Monitoring trade in drug precursors within the European Union

KEY POINTS

• The regulation distinguishes between scheduled and non-scheduled⁵ 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.