisation of plant protection

products already authorised to minor uses.104

Furthermore, the possibility of mutual recognition of a minor use should no longer be

subject to the requirement that the use is minor in the reference Member State.105

Such relaxations must be viewed critically, because authorisations of minor uses are

exempt from some authorisation criteria, such as sufficient efficacy, and therefore do not

rely on a comprehensive assessment.

.

100 See Article 49(4), Regulation (EC) No 1107/2009 (Draft). 101 Article 49(7), Regulation (EC) No 1107/2009 (Draft). 102 Recital 22 of the draft amending regulation. 103 Article 51(2), Regulation (EC) No 1107/2009 (Draft). 104 Art. 51(3) Regulation (EC) No 1107/2009 (Draft). 105 Article 51(7), Regulation (EC) No 1107/2009 (Draft).

27

II. Compatibility with higher-ranking law

In shaping EU plant protection product law, the requirements of Article 191(2) in conjunc-

tion with Articles 114, 11 and 168 TFEU and Articles 35, second sentence, and 37 CFR,

as well as state duties of protection derived from fundamental rights, must be observed.

The proposed amendments give rise to serious doubts as to their compatibility with the

precautionary principle based on these provisions and the high level of protection for

health and the environment that must be ensured.

1. Article 191 TFEU

The principles laid down in Article 191 are to be regarded as legally binding, fundamental

and formative principles of European environmental policy and European environmental

law.106 They must be taken into account not only when interpreting secondary law107 but

also have a binding effect on the Union legislator.108

When exercising its powers in the environmental field pursuant to Articles 191 and

192 TFEU, the EU legislature enjoys a broad discretion.109 Judicial review is limited to

determining whether the EU legislature committed a manifest error of assessment.110

Article 191(2), first sentence, TFEU imposes on the Union an obligation, in its environ-

mental policy, to aim at a high level of protection. The objective of protecting human and

animal health and the environment takes precedence when granting an authorisation for

a plant protection product, over the objective of improving plant production.111 The high

level of protection to be ensured in plant protection product law also takes precedence

106 See, on Article 174 EC: CJEU, judgment of 14 July 1998, C-284/95, para. 36; judgment of 15 June 2002, C-9/00, para. 23. 107 See in the context of plant protection product law, for example, CJEU, judgment of 6 May 2021, C-499/18 P. 108 CJEU, judgment of 13 November 1990, C-331/88; judgment of 5 May 1998, C-157/96; judg- ment of 1 October 2019, C-616/17; General Court, judgment of 11 September 2002, Case T- 13/99; judgment of 11 September 2002, Case T-70/99. 109 Kahl, in: Streinz, EUV/AEUV, 3rd ed. 2018, Article 191 TFEU, para. 74; General Court, judg- ment of 2 March 2010, T‑16/04, para. 143; judgment of 31 January 2024, T-745/20, para. 114. 110 CJEU, judgment of 1 October 2019, C-616/17, para. 50; judgment of 21 December 2016, C- 444/15, para. 46. 111 CJEU, judgment of 19 January 2023, C‑162/21, para. 48; judgment of 25 April 2024, joined

Cases C‑309/22 and C‑310/22, para. 90.

28

over economic considerations and may therefore justify substantial adverse economic

consequences for certain traders.112

Pursuant to Article 191(2), second sentence, TFEU, environmental policy is also based

on the precautionary and preventive principle. These requirements also give rise to du-

ties of protection on the part of the Union in the field of environmental protection and

public health.113

According to the case-law of the European Court of Justice concerning Regulation (EC)

No 1107/2009, the precautionary principle entails that, where there is uncertainty as to

the existence or extent of risks to human health, protective measures may be taken with-

out having to wait until the reality and seriousness of those risks become fully apparent.

Where it proves impossible to determine with certainty the existence or extent of the

alleged risk because the results of the studies carried out are inconclusive, but the like-

lihood of real harm to public health persists should the risk materialise, the precautionary

principle justifies the adoption of restrictive measures.114

A correct application of the precautionary principle in the field covered by Regulation

(EC) No 1107/2009 requires, first, identification of the potentially negative effects of the

use of active substances and plant protection products falling within its scope on health

and, second, a comprehensive assessment of the health risk on the basis of the most

reliable scientific data available and the most recent results of international research.115

The EU legislature is required to establish a normative framework enabling the compe-

tent authorities, when deciding on authorisations and approvals, to have sufficient infor-

mation to assess, in a satisfactory manner, the hazards to health arising from the use of

those active substances and those plant protection products, in accordance with the pre-

cautionary principle and on the basis of the most reliable scientific data available and the

most recent results of international research.116

112 General Court, judgment of 17 May 2018, T-429/13 and T-451/13, paras 323, 106, 289; judg- ment of 9 September 2011, T‑475/07, para. 143; judgment of 6 September 2013, T‑483/11, not

published, para. 85; judgment of 12 December 2014, T‑269/11, not published, para. 138. 113 CJEU, judgment of 26 June 2019, C-723/17, para. 33. 114 CJEU, judgment of 1 October 2019, C-616/17, para. 43; cf. to that effect, CJEU, judgment of 22 December 2010, C‑77/09, paras 73, 76; judgment of 17 December 2015, C‑157/14, para. 81

et seq.; judgment of 22 November 2018, C‑151/17, para. 38. 115 CJEU, judgment of 1 October 2019, C-616/17, para. 46; judgment of 8 July 2010, C-343/09, para. 60; judgment of 22 December 2010, C-77/09, para. 75. 116 CJEU, judgment of 1 October 2019, C-616/17, para. 47.

29

The precautionary and preventive principles also imply that environmental pollution must

be addressed as a matter of priority through preventive measures, so that environmental

damage is prevented rather than merely remedied - including in situations of scientific

uncertainty.117

2. Article 114 TFEU and Article 11 TFEU

The requirement, under Regulation (EC) No 1107/2009, to maintain a high level of envi-

ronmental protection is also implemented pursuant to Article 11 TFEU, under which en-

vironmental protection requirements must be integrated into the definition and implemen-

tation of Union policies and activities, in particular with a view to promoting sustainable

development.

Article 114(3) TFEU also provides that, in its proposals for the approximation of laws

which have as their object the establishment and functioning of the internal market, the

Commission shall take as a base a high level of protection, inter alia in the field of envi-

ronmental protection, taking account, in particular, of any new development based on

scientific facts, and that the Parliament and the Council shall also seek to achieve that

objective within the scope of their respective powers.

That protection takes precedence over economic considerations, so that it may even

justify substantial adverse economic effects for certain economic operators.118

3. Article 37 CFR, Article 168 TFEU and Article 35, second sentence, CFR

Pursuant to Article 37 CFR, a high level of environmental protection and the improvement

of the quality of the environment must be integrated into the policies of the Union and

ensured in accordance with the principle of sustainable development. The quality of the

environment must therefore not only be preserved but improved.119

117 Epiney, in: Landmann/Rohmer UmweltR, 108th update (August 2025), TFEU Article 191 para. 23. 118 General Court, judgment of 19 November 2025, T-94/23, juris para. 76 et seq., with further references. 119 Jarass, Charta der Grundrechte der EU, 4th ed. 2021, Article 37 para. 6.

30

Environmental protection and the protection of human health are closely linked in the

field of environmental policy.120 In this context, the European Court of Justice refers to a

right to live in an environment that is adequate for an individual's health and well-being.121

Regulation (EC) No 1107/2009 also aims to protect human health from plant protection

products and is based, inter alia, on the public health legal basis in Article 168(4)(b)

TFEU. Accordingly, Article 168(1) TFEU and the identically worded Article 35, second

sentence, CFR must also be taken into account, pursuant to which a high level of human

health protection shall be ensured in the definition and implementation of all Union poli-

cies and activities.

That principle is aimed primarily at the preventive safeguarding of the state of health.122

In view of the potential health effects of the use of plant protection products, the precau-

tionary principle must therefore also be observed. According to the case law of the Eu-

ropean Court of Justice, it must also be applied in public health policy, and likewise where

- as here - Union institutions, on the basis of the common agricultural policy or internal

market policy, adopt measures to protect human health.123

When applying the precautionary principle, it must be borne in mind that health protection

has particular weight. The wording of the cross-cutting clause in Article 168(1) ('shall be

ensured') goes further than the wording of other cross-cutting clauses, for example in

Articles 9, 11 or 12 TFEU, which merely provide for the integration or consideration of

the relevant interest.124 Article 168(1) TFEU and Article 35, second sentence, CFR must

therefore be understood as an optimisation requirement. The greatest possible level of

health protection must be realised; health protection interests are to prevail as far as

possible.125

Accordingly, the case law of the Court of Justice shows that the protection of health must

be given priority over economic considerations.126

120 CJEU, judgment of 25 June 2024, C-626/22, para. 68. 121 CJEU, judgment of 25 June 2024, C-626/22, para. 72. 122 Jarass, Charta der Grundrechte der EU, 4th ed. 2021, Article 35 para. 9. 123 CJEU, judgment of 1 October 2019, C-616/17, para. 41, with further references. 124 Schmidt am Busch, in: Grabitz/Hilf/Nettesheim, EUV/AEUV, 85th update (May 2025), Article 168 TFEU para. 95. 125 Cf. Schmidt am Busch, in: Grabitz/Hilf/Nettesheim, EUV/AEUV, 85th update (May 2025), Arti- cle 168 TFEU para. 95, with further references. 126 CJEU, judgment of 17 July 1997, C-183/75, para. 43, with further references.

31

Furthermore, the obligation, provided for in Article 168(1) TFEU and Article 35, second

sentence, CFR, to ensure a high level of health protection means that the institutions of

the European Union must ensure that their decisions are taken with full account taken of

the best available scientific data and are based on the most recent results of international

research.127

These principles arising from Article 37 CFR, Article 168(1) TFEU and Article 35, second

sentence, CFR must be taken into account when applying Article 191 TFEU. Article 52(2)

CFR provides that rights recognised by the Charter which are based on the Treaties shall

be exercised under the conditions and within the limits defined by those Treaties.128

Article 168(1) TFEU and Article 35, second sentence, CFR must also be taken into ac-

count when reviewing compliance with the principle of proportionality laid down in Article

5 (4) TEU.

According to settled case law, the principle of proportionality, which forms part of the

general principles of EU law, requires that acts of the institutions must not exceed the

limits of what is appropriate and necessary in order to attain the objectives legitimately

pursued by the measure in question. Where there is a choice between several appropri-

ate measures, the least onerous must be used, and the disadvantages caused must not

be disproportionate to the aims pursued.129

If, in that balancing exercise, interests of health protection are not taken into account at

all or are given incorrect weight, this constitutes a breach of the cross-cutting clause in

Article 168(1), first subparagraph, TFEU and/or the principle in Article 35, second sen-

tence, CFR, which goes hand in hand with a breach of the principle of proportionality.130

In this context, due account must be taken of the principle that the protection of public

health takes precedence over economic interests.131

127 General Court, judgment of 11 September 2002, T-13/99, para. 158. 128 Cf. CJEU, judgment of 13 March 2019, C‑128/17, para. 130 et seq., with further references. 129 Cf. CJEU, judgment of 8 July 2010, C-343/09, para. 45, with further references. 130 Cf. the discussion of Article 168(1), first subparagraph, TFEU in Schmidt am Busch, in: Grabitz/Hilf/Nettesheim, EUV/AEUV, 85th update (May 2025), Article 168 para. 103, and of Arti- cle 35, second sentence, CFR in Jarass, Charta der Grundrechte der EU, 4th ed. 2021, para. 13; CJEU, judgment of 4 May 2016, C-547/14, para. 156 et seq. 131 Cf. CJEU, judgment of 19 April 2012, C-221/10 P, para. 99.

32

4. Duty to protect under Articles 2(1), 3(1) and 7 CFR

In addition, the fundamental rights enshrined in the EU Charter of Fundamental Rights

give rise to obligations on the part of the Union to protect life and health, inter alia, from

the hazards arising from the use of plant protection products.

For the interpretation of fundamental rights under the Charter, recourse must be had to

the case law of the European Court of Human Rights (ECtHR). This is because, for Char-

ter rights, Article 52(3) first sentence CFR provides that they shall have the 'same mean-

ing and scope' as the corresponding rights under the European Convention on Human

Rights (ECHR).132 The ECHR therefore has particular significance where Charter rights

overlap with the guarantees of the Convention.133 The provisions of the ECHR constitute

a minimum standard of protection. The protection guaranteed by the Charter may never

be less than that afforded by the ECHR.134

Pursuant to Article 2(1) CFR, everyone has the right to life. Article 2(1) CFR - like the

corresponding Article 2 ECHR - requires those bound by fundamental rights to protect

life through active measures.135 Article 2 ECHR must also be relied upon for the shaping

of that fundamental right as a duty of protection in environmental law.136

Under Article 3(1) CFR, everyone has the right to respect for his or her physical and

mental integrity. Article 7 CFR guarantees everyone the right to respect for his or her

private and family life, home and communications. By reference to the corresponding

Article 8 ECHR, Articles 3(1) and 7 CFR are understood as imposing an obligation to

provide protective support for the legal interest of physical integrity and to promote that

legal interest - particularly with regard to environmental burdens.137

132 Jarass, Charta der Grundrechte der EU, 4th ed. 2021, Article 52 para. 56. 133 CJEU, judgment of 25 March 2004, C-71/02, para. 48; judgment of 3 September 2009, C- 402/05, para. 283. 134 Jarass, Charta der Grundrechte der EU, 4th ed. 2021, Article 52 para. 63, with further refe- rences. 135 Borowsky, in: Meyer/Hölscheidt, Kommentar zur Charta der Grundrechte der Europäischen Union, 5th ed. 2019, Article 2 para. 37; Jarass, Charta der Grundrechte der EU, 4th ed. 2021, Article 2 para. 8. 136 Borowsky, in: Meyer/Hölscheidt, Kommentar zur Charta der Grundrechte der Europäischen Union, 5th ed. 2019, Before Title I para. 9, Article 2 para. 38; Jarass, Charta der Grundrechte der EU, 4th ed. 2021, Article 2 para. 8. 137 Jarass, Charta der Grundrechte der EU, 4th ed. 2021, Article 3 para. 10; Callies, in: Cal- lies/Ruffert, 6th ed. 2022, EU-GrCH, Article 3 para. 11, Article 7 para. 32; Borowsky, in: Meyer/Hölscheidt, Kommentar zur Charta der Grundrechte der Europäischen Union, 5th ed. 2019, Article 3 para. 39.

33

For the purposes of specifying these duties of protection, recourse must be had to the

ECtHR’s case-law on the positive obligations arising from Articles 2 and 8 ECHR.

According to the case law of the ECtHR, Article 2 ECHR entails a positive obligation to

take appropriate steps to safeguard life - both in respect of acts of public authorities and

of private actors.138

According to the ECtHR, Article 8 ECHR gives rise to a duty to protect against environ-

mental pollution, which applies well below the threshold of a risk to life. The ECtHR jus-

tifies this on the basis that severe environmental pollution may affect individuals’ well-

being and may lead to such a serious impairment of the enjoyment of their homes that it

affects their private and family life, without necessarily endangering their health.139 That

duty applies both in cases where pollution is directly caused by the State and in cases

where its responsibility is the result of a failure to regulate private activities of third parties

adequately.140

With regard to climate change, the ECtHR has only recently held that Article 8 ECHR

encompasses an individual right to effective protection by the public authorities against

serious adverse effects of climate change on his or her life, health, well-being and quality

of life.141 The same applies in relation to environmental protection.

While the scope of the duties of protection depends on the circumstances of the individ-

ual case,142 the measures to protect life and health and private and family life must nev-

ertheless be effective.143

138 ECtHR, Öneryıldız, judgment of 30 November 2004, no. 48939/99, paras 71, 89 et seq.; Bu- dayeva and Others, judgment of 20 March 2008, nos. 15339/02 et al., para. 128 et seq.; Nicolae Virgiliu Tanase, judgment of 25 June 2019, no. 41720/13, paras 140 et seq. 139 Cf. ECtHR, Fadeyeva, judgment of 9 June 2005, no. 55723/00, para. 87; López Ostra, judg- ment of 9 December 1994, no. 16798/90, para. 51; Jugheli and Others, judgment of 13 July 2007, no. 38342/05, para. 71. 140 ECtHR, Frankowski and Others, decision of 20 September 2011, no. 25002/09. 141 ECtHR, Climate Seniors and Others, no. 53600/20, para. 519. 142 Settled case-law, ECtHR, Kolyadenko and Others, judgment of 28 February 2012, nos. 17423/05 et al., paras 160 et seq.; Budayeva and Others, judgment of 20 March 2008, no. 15339/02, paras 136-137; Vilnes and Others, judgment of 5 December 2013, nos. 52806/09 and 22703/10, para. 220. 143 See, on Article 2 ECHR: ECtHR, Brincat and Others, judgment of 24 July 2014, no. 60908/11, para. 79; likewise ECtHR, L.C.B., judgment of 9 June 1998, no. 14/1997/798/1001, para. 36. See, on Article 8 ECHR: ECtHR, Oluić, judgment of 20 May 2010, no. 61260/08, paras 48 et seq., 64 et seq.; Moreno Gómez, judgment of 16 November 2004, no. 4143/02, para. 55.

34

The establishment of an effective legal and administrative framework is of particular im-

portance. The ECtHR derives from the positive obligations under Articles 2 and 8 ECHR

a duty on the State to put in place a legislative and administrative framework ensuring

effective prevention of harm to the environment and to human health and life.144 Only

under certain specific circumstances may it be assumed that positive obligations are met

in practice even in the absence of relevant statutory provisions.145

Where environmental protection standards have been enacted, there is a violation of the

Convention if they fail to strike a fair balance between the competing interests.146

The European Union’s action or failure to act must also be assessed against that stand-

ard.

5. Application to the proposed amendments

Applying those principles to the amendments proposed by the Commission, there are

serious doubts as to their compatibility with higher ranking law.

In the Blaise case, the European Court of Justice already had to rule on the compatibility

with primary law of Regulation (EC) No 1107/2009. The Court emphasised that, when

adopting rules on the placing on the market of plant protection products, the EU legisla-

ture must comply with the precautionary principle and ensure a high level of health pro-

tection:

“There is therefore an obligation on the EU legislature, when it adopts rules gov-

erning the placing on the market of plant protection products, such as those laid

down in Regulation No 1107/2009, to comply with the precautionary principle, in

order to ensure, in particular, in accordance with Article 35 of the Charter of Fun-

damental Rights of the European Union and Article 9 and Article 168(1) TFEU, a

high level of -protection of human health (see, by analogy, judgment of 4 May

2016, Pillbox 38, C‑477/14, EU:C:2016:324, paragraph 116).”

CJEU, judgment of 1 October 2019, C‑616/17, para. 42; see also General Court,

judgment of 19 November 2025, T‑412/22, juris, para. 46

144 ECtHR, Brincat and Others, judgment of 24 July 2014, no. 60908/11, para. 112; Cordella and Others, judgment of 24 January 2019, no. 54414/13, para. 159; Moreno Gómez, judgment of 16 November 2004, no. 4143/02, para. 55; judgment of 9 April 2024, Climate Seniors and Others, no. 53600/20, para. 545; on Article 2: Öneryıldız, judgment of 30 November 2004, no. 48939/99, para. 89. 145 ECtHR, Brincat and Others, judgment of 24 July 2014, no. 60908/11, para. 112. 146 ECtHR, Fadeyeva, judgment of 9 June 2005, no. 55723/00, para. 132 et seq.

35

In that judgment, the Court interpreted the safeguards laid down in Regulation (EC) No

1107/2009 in a protection‑oriented manner and in accordance with the precautionary

principle, and, based on that restrictive interpretation, upheld the Regulation as compat-

ible with primary law.

The Commission proposal provides for a significant lowering of the level of protection

achieved by Regulation (EC) No 1107/2009. It is therefore questionable whether, if this

proposal were to be implemented, the Court would still conclude that the Regulation

complies with the principles of precaution and a high level of protection.

a. Indefinite approval of active substances

Significant legal concerns are raised by the proposal to grant approvals for plant protec-

tion product active substances with an unlimited duration.

In its current form, that proposal would mean that, the regular reevaluation of risks to the

environment and human health would be removed for the vast majority of active sub-

stances.

However, as the European Court of Justice has emphasized in the Blaise-ruling, the pre-

cautionary principle requires that potential adverse effects on health be identified and

subjected to a comprehensive assessment based on the most reliable scientific data

available and the most recent results of international research.147

Those requirements are not met if an active substance approval is assessed only once

and is then no longer updated in line with scientific and technical progress.

The high level of protection required under primary law pursuant to Articles 114(3), 168(1)

and 191(2) TFEU is also unlikely to be maintained if such a far-reaching waiver of adap-

tation to scientific progress is granted. These principles require measures ensuring that

existing approvals are reviewed regularly in the light of current scientific data.

No such safeguards are foreseen in the proposal. The provisions in Articles 18 and 18a

of Regulation (EC) No 1107/2009 (Draft) cannot ensure that new scientific findings on

147 CJEU, judgment of 1 October 2019, C‑616/17, para. 46 et seq.; judgment of 8 July 2010,

C‑343/09, para. 60; judgment of 22 December 2010, C‑77/09, para. 75.

36

health and environmental hazards are taken into account in a timely manner. A mere

possibility of review provided for in discretionary provisions is insufficient in situations

where scientifically proven risks to health and the environment arise. Article 21 of Regu-

lation (EC) No 1107/2009 as well cannot fully compensate for the loss of a regular, sys-

tematic full review. That would apply even if the Commission were to abandon its hitherto

restrictive approach to applying Article 21, because the possibility (and obligation) of ad

hoc review does not render regular comprehensive review, including the generation of

new data, dispensable.

The proposal for indefinite approvals also runs counter to the Court’s findings that, in the

field of plant protection products, the principle of legal certainty must be balanced against

the precautionary principle. The Court held that those placing plant protection products

on the market must at all times expect that circumstances may come to light showing

that an active substance or a plant protection product has harmful effects on the health

of humans or animals or unacceptable effects on the environment. The Commission

and/or the Member States are required to take such findings into account and, where

appropriate, to withdraw the active substance approval or the product authorisation.148

b. Freezing the state of scientific knowledge

Serious concerns under primary law are also raised by the proposal to prohibit Member

States from taking account of the latest state of science in relation to active‑substance

data.

As explained above, the proposed rule in Article 36(1) of Regulation (EC) 1107/2009

(Draft) would mean that the national authorities would have to ignore new scientific find-

ings or would only be able to take them into account many years later.

This is incompatible with the precautionary principle and the required high level of pro-

tection within the meaning of Article 191(2) TFEU, Article 168(1) TFEU, Article 35 and 37

CFR. The precautionary principle specifically enables and requires action in situations

where there are indications of risks to human health and the environment, but the risk

cannot yet be established with certainty. The proposal runs diametrically counter to this

principle, as it not only fails to provide that action is mandatory, but even prohibits action

148 CJEU, judgment of 25 April 2024, C‑308/22, paras 107–109.

37

and directs national authorities only to initiate a multi‑year review mechanism fraught

with uncertainty.

Moreover, the proposal contradicts the findings of the European Court of Justice in its

judgments of 25 April 2024 that, when examining authorisation applications, Member

States are not confined to particular categories of scientific evidence or to specific points

in time when that evidence became available, and that they must assess applications in

the light of current scientific knowledge.149 These findings are not a mere interpretation

of secondary law, because the Court also relied on the objective, enshrined in primary

law, of ensuring a high level of protection and on the precautionary principle.150

In addition, in the Blaise-ruling the Court of Justice explained that the obligation to take

account of the latest state of science follows from the precautionary principle anchored

in primary law. It therefore cannot be curtailed by an amendment to the Regulation.

c. Waiving prior authorisation and approval for certain substances

The insufficiently defined exemptions that provide for a complete waiver of an authorisa-

tion or approval decision are also questionable under primary law. These include, in par-

ticular, new exemptions from the authorisation requirement for treated seed and the au-

tomated authorisation/recognition for products containing biocontrol substances where

the 120‑day decision period is exceeded.

The precautionary principle and the principle of ensuring a high level of health protection

are aimed at preventive safeguarding of health.151 Against that background, the require-

ments in Regulation (EC) No 1107/2009 for prior approval of active substances and prior

authorisation of plant protection products give expression to the precautionary princi-

ple.152 Purely ex post control does not satisfy the requirements of the precautionary and

preventive principles.

149 CJEU, judgment of 25 April 2024, C‑309/22 and C‑310/22, para. 77; C‑308/22, para. 91. 150 CJEU, judgment of 25 April 2024, C‑308/22, paras 102 et seq. 151 Jarass, Charta der Grundrechte der EU, 4th ed. 2021, Article 35, para. 9. 152 General Court, judgment of 19 November 2025, T‑94/23, para. 45, juris; judgment of 17 -March 2021, T‑719/17, paras 60 and 61, and the case-law cited-; CJEU, judgment of 22 De-

cember 2010, C‑77/09, para. 74.

38

According to the European Court of Justice the harmlessness of plant protection prod-

ucts must not be presumed.153 That is also reflected in the fact that the applicant must

prove that the approval criteria are met.154

A waiver of the authorisation requirement, or an automated authorisation upon expiry of

the time limit, is not compatible with these findings an the principles of precaution and a

high level of protection.

The waiver of the authorisation requirement cannot be justified by the Commission’s as-

sertion that the substances are harmless. It cannot generally be assumed that, for ex-

ample, products containing biological control substances have no harmful effects what-

soever on health and the environment, or that any doubts in that regard are purely hypo-

thetical.

The waiver of the authorisation requirement triggered by the legal fiction in case of ex-

ceedance of the 120‑day deadline also raises doubts as to the proportionality of the pro-

posal. It is not even suitable for achieving the objectives of the amending regulation. The

objective of promoting the accessibility and availability of sustainable plant protection

products is not achieved, since the chosen definition does not ensure that only safe plant

protection products benefit from the intended privilege. The objective of reducing the

burden on national authorities and companies would likewise be promoted by the legal

fiction only if, given the short deadline, the national authorities simply “capitulated” and

did not even attempt an assessment. If, by contrast, the authorities attempt to process

applications within 120 days which must be expected in a state governed by the rule of

law - the pressure created by the proposed provision of tacit authorisation would mean

that the authorities would have to build up and maintain human resources in order to

issue legally secure approval or rejection decisions within the short time available. A

streamlining of the authorities is then not to be expected. Even if relieving effects were

to be expected and the proposal succeeded in paving the way for more sustainable plant

protection products to enter the market, these marginal positive developments would be

disproportionate to the significant risks to the environment and human health described

above.

153 CJEU, judgment of 1 October 2019, C-‑616/17, para. 80. 154 CJEU, judgment of 1 October 2019, C‑-616/17, para. 80; judgment of 9 December 2021,

C‑374/20 P, para. 128; judgment of 22 Jun-e 2023, C‑259/22 P, para. 73.

39

d. Temporary approval of active substances

Similar concerns regarding compatibility with the precautionary principle and the high

level of protection are raised by the proposed relaxation of the requirements for tempo-

rary approval of active substances in accordance with Article 4(7) of Regulation (EC) No

1107/2009.

As outlined above, the planned focus on the absence of “reasonable” alternatives and

on “plant production” creates the risk that this provision could be relied upon even where

less harmful alternatives exist but entail greater effort or higher costs.

As a result, even substances that are extremely harmful to health (e.g. endocrine disrup-

tors) could, despite the availability of alternatives, obtain an approval (albeit temporary)

on economic grounds.

This is difficult to reconcile with the requirements of primary law under Article 191(2)

TFEU, Article 168(1) TFEU, Article 35and 37 CFR. According to the case law of the EU

Courts, environmental and health protection must take precedence over economic con-

siderations and the improvement of plant production.155

e. Extension of grace periods for disposal/use

It is also questionable whether the provision of sales and use-up periods of up to 18 or

even 36 months in cases where the authorisation or approval has been terminated for

reasons of environmental and health protection is compatible with primary law.

These transitional periods, which tolerate continued exposure to substances harmful to

health and the environment, appear disproportionately long and are incompatible with

the high level of protection required by primary law. Furthermore, they are diametrically

opposed to the precautionary principle. As explained above, the precautionary principle

requires that active substances and plant protection products be withdrawn from the

market as soon as there are serious indications of harmful effects on health. This is all

the more true when a decision has already been taken not to renew authorisations and

approvals for reasons of environmental and health protection.

155 See CJEU, judgment of 19 April 2012, C‑221/10 P, para. 99; judgment of 25 April 2024,

C‑309/22, para. 90.

40

The transition periods also violate the principle of proportionality. It is not clear how they

contribute to reducing administrative burdens for authorities and companies. The with-

drawal of a plant protection product authorisation is a simple administrative act. Its ne-

cessity in practice becomes apparent many months in advance. It is therefore not clear

why administration would need several months to implement the withdrawal decision.

Ultimately, the proposal seems to serve solely economic interests and the objective of

improving plant production. That interest must be weighed against the interest in reme-

dying identified risks to human health or the environment. The latter takes precedence.

In light of the foregoing, there are serious doubts as to the conformity of several of the

Commission's proposals with primary law.

D. The Commission’s procedural approach and its lawfulness

Despite the expected significant environmental impacts and contrary to the Interinstitu-

tional Agreement and the Better Regulation Guidelines, the Commission did not conduct

an impact assessment. This constitutes an infringement of the principles of proportional-

ity, equal treatment and the protection of legitimate expectations (see I. below). That

infringement is exacerbated by the decision not to conduct a public consultation (see II.

below).

I. Dispensing with an impact assessment

1. The Commission’s approach

The Commission did not conduct an impact assessment of its initiative. By way of justi-

fication, it states that a full impact assessment would add no value because the proposed

simplification measures are highly technical in nature, there are no viable alternatives to

achieve the objectives, and the proposed measures would not alter core policy objec-

tives. In any event, significant cost savings for industry and the authorities are to be

expected.156

Potential impacts on health and the environment are not mentioned in the section on the

impact assessment. In the subsequent remarks on regulatory fitness and

156 See COM(2025) 1030 final, fn. 5, p. 18.

41

fundamental‑rights relevance, it is merely stated that the proposal would not undermine

the protection of human and animal health and the environment.

Under the heading “Ex‑post evaluations/fitness checks of existing legislation”, the Com-

mission refers to the accompanying Commission Staff Working Document, which alleg-

edly provides a detailed overview of the positive impacts of the proposed amendments.

That overview is said to be based on available data and on information obtained from

the “Call for Evidence” conducted from mid‑September to mid‑October, as well as previ-

ous analyses.157

The Commission Staff Working Document referred to contains an extensive analysis of

the expected cost savings for businesses and the administration. As further positive ef-

fects, it mentions a reduced workload for businesses, faster and simpler decision‑making

by the competent authorities, and greater legal certainty. As regards possible impacts on

health and the environment, it merely states that the protection of human and animal

health would be maintained or even strengthened. There is no indication that the Com-

mission expected any impacts on those legal interests.

2. Infringement of the Interinstitutional Agreement and the Better Regulation

Guidelines

In accordance with point 13 of the Interinstitutional Agreement on Better Law‑Making,158

the Commission will carry out impact assessments of its legislative initiatives that are

expected to have significant economic, environmental or social impacts. In doing so, it

will consult as widely as possible.

The Commission has set out these Better Regulation principles for its work in the Better

Regulation Guidelines159 (hereinafter: “Guidelines”) and the accompanying Toolbox.160

157 See COM(2025) 1030 final, fn. 5, p. 17. 158 Interinstitutional Agreement between the European Parliament, the Council of the European Union and the European Commission on Better Law‑Making of 13 April 2016, OJ L 123, p. 1, available at https://eur-lex.europa.eu/legal-con- tent/de/ALL/?uri=CELEX%3A32016Q0512%2801%29, last accessed on 8 January 2026. 159 European Commission, Better Regulation Guidelines, SWD(2021) 305 final, available at https://commission.europa.eu/document/download/d0bbd77f-bee5-4ee5-b5c4- 6110c7605476_en?filename=swd2021_305_en.pdf, last accessed on 8 January 2026. 160 European Commission, Better Regulation Toolbox, July 2023, available at https://commis- sion.europa.eu/document/download/9c8d2189-8abd-4f29-84e9-abc843cc68e0_en?file- name=BR%20toolbox%20-%20Jul%202023%20-%20FINAL.pdf, last accessed on 6 January 2026.

42

In Chapter 4 of the Guidelines, the Commission notes that an impact assessment is

required for Commission initiatives that are likely to have significant economic, environ-

mental or social impacts, or entail significant expenditure, and where the Commission

has a choice of different policy options.161

In exceptional cases, the Commission may depart from the Guidelines and therefore also

dispense with an impact assessment. The exceptions mentioned include political ur-

gency, emergencies, deadlines in the legislative procedure, as well as the need to protect

security-related or confidential information.162 Where such a derogation is granted, an

analytical document in the form of a Staff Working Document is to be prepared within

three months of the initiative’s adoption, presenting the evidence behind the proposal

and the cost estimates.163

In the present case, the Commission did not carry out an impact assessment and justified

this by stating that such an assessment would add no value due to the technical nature

of the proposed measures, that there were no viable alternatives for achieving the ob-

jective, and that the measures would not alter core policy objectives.

It remains unclear whether the Commission considered that an impact assessment was

not required in the first place because no significant economic, environmental or social

impacts, or significant expenditure, were expected, or whether it claimed a derogation

for itself. The former seems more likely, since in the past the Commission has expressly

mentioned reliance on derogations on grounds of urgency.164 Furthermore, in the present

case the Commission indicated in several places that no negative impacts were to be

expected.

In any event, its approach is not consistent with the Guidelines.

161 See European Commission, Better Regulation Guidelines, fn. 159, p. 30. 162 See European Commission, Better Regulation Toolbox, fn. 160, p. 10; Better Regulation Guidelines, fn. 159, p. 4. 163 See European Commission, Better Regulation Guidelines, fn. 159, p. 30. 164 See, for example, COM(2023) 754 final, p. 10; COM(2024) 139 final, p. 6; COM(2025) 80 final, p. 10; COM(2025) 81 final, p. 14.

43

The proposed amendments are expected to have significant environmental impacts (see

above). Both under the Interinstitutional Agreement and under the Guidelines, an impact

assessment should therefore in principle have been carried out.

Moreover, the reasons relied upon do not constitute a valid justification for dispensing

with an impact assessment by way of derogation. The technical nature of measures may

be relevant to the format of consultation, but not to the need for an impact assessment.

The consequences of measures do not depend on their technical character. The asser-

tion that there were no alternatives for achieving the objective is simply incorrect. The

objective of reducing administrative burdens for businesses and the administration could

have been pursued through a range of measures that ought to have been compared

precisely in terms of their potential social, economic and environmental effects. Finally,

whether the measures alter the core policy objectives could only be assessed after an

impact assessment.

Lastly, the Commission also failed to address the expected impacts on the environment

and health in its accompanying Staff Working Document, although this would have been

required had it relied on a derogation.

3. Legal consequences

a. Violation of the principle of proportionality

Although the rules on impact assessment presumably do not confer any individual

rights,165 the absence of an impact assessment may nevertheless render a legal act un-

lawful by reason of an infringement of the principle of proportionality.166

According to settled case-law, the principle of proportionality forms part of the general

principles of EU law and requires that the means employed by EU law provisions be

appropriate for attaining the legitimate objectives pursued by the legislation at and must

not go beyond what is necessary to achieve them.167

165 General Court, judgment of 31 January 2024, T‑745/20, para. 97. 166 See the legal opinion by Baldon Acovats, Potential legal challenges under EU law to the pro- posed omnibus directive amending the CRSD and CSDD, 23 June 2025, p. 8 et seq. 167 CJEU, judgment of 3 December 2019, C‑482/17, para. 76.

44

Despite the broad margin of discretion, the EU legislature is required to base its decision

on objective criteria and to examine whether the objectives pursued by the measure

chosen can justify the adverse consequences resulting from it.168 This dictum, formulated

with reference to Article 5 of the Protocol (No 2) on the application of the principles of

subsidiarity and proportionality in order to justify negative economic consequences, must

also apply to adverse consequences for health and environment protection, given that

these are enshrined in Art. 11 TFEU and Article 191 TFEU.

In the context of judicial review of the act by the Court of Justice, the EU legislature must

be able to show that it has actually exercised its discretion, which presupposes that all

relevant factors and circumstances of the situation intended to be regulated by that act

have been taken into account.169 This, in turn, requires a sufficient degree of information

to be available in order to assess the proportionality of the measure.170 If the EU legisla-

ture did not have that information, this results in an infringement of the principle of pro-

portionality.171

This is where the impact assessments becomes relevant: the Court of Justice has ex-

pressly held, with reference to points 12 to 15 of the Interinstitutional Agreement, that the

preparation of impact assessments is a step in the legislative process which must be

carried out as soon as a legislative initiative is liable to have significant economic, envi-

ronmental or social impacts.172 The absence of an impact assessment cannot be classi-

fied as an infringement of the principle of proportionality where the EU legislature is in a

specific situation requiring it to dispense with such an assessment and has a sufficient

degree of information enabling it to assess the proportionality of the measure adopted.173

A violation of the principle of proportionality therefore exists, at the very least, where the

EU legislature dispenses with an impact assessment despite expected economic, envi-

ronmental or social consequences and has also not obtained, by other means, the

168 CJEU, judgment of 3 December 2019, C‑482/17, para. 79; judgment of 4 October 2024,

C‑541/20 to C‑555/20, paras 243 and 721. 169 CJEU, judgment of 3 December 2019, C‑482/17, para. 81; judgment of 4 October 2024, C‑541/20 to C‑555/20, paras 244 and 722. 170 CJEU, judgment of 4 October 2024, C‑541/20 to C‑555/20, paras 244 and 722. 171 CJEU, judgment of 4 October 2024, C‑541/20 to C‑555/20, paras 244 and 722. 172 CJEU, judgment of 3 December 2019, C‑482/17, para. 82 et seq.; General Court, judgment of 27 November 2024, para. 270. 173 CJEU, judgment of 3 December 2019, C‑482/17, para. 85.

45

information required to review proportionality.174 Accordingly, the Court of Justice de-

clared an EU act void in an action for annulment brought by several Member States,

because the EU legislature had taken into account the information necessary to assess

the factual situation neither in the impact assessment nor by other means.175

In the present case, the Commission dispensed with an impact assessment and instead

referred to the accompanying Staff Working Document, which was said to set out the

positive effects of the Commission proposal. That document contains no indications of

possible adverse impacts on the environment and human health.

Nor is it apparent that the Commission identified such impacts outside of an impact as-

sessment to take them into account in the exercise of its discretion. The repeated asser-

tion that the high standards for the protection of human and animal health and the envi-

ronment is not substantiated at any point in the Commission’s proposal.

If the Council and the Parliament also refrain from conducting an impact assessment or

otherwise investigating possible environmental and health impacts, it would have to be

assumed that these impacts were simply not examined and therefore could not be taken

into account in the proportionality assessment. Correspondingly, the proportionality as-

sessment in the statement of reasons of the Commission proposal is very brief and is

limited to a single sentence.176

In view of the serious adverse effects on the environment and human health which are

to be expected, their non-consideration constitutes a misuse of discretion and is incom-

patible with the principle of proportionality.

b. Violations of the principles of equal treatment and the protection of legitimate

expectations

Dispensing with an impact assessment contrary to the Guidelines also gives rise to se-

rious doubts as to compliance with the principle of equal treatment.

174 See, on the possibility of relying on other information, among others CJEU, judgement of 13 march 2019, C-128/17, paras 31 et seq., 42; judgment of 3 December 2019, C‑482/17, para. 86 et seq. 175 See CJEU, judgment of 4 October 2024, C‑541/20 to C‑555/20, para. 738. 176 “The initiative does not go beyond what is necessary to achieve the objectives of simplifica- tion and burden reduction without lowering the protection of human health and environment.”, COM(2025) 1030 final, fn. 5, p. 17.

46

According to the case-law of the Court of Justice, internal measures may form rules of

practice from which the administration may not depart in an individual case without giving

reasons that are compatible with the principles of equal treatment or the protection of

legitimate expectations. Such measures therefore constitute a general and the officials

and other staff concerned may invoke their illegality in support of an action against indi-

vidual measures adopted on their basis.177

That case-law can likewise be applied to the Better Regulation Guidelines.178 As the Eu-

ropean Ombudsman correctly points out, stakeholders rely on the Commission’s Better

Regulation rules and plan their activities in accordance with them. They expect to have

access to the Commission’s impact assessments and to be able to submit their views on

those assessments as early as possible.179

Accordingly, with regard to the general legal principles of equal treatment and the pro-

tection of legitimate expectations, the failure to carry out an impact assessment, contrary

to the guidelines, calls into question the lawfulness of the Commission’s approach.

c. Infringement of Article 168(1) TFEU

By virtue of the horizontal clause in Article 168(1) TFEU, all measures must be subjected

to a health impact assessment which must take into account the above-mentioned stand-

ard of achieving a high level of health protection, for which all developments based on

scientific findings must be taken into account.180 A health impact assessment requires

that all measures and projects be evaluated with regard to their potential effects on the

health of the individual and/or of the population.181

It is not apparent that the Commission identified the effects of its proposal on human

health. Apart from the repeated assertion that the proposal would not lower the level of

177 CJEU, judgment of 28 June 2005, C‑189/02 et al., para. 209 et seq. 178 See also European Ombudsman, Recommendation on the European Commission’s compli- ance with ‘Better Regulation’ rules and other procedural requirements in preparing legislative proposals that it considered to be urgent (983/2025/MAS – the “Omnibus” case, 2031/2024/VB - the “migration” case, and 1379/2024/MIK - the “CAP” case, recommendation of 25 November 2025, point 38. 179 European Ombudsman, fn. 178, cited above. 180 Schmidt am Busch, in: Grabitz/Hilf/Nettesheim, EUV/AEUV, 85th update (May 2025), Article 168 TFEU, para. 93. 181 Schmidt am Busch, in: Grabitz/Hilf/Nettesheim, EUV/AEUV, 85th update (May 2025), Article 168 TFEU, para. 94.

47

protection of human or animal health or the environment, there are no comments on this

subject.

The failure to carry out an impact assessment despite the expected significant impacts

on human health, and thus contrary to the Guidelines, is therefore also contrary to EU

law because of the obligation arising from Article 168(1) TFEU.

II. Insufficient stakeholder consultation

1. Approach of the Commission

The Commission did not conduct a public consultation, arguing that that the initiative did

not aim to alter the objectives of the legislation and addresses technical adjustments

aimed at efficiency gains within the existing framework.182

Instead, the Commission stated that it had carried out a proportionate, targeted stake-

holder consultation. To that end, it relied on ongoing exchange formats with Member

States and stakeholders as well as recent evaluations. In addition, in July 2025 it con-

ducted a targeted Implementation Dialogue on biocides. Furthermore, a “Call for Evi-

dence” was carried out, which generated a total of around 6,500 responses, including

319 position papers with detailed technical input. All of this was said to have been incor-

porated into the problem definition, the prioritisation of options and the safeguards.183

The Commission sets out the positions of the various stakeholder groups, clustered by

topic, in the Commission proposal itself on approximately one page, concluding that

stakeholders advocate a risk-based simplification which maintains a high level of health,

environmental and consumer protection and is underpinned by transparency, independ-

ent science and strong enforcement.

The Staff Working Document contains a more detailed presentation of the stakeholders’

positions, noting at several points that citizens and NGOs expressed the concern that

the level of protection could be reduced.184

182 See SWD(2025) 1030 final, fn. 6, p. 56. 183 See COM(2025) 1030 final, fn. 5, p. 17; SWD(2025) 1030 final, fn. 6, p. 56. 184 See SWD(2025) 1030 final, fn. 6, p. 56 et seq.

48

It is not comprehensible whether and how that concern was taken into account and ad-

dressed in the drafting of the Commission’s proposal.

2. Infringement of procedural requirements as well as the Interinstitutional

Agreement and the Better Regulation Guidelines

Pursuant to Article 11 (3) TEU, the Commission is required to conduct borad consulta-

tions with the parties concerned.

Article 2 of Protocol (No 2) on the application of the principles of subsidiarity and propor-

tionality provides that the Commission consult widely before proposing a legislative act.

In cases of exceptional urgency, it shall not conduct such consultations and give reasons

for its decision in its proposal.

Similarly, point 19 of the Interinstitutional Agreement provides that, before adopting a

proposal, the Commission shall carry out public consultations in an open and transparent

way and ensure that the modalities and time limits of those public consultations allow for

the widest possible participation.

Under the Guidelines, a public consultation of at least 12 weeks is required where an

initiative is prepared which is accompanied by an impact assessment. For initiatives that

are not accompanied by a public consultation, a Call for Evidence is planned to give

stakeholders four weeks to provide their feedback.185

The Commission merely launched the Call for Evidence and otherwise asserted that it

has taken into account existing findings from its exchanges with interest groups.

The findings already available from the past cannot replace the consultations, as they

cannot relate to the Commission’s project due to the passage of time.

The Commission limited itself to obtaining feedback in the Call for Evidence. That is con-

sistent with the approach not to conduct an impact assessment. However, it illustrates

the effects of the failure to conduct an impact assessment for stakeholder participation:

instead of being able to comment on the initiative over a 12-week period and on the basis

of extensive material, stakeholders were confined to commenting within four weeks on

185 See European Commission, Better Regulation Guidelines, fn. 159, pp. 15-16.

49

the overall five-page Call for Evidence document. 186 That document contained only a

brief overview of the planned measures and of the thematic areas to be addressed. The

Call for Evidence did not provide any information on key measures such as the removal

of the time limit on the approval of active substances.

This made it impossible to submit a targeted statement on the planned project.

3. Legal consequence: violation of the principles of proportionality, equal treat-

ment and the protection of legitimate expectations

The General Court extends the case-law on the relevance of impact assessments to the

conduct of wide consultations which are provided for in Protocol (No 2) on the application

of the principles of subsidiarity and proportionality and in the Interinstitutional Agree-

ment.187

The above-mentioned violation of the principles of proportionality, equal treatment and

the protection of legitimate expectations by refraining from conducting an impact assess-

ment is therefore exacerbated by the subsequent failure to conduct a public consultation

which is actually provided for in the Guidelines prior to an initiative such as the present

one.

Furthermore, it cannot be ruled out that the absence of the consultations provided for in

the Guidelines can be challenged as an infringement of essential procedural require-

ments within the meaning of Article 263(2) TFEU.188

However, such an infringement is only to be assumed where the failure to conduct the

consultations and hearings results in the Commission not having the necessary infor-

mation at its disposal.189 The infringement therefore merges into the violation of the

186 Available at https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14824- Food-and-feed-safety-simplification-omnibus_en, last accessed on 9 January 2026. 187 General Court, judgment of 27 November 2024, T‑526/19, paras 287–288 and 322. 188 See the Court’s assessment in General Court, judgment of 27 November 2024...; see also the legal opinion by Baldon Acovats, Potential l...us directive amending the CRSD and CSDD, 23 June 2025, p. 20 et seq. 189 See the Court’s assessment in General Court, judgment of 27 November 2024, T‑526/19, para. 280.

50

principles of proportionality, equal treatment and the protection of legitimate expectations

already described above.190

III. Statement of reasons of the proposal

Article 168(1) TFEU gives rise to an obligation to reflect the health-policy considerations

to be undertaken, pursuant to Article 296(2) TFEU, in the statement of reasons. This

requires that the statement of reasons disclose the key considerations, so that it can be

reviewed whether the health-protection requirements were observed and correctly

weighed.191

This did not occur, since the identification of the possible consequences for health was

already omitted. The approach therefore also contravenes Article 296(2) TFEU in con-

junction with Article 168(1) TFEU.

E. Conclusion and outlook

The amendments provided for in the Commission proposal significantly weaken the pro-

tection of human health and the environment under the EU Legislation on Plant Protec-

tion Products.

In addition to the extensive removal of time limits on active substance approvals, the

freezing of the state of scientific knowledge at the time of approval of the active sub-

stance and the envisaged privileging of certain substances and substance groups, it is

in particular the extension of grace periods which leads to a lowering of the level of pro-

tection.

The Commission proposal violates higher-ranking EU law in several respects, both in

terms of its content and the procedure followed in its preparation. It is compatible neither

with the precautionary principle laid down in Article 191(2) TFEU, nor does the Union

fulfil its positive obligations guaranteed in the Charter of Fundamental Rights with the

amended Regulation (EC) No 1107/2009. From a procedural point of view, the failure to

carry out an impact assessment and the insufficient statement of reasons due to the lack

190 See CJEU, judgment of 3 December 2019, C‑482/17, para. 79; judgment of 4 October 2024, C‑541/20 to C‑555/20, para. 689. 191 Schmidt am Busch, in: Grabitz/Hilf/Nettesheim, EUV/AEUV, 85th update (May 2025), Article 168 TFEU, para. 98.

51

of considerations on the effects on health lead to a violation of the principle of propor-

tionality as well as of Article 168(1) TFEU and Article 296(2) TFEU.

Considering past experience with the so-called Omnibus packages, it is to be expected

that the ordinary legislative procedure under Article 294 TFEU will be further accelerated

by a whole series of measures, so that there can scarcely be any expectation of sub-

stantive debate in plenary of the European Parliament.

‘Food and feed safety omnibus’

threatens EU pesticide rules

Position paper- 27/01/2026

Overview The Commission’s proposal for a “food and feed safety omnibus” seriously weakens the EU's

current pesticide rules, which aim to protect health and the environment.

● It removes the limited approvals and the procedure for systematic, regular toxicity reviews

that incorporate new scientific evidence and instead makes the unlimited approval of

pesticides the default.

● It restricts Member States’ ability to use the most recent scientific evidence when

authorising pesticide products at the national level.

● It extends grace periods for harmful pesticides, allowing these substances to remain on the

market for much longer before they are banned.

● It broadens the possibility of approving harmful pesticides by derogation from the safety

approval criteria.

● It introduces a poor definition of biocontrol, which could include synthetically produced

substances that may have unknown or harmful effects.

● It broadens the possibility of using drones for pesticide application.

The proposal undermines the primary purpose of the EU pesticide regulation, which is to ensure a

high level of protection of human health and the environment. It was found to breach EU primary law, notably the precautionary principle and the principle of proportionality.

The proposal also contradicts the EU’s goal of moving away from a pesticide-dependent

agricultural model. Far from promoting biocontrols, it functions as a deregulation “Trojan horse”

for hazardous pesticides and disregards citizens’ repeated calls for stricter pesticide rules and

better protection of health and the environment.

We urge the European Parliament and Council to oppose and reject the proposal.

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Position Paper- PAN Europe

Introduction

The European Commission’s proposal for a ‘food and feed safety omnibus’ would fundamentally

undermine the current system for approving and authorising pesticide active substances and

pesticide products, as established under the EU Pesticide Regulation (1107/2009).

In force since 2011, the Pesticide Regulation requires that pesticides must have no harmful effects on human or animal health, and no unacceptable effects on the environment. To meet

these requirements, pesticides are subject to a rigorous assessment and regular re-evaluation to

be placed or remain on the market. This is a crucial step as pesticides are intentionally designed to

be highly toxic to target organisms but are inevitably toxic to other non-target organisms, such as

bees, fish, amphibians, as well as mammals, including humans.

According to the Commission itself, the existing Regulation has been largely effective in protecting human health and the environment, and has improved protection thanks to the stringency of its approval criteria and the mandatory regular reviews of all active substances. It

is through these periodic reviews, based on the latest scientific evidence, that previously unknown

toxic effects on non-target species, including humans, have been identified, leading to the banning

of pesticides and their removal from the market. Indeed, some of the most toxic chemicals ever

intentionally released into the environment have been pesticides. Yet, the Commission’s proposal

to change the current system represents a serious step backwards for pesticide regulation in the

EU, potentially allowing hazardous substances to remain on the market indefinitely.

Indeed, the proposal is to make unlimited approval periods for active substances the norm, while limited approvals would become the exception, applicable only to a few active substances.

This shift is combined with measures that would:

● restrict Member States’ ability to rely on the latest scientific evidence in product

authorisation decisions,

● extend grace periods for substances that should no longer be approved, and

● make it easier to reapprove substances that do not meet safety criteria.

Taken together, these changes would hamper the identification of hazardous properties for a wide range of pesticides and delay, or even circumvent, their ban, even once risks are known.

The proposal undermines the primary objective of Regulation 1107/2009, namely to ensure a high

level of protection of human health and the environment from pesticides based on the

precautionary principle. Therefore, the Commission’s proposal was found to violate EU primary law in both substance and procedure in a legal opinion. It is considered incompatible with the

precautionary principle under Article 191(2) TFEU and fails to meet the Union’s positive

obligations under the Charter of Fundamental Rights as applied to Regulation (EC) No 1107/2009.

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Position Paper- PAN Europe

Procedurally, the absence of an impact assessment and inadequate reasoning breach the

principles of proportionality and Articles 168(1) and 296(2) TFEU.

It also fundamentally contradicts the EU’s objective of transitioning away from an agricultural

model that is highly dependent on chemical pesticides. While the initial intention behind the

revision was to facilitate market access for biocontrol products, the current proposal acts as a

Trojan horse for deregulating all pesticides, including the hazardous ones. This is not a reform to

support safer alternatives, but a giveaway to the agro-industry, shaped by pesticide industry

demands1. Rather than accelerating the transition to sustainable farming, the proposal reinforces chemical dependency and locks the EU into a pesticide-driven agricultural model, jeopardising the resilience of farming systems and long-term food security. This reflects a

troubling lack of policy coherence. It contradicts the EU’s Green Deal and Farm to Fork objective

to reduce pesticide dependency, use and risks by 2030 and is at odds with the findings and

recommendations of the European Commission’s own REFIT evaluation, as well as repeated

reports of the European Court of Auditors. These have consistently concluded that the core

problem lies not in overly stringent pesticide rules, but in weak implementation, insufficient

enforcement, inadequate risk monitoring, and the failure to translate existing legal requirements

into measurable reductions in pesticide use and risks.

Moreover, the proposal runs counter to citizens’ long-standing and consistent demands for stricter pesticide regulation and the phase-out of synthetic pesticides. These demands are

echoed by civil society organisations representing children and youth, which warn that weakening

pesticide rules would expose children to serious and preventable health risks, violating the rights

and futures of our youngest citizens.

The proposal also blatantly disregards the recent call from the scientific community to strengthen the implementation of existing pesticide legislation to better protect the

environment, biodiversity and citizens from the harmful effects of pesticides.

Finally, the proposal has been put forward without an impact assessment and is wholly

disproportionate to the stated objective of the omnibus exercise, which is to ‘simplify’ regulation,

while at the same time maintaining a high level of protection.

1 Feedback from: Bayer AG (particularly “Data Call-In” p.4); Feedback from: BASF (cf particularly p.4).

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Position Paper- PAN Europe

I. Main concerns

a) Unlimited approval as the default

Under the current rules, active substances are approved for a limited period: up to ten years for an

initial approval and up to fifteen years for renewals. Exceptions to this general rule are candidates

for substitution, i.e. more hazardous substances, which must be approved or renewed for no

longer than seven years, and substances approved by derogation to the safety criteria (Article

4(7)), which are limited to five years.2

The Commission proposes to make unlimited approval the default for active substances, with

limited approval becoming the exception. This exception would cover three categories:

● candidates for substitution, which represent only around 10% of approved substances;

● substances approved by derogation from the safety criteria under Article 4(7) due to a

serious danger to plant health, of which none are currently approved;

● and substances subject to limited approvals/renewals due to uncertainties or data gaps.

The scope of this third exception is particularly unclear and would grant the Commission broad

discretion in determining which substances fall within it. Moreover, unlike candidates for

substitution and substances approved by derogation, which would be approved for seven and five

years respectively, there is no time limit for substances subject to limited approvals or renewals

due to uncertainties or data gaps. This leaves the decision at the discretion of the Commission and

Member States, both in determining which substances are concerned and in deciding the duration

of approval, within the context of comitology discussions.

Practically, if the proposal were adopted as it stands, substances subject to an ongoing renewal

procedure, or for which a renewal application has been submitted, would complete the renewal

process before any decision is taken on whether approval is limited or unlimited. By contrast, for

substances for which no renewal procedure is ongoing, unlimited approval would be granted automatically. According to our network’s estimates, this would cover more than 50 synthetic active substances, among them certain PFAS substances, the suspected neurotoxic and

carcinogenic fungicide folpet, and captan, suspected to be carcinogenic and highly toxic to wildlife.

Importantly, by making unlimited approval the default, the proposal reverses the burden of proof. Under the current system, companies must periodically demonstrate the safety of their

active substances through renewal procedures and the submission of new scientific data. Where

the available evidence does not sufficiently demonstrate the safety of a pesticide active substance,

approval cannot be granted or renewed. Moreover, the applications for approvals submitted by

the companies have to include scientific peer-reviewed literature of the last ten years on the

2 Exceptions also apply to low-risk substances, which receive direct approval for 15 years, and to basic substances, which are approved indefinitely.

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Position Paper- PAN Europe

effects of the active substance and its metabolites on health, environment and non-target species.

This system has led to the identification and banning of 54 harmful pesticide substances since 20113. These include the brain-harming chlorpyrifos, the bee-toxic neonicotinoids, the reprotoxic,

endocrine disruptor mancozeb and the PFAS endocrine disruptor flufenacet. Under the proposal,

the burden of proof would shift from industry to regulators to identify and assess potentially

harmful substances based on existing suspicions of harm. This process would depend largely on

publicly available literature and monitoring, shifting the costs to the public rather than the

industry.

Under the proposal, indeed, the Commission is required, periodically, to determine which other

substances (not falling under one of these three categories) should be subject to a renewal

procedure. It should take into account health or environmental concerns, new scientific or

technical knowledge, available monitoring data, and requests from Member States. While this

identification process must take place within three years following the adoption of new criteria or

data requirements, the Commission would retain discretion over the deadline for the submission

of data, the designation of the rapporteur Member State, and the expiry date of the approval.

Moreover, the Commission would not be obliged to respond to review requests from Member

States. Despite the Commission’s claim that this would increase agility and improve resource

allocation, the proposal once again affords the Commission broad discretion. It risks resulting in

very lengthy assessment procedures for substances for which concerns have already been

identified. Last, the implementing acts identifying the active substances that need to undergo a

renewal procedure are to be adopted by Member States, creating a risk of political influence.

One argument put forward by the Commission to justify this new system is that new active

substances are expected to have improved toxicological and ecotoxicological properties. However,

reality presents a different picture. Among the new active substances currently under assessment and awaiting approval, several exhibit harmful properties, such as the PFAS and

potential TFA precursor fluazaindolizine or the suspected carcinogenic metyltetraprole. Likewise,

‘new' substances recently put on the market, such as the bee-toxic sulfloxaflor, have been found to

be harmful and restricted quickly after their first approval.

b) Restrictions on Member States’ use of the latest science

For national authorisations of products containing substances with unlimited approval, the

maximum duration would be fifteen years. However, the proposal introduces a highly restrictive

interpretation of what constitutes the “latest scientific and technical knowledge” for the purposes of

product authorisation, directly contradicting recent EU case law. A recent preliminary ruling by

the Court of Justice of the European Union clarified that Member States are obliged to consider

the most up-to-date scientific evidence when assessing the authorisation of pesticide products.

3The figure of 54 included 19 CfS and 35 non-CfS, including one prohibited under Article 21 (see annex, Générations Futures, PAN Europe).

5

Position Paper- PAN Europe

This implies that the latest scientific evidence must be taken into account, even in the absence of

any guidance document. In another recent ruling, the French State was recently held accountable

for ecological harm resulting from outdated and inadequate pesticide environmental risk

assessments, and obliged to review authorisation in light of the latest science. Under the amended

text, however, Member States would be required to rely exclusively on “the last assessment conducted at EU level” for the active substance, even if that assessment is already decades old.

In other words, instead of strengthening protection and aligning the Regulation with EU case law

by ensuring pesticide products are evaluated against the most recent science, the Commission is

proposing a deliberate weakening of the law. This is unacceptable.

In practice, this would severely limit the ability of Member States to respond to emerging science.

Because active substances would be granted unlimited approval, EU-level assessments may be

decades old by the time a national product authorisation is granted. By freezing the scientific basis

of evaluations at the date of the most recent EU assessment, even if this was done over a decade

ago, Member States would be prevented from taking into account new peer-reviewed studies or

other emerging evidence of risks. In cases where concerns arise, Member States would be

required to notify the Commission so that an EU-level assessment can be initiated.

c) Extended grace periods for harmful substances

The proposal extends grace periods for substances that risk assessments indicate should no longer

be approved. Currently, these substances may remain on the market for up to eighteen months

when non-renewal does not concern health or environmental protection. However, in practice,

harmful substances such as endocrine disruptors have still been granted grace periods of 9 to 18

months (e.g., the recent case of flufenacet), in clear violation of the Regulation.

Under the new proposed rules, the Commission’s proposal would legalise these 18 months for substances banned due to health and environmental concerns, and even extend the grace period up to three years “when there are no alternatives” (one year allowed for sale and distribution and

two more years for disposal, storage, or use). This contradicts Recital 24 of the Regulation and

established case law, which state that the protection of human health and the environment must

always take precedence over plant production. Moreover, applicants are not required to submit

information on available alternatives in the context of renewal procedures, unless they apply for

approval by derogation under Article 4(7). As a result, the decision to grant an extended grace

period of up to three years would be largely arbitrary and politically driven. Immediate withdrawal

of substances would only occur in cases of “immediate and serious concerns” for human health or the

environment, but this concept is not defined. It therefore appears that the standard would be to

grant a long grace period to substances that are prohibited because they are hazardous.

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Position Paper- PAN Europe

d) Easier derogations from safety criteria

Under the current Regulation, Article 4(7) allows for a very narrow and exceptional derogation: an

active substance that does not meet the safety approval criteria may still be approved for a strictly

limited period of five years, but only if it can be demonstrated, based on documented evidence that

there is a serious danger to plant health which cannot be contained by any other available means,

including non-chemical alternatives. In practice, this derogation has never been used, because in

no case has it been proven that an active substance was truly essential and that no alternative

solution existed.

The proposal “clarifies” that Article 4(7) cannot apply to certain highly hazardous pesticides:

Carcinogenic (Categories 1A & 1B but only those with “no threshold”), Mutagenic (Categories

1A/1B) and Toxic for reproduction (Category 1A, based on data on humans), Persistent Organic

Pollutant (POP), Persistent, Bioaccumulative and Toxic (PBT), or very Persistent and very

Bioaccumulative (vPvB) substances. This restriction, however, does not cover

endocrine-disrupting substances, some carcinogenic category B and toxic to reproduction

category 1B (presumed to be toxic for human health based on animal studies), which fall under the

cut-off criteria in the same way as substances classified under Carcinogens and Mutagens 1A/1B,

POP, PBT, or vPvB. Moreover, there is currently no scientific evidence that can be relied upon to

set a safe threshold value for endocrine disruptors, nor toxic to reproduction according to animal

studies4. The Commission is “normalising” a long-standing industry claim that carcinogenic or

reprotoxic pesticides can be assigned safe exposure thresholds, rather than being removed from

the market altogether.

Moreover, while this scope’s restriction appears positive at first glance, the drafting

simultaneously broadens the scope of Article 4(7) by introducing the concept of substances

necessary not only for plant health but also for plant production. This means the derogation could be invoked to approve harmful substances when production (yield) levels for a specific crop are at risk. This amendment runs directly against Recital 24, which states that the objective of

ensuring a high level of protection for human and animal health and the environment must take

priority over the objective of improving plant production. Moreover, how this would be assessed in

practice remains unclear. Farmers are expected to transition from intensive synthetic pesticide

use to integrated pest management practices, which, while agriculturally environmentally

beneficial, require long-term evaluation and may not provide immediate yield benefits. The

assessment of “necessity” for derogations should not rely on narrow yield comparisons that focus

only on immediate output, without considering the broader context of long-term soil health,

biodiversity, and overall farm resilience and food security.

4 Zoeller RT, Brown TR, Doan LL, Gore AC, Skakkebaek NE, Soto AM, Woodruff TJ, Vom Saal FS.

Endocrine-disrupting chemicals and public health protection: a statement of principles from The Endocrine

Society. Endocrinology. 2012 Sep;153(9):4097-110. doi: 10.1210/en.2012-1422.

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Position Paper- PAN Europe

Last, the proposal waives the obligation on the Member States authorising plant protection

products containing active substances approved under Article 4(7) to draw up a phasing-out plan.

e) Biocontrol substances

The proposal includes several measures aimed at facilitating market access for biocontrol

products. This objective is welcome, as biocontrol plays a key role in Integrated Pest Management

and is essential for phasing out synthetic pesticides5. At the same time, several elements of the

proposed changes risk compromising safety and data transparency. Accelerated access for

biocontrol products should be pursued through strengthening assessment capacity, maintaining

robust risk evaluation, and ensuring comprehensive monitoring.

The proposal introduces a problematic definition of biocontrol active substances. It describes

them as micro-organisms, inorganic substances occurring in nature (excluding heavy metals and

their salts), or substances of biological origin or produced synthetically that are functionally

identical and structurally similar to natural substances. However, it is necessary to ensure that

biocontrol remains restricted to substances that are truly natural, and therefore, “identical” must

be clearly defined. It should require that the substance contains only naturally occurring amino

acids, that its three-dimensional molecular structure is identical to the natural substance, that its

function is identical, and that it is biologically degraded through predictable, natural pathways.

Without these clarifications, there is a risk of widening the category to synthetically produced

substances that may have unknown or harmful effects.

The Commission also proposes requiring Member States to prioritise the assessment of biocontrol

substances. This should not result in further delays in the evaluation of synthetic substances.

Moreover, the Commission proposes provisional authorisation for products containing an active

biocontrol substance not yet approved. While faster access to biocontrol products is desirable,

natural substances, particularly microbial organisms, can present risks. Microbials have the

potential to survive, multiply, move, and colonise new environments, with possible unintended

impacts on biodiversity. These characteristics make a robust risk assessment essential prior to

authorising their use.

Finally, the text removes the obligation to keep records of biocontrol product use. Such records

are critical to monitor trends, assess environmental and health impacts, and inform policy

decisions. Even natural substances can have unexpected harmful effects, and comprehensive data

collection is essential for timely detection and management of any risks.

5 Will the Commission’s plan to fast-track biocontrol miss the mark for pesticide reductions? (Oct. 2025)

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Position Paper- PAN Europe

f) Low-risk substances

The criteria for identifying low-risk substances are being relaxed. While hazard-based criteria,

such as classification as carcinogenic, mutagenic, or toxic to reproduction (CMR), or the presence

of neurotoxic effects, must still be met, other requirements are being removed. These include the

obligation to provide information on co-formulants and the requirement to apply for maximum

residue levels (MRLs). Moreover, the proposal introduces the possibility of requesting a change in

the status of an already approved active substance to low-risk.

g) Mutual recognition

The system of mutual recognition implies that authorisations to a pesticide product granted by

one Member State should, in principle, be accepted by the other Member States of the same

geographical area. This is unless there are concerns relating to human health or the environment.

The proposal introduces several changes to the system to improve its implementation. Positively,

the proposal requires that a product must actually be placed on the market in the reference

Member State, helping prevent abuse of the system to circumvent higher fees, by placing the

product authorisation application in one Member State while selling the product in another.

However, the proposal also makes it easier for official or scientific bodies and professional agricultural organisations to apply for mutual recognition without demonstrating public interest, while it expands the types of eligible uses, and reduces documentation and assessment requirements for certain applications (for biocontrol, submitted by official or scientific bodies

involved in agricultural activities or professional agricultural organisations or submitted for minor

uses). Lastly, the proposal introduces the possibility for detailed implementation rules to be

adopted by the EU Commission via an implementing regulation. It remains unclear what these

rules would entail.

h) Minor uses

A minor use is defined as a use on a crop that is either not widely grown in a Member State or

widely grown but addressing an exceptional plant protection need. Under the current pesticide

regulation, uses meeting this definition benefit from a simplified authorisation procedure: an

existing pesticide authorisation may be extended to cover minor uses if certain conditions are met,

including a demonstrated public interest, without requiring a full comprehensive assessment.

However, this system is increasingly misused due to the lack of a clear and harmonised definition

of minor uses, leading to inconsistent application across Member States and enabling some

applicants to circumvent standard authorisation requirements by falsely claiming a minor use. The Commission proposal aims to increase the availability of pesticides for minor uses, namely by removing the public interest requirement and obliging Member States to facilitate or encourage

9

Position Paper- PAN Europe

extensions for minor uses. These changes raise concerns that they would weaken the

requirements for minor uses without addressing the underlying problem of an inconsistent,

non-harmonised definition and the ongoing misuse of minor-uses.

i) Application of drones

Under Directive 2009/128/EC on the sustainable use of pesticides, aerial spraying of pesticides by

aircraft is currently prohibited because of its devastating impacts to local communities and

ecosystems. Derogation is only possible on an individual basis and under certain conditions, for

professional users who have submitted a formal request. The Commission proposes allowing the use of certain drones without needing individual derogations, provided the pesticide has been explicitly authorised for drone applications under the Pesticide Regulation (1107/2009).

The use of drones for pesticide application requires a comprehensive scientific assessment. Aerial

spraying by drones increases the risk of pesticide drift, leading to higher exposure of the

environment and nearby populations. Small load capacities may result in pesticides being applied

at higher concentrations, which can have more serious impacts on soil biodiversity, food safety,

and operator and citizen health. Risk levels are further influenced by weather conditions, flight

height, speed, and crop type. Therefore, drones should only be considered for targeted application

of natural, low-risk pesticides as a last resort, after all preventive Integrated Pest Management

(IPM) measures have been implemented. Any derogations must be strictly recorded by Member

States, and the public should be informed in advance, in line with the Directive.

j) Residues of pesticides in food

When pesticides are banned in the EU due to their harmful effects on human health or the

environment, their residues are not automatically prohibited in all food products. In many cases,

residues continue to be allowed in certain imported products to accommodate trade demands.

Currently, residues of 67 EU-banned (PIC) pesticides are permitted in specific imported products6.

The omnibus proposal introduces a timid change to this practice, but it remains wholly insufficient.

The proposal would remove the term “import tolerance” and replace it with “Good Agricultural

Practices (GAPs) implemented in a third country” (i.e., recommended, authorised, or registered use

of a pesticide). However, this cosmetic change does little in practice, as the possibility to apply for

authorisation to import products containing residues of EU-banned pesticides would still remain.

The notable change is that the Commission would now be empowered to reject such applications or revoke existing Maximum Residue Levels (MRLs) for EU-banned pesticides when the active

6 Report, Double Standards, Double Risks, Annex II (p. 58).

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Position Paper- PAN Europe

substance meets one of the “cut-off” criteria of the Pesticide Regulation (1107/2009)7. However,

this measure remains very limited and insufficient. First, it is framed as a derogation, which must

be interpreted narrowly, i.e., the general practice would still allow residues in imported food.

Second, the proposal conditions revocation on the outcome of an impact assessment. Finally, the

measure would apply only to a small proportion of EU-banned pesticides since ‘cut-off’ pesticides

represent just a small fraction8 of the EU-banned pesticides. As a result, through trade, the EU will

continue to allow the use of hazardous pesticides in the production of food imported into the EU,

turning a blind eye to the impacts on local communities, water resources, and biodiversity where

these chemicals are used. European farmers face unfair competition, as products grown with these

toxic substances can be imported at lower costs, while European consumers are exposed to

residues of dangerous pesticides.

Moreover, these trade-related changes should not obscure other problematic aspects of the proposal. In particular, the proposal allows for transitional measures to keep products on the

market with MRLs that are to be deleted, even when the reason for deletion is related to human

health. The obligation to review temporary MRLs every ten years based on monitoring data is

being removed from the regulation.

II. Recommendations PAN Europe calls on the European Parliament and the Council to oppose and reject the “Food and Feed Safety Omnibus” proposal. Rather than deregulating pesticides, the EU must urgently

implement the existing Regulation effectively. The current legal framework already provides a

robust system for identifying and banning toxic pesticides, but it has been undermined by weak

implementation.

In its 2020 report on the assessment of the implementation of the Pesticide Regulation (REFIT),

the European Commission provided recommendations which we consider the way forward today

to address procedural delays and inefficiencies.

1. Member States should only accept complete, high-quality dossiers as admissible for both

first-time and renewal approvals of active substances, as well as product authorisations.

2. Member States should review and adjust fees to fully cover costs and ensure they directly

fund the authorities performing the work. Some Member States charge fees that do not

fully cover their costs, and often the fees are not ring-fenced for the responsible

authorities, resulting in insufficient resources.

8Report, Double Standards, Double Risks, Annex II (p. 58).

7 These are substances that are Carcinogenic, Mutagenic and Toxic for reproduction (CMR) Categories

1A/1B, Endocrine Disruptors for humans or non-target organism, Persistent Organic Pollutant (POP),

Persistent, Bioaccumulative and Toxic (PBT), or very Persistent and very Bioaccumulative (vPvB).

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Position Paper- PAN Europe

3. The Commission should open infringement proceedings against Member States that fail to

enforce the regulation.

4. Risk assessment should only continue if active substances do not meet the cut-off criteria

or if at least one derogation option is invoked.

PAN Europe has also identified urgent priorities that must be addressed within the current

regulatory framework to improve the protection of human health and the environment from

pesticides.

Contact details:

Dr Angeliki Lysimachou, Head of Science and Policy, [email protected], +32 2 318 62 55

Salomé Roynel, Policy Officer, [email protected], +32 451 02 31 33 PAN Europe, Rue de la Pacification 67, 1000, Brussels, Belgium Who we are | PAN Europe

Pesticide Action Network (PAN Europe) is a network of NGOs working to reduce the use of

hazardous pesticides and have them replaced with ecologically sound alternatives. We work to

eliminate dependency on chemical pesticides and to support safe sustainable pest control

methods. Our network brings together over 45 consumer, public health and environmental

organisations and women’s groups from across Europe.

Co-funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the

European Union or CINEA. Neither the European Union nor the granting authority can be held responsible for them.

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