Riigikantselei resolutsioon: Narkootikumide lähteainete määrus

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EUROPEAN COMMISSION

Brussels, 3.12.2025

COM(2025) 747 final

2025/0384 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on monitoring and controlling drug precursors and repealing Regulations (EC) No

273/2004 and (EC) No 111/2005

{SEC(2025) 328 final} - {SWD(2025) 397 final} - {SWD(2025) 398 final} -

{SWD(2025) 399 final}

(Text with EEA relevance)

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EXPLANATORY MEMORANDUM

1. CONTEXT OF THE PROPOSAL

• Reasons for and objectives of the proposal

Recent years have witnessed a rise in drug-related violence and criminal activity amongst EU

Member States, with illicit drugs like cocaine, heroin, opioids, and amphetamine-type

stimulants (ATS) posing serious health and security problems. Moreover, the drug market is

increasingly marked by the widespread availability of a broader range of drugs, often with

higher potency or purity, and in new forms(1), aided by drug precursors. Drug precursors are

chemicals necessary for the illicit production of drugs. However, they can also have

significant legitimate use.

In recognition of the need to maintain controls to prevent the diversion of drug precursors

towards illicit trade, the UN Convention against Illicit Traffic in Narcotic Drugs(2) obliges its

Parties to take measures to prevent the diversion of substances frequently used in the illicit

manufacture of drugs.

The Union concluded the UN Convention in 1990(3), and subsequently adopted rules on drug

precursors. Currently, the UN Convention is implemented by Regulation (EC) No 273/2004

(‘the Internal Market Regulation’)(4) on monitoring and controlling drug precursors for their

possession and placing on the market, and Regulation (EC) No 111/2005 (‘the External Trade

Regulation’)(5) , for their trade between the Union and third countries.

These two regulations classify drug precursors as either scheduled (listed and controlled in the

regulations) or non-scheduled (for which there are no legally binding obligations). Scheduled

drug precursors are classified into several categories(6) depending on their role in illicit drug

production and the existing legitimate trade, and thus varying degrees of controls. In addition,

in 2013 the provisions granting powers to competent authorities were clarified regarding the

possibility to take national measures to control suspicious transactions of non-scheduled drug

precursors.

However, the situation has evolved since the adoption of these two regulations, with the rapid

increase in designer precursors – drug precursors without any known legitimate use, except

(1) EUDA, The European Drug Report 2025: Understanding Europe’s drug situation in 2025 – key

developments (European Drug Report 2025) | www.euda.europa.eu. (2) The United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances,

adopted in Vienna on 19 December 1988. (3) Council Decision (90/611/EEC) of 22 October 1990 concerning the conclusion, on behalf of the

European Economic Community, of the United Nations Convention against Illicit Traffic in Narcotic

Drugs and Psychotropic Substances, OJ L 326, 24.11.1990, p. 56. (4) Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004 on

drug precursors (OJ L 47, 18.2.2004, p. 1), ELI: http://data.europa.eu/eli/reg/2004/273/oj). (5) Council Regulation (EC) No 111/2005 of 22 December 2004 laying down rules for the monitoring of

trade between the Community and third countries in drug precursors (OJ L 22, 26.1.2005, p. 1, ELI:

http://data.europa.eu/eli/reg/2005/111/oj). (6) Category 1 substances are the most critical, comprising chemicals that form the essential core molecules

of drugs, making it impossible to produce these drugs without them. Category 2 covers less sensitive

substances compared to Category 1. For internal trade, Category 2 is divided into categories 2A and 2B

due to a higher risk of diversion of category 2A substances. Category 3 contains bulk chemicals which

are significant in the illicit drug production but also have widespread legitimate uses. For external trade,

Category 4 includes medicinal products that contain ephedrine and pseudoephedrine.

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research and innovation. Equally, the obligations(7) set out in the regulations create

administrative burden across the four categories of scheduled substances. Enforcement

measures need to be strengthened in order to ensure the uniform implementation of rules

across the EU.

From a security perspective, the proliferation and trafficking of designer precursors present

significant challenges to drug precursor control at global level. In response, both the United

Nations Commission of Narcotic Drugs (CND)(8) and the International Narcotics Control

Board in its 2024 report recommend controlling chemicals that are closely related to

controlled precursors – such as families or derivatives of controlled precursors.

In alignment with this strategy, countries like the USA, Canada, Argentina, Mexico and

recently China introduced extended scheduling to families or derivatives of controlled

precursors. This proactive approach is being followed at multilateral level through the

CND(9). Drug precursor controls are a crucial component of drug supply reduction policy as

outlined in the EU Drugs Strategy 2021-2025(10) . The EU Drugs Action Plan 2021-2025(11)

further highlights the need to address the challenge posed by designer precursors.

Additionally, the 2023 EU Roadmap to fight drug trafficking and organised crime(12) stresses

the need to set out innovative ways to speed up and broaden the current approach to

regulating drug precursors in response to new methods of illicit drug production.

Protect EU: a European Internal Security Strategy(13) announced a new EU Drugs Strategy

and an EU Action Plan against drug trafficking to disrupt routes and business models. The

2025 Commission Work Programme, under its security heading, announced the proposal of

new rules governing drug precursors(14).

Drug precursors are chemicals with an essential role in industries such as pharmaceuticals,

flavouring and fragrance, batteries, cosmetics, textiles, oil refinery, water treatment, food

additives, explosives, rubber production, fertilisers, plastics or dyes.(15) Within the EU,

there were approximately 4 000 active licenses or registrations to trade in drug precursors in

2023(16). 92 % of these companies are small and medium-sized enterprises (SME)(17).

(7) Depending on the category, operators and users must either hold a license or registration, secure their

premises, report suspicious transactions, ensure proper labelling and documentation, maintain

transaction records for three years, designate a responsible officer, obtain import and export

authorisations, including pre-export notification, and limit trade to customers which have a licence or a

registration. (8) CND Resolution 65/3 ‘Intensifying efforts to address the diversion of non-scheduled chemicals

frequently used in the illicit manufacture of drugs and the proliferation of designer precursors’ agreed in

March 2022. (9) At the March 2024 Commission on Narcotic Drugs, the INCB recommended scheduling as a direct

application of UN Resolution 65/3, introducing proactive scheduling at the UN level. (10) Council Conclusions on the EU Drugs Strategy 2021-2025, 14178/20, 18 December 2020. (11) COM (2020) 606 final (12) COM (2023) 641 final (13) COM (2025) 148 final (14) COM (2025) 45 final (15) For more detailed information, including the latest trends in the (diversion of) legitimate trade of these

substances and their regulatory challenges, see the INCB's technical reports on precursors, available at:

https://www.incb.org/incb/en/precursors/technical_reports/precursors-technical-reports.html. (16) Namely, economic operators holding at least one active licence or registration for the EU market of

drug precursors. Note that, as a proxy, this underestimates the figure since – at present – economic

operators trading in Category 3 internally only, are not required to register and those trading in

Category 4 are not required to register.

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Supply chains for these chemicals involve a diverse range of actors, including large-scale

chemical manufacturers who produce these substances in bulk for industrial use, as well as

specialised producers who create more refined or custom chemical products tailored to

specific industrial and research needs. Distributors and other logistics providers play key roles

in ensuring that these substances are transported and stored safely. The Union chemical

industry is a strategic sector, with 56 % of chemicals going to other sectors. It is therefore

vital to simplify conditions to ensure that the legitimate industry is able to fully reap the

benefits of the Single Market.

The proposal thus aims to address the challenge of preventing the use of drug precursors in

the illicit manufacture of drugs, whilst simplifying rules and procedures for legitimate trade.

More specifically, the introduction of specific rules on designer precursors and innovative

means for their inclusion will allow quicker action to prevent their diversion. Through

digitalisation, several obligations could be automated, leading to a significant reduction in the

costs and the administrative burden for operators and the Member State national authorities.

The proposal would contribute towards the objectives set out in political guidelines of the

Commission for 2024-2029, which announce the facilitation of business operations,

particularly for SMEs(18), and aim to deepen the Single Market. The Competitiveness

Compass emphasizes simplification as a key factor in boosting industry competitiveness.(19)

• Consistency with existing policy provisions in the policy area

The merging of currently separate instruments for EU internal and external trade will enhance

legal clarity and consistency:

• The obligations under the two regulations have been simplified or automated, in line

with the digital agenda. This will help reduce the administrative burden for operators

and Member State authorities. In addition, a new category has been introduced for

designer precursors.

• The inclusion of special rules for designer precursors in the proposal allows for the

more effective monitoring and prevention of the proliferation of drug precursors

towards illicit aims. Streamlined administrative procedures and a central electronic

system will enable greater simplification and reduce overall burden for authorities

and business alike, offsetting enforcement and due diligence costs, thereby resulting

in a net cost saving. In addition, the drug precursors information repository will

provide the necessary guidance to stakeholders.

• Merging the two existing regulations will enable the application of the same rules for

internal and external trade, wherever possible.

• Consistency with other Union policies

The proposal is consistent with other Union policies and legislation, namely:

• Regarding illicit drug trafficking, the drug precursors regulations help determine the

material scope of minimum national rules on criminal acts concerning precursors set

out by Member States in accordance with Council Framework Decision

(17) There is no public source regarding share of SMEs trading in drug precursors. The percentage of the

relevant (closest) manufacturing chemicals sub-sectors according to Eurostat data is 92%, which aligns

with the view of public authorities consulted as part of the stakeholder consultations for this initiative. (18) Ursula von der Leyen, Political Guidelines for the next European Commission 2024-2029, 18 July

2024, e6cd4328-673c-4e7a-8683-f63ffb2cf648_en (europa.eu). (19) COM (2025)30 final

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2004/757/JHA(20). The EU Drugs Agency (EUDA) plays an important role with its

new mandate(21) in the field of drug precursors, and the proposal duly acknowledges

its expertise.

• The proposal does not interfere with other rules on chemicals such as the REACH

Regulation(22) or the CLP Regulation(23), or other sectoral chemical legislation such

as the Cosmetic Products Regulation(24) or the Detergents Regulation(25).

• Furthermore, with respect to customs policy, this initiative supports the EU Customs

Reform(26) which aims to establish a new EU Customs Authority maintaining an EU

Customs Data Hub. The Data Hub will replace the current fragmented customs IT

infrastructure in EU Member States, enhancing interoperability with related policy

areas. Data on drug precursors will be integrated into the Data Hub.

2. LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY

• Legal basis

The proposal is based on Articles 33, 114 and 207 of the Treaty on the Functioning of the

European Union.

• Subsidiarity (for non-exclusive competence)

The Union has shared competence in setting out rules on the control and monitoring of drug

precursors within the internal market. The EU set out harmonisation rules on drug precursors

since 1990. Two key arguments continue to justify EU action in this field. Firstly, illicit drug

production is a Union-wide problem, not confined to a few Member States. EU action is

needed to ensure that the efficiency of controls of drug precursors across the Union is not

diminished by the existence of diverse national rules with various degrees of strictness, which

would inadvertently lead to weaknesses. Secondly, Member States have the obligation to

control and monitor transactions with drug precursors, in accordance with the UN

Convention. Maintaining harmonised rules would ensure a smooth legitimate trade of

chemicals in the single market. EU action would have clear benefits for businesses, national

(20) Council Framework Decision 2004/757/JHA of 25 October 2004 laying down minimum provisions on

the constituent elements of criminal acts and penalties in the field of illicit drug trafficking (OJ L 335,

11.11.2004, p. 8–11, ELI: https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32004F0757). (21) Regulation (EU) 2023/1322 of the European Parliament and of the Council of 27 June 2023 on the

European Union Drugs Agency (EUDA) and repealing Regulation (EC) No 1920/2006 (22) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006

concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH),

establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council

Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council

Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and

2000/21/EC (OJ L 396, 30/12/2006, p. 1, ELI: http://data.europa.eu/eli/reg/2006/1907/oj). (23) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on

classification, labelling and packaging of substances and mixtures, amending and repealing Directives

67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31/12/2008, p.

1, ELI: http://data.europa.eu/eli/reg/2008/1272/oj). (24) Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009

on cosmetic products (OJ L 342, 22/12/2009, p. 59, ELI: http://data.europa.eu/eli/reg/2009/1223/oj). (25) Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on

detergents (OJ L 104, 8.4.2004, p. 1, ELI: http://data.europa.eu/eli/reg/2004/648/oj). (26) Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

establishing the Union Customs Code and the European Union Customs Authority, and repealing

Regulation (EU) No 952/2013, COM/2023/258 final, 2023/0156 (COD)

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authorities and society as a whole, by empowering national authorities to better fight against

illicit drug production, ensuring the good functioning of the internal market and reducing

administrative burdens for economic operators and national authorities.

• Proportionality

The proposal does not exceed what is necessary for reaching the objectives pursued. The

measures concern a limited number of precursors, thus targeting the controls without unduly

hampering legal trade and innovation. The proposal reflects the risks associated with each

category of precursors and takes full advantage of digitalisation. It strikes a fair balance

between the need to reduce the availability of drug precursors for the illicit manufacture of

drugs, and the need to facilitate legitimate trade. Thus, despite a reduction of administrative

processes notably on bulk materials with significant legitimate use, the diversion risk is

properly addressed by strengthening the enforcement.

• Choice of the instrument

The rules on controls and monitoring of drug precursors are to be set out in a Regulation, and

thus directly applicable in all Member States. Drug precursors are often part of supply chains

with operators in more than one Member State. The existence of uniform rules will ensure a

level playing field among economic operators.

3. RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER

CONSULTATIONS AND IMPACT ASSESSMENTS

• Ex-post evaluations/fitness checks of existing legislation

The 2020 report from the Commission to the European Parliament and the Council on the

evaluation of the EU drug precursor regulations (27) reveals a number of shortcomings that

have emerged since the adoption of the Internal market and External Trade regulations, along

with possible measures to address them. Notably:

• It underlines the need for action specifically targeting designer precursors. The

current rules concern drug precursors where there is evidence of legitimate trade.

Also, the current scheduling mechanism, based on a substance-by-substance

approach, is too slow in keeping up with the fast pace of innovation by illicit drug

manufacturers. There are hardly any limitations to the innovations of the producers

of designer-precursors. In other words, each time a new substance is scheduled the

criminals will be able to ‘tweak some molecules’ and come up with a new designer-

precursor. The time needed for this can be short and in any case is often shorter than

the period needed to schedule a new substance.

• Equally, the evaluation also underscores the administrative burden on operators and

competent authorities, and the potential digitalisation offers in this regard, such as

through e-licencing and the automatic validation through the European Union Single

Window Environment for Customs(28). Further examples of possible reduction of the

administrative burden identified a facilitation of trade in low quantities of scheduled

(27) Report from the Commission to the European Parliament and the Council on the Evaluation of the EU

drug precursors regulations, COM (2020) 768. For security reasons, the document accompanying the

report is not publicly available. (28) Regulation (EU) 2022/2399 of the European Parliament and of the Council of 23 November 2022

establishing the European Union Single Window Environment for Customs and amending Regulation

(EU) No 952/2013 (OJ L 317, 9.12.2022, p. 1, ELI: http://data.europa.eu/eli/reg/2022/2399/2024-10-

17).

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drug precursors and the elimination of certain wait periods related to pre-export

notifications for external trade.

• Moreover, consideration for the role of online marketplaces in the possible diversion

and trafficking of drug precursors would help maintain the relevance of the

regulations in the foreseeable future. In addition, the evaluation recommends

strengthening the catch-all clause to allow more effective enforcement.

• Stakeholder consultations

The Commission carried out a number of consultation activities to collect evidence and views

from a broad range of stakeholders on the problems identified with the Drug Precursors

Regulations. Activities included (i) a twelve-week dedicated public consultation concluded in

July 2024; (ii) two stakeholder workshops held on 14 November 2023 and 19 September

2024; (iii) discussions with Member States and other stakeholders in the Expert Group on

Drug Precursors; and (iv) feedback collected in response to the Commission’s Call for

Evidence. As part of the impact assessment study, an external contractor also organised

interviews with 78 relevant stakeholders, and two targeted surveys of national authorities and

economic operators ran from 25 March to 17 May 2024 and 18 April to 14 June 2024

respectively. Consulted stakeholders included industry associations, economic

operators, citizens, and national authorities. Most responses came from a business

environment or from national authorities.

National authorities supported strengthening measures to prevent the diversion of drug

precursors and, in particular, measures concerning the proliferation of designer precursors.

They supported a moderate scope for a ban that would still enable legitimate activities such as

research. They noted that this may lead to a higher implementation burden. Economic

operators also supported measures in this field but stressed the need for a clear and univocal

identification of banned substances (ideally through CAS number or other machine-readable

coding) as a prerequisite to avoid undue increase of due diligence costs for legitimate trade.

While the consultation activities gave mixed results on current administrative burdens, many

stakeholders believed that transitioning to a fully digitalised system would significantly

reduce administrative burdens by streamlining processes, improving accuracy, and enabling

real-time access to necessary data.

• Collection and use of expertise

Evidence supporting this initiative was gathered from existing documentary sources including

legislation and other policy documents, customs and trade statistics, evaluations and reports

on relevant policies and information on related initiatives, as listed in Annex 6 to the

impact assessment.

• Impact assessment

The Commission carried out an impact assessment on the revision of the Drug

Precursor Regulations. The Regulatory Scrutiny Board issued a positive opinion on the draft

impact assessment on 6 June 2025. The impact assessment report was revised to take into

account the Board’s comments, in particular by better explaining how the uneven

implementation and enforcement among Member States is a driving factor behind the

problem; the extent to which the existing burdens pose a problem for economic operators and

public authorities and why removing some measures would not increase the risks; why the

two comprehensive review options are considered to be equally effective in reducing illicit

trade and manufacturing; the evidence and methodology used to support the estimates of

social impacts; and the key indicators to measure success.

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The opinion of the Board as well as the final impact assessment and its executive summary

are published together with this proposal. Based on the available information, the impact

assessment examined and compared three policy options to address each of the two main

problems identified. These policy options were in addition to the baseline option of no

change, which would still allow for the inclusion of designer precursors in the scope of the

current rules.

Policy option 1:

Policy option 1 aims at assessing the extent to which the current empowerments would be an

effective and efficient means to meet the policy objectives of the initiative. The key measures

of option 1 that would be underpinned by guidance and transparency measures involving the

drug precursors information repository are the following:

• Specific rules for designer precursors in internal trade. Designer precursors rarely enter

legitimate supply chains. Yet, their legitimate use in research and innovation, often in very

small quantities, needs to remain possible. This is why for internal trade the obligations

attached to designer precursors are rendered more targeted. Legitimate use is notified to the

competent authority who may then investigate further.

• Simplify reporting obligations by switching from an ex-post to an ex-ante for internal trade:

In line with the idea of maintaining high levels of control while streamlining the

administrative requirements linked to the controls, this option also seeks to facilitate reporting

for economic operators and authorities.

Policy option 2:

Policy option 2 makes use of the wider possibilities provided by a full legislative revision.

This enables, notably, a better alignment of external and internal trade controls. The idea of

policy option 2 is to gauge to what extent controls of drug precursors trade can be streamlined

without compromising their effectiveness. The key measures of option 2 are the following:

• Streamlining and reorganisation of the existing categories of substances: The new set of

categories therefore aim to clarify and streamline obligations and controls based on an

updated perception of the risk-profile of a group of substances.

• Introducing a new category for designer precursors with an a priori ban: Designer precursors

are different from traditional designer precursors in that their legal use is often limited to

research activities, but other future legitimate uses cannot be excluded a priori. Use or

transactions of such precursors in small quantities for research and innovation should be

subject to a prior notification to national authorities, while transactions and use in larger

quantities is to be subject to a licence.

• Innovative and more forward-looking ways of scheduling: Option 2 would adapt the rules to

the inclusion of groups of substances, for instance based on a chemical base molecule and a

limited number of precise modifications to these base molecules.

Policy option 3:

Option 3 is also based on a full legislative revision. Its basic structure is shared with option 2

but it is rather based on the premise of maximising controls. Its key measures are the

following:

• Streamlining existing categories of substances and increasing control measures applicable to

them: While option 3 also entails a streamlining of categories, the focus is on increasing

controls. The aim of extending controls is to have a better overview of legal trade in all

precursor substances. This should enable authorities to monitor trade more closely.

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• Introducing a new category for designer precursors with a greater focus on ex-ante controls

by requiring special licences in all cases.

• Broader approach to innovative scheduling: Option 3 would imply including group of

substances with base molecules (represented by their structural formula) and allow for an

extended number of modifications to these, resulting in a larger number of substances to be

scheduled.

Comparison of the options:

Option 1, while reducing time for scheduling and facilitating knowledge, was expected to fall

short of expectations in terms of addressing the proliferation of designer precursors and

related social impacts. It was considered to lead to limited burden reduction for internal trade

only and have marginal environmental impacts.

Option 3 was expected to largely deliver the same results as Option 2. It was expected to

maximise the reduction in the availability of precursors used in the manufacturing of illicit

drugs. Given that it would be more costly to enforce due to the larger number of substances to

be screened and higher control burdens on legitimate businesses, some Member States did not

support excessively broad scheduling of substances as they may not be in the position to cope

with the required effort.

Preferred policy option

Policy option 2 is the preferred option 2 as it was considered to be most effective against the

proliferation of designer precursors and the trafficking of non-scheduled substances.

In terms of economic impacts, this option and especially the larger scope of substances

scheduled as designer precursors is expected to come with an increase of about 10% in

enforcement costs. Economic operators would face a one-off cost of about EUR M 7.7 for

ensuring that newly scheduled designer precursors are not included in their portfolio. of the

measures on designer precursors are offset by the streamlining and simplification of the

regulatory framework. Yet, the development of an electronic system provides for the

modernisation of the control system, alongside the provisions for digital verification of

customers in the internal trade of Category 1 and Category 3 drug precursors. The burden of

the EU control system for legal trade is reduced through the lifting/automation of various

requirements. Overall, the streamlining and digitalisation of procedures is expected to lead to

an administrative burden reduction of EUR M 25.27 per year. These changes should

contribute to effectively facilitating trade and promoting the competitiveness of the sector.

For social impacts, the real-time reporting of significant seizures and urgency procedure will

reduce significantly the time to detect and respond to new threats, while enabling authorities

to target controls more specifically on those substances that are at a higher risk of being used

in illegal drug production. Overall, this is expected to help reduce the availability of

precursors used in the manufacturing of illicit drugs (especially synthetic drugs). Economic

operators’ awareness, and engagement will improve. Indirectly, the initiative should therefore

reduce the availability of illicit drugs and may thus contribute to a reduction of social costs

caused by illicit drug trafficking and consumption.

No direct environmental effects are expected but an overall reduction of illicit drug

production may reduce illegal waste disposal from drug productions sites.

This option is also expected to contribute to the achievement of three of the United Nations

Sustainable Development Goals (SDGs): SDG #9 ‘Industry, innovation’; SDG #3 ‘Good

health and well-being and infrastructure’ and SDG #16 ‘Peace, justice, and strong

institutions’.

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• Regulatory fitness and simplification

The initiative has a strong simplification dimension. Namely, through:

• A merger of the two regulations into a single regulation, aligning rules for both the

internal market and external trade wherever possible.

• Fewer categories of scheduled drug precursors, from 4 to 3. Introducing a specific

category for designer precursors provides greater clarity to operators and national

authorities alike that such substances are subject to an outright ban. In addition, the

initiative includes an exemption to this ban for small quantities for research and

innovation. In case a legitimate use for a Category 3 drug precursor is discovered, the

Commission and Member States will assess if such a substance should be placed in

another category or exempt from the scope of the regulation.

• Due to the risk of diversion, the proposal does not exempt micro enterprises.

However, where reasonable the proposal foresees exemptions for small quantities

and for pharmacies and veterinary dispensaries.

• From a digital perspective, the development of a central electronic system allows for

several improvements:

• Digital applications for licences (new Categories 1 and 3) and registration for

external trade (new Category 2).

• Digital controls for imports and exports by the EU Single Window

Environment for Customs and the lifting of the Pre-Export Notification (PEN)

waiting period.

• Reporting obligations are automated by aggregating the data entered into the

central electronic system. The process of verifying customers will be

digitalised.

The above should lead to reduced administrative costs for operators and public authorities.

The benefits accruing from the consolidation of the two regulations are difficult to quantify

since they relate to the time spent understanding the rules and how to comply with them (i.e.

they are a complementary action for the compliance with the actual obligations themselves).

The initiative will reduce obligations for certain substances to better facilitate trade (such as in

the removal of administrative costs related to the reporting requirement). It will also extend

obligations to support enhanced control (i.e., due diligence costs for the implementation of the

ban on designer precursors. Globally there will be a net reduction in costs, with the impact

assessment estimating this net cost saving as amounting to approximately EUR 25,27 million

per year.

• Fundamental rights

The proposal complies with the EU Charter of Fundamental Rights. The freedom to conduct

business set out in the charter is not absolute. The restrictions set out in this proposal such as

requesting a licence for performing activities involving Category 1 or Category 3 drug

precursors are justified by the need to monitor activities with such precursors and reduce their

availability for the illicit manufacture of drugs. This objective is in line with the general

objective of providing a high level of human health protection in the definition and

implementation of all the Union's policies.

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4. BUDGETARY IMPLICATIONS

Member States and operators will rely on a centralised electronic system that will streamline

and support the process for managing licences, registrations, customer verifications, quantity

management, and prior notifications. The new rules will eventually remove the periodic

reporting obligations for operators and authorities.

Comprehensive digital solutions are expected to facilitate the completion of administrative

tasks for operators and to expedite the overall process. Moreover, it will enable competent

authorities to verify the legality of drug precursors movements more effectively, improving

traceability.

Digitalisation will enhance the effectiveness and efficiency of controls, providing authorities

with faster access to structured, high-quality information that allows for automatic checks of

licences/registrations and perform quantity management. This will support faster clearance

times for imports and exports while strengthening the EU’s ability to detect and prevent illicit

trade.

• To achieve this, budgetary needs for the internal market IT system and human

resources are estimated to amount to EUR M 1.322, starting from 2028.

• For external trade, a preliminary analysis led to a budget requirements estimation of

up to EUR M 24.148, including human resources, depending on the IT solution

delivery model chosen.

• An information repository of drug precursors which will cover all relevant scheduled

and non-scheduled substances having or not a known industrial or commercial use

which will, including human resources, cost approximately EUR 0.530 M.

Further information on these costs can be found in Section 3.2 of the Legislative Financial

Digital Statement. The post-2027 figures are indicative, without pre-empting and pre-judging

the Commission proposal and the agreement on the next MFF.

5. OTHER ELEMENTS

• Implementation plans and monitoring, evaluation and reporting arrangements

The Commission will evaluate the Regulation 10 years after its entry into application with a

view to assessing its effectiveness, efficiency, relevance, added value and coherence. The

Commission will submit a report on the main findings to the European Parliament and to the

Council.

• Detailed explanation of the specific provisions of the proposal

Article 1 defines the subject matter of the Regulation, which is to set out rules for monitoring

and controlling drug precursors both for activities in the internal market and for external trade.

Article 2 defines the most important notions used in the Regulation, using whenever possible

cross-references from other related Union acts to ensure consistency.

Article 3 defines the material scope of the rules. Drug precursors are to be understood as

referring to substances, mixtures, organisms and substances which occur in nature which can

be used in the illicit production of drugs. While both scheduled and non-scheduled drug

precursors are covered, there are specific conditions in which certain mixtures are excluded

from the scope. In addition, the activities of public authorities, such as armed forces or police,

acting within the scope of their official duties, as well as the use or possession of drug

precursors by pharmacies and veterinary dispensaries are also excluded from the scope, due to

the low risk of diversion. Furthermore, while making available on the market, use and

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possession of medicinal products or veterinary medicinal products are excluded from the

scope of the Regulation, external trade is covered only for those products included in Part II

of Annex II to the Regulation.

Article 4 includes the standard free movement clause, which will ensure that Member States

will not impede making available on the market scheduled drug precursors, if the

requirements in the Regulation are fulfilled, by imposing additional monitoring measures, for

instance.

Article 5 lists the 3 categories of scheduled drug precursors and sets out the conflict rules to

be used to determine the requirements in specific cases where either a substance belongs to

two categories, or a mixture contains substances belonging to two or three categories.

Articles 6 to 8 set out the general obligations applicable to operators trading with scheduled

drug precursors. Operators have a general obligation of cooperation with national authorities

and to keep documentation on their transactions with scheduled drug precursors. To support

national authorities in fighting the illicit manufacture of drugs, operators and providers of

online marketplaces have the obligation to notify suspicious transactions and significant

disappearances or thefts of scheduled drug precursors.

Articles 9 to 14 lay down the requirements for placing on the market, use, possession, import,

export or intermediary activities with Category 1 drug precursors. These are the drug

precursors with legitimate uses in the chemical industry with the highest risk of

diversion. Therefore, they are subject to strict control measures. In addition to the requirement

to hold a licence, the operators have to designate a responsible officer, secure premises and

trade in the internal market only with operators also holding a licence. Equally, operators

using or possessing Category 1 drug precursors also have to keep the documentation, in

similar conditions as those for operators trading with any scheduled drug precursor.

Article 15 lays down the requirements for import, export or intermediary activities with

Category 2 drug precursors. External traders of Category 2 scheduled drug precursors will no

longer need to apply for, and subsequently be granted, a registration for import, export, or

intermediary activities. Instead, they will simply register information on their activities,

including the estimates of maximum quantities envisaged during a validity period of three

years, after which they can start activities involving the scheduled drug precursors they

register. This information will be updated as required. Competent authorities may decide to

suspend or cease the activities included in the registration in case the conditions declared are

no longer fulfilled or in case of suspicion of risk of diversion towards illicit purposes.

Articles 16 to 19 set out the requirements for the newly introduced Category 3 drug precursors

concerning designer precursors. Category 3 drug precursors contain substances which have no

known legitimate use other than research or innovation at the moment of placing them under

control. Therefore, the trade, use or possession of such substances should, a priori, be

banned. Transactions, use or possession of small quantities for research and innovation should

be allowed subject to a prior notification. If needed in larger quantities or for other legitimate

uses, a licence is to be requested.

Articles 20 to 23 lay down procedures related to external trade in drug precursors. The new

rules enable the simplification of external trade procedures through automation. Articles 20

and 22 set out the requirements for import and export authorisations, which are replaced by a

system of quantity management, whereby the operator notifies the competent authority of the

maximum quantity of scheduled substances to be imported or exported over a specific time

period. This would also cover one or more intended import or export activities during this

time up to a ceiling of the total quantity originally indicated. Article 23 sets out the provision

EN 12 EN

for customs verification, whereby the central electronic system will connect to the Single

Window Environment for customs to verify the information provided on intended imports or

exports against the operator’s licence, registration, or prior notification details.

Article 21 sets out the process for pre-export notifications, which has been further

streamlined. The pre-export notification obligation has been waived for countries in the

European Economic Area (EEA). In addition, the 15-day wait period provided to third

countries to reply to such a pre-export notification has been lifted.

Article 24 maintains the current provisions that external traders will continue to have the

obligation to demonstrate the licit purpose when the scheduled drug precursors are

transhipped, placed in temporary storage, or stored in a free zone.

Article 25 sets out a Drug Precursors Information Repository, which is to replace the existing

Voluntary Monitoring List. The Repository is to contain information on the scheduled and

non-scheduled drug precursors. It has several purposes: to support the operators in identifying

suspicious transactions and in determining if specific substances are within the scope of the

Regulation in case of including groups of substances identified in a generic way, and to

support the Commission and national authorities in identifying the need to place new

substances under control. The Repository is to be developed and maintained by the European

Union Drugs Agency.

As additional measures to raise awareness and support Member States in the fight against the

illicit manufacture of drugs, Article 26 sets out rules on training both for national authorities

and operators.

Article 27 sets out provisions on mutual assistance between the Member States and between

the Member States and the Commission, in particular by recourse to Council Regulation (EC)

No 515/97(29).

Article 28 sets out an obligation for competent authorities to perform controls on the

fulfilment of the obligations of this legislation with regard to scheduled drug precursors.

Articles 29 and 30 provide catch-all provisions for drug precursors. Competent authorities are

empowered to intervene to avoid diversion towards the illicit production of drugs in the

internal market by seizing scheduled drug precursors for a determined period of time in the

conditions set out in the national law. For external trade, the powers of customs and

competent authorities to monitor and control the possible diversion of both scheduled and

non-scheduled precursors are strengthened by enabling Member State competent authorities

with the tools to adopt stricter provisions for non-scheduled precursors, such as temporary

detention, if they deem necessary. In addition, the requirement of strict control measures for

all customs procedures is highlighted.

Article 31 sets out an obligation for Member States to adopt national rules on penalties, to

ensure the enforcement of the Regulation.

Article 32 concerns the reporting of information on seizures by competent authorities and

customs authorities, while Article 33 sets out specific information obligations for Member

States which could lead to future developments as regards substances included in the

categories of scheduled drug precursors or in the Repository, as non-scheduled drug

precursor.

(29) OJ L 82, 22.3.1997, p. 1. Regulation as last amended by Regulation (EC) No 807/2003 (OJ L 122,

16.5.2003, p. 36).

EN 13 EN

Article 34 elaborates on the annual reporting obligation to the UN, to be performed by the

Commission in consultation with Member States. The existing annual reporting obligations of

operators are removed, as automation can provide this information. This allows the reporting

obligations as per international obligations to continue with a more sustainable focus of

resource utilisation.

Article 35 sets out the main functions of a centralised IT system for drug precursors which is

to support the implementation of the various obligations. The system should allow operators

to fulfil their obligations laid down in this Regulation and competent authorities, to make their

decisions on the implementation of this Regulation and perform their reporting obligations.

The system should also facilitate the communication by the Commission of information

requested under the UN Convention. The centralised system is to be interconnected with the

Single Windows Customs system, to enable the application of a quantity management system

and thus replace the existing system of import and export authorisations. In addition, the

system could be made compatible with the UN system for reporting of precursors incidents,

so that the reporting of seizures in the electronic system is not a duplication of the existing

reporting obligation under the UN Convention. The Commission is to adopt an implementing

act setting out implementation arrangements for the electronic system, including the technical

and the procedural requirements that stem from its functions.Article 36 covers the protection

of personal data in the context of the operation of the electronic system.

Article 37 sets out the Commission empowerment for technical adaptations to the Annexes to

amend the substances placed under control. In addition, the Commission is to amend other

non-essential elements regarding, for instance, licences, registrations, prior notifications,

quantity notifications for import or export, reporting obligations or transitional measures.

Article 38 describes the conditions for exercising the empowerment to adopt delegated acts.

Article 39 allows the Commission to use the urgency procedure to adopt delegated acts in

duly justified cases, for changes to the controlled substances.

Article 40 ensures that the Commission will follow the examination procedure when adopting

implementing acts regarding the implementation arrangements for the IT system.

Articles 41 to 45 refer to final and transitional arrangements. The Commission is to review the

Regulation after a period of 10 years of application. This will allow the Commission to also

consider the application of the quantity management system in the first evaluation of the

Regulation, which is an essential element, and which is applicable only at a later stage when

the IT system is fully developed. While Regulation (EC) No 273/2004 and Regulation (EC)

No 111/2005 are to be repealed, transitional provisions are also proposed to ensure legal

clarity as regards documents issued under the old rules. The application of the new rules

should be deferred with 3 years to give the Commission time to develop part of the functions

of the IT system to support its implementation and the operators and national authorities time

to adapt. Since the other functions of the IT system supporting the quantity management for

imports and exports will be operational at a later stage, a dedicated Annex sets out the

transitional arrangements for the additional period as regards external trade and the reporting

of external traders on their annual transactions.

EN 14 EN

2025/0384 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on monitoring and controlling drug precursors and repealing Regulations (EC) No

273/2004 and (EC) No 111/2005

(Text with EEA relevance)

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

Articles 33, 114 and 207 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(1),

Acting in accordance with the ordinary legislative procedure(2),

Whereas:

(1) The United Nations Convention against Illicit Traffic in Narcotic Drugs and

Psychotropic Substances adopted in Vienna on 19 December 1988 ('the UN

Convention') is part of the worldwide effort to combat the production and trafficking

of illicit drugs. The Union concluded the UN Convention by means of Council

Decision 90/611/EEC(3).

(2) Article 12 of the UN Convention requires the Parties thereto to take the measures they

deem appropriate to prevent the diversion of substances which are included in the

tables annexed to the Convention and used for the purpose of the illicit manufacture of

drugs (drug precursors). The adoption of rules to monitor and control these drug

precursors was implemented in the Union by Regulation (EC) No 273/2004 of the

European Parliament and of the Council(4), regarding the control and monitoring

measures within the internal market; and Council Regulation (EC) No 111/2005(5) on

trade between the Union and third countries.

(1) OJ C [...], [...], p. [...] (2) Position of the European Parliament of [date] (not yet published in the Official Journal) and decision of

the Council of [date]. (3) Council Decision of 22 October 1990 concerning the conclusion, on behalf of the European Economic

Community, of the United Nations Convention against Illicit Traffic in Narcotic Drugs and

Psychotropic Substances (OJ L 326, 24.11.1990, p. 56, ELI: http://data.europa.eu/eli/dec/1990/611/oj). (4) Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004 on

drug precursors (OJ L 47, 18.2.2004, ELI: http://data.europa.eu/eli/reg/2004/273/oj). (5) Council Regulation (EC) No 111/2005 of 22 December 2004 laying down rules for the monitoring of

trade between the Community and third countries in drug precursors (OJ L 22, 26.1.2005, ELI:

http://data.europa.eu/eli/reg/2005/111/oj).

EN 15 EN

(3) The Evaluation of the Union drug precursor regulations(6) has shown that additional

action with regard to designer precursors is necessary. Designer precursors are

substances closely related to controlled drug precursors, with no known legitimate use,

and which evade the controls set out in Regulations (EC) No 273/2004 and 111/2005.

Those Regulations have been conceived to address the diversion of traditional drug

precursors from licit channels towards the illicit manufacture of drugs, and do not

include specific rules addressing designer precursors. The evaluation also pointed out

to the need to take a holistic approach in regulating drug precursors, to ensure

consistency with recent policy developments at Union level against drug

trafficking. Recent developments include the EU Drugs Strategy and Action Plan, the

adoption of Regulation (EU) 2023/1322(7) on the European Union Drugs Agency, the

European Digital Strategy and the adoption of Regulation (EU) 2022/2399(8).

(4) Drug precursor controls are a crucial component of drug supply reduction policy as

outlined in the EU Drugs Strategy 2021-2025(9). Furthermore, the EU Drugs Action

Plan 2021-2025(10) highlights the need to address the challenge posed by designer

precursors. Additionally, the 2023 EU Roadmap to fight drug trafficking and

organised crime(11) stresses the need to set out innovative ways to speed up and

broaden the current approach to regulating drug precursors in response to new

methods of illicit drug production. Equally, as part of the new EU Drugs Strategy and

EU Action Plan against drug trafficking, announced in Protect EU: a European

Internal Security Strategy(12), the EU will boost operational efforts to stop the inflow

of drug precursors, including designer precursors. .

(5) Therefore, new rules on drug precursors should be adopted, to better address the

developments in the illicit manufacture of drugs, and in particular, the proliferation of

designer precursors. These new rules would also give effect to the obligations deriving

from Article 12 of the UN Convention.

(6) In order to streamline current procedures and to reduce administrative burden,

Regulation (EC) No 273/2004 and Regulation (EC) No 111/2005 should also be

merged into one Regulation. That should also facilitate the free movement of

chemicals in the internal market. This Regulation should apply without prejudice to

other Union legislation applicable to the substances contained in drug precursors

(6) Report from the Commission to the European Parliament and the Council of 30.11.2020 - Evaluation of

the EU drug precursors regulations (COM/2020/768 final). (7) Regulation (EU) 2023/1322 of the European Parliament and of the Council of 27 June 2023 on the

European Union Drugs Agency (EUDA) and repealing Regulation (EC) No 1920/2006 (OJ L 166,

30.6.2023, p. 6., ELI: http://data.europa.eu/eli/reg/2023/1322/oj). (8) Regulation (EU) 2022/2399 of the European Parliament and of the Council of 23 November 2022

establishing the European Union Single Window Environment for Customs and amending Regulation

(EU) No 952/2013 (OJ L 317, 9.12.2022, p. 1, ELI: http://data.europa.eu/eli/reg/2022/2399/oj). (9) Council Conclusions on the EU Drugs Strategy 2021-2025, 14178/20, 18 December 2020. (10) Communication COM (2020) 606 final of 24.7.2020 from the Commission to the European Parliament,

the Council, the European Economic and Social Committee and the Committee of the Regions - EU

Agenda and Action Plan on Drugs 2021-2025. (11) Communication COM (2023) 641 final of 18.10.2023 from the Commission to the European Parliament

and the Council on the EU roadmap to fight drug trafficking and organised crime. (12) Communication COM (2025) 148 final of 1.4.2025 from the Commission to the European Parliament,

the Council, the European Economic and Social Committee and the Committee of the Regions on

ProtectEU: a European Internal Security Strategy.

EN 16 EN

covered by this Regulation, such as Regulation (EC) No 1907/2006(14), Regulation

(EC) No 1272/2008(15) or Regulation (EU) 2019/1148(16). It should also apply without

prejudice to the obligations of Member States to set out national rules on the

constituent elements of criminal acts and penalties in the field of illicit drug trafficking

in accordance with Council Framework Decision 2004/757/JHA(17). This Regulation

should not apply to customs, police, armed forces and laboratories of competent

authorities in the Member States when they are acting within the scope of their official

duties, as the risk of diversion of drug precursors in such cases is minimal. The

possession and use of drug precursors by pharmacies and veterinary dispensaries

within the scope of their regular activities should also be exempt from the scope of the

Regulation, as such operators are already subject to strict rules under Union and

national legislation. The possibility of setting out simplified formalities for specific

external traders, such as pharmacies and dispensaries of veterinary products, should be

maintained to reduce the administrative burden for operators with a low risk profile.

(7) Scheduled drug precursors consist of or contain substances covered by the annexes to

this Regulation. The annexes should include all the substances already covered by

Regulation (EC) No 273/2004 of the European Parliament and of the Council and

Council Regulation (EC) No 111/2005. Such substances are either covered by the UN

Convention or are placed under control at Union level, in response to specific risks of

diversion identified in the Union. To facilitate their free movement in the internal

market and their external trade, harmonised rules should be set out to enable national

authorities to control and monitor legitimate trade effectively, with a view to avoiding

their diversion towards the illicit manufacture of drugs, without creating

disproportionate administrative burdens. As is the case under the current rules,

operators should continue to have the obligation to notify suspicious transactions. This

is an important source of information for competent authorities to discover illicit

activities. The obligation should be extended to significant disappearances and thefts,

as such incidents could also indicate possible diversion towards the illicit manufacture

of drugs. Similarly, operators should maintain their obligation to keep the

documentation regarding transactions of scheduled drug precursors. To increase the

possibility for competent authorities to gather evidence concerning illicit activities, the

obligation to keep documentation should be extended to operators using scheduled

drug precursors of the highest risk and the documentation should be kept for a longer

period of time.

(14) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006

concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH),

establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council

Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council

Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and

2000/21/EC (OJ L 396, 30.12.2006, ELI: http://data.europa.eu/eli/reg/2006/1907/oj). (15) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on

classification, labelling and packaging of substances and mixtures, amending and repealing Directives

67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008,

ELI: http://data.europa.eu/eli/reg/2008/1272/oj). (16) Regulation (EU) 2019/1148 of the European Parliament and of the Council of 20 June 2019 on the

marketing and use of explosives precursors, amending Regulation (EC) No 1907/2006 and repealing

Regulation (EU) No 98/2013 (OJ L 186, 11.7.2019,ELI: http://data.europa.eu/eli/reg/2019/1148/oj). (17) Council Framework Decision 2004/757/JHA of 25 October 2004 laying down minimum provisions on

the constituent elements of criminal acts and penalties in the field of illicit drug trafficking (OJ L 335,

11.11.2004, p. 8, ELI: http://data.europa.eu/eli/dec_framw/2004/757/oj).

EN 17 EN

(8) This Regulation should lay down specific obligations for online marketplaces with

respect to reporting suspicious transactions with scheduled drug precursors that take

place on their websites or that use their computing services, once they have become

aware of information leading to such a suspicion. The obligations on online

marketplaces under this Regulation should not amount to a general monitoring

obligation.

(9) Category 1 drug precursors should be subject to strict control rules as they contain

substances playing a key role in the illicit manufacture of drugs, but also with

important legitimate uses which increases the risk of diversion from licit channels.

Operators making available on the market, importing, exporting, performing

intermediary activities, possessing or using such drug precursors should continue to be

required to hold a licence, as this offers national authorities the possibility to make a

thorough check of their legitimate intentions before the activity can be performed.

Where fees are levied at national level for obtaining a licence, Member States should

adjust such fees in order to safeguard the competitiveness of small and medium-sized

enterprises within the meaning of Commission Recommendation 2003/361/EC(18). The

existing obligation of operators to verify that their customers also hold a licence

should be maintained, as it proved to be an efficient way of verifying the reliability of

such customers. However, the obligation to obtain customer declarations should no

longer be maintained, as it leads to administrative burden without clear benefits in

terms of facilitating the identification of suspicious transactions. It is also important to

maintain the existing obligation of operators trading in Category 1 drug precursors to

secure premises, and to extend it to operators using such drug precursors, given their

high risk of diversion.

(10) Category 2 drug precursors are precursors which, even though frequently used in the

illicit production of drugs, are traded in significant quantities in the internal market

and external trade and have extensive legitimate uses. While the risk of diversion is

significant, strict control measures would be very cumbersome both for the industry

and for the national authorities, with limited added value for the identification of

suspicious activities. Therefore, the control and monitoring measures under this

Regulation should be focused only on the external trade. To reduce the administrative

burden, obligations for external traders should be limited to registering their activities,

without the requirement of approval by national authorities.

(11) Category 3 drug precursors should be introduced to address the particularities and high

risks for use in illicit drug production associated with designer precursors, which play

a significant role in the illicit manufacture of drugs, as demonstrated by their high

proportion in the number of seizures in the recent years, and do not have any known

legitimate use other than research and innovation. Such precursors do not follow the

traditional pattern of diversion from licit channels towards the illicit manufacture of

drugs. In support of the fight against the production and trafficking of illicit drugs, it is

therefore important to ban them from: being made available on the market; import;

export; intermediary activities; and their use or possession.

(12) However, as Category 3 drug precursors can be used in research and innovation and

other legitimate uses may be discovered after the inclusion of various substances in the

(18) Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-

sized enterprises, C(2003) 1422 (OJ L 124, 20.5.2003, pp. 36, ELI:

http://data.europa.eu/eli/reco/2003/361/oj).

EN 18 EN

annex to this Regulation, it is important to set out rules allowing operators to perform

activities with such precursors. Should small quantities of designer precursors be

needed for research and innovation, operators should be required to file a prior

notification to the competent authority in the Member State where they are

established. That will encourage research and innovation by not imposing costly and

lengthy formalities for transactions of low quantities and therefore low risk. Should

operators need Category 3 drug precursors in higher quantities or for legitimate

purposes other than research and innovation, they should then be required to obtain a

licence in accordance with the provisions for Category 1 drug precursors, as the risks

are similar.

(13) As new designer precursors can be easily created by modifying the chemical structure

of substances placed under control, it is important that this Regulation is adapted to

cater for the introduction of both a list of substances identified individually and of

groups of substances identified in a generic way in Category 3 drug precursors.

Whenever a group of substances is included in a generic way, an exemption list should

be provided to exclude individual substances that are part of this group but for which a

legitimate use other than research and innovation has been identified and which are not

included in either Category 1 or Category 2 drug precursors.

(14) The requirement for obtaining import and export authorisations should be removed

and replaced by quantity management, comprising quantity notification by operators

and automatic verifications by customs authorities for import and export. That should

reduce the administrative burden for external traders, whilst at the same time

maintaining strict controls of drug precursors entering or leaving the customs territory

of the Union and ensuring continued fulfilment of the UN Convention by the Union

and its Members States.

(15) In accordance with Article 12(10) of the UN Convention, the effectiveness and

practicability of pre-export notifications is fully recognised. However, exports to non-

Member States participating in the Union Single Market and exports to countries

where an international agreement waives the pre-export notification, should be exempt

from the pre-export notification obligation.

(16) To enforce this Regulation effectively, it is important to enable competent authorities

to request proof of licit purposes for drug precursors entering the customs territory of

the Union.

(17) It is essential to step up efforts for raising the awareness of legitimate operators to the

risks associated with non-scheduled precursors, to support them in identifying

suspicious transactions and notifying them on voluntary basis. Thus, extensive

information on drug precursors, including non-scheduled ones, and a tool to help

determine the scope of scheduled designer precursors, will be made available through

a Drug Precursors Information Repository.

(18) The Drug Precursors Information Repository should be developed, maintained, and

kept up to date by the European Union Drugs Agency and should replace the existing

Voluntary Monitoring List. The Repository should contain comprehensive information

on scheduled and non-scheduled drug precursors, and their legitimate and illicit uses,

to support operators in identifying suspicious transactions and Member States and the

Commission in identifying new trends in the illicit production of drugs.

EN 19 EN

(19) Member States should organise regular training to raise awareness on the risks of

diversion of drug precursors and the significant role which operators can play in the

fight against the illicit manufacture of drugs.

(20) Mutual assistance between Member States and between Member States and the

Commission should be reinforced, in particular by recourse to Council Regulation

(EC) No 515/97(19).

(21) To prevent the diversion of drug precursors towards the illicit manufacturing of

drugs, national authorities and customs authorities should be empowered to seize and

confiscate both scheduled and non-scheduled drug precursors, if there are

reasonable grounds or evidence that the drug precursor is intended for illicit use.

(22) To ensure the correct application of this Regulation, Member States should lay down

rules on penalties applicable for infringement of this Regulation, which should be

effective, dissuasive and proportionate.

(23) The annual reporting obligation for operators should be removed, as it has not been

proven to be the most efficient measure in the identification of suspicious activities,

while being very burdensome for the industry. Instead, the efforts of national

authorities should be increased in reporting, without delay, significant seizures of drug

precursors. This would ensure that national authorities from other Member States can

better target their controls.

(24) Following the Union’s obligations of reporting in Article 12(12) of the UN

Convention and Resolutions of the United Nations Economic and Social Council

1995/20 on measures to strengthen international cooperation to prevent diversion of

substances included in table I of the UN Convention and used in the illicit manufacture

of stimulants and other psychotropic substances and 49/3 strengthening systems for

the control of precursor chemicals used in the manufacture of synthetic drugs, the

Commission should draw up an annual report to be sent to the International Narcotics

Control Board.

(25) A centralised electronic system should be established to digitalise all the procedures

set out in this Regulation. The system should allow operators to fulfil their obligations

laid down in this Regulation and competent authorities to make their decisions on the

implementation of this Regulation and perform their reporting obligations. The system

should also facilitate the communication by the Commission of information requested

under the UN Convention. The enforcement of drug precursors entering or leaving the

Customs territory of the Union under this Regulation should be facilitated by the

interconnection between that electronic system and the ‘EU Single Window

Environment for Customs’. In addition, the Commission should explore with the

United Nations to possibly interconnect the electronic system with the United Nations

system for the reporting of incidents with precursors or other tools, to avoid double

reporting and facilitate the international cooperation. The Agency should have access

to the information in the electronic system to facilitate the implementation of its

mandate under Regulation (EU) 2023/1322 and the development and update of the

Drug Precursors Information Repository.

(19) Council Regulation (EC) No 515/97 of 13 March 1997 on mutual assistance between the administrative

authorities of the Member States and cooperation between the latter and the Commission to ensure the

correct application of the law on customs and agricultural matters (OJ L 82, 22.3.1997, p. 1, ELI:

http://data.europa.eu/eli/reg/1997/515/oj).

EN 20 EN

(26) Any processing of personal data under this Regulation should be carried out in

compliance with the provisions of Regulation (EU) 2016/679(20) or Regulation (EU)

2018/1725(21) of the European Parliament and of the Council, within their respective

scope of application.

(27) In order to amend certain non-essential elements of this Regulation, the power to adopt

acts in accordance with Article 290 of the Treaty of the Functioning of the European

Union should be delegated to the Commission to add or remove substances from the

categories of drug precursors, where necessary as a matter of urgency. Given the

particularities of designer precursors which are close chemical relatives of scheduled

drug precursors and can be easily created, the Commission should have the possibility

to add designer precursors also by including groups of substances, identified in

a generic way and, where needed, to exclude individual substances part of such groups

which have legitimate uses other than research and innovation and which are not to be

included in a different category. However, the Commission should not add groups of

substances in Category 1 or Category 2 drug precursors, unless this is necessary to

fulfil the obligations under the UN Convention. In addition, the Commission should be

empowered to amend non-essential elements set out in the annexes concerning

licences, registrations, prior notifications, quantity management related to import and

export, pre-export notifications, demonstration of licit purposes, determining the

criteria for suspicion on intention of use in the illicit manufacture of drugs, transitional

measures and reporting. It is of particular importance that the Commission carry out

appropriate consultations during the preparatory work for the adoption of delegated

acts, including at expert level and that those consultations be conducted in accordance

with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on

Better Law-Making(22). In particular, to ensure equal participation in the preparation of

delegated acts, the European Parliament and the Council receive all documents at the

same time as Member States’ experts, and their experts systematically have access to

meetings of Commission expert groups dealing with the preparation of delegated acts.

(28) Implementing powers should be conferred on the Commission in order to determine

the implementing arrangements for the electronic system. These arrangements should

include technical requirements and procedures for the implementation of the main

obligations set out in this Regulation, such as obtaining a licence, filing a registration

or prior-notification, or those linked to quantity notification and customs verification.

These arrangements should also include the rules for the protection, safety and security

of personal data. Those powers should be exercised in accordance with Regulation

(EU) No 182/2011 of the European Parliament and of the Council1.

(20) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the

protection of natural persons with regard to the processing of personal data and on the free movement of

such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016,

p. 1, ELI: http://data.europa.eu/eli/reg/2016/679/oj). (21) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the

protection of natural persons with regard to the processing of personal data by the Union institutions,

bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No

45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39, ELI:

http://data.europa.eu/eli/reg/2018/1725/oj). (22) OJ L 123, 12.5.2016, p. 1, ELI: http://data.europa.eu/eli/agree_interinstit/2016/512/oj. 1 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011

laying down the rules and general principles concerning mechanisms for control by Member States of

the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, pp. 13, ELI:

http://data.europa.eu/eli/reg/2011/182/oj).

EN 21 EN

(29) Since the objectives of this Regulation cannot be sufficiently achieved by the Member

States and can therefore, by reason of the international and changeable nature of the

trade in drug precursors, be better achieved at Union level, the Union may adopt

measures, in accordance with the principle of subsidiarity as set out in third paragraph

of Article 5 of the Treaty on European Union. In accordance with the principle of

proportionality as set out in that Article, this Regulation does not exceed what is

necessary for reaching those objectives. This Regulation respects the fundamental

rights and observes the principles recognised, in particular, by the Charter of

Fundamental Rights of the European Union.

(30) Regulations (EC) No 273/2004 and 111/2005 should therefore be repealed.

(31) The application of this Regulation should be deferred with the time needed to establish

the electronic system needed for its implementation.

(32) Transitional arrangements should be set out to ensure the validity of documents issued

under Regulation (EC) No 273/2004 and Regulation (EC) 111/2005 and to allow for

the connection of the electronic system for competent authorities and customs systems,

to guarantee legal certainty and ensure a smooth transition towards the new rules,

HAVE ADOPTED THIS REGULATION:

Chapter 1

General provisions

Article 1

Subject matter

1. This Regulation establishes harmonised rules for the monitoring and control of the

making available on the market, import, export, possession, and use of drug

precursors and of intermediary activities involving drug precursors with a view to

ensuring their free movement in the internal market and preventing their availability

for the illicit manufacture of drugs.

2. This Regulation shall apply without prejudice to other provisions of Union

legislation applicable to the substances in Annex I, Annex II and Annex III.

Article 2

Definitions

For the purposes of this Regulation the following definitions shall apply:

(1) ‘drug precursor’ means a substance that can be used for the illicit manufacture

of drugs, as well as mixtures, organisms and substances which occur in nature

containing such substances;

(2) ‘drug’ means a drug as defined in Article 1, point 1 of Council Framework

Decision 2004/757/JHA;(25)

(3) ‘scheduled drug precursor’ means a drug precursor consisting of or containing

a substance covered by Annex I, Annex II or Annex III to this Regulation,

unless it is exempted, in accordance with that Annex;

(25) 11.2004, p. 8, ELI: http://data.europa.eu/eli/dec_framw/2004/757/oj).

EN 22 EN

(4) 'non-scheduled drug precursor’ means a drug precursor which, although not

containing or consisting of a substance covered by Annex I, Annex II or Annex

III to this Regulation, can be used for the illicit manufacture of drugs;

(5) ‘substance’ means a substance as defined in Article 3, point 1 of Regulation

(EC) No 1907/2006 of the European Parliament and of the Council;(26)

(6) ‘mixture’ means a mixture as defined in Article 3, point 2 of Regulation (EC)

No 1907/2006;

(7) ‘substances which occur in nature' means a substance as defined in Article 3,

point 39 of Regulation (EC) No 1907/2006;

(8) ‘designer precursor’ means a drug precursor which is a substance or a mixture

containing a substance which is a close chemical relative of a substance

covered by Annex I or Annex II and which does not have any known legitimate

use except research and innovation;

(9) ‘medicinal product' means a medicinal product as defined in Article 1, point (2)

of Directive 2001/83/EC;(27)

(10) ‘veterinary medicinal product' means a veterinary medicinal product as defined

in Article 4(1) of Regulation (EU) 2019/6;(28)

(11) ‘making available on the market' means any supply of a drug precursor for

distribution, consumption or use on the Union market in the course of a

commercial activity, whether in return for payment or free of charge;

(12) ‘use’ means use as defined in Article 3, point 24 of Regulation (EC) No

1907/2006;

(13) 'import' means any entry of drug precursors having the status of non-Union

goods into the customs territory of the Union, including their placement in

temporary storage, transit, storage in customs warehousing and in free zones,

temporary admission, end use or inward processing, and declared for their

release for free circulation within the meaning of [the Proposal for a ]

Regulation of the European Parliament and of the Council (EU).../...2;

(14) ‘export’ means the exit of a drug precursor from the customs territory of the

Union, including re-export, outward processing, and the export procedure

within the meaning of Regulation (EU) .../... [COM/2023/258 final,

2023/0156 (COD)];

(26) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006

concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH),

establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council

Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council

Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and

2000/21/EC (OJ L 396, 30.12.2006, pp. 1, ELI: http://data.europa.eu/eli/reg/2006/1907/oj). (27) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the

Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67, ELI:

http://data.europa.eu/eli/dir/2001/83/oj). (28) Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on

veterinary medicinal products and repealing Directive 2001/82/EC (OJ L 4, 7.1.2019, p. 43, ELI:

http://data.europa.eu/eli/reg/2019/6/oj). 2 Regulation (EU) .../... of the European Parliament and of the Council establishing the Union Customs

Code and the European Union Customs Authority, and repealing Regulation (EU) No 952/2013 (OJ, L,

... [PO: please add publication references for COM/2023/258 final, 2023/0156 (COD)].

EN 23 EN

(15) ‘release for free circulation’ means release for free circulation within the

meaning of Title VI, Chapter 2 of Regulation (EU) .../... [COM/2023/258 final,

2023/0156 (COD)];

(16) ‘temporary storage’ means temporary storage as defined in Article 5, point

(50), of Regulation (EU) .../... [COM/2023/258 final, 2023/0156 (COD)];

(17) ‘temporary admission’ means temporary admission within the meaning of Title

VIII, Chapter 4, Section 1 of Regulation (EU) .../... [COM/2023/258 final,

2023/0156 (COD)];

(18) ‘inward processing’ means inward processing within the meaning of Title VIII,

Chapter 5, Section 2 of Regulation (EU) .../... [COM/2023/258 final,

2023/0156 (COD)];

(19) ‘outward processing’ means outward processing within the meaning of Title

VIII, Chapter 5, Section 3 of Regulation (EU) .../... [COM/2023/258 final,

2023/0156 (COD)];

(20) ‘transit’ means external transit as defined in Article 111 of Regulation (EU)

.../... [COM/2023/258 final, 2023/0156 (COD)];

(21) ‘customs warehousing’ means customs warehousing within the meaning of

Title VIII, Chapter 3, Section 2 of Regulation (EU) .../... [COM/2023/258 final,

2023/0156 (COD)];

(22) ‘free zone’ means free zone within the meaning of Title VIII, Chapter 3,

Section 3 of Regulation (EU) .../... [COM/2023/258 final, 2023/0156 (COD)];

(23) ‘re-export notification’ means re-export notification as defined in Article 5,

point (46), of Regulation (EU) .../...[COM/2023/258 final, 2023/0156 (COD)];

(24) ‘provider of an online marketplace’ means a provider of an online platform

within the meaning of Article 3, point (i), of Regulation (EU) 2022/2065(31) that

allows consumers or operators to conclude distance contracts with traders for

the sale of scheduled drug precursors;

(25) ‘intermediary' means any natural or legal person arranging the purchase and

sale or supply of scheduled drug precursor, where the goods subsequently will

be imported or exported and aiming to obtain an agreement between two

parties or to do so through acting on behalf of at least one of these parties

without taking these drug precursors into their possession or taking control of

the carrying out of such transaction; this definition shall also pertain to any

activity involving purchase and sale or supply of scheduled drug precursors

without these precursors being introduced into the Union customs territory;

(26) ‘operator’ means any natural or legal person making available on the market,

possessing or using drug precursors or any external trader of such precursors;

(27) 'external trader' means any importer, exporter, or intermediary of drug

precursors;

(31) Regulation (EU) 2022/2065 of the European Parliament and of the Council of 19 October 2022 on a

Single Market For Digital Services and amending Directive 2000/31/EC (Digital Services Act) (OJ L

277, 27.10.2022, p. 1, ELI: http://data.europa.eu/eli/reg/2022/2065/oj).

EN 24 EN

(28) 'name of a substance covered by Annex I, Annex II or Annex III' means either

the name of the substance as listed in Annex I, Annex II or Part I, of Annex

III to this Regulation for substances identified individually, or the International

Union of Pure and Applied Chemistry (IUPAC) name of the substance

identified in a generic way, followed by the name of the generic group, as

stated in this Regulation;

(29) ‘importer’ means importer as defined in Article 5, point (12), of Regulation

(EU) .../... [COM/2023/258 final, 2023/0156 (COD)];

(30) ‘exporter’ means exporter as defined in Article 5, point (14), of

COM/2023/258 final, 2023/0156 (COD);

(31) ‘customs representative’ means customs representative as defined in Article 5,

point (15), of Regulation (EU) .../... [COM/2023/258 final, 2023/0156 (COD)];

(32) ‘carrier’ means carrier as defined in Article5, point (25), of Regulation (EU)

.../... [COM/2023/258 final, 2023/0156 (COD)];

(33) ‘ultimate consignee’ means any natural or legal person to whom the scheduled

drug precursors are delivered from or to a third country; this person may be

different from the end-user;

(34) ‘suspicious transaction’ means any transaction concerning drug precursors for

which there are reasonable grounds for suspecting that the drug precursors

concerned are intended for the illicit manufacture of drugs;

(35) ‘seizure’ means the temporary prohibition of the transfer, destruction,

conversion, disposal or movement of drug precursors or temporarily assuming

custody or control of drug precursors;

(36) ‘International Narcotics Control Board' means the Board established by the

Single Convention on Narcotic Drugs, 1961, as amended by the 1972 Protocol;

(37) ‘the Agency’ means the European Union Drugs Agency established by

Regulation (EU) 2023/1322 of the European Parliament and of the Council(32).

Article 3

Scope

1. This Regulation shall apply to scheduled drug precursors, which are:

(a) substances covered by Annex I, Annex II or Annex III;

(b) mixtures containing substances covered by Annex I, Annex II or Annex III,

except if:

(i) the substance cannot be easily used or extracted by readily applicable or

economically viable means; or

(ii) the substance is below the concentration threshold set out in Annex I,

Annex II or Annex III and, where applicable, does not meet the special

conditions set out in Annex I, Annex II or Annex III;

(32) Regulation (EU) 2023/1322 of the European Parliament and of the Council of 27 June 2023 on the

European Union Drugs Agency (EUDA) and repealing Regulation (EC) No 1920/2006 (OJ L 166,

30.6.2023, p. 6, ELI: http://data.europa.eu/eli/reg/2023/1322/oj).

EN 25 EN

(c) organisms or parts thereof and substances which occur in nature, which contain

substances covered by Annex I, Annex II or Annex III, unless the condition set

out in point (b)(i) is met;

2. This Regulation shall also apply to non-scheduled drug precursors which are

substances that can be used for the illicit manufacture of drugs, and mixtures

containing such substances, unless the condition in paragraph 1, point (b)(i) is met.

3. This Regulation shall not apply to the following operators:

(a) customs, police, armed forces and official laboratories of competent authorities

in so far as these operators act within the scope of their official duties;

(b) pharmacies and dispensaries of veterinary medicinal products possessing or

using Category 1 or Category 2 drug precursors, within the scope of their

regular activities.

4. This Regulation shall not apply to:

(a) making available on the market, possession or use of medicinal products or

veterinary medicinal products;

(b) import, export or intermediary activities with medicinal products or veterinary

medicinal products except those listed in Part II of Annex II.

Article 4

Free movement

Unless otherwise provided for in this Regulation or in other legal acts the Union, Member

States shall not prohibit, restrict or hinder making available on the market of scheduled drug

precursors by operators complying with this Regulation on grounds related to monitoring the

legitimate trade for the prevention of the illicit manufacture of drugs.

Article 5

Categories of scheduled drug precursors

1. Scheduled drug precursors shall belong to one of the following categories:

(a) Category 1 drug precursors containing or consisting of substances covered by

Annex I;

(b) Category 2 drug precursors:

(i) containing or consisting of substances covered by Part I, of Annex II; or

(ii) medicinal products and veterinary medicinal products containing

substances covered by Part II, of Annex II;

(c) Category 3 drug precursors containing or consisting of substances covered by

Annex III which are designer precursors with no known legitimate use except

research and innovation at the moment of their scheduling. The substances

covered by Annex III shall be either listed individually or identified in a

generic way by listing groups of substances. Individual substances included in

such a group that have a legitimate use other than research and innovation and

that are not included in Annex I or Annex II, shall be exempted from Category

3 and listed in Part II, Section 2, of Annex III.

EN 26 EN

2. Scheduled drug precursors which are mixtures containing substances covered by

Annex I above the concentration threshold set out in that Annex, organisms or

substances which occur in nature containing such substances, and in

addition containing substances covered by Annex II or Annex III shall be subject to

the requirements for Category I drug precursors.

3. Scheduled drug precursors, which are mixtures containing substances covered by

Annex III above the concentration threshold set out in that annex, organisms or

substances which occur in nature containing such substances, and in addition

containing substances covered by Annex II shall be subject to the requirements for

Category 3 drug precursors.

4. Scheduled drug precursors containing or consisting of a substance covered by Annex

I or Annex II, which are also identified in a generic way in Part II, Section 1, of

Annex III shall be subject to the requirements for Category 1 or, respectively,

Category 2 drug precursors.

Chapter 2

Obligations of operators

SECTION 1

COMMON PROVISIONS

Article 6

Obligation of cooperation

1. Operators shall provide accurate, complete and up-to-date information to the

competent authority or customs authorities of the Member State concerned when

fulfilling their obligations under this Regulation.

2. Operators shall, further to a reasoned request, provide competent authorities or

customs authorities with the information and documentation necessary to

demonstrate that they fulfilled their obligations based on this Regulation, without

delay, in a machine-readable and structured way, using open standards, transferred

through a secure communication channel without vendor lock-in.

3. Operators shall cooperate with those authorities, upon request, on any action taken to

eliminate the risks of diversion of scheduled drug precursors towards the illicit

manufacture of drugs.

Article 7

Documentation

1. Operators making available on the market, importing, exporting and performing

intermediary activities with scheduled drug precursors shall keep commercial

documents for each transaction, which will include the following information:

(a) the name of the substance covered by Annex I, Annex II or Annex III, or, in

the case of a mixture or a an organism or a substance which occurs in nature,

their name and the name of the substance covered by Annex I, Annex II or

Annex III, contained in the mixture, organism or substance which occurs in

EN 27 EN

nature; for import, export or intermediary activities, the name shall be followed

by the term 'DRUG PRECURSOR';

(b) the quantity of the substance covered by Annex I, Annex II or Annex III and,

in the case of a mixture, an organism or a substance which occurs in nature, the

quantity or the percentage of any such substance contained therein; and

(c) the names and addresses of the other operators involved in the transaction.

2. Operators shall keep the documentation referred to in paragraph 1 for a period of 5

years from the end of the calendar year in which the transaction took place.

Article 8

Provision of information on suspicious transactions, disappearances and thefts

1. Operators shall report to the competent authorities immediately suspicious

transactions, significant disappearances and thefts of scheduled drug

precursors. Where providers of online marketplaces become aware of any

information regarding suspicious transactions, significant disappearances, and thefts

of scheduled drug precursors, they shall immediately report that information to the

competent authorities.

2. For the purposes of paragraph 1, operators and providers of online marketplaces shall

provide any available information, such as:

(a) the name of the substance covered by Annex I, Annex II or Annex III;

(b) the quantity of the substance;

(c) the names and addresses of the operators involved in the supply chain.

SECTION 2

CATEGORY 1 DRUG PRECURSORS

Article 9

Licence

1. Without prejudice to paragraph 7, operators shall obtain a licence from the competent

authorities of the Member State in which they are established before they make

available on the market, import, export, perform intermediary activities, possess

or use Category 1 drug precursors in quantities exceeding the quantity thresholds set

out in Annex I over one calendar year. This obligation shall not apply to:

(a) direct customs representatives, carriers and other transporters acting solely in

that capacity;

(b) Category 1 drug precursors which are transhipped, placed under temporary

storage, stored in a free zone, or leaving the customs territory of the Union by a

re-export notification.

2. When considering whether to grant a licence, the competent authorities shall take

into account the conditions set out in Annex IV regarding the competence and

integrity of the applicant. The licence shall be refused if there are reasonable grounds

for doubting the suitability and reliability of the operator or its responsible officer.

EN 28 EN

3. The licence shall include the information set out in Annex IV and shall be granted for

a period not exceeding three years, unless the operator requests it for a shorter time

period.

4. The competent authorities may grant simplified licences for an unlimited time

period, subject to the conditions set out in Annex IV.

5. Operators shall inform the competent authority of any changes to the activities to be

performed, the scheduled drug precursors or the relevant quantities during the

validity period of the licence, which would require an update of the licence already

granted.

6. The licence may be suspended or revoked by the competent authorities whenever the

conditions under which the licence was granted are no longer fulfilled or where there

are reasonable grounds for suspecting that there is a risk of diversion of scheduled

drug precursors towards the illicit manufacture of drugs.

7. External traders that import, export, or perform intermediary activities with Category

1 drug precursors in quantities not exceeding the quantity thresholds set out in Annex

I over one calendar year shall be subject to the obligations applicable under Article

15.

8. The competent authorities may require operators to pay a fee for processing the

application for a licence. Where a fee is levied, competent authorities shall adjust the

level of the fee set for small and medium-sized enterprises. Such a fee shall be levied

in a non-discriminatory manner and shall not exceed the cost of processing the

application.

Article 10

Responsible officer

1. Operators referred to in Article 9(1) shall appoint a responsible officer established in

the Union empowered to represent them in matters relating to the application of this

Regulation.

2. The responsible officer shall be empowered to take all decisions needed to ensure

that the activities performed by the operator comply with this Regulation.

Article 11

Labelling

Operators making available on the market, importing, exporting, or performing intermediary

activities with Category 1 drug precursors shall ensure that the name of the substance covered

by Annex I is indicated on the packaging or its label, or, in case of products supplied in bulk,

in the accompanying documents.

Article 12

Documentation for use or possession

1. Operators using or possessing Category 1 drug precursors shall keep documentation

on their activities in accordance with Article 7(1).

EN 29 EN

2. The operators referred to in paragraph 1 shall keep the documentation for a period of

5 years from the end of the calendar year in which the specific drug precursor was

possessed for the last time.

Article 13

Verification of operators

Operators shall make available on the market Category 1 drug precursors only after having

verified that the other operators involved in such a transaction hold a valid licence.

Article 14

Securing premises

Operators shall take adequate measures to secure business premises and the places of use

against the unauthorised removal of Category 1 drug precursors.

SECTION 3

CATEGORY 2 DRUG PRECURSORS

Article 15

Registration

1. External traders engaged in import, export or intermediary activities involving

Category 2 drug precursors shall register information on their activities with the

competent authority in the Member State where they are established. This obligation

shall not apply to:

(a) direct customs representatives, carriers and transporters when acting solely in

those capacities;

(b) Category 2 drug precursors transhipped, placed under temporary storage,

stored in a free zone, or leaving the customs territory of the Union by a re-

export notification.

2. The registration shall include the information set out in Annex V and shall be made

for a period not exceeding three years.

3. By way of derogation from paragraph 2, a registration may be valid for an unlimited

period of time, subject to the conditions set out in Annex V.

4. The external traders referred to in paragraph 1 shall update the information in the

registration, as needed, in accordance with Annex V.

5. The competent authority in the Member State of establishment of the external trader

may order the external trader to suspend or cease the activities covered by the

registration, where the registration does not comply with this Regulation; the

conditions declared are no longer fulfilled; or, where there are reasonable grounds for

suspecting that there is a risk of diversion of the scheduled drug precursors towards

the illicit manufacture of drugs.

6. The external traders referred to in paragraph 1 shall appoint a responsible officer in

accordance with Article 10.

EN 30 EN

7. The external traders referred to in paragraph 1 shall ensure that the name of the

substance covered by Annex II is indicated on the packaging or its label, or, in case

of products supplied in bulk, in the documents accompanying them.

SECTION 4

CATEGORY 3 DRUG PRECURSORS

Article 16

Ban

1. The making available on the market, import, export, possession, use of Category 3

drug precursors, and performing intermediary activities involving such drug

precursors shall be prohibited.

2. By way of derogation from paragraph 1, operators may tranship Category 3 drug

precursors, place them under temporary storage, store them in a free zone, or re-

export them from the customs territory of the Union by a re-export notification.

Article 17

Prior notification for research and innovation

1. By way of further derogation from Article 16(1), operators may make available on

the market, import, export, perform intermediary activities, possess and use Category

3 drug precursors subject to the conditions set out in this Article.

2. Operators intending to make available on the market, import, export, possess, use, or

perform intermediary activities involving Category 3 drug precursors for research

and innovation in quantities not exceeding the maximum quantity threshold set out in

Part I of Annex III shall notify their intended activities over a period of maximum six

months to the competent authority in the Member State where they are established, 5

days before the first transaction or possession. This obligation does not apply to

direct customs representatives, carriers and other transporters acting solely in that

capacity.

3. The prior notification referred to in paragraph 2 shall include the information set out

in Annex VI.

4. The competent authority may request additional information and perform inspections

to check the accuracy of the information provided, including the use of drug

precursors for research and innovation.

5. The competent authority of the Member State of establishment of the operator may

order the operator to suspend or cease the activities covered by the prior notification,

where the prior notification does not comply with this Regulation; the conditions

declared are no longer fulfilled; or, there are reasonable grounds for suspecting that

there is a risk of diversion of the Category 3 drug precursor towards the illicit

manufacture of drugs.

Article 18

Licence for Category 3 precursors

By way of further derogation from Article 16(1), operators may make available on the market,

import, export, perform intermediary activities, possess or use Category 3 drug precursors for

EN 31 EN

research and innovation in quantities exceeding the maximum quantity threshold set out in

Part I of Annex III or for other legitimate use, provided they obtain a licence in accordance

with Article 9(1), (2) and (3). Article 9(5), (6) and (8) shall also apply to that licence.

Article 19

Additional obligations for Category 3 drug precursors

1. Operators referred to in Article 17 or Article 18 shall make available on the market

Category 3 drug precursors only after having verified that the operators involved in

the transaction have made a prior notification or hold a licence in accordance with

Article 17 or Article 18 respectively.

2. Operators using or possessing Category 3 drug precursors subject to the conditions

set out in Article 17 or Article 18 shall keep documentation on their activities in

accordance with Article 12.

3. Operators referred to in Article 17 and Article 18 shall meet the following

obligations:

(a) appoint a responsible officer in accordance with Article 10;

(b) secure premises in the conditions set out in Article 14.

4. External traders importing, exporting or performing intermediary activities with

Category 3 drug precursors in accordance with Article 17 and Article 18 shall ensure

that the name of the substance covered by Annex III is indicated on the packaging or

its label, or, in case of products supplied in bulk, on the accompanying documents.

SECTION 5

EXTERNAL TRADE

Article 20

Import

1. The importer shall notify the competent authority of the total quantity of the intended

imports for each substance covered by Annex I or Annex II over a specified time

period before the first import. The quantity of substances imported during that time

period shall not exceed the quantities notified.

2. Paragraph 1 shall also apply for imports of substances covered by Annex III, subject

to the conditions set out in Article 17 or Article 18.

3. The information to be provided in accordance with paragraphs 1 and 2 is set out in

Chapter 1, of Annex VII.

4. Where the substances referred to in paragraph 1 and paragraph 2 are transhipped,

placed under temporary storage, inward processing, transit, in customs warehousing,

or stored in a free zone, paragraph 1 and paragraph 2 shall not apply.

Article 21

Pre-export notification

1. All exports of Category 1 drug precursors and exports of Category 2 drug precursors

to certain countries of destination, as referred to in Chapter 2 of Annex VII, shall be

EN 32 EN

preceded by a pre-export notification by the competent authorities of the Member

State concerned to the competent authorities of the country of destination.

2. Exports of Category 3 drug precursors, subject to the conditions set out in Article 17

or Article 18, shall also be preceded by a pre-export notification, as set out in

paragraph 1.

3. The pre-export notification shall be waived for exports from the Union to a third

country or territory outside the customs territory of the Union where that third

country or territory is also part of the Union single market or there is an international

agreement between the Union and a third country or territory waiving the pre-export

notification.

4. Operators shall inform competent authorities of the Member State of establishment

of their intention to export the scheduled drug precursors referred to in paragraph 1

and paragraph 2.

5. In case the export of scheduled drug precursors is to be notified in accordance with

paragraph 1 and paragraph 2, the competent authorities of the Member State

concerned shall, prior to the export of such drug precursors, supply the information

set out in Chapter 2 of Annex VII of the intended export to the competent authorities

of the country of destination.

6. The competent authority supplying such information shall require the competent

authority in the country of destination receiving the information to keep confidential

any trade, business, commercial or professional secret or any trade process referred

to therein.

7. Simplified pre-export notification procedures may be applied by the competent

authorities under the conditions set out in Chapter 2, point 4, of Annex VII where

they are satisfied that this will not result in any risk of diversion of scheduled drug

precursors.

Article 22

Export

1. The exporter shall notify the competent authority of the total quantity of the intended

exports for each substance covered by Annex I or Annex II in a specified time period

before the first export. The quantity of substances exported during that time period

shall not exceed the quantity notified.

2. Paragraph 1 shall also apply for exports of substances covered by Annex III, subject

to the conditions set out in Article 17 or Article 18.

3. The information to be provided in accordance with paragraph 1 and paragraph 2 is

set out in Chapter 3 of Annex VII.

4. Where the drug precursors referred to in paragraph 1 or paragraph 2 are leaving the

customs territory of the Union under the transit procedure or by a re-export

notification, paragraphs 1 and 2 shall not apply.

5. Whenever, under an agreement between the Union and a third country, an export

requires that an import authorisation has been issued by the competent authorities of

that third country for the drug precursor in question, that import authorisation shall

be provided to the competent authorities in the Member State of establishment before

the export can be done.

EN 33 EN

6. Following the notification referred to in Article 21(1) and Article 21(2), the

competent authorities or the customs authorities of the Member States may prevent

the export if an objection, indicating that this export might be intended for the illicit

manufacture of drugs, is received from the competent authorities or customs

authorities of the country of destination.

Article 23

Customs verification

1. For the purposes of import, except for the transit procedure, the operator holding the

licence, registration, or prior notification as required under this Regulation, shall be

the importer indicated in the customs declaration.

In the case of transit procedure, the operator holding the licence, registration, or prior

notification as required under this Regulation, shall be the holder of the transit

procedure indicated in the customs declaration.

For the purposes of exports, the operator holding the licence, registration, or prior

notification as required under this Regulation, shall be the exporter indicated in the

customs declaration.

2. The importer, exporter or holder of a transit procedure as referred to in paragraph 1

shall provide or make available to customs authorities either: proof of possession of a

valid licence as referred to in Article 9 or Article 18; registration as referred to

Article 9(7) or Article 15; or prior notification as referred to in Article 17, including,

where applicable, the proof of notification of quantities in accordance with Articles

20 and 22.

3. Customs authorities may release a substance for a customs procedure or re-export

only after having verified as a minimum that an active licence, registration, or prior

notification exists, where those are required.

4. In addition to paragraph 3, the customs authorities shall verify that the quantities are

within the thresholds notified in Article 20 and Article 22 before releasing substances

for free circulation, temporary admission, end use, outward processing, export or re-

export where a re-export declaration is submitted.

5. The release of the goods shall not be deemed to be proof of compliance with this

Regulation or other Union legislation.

6. The verification referred to in paragraph 3 and paragraph 4 shall be done

electronically and automatically via the interconnection referred to in Article 35(5)

from the date that interconnection is operational.

7. The Commission and the customs authorities may use the data included in

the electronic system referred to in Article 35 of this Regulation for carrying out their

duties pursuant to Union legislation, including risk management, customs controls

and release to a customs procedure within the meaning of Regulation (EU) .../...

[COM/2023/258 final, 2023/0156 (COD)].

8. Paragraph 2, 3, and 4 shall not apply to drug precursors that are transhipped, placed

under temporary storage, stored in a free zone, or when they are leaving the customs

territory of the Union by a re-export notification.

9. Paragraph 4 shall not apply to drug precursors that are placed under customs

warehousing, inward processing, or transit procedure.

EN 34 EN

Article 24

Demonstration of licit purposes

Where a scheduled drug precursor enters into the customs territory of the Union for

transhipment, placement in temporary storage or storage in a free zone for licit purposes, the

operator shall demonstrate those licit purposes in accordance with Chapter 4 of Annex VII,

upon request by the competent authorities or the customs authorities.

Chapter 3

Awareness raising activities

Article 25

The Drug Precursors Information Repository

1. By [OP please add date: 3 years after entry into force of this Regulation] the Agency

shall establish a Drug Precursors Information Repository (‘Repository’).

2. The Repository shall contain information on the substances covered by Annex I,

Annex II and Annex III and on other substances which can be used in the illicit

manufacture of drugs, in particular:

(a) general description of the substance and its chemical properties;

(b) information on legitimate uses and trade;

(c) information on the use of the substance in the illicit production of drugs.

3. If substances are as a group of substances identified in a generic way in accordance

with Article 37(1), the Repository referred to in paragraph 1 shall include an

indicative list of the most relevant individual substances covered by the group of

substances and a specific function allowing operators to check if a specific substance

is to be considered as being part of the group.

4. The information referred to in paragraph 2, points (a) and (b) and the specific

function referred to in paragraph 3 shall be publicly available and free of charge.

5. The information referred to in paragraph 2, point (c) may be used by the

Commission, the Agency and other Union bodies and the Member States to identify

new trends in the illicit manufacture of drugs and appropriate measures.

6. The Agency shall maintain and keep the Repository up to date.

Article 26

Training activities

1. Member States shall ensure that law enforcement authorities and customs authorities

are provided with training, such as risk management training, to detect, in the course

of their duties, scheduled or non-scheduled drug precursors that may be used in the

illicit manufacture of drugs, and to react in a timely and appropriate manner to a

suspicious activity.

2. Member States shall organise, at least once a year, awareness-raising actions for

operators making available on the market, importing, exporting, performing

intermediary activities, possessing or using drug precursors.

EN 35 EN

3. Operators shall be responsible for providing information to their personnel on the

obligations of the operators under this Regulation and for raising personnel

awareness in this regard.

Chapter 4

Cooperation with and tasks of national authorities

Article 27

Administrative cooperation

1. Each Member State shall designate the competent authority or authorities responsible

for ensuring the application of this Regulation and shall inform the Commission, the

other Member States and the Agency thereof.

2. For the purposes of applying this Regulation, the provisions of Regulation (EC) No

515/97 shall apply with the necessary adaptations. The competent authorities

designated under paragraph 1 shall act as competent authorities within the meaning

of Article 2(2) of Regulation (EC) No 515/97.

Article 28

Controls by competent authorities

1. Competent authorities shall carry out controls to determine if operators fulfil the

obligations laid down in this Regulation. When there is reason to believe that a drug

precursor might be diverted towards the illicit manufacture of drugs, the competent

authority shall perform additional controls without delay under the conditions set out

in Article 29 and Article 30.

2. The competent authorities shall respect the principles of confidentiality and of

professional and commercial secrecy and shall protect personal data in accordance

with Union and national law.

3. Member States shall ensure that the competent authorities have the resources

necessary to ensure the proper administration of their tasks under this Regulation.

Article 29

Control of internal market

Competent authorities may seize scheduled drug precursors for up to 30 days subject to the

conditions set out under national law, to verify the identification of the drug precursors and

compliance with this Regulation.

Article 30

Control of export and import

1. The competent authorities of each Member State shall prohibit the introduction of

scheduled drug precursors into the Union customs territory or their departure from it,

if there are reasonable grounds for suspecting that the drug precursors are intended

for the illicit manufacture of drugs.

2. The competent authorities of each Member State shall prohibit the introduction of

non-scheduled drug precursors into the customs territory of the Union or their

EN 36 EN

departure from it where there is sufficient evidence that those drug precursors are

intended for the illicit manufacture of drugs.

3. Customs authorities shall detain or suspend the release of the scheduled drug

precursors for the respective customs procedure, and only release them for the

respective customs procedure after verifying their compliance with this Regulation.

4. The customs authorities may temporarily detain non-scheduled drug precursors for

which there is suspicion that they are intended to be used in the illicit manufacture of

drugs in accordance with the conditions laid down in national law.

5. The period of temporary detention referred to in paragraph 4 shall not exceed 30

days.

6. Customs authorities or competent authorities shall be empowered to carry out

controls and monitor suspicious transactions during import and export involving

scheduled or non-scheduled drug precursors, including:

(a) obtaining information on any orders for or activities involving import, export

and transit of scheduled or non-scheduled drug precursors;

(b) entering the business premises of operators in order to obtain evidence of

irregularities;

(c) establishing that a diversion or attempted diversion of scheduled drug

precursors has taken place, and carry out follow up measures, where required.

7. When determining if there is suspicion that scheduled or non-scheduled drug

precursors are intended to be used in the illicit manufacture of drugs, customs

authorities or competent authorities shall use the criteria laid out in Chapter 5 of

Annex VII. Should the criteria laid out in chapter 5, point 8 (b), of Annex VII be

fulfilled the external trader importing, exporting, or performing intermediary

activities with the non-scheduled substance shall be required to prove that the

substance is destined for legitimate use.

8. For the purpose of preventing specific risks of diversion of drug precursors stored in

free zones and under temporary storage as well as in other sensitive areas, such as

customs warehouses, Member States shall ensure that effective controls are applied

to activities carried out in these areas at every stage, and that the controls are no less

stringent than those applied in the other parts of the customs territory.

Article 31

Penalties

Member States shall lay down the rules on penalties applicable to infringements of the

provisions of this Regulation and shall take all measures necessary to ensure that they are

implemented.

The penalties provided for shall be effective, proportionate and dissuasive.

Member States shall notify the Commission of those rules and of any subsequent amendment

affecting them.

Article 32

Reporting obligation

EN 37 EN

The competent authorities and customs authorities shall report information on seizures of drug

precursors and information on the implementation of this Regulation subject to the conditions

set out in Annex VIII.

Article 33

Obligation of information

1. Where the information referred to in Article 32 concerns significant seizures of non-

scheduled drug precursors, the competent authority or customs authority shall notify

the Commission, the Agency and other Member States without delay.

2. The competent authority of a Member State shall inform the Commission, the

Agency and the competent authorities of other Member States without delay, if it

receives a request for a licence for a Category 3 drug precursor in accordance with

Article 18.

Article 34

UN reporting

The Commission shall, in consultation with Member States, submit an annual report to the

International Narcotics Control Board based on information provided by operators and

competent authorities, subject to the conditions set out in Annex VIII.

Chapter 5

Drug precursors electronic system

Article 35

Electronic system

1. The Commission shall establish and maintain a centralised electronic system for the

submission, storage, processing, decision-making, and exchange of information for

the monitoring and control of drug precursors in accordance with this Regulation.

2. The Commission shall establish the electronic system referred to in paragraph 1, in

particular with the following functions:

(a) To enable operators to:

(i) register in the system in order to perform formalities set out in this

Regulation;

(ii) request a licence in accordance with Article 9 and Article 18;

(iii) make the registration required by Article 9(7) and Article 15;

(iv) file a prior notification in accordance with Article 17(2);

(v) verify in accordance with Article 13 and Article 19(1) that other

operators hold a licence or made a prior notification;

(vi) notify quantities to competent authorities in accordance with Articles 20

and 22;

(b) To enable operators and providers of online marketplaces to report

on suspicious transactions in accordance with Article 8;

EN 38 EN

(c) To enable competent authorities to:

(i) issue, suspend or revoke a licence;

(ii) order operators to suspend or cease activities covered by a registration or

a prior notification, in accordance with Article 15(5) or Article 17(5)

respectively;

(iii) provide information in accordance with Article 32 and Article 33;

(d) facilitate the preparation of the report to the International Narcotic Control

Board in accordance with Article 34, by the Commission in consultation with

Member States.

3. The functions referred to in paragraph 2, points (a)(i), (ii), (iii), (iv) and (v), points

(b), (c) and (d) shall be operational at the latest 18 months after the entry into force

of the implementing act referred to in paragraph 8.

4. The functions referred to in paragraph 2, point (a)(vi) shall be operational at the latest

6 years after the entry into force of the implementing act referred to in paragraph 8.

5. The Commission shall interconnect the electronic system referred to in paragraph 1

with the EU Single Window Environment for Customs established by Regulation

(EU) 2022/2399 for the purpose of enabling the performance of the verifications

referred to in Article 23(3) and Article 23(4) at the latest 6 years from the entry into

force of the implementing act referred to in paragraph 8 of this Article.

6. The Commission may, in cooperation with the United Nations, interconnect the

system referred to in paragraph 1 with the systems of the United Nations for

incidents reporting or other United Nations systems for drug precursors.

7. The Commission, the Agency, the competent authorities and the operators shall have

access to the data in the electronic system needed for performing their tasks under

this Regulation

8. By [OP please add date: 18 months after the entry into force of this Regulation], the

Commission shall adopt an implementing act establishing implementing

arrangements for the development and operation of the electronic system, including

technical specifications and the procedures to be followed for the implementation of

Articles 6, 8, 9, 13, 15, 17, 18, 19(1), 20, 21, 22, 23, 32, 33 and 34.

9. The implementing act referred to in paragraph 8 shall be adopted in accordance with

the examination procedure referred to in Article 40(2).

Article 36

Data protection

1. The processing of personal data within the electronic system referred to in Article 35

shall be carried out in compliance with Regulation (EU) 2016/679 or Regulation

(EU) 2018/1725, as applicable.

2. The processing of personal data under this Regulation shall take place solely for the

purposes established in this Regulation.

3. Access to personal data shall be limited to duly authorised staff of the Commission

and other Union bodies, competent authorities and customs authorities to the extent

necessary for the performance of their tasks under this Regulation. Those Union

bodies and authorities shall ensure the confidentiality and integrity of such data and

EN 39 EN

protect them against unauthorised access, use or disclosure, in accordance with the

applicable Union data protection rules.

Chapter 6

Delegation of powers and committee procedure

Article 37

Delegation of power

1. The Commission is empowered to adopt delegated acts in accordance with Article

38 amending Annex I, Annex II and Annex III to adapt those Annexes to new trends

in diversion of drug precursors or to align them with any amendment to the tables

annexed to the UN Convention, by adding or removing substances and adapting

existing entries. The Commission may only add substances identified individually to

Annex I or Annex II, unless otherwise required to align those Annexes with the

tables annexed to the UN Convention. The Commission may add substances in

Annex III either identified individually or in a generic way. When adding substances

in a generic way, the Commission shall clearly identify the group of substances and,

if applicable, the individual substances which are to be exempted from the control

and monitoring measures for scheduled drug precursors.

2. When a substance covered by Annex III has legitimate use other than in research and

innovation, as reported in accordance with Article 33(2), where applicable, the

Commission shall adopt a delegated act amending that Annex by removing the

substance from Part I of that Annex and, as appropriate, including it in Annex I or

Annex II or in the exemption list in Part II, Section 2 of Annex III.

3. When adopting delegated acts in accordance with paragraphs 1 and 2, the

Commission shall also indicate for the substances concerned:

(a) the concentration threshold for a substance in Annex I, II or III below which

and, where appropriate, the special conditions under which a mixture

containing that substance is excluded from the scope of this Regulation in

accordance with Article 3(1), point (b)(ii);

(b) a quantity threshold during one calendar year below which the obligations set

out in Article 9(1), first subparagraph, do not apply;

(c) a maximum quantity threshold which can be notified for use in research and

innovation, in the conditions laid down in Article 17(2), as applicable.

The Commission shall adopt delegated acts amending Annex I, Annex II and Annex

III to set up the thresholds referred to in the first subparagraph, points (a), (b) and (c),

for substances already included in those Annexes.

4. The Commission is empowered to adopt delegated acts amending Annex IV, Annex

V, Annex VI, Annex VII, Annex VIII and Annex IX to adapt the general conditions

and other technical rules for: licences; registrations; prior notifications; quantity

notifications for import or export; pre-export notifications; the criteria to determine

the licit purposes of the transaction referred to in Article 24; determining the criteria

for suspicion on intention of use in the illicit manufacture of drugs as referred to in

Article 30(7); reporting obligations; and transitional measures.

EN 40 EN

5. When adopting delegated acts in accordance with this Article, the Commission shall

take into account both the risk of diversion of drug precursors for the production and

manufacture of illicit drugs and the impact on legitimate trade.

Article 38

Exercise of the delegation

1. The power to adopt delegated acts is conferred on the Commission subject to the

conditions laid down in this Article.

2. The power to adopt delegated acts referred to in Article 37 shall be conferred on the

Commission for a period of five years from [OP please add date: the date of entry

into force of this Regulation]. The Commission shall draw up a report in respect of

the delegation of power not later than nine months before the end of the five-year

period. The delegation of power shall be tacitly extended for periods of an identical

duration, unless the European Parliament or the Council opposes such extension not

later than three months before the end of each period.

3. The delegation of power referred to in Article 37 may be revoked at any time by the

European Parliament or by the Council. A decision to revoke shall put an end to the

delegation of the power specified in that decision. It shall take effect the day

following the publication of the decision in the Official Journal of the European

Union or at a later date specified therein. It shall not affect the validity of any

delegated acts already in force.

4. Before adopting a delegated act, the Commission shall consult experts designated by

each Member State acting in accordance with the principles laid down in the

Interinstitutional Agreement of 13 April 2016 on Better Law-Making.

5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to

the European Parliament and to the Council.

6. A delegated act adopted pursuant to Article 37 shall enter into force only if no

objection has been expressed either by the European Parliament or the Council

within a period of two months of notification of that act to the European Parliament

and the Council or if, before the expiry of that period, the European Parliament and

the Council have both informed the Commission that they will not object. That

period shall be extended by two months at the initiative of the European Parliament

or of the Council.

Article 39

Urgency procedure

1. Delegated acts amending Annex I, Annex II and Annex III adopted under this Article

shall enter into force without delay and shall apply as long as no objection is

expressed in accordance with paragraph 2. The notification of a delegated act to the

European Parliament and to the Council shall state the reasons for the use of the

urgency procedure.

2. Either the European Parliament or the Council may object to a delegated act in

accordance with the procedure referred to in Article 38. In such a case, the

Commission shall repeal the act immediately following the notification of the

decision to object by the European Parliament or by the Council.

EN 41 EN

Article 40

Committee procedure

1. The Commission shall be assisted by the Drug Precursors Committee. That

committee shall be a committee within the meaning of Regulation (EU) No 182/2011

of the European Parliament and of the Council.

2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No

182/2011 shall apply.

Chapter 7

Transition and final provisions

Article 41

Review

By [OP please add date: 10 years from the date of application of this Regulation], the

Commission shall submit to the European Parliament and to the Council a report on the

application of this Regulation. The report shall contain an assessment of how this Regulation

is achieving its objectives.

Article 42

Repeal

1. Regulation (EC) No 273/2004 and Regulation (EC) No 111/2005 are repealed.

2. References to the repealed Regulations shall be construed as references to this

Regulation and read in accordance with the correlation table in Annex X.

Article 43

Transitional provisions on licences, registrations and import and export authorisations

issued or applied for under Regulations (EC) No 273/2004 or (EC) No 111/2005

1. Licences, special licences, registrations and special registrations issued under

Regulation (EC) No 273/2004 or Regulation (EC) No 111/2005 before [OP please

add date: 3 years after the date of entry into force of this Regulation] shall be valid

until their expiry date or until [OP please add date: 4 years after the date of entry

into force of this Regulation] whichever is soonest.

2. Licences and special licences for which an application is made before [OP please

add date: 3 years after the date of entry into force of this Regulation] based on

Regulation (EC) No 273/2004 and Regulation (EC) No 111/2005 shall be granted in

accordance with those Regulations and be valid until maximum [OP please add date:

4 years after the date of entry into force of this Regulation].

3. When relevant, licences, special licences, registrations and special registrations

issued under Regulation (EC) No 273/2004 or Regulation (EC) No 111/2005 shall be

revoked or suspended pursuant to those Regulations for the duration of the

transitional period.

4. Import and export authorisations issued under Regulation (EC) No 111/2005 before

[OP please add date: 3 years after the date of entry into force of this Regulation]

shall be valid until their expiry date.

EN 42 EN

5. Import and export authorisations applied for under Regulation (EC) No 111/2005 but

not issued before [OP please add date: 3 years after the date of entry into force of

this Regulation] shall be deemed to have been applied for under the conditions set

out in Annex IX.

Article 44

Transitional rules on import and export authorisations and reporting

From the date of application of this Regulation and until the function referred to in Article

35(2), point (a)(vi) is operational, the transitional rules on import and export authorisations

and reporting provided for in Annex IX shall apply.

Article 45

Entry into force and application

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

the Official Journal of the European Union.

It shall apply from [OP please add date: 3 years after the date of entry into force of this

Regulation].

However, Article 25, Article 35(8) and (9), Articles 37, 38, 39, 40 and this article shall apply

from [OP please add: date of entry into force of this Regulation], and Articles 20, 22, and 23

shall apply when the function referred to in Article 35(2), point (a)(vi) is operational.

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

Done at Brussels,

For the European Parliament For the Council

The President The President

[...] [...]

EN 43 EN

LEGISLATIVE FINANCIAL AND DIGITAL STATEMENT

1. FRAMEWORK OF THE PROPOSAL/INITIATIVE

1.1. Title of the proposal/initiative

Regulation of the European Parliament and Council on monitoring and controlling

drug precursors and repealing Regulations (EC) No 273/2004

1.2. Policy area(s) concerned

Internal Market

Customs Union

External Trade

1.3. Objective(s)

1.3.1. General objective(s)

There are two general policy objectives to be pursued when revising the regulations:

Objective 1: to reduce the availability of drug precursors for illicit drug

manufacturing

Objective 2: to facilitate legitimate trade and use of drug precursors, both in the

Internal Market and in relation to external trade

1.3.2. Specific objective(s)

Specific objective SO No 1.1 - To establish more effective and rapid control measures

to address designer precursors

The aim of SO 1.1 is to ensure that rules do not only address traditional drug

precursors but also newly emerging designer precursors, for which a global approach

is crucial.

Specific Objective 1.2 – To address gaps and shortcomings that hamper the

implementation and the functioning of the control system

SO 1.2 is to improve the regulations by filling in identified gaps and clarifying

existing provisions to provide for a uniform application across the EU and enhance

cooperation between authorities as well as with businesses.

Specific objective 2.1 – To simplify, modernise and streamline the EU provisions for

legal trade

SO 2.1 is about removing unnecessary obstacles and administrative burdens for legal

trade in drug precursors.

1.3.3. Expected result(s) and impact

Specify the effects which the proposal/initiative should have on the

beneficiaries/groups targeted.

For Objective 1, Member States and operators will have to implement a new ban on

designer precursors, that are chemically viable and easy to use, identified with

sufficient precision to allow operators to conduct due diligence checks on their

portfolios. For Member State authorities, the ban entails an extension of the scope of

existing control and monitoring rules.

Other measures include requiring online marketplaces service providers to notify

suspicious transactions, disappearances and thefts.

EN 44 EN

National authorities and customs authorities are being empowered to seize and

confiscate both scheduled and non-scheduled drug precursors, if there are reasonable

grounds or evidence that the drug precursor is intended for illicit use. In the internal

market, Member States remain competent to adopt national rules to investigate such

cases, and no additional requirements should be set out in this Regulation.

Ultimately, the measures are aimed at reducing the supply of illicit drugs with

corresponding indirect effects on drug consumption, public health, and crime, even if

this is not directly measurable.

For Objective 2, Member States and operators will rely on a centralised EU portal

that will streamline and support the process for managing licences,

registrations, customer verifications, import/export quantity management, and prior

notifications. The new rules will also eventually remove periodic reporting

obligations for operators and authorities.

Comprehensive digital solutions are expected to facilitate the completion of

administrative tasks for operators and to expedite the overall process. Moreover, it

will enable competent authorities to verify the legality of drug precursors movements

more effectively, improving traceability.

From a customs perspective, digitalisation will enhance the effectiveness and

efficiency of controls, providing authorities with faster access to structured, high-

quality information that allows for automatic checks of licences/registrations and

perform quantity management. This will support faster clearance times for imports

and exports while strengthening the EU’s ability to detect and prevent illicit trade.

1.3.4. Indicators of performance

Specify the indicators for monitoring progress and achievements.

Indicator linked to objective 1:

A substantial reduction of availability of precursors for illicit drug manufacturing,

based on the annual volume of seized scheduled precursors (2 100 incidents,

corresponding to approximately 541 tonnes of precursors seized in 2023, reporting

based on the EU database of drug precursors). Previous interventions lead to a

reduction of about 60 %.

Indicator linked to objective 2:

A reduction of net administrative burdens for businesses of EUR M 19.84, down

from a baseline of annual recurrent costs of EUR M 32.34. This is to be verified by

an evaluation no later than 10 years after the entry into application of the revised

rules.

1.4. The proposal/initiative relates to:

☑ a new action

☐ a new action following a pilot project/preparatory action (1)

☑ the extension of an existing action

☐ a merger or redirection of one or more actions towards another/a new

action

(1) As referred to in Article 58(2), point (a) or (b) of the Financial Regulation.

EN 45 EN

1.5. Grounds for the proposal/initiative

1.5.1. Requirement(s) to be met in the short or long term including a detailed timeline for

roll-out of the implementation of the initiative

The new rules for the internal market for drug precursors will start applying to

economic operators and national authorities 2 years after the adoption of the new

rules.

Amongst others, they concern the ban of designer precursors, the need for prior

notifications and the verification of customers.

Experience with developing the system of past projects of integrating certificates in

the EU CSW-CERTEX, shows that a period of three years after entry into force of

the implementing acts is required to specify, develop, test and deploy the connection

of the central e-licensing solution with quantity management, after which three years

are needed for the EU CSW-CERTEX interconnection with the national customs

systems.

The digitalisation of the supervision of imports, exports and licit trade of drug

precursors will replace current procedures, some of which remain paper-based. It will

enable a swift and secure electronic communication between actors: economic

operators, their customers, competent and customs authorities in Member States.

Once the electronic system has been developed and deployed by the Commission,

Member States Customs authorities are expected to connect to it via the EU Customs

Single Window – CERTEX (EU CSW-CERTEX).

Competent authorities for single market matters will connect through another

affiliated IT system. The IT system for formalities in the internal market will be

operational 2 years after the entry into force of the regulation. The Commission will

explore how existing IT systems with a similar purpose could be re-used, such as, for

instance, the Single Market Compliance Space (SMCS), or the software used for the

Digital Waste Shipment System (DIWASS) which will be used for the exchange of

documents and information as of 21 May 2026. The DIWASS should be

interoperable with other systems and software that are used by some competent

authorities or economic operators, as set out in Commission Implementing

Regulation (EU) 2025/1290.

Budgetary needs for the internal market IT system managed by GROW are estimated

to amount to EUR M 1.070 starting from 2028.

To proceed with the preparations for an electronic system for the control of trade in

drug precursors, financial and human resources need to be allocated to TAXUD as

soon as possible, starting from 2025. A preliminary analysis based on the possible re-

use of the Commission’s electronic licensing systems and building on experience

from other e-Licensing systems and the EU Customs Single Window, led to a budget

requirements estimation of up to EUR M 25, depending on the IT solution delivery

model chosen, for a period from 2025 to 2034(including time dedicated to the

preparation of the Implementing Act). The subsequent yearly maintenance cost of the

digitalisation of controls at the external borders is estimated at EUR M 0.5. The

EUDA will deliver an information repository of drug precursors which will cover all

relevant scheduled and non-scheduled substances having or not a known industrial or

commercial use which will cost approximately 0.182 M. For the current MFF, the

need for additional resources (one contractual agent post) for EUDA will be covered

by a contribution agreement to be financed from the existing envelope of the

EN 46 EN

Customs Programme (DG TAXUD) up to and including 2030. The funding for a

second additional FTE as of 2028 until 2030 will be covered by the amounts in the

EU Facility otherwise foreseen to fund actions in the domain of Home Affairs.

Overall, the digitalisation part of this initiative is aligned with the EU digital strategy

to increase the efficiency of public services, improving the quality of communication

with economic operators.

1.5.2. Added value of EU involvement (it may result from different factors, e.g.

coordination gains, legal certainty, greater effectiveness or complementarities). For

the purposes of this section 'added value of EU involvement' is the value resulting

from EU action, that is additional to the value that would have been otherwise

created by Member States alone.

Reasons for action at EU level (ex-ante):

The two current EU drug precursors regulations set the rules for the legitimate trade

of chemical substances, respectively within the EU and with third countries, that can

also be used in illicit drug production. The monitoring and control of trade between

the EU and non-EU countries falls under a policy area where the EU has exclusive

powers and, therefore, the subsidiarity principle does not apply.

For the internal market, any changes to the scope or requirements of such rules must

be made at EU level to avoid: (i) distorting the market; (ii) creating barriers to the

free movement of products; or (iii) undermining efforts to prevent diversion of drug

precursors.

Expected generated EU added value (ex-post):

EU action would have clear benefits for businesses, national authorities and society

as a whole, by simplifying licit trade flows between legitimate businesses within the

single market and third countries, and by supporting the fight against illicit drug

production. This will also remove unnecessary administrative burdens and reduce

those that are necessary for supervising trade flows, such as licenses, registrations or

prior notifications.

By ensuring uniform rules instead of 27 different sets of rules and procedures, EU

action strengthens the competitiveness of EU businesses.

A fully digitised environment also offers advantages such as an increased

effectiveness and speed of controls.

1.5.3. Lessons learned from similar experiences in the past

The evaluation of EU rules on drug precursors (Regulation (EC) No 273/2004 and

Council Regulation 111/2005) found several shortcomings, especially

concerning designer precursors (drug precursors with no known legitimate use

except research and innovation).

Equally, it highlighted opportunities to simplify the complex legal framework and

improve procedures for legitimate trade of drug precursors, thus reducing

administrative burdens.

From an enforcement perspective, it demonstrated possibilities for quicker action

from Member States, based on a more uniform application of rules.

EN 47 EN

Experience has shown that industry and Member States authorities need sufficient

time to familiarise themselves with new requirements and to adapt their business

processes accordingly.

Developing the IT system of past projects of integrating certificates in the EU CSW-

CERTEX, shows that a period of three years after entry into force of the

implementing acts is required to specify, develop, test and deploy the connection of

the central e-licensing solution with quantity management, after which three years

for the EU CSW-CERTEX interconnection with the national customs systems are

needed. The synergies with the existing e-Licensing platforms are key, using a

comprehensive online platform for processing applications and issuing licences,

brings further harmonisation of the applied procedures. It is however to be noted that

the drug precursors project presents certain particularities when compared to existing

systems, and this will have to be reflected in its architecture.

1.5.4. Compatibility with the multiannual financial framework and possible synergies with

other appropriate instruments

Synergies are expected through an improvement in the enforcement of rules on illicit

drug trafficking and a stronger cooperation with the EU Drugs Agency (EUDA).

Scheduled drug precursors are part of the material scope of minimum national rules

on criminal acts concerning precursors set out by Member States in accordance with

Council Framework Decision 2004/757/JHA on combatting drug trafficking. By

extending the scope of substances scheduled, the application of the Framework

Decision is expected to be strengthened.

The initiative also reduces administrative and reporting requirements for economic

operators and national authorities.

1.5.5. Assessment

The costs incurred between 2025 and 2027 for DG TAXUD will be covered by the

Customs programme. The amount of around EUR M 1.3 will be financed by the

financial envelope allocated to the Customs programme under the Commission’s

MFF 2021-2027. The next financial envelope allocated to the Customs programme in

the next MFF should cover the remaining costs of fully digitalising the drug

precursors domain. The costs depend on the IT solution delivery model and might be

up to additional around EUR M 24 (see below tables). That amount, estimated in the

period 2028-2034, is subject to the revision of the related rates of the new DG

TAXUD framework contracts that will be revised presumably in 2028. In addition,

from 2035 onwards, an annual maintenance fee for this system of EUR M 0.5 should

be foreseen. The post-2027 figures are indicative, without pre-empting and pre-

judging the Commission proposal and the agreement on the next MFF.

For the internal market aspects of the proposal, no costs will be incurred under the

current MFF.

1.6. Duration of the proposal/initiative and of its financial impact

☐ limited duration

☐ in effect from [DD.MM]YYYY to [DD.MM]YYYY

☐ financial impact from YYYY to YYYY for commitment appropriations

and from YYYY to YYYY for payment appropriations.

☑ unlimited duration

EN 48 EN

Implementation with a start-up period from 2025 to 2032,

followed by full-scale operation.

1.7. Method(s) of budget implementation planned(2)

☑ Direct management by the Commission

☑ by its departments, including by its staff in the Union delegations;

☐ by the executive agencies

☐ Shared management with the Member States

☐ Indirect management by entrusting budget implementation tasks to:

☐ third countries or the bodies they have designated;

☐ international organisations and their agencies (to be specified);

☐ the European Investment Bank and the European Investment Fund;

☑ bodies referred to in Articles 70 and 71 of the Financial Regulation;

☐ public law bodies;

☐ bodies governed by private law with a public service mission to the

extent that they are provided with adequate financial guarantees;

☐ bodies governed by the private law of a Member State that are entrusted

with the implementation of a public-private partnership and that are

provided with adequate financial guarantees;

☐ bodies or persons entrusted with the implementation of specific actions in

the common foreign and security policy pursuant to Title V of the Treaty

on European Union, and identified in the relevant basic act

☐ bodies established in a Member State, governed by the private law of a

Member State or Union law and eligible to be entrusted, in accordance

with sector-specific rules, with the implementation of Union funds or

budgetary guarantees, to the extent that such bodies are controlled by

public law bodies or by bodies governed by private law with a public

service mission, and are provided with adequate financial guarantees in

the form of joint and several liability by the controlling bodies or

equivalent financial guarantees and which may be, for each action,

limited to the maximum amount of the Union support.

Comments

[...]

2. MANAGEMENT MEASURES

2.1. Monitoring and reporting rules

(2) Details of budget implementation methods and references to the Financial Regulation may be found on

the BUDGpedia site: https://myintracomm.ec.europa.eu/corp/budget/financial-rules/budget-

implementation/Pages/implementation-methods.aspx.

EN 49 EN

The impact of the initiative will be assessed through its evaluation which is planned

no later than 10 years after the entry into application of the revised rules.

The centralised electronic system will allow for an efficient and continuous

monitoring of operational activities. Most notably, it will harmonise the annual

reporting requirements to the UN on legal trade and incidents related to drug

precursors.

In addition, the Commission and to some extent EUDA will continuously monitor

the application of the rules and the developments in precursor trade that may warrant

an adaptation of the scope of the measures.

2.2. Management and control system(s)

2.2.1. Justification of the budget implementation method(s), the funding implementation

mechanism(s), the payment modalities and the control strategy proposed

The Regulation establishes new substantive requirements with regard to controlling

the licit trade of drug precursors while ensuring fair competition among market

actors in the internal market.

These new rules require an improved digital system for monitoring and controlling

the internal and external trade of drug precursors. The enforcement and successful

implementation of the new Regulation is estimated to require an additional FTE in

the European Drugs Agency (EUDA) that will be financed under the contribution

agreement between DG TAXUD and EUDA up to and including 2030

2.2.2. Information concerning the risks identified and the internal control system(s) set up

to mitigate them

The risks associated to the financial transactions implementing the central electronic

system are limited.

The specifications, development and operations of the central electronic system are

implemented using existing framework contracts and/or via co-delegation to other

Commission services.

GROW: N/A

2.2.3. Estimation and justification of the cost-effectiveness of the controls (ratio between

the control costs and the value of the related funds managed), and assessment of the

expected levels of risk of error (at payment & at closure)

The costs of controls are negligible compared to the appropriations for the

development of the IT tool itself

GROW: N/A

2.3. Measures to prevent fraud and irregularities

The measures implemented by the Commission will be subject to the ex-ante and ex-

post controls in accordance with the Financial Regulation. Contracts and agreements

financing the implementation of this Regulation will expressly entitle the

Commission, including OLAF and the Court of Auditors to conduct audits, on the

spot checks and inspections.

EN 50 EN

3. ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE

3.1. Heading(s) of the multiannual financial framework and expenditure budget line(s) affected

Existing budget lines

In order of multiannual financial framework headings and budget lines.

Heading

of

multiannu

al

financial

framework

Budget

line

Type of

expenditur

e

Contribution

Number Diff./Non-

diff. (3)

from

EFTA

countries (4)

from

candidate

countries

and

potential

candidates (5)

from other

third

countries

other

assigned

revenue

5 121003 Diff./Non-

diff. YES/NO YES/NO YES/NO YES/NO

[XX.YY.Y

Y.YY]

Diff./Non-

diff. YES/NO YES/NO YES/NO YES/NO

[XX.YY.Y

Y.YY]

Diff./Non-

diff. YES/NO YES/NO YES/NO YES/NO

New budget lines requested

(3) Diff. = Differentiated appropriations / Non-diff. = Non-differentiated appropriations. (4) EFTA: European Free Trade Association. (5) Candidate countries and, where applicable, potential candidates from the Western Balkans.

EN 51 EN

In order of multiannual financial framework headings and budget lines.

Heading

of

multiannu

al

financial

framework

Budget

line

Type of

expenditur

e

Contribution

Number Diff./non-

diff.

from

EFTA

countries

from

candidate

countries

and

potential

candidates

from other

third

countries

other

assigned

revenue

[XX.YY.Y

Y.YY]

Diff./Non-

diff. YES/NO YES/NO YES/NO YES/NO

[XX.YY.Y

Y.YY]

Diff./Non-

diff. YES/NO YES/NO YES/NO YES/NO

[XX.YY.Y

Y.YY]

Diff./Non-

diff. YES/NO YES/NO YES/NO YES/NO

3.2. Estimated financial impact of the proposal on appropriations

3.2.1. Summary of estimated impact on operational appropriations

☐ The proposal/initiative does not require the use of operational appropriations

☐ The proposal/initiative requires the use of operational appropriations, as explained below

☐ The amounts indicated are strictly indicative, pending the final outcome of the MFF negotiations 2028-2034.

3.2.1.1. Appropriations from voted budget

EUR million (to three decimal places)

EN 52 EN

Heading of multiannual financial framework Number

DG: GROW Year

2028

Year

2029

Year

2030

Year

2031

Year

2032

TOTAL MFF

Operational appropriations

Budget line

Commit

ments (1a) 0.550 0.400 0.070 0.050 0.000 1.070

Payment

s (2a) 0.165 0.505 0.300 0.065 0.035 1.070

Budget line

Commit

ments (1b) 0.000

Payment

s (2b) 0.000

Appropriations of an administrative nature financed from the envelope of specific programmes (6)

Budget line (3) 0.000

TOTAL appropriations

for DG GROW

Commit

ments

=1a+1

b+3 0.550 0.400 0.070 0.050 1.070

Payment

s

=2a+2

b+3 0.165 0.505 0.300 0.065 0.035 1.070

(6) Technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions (former 'BA' lines), indirect research,

direct research.

EN 53 EN

DG:TAXUD Year

2024

Year

2025

Year

2026

Year

2027

TOTAL MFF

2021-2027

Operational appropriations

Budget line E.03050100

Commit

ments (1a)

Payment

s (2a)

Budget line

Commit

ments (1b) 0.000

Payment

s (2b) 0.000

Appropriations of an administrative nature financed from the envelope of specific programmes (7)

Budget line E.03050100 (3)

TOTAL appropriations

for DGTAXUD

Commit

ments =1a+1b+3 0.000 0.000

Payment

s =2a+2b+3 0.000 0.000

DG:TAXUD Year

2028

Year

2029

Year

2030

Year

2031

Year

2032

Year

2033

Year

2034

TOTAL MFF

2028-2034

(7) Technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions (former 'BA' lines), indirect research,

direct research.

EN 54 EN

Operational appropriations

Budget line E.03050100

Commit

ments (1a)

1.12

5

1.72

7 4.492 4.056 4.986 4.800 2.165 23.351

Payment

s (2a)

0.76

8

1.27

1 2.989 3.721 4.608 4.707 3.52 21.584

Budget line

Commit

ments (1b) 0.000

Payment

s (2b) 0.000

Appropriations of an administrative nature financed from the envelope of specific programmes (8)

Budget line E.03050100 (3) 0.10

7

0.10

9

0.11

2 0.114

0.11

6 0.118 0.121 0.797

TOTAL appropriations

for DGTAXUD

Commit

ments

=1a+1

b+3

1.23

2

1.83

6 4.604 4.170 5.102 4.918 2.286 24.148

Payment

s

=2a+2

b+3

0.87

5 1.38 3.101 3.835 4.724 4.825 3.641 22.381

Year

2028

Year

2029

Yea

r

203

0

Year

2031

Yea

r

203

2

Yea

r

203

3

Year

2034

TOTA

L

MFF

2028-

(8) Technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions (former 'BA' lines), indirect research,

direct research.

EN 55 EN

2034

TOTAL operational

appropriations (all

operational headings)

Comm

itment

s

(4) 1.782 2.236 4.67

4 4.22

5.10

2

4.91

8 2.286 25.218

Payme

nts (5) 1.04 1.885

3.40

1 3.9

4.75

9

4.82

5 3.641 23.451

TOTAL appropriations of an

administrative nature financed from

the envelope for specific

programmes (all operational

headings)

(6) 0.000 0.000 0.00

0 0.000

0.00

0

0.00

0 0.000 0.000

TOTAL appropriations

Under Heading 1

of the multiannual

financial framework

(Reference amount)

Comm

itment

s

=4+6 1.782 2.236 4.67

4 4.22

5.10

2

4.91

8 2.286 25.218

Payme

nts =5+6 1.04 1.885

3.40

1 3.9

4.75

9

4.82

5 3.641 23.451

EUR million (to three decimal places)

Year

2024

Year

2025

Year

2026

Year

2027

TOTAL MFF

2021-2027

TOTAL operational

appropriations

Commit

ments (4)

Payments (5)

EN 56 EN

TOTAL appropriations of an

administrative nature financed from the

envelope for specific programmes

(6)

TOTAL appropriations

under HEADING1 to 6

of the multiannual financial

framework

Commit

ments =4+6

Payments =5+6

Year

2028

Year

2029

Yea

r

2030

Year

2031

Year

2032

Yea

r

2033

Year

2034

TOTAL

MFF

2028-2034

TOTAL operational

appropriations (all

operational headings)

Com

mitme

nts

(4) 1.782 2.236 4.67

4 4.22 5.102

4.91

8 2.286 25.218

Paym

ents (5) 1.04 1.885

3.40

1 3.9 4.759

4.82

5 3.641 23.451

TOTAL appropriations of an

administrative nature financed

from the envelope for specific

programmes (all operational

headings)

(6)

TOTAL appropriations

Under Heading 1 to 6

of the multiannual

financial framework

(Reference amount)

Com

mitme

nts

=4+6 1.782 2.236 4.67

4 4.22 5.102

4.91

8 2.286 25.218

Paym

ents =5+6 1.04 1.885

3.40

1 3.9 4.759

4.82

5 3.641 23.451

EN 57 EN

Heading of multiannual financial framework 7 ‘Administrative expenditure’ (10)

DG: <.GROW......> Year

2028

Year

2029

Year

2030

Year

2031 TOTAL MFF

Human resources 0.063 0.063 0.063 0.063 0.252

Other administrative expenditure 0.000 0.000 0.000 0.000 0.000

TOTAL DG

<.......>GROW Appropriations 0.063 0.063 0.063 0.063 0.252

DG: <.TAXUD......> Year

2024

Year

2025

Year

2026

Year

2027

TOTAL MFF

2021-2027

Human resources 0.000 0.000

Other administrative expenditure 0.000 0.000 0.000 0.000 0.000

TOTAL DG TAXUD Appropriations 0.000 0.000

DG: <.TAXUD......> Year

2028

Year

2029

Year

2030

Year

2031 TOTAL MFF 2028-2031

Human resources

Other administrative expenditure

(10) The necessary appropriations should be determined using the annual average cost figures available on the appropriate BUDGpedia webpage.

EN 58 EN

TOTAL DG TAXUD

DG: <.TAXUD......> Year

2032

Year

2033

Year

2034 TOTAL MFF 2032-2034

Human resources

Other administrative expenditure

TOTAL DG TAXUD

DG GROW, DG Year

2024

Yea

r

2025

Yea

r

202

6

Yea

r

2027

Yea

r

2028

Ye

ar

202

9

Ye

ar

20

30

Yea

r

203

1

Ye

ar

203

2

Yea

r

203

3

Yea

r

203

4

TOTA

L MFF

TOTAL appropriations

under HEADING 7 of the

multiannual financial

framework

(Total

commitm

ents =

Total

payments

)

0.00

0

0.00

0

0.06

3

0.0

63

0.0

63

0.06

3 0.252

EUR million (to three decimal places)

Yea

r

2024

Yea

r

2025

Yea

r

2026

Yea

r

2027

Yea

r

2028

Yea

r

202

9

Yea

r

203

0

Yea

r

203

1

Yea

r

203

2

Yea

r

203

3

Yea

r

203

4

TOTAL MFF

EN 59 EN

TOTAL

appropriat

ions under

HEADING

S 1 to 7

of the

multiannu

al financial

framework

Com

mit

men

ts

000 0.10

3

0.19

6

1.84

5

2.29

9

4.73

7

4.28

3

5.10

2

4.91

8

2.28

6 25.769

Pay

men

ts

0.00 0.10

3

0.19

6

1.10

3

1.94

8

3.46

4

3.96

3

4.75

9

4.82

5

3.64

1 24.002

3.2.1.2.

For the current MFF, the need for the

additional Contractual agent post for

EUDA will be covered by a

contribution agreement to be financed

from the existing envelope of the

Customs Programme.

For the next MFF the funding for the temporary agent as of 2028 until 2030 will be covered by the amounts in the EU Facility otherwise

foreseen to fund actions in the domain of Home Affairs.

3.2.1.3. Appropriations from external assigned revenues

EUR million (to three decimal places)

Heading of multiannual financial

framework Number

DG: <.......> Year

2024

Year

2025

Year

2026

Year

2027

TOTAL MFF

2021-2027

EUDA: 12 10 03 Year

2028 Year

2029 Year

2030

TOTAL

MFF 2028-

2030

Budget line: 12 10 03 0.087 0,173 0,173 0,433

EN 60 EN

Operational appropriations

Budget line

Commitm

ents (1a) 0.000

Payments (2a) 0.000

Budget line

Commitm

ents (1b) 0.000

Payments (2b) 0.000

Appropriations of an administrative nature financed from the envelope of specific programmes (11)

Budget line (3) 0.000

TOTAL appropriations

for DG <.......>

Commitm

ents

=1a+1b+

3 0.000 0.000 0.000 0.000 0.000

Payments =2a+2b+

3 0.000 0.000 0.000 0.000 0.000

DG: <.......> Year

2024

Year

2025

Year

2026

Year

2027

TOTAL MFF

2021-2027

Operational appropriations

Budget line

Commitm (1a) 0.000

(11) Technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions (former 'BA' lines), indirect research,

direct research.

EN 61 EN

ents

Payments (2a) 0.000

Budget line

Commitm

ents

(1b) 0.000

Payments (2b) 0.000

Appropriations of an administrative nature financed from the envelope of specific programmes (12)

Budget line (3) 0.000

TOTAL appropriations

for DG <.......>

Commitm

ents

=1a+1b+

3

0.000 0.000 0.000 0.000 0.000

Payments

=2a+2b+

3

0.000 0.000 0.000 0.000 0.000

Heading of multiannual financial

framework Number

DG: <.......> Year

2024

Year

2025

Year

2026

Year

2027

TOTAL MFF

2021-2027

(12) Technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions (former 'BA' lines), indirect research,

direct research.

EN 62 EN

Operational appropriations

Budget line

Commitm

ents (1a) 0.000

Payments (2a) 0.000

Budget line

Commitm

ents (1b) 0.000

Payments (2b) 0.000

Appropriations of an administrative nature financed from the envelope of specific programmes (13)

Budget line (3) 0.000

TOTAL appropriations

for DG <.......>

Commitm

ents

=1a+1b+

3 0.000 0.000 0.000 0.000 0.000

Payments =2a+2b+

3 0.000 0.000 0.000 0.000 0.000

DG: <.......> Year

2024

Year

2025

Year

2026

Year

2027

TOTAL MFF

2021-2027

Operational appropriations

Budget line

Commitm (1a) 0.000

(13) Technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions (former 'BA' lines), indirect research,

direct research.

EN 63 EN

ents

Payments (2a) 0.000

Budget line

Commitm

ents

(1b) 0.000

Payments (2b) 0.000

Appropriations of an administrative nature financed from the envelope of specific programmes(14)

Budget line (3) 0.000

TOTAL appropriations

for DG <.......>

Commitm

ents

=1a+1b+

3

0.000 0.000 0.000 0.000 0.000

Payments

=2a+2b+

3

0.000 0.000 0.000 0.000 0.000

Year

2024

Year

2025

Year

2026

Year

2027

TOTAL MFF

2021-2027

TOTAL operational

Commitm (4) 0.000 0.000 0.000 0.000 0.000

(14) Technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions (former 'BA' lines), indirect research,

direct research.

EN 64 EN

appropriations ents

Payments (5) 0.000 0.000 0.000 0.000 0.000

TOTAL appropriations of an

administrative nature financed from the

envelope for specific programmes

(6) 0.000 0.000 0.000 0.000 0.000

TOTAL appropriations

under HEADING <....>

of the multiannual financial

framework

Commitm

ents

=4+6 0.000 0.000 0.000 0.000 0.000

Payments =5+6 0.000 0.000 0.000 0.000 0.000

Heading of multiannual financial

framework 7 ‘Administrative expenditure’ (15)

EUR million (to three decimal places)

DG: <.......> Year

2024

Year

2025

Year

2026

Year

2027

TOTAL

MFF

2021-2027

Human resources 0.000 0.000 0.000 0.000 0.000

Other administrative expenditure 0.000 0.000 0.000 0.000 0.000

TOTAL DG <.......> Appropriations 0.000 0.000 0.000 0.000 0.000

(15) The necessary appropriations should be determined using the annual average cost figures available on the appropriate BUDGpedia webpage.

EN 65 EN

TOTAL appropriations under HEADING 7 of the

multiannual financial framework

(Total

commit

ments

= Total

payme

nts)

0.000 0.000 0.000 0.000 0.000

EUR million (to three decimal places)

Year

2024

Year

2025

Year

2026

Year

2027

TOTAL

MFF

2021-

2027

TOTAL appropriations under HEADINGS 1 to 7

of the multiannual financial framework

Commitments 0.000 0.000 0.000 0.000 0.000

Payments 0.000 0.000 0.000 0.000 0.000

3.2.2. Estimated output funded from operational appropriations (not to be completed for decentralised agencies)

Commitment appropriations in EUR million (to three decimal places)

Ind

icat

e

obj

ecti

ves

and

out

put

s

⇓

Year

2024

Year

2025

Year

2026

Year

2027

2028-2034 Enter as many years as necessary to

show

the duration of the impact (see Section 1.6)

TOTAL

OUTPUTS

Typ

e

Average

cost No Cost No Cost No

Co

st No Cost No

C

o

st

No Cost No Cost No Cost

Tota

l

No

Total

Cost

EN 66 EN

SPECIFIC

OBJECTIVE No 1 : [...]

-

Out

put

-

Out

put

-

Out

put

Subtotal for specific

objective No 1

SPECIFIC

OBJECTIVE No 2 : [...]

-

Out

put

Subtotal for specific

objective No 2

TOTALS

3.2.3. Summary of estimated impact on administrative appropriations

☐ The proposal/initiative does not require the use of appropriations of an administrative nature

EN 67 EN

☐ The proposal/initiative requires the use of appropriations of an administrative nature, as explained below:

3.2.3.1. Appropriations from voted budget

VOTED

APPROPRIATIONS

Year

2024

Year

2025

Year

2026

Year

2027

Year

2028

Year

2029

Year

2030

Year

2031

Year

2032

Yea

r

2033

Yea

r

203

4

TOTAL MFF

HEADING 7

Human resources 0.000 0.000 0.103 0.30

1

0.37

4

0.17

7 0.181

0.18

5 0.116

0.11

8

0.12

1 1.676

Other administrative

expenditure 0.000 0.000 0.000

0.00

0 0.000

Subtotal HEADING 7 0.000 0.000 0.103 0.30

1

0.37

4

0.17

7 0.181

0.18

5 0.116

0.11

8

0.12

1 1.676

Outside HEADING 7

Human resources 0.000 0.000 0.000 0.00

0 0.000

Other expenditure of an

administrative nature 0.000 0.000 0.000

0.00

0 0.000

Subtotal outside

HEADING 7 0.000 0.000 0.000

0.00

0 0.000

TOTAL 0.0 0.000 0.103 0.30 0.37 0.17 0.181 0.18 0.116 0.11 0.12 1.676

EN 68 EN

1 4 7 5 8 1

3.2.3.2. Appropriations from external assigned revenues

EXTERNAL ASSIGNED REVENUES Year

2024

Year

2025

Year

2026

Year

2027

TOTAL MFF

2021-2027

HEADING 7

Human resources 0.000 0.000 0.000 0.000 0.000

Other administrative expenditure 0.000 0.000 0.000 0.000 0.000

Subtotal HEADING 7 0.000 0.000 0.000 0.000 0.000

Outside HEADING 7

Human resources 0.000 0.000 0.000 0.000 0.000

Other expenditure of an administrative nature 0.000 0.000 0.000 0.000 0.000

Subtotal outside HEADING 7 0.000 0.000 0.000 0.000 0.000

TOTAL 0.000 0.000 0.000 0.000 0.000

3.2.3.3. Total appropriations

TOTAL

VOTED

APPROPRIATIONS

+

EXTERNAL ASSIGNED

Year

2024

Yea

r

202

5

Yea

r

2026

Yea

r

2027

Yea

r

202

8

Year

2029

Year

2030

Yea

r

2031

Yea

r

203

2

Yea

r

203

3

Year

2034

TOTAL

MFF

2021-2027

EN 69 EN

REVENUES

HEADING 7

Human resources 0.000 0.00

0

0.10

3

0.30

1

0.37

4 0.177

0.18

1

0.18

5

0.11

6

0.11

8 0.121 1.676

Other administrative

expenditure

Subtotal HEADING 7 0.000 0.00

0

0.10

3

0.30

1

0.37

4 0.177

0.18

1

0.18

5

0.11

6

0.11

8 0.121 1.676

Outside HEADING 7

Human resources 0.000 0.00

0

0.00

0

0.00

0 0.000

Other expenditure of an

administrative nature 0.000

0.00

0

0.00

0

0.00

0 0.000

Subtotal outside

HEADING 7 0.000

0.00

0

0.00

0

0.00

0 0.000

TOTAL 0.0 0.00

0

0.10

3

0.30

1

0.37

4 0.177

0.18

1

0.18

5

0.11

6

0.11

8 0.121 1.676

The appropriations required for human resources and other expenditure of an administrative nature will be met by appropriations from

the DG that are already assigned to management of the action and/or have been redeployed within the DG, together, if necessary, with

any additional allocation which may be granted to the managing DG under the annual allocation procedure and in the light of budgetary

constraints.

EN 70 EN

3.2.4. Estimated requirements of human resources

☐ The proposal/initiative does not require the use of human resources

☑ The proposal/initiative requires the use of human resources, as explained below

3.2.4.1. Financed from voted budget

Estimate to be expressed in full-time equivalent units (FTEs) (16)

VOTED APPROPRIATIONS Year

2024

Year

2025

Year

2026

Year

2027

Establishment plan posts (officials and temporary staff)

20 01 02 013 (Headquarters and Commission's Representation

Offices) 0 0 0 0

20 01 02 03 (EU Delegations) 0 0 0 0

01 01 01 01 (Indirect research) 0 0 0 0

01 01 01 11 (Direct research) 0 0 0 0

Other budget lines (specify) 0 0 0 0

External staff (in FTEs)

20 02 01 (AC, END from the 'global envelope') 0 0

20 02 03 (AC, AL, END and JPD in the EU Delegations) 0 0 0 0

(16) Please specify below the table how many FTEs within the number indicated are already assigned to the management of the action and/or can be redeployed within

your DG and what are your net needs. 3 Starting from 2028 and up to 2031, it is to be noted that there are 0.3 establishment plan posts

EN 71 EN

Admin. support

line

[XX.01.YY.YY]

- at Headquarters 0 0 0 0

- in EU Delegations 0 0 0 0

01 01 01 02 (AC, END - Indirect research) 0 0 0 0

01 01 01 12 (AC, END - Direct research) 0 0 0 0

Other budget lines (specify) - Heading 7 0 0 0 0

Other budget lines (specify) - Outside Heading 7 0 0 0 0

TOTAL 0

3.2.4.2. Financed from external assigned revenues

EXTERNAL ASSIGNED REVENUES Year

2024

Year

2025

Year

2026

Year

2027

Establishment plan posts (officials and temporary staff)

20 01 02 01 (Headquarters and Commission's Representation Offices) 0 0 0 0

20 01 02 03 (EU Delegations) 0 0 0 0

01 01 01 01 (Indirect research) 0 0 0 0

01 01 01 11 (Direct research) 0 0 0 0

Other budget lines (specify) 0 0 0 0

External staff (in full time equivalent units)

EN 72 EN

20 02 01 (AC, END from the global envelope) 0 0 0 0

20 02 03 (AC, AL, END and JPD in the EU Delegations) 0 0 0 0

Admin. support line

[XX.01.YY.YY]

- at Headquarters 0 0 0 0

- in EU Delegations 0 0 0 0

01 01 01 02 (AC, END - Indirect research) 0 0 0 0

01 01 01 12 (AC, END - Direct research) 0 0 0 0

Other budget lines (specify) - Heading 7 0 0 0 0

Other budget lines (specify) - Outside Heading 7 0 0 0 0

TOTAL 0 0 0 0

3.2.4.3. Total requirements of human resources

TOTAL

VOTED APPROPRIATIONS

+

EXTERNAL ASSIGNED REVENUES

Year

2024

Year

2025

Year

2026

Year

2027

Establishment plan posts (officials and temporary staff)

20 01 02 01 (Headquarters and Commission's Representation Offices) 0 0 0 0

20 01 02 03 (EU Delegations) 0 0 0 0

01 01 01 01 (Indirect research) 0 0 0 0

EN 73 EN

01 01 01 11 (Direct research) 0 0 0 0

Other budget lines (specify) 0 0 0 0

External staff (in full time equivalent units)

20 02 01 (AC, END from the global envelope) 0 0

20 02 03 (AC, AL, END and JPD in the EU Delegations) 0 0 0 0

Admin. support

line

[XX.01.YY.YY]

- at Headquarters 0 0 0 0

- in EU Delegations 0 0 0 0

01 01 01 02 (AC, END - Indirect research) 0 0 0 0

01 01 01 12 (AC, END - Direct research) 0 0 0 0

Other budget lines (specify) - Heading 7 0 0 0 0

Other budget lines (specify) - Outside Heading 7 0 0 0 0

TOTAL 0 0

The staff required to implement the proposal (in FTEs):

To be covered by

current staff

available in the

Commission

services

Exceptional additional staff*

To be financed To be financed To be financed

EN 74 EN

under Heading

7 or Research

from BA line from fees

Establishment

plan posts 0.3 N/A

External staff

(CA, SNEs,

INT)

Description of tasks to be carried out by:

Officials and temporary staff

GROW: Plan, organize, and oversee IT project to ensure timely and

budget-driven completion, managing resources, risks, and stakeholders

to deliver system according to requirements.

External staff

3.2.5. Overview of estimated impact on digital technology-related investments

Compulsory: the best estimate of the digital technology-related investments entailed by the proposal/initiative should be included in the

table below.

Exceptionally, when required for the implementation of the proposal/initiative, the appropriations under Heading 7 should be presented

in the designated line.

The appropriations under Headings 1-6 should be reflected as "Policy IT expenditure on operational programmes". This expenditure

refers to the operational budget to be used to re-use/ buy/ develop IT platforms/ tools directly linked to the implementation of the

initiative and their associated investments (e.g. licences, studies, data storage etc). The information provided in this table should be

consistent with details presented under Section 4 "Digital dimensions".

TOTAL Digital and IT

appropriations

Year

2024

Year

2025

Year

2026

Year

2027

Year

2028

Year

2029

Year

2030

Year

2031 Year 2032 Year 2033

Year

2034

TOTAL

MFF

2021-2034

EN 75 EN

HEADING 7

IT expenditure (corporate) 0.000 0.000

Subtotal HEADING 7 0.000 0.000

Outside HEADING 7

Policy IT expenditure on

operational programmes 0.000 0.000 0.103 0.196 2.692 2.236 4.674 4.22 5.102 4.918 2.286 26.427

Subtotal outside HEADING

7 0.000 0.000 0.103 0.334 2. -966 2.508 4.948 4.22 5.102 4.918 2.286 27.385

TOTAL 0.000 0.000 0.206 0.635 3.34 2.685 5.129 4.405 5.218 5.036 2.407 29.061

EN 76 EN

3.2.6. Compatibility with the current multiannual financial framework

The proposal/initiative:

☑ can be fully financed through redeployment within the relevant heading of the

multiannual financial framework (MFF).

☐ requires use of the unallocated margin under the relevant heading of the MFF

and/or use of the special instruments as defined in the MFF Regulation.

☐ requires a revision of the MFF.

EN 77 EN

3.2.7. Third-party contributions

The proposal/initiative:

☐ does not provide for co-financing by third parties

☐ provides for the co-financing by third parties estimated below:

Appropriations in EUR million (to three decimal places)

Year

2024

Year

2025

Year

2026

Year

2027 Total

Specify the co-financing body

TOTAL appropriations co-financed

3.2.8. Estimated human resources and the use of appropriations required in a decentralised agency

Staff requirements (full-time equivalent units)

A contribution agreement will be signed between DG TAXUD and EUDA to finance 1 contract agent from 2027 till 2030 (in total EUR

297000) and also the operational expenses concerning the repository of drug precursors (EUR 182.000 for years 2027 and 2028).

EU budget contribution to EUDA will be increased by EUR 433000 to finance 1 establishment plan post (TA) from 2028 till 2030. The

funding will need to be covered by a compensatory reduction of the programmed spending of applicable programme budget lines

of DG HOME, and without prejudice to the future MFF Agreement.”

Agency: EUDA Year 2024 Year

2025

Year

2026

Year

2027 MFF 2028-2030

Temporary agents (AD Grades) 1

EN 78 EN

Temporary agents (AST grades)

Temporary agents (AD+AST)

subtotal 0 0 0 1

Contract agents 1 1

Seconded national experts

Contract agents and seconded

national experts subtotal 1 1

TOTAL staff 1 2

Appropriations covered by the EU budget contribution and a contribution agreement4 in EUR million (to three decimal places)

Agency: EUDA Year 2026 Year

2027 TOTAL 2021-2027 MFF 2028-2030

Title 1: Staff expenditure 0.047 0.047 0.729

Title 2: Infrastructure and

operating expenditure

Title 3: Operational expenditure 0.091 0.091 0.091

TOTAL of appropriations

covered by the EU budget 0.138 0.138 0.820

Appropriations covered by fees, if applicable, in EUR million (to three decimal places)

4 One CA (0.343) covered by the contribution agreement plus operational expenses concerning the repository of drug precursors (0.182) and one TA (0.433)

EN 79 EN

Agency: <.......> Year 2026 Year 2027 TOTAL 2021-

2027 MFF 2028-2034

Title 1: Staff expenditure 0.000

Title 2: Infrastructure and

operating expenditure 0.000

Title 3: Operational

expenditure 0.000

TOTAL of appropriations

covered by fees 0.000 0.000

Appropriations covered by co-financing, if applicable, in EUR million (to three decimal places)

Agency: <.......> Year 2027 Year

2028

Year

2029

Year

2030

Year

2031

Year

2032

Year

2033

Year

2034

TOTA

L

2028-

2034

Title 1: Staff expenditure 0.000

Title 2: Infrastructure and

operating expenditure 0.000

Title 3: Operational

expenditure 0.000

TOTAL of appropriations

covered co-financing 0.000 0.000 0.000 0.000 0.000 0.000 0.000 0.000

EN 80 EN

Overview/summary of human resources and appropriations (in EUR million) required by the proposal/initiative in a decentralised

agency

Agency: EUDA Year 2027 TOTAL

2021 -

2027

Year

2028

Year

2029

Year

2030

TOTA

L

2028-

2030

Temporary agents

(AD+AST) 0 1 1 1 1

Contract agents 1 1 1 1 1 1

Seconded national experts 0 0 0 0 -

Total staff 0 0 0 0 -

Appropriations covered by

the EU budget from 2028

and a contribution

agreement

0.047 0.04700 0.183 0.272 0.274 0.729

Appropriations covered by

fees (if applicable) 0.000 0.000 0.000 0.000 0.000

Appropriations co-financed

(if applicable) 0.000 0.000 0.000 0.000 0.000

TOTAL appropriations 0.047 0.047 0.183 0.272 0.274 0.729

3.3. Estimated impact on revenue

☐ The proposal/initiative has no financial impact on revenue.

EN 81 EN

☐ The proposal/initiative has the following financial impact:

☐ on own resources

☐ on other revenue

☐ please indicate, if the revenue is assigned to expenditure lines

EUR million (to three decimal places)

Budget revenue line:

Appropriations

available for the

current financial year

Impact of the proposal/initiative (17)

Year

2024

Year

2025

Year

2026

Year

2027

Article ..........

For assigned revenue, specify the budget expenditure line(s) affected.

[...]

Other remarks (e.g. method/formula used for calculating the impact on revenue or any other information).

[...]

4. DIGITAL DIMENSIONS

4.1. Requirements of digital relevance

The effects of simplification of the legal framework, digitisation of processes and streamlining of obligations should contribute to

positive impacts related to Objective #2, the facilitation of trade (and competition). Processes should be more efficient, there are fewer

obligations to comply with overall.

Where currently Regulation (EC) 273/2004 requires verification of customer declarations through, in practice, paper-based procedures

(since stamped copies of declarations are required), this measure would ensure a digital solution for the verification of customers trading

(17) As regards traditional own resources (customs duties, sugar levies), the amounts indicated must be net amounts, i.e. gross amounts after deduction of 20% for

collection costs.

EN 82 EN

in drug precursors internally. The digital solution would be an off-the-shelf digital solution, which provides for secure electronic

interactions across the EU between businesses and public authorities.

The obligations would be significantly streamlined for operators, with negligible implications for control overall, and significant savings

for both public authorities and economic operators. Obligations that can be digitalised become digital, and those that (due to a centrally -

EU - developed and digital solution) can be automated, are removed for operators. The solution would need to have the necessary

functions listed in the Table below, including the requirements for customer verification (i.e., it allows for mutually recognised digital

signatures, exchanging, and storing of documentation, etc.)

The proposed requirements would be driven by a centralised system connected with customs IT solutions via EU CSW-CERTEX to

allow cross-check and availability check of license and/or registration for import or export transaction and quantity management. As

such, the most significant work to establish the digital solution would be borne by the European Commission. Economic operators and

Competent authorities responsible for the registration of operators and issuance of licences will use the central solution. With the digital

solution, the EU eLicensing central portal for licenses and registrations would be connected to the EU Customs Single Window

Certificates Exchange System and would contain information on substances, validity, quantity and whether exemptions apply, meaning

that the authorisation process could be automated. Customs authorities of Member States stand to implement and interconnect the

central solution with their national export and import systems once the processes are digitised.

The requirements of digital relevance are listed in the table below:

Reference to the

requirement

Requirement

description

Actor(s) affected or

concerned by the

requirement

High-level

Processes Categories

R1: Article 35(2),

point (a)(i)

Access to the digital

solution for

operators (legal

entities) legally

trading with DP and

public authorities

Economic operators,

online market places,

competent authorities,

Commission

Management of

registries

Digital

Public

Service,

Digital

Solution,

Data

R2: Article 35(2),

points

Submission of

licence application,

registration or prior-

Economic operators,

competent authorities,

Filing an

application or

Digital

Public

Service.

EN 83 EN

(a)(ii), (iii) and (iv) notification by

economic operators

Commission notification Data

R3:Article 35(2),

point (a)(v)

Verification of

operators Economic operators

Identification,

fraud prevention

Digital

Public

Service,

Process

R4: Article 35(2),

point (b)

Provision of

information on

suspicious

transactions

Economic operators,

online market places,

competent national

authorities

Fraud

prevention

Digital

Public

Service,

Data

R5: Article 25

Drug Precursors

Information

Repository

General Public,

Economic operators,

competent authorities,

Commission, EUDA

Management of

registries

Digital

Solution,

Data

R6: Article 25(3)

Tool of the

repository to check

if a specific

substance is part of

group scheduling

Economic operators,

competent authorities,

Commission

Information and

guidance

Digital

Solution

R7: Article 35(2),

points

(c)(i) and (ii)

Validity check of

registration and prior

notification, and

issuing licences or

rejecting prior

notifications,

registrations or

licenses

Economic operators,

competent authorities

Fraud

prevention

Digital

Public

Service,

Process

EN 84 EN

R8: Article 35(2),

point (a)(vi)

Information

obligations

regarding import /

exports, and

intermediary

activities

Third countries,

economic operators,

competent authorities

Reporting

Digital

Public

Service,

Data

R9: Article

23(2) and (6)

Validity check of

registration/prior

notification/license

in course of import

and export

transactions

Third countries,

economic operators,

competent authorities

Fraud

prevention

Digital

Public

Service,

Process

R10: Article 35(5)

Interoperability with

UN system for Pre-

export notification

Third countries,

economic operators,

competent authorities

Reporting Digital

Solution

R11: Article 35(2),

point (c)(iii)

Reporting of

seizures by

competent

authorities

competent authorities Reporting Process

R12: Article 35(2),

point (d)

Reporting to the

International

Narcotic Control

Board

Commission,

competent authorities Reporting Process

R13: Article 35(4)

Interconnection to

the EU Single

Window

Environment for

Customs authorities,

Commission

The

Commission

shall

interconnect the

Digital

Public

Service,

Digital

EN 85 EN

Customs central

electronic

system with the

EU Single

Window

Environment for

Customs

established by

Regulation (EU)

2022/2399

Solution

R14: Article 35(5)

Interoperability with

UN system

for seizure reporting

Commission

The

Commission

could

interconnect the

central

electronic

system with the

electronic

system of the

United Nations

Digital

Solution

R15: 35(2)c

Reporting to demonstrate

fulfilment of obligations upon

a reasoned request of

competent authority with an

"ad hoc" frequency.

Economic operators,

Competent authorities

and Customs

Fraud

prevention,

reporting

Data

R16:

Verification of generated

annual reports by competent

authorities

Competent authorities

and Commission Reporting

Digital

public

Service,

EN 86 EN

Data,

Process

4.2. Data

High-level description of the data in scope and any related standards/specifications

Type of data Reference to the requirement(s) Standard and/or specification (if

applicable)

R1: Article 35(2), point (a)(i) Information about economic operators

R2: Article 35(2), points (a)(ii), (iii) and

(iv)

License application, registration or prior

notification

R4: Article 35(2), point (b) Report on suspicious transactions

R5: Article 25

Information about substances covered by

Annex I, II and III, in particular a general

description of the substance and its

chemical properties; information on

legitimate uses and trade; information on

the substance in the illicit production of

drugs.

R8: Article 35(2), point (a)(vi) Information from operators about

quantities to be imported or exported

Alignment with the European Data Strategy

EN 87 EN

Explain how the requirement(s) are aligned with the European Data Strategy

For all requirements data management within the system is aligned with the European Data Strategy and its various aspects, ensuring

following principles:

Digital by default:

All processes will be fully digitised.

Security and privacy:

As personal information will be stored in the central data base, compliance with the data protection legal acts is a must. Ownership of

information remains at any time at national level, while ensuring strong security of information. The information to which each

user/system will get access will be based on a strict need-to-know policy.

Openness and transparency:

The availability of all data is foreseen for validity check of license, self-registration and prior notification by trade partners of operators.

The information will be available on a need-to-know basis as users will be assigned access to the database based on the credential

provided by trader to its trade partner (by using QR code or eWallet). Transparency, harmonisation, and cross-checks of

licences/registration will be ensured by the centralised repository storing the related information accessible to the authorities involved in

the process.

Alignment with the EU Customs Data Model

The interaction with customs systems will be ensured by the compliance with the EU Customs Data Model (EUCDM). The data in

scope and content is information related to the export and import of the goods. It will be available in the Commission Implementing Act,

the specification of data requirement of every data field relevant for external trade will be described in the Delegated Regulation. The

EU Customs Data Model is fully aligned with European Data Strategy.

User-centric, data-driven, agile

The data exchange is organized around the registration and licenses and related documents for the purpose of cross-border collaboration.

Stakeholders of data

Stakeholders for data flows are as per the table in ch.4.1 (EU institutions, Member States, third countries, businesses, public

authorities).The information will be exchanged also between the actors involved as indicated in the Table

Alignment with the once-only principle

EN 88 EN

Data flows

For each data flow, please fill the table below:

Type of data Reference(s) to the

requirement(s)

Actor who

provides the data

Actor who

receives the data

Trigger for the

data exchange

Frequency (if

applicable)

Personal data of

responsible officers

in charge of

licenses, self-

registration or prior

notification

R1

Competent

authorities,

economic operators

Competent

authorities,

Commission

Once the IT system

is operational 24/7

Data relevant for

licenses,

registrations and

prior notifications

of operators

R2, R3, R7, R9,

R12, R15, R16 Economic operators

Competent

authorities,

Economic operators

Request of operator 24/7

Data on suspicious

transactions R4, R15 Economic operators

Competent

authorities Request of operator 24/7

Data on seizures R11, R12 Comptetent

authorities

Commission,

Competent

authorities

Request of operator 24/7

Data on precursor

substances R5, R6 EUDA

Competent

authorities,

eonomic operators,

General Public,

Commission

Once uploaded 24/7

EN 89 EN

Data on drug

precursor, quantity

and time.

R8, R10, R12, R13,

R15, R16

Competent

authorities,

Customs,

Commission

Request of

competent

authorities,

Commission

EN 90 EN

Pre-export

notification R10

Competent

authorities,

Customs, third

countries

4.3. Digital solutions

For each digital solution, please provide the reference to the requirement(s) of digital relevance concerning it, a description of the

digital solution's mandated functionality, the body that will be responsible for it, and other relevant aspects such as reusability and

accessibility. Finally, explain whether the digital solution intends to make use of AI technologies.

Digital solution

Reference(s) to

the

requirement(s)

Main mandated

functionalities

Responsible

body

How is

accessibility

catered for?

How is

reusability

considered?

Use of AI

technologies (if

applicable)

Licensing,

registration and

prior notification

platform

R1, R2, R3, R7,

R9, R12, R16

Submission of

licence

application,

registration or

prior notification

by economic

operators, Verifi

cation of

operators,

validity checks

of licences,

registrations and

prior

notifications,

possibility to

grant/revoke/sus

pend licenses,

order operators

GROW

The system will

be built based on

the EU DP

database or any

other appropriate

IT component

(tbc by ITCB

based on

Business Case)

no

EN 91 EN

to suspend or

cease an activity

covered by prior

notifications and

registrations,

sending ad hoc

information

requests

Interconnection

with customs R8, R9, R13

Information

provision,

validity checks

for import and

export,

TAXUD

The system will

be built based on

the EU DP

database or any

other appropriate

IT component

(tbc by ITBC

based on

business case)

no

Drug Precursors

Information

Repository

R5, R6

(List of

precursor

substances to be

filled in by

EUDA,

translation tool

for extended

scheduling

EUDA

This could be

part of existing

EUDA tools

no

Interface with

INCB R10, R12, R14

Sending and

receiving of pre-

export

notifications

with third

The concrete

materialisation

of the solution

will be assessed

during the

The solution will

be built based on

the EU DP

database or any

other appropriate

no

EN 92 EN

countries

to/from

UN/INCB

solution via

machine-to-

machine

interface to be

built; Opening,

reviewing,

processing and

responding (if

necessary) to the

pre-export

notifications sent

by third

countries’

authorities to

customs authorit

ies; Drafting and

completion of

Annual reporting

and statistics

based on the

information in

Licensing

platform,

seizures reported

and QM

calculator

upcoming

business

analysis.

(TAXUD

responsibility)

IT component

(tbc by ITBC

based on

business case)

Administrative

cooperation R4, R11, R15

Provide a

platform for

competent

GROW This will be part

of the internal

market IT

no

EN 93 EN

authorities and

economic

operators to

report seizures

and suspicious

transactions. Re

quest ad hoc

information to

operators

system

For each digital solution, explain how the digital solution complies with the requirements and obligations of the EU cybersecurity

framework, and other applicable digital policies and legislative enactments (such as eIDAS, Single Digital Gateway, etc.).

Digital and/or sectorial policy

(when these are applicable) Explanation on how it aligns

AI Act n/a

EU Cybersecurity framework

The Commission shall ensure the security, integrity, authenticity, and confidentiality of the

data collected and stored for the purpose of this Regulation. To be further detailed in the

specifications.

eIDAS Most likely to be used for customer verification

Single Digital Gateway and IMI IMI cannot provide for the real-time interoperability with customs systems.

EU SWE-C Framework

The Commission in cooperation with Member States will compose technical and functional

specifications for interconnection of the system with national customs systems. Member

States shall ensure the implementation.

4.4. Interoperability assessment

High-level description of the digital public service(s) affected by the requirements

EN 94 EN

Digital public

service or category

of digital public

services

Description Reference(s) to the

requirement(s)

Interoperable

Europe Solution(s)

(NOT

APPLICABLE)

Other interoperability solution(s)

EU licensing,

registration and prior

notification

platform,

Verification of

operators,

administrative

cooperation platform

Economic operators submit

applications and competent

authorities process them,

operators holding a licence and

those who submitted a prior

notification are to check that the

operators to which they are

planning to supply the relevant

substances have a licence or

submitted a prior notification.

Notification of suspicious

transactions, seizures, request

information from operators

Art. 35(2) //

Connection to

Customs systems

Quantity management, Art. 35(4) and Article 23(2) and (6)

Interconnection to the EU Single

Window Environment for Customs

Impact of the requirement(s) as per digital public service on cross-border interoperability

Licensing, registration prior notification platform, customer verification and administrative cooperation platform

Assessment Measure(s) Potential remaining barriers (if applicable)

Alignment with existing - EU DP database of DG GROW or -

EN 95 EN

digital and sectorial policies

eLicencings system from DG SANTE, or

DG TRADE (to be confirmed by ITCB

based on future Business Case)

- Customer verification will leverage the

European Business Wallets to

authenticate and identify economic

operators and public sector bodies across

borders, while ensuring interoperability.

In addition, the use of the European

Business Wallets can be extended to the

exchange of credentials (e.g., eLicences

and eCertificates) and to the streamlining

of reporting obligations.

Organisational measures

for a smooth cross-border

digital public services

delivery

- Art. 4 Free Movement

- Chapter 2, in particular obligations of

operators

- Chapter 4, cooperation with and tasks of

national authorities

Measures taken to ensure a

shared understanding of the

data

- A single centralised system will provide

the interface for all drug precursor

formalities

- Interoperability with customs systems will not be

immediately available.

Use of commonly agreed

open technical

specifications and standards

- Art. 6 communication is to happen in a

machine-readable open standard.

-

EN 96 EN

Impact of the requirement(s) as per digital public service on cross-border interoperability

Connection to Customs Systems

Assessment Measure(s) Potential remaining barriers (if applicable)

Alignment with existing digital and

sectorial policies

Please list the applicable digital and

sectorial policies identified

Regulation (EU) 2022/2399

Organisational measures for a

smooth cross-border digital public

services delivery

Please list the governance measures

foreseen

The solution will alter the way actors interact

with one another; paper documents will be

replaced by electronic documents or

messages, happening at a faster pace.

The solution will have a significant impact on

the following stakeholders:

• Economic operators involved in

external trade in drug precursors, who

apply for licences electronically via

the new system.

• EU Member States competent

authorities who receive applications

for and issue licences

• EU countries’ customs offices who

control customs declarations of drug

precursors and verify the relevant

licences electronically.

The European Commission, which is

responsible for the development and

maintenance of the system, ensuring its

functionality and compliance. The EU

EN 97 EN

countries are responsible for connecting their

national customs systems to the EU CSW-

CERTEX, which in turn ensures connection

to the central solution.

Measures taken to ensure a shared

understanding of the data

Please list such measures

-

Data management will prioritise usability,

reliability, and security, and support agile

updates to meet evolving legal and

operational requirements.

The system will be aligned with

the EU Customs Data Model

(EUCDM) to ensure full

interoperability with customs IT

systems and compliance with EU

customs legislation. Data elements

required for import and export

procedures will be harmonised

and incorporated into future

amendments to implementing and

delegated regulations related to

external trade in drug precursors.

-

Use of commonly agreed open

technical specifications and

standards

Please list such measures

-

Interoperability with customs systems such as

EU CSW-CERTEX and TARIC is foreseen.

-

Describe the digital public service(s) affected by the requirements

EN 98 EN

The solution needs to be consistent with the EU Customs Single Window Digital Framework Policy. Where relevant, national single

window systems would be connected to the EU Customs Single Window Certificates Exchange System, which in turn would be

connected to the EU web portal for EO drug precursor procedures. Interoperability with international IT solutions such as PEN online

could be ensured by the elaboration of the necessary technical specifications and the compliance to them. A machine-to-machine

interface for communication with third countries authorities would facilitate the cross-border collaboration and administrative

cooperation. MSs could access and see the messages such as PEN notifications received from third countries’ partners in a web-based

interface.

In line with the recommendations of the F4F Platform, Member States are requested to report incidents once only and in real-time

through the EU. To avoid a duplication of reporting requirements an IT solution that allows for an exchange with the current UN alert

system (PICS) would be required . If possible , the platform should communicate with INCB’s PICS to avoid ‘double reporting’ burden

and ensure consistency in the data gathered at EU and international level. MS will have to upload the information in the EU system, and

such system could transmit the information to PICS.

The digital solutions could ensure interoperability across domains, including between the EU DP solution and customs systems for trade

formalities and the reporting requirements of the international control system (e.g. PEN online, Form D, etc.).

The Interoperable Europe solutions identified for (re)use:

-

Interoperability with MSs national customs IT solutions should be ensured in line with rules and agreements on personal data processing

and control.

As regards the possible interoperability of the new system with the solutions of the INCB who is responsible for the building of IT

application of United Nations the EU signed the UN convention with elements of international cooperation in the area of preventing

diversion of drug precursors. If applicable, the UN therefore should ensure compliance of its systems to the GDPR rules and conditions

of SLA agreements allowing EU authorities to perform the work without delay. The centralised solution will ensure that the issued and

electronically submitted certificates are available to customs authorities for cross-checks 24/7 (classified as “Silver” CI), hence not

depending on non-synchronised working hours. No remaining barriers to cross-border interoperability are detected at the moment.

Interoperability with other customs systems such as the TARIC, EORI, CRMS etc. is envisaged.

4.5. Measures to support digital implementation

High-level description of measures supporting digital implementation

EN 99 EN

Description of the measure Reference(s) to the

requirement(s)

Commission

role

(if applicable)

Actors to be

involved

(if applicable)

Expected timeline

(if applicable)

The Commission shall adopt

implementing acts establishing common

technical specifications for the electronic

system

Art. 35(7), Art. 37 Commission to

adopt the act

Member States 18 months after entry

into force of the basic

act.

Committee procedure

Art. 35(7) The

Commission

shall be assisted

by a committee.

That committee

shall be a

committee

within the

meaning of

Regulation (EU)

No 182/2011.

The

Commission;

committee;

Member States

18 months after entry

into force into force of

the basic act.

The list of business functionalities is at high level and purely indicative at this stage and will be fine-tuned in context of the business

analysis and inception phases, supported in part by the COM IT governance (Business Case and Project Charter), and to be legally

covered in the dedicated Implementing Act for the external and international dimensions of the initiative.

EN 100 EN

Depending on the decision of ITCB5 on the alternatives for development of the solution and delivery model, The Commission will chose

between outsourcing the work to an external contractor or developing in-house (e.g. by DG GROW/DG SANTE/DG Trade etc).

As a first activity related to the development of the DP Licencing system and based on the experience gained from other EU projects for

the issuance of digital certificates, a prototype for the issuance module shall be prepared, followed by a piloting activity. The

Commission will organize a Conformance tests (CT) campaign in cooperation with MSs. All necessary information and documentation

for the CT campaign (Integration Guide for Member States, CT Plan, CT Organization Document) will be provided and organizational

meetings will be organized prior to the campaign.

To ensure the smooth implementation of the requirements, the Commission will:

- Create a dedicated team to manage the specifications (functional and technical ones) and the implementation of the system, facilitating

the collaboration between all stakeholders.

- Create guidelines for the implementation (functional and technical specifications) of the needed services for interaction with the DP

eLicencing system by the EU MSs.

- Develop and maintain the common components of the system needed for the issuance and the exchange of certificates with a central

repository, and an administrative cooperation.

- Extend the functionalities of EU CSW-CERTEX for the new domain of drug precursors and interaction with the EU MS National

customs systems.

- Maintain (in technical means) a central registry of authorised users, including EOs of EU MSs and partner countries.

- Extend the existing platforms used in the EU for the authentication, authorisation and connection of users from the international

partners.

- Provide the relevant guidelines (i.e., user manuals, GUI help desk procedures, and training materials) for the DP eLicencing system

GUI.

- Discuss, elaborate and provide the needed information guidelines (e.g., specifications, connectivity instructions, training materials) to

international partners to be connected via machine-to-machine interface such as INCB.

- Provide trainings for the users of the system, including operators, officials of MS medicine and customs authorities.

5 IT development and procurement strategy choices will be subject to pre-approval by the European Commission Information Technology and Cybersecurity Board.

EN 101 EN

- Provide the GUI (user interface) of the system in all EU languages. The platform will be able to support other languages for the future

needs, apart from Latin and Cyrillic alphabet

- Provide a centralised 3rd level IT support in English.

The central support from EC will be provided only to national service desks of customs authorities, not for businesses. Technical

Support will be provided by DG DIGIT. After the adoption of the proposal by the Commission the process of interinstitutional

negotiations between co-legislators will start. In parallel with this process the responsible body in charge of digitalisation will start

business analysis in order to compose Project Initiation Request and Business Case for submission to ITCB. In parallel to this work the

Commission shall start drafting implementing acts on details of IT solution and data elements and its formats to be exchanged to be

adopted based on business analysis. The Commission could also negotiate and adopt agreements on bilateral arrangements with third

parties such as UN/INCB on data exchange together with Annex on technical arrangements.

EN EN

EUROPEAN COMMISSION

Brussels, 3.12.2025

COM(2025) 747 final

ANNEXES 1 to 10

ANNEXES

to the

Proposal for a Regulation of the European Parliament and of the Council

on monitoring and controlling drug precursors and repealing Regulations (EC) No

273/2004 and (EC) No 111/2005

{SEC(2025) 328 final} - {SWD(2025) 397 final} - {SWD(2025) 398 final} -

{SWD(2025) 399 final}

EN 1 EN

ANNEX I

Category 1 drug precursors

Category 1 drug precursors contain or consist of:

Substanc

e

CAS

number CN code

CUS

number

Quantity

threshold

referred

to

in Article

9(1), first

subparag

raph

Concentr

ation

threshold

in

mixtures

referred

to

in Article

3(1),

point

(b)(ii)

Special

condition

s on

mixtures

1-phenyl-

2-

propanon

e (BMK),

also

known as

phenylace

tone

103-79-7 2914 31

00 00 - - -

3’-

chloropro

piopheno

ne

34841-

35-5

2914 79

00 00 - - -

2-bromo-

3’-

chloropro

piopheno

ne

34911-

51-8

2915 79

00 00 - - -

4’-

methylpro

piopheno

ne

5337-93-

9

2916 79

00 00 - - -

2-Bromo-

4’-

methylpro

piopheno

ne

1451-82-

7

2917 79

00 00 - - -

3’-

Methylpr 51772- 2918 79 - - -

EN 2 EN

Substanc

e

CAS

number CN code

CUS

number

Quantity

threshold

referred

to

in Article

9(1), first

subparag

raph

Concentr

ation

threshold

in

mixtures

referred

to

in Article

3(1),

point

(b)(ii)

Special

condition

s on

mixtures

opiophen

one

30-6 00 00

2-Bromo-

3’-

methylpro

piopheno

ne

1451-83-

8

2919 79

00 00 - - -

4’-

Chloropro

piopheno

ne

6285-05-

8

2920 79

00 00 - - -

2-Bromo-

4’-

chloropro

piopheno

ne

877-37-2 2921 79

00 00 - - -

Phenyl-2-

nitroprop

ene

705-60-2 2922 79

00 00 - - -

N-

acetylanth

ranilic

acid, also

known as

2-

acetamido

benzoic

acid

89-52-1 2924 23

00 00 - - -

Isosafrol

(cis +

trans)

120-58-1 2932 91

00 00 - - -

3,4- 4676-39- 2932 92 - - -

EN 3 EN

Substanc

e

CAS

number CN code

CUS

number

Quantity

threshold

referred

to

in Article

9(1), first

subparag

raph

Concentr

ation

threshold

in

mixtures

referred

to

in Article

3(1),

point

(b)(ii)

Special

condition

s on

mixtures

methylen

edioxyph

enylpropa

n-2-one

(PMK)

5 00 00

Piperonal 120-57-0 2932 93

00 00 - - -

Safrole 94-59-7 2932 94

00 00 - - -

N-phenyl-

1-(2-

phenyleth

yl)piperid

in-4-

amine

(ANPP)

21409-

26-7

2933 36

00 00 - - -

1-(2-

phenyleth

yl)piperid

in-4-one

(NPP)

39742-

60-4

2933 37

00 00 - - -

N-

phenylpip

eridin-4-

amine (4-

AP)

23056-

29-3

2933 39

99 01 - - -

Ephedrine 299-42-3 2939 41

00 00 - - -

Pseudoep

hedrine 90-82-4

2939 42

00 00 - - -

Norephed 14838- 2939 44 - - -

EN 4 EN

Substanc

e

CAS

number CN code

CUS

number

Quantity

threshold

referred

to

in Article

9(1), first

subparag

raph

Concentr

ation

threshold

in

mixtures

referred

to

in Article

3(1),

point

(b)(ii)

Special

condition

s on

mixtures

rine 15-4 00 00

Ergometri

ne 60-79-7

2939 61

00 00 - - -

Ergotami

ne 113-15-5

2939 62

00 00 - - -

Lysergic

acid 82-58-6

2939 63

00 00 - - -

The salts of the substances listed in this Annex, whenever the existence of such salts

is possible and not being the salts of cathine.

The stereoisomeric forms of the substances listed in this category not being cathine,

whenever the existence of such forms is possible.

EN 5 EN

ANNEX II

Category 2 drug precursors

EN 6 EN

Part I

Individually listed substances

Category 2 drug precursors contain or consist of:

Substance CAS

number CN code

CUS

number

Concentrat

ion

threshold

in mixtures

referred to

in Article

3(1), point

(b)(ii)

Special

conditions

for

mixtures

Red

phosphorus 7723-14-0

2804 70 10

00 -

Hydrochlori

c acid 7647-01-0

2806 10 00

00 -

Sulphuric

acid 7664-93-9

2807 00 00

00 -

Potassium

permangana

te

7722-64-7 2841 61 00

00 -

Toluene 108-88-3 2902 30 00

00 -

Ethyl ether 60-29-7 2909 11 00

00 -

Acetone 67-64-1 2914 11 00

00 -

Methylethyl

ketone

(MEK)

78-93-3 2914 12 00

00 -

Acetic

anhydride 108-24-7

2915 24 00

10 -

Phenylaceti

c acid 103-82-2

2916 34 00

00 -

Anthranilic

acid 118-92-3

2922 43 00

10 -

EN 7 EN

Substance CAS

number CN code

CUS

number

Concentrat

ion

threshold

in mixtures

referred to

in Article

3(1), point

(b)(ii)

Special

conditions

for

mixtures

Piperidine 110-89-4 2933 32 00

00 -

The salts of the substances listed in this Annex, whenever the existence of such salts

is possible, with the exception of salts of hydrochloric acid and sulphuric acid.

EN 8 EN

Part II

Medicinal products and veterinary medicinal products

Category 2 drug precursors also consist of the following medicinal products:

Products CN code CUS number

Medicinal products and

veterinary medicinal

products containing

pseudoephedrine or its

salts

3003 42 00 00 -

Medicinal products and

veterinary medicinal

products containing

ephedrine or its salts

3003 41 00 00 -

EN 9 EN

ANNEX III

Category 3 drug precursors

EN 10 EN

Part I

Individually listed substances

Category 3 drug precursors contain or consist of:

Group

(1)1 Substance IUPAC Other names

CAS

number

CUS

number

Maxi

mum

quan

tity

thres

hold

for

resea

rch

and

innov

ation

refer

red

to in

Artic

le 17

(2)

Conce

ntratio

n

thresh

old in

mixtur

es

referr

ed to

in

Article

3(1),

point

(b) (ii)

Special

conditi

ons for

mixtur

es

AA Methyl 2-phenyl-3-

oxobutanoate

Methyl alpha-

phenylacetoacetate , CN

Code : 2918 30 00,

MAPA

16648-

44-5 - - - -

AA Ethyl 2-phenyl-3-

oxobutanoate

Ethyl alpha-

phenylacetoacetate, CN

Code : Ex 2918 30 00,

EAPA; ethyl 3-oxo-2-

phenylbutanoate

5413-05-

8 - - - -

AB

2-methyl-3-

phenyloxirane-2-

carboxylic acid

CN Code : 2918 99 90,

BMK glycidic acid

25547-

51-7 - - - -

AB

Methyl 2-methyl-3-

phenyloxirane-2-

carboxylate

CN Code : 2918 99 90 80532-

66-7 - - - -

1 AA: Propylbenzene derivatives, Oxobutanoate esters

AB: Propylbenzene derivatives, Glycidic acid and its esters

AG: Propylbenzene derivatives, Amides

AK: Propylbenzene derivatives, Others

BA: 5-propyl-1,3-benzodioxole (dihydrosafrole) derivatives, Oxobutanoate esters

BB: 5-propyl-1,3-benzodioxole (dihydrosafrole) derivatives, Glycidic acid and its esters

EN 11 EN

AB

Ethyl 2-methyl-3-

phenyloxirane-2-

carboxylate

CN Code : 2918 99 90 - - - -

AB

Propyl 2-methyl-3-

phenyloxirane-2-

carboxylate

CN Code : 2918 99 90 - - - -

AB

Isopropyl 2-methyl-3-

phenyloxirane-2-

carboxylate

CN Code : 2918 99 90 - - - -

AB

Butyl 2-methyl-3-

phenyloxirane-2-

carboxylate

CN Code : 2918 99 90 - - - -

AB

Sec-butyl 2-methyl-3-

phenyloxirane-2-

carboxylate

CN Code : 2918 99 90 - - - -

AB

Tert-butyl 2-methyl-3-

phenyloxirane-2-

carboxylate

CN Code : 2918 99 90 - - - -

AG 3-Oxo-2-

phenylbutanamide

Alpha-

phenylacetoacetamide,

CN Code : 2924 29 70,

APAA

4433-77-6 - - - -

AK 3-Oxo-2-

phenylbutanenitrile

Alpha-

phenylacetoacetonitrile,

CN Code : 2926 40 00,

APAAN

4468-48-8 - - - -

AK

2-Methyl-2-propanyl

4-oxo-1-

piperidinecarboxylate

1-boc-4-piperidone, CN

Code : 2933 39 99

79099-07- 3

- - - -

AK

(1R,2S)-1-(4-

chlorophenyl)-2-

(methylamino)propan-

1-ol

(1R,2S)-(-)-

chloroephedrine, CN

Code : 2939 79 90

110925- 64-9

- - - -

AK

(1S,2R)-1-(4-

chlorophenyl)-2-

(methylamino)propan-

1-ol

(1S,2R)-(+)-

chloroephedrine, CN

Code : 2939 79 90

1384199- 95-4

- - - -

EN 12 EN

AK

(1S,2S)-1-(4-

chlorophenyl)-2-

(methylamino)propan-

1-ol

(1S,2S)-(+)-

chloropseudoephedrine,

CN Code : 2939 79 90

73393-61- 0

- - - -

AK

(1R,2R)-1-(4-

chlorophenyl)-2-

(methylamino)propan-

1-ol

(1R,2R)-(-)-

chloropseudoephedrine,

CN Code : 2939 79 90

771434- 80-1

- - - -

AK

2-Methyl-2-propanyl

4-anilino-1-

piperidinecarboxylate

Tert-butyl 4-

anilinopiperidine-1-

carboxylate, CN Code :

2933 39 99, 1-boc-4-AP

125541- 22-2

- - - -

AK

Diethyl 2-(2-

phenylacetyl)propane

dioate

Diethyl (phenylacetyl)

propanedioate, CN Code

: 2918 30 00, DEPAPD

20320-59- 6

- - - -

AK

Isopropylidene (2-(3,4-

methylenedioxyphenyl

)acetyl)malonate

CN Code : 2932 99 00,

IMDPAM; 5-[2-(1,3-

benzodioxol-5-yl)acetyl] -

2,2-dimethyl-1,3-dioxane-

4,6-dione

- - - -

BA

Methyl 2-(2H-1,3-

benzodioxol-5-yl)-3-

oxobutanoate

Methyl 3-oxo-2-(3,4-

methylenedioxyphenyl)b

utanoate, CN Code : Ex

2932 99 00, MAMDPA,

methyl 2-(2H-1,3-

benzodioxol-5-yl)-3-

oxobutanoate

1369021- 80-6

- - - -

BB

3-(1,3-benzodioxol-5-

yl)-2-methyl-oxirane-

2-carboxylic acid

CN Code : 2932 99 00,

PMK glycidic acid

2167189- 50-4

- - - -

BB

Methyl 3-(1,3-

benzodioxol-5-yl)-2-

methyl-oxirane-2-

carboxylate

CN Code : 2932 99 00 13605-48- 6

- - - -

BB

Ethyl 3-(1,3-

benzodioxol-5-yl)-2-

methyl-oxirane-2-

carboxylate

CN Code : 2932 99 00 28578-16- 7

- - - -

EN 13 EN

BB

Propyl 3-(1,3-

benzodioxol-5-yl)-2-

methyl-oxirane-2-

carboxylate

CN Code : 2932 99 00 - - - -

BB

Isopropyl 3-(1,3-

benzodioxol-5-yl)-2-

methyl-oxirane-2-

carboxylate

CN Code : 2932 99 00 - - - -

BB

Butyl 3-(1,3-

benzodioxol-5-yl)-2-

methyl-oxirane-2-

carboxylate

CN Code : 2932 99 00 - - - -

BB

Sec-butyl 3-(1,3-

benzodioxol-5-yl)-2-

methyl-oxirane-2-

carboxylate

CN Code : 2932 99 00 - - - -

BB

Tert-butyl 3-(1,3-

benzodioxol-5-yl)-2-

methyl-oxirane-2-

carboxylate

CN Code : 2932 99 00 - - - -

The stereoisomeric forms of the substances listed in this Part, whenever the existence

of such forms is possible.

The salts of the substances listed in this part whenever the existence of such salts is

possible.

EN 14 EN

Part II

Groups of substances identified in a generic way

SECTION 1

GROUPS OF SUBSTANCES

SECTION 2

SUBSTANCES EXEMPTED IN ACCORDANCE WITH ARTICLE 5(1)(C) OR ARTICLE

37(2)

The following substances are exempt from the groups of substances included in

Section 1 of this Part:

Substance

(IUPAC)

Other

Names CAS

CUS

number

EN 15 EN

ANNEX IV

Licence referred to in Article 9 and Article 18

1. In order to obtain a licence pursuant to Article 9 or Article 18 of this Regulation,

operators shall make an application to the competent authority through the electronic

system referred to in Article 35 containing the following:

(a) the name and contact details of the operator, including postal and

electronic address, and telephone number;

(b) for import and export activities, if applicable, the external trader's Economic

Operators Registration and Identification (EORI) number referred to in Article

19 (1) of Regulation (EU) [COM/2023/258 final, 2023/0156 (COD)];

(c) if applicable, the reference to status as Authorised Economic Operator or Trust

and check trader issued under Chapter 4 of Title II of Regulation (EU)[

COM/2023/258 final, 2023/0156 (COD)];

(d) the name of the responsible officer appointed in accordance with Article 10 of

this Regulation, its contact details, and a description of its position and tasks;

(e) the addresses of the business premises where Category 1 or, if applicable

Category 3 drug precursors are to be possessed or used;

(f) information showing that the adequate measures referred to in Article 14 have

been taken;

(g) the name and the CN code of the substances covered by Annex I or Annex III,

as applicable;

(h) in case of mixtures, organisms or substances which occur in nature, their name

and the maximum concentration of the substances covered by Annex I or

Annex III as applicable;

(i) the quantity of each substance covered by Annex I or Annex III, as applicable,

estimated for transactions or use during a validity period requested for the

licences, expressed per year;

(j) an exhaustive list of the envisaged type of activities referred to in Article 9(1),

first subparagraph and their detailed description;

(k) when requesting a licence for Category 3 drug precursors in accordance with

Article 18, a justification for exceeding the maximum threshold set out in

Annex III and documents demonstrating the legitimate use;

(l) an extract from the registry of commerce, if applicable;

(m) a certificate of good conduct of the operator and of the responsible officer or a

document showing that they offer the necessary guarantee for the proper

conduct of the activities;

(n) proof of competence in dealing with Category 1 or, if applicable, Category 3

drug precursors, such as a copy of internal procedures on dealing with drug

precursors, including notifying suspicious transactions; or other documents

demonstrating experience in dealing with Category 1 or, if applicable,

Category 3 drug precursors;

(o) the period for which the licence is requested unless an application is made for a

simplified licence in accordance with Article 9(4).

EN 16 EN

2. Upon request from the relevant competent authority, the operator shall submit any

relevant additional information.

3. The competent authority shall issue a licence through the electronic system referred

to in Article 35 after performing documentary checks and inspecting the business

premises where Category 1 or, if applicable, Category 3 drug precursors are to be

possessed or used.

In accordance with Article 9(2), the competent authority shall grant a licence if the

operator demonstrates:

(a) competence in dealing with Category 1 or, if applicable, Category 3 drug

precursors, including in identifying suspicious transactions, for instance by

setting out internal procedures for dealing with Category 1, or, if applicable,

Category 3 drug precursors, including notifying suspicious transactions, or

otherwise showing experience in dealing with such drug precursors;

(b) integrity by the absence of any serious infringement or repeated infringements

of legislation in the field of drug precursors and the absence of a record of any

serious criminal offence.

In accordance with Article 9(4), the competent authority may grant a simplified

licence for an unlimited time period to pharmacies and dispensaries of veterinary

medicines, importing or exporting Category 1 drug precursors, without inspecting the

business premises. In such cases, the provision of the documentation referred to

in Article 7 of this Regulation as well as the obligation to appoint a responsible

officer set out in Article 10 of this Regulation shall not apply.

4. The licence shall be granted per Member State covering all activities for Category 1

or, if applicable, Category 3 drug precursors and all business premises in that

Member State.

The licence shall not be transferable.

5. An operator shall request an update of the licence granted in accordance with point

3 when it intends to:

(a) make available on the market, import, export, perform intermediary activities,

use or possess substances covered by Annex I or Annex III, in quantities

exceeding those estimated in the application for a period of one calendar year;

(b) make available on the market, import, export, perform intermediary activities,

use or possess substances covered by Annex I or Annex III, other than those

included in the initial licence;

(c) undertake additional types of activities among the activities referred to

in Article 9(1), first subparagraph, which have not been included in the initial

licence;

(d) change or extend to new business premises.

The competent authority may decide to update the licence for the remaining period

of validity based on documentary checks only.

6. The decision to refuse a licence in accordance with Article 9(2) or to revoke or

suspend an existing licence in accordance with Article 9(6) shall be communicated

through the electronic system referred to in Article 35, shall be motivated and subject

to appeal under the conditions set out in the national law.

EN 17 EN

7. The operator may request the renewal of a licence in accordance with point 1, for a

period of up to three years. The competent national authority may decide to renew a

licence based on documentary checks only.

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ANNEX V

Registration of information pursuant to Article 9(7) and Article 15

1. The registration pursuant to Article 9(7) or Article 15 of this Regulation shall be

made through the electronic system referred to in Article 35 and shall include the

following:

(a) the name and contact details of the external trader, including postal and

electronic address, and telephone number;

(b) if applicable, the external trader's Economic Operators Registration and

Identification (EORI) number referred to in Article 19 of Regulation (EU)

[COM/2023/258 final, 2023/0156 (COD)];

(c) if applicable, the reference to status as Authorised Economic Operator or Trust

and check trader issued under Chapter 4 of Title II of Regulation (EU)

[COM/2023/258 final, 2023/0156 (COD)];

(d) the name of the responsible officer appointed in accordance with Article 10, its

contact details, and a description of its position and tasks;

(e) the addresses of the business premises where Category 2 drug precursors or

Category 1 drug precursors, as applicable, are to be stored;

(f) the name and the CN code of the substances as covered by Part I, of Annex

II or of the products referred to in Part II, of Annex II, or of the substances

covered by Annex I, as applicable;

(g) in case of mixtures, organisms or substances which occur in nature, their name

and the maximum concentration of the substances covered by Part I, of Annex

II, or in Annex I, as applicable;

(h) the quantity of each substance covered by Annex II or Annex I, as applicable,

estimated for transactions during the validity period of the registration for each

year;

(i) an exhaustive list of the envisaged type of activities referred to in Article 9(7)

or Article 15(1), first subparagraph, as applicable, and their detailed

description;

(j) the period for which the registration is made, unless the registration is made in

accordance with Article 15(3).

2. Pharmacies and dispensaries of veterinary medicinal products may file a registration

for an unlimited period of time, in accordance with Article 15(3). In that case, the

provision of documentation referred to in Article 7 of this Regulation as well as the

obligation to appoint a responsible officer set out in Article 15(6) of this Regulation

shall not apply.

3. An external trader shall update the registration, in accordance with Article 15(4),

when it intends to:

(a) import, export, or perform intermediary activities involving substances covered

by Annex I or Annex II , as applicable, in quantities exceeding those estimated

in the initial registration for a period of one year;

(b) import, export, or perform intermediary activities involving substances covered

by Annex I or Annex II, as applicable, other than those indicated in the initial

registration;

EN 19 EN

(c) undertake additional activities;

(d) change or extend to new business premises.

4. The decision of a competent authority to order the suspension or cessation of the

activity in accordance with Article 15(5) of this Regulation shall be communicated

through the electronic system referred to in Article 35, motivated and subject to

appeal under the conditions set out in the national law.

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ANNEX VI

Prior notification under Article 17(2)

1. The prior notification referred to in Article 17(2) of this Regulation shall be made

through the electronic system referred to in Article 35 and shall contain at least the

following:

(a) the name and contact details of the operator, including postal and electronic

address, and telephone number;

(b) for import and export activities, if applicable, the external trader's Economic

Operators Registration and Identification (EORI) number referred to in Article

19 of Regulation (EU) [COM/2023/258 final, 2023/0156 (COD)];

(c) if applicable, the reference to status as Authorised Economic Operator or Trust

and check trader issued under Chapter 4 of Title II of Regulation (EU)

[COM/2023/258 final, 2023/0156 (COD)];

(d) the name of the responsible officer appointed in accordance with Article 10 of

this Regulation, its contact details, and a description of its position and tasks;

(e) the addresses of the business premises where Category 3 drug precursors are to

be possessed or used;

(f) information showing that the adequate measures referred to in Article 14 of this

Regulation have been taken;

(g) the name and the CN code of the substances as covered by Annex III to this

Regulation;

(h) the quantity of each substance covered by Annex III to this Regulation during

the validity period of the prior notification;

(i) in case of mixtures, organisms or substances which occur in nature, their

quantity, name and the maximum concentration of the substances covered by

Annex III to this Regulation;

(j) the date when the drug precursor is to be made available on the market,

imported, exported, subject to intermediary activities, possessed or used for the

first time;

(k) an exhaustive list of the envisaged type of activities referred to in Article 17(1)

of this Regulation and their detailed description;

(l) details of the transport arrangements, where applicable, such as the expected

date of dispatch, method of transport, name of the customs office where the

customs declaration is to be made and, where available at this stage,

identification of the means of transport, itinerary, for exports; the expected

point of exit from customs territory of the Union and the point of entry into the

importing country and for imports; the expected date of arrival in the customs

territory of the Union;

(m) the names and contact details of the other operators to which the drug precursor

is made available, imported, exported, or involved in the intermediary

activities.

(n) a certificate of good conduct of the operator and of the responsible officer or a

document showing that they offer the necessary guarantee for the proper

conduct of the activities;

EN 21 EN

(o) an extract from the registry of commerce, if applicable.

2. The prior notification shall be presented to the customs office when required by the

customs authority.

3. The decision of a competent authority ordering operators to suspend or cease

activities covered by the prior notification in accordance with Article 17(5) shall be

communicated through the electronic system referred to in Article 35, motivated and

subject to appeal under the conditions set out in the national law.

EN 22 EN

ANNEX VII

External trade (Articles 20 to 24 and 30)

Chapter 1

Import

1. The following information shall be provided in accordance with Article 20:

(a) the name, the CN code, and the CUS number of the substance covered by

Annex I, Annex II, or Annex III or, in the case of a mixture, or an organism or

a substance which occurs in nature, its name the eight-digit CN code, and the

name and CUS number of any substance covered by Annex I, Annex II or

Annex III contained in the mixture, or in the organism or substance which

occurs in nature;

(b) the quantity of the substance and, in the case of a mixture, or an organism or a

substance which occurs in nature, the quantity, and, if available, the percentage

of any substance covered by Annex I, Annex II or Annex III contained therein;

(c) the reference to the licence referred to in Articles 9 or 18, the registration

referred to in Article 15, or the prior notification referred to in 17;

The quantity notified under Article 20(1) will be valid for a period of 180 calendar

days.

Chapter 2

Pre-export notification

2. The pre-export notification referred to in Article 21 shall contain at least the

following:

(a) the names and addresses of the exporter, the importer in the third country, any

other operator involved in the export operation or shipment, and the ultimate

consignee;

(b) the name of the drug precursor covered by Annex I, Annex II or Annex III, in

the case of a mixture, or an organism or a substance which occurs in nature, its

name and eight-digit CN code and the name of any drug precursor covered by

the Annex, contained in the mixture, or in the organism or substance which

occurs in nature;

(c) the quantity and weight of the drug precursor and, in the case of a mixture, or

an organism or a substance which occurs in nature, the quantity, weight, and, if

available, the percentage of any drug precursor contained therein;

(d) details of the transport arrangements, such as the expected date of dispatch,

method of transport, name of the customs office where the customs declaration

is to be made and, where available at this stage, identification of the means of

transport, itinerary, the expected point of exit from customs territory of the

Union and the point of entry into the importing country.

3. The certain countries of destination referred to in Article 21(1) to which a pre-export

notification for the drug precursors covered by Annex II is required shall include all

of the following:

EN 23 EN

(a) third countries with whom the Union has concluded a specific agreement on

drug precursors;

(b) third countries which have requested to receive pre-export notifications in

accordance with Article 12(10) of the UN Convention ;

(c) third countries which have requested to receive pre-export notifications in

accordance with Article 24 of the 1988 UN Convention .

The lists of the countries of destination for export of the drug precursors covered

by Annex II referred to in points (a), (b), and (c) shall be published on the

Commission's website.

4. The competent authority may send a simplified pre-export notification, in accordance

with Article 21(7), covering several export operations for a period of 180 calendar

days.

5. The competent authority of the country of export shall supply the information

specified in point 2 to the competent authority of the third country of destination.

6. The competent authority shall inform the country of destination accordingly and use

the PEN-online system for this purpose.

Chapter 3

Export

7. The following information shall be provided in accordance with Article 22:

(a) the name, CN code and CUS number of the substance covered by Annex I,

Annex II or Annex III or, in the case of a mixture, or an organism or a

substance which occurs in nature, its name and eight-digit CN code and the

name and CUS number of any substance, as covered by Annex I, Annex II or

Annex III contained in the mixture, or in the organism or substance which

occurs in nature;

(b) the quantity of the substance and, in the case of a mixture, or an organism or a

substance which occurs in nature, the quantity, and, if available, the percentage

of any substance covered by Annex I, Annex II or Annex III contained therein;

(c) the reference to the licence referred to in Articles 9 or 18, the registration

referred to in Article 15, or the prior notification referred to in Article 17;

(d) for exports referred to in Article 22(5), a copy of the import authorisation

issued by the country of destination.

The quantity notified under Article 22(1) will be valid for a period of 180 calendar

days.

Chapter 4

Demonstration of licit purposes

8. The external trader shall provide information that the consignment has left the

country of export in accordance with the national provisions in force adopted

pursuant to Article 12 of the UN Convention to demonstrate the licit purpose of his

transaction pursuant to Article 24.

EN 24 EN

For that purpose, the external trader may provide the reference to the licence referred

to in Articles 9 or 18, the registration referred to in Article 15, or the prior

notification as referred to in Article 17 to the competent authority or the customs

authority; or the import or export authorisation, or any other official document

demonstrating the licit use of drug precursors by the operator from the third country,

as the case may be.

Chapter 5

Criteria to determine if there is suspicion of intended use in illicit

manufacture of drugs

9. The following non-exhaustive list of criteria indicate an intended use of drug

precursors in the illicit manufacture of drugs:

(a) the substances have not been correctly identified on the labels of the goods or

consignment and have not been correctly declared to customs in accordance

with Regulation (EU) .../... [COM/2023/258 final, 2023/0156 (COD)], in

particular as regards the description of the goods or the CN-codes;

(b) the substances are included in the Drug Precursors Information Repository as

substances with no known legitimate uses.

EN 25 EN

ANNEX VIII

Reporting in accordance with Articles 32, 33 and 34

1. In accordance with Article 32, the competent authorities and customs authorities

shall provide information on:

(a) total annual seizures of drug precursors;

(b) the methods of diversion of drug precursors and illicit manufacturing of drugs,

including information on stopped shipments and thefts;

(c) information on administrative and law enforcement authorities responsible for

regulating or enforcing national controls of drug precursors.

2. Member States shall provide the information referred to in point 1 and confirm the

accuracy of the data provided, by 31 March at the latest, for the previous calendar

year.

Without prejudice to the first subparagraph, the competent authorities or customs

authorities shall report significant seizures of drug precursors without delay.

3. The communication of information on seizures in accordance with point 1(a) shall

include the following:

(a) the name of the substances covered by Annex I, Annex II or Annex III, or the

name as indicated in the Drug Precursors Information Repository referred to in

Article 25, or the IUPAC name, as applicable;

(b) if known, the origin, provenance and destination of the drug precursors;

(c) the quantity of the substances, their customs status and the means of transport

used, as applicable.

4. Significant seizures within the meaning of Article 33 and point 2 of this Annex cover

seizures of significant quantities of scheduled drug precursors or non-scheduled drug

precursors included in the Drug Precursors Information Repository, as applicable, or

seizures of such drug precursors which point to organised crime taking place in more

than one Member State, or seizures of newly discovered substances.

5. Member States shall report the information referred to in point 1 in the electronic

system referred to in Article 35.

6. The report referred to in Article 34 shall contain the following:

(a) information on quantities of scheduled drug precursors subject to legitimate

trade and use in the internal market in the previous calendar year;

(b) information on all seizures in the previous calendar year;

(c) information on the substances used for the illicit manufacture of drugs and

methods of diversion and illicit manufacture;

(d) information on quantities of scheduled drug precursors subject to legitimate

trade for imports and exports in the previous calendar year;

(e) estimated needs for operators for the subsequent calendar year;

(f) information on administrative and law enforcement authorities responsible for

regulating or enforcing national controls of drug precursors.

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The information referred to in points (a) and (e) shall be based on estimations done

by operators requesting a licence for Category 1 drug precursors in accordance with

Article 9 or Article 18, registering for import, export or intermediary activities in

accordance with Article 15 or sending a prior notification for Category 3 drug

precursors in accordance with Article 17.

The information referred to in point (d) shall be based on information provided by

external traders as per their obligations under Articles 20 and 22. Until the date of

application of Articles 20 and 22, the information in point (d) shall be based on the

information referred to in point 19 of Annex IX.

The information referred to in points (b), (c) and (f) shall be based on the information

provided by competent authorities in accordance with Article 32.

EN 27 EN

ANNEX IX

Transitional measures for import, export and reporting on external trade (Articles 20,

22, 23, 34, 43(5) and Article 44)

Chapter 1

Export authorisation

1. Exports of drug precursors including exports of drug precursors leaving the customs

territory of the Union following their storage in a free zone for a period of at least 10

days, shall be subject to an export authorisation. Where a drug precursor is re-

exported within 10 days from the date of its placement in temporary storage or in a

free zone, an export authorisation shall not be required.

The export authorisation shall be issued by the competent authorities of the Member

State where the exporter is established.

By way of derogation from the first subparagraph the following products shall only

be subject to an export authorisation when a pre-export notification is required

pursuant to Article 21:

(a) Hydrochloric acid;

(b) Sulphuric acid;

(c) Toluene;

(d) Ethyl ether;

(e) Acetone;

(f) Methylethylketone.

2. 2.1. The application for the export authorisation referred to in point 1 shall contain at

least the following:

(a) the names and addresses of the exporter, the importer in the third country, any

other operator involved in the export activity or shipment, and the ultimate

consignee;

(b) the name of the substance covered by Annex I, Annex II or Annex III or, in the

case of a mixture, an organism or a substance which occurs in nature, its name

and eight-digit CN code and the name of any scheduled substance covered by

those Annexes, contained in the mixture, or in the organism or substance which

occurs in nature;

(c) the quantity and weight of the drug precursor and, in the case of a mixture, an

organism or a substance which occurs in nature, the quantity, weight, and, if

available, the percentage of any scheduled substance contained therein;

(d) details of the transport arrangements, such as the expected date of dispatch,

method of transport, name of the customs office where the customs declaration

is to be made and, where available at this stage, identification of the means of

transport, itinerary, expected point of exit from customs territory of the

Union and the point of entry into the importing country;

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(e) in the cases referred to in point 6, a copy of the import authorisation issued by

the country of destination;

(f) the number of the licence referred to in Articles 9 or 18, the registration

referred to in Article 15, or the prior notification referred to in Article 17.

2.2. A decision on the application for the export authorisation referred to in point 1

shall be taken within a period of 15 working days from the date on which the

competent authority considers the file to be complete.

That period shall be extended if, in the cases referred to in point 6, the competent

authorities are obliged to make further enquiries under the second subparagraph of

that point.

3. 3.1. If the details of the itinerary and means of transport are not provided in the

application, the export authorisation referred to in point 1 shall state that the external

trader must supply those details to the customs office of exit or other competent

authorities at the point of exit from the customs territory of the Union before the

physical departure of the consignment. In such cases the export authorisation shall be

annotated accordingly at the time of issue.

Where the export authorisation is presented to a customs office in a Member State

other than that of the issuing authority, the exporter shall make available any

certified translation of parts or all of the information contained on the authorisation,

upon request.

3.2. The export authorisation referred to in point 1 shall be presented to the customs

office when the customs declaration is made, or in the absence of a customs

declaration, at the customs office of exit or other competent authorities at the point of

exit from the customs territory of the Union. The authorisation shall accompany the

consignment to the third country of destination.

The customs office of exit or other competent authorities at the point of exit from the

customs territory of the Union shall insert the necessary details referred to in point

2(2.1) (d) in the export authorisation and affix its stamp thereon.

4. Without prejudice to measures adopted in accordance with Article 30, the granting of

the export authorisation shall be refused if:

(a) details supplied in accordance with point 2.1 are incomplete;

(b) there are reasonable grounds for suspecting that the details supplied in

accordance with point 2.1 are false or incorrect;

(c) in the cases referred to in point 6, it is established that the import of the drug

precursor has not been authorised by the competent authorities of the country

of destination, or

(d) there are reasonable grounds for suspecting that the drug precursors in question

are intended for the illicit manufacture of drugs.

5. The competent authorities may suspend or revoke an export authorisation whenever

there are reasonable grounds for suspecting that the drug precursors are intended for

the illicit manufacture of drugs.

6. Whenever, under an agreement between the Union and a third country, exports are

not to be authorised unless an import authorisation has been issued by the competent

authorities of that third country for the drug precursor in question, the Commission

EN 29 EN

shall communicate to the competent authorities of the Member States the name and

address of the competent authority of the third country, together with any operational

information obtained from it.

The competent authorities in the Member States shall satisfy themselves as to the

authenticity of such import authorisation, if necessary by requesting confirmation

from the competent authority of the third country.

7. The period of validity of the export authorisation within which the goods must have

left the customs territory of the Union shall not exceed six months from the date of

issue of the export authorisation. Under exceptional circumstances, the period of

validity may be extended, upon request.

8. The simplified procedures in point 9 to grant an export authorisation may be applied

by the competent authorities where they are satisfied that this will not result in any

risk of diversion of drug precursors.

9. 9.1. Following an application by the external trader concerned the competent

authority may grant an export authorisation by means of a simplified procedure in

cases of frequent exports of one specific drug precursor covered by Annex II

involving the same exporter established in the Union and the same importer in the

same third country of destination covering a specific time period of either 6 or 12

months.

Such simplified export authorisation may only be granted in the following cases:

(a) where during previous exports the external trader has shown the capacity to

fulfil all obligations in relation to those exports, and has not committed any

offences against relevant legislation;

(b) where the competent authority can satisfy itself as to the licit purposes of those

export activities.

9.2. The application for a simplified export authorisation shall contain at least the

following:

(a) the names and addresses of the exporter, the importer in the third country, and

the ultimate consignee;

(b) the name of the substance covered by Annex II, or, in the case of a mixture, an

organism or a substance which occurs in nature, its name and CN code and the

name of any substance covered by Annex II, contained in the mixture, or the

organism or substance which occurs in nature;

(c) the maximum quantity of the drug precursors intended for export;

(d) the intended specific time period for the export activities.

9.3. The competent authority shall take the decision on the application for simplified

export authorisation within a period of 15 working days from the date on which it

received the required information.

9.4. In case of emergency medical care, where the conditions under point 9(9.1),

points (a) and (b) of this Article are fulfilled, the competent authority shall take the

decision on the application for simplified export authorisation for exports of the drug

precursors referred to in Part II, of Annex II immediately or at the latest within 3

working days after receipt of the application.

EN 30 EN

Chapter 2

Import authorisation

10. Imports of drug precursors covered by Annex I or Annex III shall be subject to an

import authorisation. An import authorisation may only be granted to an external

trader established in the Union. The import authorisation shall be issued by the

competent authorities of the Member State where the importer is established.

However, where the drug precursors referred to in the first subparagraph are

unloaded or transhipped, placed under temporary storage, stored in a free zone, or

placed under the external Union transit procedure, such import authorisation shall not

be required.

11. 11.1. The application for the import authorisation referred to in point 10 shall contain

at least the following:

(a) the names and addresses of the importer, the exporter of the third country, any