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Document 02004R0273-20230220

Monitoring trade in drug precursors within the European Union

Date of last review:
20/02/2023
Initial creation date:
02/07/2014
Summarised document(s):
Author:
Publications Office of the European Union
Responsible entity(ies):
Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs

Monitoring trade in drug precursors within the European Union

 

SUMMARY OF:

Regulation (EC) No 273/2004 on drug precursors

WHAT IS THE AIM OF THE REGULATION?

KEY POINTS

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

Obligations of operators

  • Operators wishing to place category 1 and 2 substances on the market must:
    • appoint an officer responsible for the trade in scheduled substances;
    • notify or update the relevant national authorities of the details of the officer.
  • They must document and label all transactions and keep records for 3 years.

Licence for category 1 substances

  • Operators and users must obtain a licence from the relevant authorities of the EU Member State in which they are based before they may possess or place category 1 substances on the market. The relevant authorities may grant special licences to pharmacies, dispensaries of veterinary medicine, certain types of public authorities or the armed forces.
  • 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).
  • Before granting a licence, the relevant authorities must check the applicant’s competence and integrity.
  • 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

  • Operators must obtain registration from the relevant authorities of the Member State in which they are established before placing category 2 substances on the market.
  • From 1 July 2015, users must be registered with the authorities of the Member State 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.
  • Any registered operator may only supply subcategory 2A substances to other operators or users who are also registered 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

  • All operators who supply a customer with a category 1 or 2 substance must obtain a declaration from the customer that shows the specific use or uses of the scheduled substances. A separate declaration is required for each scheduled substance.
  • 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

Operators must:

  • notify the relevant 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;
  • provide the authorities with relevant information in summary form about their transactions involving scheduled substances;
  • not disclose any personal data collected other than to the relevant authorities.

Member States’ relevant authorities – powers and obligations

  • Member States must adopt measures to enable their relevant authorities to perform their control and monitoring duties. They may also adopt measures to enable their relevant authorities to control and monitor suspicious transactions involving non-scheduled substances. In particular, these measures should include:
    • obtaining information on any orders for, or operations involving, scheduled and non-scheduled substances;
    • entering operators’ and users’ business premises to obtain evidence of irregularities;
    • where necessary, detaining and seizing consignments that fail to comply with this regulation or preventing the use of non-scheduled substances for the illicit manufacture of narcotic drugs or psychotropic substances.
  • They must ensure relevant authorities respect confidential business information and introduce and enforce penalties for infringing the rules.

European database

The regulation creates a European database on drug precursors. It serves to:

  • simplify the procedure for Member States to report seizures and stopped shipments;
  • maintain a list of EU-licensed or registered operators and users legally trading or using drug precursors;
  • enable operators to provide relevant authorities with information in summary form about their transactions involving scheduled substances.

Implementing and delegated acts

  • 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.
  • Regulation (EU) 2015/1011:
    • lays down conditions for granting licences and registrations;
    • determines cases where a licence or registration is not required;
    • establishes the criteria to demonstrate the legal purpose of a transaction;
    • determines the information required to monitor trade; and
    • specifies the requirements concerning the information to be provided on implementing the monitoring measures as regards trade in drug precursors.
  • Regulations (EU) 2016/1443, (EU) 2018/729 and (EU) 2020/1737 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?

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

BACKGROUND

For further information, see:

KEY TERMS

Drug precursor. Substances used for the illicit manufacture of narcotic drugs or psychotropic substances.
Scheduled substance. Any substance listed in Annex I to 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 that, although not listed in Annex I to this regulation, is identified as having been used for the illicit manufacture of narcotic drugs or psychotropic substances.

MAIN DOCUMENT

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.

RELATED DOCUMENTS

Commission Implementing Regulation (EU) 2015/1013 of 25 June 2015 laying down rules in respect of Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug precursors and of Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Union and third countries in drug precursors (OJ L 162, 27.6.2015, pp. 33–64).

Commission Delegated Regulation (EU) 2015/1011 of 24 April 2015 supplementing Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug precursors and Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Union and third countries in drug precursors, and repealing Commission Regulation (EC) No 1277/2005 (OJ L 162, 27.6.2015, pp. 12–25).

See consolidated version.

Council Regulation (EC) No 111/2005 of 22 December 2004 laying down rules for the monitoring of trade between the Union and third countries in drug precursors (OJ L 22, 26.1.2005, pp. 1–10).

See consolidated version.

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, pp. 56–57).

last update 20.02.2023

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