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Document 32005R0111

Drug precursors: external aspects

This summary has been archived and will not be updated, because the summarised document is no longer in force or does not reflect the current situation.

Drug precursors: external aspects

This regulation aims to strengthen controls on imports, exports and transits of chemical substances used for the manufacture of illicit synthetic drugs, including amphetamine-type stimulants such as ecstasy. Its purpose is to address the increasing threat posed by the manufacture of synthetic drugs in western Europe by preventing the diversion of these substances.


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.


This regulation lays down rules for the monitoring of trade in precursor drugs between the European Union (EU) and non-EU countries. Drug precursors refer to substances used for the illicit manufacture of narcotic drugs and psychotropic substances. The regulation applies to imports, exports and transit of drug precursors with a view to preventing their diversion.

The aim of current legislation in this area is to apply Article 12 of the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, adopted in Vienna on 19 December 1988, which concerns trade in such substances.

Historically, the EU has been a significant exporter of precursors and an importer of illicitly manufactured drugs. Recently, the EU has also become one of the leading exporters of illicitly manufactured synthetic drugs and an importer of the precursors needed to manufacture them. Consequently, the provisions relating to the application for a licence to import or export drug precursors, the granting or refusal of such a licence and its suspension or revocation must be harmonised at EU level.

Given the magnitude of the trade in precursor drugs, current legislation in this area must be modernised. The new procedures are aimed at the most sensitive drug precursors so as not to place an excessive administrative burden on legitimate importers.

Trade monitoring

The purpose of this regulation is to:

  • introduce import and export authorisation requirements for the drug precursors concerned;
  • require all operators to label and properly document drug precursors;
  • require that all operators be licensed;
  • make sure that all drug precursor consignments are inspected in the EU;
  • strengthen import and export controls;
  • conduct special controls at EU level in areas where the risk of diversion is high, such as free zones and transhipment zones.

The import, export and transit of a substance listed in the annex to this regulation must be documented in such a way as to disclose the name of the substance, its quantity and weight, and the name and address of the exporter, importer, distributor and the ultimate consignee. The operators concerned must keep records of all transactions for a period of three years.

These operators must be licensed and registered as such by the competent authorities of the country in which they are established.

EU countries are responsible for establishing cooperation between operators and the competent authorities to enable the latter to prevent diversions from occurring. To this end, operators must transmit to the competent authorities all relevant information and notify them of all transactions involving scheduled substances.

In addition, operators must lodge an application for an import or export authorisation in respect of each transaction with the competent authorities of the EU country in which the importer or exporter is established. Applications for authorisations must contain full information on the transport arrangements, the name and address of all operators involved, and the nature, quantity and weight of the substance. The competent authorities must reach a decision within 15 working days from the completion of the application file.

If there are grounds for suspecting that diversion might occur, the competent authorities may refuse the import or export of the substance.

A similar procedure applies to non-EU countries having requested the Commission to inform them of any export of substances that concerns them or that have concluded an agreement with the EU on the issuing of import authorisations. A specific procedure applies to countries identified as sensitive as regards the possible diversion of certain scheduled substances.

EU countries are responsible for providing their competent authorities with the means to obtain information and conduct enquiries in order to prevent diversion from occurring.

Mutual assistance and confidentiality between the administrations of EU countries is essential. EU countries determine appropriate penalties for infringements. Each year they communicate to the Commission the results of their monitoring measures, on the basis of which the Commission draws up an annual report to be submitted to the International Narcotics Control Board.

The Commission prepares guidelines for the chemical industry. These will include information on how to recognise and report suspicious transactions and an updated list of non-scheduled substances used to illicitly manufacture narcotic drugs and psychotropic substances.


Following the adoption of the 2000-04 EU action plan on drugs, the Commission organised an assessment of the control system of trade in drug precursors. It considered it necessary to extend monitoring requirements to operators trading with non-EU countries, to introduce a common approach to procedures for granting licences and to strengthen customs monitoring requirements. Consequently, this regulation replaces Regulation (EEC) No 3677/90, which originally laid down measures to discourage the diversion of drug precursors.



Entry into force

Deadline for transposition in the Member States

Official Journal

Regulation (EC) No 111/2005



OJ L 22 of 26.1.2005


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 111/2005 (above) and 273/2004.

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 in drug precursors between the Community and third countries [Official Journal L 202 of 03.08.2005]. The regulation lays down implementing rules concerning the responsible officer, the licensing and registration of operators, the provision of information, pre-export notifications and export and import authorisations in the area of drug precursors.

Last updated: 24.02.2011