Drug precursors: internal aspects

Drug precursors: internal aspects

Outline of the Community (European Union) legislation about Drug precursors: internal aspects


These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.


Drug precursors: internal aspects

Document or Iniciative

Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004 on drug precursors [See amending act(s)].


Effective control of chemicals used in the illicit manufacture of narcotic drugs and psychotropic substances is an important tool in combating drug trafficking. However, these chemicals (known as “precursors”) also have legal and legitimate industrial uses. Therefore, it is necessary to recognise and protect the legal trade in these substances, while discouraging their diversion for illicit purposes.

The objective is to strike a balance between taking action to prevent the manufacture of illegal drugs and avoiding barriers to the legal trade in chemicals.

Measures to control precursors

This regulation establishes harmonised measures for controlling and monitoring within the European Union (EU) certain chemical substances that are frequently used in the illicit manufacture of narcotic drugs. It defines “scheduled substances” * in accordance with Article 12 of the United Nations (UN) Convention (see below). For these scheduled substances, the regulation contains provisions relating to licences, customer declarations and labelling. A monitoring procedure is put in place to prevent obstacles to the free trade in these substances between EU countries.

At the same time, the regulation also defines “non-scheduled substances” * in accordance with Article 12 of the UN Convention. For these substances, the Commission draws up guidelines establishing a more flexible control system than the one applicable to scheduled substances.

Under the regulation, operators * must immediately notify the competent authorities of any circumstances, such as unusual orders or transactions involving scheduled substances to be placed on the market *, which suggest that such substances might be diverted for the illicit manufacture of narcotic drugs or psychotropic substances.

Obligations of operators

Operators wishing to place on the market substances scheduled as precursors (categories 1 or 2 of Annex I) have the following obligations:

  • to appoint an officer responsible for the trade, and to notify the competent authorities of the name and contact details of that officer;
  • to declare the addresses of the premises at which they manufacture or from which they trade in these substances (for category 2);
  • to obtain a licence from the competent authorities for possession of substances listed in category 1 (special licences may be granted to pharmacies, dispensaries of veterinary medicine, certain types of public authorities or armed forces);
  • to ask customers to sign a declaration specifying the use(s) made of the substance provided to them;
  • to supply scheduled substances only to natural or legal persons in possession of a licence for possession of such substances (for category 1);
  • to affix a label to scheduled substances before they are transported, showing the name, quantity and weight of the substance and the name and address of the supplier and the recipient.

To prevent creating unnecessary barriers to trade, the requirements for scheduled substances in category 2 are less restrictive than for those in category 1, particularly where the quantities involved do not exceed those indicated in Annex II.

Assisted by a committee, the Commission draws up and keeps updated a list of substances to monitor. EU countries must distribute these lists to operators.

This regulation repeals Council Directive 92/109/EEC, Commission Directives 93/46/EEC, 2001/8/EC and 2003/101/EC, and Commission Regulations (EC) Nos 1485/96 and 1533/2000.

Background: internal and external aspects of the fight against drugs

In 1990, the UN Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances was adopted by the EU through Council Decision 90/611/ EEC. Article 12 of the UN Convention required measures to be taken to monitor the manufacture and distribution of precursors. As regards the external aspect of this requirement, i.e. monitoring the trade in precursors between EU and non-EU countries, the requirements of Article 12 have been met by Council Regulation (EEC) No 111/2005.

Key terms used in the act
  • Scheduled substance: any substance listed in Annex I liable to be used for the illicit manufacture of narcotic drugs and psychotropic substances, including mixtures and natural products containing such substances. This excludes medicinal products, pharmaceutical preparations, mixtures, natural products and other preparations containing scheduled substances that are compounded in such a way that they cannot be easily used or extracted by readily applicable or economically viable means.
  • Non-scheduled substance: any substance which, although not listed in Annex I, is identified as having been used for the illicit manufacture of narcotic drugs or psychotropic substances.
  • Placing on the market: any supply, whether in return for payment or free of charge, of scheduled substances in the EU; or the storage, manufacture, production, processing, trade, distribution or brokering of these substances for the purpose of supply in the EU.
  • Operator: any natural or legal person engaged in the placing on the market of scheduled substances.


Act Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 273/2004


JO L 47 of 18.2.2004

Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 219/2009


OJ L 87 of 31.3.2009

Related Acts

Report from the Commission to the Council and the European Parliament of 7 January 2010 pursuant to Article 16 of Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004 and to Article 32 of Council Regulation (EC) No 111/2005 on the implementation and functioning of the Community legislation on monitoring and control of trade in drug precursors [COM(2009) 709 final – Not published in the Official Journal].
This report evaluates the implementation as well as the functioning of Regulations (EC) Nos 273/2004 (above) and 111/2005.
Based on data received form EU countries, the Commission’s evaluation concludes that the legal framework for controlling trade generally provides measures that are proportionate for preventing the diversion of drug precursors without obstructing their legitimate trade. The well-functioning cooperation between operators and competent authorities has greatly contributed to this. Furthermore, the EU guidelines for the chemical industry, together with a new eLearning course for economic operators, complements well this legal framework.
EU countries have applied the common licensing system for category 1 precursors satisfactorily and it functions effectively for the competent authorities as well as for the industry. However, the registration requirement for category 2 precursors might have certain weak points for properly controlling, and preventing diversion in the trade of these substances. In addition, certain provisions (e.g. relating to customer declarations or criteria for determining mixtures) are interpreted differently by EU countries. Other difficulties concern the insufficient rate of reporting by operators to competent authorities and certain aspects of the legislation on external trade, such as inflexible time limits for pre-export notifications and lack of simplified authorisation procedures.
Consequently, the report makes the following recommendations:

  • enhance the harmonised application of the legislative framework by EU countries, especially by sharing best practice;
  • improve reporting, for example by increasing the frequency with which operators must report to competent authorities;
  • possibly modify existing legislation to strengthen controls on category 2 precursors;
  • strengthen controls on pharmaceutical preparations/medicinal products containing ephedrine or pseudo-ephedrine that transit through the EU;
  • modify the procedural requirements to achieve a level of controls that is proportionate to the risk of diversion.

Commission Regulation (EC) No 1277/2005 of 27 July 2005 laying down implementing rules for Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug precursors and for Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Community and third countries in drug precursors [Official Journal L 202 of 03.08.2005].
This regulation lays down rules for the implementation of the abovementioned regulations as regards the responsible officer, the licensing and registration of operators, the provision of information, pre-export notifications and authorisation of exports and imports in the field of drug precursors.

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