Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004 on drug precursors (Text with EEA relevance)

Article 1

Scope and objectives

This Regulation establishes harmonised measures for the intra-Union control and monitoring of certain substances frequently used for the illicit manufacture of narcotic drugs or psychotropic substances with a view to preventing the diversion of such substances.

Article 2

Definitions

For the purposes of this Regulation the following definitions shall apply:

(a) ‘scheduled substance’ means any substance listed in Annex I that can be used for the illicit manufacture of narcotic drugs or psychotropic substances, including mixtures and natural products containing such substances but excluding mixtures and natural products which contain scheduled substances and which are compounded in such a way that the scheduled substances cannot be easily used or extracted by readily applicable or economically viable means, medicinal products as defined in point 2 of Article 1 of Directive 2001/83/EC of the European Parliament and of the Council (¹) and veterinary medicinal products as defined in point 2 of Article 1 of Directive 2001/82/EC of the European Parliament and of the Council (²);

(b) ‘non-scheduled substance’ means 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;

(c) ‘placing on the market’ means any supply, whether in return for payment or free of charge, of scheduled substances in the Union; or the storage, manufacture, production, processing, trade, distribution or brokering of these substances for the purpose of supply in the Union;

(d) ‘operator’ means any natural or legal person engaged in the placing on the market of scheduled substances;

(e) ‘International Narcotics Control Board’ means the Board established by the Single Convention on Narcotic Drugs, 1961, as amended by the 1972 Protocol;

(f) ‘special licence’ means a licence that is granted to a particular type of operator;

(g) ‘special registration’ means a registration that is made for a particular type of operator;

(h) ‘user’ means a natural or legal person other than an operator 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;

(i) ‘natural product’ means an organism or a part thereof, in any form, or any substances which occur in nature as defined in point 39 of Article 3 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (³).

Article 3

Requirements for the placing on the market of scheduled substances

Where a fee is levied, competent authorities shall consider adjusting the level of the fee depending on the size of the enterprise. Such a fee shall be levied in a non-discriminatory manner and shall not exceed the cost of processing the application.

The Commission shall be empowered to adopt delegated acts in accordance with Article 15a concerning the requirements and conditions for:

(a) granting the licence, including, where relevant, the categories of personal data to be provided;

(b) granting registration, including where relevant the categories of personal data to be provided;

(c) listing operators and users in the European database referred to in Article 13a, in accordance with paragraph 7 of this Article.

The categories of personal data referred to in points (a) and (b) of the first subparagraph of this paragraph shall not include special categories of data as referred to in Article 8(1) of Directive 95/46/EC of the European Parliament and of the Council (⁴).

Article 4

Customer declaration

As an alternative to the above declaration for an individual transaction, an operator who regularly supplies a customer with a scheduled substance of category 2 of Annex I may accept a single declaration in respect of a number of transactions involving this scheduled substance over a period not exceeding one year, provided that the operator is satisfied that the following criteria have been met:

(a) the customer has been supplied by the operator with the substance on at least three occasions in the preceding 12 months;

(b) the operator has no reason to suppose that the substance will be used for illicit purposes;

(c) the quantities ordered are consistent with the usual consumption for that customer.

This declaration shall conform to the model set out in point 2 of Annex III. In the case of legal persons, the declaration shall be made on headed notepaper.

Article 5

Documentation

Commercial documents such as invoices, cargo manifests, administrative documents, transport and other shipping documents shall contain sufficient information to identify positively:

(a) the name of the scheduled substance as given in categories 1 and 2 of Annex I;

(b) the quantity and weight of the scheduled substance and, where a mixture or natural product is concerned, the quantity and weight, if available, of the mixture or natural product as well as the quantity and weight, or the percentage by weight, of any substance or substances of categories 1 and 2 of Annex I which are contained in the mixture;

(c) the name and address of the supplier, distributor, consignee, and, if possible, of other operators directly involved in the transaction, as referred to in Article 2(c) and (d).

The documentation may also be kept in the form of reproductions on an image medium or other data media. It must be ensured that the data stored:

(a) match the documentation in appearance and content when made readable, and

(b) are readily available at all times, can be made readable without delay and can be analysed by automated means for the duration of the period specified in paragraph 5.

Article 6

Exemptions

The obligations according to Articles 3, 4 and 5 shall not apply to transactions involving scheduled substances of category 2 of Annex I where the quantities involved do not exceed those indicated in Annex II over a period of one year.

Article 7

Labelling

Operators shall ensure that labels are affixed to scheduled substances of categories 1 and 2 of Annex I before they are supplied. The labels must show the names of the substances as given in Annex I. Operators may in addition affix their customary labels.

The Commission shall be empowered to adopt delegated acts in accordance with Article 15a concerning the requirements and conditions for the labelling of mixtures containing scheduled substances.

Article 8

Notification of the competent authorities

Article 9

Guidelines

The guidelines shall provide in particular:

(a) information on how to recognise and notify suspect transactions;

(b) a regularly updated list of non-scheduled substances to enable the industry to monitor on a voluntary basis the trade in such substances;

(c) other information which may be deemed useful.

Article 10

Powers and obligations of competent authorities

In order to ensure the correct application of Articles 3 to 8, each Member State shall adopt the measures necessary to enable its competent authorities to perform their control and monitoring duties, and in particular:

(a) to obtain information on any orders for scheduled substances or operations involving scheduled substances;

(b) to enter operators’ and users’ business premises in order to obtain evidence of irregularities;

(c) where necessary, to detain and seize consignments that fail to comply with this Regulation.

Each Member State may adopt the measures necessary to enable its competent authorities to control and monitor suspicious transactions involving non-scheduled substances, and in particular:

(a) to obtain information on any orders for non-scheduled substances or operations involving non-scheduled substances;

(b) to enter business premises in order to obtain evidence of suspicious transactions involving non-scheduled substances;

(c) where necessary, to detain and seize consignments to prevent the use of specific non-scheduled substances for the illicit manufacture of narcotic drugs or psychotropic substances.

Article 11

Cooperation between the Member States and the Commission

Article 12

Penalties

The Member State shall lay down the rules on penalties applicable for infringement of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive.

Article 13

Communications from Member States

Article 13a

European database on drug precursors

The Commission shall establish a European database on drug precursors with the following functions:

(a) to facilitate the communication of information, where possible in an aggregated and anonymised manner, pursuant to Article 13(1), the synthesis and analysis of that information at the Union level, and the reporting to the International Narcotics Control Board pursuant to Article 13(3);

(b) to create a European register of operators and users, which have been granted a licence or registration;

(c) to enable operators to provide the competent authorities with information about their transactions in accordance with Article 8(2) in electronic form, as specified in implementing measures adopted pursuant to Article 14.

Personal data shall be included in the European database only after the adoption of the delegated acts referred to in Articles 3(8) and 8(3).

Article 13b

Data protection

Article 14

Implementing acts

The Commission may adopt the following implementing acts:

(a) rules on how to provide customer declarations referred to in Article 4 in electronic form, where appropriate;

(b) rules on how to provide the information referred to in Article 8(2), including, where appropriate, in electronic form to a European database;

(c) procedural rules for granting licences and registrations and for listing operators and users in the European database, as referred to in Article 3(2), (6) and (7).

Article 14a

Committee procedure

Article 15

Adaptation of Annexes

The Commission shall be empowered to adopt delegated acts in accordance with Article 15a in order to adapt Annexes I, II and III to new trends in diversion of drug precursors and to follow any amendment to the tables in the Annex to the United Nations Convention.

Article 15a

Exercise of the delegation

Article 16

Information about measures adopted by Member States

Article 17

Repeals

Article 18

Entry into force

This Regulation shall enter into force on 18 August 2005, except for Articles 9, 14 and 15, which shall enter into force on the day of publication of this Regulation in the Official Journal of the European Union, in order to permit the adoption of the measures provided for in those Articles. Such measures shall enter into force at the earliest on 18 August 2005.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

ANNEX I

Substance	CN designation (if different)	CN code (1)	CAS No (2)
1-phenyl-2-propanone	Phenylacetone	2914 31 00	103-79-7
Diethyl (phenylacetyl) propanedioate (DEPAPD)		2918 30 00	20320-59-6
Methyl alpha-phenylacetoacetate (MAPA)		2918 30 00	16648-44-5
Ethyl alpha-phenylacetoacetate (EAPA) (4)		Ex 2918 30 00	5413-05-8
—————
2-methyl-3-phenyloxirane-2-carboxylic acid (BMK glycidic acid) (6)		2918 99 90	25547-51-7
N-acetylanthranilic acid	2-acetamidobenzoic acid	2924 23 00	89-52-1
Alpha-phenylacetoacetamide (APAA)		2924 29 70	4433-77-6
Alpha-phenylacetoacetonitrile (APAAN)		2926 40 00	4468-48-8
Isosafrol (cis + trans)		2932 91 00	120-58-1
3,4-methylenedioxyphenylpropan-2-one	1-(1,3-Benzodioxol-5-yl)propan-2-one	2932 92 00	4676-39-5
Piperonal		2932 93 00	120-57-0
Safrole		2932 94 00	94-59-7
—————
Methyl 3-oxo-2-(3,4-methylenedioxyphenyl)butanoate (MAMDPA) (5)	Methyl 3-oxo-2-(3,4-methylenedioxyphenyl)butanoate	Ex 2932 99 00	1369021-80-6
3-(1,3-benzodioxol-5-yl)-2-methyl-oxirane-2-carboxylic acid (PMK glycidic acid) (7)		2932 99 00	2167189-50-4
Isopropylidene (2-(3,4-methylenedioxyphenyl)acetyl)malonate (IMDPAM) (8)	IMDPAM	2932 99 00
N-phenyl-1-(2-phenylethyl)piperidin-4-amine	4-anilino-N- phenethylpiperidine (ANPP)	2933 36 00	21409-26-7
1-(2-phenylethyl)piperidin-4-one	N-phenethyl-4-piperidone (NPP)	2933 37 00	39742-60-4
N-phenylpiperidin-4-amine (4-AP)		2933 39 99	23056-29-3
Tert-butyl 4-anilinopiperidine-1-carboxylate (1-boc-4-AP)		2933 39 99	125541-22-2
N-phenyl-N-(piperidin-4-yl)propanamide (norfentanyl)		2933 39 99	1609-66-1
4-piperidone	Piperidin-4-one	2933 39 99	41661-47-6
1-boc-4-piperidone	tert-butyl 4-oxopiperidine-1-carboxylate	2933 39 99	79099-07-3
Ephedrine		2939 41 00	299-42-3
Pseudoephedrine		2939 42 00	90-82-4
Norephedrine		2939 44 00	14838-15-4
Ergometrine		2939 61 00	60-79-7
Ergotamine		2939 62 00	113-15-5
Lysergic acid		2939 63 00	82-58-6
The stereoisomeric forms of the substances listed in this category not being cathine (3), whenever the existence of such forms is possible.
The salts of the substances listed in this category, whenever the existence of such salts is possible and not being the salts of cathine.
(1R,2S)-(-)-chloroephedrine		2939 79 90	110925-64-9
(1S,2R)-(+)-chloroephedrine		2939 79 90	1384199-95-4
(1S,2S)-(+)-chloropseudoephedrine		2939 79 90	73393-61-0
(1R,2R)-(-)-chloropseudoephedrine		2939 79 90	771434-80-1
(1) OJ L 290, 28.10.2002, p. 1. (2) The CAS No is the ‘chemical abstracts service registry number’, which is a unique numeric identifier specific to each substance and its structure. The CAS No is specific to each isomer and to each salt of each isomer. It must be understood that the CAS Nos for the salts of the substances listed above will be different to those given. (3) Also named (+)-norpseudoephedrine, CN code 2939 43 00 , CAS No 492-39-7. (4) Also known as ethyl 3-oxo-2-phenylbutanoate, according to IUPAC (The International Union of Pure and Applied Chemistry). (5) Also known as methyl 2-(2H-1,3-benzodioxol-5-yl)-3-oxobutanoate, according to IUPAC. (6) And its ethyl, methyl (CAS No 80532-66-7), propyl, isopropyl, butyl, isobutyl, sec-butyl and tert-butyl esters, with the same CN code as BMK glycidic acid. (7) And its ethyl (CAS No 28578-16-7), methyl (CAS No 13605-48-6), propyl, isopropyl, butyl, isobutyl, sec-butyl and tert-butyl esters, with the same CN code as PMK glycidic acid. (8) Also known as 5-[2-(1,3-benzodioxol-5-yl)acetyl]–2,2-dimethyl–1,3-dioxane–4,6-dione, according to IUPAC (The International Union of Pure and Applied Chemistry).

CATEGORY 2