COM(2025) 1020

EN EN

EUROPEAN COMMISSION

Strasbourg, 16.12.2025

COM(2025) 1020 final

2025/0408 (COD)

Simplification Omnibus Package

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

amending Regulation (EU) No 528/2012 as regards the extension of certain data

protection periods

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EXPLANATORY MEMORANDUM

1. CONTEXT OF THE PROPOSAL

• Reasons for and objectives of the proposal

The proposal is part of the cross-cutting legislative simplification package announced in the

European Commission’s Vision for Agriculture and Food1. The aim of the package is to

reduce unnecessary regulatory burdens identified as particularly burdensome by industry and

authorities while maintaining high standards for food and feed safety, and the protection of

human and animal health, and the environment. The package responds to repeated requests

from stakeholders and EU Member States for faster and clearer regulatory procedures. It aims

to simplify certain provisions and procedures of the following acts: Regulation (EC) No

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

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

No 853/2004, Regulation 1099/2009, Regulation (EC) No 999/2001, Regulation (EU)

2017/625, Directive 98/58/EC and Directive 2009/128/EC.

More specifically, this initiative aims at modifying Regulation (EU) No 528/2012 of the

European Parliament and of the Council of 22 May 2012 concerning the making available on

the market and use of biocidal products2, in order to address specific concerns which have

been expressed by Member States competent authorities on biocidal products and economic

operators regarding the expiry of the protection of certain data by 31 December 2025 in

accordance with Article 95(5) of that Regulation.

The completion of the review programme of existing biocidal active substances set out in

Article 89 of Regulation (EU) No 528/2012 has suffered from major delays. Initiated on 14

May 2000 under Directive 98/8/EC3, and planned to be completed by 14 May 2010, the

review programme had to be extended a first time in 2009 until 14 May 20144, a second time

in 2013 until 31 December 20245, and recently a third time until 31 December 20306.

The vast majority of the Member State competent authorities have not met the time limits for

submitting the assessment reports for applications for approval of existing active substances.

The main reasons for the delays, as identified in the Commission implementation report

1 Communication from the Commission to the European Parliament, the Council, the European

Economic and Social Committee and the Committee of the Regions, A Vision for Agriculture and Food

Shaping together an attractive farming and agri-food sector for future generations, COM/2025/75,

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52025DC0075 2 OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj. 3 Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the

placing of biocidal products on the market (OJ L 123, 24.4.1998, pp. 1–63,

ELI: http://data.europa.eu/eli/dir/1998/8/oj) 4 Directive 2009/107/EC of the European Parliament and of the Council of 16 September 2009 amending

Directive 98/8/EC concerning the placing of biocidal products on the market as regards the extension of

certain time periods (OJ L 262, 6.10.2009, p. 40, ELI: http://data.europa.eu/eli/dir/2009/107/oj). 5 Commission Delegated Regulation (EU) No 736/2013 of 17 May 2013 amending Regulation (EU) No

528/2012 of the European Parliament and of the Council as regards the duration of the work programme

for examination of existing biocidal active substances (OJ L 204, 31.7.2013, p. 25,

ELI: http://data.europa.eu/eli/reg_del/2013/736/oj). 6 Commission Delegated Regulation (EU) 2024/1398 of 14 March 2024 amending Regulation (EU) No

528/2012 of the European Parliament and of the Council as regards a further extension of the duration

of the work programme for the systematic examination of all existing biocidal active substances (OJ L,

2024/1398, 22.5.2024, ELI: http://data.europa.eu/eli/reg_del/2024/1398/oj).

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submitted to the Council and the European Parliament in June 20217, are: i) the lack of

resources in Member State competent authorities; ii) quality of the initial applications and

delays by applicants in submitting additional data; iii) complex technical questions on specific

dossiers that need to be resolved first; iv) evolution of technical guidance; and v) the adoption

of new scientific criteria for determining endocrine disrupting properties8, which triggered the

need for further data and assessments. That implementation report also announced that,

instead of a second implementation report, an evaluation of the Regulation (EU) No 528/2012

will start in 2025 with the aim of analysing the fitness of the regulatory system set out in the

Regulation. While any fundamental changes to Regulation (EU) No 528/2012 should await

the outcome of that evaluation, a few targeted amendments should be enacted earlier to

increase the efficiency of its implementation.

Article 95(5) of Regulation (EU) No 528/2012 foresees that on 31 December 2025 protection

expires for all data submitted for existing active substance/product-type combinations in the

review programme but for which a decision on inclusion in Annex I to Directive 98/8/EC was

not taken before 1 September 2013 and which will still be under examination in the review

programme after 31 December 2025. The protection period was set to expire 10 years after

mandatory listing of active substance suppliers of existing active substances on a specific list

maintained by the European Chemicals Agency (ECHA) that took effect on 1 September 2015

(the Article 95 list). The purpose was to guarantee a fair compensation period for review

programme participants, considering also that, for most participants, their data had already

been protected since 2004-2008 (the time of submission of most of the applications for

approval in the review programme), while foreseeing the possibility for other economic

operators to use freely the data as from the beginning of 2026 to access more easily the

market and bring down costs for the producers of biocidal products who buy active substances

from the suppliers – and hence ultimately for the users of the biocidal products.

However, a number of active substance suppliers and their representative organisations have

repeatedly raised concerns that, in the light of the delays in the completion of the review

programme, as described above, the expiry of all data protection needs to be reconsidered,

among others, at an Implementation Dialogue on the Regulation (EU) No 528/2012 held on

15 July 2025 with stakeholders representing businesses (active substance manufacturers,

product formulators and downstream users) and civil society9, in recent discussions with

experts of Member State competent authorities on biocidal products10, as well as during the

7 The Commission Report is available at this link: https://eur-lex.europa.eu/legal-

content/EN/TXT/?qid=1623326515401&uri=CELEX%3A52021DC0287 and the Staff Working

Document, which presents detailed evidence for the findings outlined in the report, is available here:

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52021SC0128&qid=1623670527414 8 Commission Delegated Regulation (EU) 2017/2100 of 4 September 2017 setting out scientific criteria

for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012 of

the European Parliament and Council (OJ L 301, 17.11.2017, p. 1, ELI:

http://data.europa.eu/eli/reg_del/2017/2100/oj). 9 The dialogue aimed to gather feedback from companies on the main challenges faced in bringing

biocidal active substances and products to the market and their ideas on how to address them and, more

in general, on how to simplify the regulatory framework for biocidal products and encourage

innovation. It also aimed to obtain views of non-industry stakeholders on the implementation of the

Biocidal Products Regulation and on its contribution to a high level of safety for humans, animals and

the environment. This constituted a first step for the evaluation of the Biocidal Products Regulation

(https://health.ec.europa.eu/events/implementation-dialogue-biocides-2025-07-15_en). 10 Commission expert group ‘Competent Authorities for Biocidal Products (Regulation (EU) No

528/2012)’ (the ‘CA meetings’), Register Code E03125 (Register of Commission expert groups and

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Call for Evidence on the Food and Feed Safety Simplification Omnibus11. In fact, the

adoption of new scientific criteria for determining endocrine disrupting properties, which

were adopted by Commission Delegated Regulation (EU) 2017/210012 and are applicable

since 7 June 2018, required that specific data had to be generated since then – or are still in

the process of being generated – for those active substances still under examination in the

review programme after 31 December 2025. In addition, other data had also to be generated

and submitted due to the lack of quality of initial data submitted in the concerned applications

and/or due the need to submit new data following the evolution of technical guidance or

requirements. These data would currently not benefit from appropriate periods of data

protection (or no data protection at all). Therefore, the end date for the protection of the data

for existing active substances that were still in the review programme on 7 June 2018 should

be extended, striking a balance between the interests of review programme participants, on

one side, and the interests of alternative suppliers of active substance and product

authorisation applicants, on the other side. The scope of the data concerned by the extension

of the protection, as well as the duration of the extended protection, should be considered for

this balance. Until the proposal is eventually adopted by the Council and the European

Parliament the potential risks for the competitiveness of review programme participants and

incentives for innovation, referred to by stakeholders, will remain. In practical terms, this

means that other companies, in particular the alternative suppliers of active substances who do

not support the active substance in the review programme, will be able to re-use freely data

without having to negotiate compensation for access rights with the owners of the data.

In this context, to ensure that the period during which the data will not be protected is limited

to the minimum possible, a proposal separate from the rest of the other measures proposed in

the Food and Feed Safety Simplification Omnibus, which is dedicated solely to the

modification of the data protection under Article 95(5) of Regulation (EU) No 528/2012 and

related modifications, is needed. This is the purpose of the present initiative.

• Consistency with existing policy provisions in the policy area

The proposal is part of a package of measures concerning simplification, aiming at reducing

administrative burden and costs for industries.

• Consistency with other Union policies

This initiative contributes to simplification and reduction of regulatory burdens for the

agrifood sector, as announced in the Vision on Agriculture and Food while maintaining the

high standards of protection for the human, animal health and the environment.

2. LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY

• Legal basis

Article 114 of the Treaty on the Functioning of the European Union (TFEU).

other similar entities) ; CA-June25-Doc.7.10 - Point from NL on data protection.pdf, CA-June23-

Doc.11.b - CEFIC-BfE-Data Protection.pdf 11 https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14824-Food-and-feed-safety-

simplification-omnibus_en 12 Commission Delegated Regulation (EU) 2017/2100 of 4 September 2017 setting out scientific criteria

for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012 of

the European Parliament and Council (OJ L 301, 17.11.2017, pp. 1–5,

ELI: http://data.europa.eu/eli/reg_del/2017/2100/oj).

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• Subsidiarity (for non-exclusive competence)

The proposed amendment is adopted at EU level as the Regulation concerned was adopted at

EU level before and only a modification of the provisions of Article 95(5) of Regulation (EU)

No 528/2012 performed at EU level can address the issue on data protection. Accordingly, an

amendment to this Regulation needs to be made at EU level.

• Proportionality

The initiative only proposes to modify a specific provision of Regulation (EU) No 528/2012

related to the expiry of data protection for data related to active substances still in the review

programme of existing active substances on 7 June 2018, and does not go beyond what is

necessary to achieve the objectives of ensuring an appropriate period protection of data

generated by review programme participants.

• Choice of the instrument

This proposal for revision is a legislative proposal as the relevant Regulation to be amended

was adopted by co-decision / ordinary legislative procedure.

3. RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER

CONSULTATIONS AND IMPACT ASSESSMENTS

• Ex-post evaluations/fitness checks of existing legislation

This proposal is accompanied by a Commission Staff Working Document that includes a

detailed overview of the positive impacts of the proposed amendment of the relevant

provisions of food and feed safety legislation, based on existing data and information gathered

during the Call for evidence and the previous analyses, including on the specific data

protection issue under Article 95(5) of Regulation (EU) No 528/2012.

• Stakeholder consultations

The limitation of data protection until 31 December 2025 for existing active substances in the

review programme, as set out in Article 95(5) of Regulation (EU) No 528/2012, has triggered

calls from parts of industry as well as some Member States’ competent authorities on biocidal

products for action to provide appropriate protection for data only recently generated (or still

to be generated) for the purposes of the review programme for existing active substances,

which is significantly delayed. Several industry stakeholders requested meetings with the

responsible Commission services on this topic. CEFIC (Biocides for Europe) requested an

extension of data protection for all data generated since 7 June 2018 (date of application of

the scientific criteria for identifying endocrine disrupting properties). Member State

competent authorities for biocidal products requested to extend data protection for substances

in the Review Programme, at least those related to endocrine disrupting (ED) properties, until

31 December 2031. On the other hand, the Commission services have also been contacted by

companies who reported difficulties in obtaining letters of access to protected data or in

getting agreement from established review programme participants to join them in the support

of the substance and may thus benefit from free access to data. For instance, SME United

indicated the importance to strive for a balance between the interest of data owners in the

review programme and other actors13.

13 CA-Sept25-Doc.7.11 - SMEunited feedback.pptx

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During the Call for Evidence on the Food and Feed Safety Simplification Omnibus, a large

number of companies and associations criticised the current hard stop of data protection for

substances in the review programme, arguing that it is misaligned with the extended review

programme and creates free-rider risks, distorts competition, and disincentives to invest in

data packages, notably the costly studies that are necessary for the application of the scientific

criteria to identify endocrine disrupting properties. Many explicitly supported extending or

resetting protection for all data generated after 2018 and not solely those data submitted to

determine endocrine disrupting properties as they argued that other updated data had to be

generated due to the evolution of other technical documents or requirements, but had diverse

views on what should be the extension period: until the end of the review programme; a 10-

year extension from 2025 (i.e. until 2035); normal application of Article 60 of Regulation

(EU) No 528/2012 which provides for data protection after the approval of a substance for a

period of 10 years; up to 15 years after the decision on the approval of the active substance;

until the end of the review programme or 10 years after the approval of the substance,

whichever is the earliest. Manufacturers warned that companies that invested early in

compliance would lose protection before competitors have to share costs, undermining

innovation and supply security. On the other side, a stakeholder was against the extension of

data protection beyond 2025 and worried about over-changing the rules which were clear

since 2013, extending exclusivity and complicating data-sharing, potentially slowing

authorisations if access negotiations stall, discouraging innovation by prolonged market

protection for the benefit of a few companies. It indicated that steady delays in the review

programme resulted already in considerably longer amortisation of costs periods, and that an

extension of data protection decreases competition and keeps product costs at high level,

maintaining oligopolistic-like situations. It described difficult experiences in data sharing

negotiations. NGOs and citizens did not provide comments. This proposal takes into account

the input received, with the objective to strive for a balance between the interests of data

owners who are participants in the review programme of existing active substances and other

actors, taking also into account the original intentions of the expiry date for data protection set

in Article 95(5).

• Collection and use of expertise

Different suggestions for clarifying certain provisions of food and feed safety legislation and

removing the excessive administrative burden stemming from these provisions have emerged

through stakeholders’ proposals concerning the provisions of Article 95(5) of Regulation

(EU) No 528/2012, as described above. Furthermore, in response and the follow-up of the

Call of evidence mentioned above, the Commission received detailed position papers from

stakeholders.

• Impact assessment

The proposed simplification measures are highly technical in nature. There are no viable

alternatives to achieve the objectives, and the proposed measures do not alter core policy

objectives or introduce significant new obligations. For these reasons, a full impact

assessment would not bring added value. Instead, the proposal is accompanied by an

analytical staff working document. The document clearly explains the proposed measures and

present the underlying evidence, analysis and stakeholders’ views, as well as estimating the

potential cost savings.

No direct cost savings are expected for industry, since the data in question must in any case be

generated and submitted to complete the assessment of the active substance, and in particular

for the assessment of endocrine-disrupting properties. However, data owners would benefit

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from greater legal certainty and the possibility of obtaining compensation from other

interested companies through letters of access. Access to protected data may be granted to

alternative suppliers of the same active substance, or to companies seeking product

authorisations once the substance is approved. The terms of access could vary, ranging from

financial compensation to free access when data owners also act as substance suppliers.

In the Impact Assessment performed in 2009 for the proposal of Regulation (EU) No

528/2012 revising the former Directive 98/8/EC, the cost of preparation of an application for

approval of an active was estimated between 3 to 5 million euros (based on a study performed

in 2007)14. Although no specific figures are available on the average costs of generating data

related to endocrine-disrupting properties, these studies are generally considered highly

costly, particularly because they often involve vertebrate testing. The costs for the generation

of new studies related to other elements of an application are highly variable, depending on

the particular issue for which evaluating competent authorities have requested a new study.

By ensuring an appropriate period of protection, the measure helps secure a fair return on

these investments and maintains incentives for data generation, which is essential for the

scientific robustness of the review programme.

• Regulatory fitness and simplification

This proposal is part of the commitment of the European Commission to lighten the

regulatory burden for people, businesses and administrations in the EU to boost prosperity

and resilience of the EU. The proposal is part of a package of measures which are therefore

aiming at simplifying provisions of food and feed safety legislation, reducing unnecessary

burdens and costs for businesses and authorities, without undermining the protection of

human and animal health and the environment.

• Fundamental rights

The proposal respects the fundamental rights enshrined in the Charter of Fundamental Rights

of the European Union and adheres to the principles recognised therein. The reduction of

administrative burden on companies should lead to societal gains in terms of wealth creation,

employment and innovation. At the same time, the proposal will not undermine the objective

of ensuring a high level of protection of human health and of the environment.

4. BUDGETARY IMPLICATIONS

This initiative will not imply any additional costs for the Commission or any regulatory

Agency.

5. OTHER ELEMENTS

• Implementation plans and monitoring, evaluation and reporting arrangements

The Commission will monitor the implementation and application of the new provisions and

compliance with them. Furthermore, the Regulation to be amended by this proposal is subject

to regular evaluation of its efficiency, effectiveness in reaching its objectives, relevance,

14 See pages 13, 14, 85 and 86 of Commission Staff Working document Accompanying document to the

Proposal for a Regulation of the European Parliament and of the Council concerning the placing on the

market and use of biocidal products, Impact assessment, SEC(2009)774, https://eur-lex.europa.eu/legal-

content/EN/TXT/PDF/?uri=CELEX:52009SC0773

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coherence and value added in accordance with better regulation principles. This proposal does

not require an implementation plan.

• Detailed explanation of the specific provisions of the proposal

The cut-off date for the protection of data related to existing active substances, which were

still under review in the review programme on 1 September 2013, should be reconsidered,

striking a balance between the interests of review programme participants, on the one side,

and the interests of alternative suppliers of active substance and applicants for product

authorisation, on the other side, taking also into account the original intentions of the expiry

of data protection set out in Article 95(5) of Regulation (EU) No 528/2012. The balance in the

various interests should be reflected in the scope of the active substances and data concerned

by the extension of protection, as well as in the duration of protection.

The evaluation of active substances/product-type combinations which were still in the review

programme on 7 June 2018 has been further delayed due to the need to generate new data to

allow for the evaluation of the new scientific criteria for determining endocrine disrupting

properties15 that became applicable on that day. Furthermore, since that date, other data had

also to be generated and submitted to evaluating Member States who considered this

necessary due to the lack of quality of initial data submitted in the concerned applications

and/or following the evolution of technical guidance or updated data requirements. It is

therefore proposed to extend the protection period for all data for active substance/product-

type combinations for which a decision on the approval had not been adopted in accordance

with Article 89(1), third subparagraph, of Regulation (EU) No 528/2012 by 7 June 2018. In

order to ensure a simple application of the new provision by all parties, the extension of

protection covers all data without any distinction.

The completion of the review programme of existing biocidal active substances has been

extended until 31 December 203016. It is therefore proposed to extend the protection of the

concerned data until the same date. This corresponds to a period of maximum 11.5 years for

data generated since 7 June 2018, which is considered an appropriate period of time of

protection during which participants in the review programme can obtain compensation for

the costs of the generation of data required by evaluating Member States. It should also be

noted that under the rules of Regulation (EU) No 528/2012, the evaluation of an application

of an active substance should last normally for one year during which the data is protected,

followed by a 10-year period of protection after the finalisation of the evaluation and adoption

of the decision on the approval, which overall would correspond to a period of 11-12 years of

protection of the data17. While the period of protection will be shorter for data generated only

in recent years, the proposed extension of protection will cover all data in the application,

15 Commission Delegated Regulation (EU) 2017/2100 Commission Delegated Regulation (EU)

2017/2100 of 4 September 2017 setting out scientific criteria for the determination of endocrine-

disrupting properties pursuant to Regulation (EU) No 528/2012 of the European Parliament and

Council, (OJ L 301, 17.11.2017, pp. 1–5, http://data.europa.eu/eli/reg_del/2017/2100/oj), entered into

application on 7 June 2018. 16 Commission Delegated Regulation (EU) 2024/1398 of 14 March 2024 amending Regulation (EU) No

528/2012 of the European Parliament and of the Council as regards a further extension of the duration

of the work programme for the systematic examination of all existing biocidal active substances (OJ L,

2024/1398, 22.5.2024, ELI: http://data.europa.eu/eli/reg_del/2024/1398/oj). 17 Duration of evaluation by the evaluating Member State of 12 months with possible suspension of 6

months, followed by a peer review by ECHA of 9 months, and the time for decision-making process at

Commission level.

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including data submitted since the submission of the applications which have already

benefitted from a longer period of protection18. It remains necessary to maintain the initial

objectives of Article 95(5). For these reasons, no clause of revision of this new period of

protection is proposed. Furthermore, the Commission will conduct a full evaluation of

Regulation (EU) No 528/2012 in the course of 2026/2027, including its rules on data

protection, which will provide a basis for the consideration of potential changes in the future.

Article 95(5) is modified to achieve this extension of data protection.

Until the proposal is adopted, there will be a period during which the concerned data will no

longer be protected, i.e. from 1st January 2026 until the data is protected again in application

of the new provisions in Article 95(5). Article 60(1), second subparagraph, established that

data for which the protection period has expired shall not be protected again. As a protection

will be conferred again to the concerned data, Article 60(1), second subparagraph, is modified

to establish a derogation to that rule for the concerned data. A provision is also established in

Article 95(5) to allow data owners to claim compensation from a substance supplier or

product supplier having benefitted from the absence of protection and having been included in

the Article 95 list during that period, if they find it appropriate.

18 Most of the applications were submitted since 2004-2008.

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2025/0408 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

amending Regulation (EU) No 528/2012 as regards the extension of certain data

protection periods

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular

Article 114 thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee,

Acting in accordance with the ordinary legislative procedure,

Whereas:

(1) In its Communication A Vision for Agriculture and Food1, the Commission announced

a cross-cutting simplification package aimed at reducing unnecessary regulatory

burdens while maintaining high standards for food and feed safety, for human and

animal health, and environmental protection.

(2) Regulation (EU) No 528/2012 of the European Parliament and of the Council2 sets out

the procedures for approval of biocidal active substances and authorisation and placing

on the market of biocidal products. The vast majority of Member State competent

authorities have not met the time limits for submitting the assessment reports for

applications for approval of existing active substances, which has delayed the

finalisation of the review programme of existing biocidal active substances set out in

Article 89 of that Regulation. The main reasons for the delays, as identified in the

Commission implementation report submitted to the Council and to the European

Parliament in June 20213, are: i) the lack of resources in Member States competent

authorities; ii) the quality of the initial applications and delays by applicants in

submitting additional data; iii) complex technical questions arising on specific dossiers

that need to be resolved; iv) evolution of technical guidance; and v) the adoption of

1 Communication from the Commission to the European Parliament, the Council, the European

Economic and Social Committee and the Committee of the Regions, A Vision for Agriculture and Food

Shaping together an attractive farming and agri-food sector for future generations, COM/2025/75,

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52025DC0075 2 Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012

concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, pp.

1–123, ELI: http://data.europa.eu/eli/reg/2012/528/oj) 3 The Commission Report is available at this link: https://eur-lex.europa.eu/legal-

content/EN/TXT/?qid=1623326515401&uri=CELEX%3A52021DC0287 and the Staff Working

Document, which presents detailed evidence for the findings outlined in the report, is available here:

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52021SC0128&qid=1623670527414

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new scientific criteria for determining endocrine disrupting properties by Commission

Delegated Regulation (EU) 2017/21004.

(3) Article 95(5) of Regulation (EU) No 528/2012 provides, by way of derogation from

Article 60, that all data protection periods for active substance/product-type

combinations listed in Annex II to Commission Regulation (EC) No 1451/20075, but

for which a decision on inclusion in Annex I to Directive 98/8/EC of the European

Parliament and of the Council6 was not taken before 1 September 2013, are to end on

31 December 2025. The objective was, on the one hand, to provide for a fair

compensation of review programme participants which are data owners, and on the

other hand, to avoid avoiding the establishment of monopolies and a disproportionate

protection period, by foreseeing the possibility for other economic operators to use

freely the data as from the beginning of 2026 in order to access more easily the market

and to reduce the costs for the producers of biocidal products who buy active

substances from the suppliers and ultimately for the users of the biocidal products.

(4) Due to the delays in the finalisation of the review programme, the end date of 31

December 2025 for the protection of data set out in Article 95(5) of Regulation (EU)

No 528/2012 should be adapted, to strike a balance between the interests of review

programme participants on the one hand, and the interests of alternative suppliers of

active substances and applicants for product authorisation, on the other hand. Such a

balance between the various interests should concern the scope of the active

substances and data concerned by the extension of protection, as well as in the

extended duration of protection.

(5) In particular, the evaluation of active substance/product-type combinations which were

still in the review programme on 7 June 2018 has been further delayed due to the need

to generate new data to allow for the evaluation of the new scientific criteria for

determining endocrine disrupting properties which became applicable on that date.

Furthermore, since then, other new data had also to be generated on request of the

evaluating Member States due to the lack of quality of initial data submitted in the

concerned applications and following the evolution of technical guidance or data

requirements. As a consequence, due to the end date for data protection periods

currently specified in Article 95(5) of Regulation (EU) No 528/2012, the protection

period for such newly generated data for active substance/product-type combinations

for which a decision on the approval had not been adopted in accordance with Article

89(1), third subparagraph, of Regulation (EU) No 528/2012, by 7 June 2018, would be

considerably shorter than for other data generated earlier. Therefore, the period of

protection for such data should be extended. In order to ensure an administratively

4 Commission Delegated Regulation (EU) 2017/2100 of 4 September 2017 setting out scientific criteria

for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012 of

the European Parliament and Council (OJ L 301, 17.11.2017, pp. 1–5,

ELI: http://data.europa.eu/eli/reg_del/2017/2100/oj) 5 Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year

work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of

the Council concerning the placing of biocidal products on the market (OJ L 325, 11.12.2007, pp. 3–65,

ELI: https://eur-lex.europa.eu/eli/reg/2007/1451/oj/eng) 6 Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the

placing of biocidal products on the market (OJ L 123, 24.4.1998, pp. 1–63,

ELI: http://data.europa.eu/eli/dir/1998/8/oj).

EN 3 EN

simple implementation of the new provision by all parties, the extension of protection

should cover all data for the concerned active substance/product-type combinations.

(6) The completion of the review programme of existing biocidal active substances has

been extended until 31 December 20307. The period of protection of the concerned

data should therefore be extended until 31 December 2030. This corresponds to a

period of maximum 11.5 years for data generated since 7 June 2018, which is

considered an appropriate period of time of protection during which participants in the

review programme can obtain compensation for the costs of the generation of data

required by evaluating Member States. While the period of protection will be shorter

for data generated only in recent years, the proposed extension of protection will cover

all data in the application, including data submitted since the submission of the

applications which have already benefitted from a longer period of protection.

Furthermore, the Commission will conduct a full evaluation of Regulation (EU) No

528/2012 in the course of 2026/2027, including its rules on data protection, which will

provide a basis for the consideration of potential changes in the future.

(7) Article 95(5) should be amended to extend the data protection period accordingly.

(8) From 1 January 2026 and until this Regulation enters into force, the data concerned

will no longer be protected. Article 60(1), second subparagraph, of Regulation (EU)

No 528/2012 provides that data for which the protection period has expired is not to be

protected again. As protection will be conferred again to the data concerned, that

second subparagraph should be amended to establish a derogation to that rule for such

data. As alternative substance suppliers and product suppliers that will be included in

the Article 95 list during the period of absence of protection could have benefitted

from the investments done by the review programme participants for the generation of

such data, a provision should also be established in Article 95(5) to allow data owners

to claim compensation from these suppliers, if they find it appropriate,

HAVE ADOPTED THIS REGULATION:

Article 1

Amendments to Regulation (EU) No 528/2012

Regulation (EU) No 528/2012 is amended as follows:

(1) in Article 60, paragraph 1, the second subparagraph is replaced by the following:

‘Without prejudice to Article 95(5), second subparagraph, protection periods under

this Article, which have expired, shall not start to run again.’;

(2) in Article 95, paragraph 5, the following subparagraph is added:

‘By way of derogation from the first subparagraph, all data protection periods for

active substance/product-type combinations for which a decision on the approval has

not been adopted in accordance with Article 89(1), third subparagraph, by 7 June

2018, shall end on 31 December 2030. Data owners may claim compensation for

access to their data for the period starting from 1 January 2026 until [OP, please

insert the date: date of the entry into force of this Regulation] from a substance

7 Commission Delegated Regulation (EU) 2024/1398 of 14 March 2024 amending Regulation (EU) No

528/2012 of the European Parliament and of the Council as regards a further extension of the duration

of the work programme for the systematic examination of all existing biocidal active substances (OJ L,

2024/1398, 22.5.2024, ELI: http://data.europa.eu/eli/reg_del/2024/1398/oj).

EN 4 EN

supplier or product supplier having benefitted from the absence of protection and

having been included in the list referred to in paragraph 1 during that period.’

Article 2

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in

the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Strasbourg,

For the European Parliament For the Council

The President The President

    Resolutsiooni liik: Riigikantselei resolutsioon Viide: Regionaal- ja Põllumajandusministeerium /  / ; Riigikantselei /  / 2-5/26-00152

Resolutsiooni teema: Toidu- ja söödaohutuse nõuete lihtsustamise omnibus

Adressaat: Regionaal- ja Põllumajandusministeerium Ülesanne: Tulenevalt Riigikogu kodu- ja töökorra seaduse § 152` lg 1 p 2 ning Vabariigi Valitsuse reglemendi § 3 lg 4 palun valmistada ette Vabariigi Valitsuse seisukohtade ja otsuste eelnõud järgmiste algatuste kohta, kaasates seejuures olulisi huvigruppe ja osapooli:

- Simplification Omnibus Package Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EU) No 528/2012 as regards the extension of certain data protection periods,COM(2025)1020

- Simplification Omnibus Package Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Council Directive 98/58/EC and Directive 2009/128/EC of the European Parliament and of the Council as regards the simplification and strengthening of food and feed safety requirements, and repealing Council Directives 82/711/EEC and 85/572/EEC,COM(2025)1021

- Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 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, (EU) 2017/625 as regards the simplification and strengthening of food and feed safety requirements, COM(2025)1030

EISi toimiku nr: 26-0029 Tähtaeg: 27.02.2026

Adressaat: Justiits- ja Digiministeerium, Kliimaministeerium, Majandus- ja Kommunikatsiooniministeerium, Sotsiaalministeerium, Välisministeerium Ülesanne: Palun esitada oma sisend Regionaal - ja Põllumajandusministeeriumile seisukohtade kujundamiseks antud eelnõude kohta (eelnõude infosüsteemi (EIS) kaudu). Tähtaeg: 06.02.2026

Lisainfo: Eelnõude on kavas arutada valitsuse 12.02.2026 istungil ja Vabariigi Valitsuse reglemendi § 6 lg 6 kohaselt sellele eelneval nädalal (04.03.2026) EL koordinatsioonikogus. Esialgsed materjalid EL koordinatsioonikoguks palume esitada hiljemalt 27.02.2026. 

Kinnitaja: Merli Vahar, Euroopa Liidu asjade direktori asetäitja Kinnitamise kuupäev: 22.01.2026 Resolutsiooni koostaja: Sandra Metste [email protected],  

.

22.01.2026

Toidu- ja söödaohutuse nõuete lihtsustamise omnibus

Otsuse ettepanek koordinatsioonikogule

Kujundada seisukoht

Kaasvastutaja sisendi tähtpäev 30.01.2026

KOKi esitamise tähtpäev 04.03.2026

VV esitamise tähtpäev 12.03.2026

Vastutav ministeerium: Regionaal- ja Põllumajandusministeerium

Kaasvastutajad: Sotsiaalministeerium, Kliimaministeerium, Majandus- ja Kommunikatsiooniministeerium, Välisministeerium, Justiits- ja Digiministeerium

Seisukoha valitsusse toomise alus ja põhjendus

Algatuse reguleerimisala nõuab vastavalt Eesti Vabariigi põhiseadusele seaduse või Riigikogu otsuse vastuvõtmist, muutmist või kehtetuks tunnistamist (RKKTS § 152¹ lg 1 p 1);

Algatuse vastuvõtmisega kaasneks oluline majanduslik või sotsiaalne mõju (RKKTS § 152¹ lg 1 p 2);

Seisukoha võtmist peab oluliseks peaminister või minister (VVS § 20¹ lg 2);

Sisukokkuvõte

Euroopa Komisjon avaldas 16. detsembril 2025 meetmepaketi (omnibusi), mille eesmärk on ELi toidu- ja söödaohutuse alaste õigusaktide ühtlustamine ja lihtsustamine.

Peamiste kavandatud meetmete hulka kuuluvad:

 bio-pestitsiidide turulepääsu menetluste kiirendamine, et tagada põllumajandustootjatele terviklik tööriistakast põllukultuuride kaitseks;

 pestitsiidide ja biotsiidide uuendamise menetluste muutmine sihitumaks, tõhusamaks ja kiiremaks;

 kooskõlas põllumajanduse visiooniga töötamine selle nimel, et viia impordi tootmisstandardid pestitsiidijääkide osas vastavusse käimasoleva mõjuhinnangu tulemustega, tagamaks võrdsed konkurentsitingimused;

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 sööda lisaainete lubade uuendamise kohustuse leevendamine ja sööda lisaainete märgistamise digitaliseerimine;

 fermentatsioonitoodete turulepääsu hõlbustamine;

 ametlike laborite akrediteerimisreeglite lihtsustamine;

 praktilisema lähenemise rakendamine taimsete toodete piirikontrollis;

 veiste spongioosse entsefalopaatia (BSE) seire- ja riskimaandamisnõuete kohandamine kooskõlas teaduslike teadmistega.

Toidu- ja söödaohutuse nõuete lihtsustamise omnibus koosneb kolmest seadusandlikust ettepanekust, mis hõlmavad järgmisi muudatusi:

1. Määruse ettepanek (COM (2025) 1020), millega pikendatakse kehtivas biotsiidide turulelaskmist ja kasutamist reguleerivat määruses (EL) 528/2012 olemasolevate biotsiidide toimeainete andmekaitseperioodi. Ettepanekuga nähakse ette, et andmekaitse kehtib kuni 31. detsembrini 2030 kõigi andmete suhtes, mis on esitatud olemasolevate toimeainete/tooteliikide kombinatsioonide hindamiseks ja mis olid veel läbivaatamisel 7. juunil 2018.

2. Direktiivi ettepanek (COM (2025) 1021), millega kaotatakse direktiivis 98/58/EÜ (loomade heaolu farmis) loomapidajatele kehtestatud kohustus pidada eraldi arvestust surnud loomade ja veterinaarravimite kasutamise kohta, kuivõrd samasisuline arvestuse pidamise nõue tuleneb juba loomade tervise määrusest (EL) 2016/429 ja veterinaarravimeid käsitlevast määrusest (EL) 2019/6. Ettepanekuga muudetakse ka direktiivi 2009/128/EÜ (pestitsiidide säästev kasutamine), et võimaldada liikmesriikidel teha üldine erand taimekaitsevahendite kasutamiseks teatavat tüüpi mehitamata õhusõidukitega (droonidega). Komisjonile antakse volitus määrata delegeeritud õigusaktidega droonitüübid, mille suhtes erandit võib kohaldada.

3. Määruse ettepanek (COM (2025) 1030), millega muudetakse järgmisi määrusi seoses toidu- ja söödaohutuse nõuete lihtsustamise ja tugevdamisega: 3.1 Määrust (EL) 999/2001, millega sätestatakse transmissiivsete spongioossete

entsefalopaatiate (TSE) ennetamise, tõrje ja likvideerimise eeskirjad, muudetakse, et anda komisjonile volitus võtta ELi toimimise lepingu artikli 290 alusel vastu delegeeritud õigusakte. Sellega võimaldatakse paindlikult ja kiiremini muuta määruse lisasid ning täpsustada sätteid, mis käsitlevad TSE- de järelevalvet, määratletud riskimaterjali (SRM) ja loomset päritolu tooteid. Muudatusega tagatakse, et TSE-de kontrollimeetmed püsivad teaduspõhised, ajakohased ja proportsionaalsed ning vastavad rahvusvahelistele standarditele, vähendades samal ajal ebavajalikku halduskoormust.

3.2 Määrust (EL) 1829/2003 (geneetiliselt muundatud toit ja sööt) täpsustatakse seoses fermenteeritud toodetega, mille tootmisel kasutatakse geneetiliselt muundatud mikroorganisme (GMM). Selgitatakse, et juhul kui fermenteeritud

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lõpptootes esinevad tehniliselt vältimatud abiainena kasutatud GMMi jäägid (nt rekombinantne DNA), kuid need ei kujuta endast terviseriski ega oma lõpptootes tehnoloogilist funktsiooni, ei käsitleta sellist toitu ega sööta GMMidest toodetud GM-toidu või -söödana määruse (EL) 1829/2003 tähenduses. Hinnang selle kohta, kas fermenteeritud lõpptootes esineval abiainena kasutatud GMMi jäägil on mõju tervisele või tehnoloogiline funktsioon lõpptootes, antakse vastava valdkondliku õigusakti (nt toiduensüümide, sööda lisaainete või muude eriregulatsioonide) alusel.

3.3 Määrust (EL) 1831/2003 (sööda lisaained) muudetakse, et lihtsustada sööda lisaainete lubade uuendamise ja kehtivate lubade muutmise menetlusi. Muudatustega vähendatakse ettevõtjate ning menetluses osalevate liikmesriikide ja Euroopa Toiduohutusameti (EFSA) halduskoormust, eelkõige seoses loa pikendamise nõuetega. Samuti nähakse ette võimalus muuta teatavad märgistamisnõuded paindlikumaks, sealhulgas võimaldada digitaalse märgistamise kasutamist sellise teabe esitamisel, mis ei ole otseselt seotud sööda ohutusega.

3.4 Määrusi (EL) 852/2004 ja 853/2004 (toiduhügieen) muudetakse, et lihtsustada liikmesriikide kohustust teavitada komisjoni siseriiklikest hügieeninõuetest. Edaspidi toimub selliste siseriiklike meetmete teavitamine tehniliste normide teabesüsteemi (TRIS) kaudu, vähendades halduskoormust ja parandades teabevahetuse tõhusust.

3.5 Määrust (EL) 396/2005 (pestitsiidijääkide piirnormid) muudetakse, et täpsustada imporditud toodetele kohaldatavate jääkide piirnormide käsitlust ja vältida ebaõiget arusaama, nagu kehtiks imporditud toodetele ELi toodetest erinevad toiduohutuse standardid. Sel eesmärgil tunnistatakse kehtetuks mõiste „impordile kehtestatav jääkide piirnorm“ ning rõhutatakse, et kolmandatest riikidest pärit toodete puhul lähtutakse kolmanda riigi heast põllumajandustavast, tingimusel et tagatud on samaväärne ohutuse tase. Samuti nähakse ette võimalus hinnata üksikjuhtumipõhiselt pika säilivusajaga toodete turustamise jätkamist pärast uute madalamate piirnormide kehtestamist, et vähendada toidukadu. Lisaks võimaldatakse teatavate varem pestitsiididena kasutatud toimeainete puhul kehtestada alaliselt madala tarbimisega toodetele piirnormid seireandmete alusel, vältides ebaproportsionaalselt kulukat ajutiste piirnormide korduvat läbivaatamist.

3.6 Määruses (EL) 1099/2009 (loomade heaolu tapmisel) kaotatakse kohustus esitada komisjonile eraldi iga-aastane aruanne haiguspuhangute või muude põhjuste tõttu toimunud loomade hukkamiste kohta. Muudatusega välditakse dubleerimist, kuna sama teave kajastub juba määruse (EL) 2017/625 alusel esitatavates ametlike kontrollide aruannetes. Alles jääb üldine loomade heaolu käsitlev aruandlus, vähendades liikmesriikide pädevate asutuste halduskoormust, ilma et see kahjustaks loomade heaolu kaitse taset.

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3.7 Määrust (EL) 1107/2009 (taimekaitsevahendid) muudetakse, et lihtsustada ja kiirendada eelkõige biotõrje ja madala riskiga toimeainete turulepääsu. Ettepanekuga kehtestatakse biotõrje toimeainete õiguslik määratlus ning nähakse ette nende prioriteetne hindamine ja loa andmine. EFSA-le antakse võimalus tegutseda vajaduse korral referentasutusena ning liikmesriikidel võimaldatakse anda ajutisi lube biotõrjeainetel põhinevatele toodetele pärast EFSA positiivset eelhinnangut. Kolme tsooni süsteem asendatakse ühtse tsooniga ning tähtaegade ületamisel rakendub vaikiv loa andmine. Biotõrjeaineid sisaldavate toodete puhul kaotatakse põllumajandustootjate arvestuse pidamise kohustus. Lisaks lihtsustatakse madala riskiga toimeainete määratlemist, täpsustatakse põhiaine mõistet ning võimaldatakse samal ainel olla nii põhiaine kui ka taimekaitsevahendi koostisosa. Toimeainete heakskiit muutub üldjuhul tähtajatuks, säilitades sihipärase ja riskipõhise läbivaatamise võimaluse. Täpsustatakse erandite kohaldamist ning pikendatakse üleminekuperioode olemasolevate varude müügiks ja kasutamiseks. Samuti ühtlustatakse andmekaitse kestus ja selgitatakse teatavaid kasutus- ja menetlussätteid, et vähendada halduskoormust ja parandada õigusselgust.

3.8 Määrust (EL) 2017/625 muudetakse, et muuta ametlikud kontrollid paindlikumaks ja tõhusamaks. Edaspidi võimaldatakse ELi imporditavate taimede ja taimsete saaduste saadetiste jagamist osadeks enne kogu saadetise ametliku kontrolli lõppu, et vabastada need partiid, mille kontroll on lõpetatud, vältides tarbetuid viivitusi ja majanduslikku kahju, eelkõige kiiresti riknevate toodete puhul. Samuti muudetakse paindlikumaks laborite akrediteerimisnõudeid, võimaldades kasutada ka muid asjakohaseid laboristandardeid peale standardi EN ISO/IEC 17025. Sellega vähendatakse laborite akrediteerimis- ja personalikulusid, ilma et see mõjutaks analüüsitulemuste usaldusväärsust.

3.9 Määrust (EL) 528/2012 muudetakse, et lihtsustada ja kiirendada biotsiidide lubade uuendamise menetlusi ning vähendada halduskoormust. Muudatustega muudetakse uuendamismenetlused sihitumaks ja tõhusamaks, eelkõige juhtudel, kus biotsiidi ohutus- ja riskiprofiil ei ole muutunud. Samuti vähendatakse teatavaid aruandlus- ja menetlusnõudeid ning parandatakse ELi-sisest ühtlustamist, säilitades kehtivad inimtervise, loomatervise ja keskkonnakaitse nõuded.

Kas EL algatus reguleerib karistusi või haldustrahve? Ei

Kas nähakse ette uue asutuse loomine (järelevalvelised või muud asutused)? Ei

Kas lahenduse rakendamine vajab IT-arendusi? Ei

Eesmärgid

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Eesmärk: Toidu- ja söödaohutuse nõuete lihtsustamise pakett on valdkondade ülene seadusandlik ettepanek, mis on suunatud ELi põllumajandus- ja toidusektori, rahva- ja taimetervise ning loomade heaolu raamistiku kaasajastamisele ja tõhustamisele. Selle eesmärk on vähendada halduskoormust, kiirendada uuendusi (eriti biotõrje ja väikese riskiga taimekaitsevahendite puhul) ning tagada sektoriteülene regulatiivne kooskõla. Algatus toob kaasa teatud lubade tähtajatuse, lihtsustatud lubade ja andmemenetlused, suurema paindlikkuse ametlikes kontrollides ning laborite akrediteerimises. Lisaks tugevdab see tarbija ja keskkonnakaitset uue reegli kaudu, mis keelab ohtlike pestitsiidide jääkidega toodete importi.

Mõju ja sihtrühm

Mõju valdkonnad

Majandus

Ettevõtlus

Sihtrühm: Ettevõtted

Mõju sihtrühmale: algatuste majanduslik mõju ettevõtetele on valdavalt positiivne, väljendudes halduskoormuse ja menetluskulude vähenemises ning suuremas õiguskindluses, ilma et ohutusnõuded muutuksid. Algatustega kiireneb eelkõige biotõrje- ja madala riskiga taimekaitsevahendite, sööda lisaainete, biotsiidide ning teatavate fermenteeritud toodete turulepääs ning väheneb impordiga seotud tarbetu viivitus ja kaubakadu.

Halduskoormus

Kas lahendusega kaasneb mõju halduskoormusele? Jah

Kas ettevõtetele halduskoormus: kahaneb

Mõju sihtrühmale: Algatustega lihtsustatakse ja kiirendatakse loamenetlusi (nt biotõrje ja madala riskiga taimekaitsevahendid, sööda lisaained, biotsiidid), vähendatakse aruandlus- ja märgistamisnõudeid (sh digitaalse märgistamise võimaldamine) ning kaotatakse dubleerivaid kohustusi. See vähendab ettevõtjate haldus- ja menetluskulusid ning parandab turulepääsu prognoositavust.

Kas avaliku sektori töökoormus: kahaneb

Mõju sihtrühmale: Algatustega kaotatakse dubleerivad aruandlus- ja menetlusnõuded, lihtsustatakse loamenetlusi ning kasutatakse olemasolevaid teavitussüsteeme (nt TRIS). Kuigi mõnes valdkonnas (nt EFSA kaasamine hindamisse) toimub tööülesannete ümberjaotus, ei kaasne uusi püsivaid kohustusi ega töömahu kasvu. Tervikuna väheneb pädevate asutuste menetluskoormus.

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Põllu-, metsa- ja kalamajandus ning toiduainetööstus

Sihtrühm: Põllumajandusettevõtted, toiduainetööstused

Mõju sihtrühmale: Algatusel on valdavalt positiivne majanduslik mõju põllumajandusele ja toiduainetööstusele, kuna see vähendab haldus- ja vastavuskulusid ning parandab tootmissisendite ja toodete kättesaadavust. Põllumajanduses kiireneb biotõrje- ja madala riskiga taimekaitsevahendite turulepääs ning väheneb arvestus- ja aruandluskoormus, sh biotõrjeainet sisaldavate toodete kasutamisel. Paindlikum käsitlus pestitsiidijääkide piirnormide üleminekul aitab vältida saagi ja tooraine kadu ning vähendada majanduslikke kahjusid. Toiduainetööstuses lihtsustub fermenteeritud toodete, sealhulgas ensüümide ja lisaainete regulatiivne käsitlus, väheneb lubade uuendamise ja märgistamisega seotud halduskoormus ning paraneb tarneahelate toimimine, eriti imporditavate ja kiiresti riknevate toodete puhul, toetades seeläbi sektori konkurentsivõimet ja innovatsiooni.

Riigivalitsemine

Riigieelarve

Kas lahendusega kaasneb mõju riigieelarve kuludele? Ei

Algatustega ei kaasne täiendavaid riigieelarvelisi kulusid. Muudatused on menetluslikud ja rakenduvad olemasolevate struktuuride, asutuste ja IT-süsteemide kaudu ning toovad pigem kaasa haldus- ja töökoormuse vähenemise, mitte uusi kulusid.

Kaasamine

Kaasata kõik asjassepuutuvad huvirühmad.