COM(2020)0768
EUR-Lex

COM(2018)0159
EUR-Lex

The Commission presents its report on the implementation and functioning of the Community legislation on monitoring and control of trade in drug precursors. The current regulatory framework of the Community for drug precursors is made up of Regulation (EC) No 273/2004, which lays down harmonised rules for the intra-Community control and monitoring, and Regulation (EC) No 111/2005, which lays down the rules governing the monitoring of the trade between the Community and third countries in drug precursors. The report examines Community legislation, including guidance documents, mutual administrative assistance, the EU Action Plan on Drugs , actions under the Customs 2013 Programme, bilateral agreements and actions at UN level. It describes Commission actions taken to evaluate the implementation and functioning of the Community legislation.

Findings: overall, the provisions of Regulation (EC) No 273/2004, Regulation (EC) No 111/2005 and the implementing rules contained in Regulation (EC) No 1277/2005 function well and reach the objective pursued, i.e. prevention of diversion without creating unnecessary barriers to the legitimate trade activities for the scheduled drug precursors. Control and monitoring focus on operators rather than on each transaction. The implementation and functioning of the common licensing system introduced for intra- Community trade and for the trade between the Community and third countries for operators handling precursors in Category 1 (the most sensitive substances) proves to work efficiently from both the competent authorities' and industry's perspectives.

However, the registration requirement for operators handling somewhat less sensitive precursors in Category 2 both as regards intra-Community trade and trade between the Community and third countries appears to be insufficient to allow adequate control by competent authorities and prevention of diversion from the important volume of intra-Community trade within these substances. In fact, end-users of Category 2 substances, who do not place on the market the substances, are neither required to register nor to report the quantities they buy for their own end-use. Thus they are hardly known to competent authorities. It is also very difficult for manufacturers or brokers of Category 2 substances to exercise their obligation to check the legitimacy of their customers and of the reported end-use of the substance and consequently to notify as appropriate any suspicious transaction to the competent authorities. The control by competent authorities of the legitimacy of operators is difficult and even more when the manufacturers/brokers and the end-users of the Category 2 substances are based in different Member States, and when the trade chain involves more than two entities based in more than one Member State. These problems have been highlighted particularly for acetic anhydride , a key precursor for illicit heroin manufacture.

The evaluation found differing interpretation of some legislative provisions that would need to be addressed in order to facilitate their correct harmonised implementation within the Community. This includes in particular the application of existing thresholds for exemption of registration for mixtures containing Category 2 substances in accordance with Article 6 of (EC) No 273/2004, when compared to the wording of Article 14 of Regulation (EC) No 1277/2005.

The provisions regarding the frequency of reporting by the operator to the competent authorities does not provide sufficient basis for carrying out the control and monitoring duties. An overview of the legal trade movements constitutes an important instrument to detect suspicious consignments.

Pharmaceutical preparations / medicinal products for human use containing drug precursors are currently excluded from the scope of the drug precursor legislation. The manufacture, import and wholesale distribution of medicinal products, including products for export is subject to an authorisation, specific obligations and regular inspections in line with Community pharmaceutical legislation (Directive 2001/83/EC). Therefore it is considered that these activities should be under sufficient systematic control by Member States' competent authorities. However, such manufacturers, importers and wholesale distributors are not subject to specific pre-notification requirements from drug precursors' legislation when exporting those medicinal products which contain drug precursors. This has led to a situation where in some Member States exports and transit/transhipments of pharmaceutical preparations/medicinal products containing drug precursors - in particular ephedrine or pseudoephedrine - have not been seized even though it was very likely that they would be misused for illicit drug manufacture.

There appear to be further minor weaknesses related to the precursor legislation regarding the external trade . These include in particular the lack of flexibility for competent authorities as regards the period required to wait for the response to pre-export notifications, the lack of simplified authorisation procedures for repetitive consignments between well-known operators in the Community and in the EFTA countries, and the need to further streamline the authorising procedures with the electronic customs environment.

Recommendations : the Commission suggests the following:

improving harmonised implementation of the current legislation; enhancing reporting by increasing the reporting frequency and using modern secured electronic means of exchanging information; modifying some requirements for Category 2 substances specifically for acetic anhydride; ensuring appropriate control of pharmaceutical preparations/medicinal products containing ephedrine or pseudo-ephedrine; improving procedural requirements with regard to the risk of diversion.

The Commission notes that any option pursued would need to be carefully examined in particular towards its impact on economic operators legally trading those substances for legitimate purposes and its effectiveness in preventing their diversion for the illicit drug manufacture.

COM(2009)0709
EUR-Lex

LEGISLATIVE ACT: Commission Regulation 1277/2005/EC laying down implementing rules for Regulation 273/2004/EC of the European Parliament and of the Council on drug precursors and for Council Regulation 111/2005/EC laying down rules for the monitoring of trade between the Community and third countries in drug precursors.

CONTENT: Regulation 273/2004/EC on drug precursors harmonises the provisions concerning the placing on the market of certain substances used in the illicit manufacture of narcotic drugs and psychotropic substances within the Community. In order to enhance the smooth operation of the internal market, for the trade in drug precursors, the provisions for the application for a licence, the granting or refusal of the granting of a licence, its suspension or revocation, are harmonised at Community level. This Regulation lays down rules for the implementation of Regulations 273/2004/EC and 111/2005/EC 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.

The following points should be noted:

-Since it is important to avoid the unauthorised removal of Category 1 substances, the business premises where these substances are stored or used must be secured against unauthorised removal.

-The competent authority must take a decision on the application for licences within 60 working days from the date of receipt of that application. In the case of a renewal of a licence, the decision shall be taken within 30 working days. There is a model licence set out in Annex I.

-The Regulation contains provisions on the types of operators engaged in intra-Community trade who may benefit from special licences and special registrations. It sets out the cases where operators engaged in trade between the Community and third countries may be exempted from the licensing and registration requirement.

-The provisions governing the licence conditions and the notification obligations of operators engaged in intra- Community trade and trade between the Community and third countries will, to the extent possible, be identical.

-The Regulation contains provisions allowing the verification of the licit purposes of all drug precursor consignments entering the Community customs territory, including, in particular, transit and transhipment consignments and sensitive areas such as Community free zones.

-Specific import authorisation procedures are set out to monitor individual import consignments of Category 1 substances in order to prevent diversion at an early stage and in particular to address the growing problem of amphetamine-type stimulants.

- Detailed rules concerning pre-export notification should allow it to adapt the information transfer and the necessary type of response to the sensitivity of the export consignment. In order to fully exploit the pre-export notification and export authorisation system, efforts should in principle target high risk consignments. Detailed rules on the simplified use of pre-export notifications and the granting of export authorisations by simplified procedure should allow the easing of the administrative burden for mass chemicals with common licit uses.

-In view of an efficient monitoring of trade Member States must enable the competent authorities to exchange information.

-To improve the coordination of the monitoring of drug precursors Member States must provide the Commission regularly with information on the prevention of the diversion of drug precursors.

ENTRY INTO FORCE: 03/08/2005

DATE OF IMPLEMENTATION: from 18/08/2005.

32005R1277
OJ L 202 03.08.2005, p. 0007-0033

PURPOSE : To control the sale of drug precursors on the open market. LEGISLATIVE ACT : Regulation 273/2004/EC of the European Parliament and of the Council on drug precursors. CONTENT : The stated purpose of this Regulation is to harmonise measures for the intra-Community control and monitoring of certain substances frequently used for the illicit manufacture of narcotic drugs or psychotropic substances. It is an update of existing Directives and has been created in order to simplify the implementation of its provisions following the accession of the new Member States in May 2004. The Regulation provides a list of definitions including classifications for "scheduled substance", "non-scheduled substance", "placing on the market", "operator" "international Narcotic Control Board", "special license" and "special registration". The substances covered by the provisions of this Regulation are listed in Annex I to the Regulation. Before substances are allowed onto the market operators must fulfil certain requirements. These include, for example, - The appointment of special officers; - Requiring operators to obtain special licenses from competent authorities before scheduled substances can be placed on the market. Special licenses may be granted by the competent authorities to pharmacies, dispensaries of veterinary medicine, certain types of public authorities and the armed forces; - Prior to granting a license competent authorities must take into account the competence and integrity of the applicant. If there are any grounds for doubting the suitability of the applicant a licence can be refused. Similarly, the licence can be suspended if there are grounds to believe that the holder is no longer fit for holding such a licence; - In the case of category 2 substances, operators are required to register and update the addresses from which they trade and/or manufacture. Pharmacies, dispensaries of veterinary medicine, certain types of public authorities or the armed forces may be given a special registration. Other additional measures include: - A customer declaration stating the use of a substance. A separate declaration is required for each separate substance; - Proper documentation on the sale of substances; - Commercial documents must contain information such as the name of the substance, the quantity and weight of the substance and the name/address of the supplier, distributor, consignee etc involved in any transactions; - Documentation must be kept for at least three years and must be readily available for inspection; - Operators must ensure that labels are affixed to scheduled substances before they are supplied, and - Notification to the competent authorities in case of unusual orders or transactions involving scheduled substances. The Commission will regularly draw up guidelines on how to recognise and notify suspect transactions as well as updated lists of non-scheduled substances. Member States are asked to co-operate closely with each other when applying the Regulation's provisions. They are also responsible for laying down infringement penalties. Lastly, the competent authorities are obliged to send annual reports to the Commission on theimplementation of the measures outlined above. ENTRY INTO FORCE: 18/08/2005 (Articles 9, 14 and 15 shall enter into force on 18/02/2004).

Regulation 2004/273
OJ L 047 18.02.2004, p. 0001-0010

T5-0562/2003
OJ C 091 15.04.2004, p. 0027-0068 E

T5-0562/2003

A5-0430/2003

A5-0430/2003

SEC(2003)1073
EUR-Lex

09732/1/2003
OJ C 277 18.11.2003, p. 0031-0044 E

09732/1/2003

11228/1/2003

COM(2003)0304
EUR-Lex

COM(2003)0304
EUR-Lex

T5-0069/2003
OJ C 061 10.03.2004, p. 0023-0075 E

T5-0069/2003

CES0277/2003
OJ C 095 23.04.2003, p. 0022-0023

A5-0038/2003

A5-0038/2003

COM(2002)0494
EUR-Lex
OJ C 020 28.01.2002, p. 0160 E

COM(2002)0494
EUR-Lex