2004 on drug precursors - Main contents

Summary of Legislation
Legislative text

1. Summary of Legislation

Monitoring intra-EU trade in drug precursors

SUMMARY OF:

Regulation (EC) No 273/2004 on drug precursors

WHAT IS THE AIM OF THE REGULATION?

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It implements the EU’s obligations under the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances (1988) which requires measures to be taken to monitor the placing on the market of drug precursors*.
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It lays down measures to control and monitor the trade of drug precursors within the EU.
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It was amended by Regulation (EU) No 1258/2013 in particular to clarify certain terms used in the text, notably ‘scheduled substance’*, ‘user’* and ‘operator’*.
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It is complemented by Regulation (EC) No 111/2005 (see summary) covering the trade of drug precursors with non-EU countries.
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Current status: three delegated acts (Regulations (EU) 2015/1011, (EU) 2016/1443 and (EU) 2018/729) amending the regulation, as well as one implementing act (Regulation (EU) 2015/1013) have been adopted.

KEY POINTS

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The regulation distinguishes between scheduled and non-scheduled* substances.
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There are 3 categories of scheduled substances in Annex I of the regulation:
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  category 1: the most sensitive substances, from which illicit drugs can be produced most easily (for example, 1-phenyl-2-propanone, ephedrine, piperonal);
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  category 2:less sensitive substances (subcategory 2A: acetic anhydride; subcategory 2B: phenylacetic acid, anthranilic acid, piperidine and potassium permanganate);
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  category 3:bulk chemicals which can have different types of uses in the manufacturing process (for example, acetone, hydrochloric acid).

Obligations of operators

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Operators wishing to place on the market category 1 and 2 substances must:
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  appoint an officer responsible for the trade in scheduled substances;
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  notify or update the national competent authorities of the details of the officer.

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They must document and label all transactions and keep records for 3 years.

Licence for category 1 substances

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Operators and users must obtain a licence from the competent authorities of the EU country in which they are based before they may possess or place on the market category 1 substances. The competent authorities may grant special licences to pharmacies, dispensaries of veterinary medicine, certain types of public authorities or the armed forces.
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An operator holding a licence may only supply category 1 substances to operators or users who also hold a licence and have signed a customer declaration (see below).
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Before granting a licence, the competent authorities must check the applicant’s competence and integrity.
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The licence may be suspended or revoked by the authorities where there are reasonable grounds for believing that the holder is no longer a fit and proper person to hold a licence, or that the conditions under which the licence was granted are no longer fulfilled.

Registration for category 2 substances

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Operators must obtain registration from the competent authorities of the EU country in which they are established before placing on the market category 2 substances.
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From 1 July 2015, users must obtain a registration from the authorities of the EU country in which they are established before possessing subcategory 2A substances. The authorities may grant special registrations to pharmacies, dispensaries of veterinary medicine, certain types of public authorities or the armed forces.
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Any operator holding a registration may only supply subcategory 2A substances to other operators or users who also hold a registration and have signed a customer declaration (see below).

Detailed rules on the award of licences and registrations are set out in Regulation (EU) 2015/1011.

Customer declaration

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All operators who supply a customer with a category 1 or 2 substance must obtain a declaration from the customer which shows the specific use or uses of the scheduled substances. A separate declaration is required for each scheduled substance.
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An operator supplying category 1 substances must stamp and date a copy of the declaration, certifying it to be a true copy of the original. This copy must always accompany the substances being moved within the EU and be presented on request to the authorities.

Notification of the authorities

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Operators must:
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  notify the competent authorities immediately of any circumstances, such as unusual orders or transactions which suggest that substances might be diverted for the illicit manufacture of narcotic drugs or psychotropic substances;
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  provide the competent authorities with relevant information in summary form about their transactions involving scheduled substances;
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  not disclose any personal data collected other than to the competent authorities.

EU countries’ competent authorities — powers and obligations

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EU countries must adopt measures to enable their competent authorities to perform their control and monitoring duties. They may also adopt measures to enable their competent authorities to control and monitor suspicious transactions involving non-scheduled substances. In particular, these measures may include:
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  to obtain information on any orders for, or operations involving, scheduled and non-scheduled substances,
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  to enter operators’ and users’ business premises to obtain evidence of irregularities,
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  where necessary, to detain and seize consignments that fail to comply with this regulation or to prevent the use of non-scheduled substances for the illicit manufacture of narcotic drugs or psychotropic substances.

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They must ensure competent authorities respect confidential business information and introduce and enforce penalties for infringing the rules.

European database

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The regulation creates a European database on drug precursors. It serves to:
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  simplify the procedure for EU countries to report seizures and stopped shipments;
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  maintain a list of EU licensed or registered operators and users legally trading or using drug precursors;
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  enable operators to provide competent authorities with information in summary form about their transactions involving scheduled substances.

Implementing and delegated acts

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Regulation (EU) 2015/1013 sets out rules on the licensing and registration of operators and users and their listing in the European database on drug precursors, the provision by operators of information required to monitor trade and authorisation of exports and imports in the field of drug precursors.
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Regulation (EU) 2015/1011:
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  lays down conditions for granting licences and registrations;
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  determines cases where a licence or registration is not required;
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  establishes the criteria to demonstrate the legal purpose of a transaction;
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  determines the information required to monitor trade; and
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  specifies the requirements concerning the information to be provided on implementing the monitoring measures as regards trade in drug precursors.

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Regulations (EU) 2016/1443 and (EU) 2018/729 extend the list of category 1 substances.

Repeal

The regulation repeals Directive 92/109/EEC, Directives 93/46/EEC, 2001/8/EC and 2003/101/EC and Regulations (EC) No 1485/96 and (EC) No 1533/2000.

FROM WHEN DOES THE REGULATION APPLY?

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Regulation (EC) No 273/2004 has applied since 18 August 2005.
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Amending Regulation (EU) No 1258/2013 has applied since 30 December 2013.

BACKGROUND

For more information, see:

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Drug precursors control (European Commission).

KEY TERMS

Drug precursor: chemicals that are primarily used for the legitimate (legal) production of a wide range of products including medicines, plastics, and cosmetics. These substance may also be misused for illegal/illicit purposes, such as the production of methamphetamines, heroin or cocaine.

Scheduled substance: any substance listed in Annex I of this regulation and is identified as having been used for the illicit manufacture of narcotic drugs or psychotropic substances.

User: a natural or legal person other than an operator (see next entry) who possesses a scheduled substance and is engaged in the processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, transformation or any other utilisation of scheduled substances.

Operator: any natural or legal person engaged in the placing on the market of scheduled substances.

Non-scheduled substance: any substance which, although not listed in Annex I of this regulation, is identified as having been used for the illicit manufacture of narcotic drugs or psychotropic substances.

MAIN DOCUMENTS

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, pp. 1-10)

Successive amendments to Regulation (EC) No 273/2004 have been incorporated into the original text. This consolidated version is of documentary value only.

2. Legislative text

Regulation (EU) No 1258/2013 of the European Parliament and of the Council of 20 November 2013 amending Regulation (EC) No 273/2004 on drug precursors Text with EEA relevance

Contents

1.

Summary of Legislation

2.

Legislative text