The trade of drug precursors cannot be prohibited, as they have a wide range of legitimate uses in various industrial processes and in the manufacture of different products (medicinal products, perfumes, plastics, cosmetics etc). Both at international and at EU level, specific regulatory frameworks have been put in place to ensure that diversion of drug precursors is prevented through control of their legitimate trade at EU borders and in the internal market. The legislation aims to strike a balance between the necessary control to prevent diversion of drug precursors and allowing their legitimate trade without creating unnecessary administrative burdens.
At EU level 28 drug precursors are "scheduled" (controlled) and they are divided into four categories:
Table 1. Categories of drug precursors
CATEGORY 1
Substance |
CN designation (if different) |
CN code (1) |
CAS No (2) |
|
1-phenyl-2-propanone (BMK) | Phenylacetone | 2914 31 00 | 103-79-7 | |
▼M5 | 3,4-Methylenedioxy-Phenylpropan-2-one (PMK) | 2918 30 00 | 16648-44-5 | |
▼M6 | Ethyl alpha-phenylacetoacetate (EAPA) (4) | Ex 2918 30 00 | 5413-05-8 | |
▼M5 | Methyl 2-methyl-3-phenyloxirane-2-carboxylate (BMK methyl glycidate) | 2918 99 90 | 80532-66-7 | |
2-methyl-3-phenyloxirane-2- carboxylic acid (BMK glycidic acid) | 2918 99 90 | 25547-51-7 | ||
▼B | N-acetylanthranilic acid | 2-acetamidobenzoic acid | 2924 23 00 | 89-52-1 |
▼M5 |
Alpha-phenylacetoacetamide (APAA) |
2924 29 70 | 4433-77-6 | |
Alpha-phenylacetoacetonitrile (APAAN) | 2926 40 00 | 4468-48-8 | ||
▼B | 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 | ||
▼M5 |
Methyl 3-(1,3-benzodioxol-5- yl)-2-methyloxirane-2- carboxylate (PMK methyl glycidate) |
2932 99 00 | 13605-48-6 | |
▼M6 |
6 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 |
▼M5 |
3-(1,3-benzodioxol-5-yl)-2- methyloxirane-2-carboxylic acid (PMK glycidic acid) |
2932 99 00 | 2167189-50-4 | |
▼M4 |
4-anilino-N-phenethylpiperidine (ANPP) |
2933 39 99 | 21409-26-7 | |
N-phenethyl-4-piperidone (NPP) | 2933 39 99 | 39742-60-4 | ||
▼B |
Ephedrine |
2939 41 00 | 299-42-3 | |
Pseudoephedrine |
2939 42 00 | 90-82-4 | ||
Norephedrine |
||||
Ergometrine | ||||
Ergotamine | ||||
Lysergic acid | ||||
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. | ||||
▼M3 |
(1R,2S)-(-)-chloroephedrine |
►M5 2939 79 90 ◄ | 110925-64-9 | |
(1S,2R)-(+)-chloroephedrine |
►M5 2939 79 90 ◄ | 1384199-95-4 | ||
(1S,2S)-(+)-chloropseudoephedrine |
►M5 2939 79 90 ◄ | 73393-61-0 | ||
(1R,2R)-(-)-chloropseudoephedrine |
►M5 2939 79 90 ◄ | 771434-80-1 | ||
▼B (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. |
CATEGORY 2
SUBCATEGORY 2A
Substance |
CN designation (if different) |
CN code (1) |
CAS No (2) |
|
▼M5 | Red phosphorus | 2804 70 00 | 7723-14-0 | |
▼M2 | Acetic anhydride | 2915 24 00 | 5108-24-7 | |
The salts of the substances listed in this category, whenever the existence of such salts is possible. | ||||
2-methyl-3-phenyloxirane-2- carboxylic acid (BMK glycidic acid) | 2918 99 90 | 25547-51-7 |
SUBCATEGORY 2B
Substance |
CN designation (if different) |
CN code (1) |
CAS No (2) |
|
Phenylacetic acid | 2916 34 00 | 103-82-2 | ||
Anthranilic acid | ►M5 ►C1 2922 43 00 ◄ ◄ | 118-92-3 | ||
▼M2 | Piperidine | 2933 32 00 | 110-89-4 | |
Potassium permanganate | 2841 61 00 | 7722-64-7 | ||
The salts of the substances listed in this category, whenever the existence of such salts is possible | ||||
(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. |
CATEGORY 3
Substance |
CN designation (if different) |
CN code (1) |
CAS No (2) |
|
Hydrochloric acid | Hydrogen chloride | 2806 10 00 | 7647-01-0 | |
Sulphuric acid | ►M5 2807 00 00 ◄ | 7664-93-9 | ||
Toluene | 2902 30 00 | 108-88-3 | ||
Ethyl ether | Diethyl ether | 2909 11 00 | 60-29-7 | |
Acetone | 2914 11 00 | 67-64-1 | ||
Methylethylketone | Butanone | 2914 12 00 | 78-93-3 | |
The salts of the substances listed in this category, whenever the existence of such salts is possible and not being the salts of hydrochloric acid and sulphuric acid. | ||||
(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. |
Who controls the handling of drug precursors?
In order to prevent illicit drug manufacture from drug precursors their handling is internationally controlled and regulated.
In the European Union the competent authorities responsible for the control of drug precursor handling are customs, police and public health agencies. They work in close cooperation with industry, as this is a core element of international drug precursor control.
In Estonia the competent authority responsible for the supervision of the legal trade of drug precursors is the State Agency of Medicines, we issue the licences and registrations for handling precursors, import and export authorisations, collect and submit annual data on the trade of drug precursors and regularly inspect the handlers to determine that they are conducting their trade in compliance with legislation. Cases of illicit handling and trade are managed by Estonian Police and Border Guard Board and Tax and Customs Office.
What are the handling requirements of drug precursors?
The requirements for handling drug precursors depend on the category of any specific substance and the purpose of the handling. The main types of handling are as follows:
Placing on the market - any supply, whether in return for payment or free of charge, of drug precursors in the EU; or the storage, manufacture, production, processing, trade, distribution or brokering of them for the purpose of supply in the EU
Import - any entry of drug precursors having the status as non-EU goods into the customs territory of the Community, including temporary storage, the placing in a free zone or free warehouse, the placing under a suspensive procedure and the release for free circulation
Export - any departure of drug precursors from the customs territory of the EU, including the departure of drug precursors that requires a customs declaration and the departure of them after their storage in a free zone of control type I or free warehouse
Intermediary activities - any activity to arrange purchase and sale or supply of drug precursors carried out by any natural or legal person who aims to obtain agreement between two parties or to do so through acting on behalf of at least one of these parties without taking these substances into its possession or taking control of the carrying out of such transaction; this definition also includes any activity carried out by any natural or legal person established in the Community involving purchase and sale or supply of drug precursors without these substances being introduced into the Community customs territory;
Special licence and special registration: depending on the specific drug precursor and the purpose of the handling, the companies handling drug precursors have to obtain a special licence or register themselves. Check from this scheme wheter a licence or registration is required.
Import and export authorisations: depending on the specific drug precursor, purpose of the handling and amount handled, the companies handling drug precursors have to obtain an export or import authorisation. Check from this scheme whether an import or export authorisation is required.
Please note that state fees apply for the applications for a special licence and for an export authorisation.
Appoint a responsible officer. In order to place on the market category 1 and 2 substances and in order to obtain a licence/registration to handle drug precursors the operator shall appoint an officer responsible for the trade in drug precursors.
Documentation. All transactions leading to the placing on the market of category 1 and 2 drug precursors must be properly documented. This includes invoices, cargo manifests, administrative documents, transport and other shipping documents that must contain information on the drug precursor, the name quantity and weight of the drug precursor and on all parties to the transaction. The documentation and records shall be kept for at least three years from the end of the calendar year in which the transaction.
Customer declaration. Any operator that holds a licence/registration who supplies a customer with category 1 and 2 drug precursors, shall obtain a declaration from the customer which shows the specific use or uses of the scheduled substances.
Labelling. Operators shall ensure that labels are affixed on any packaging containing drug precursors indicating their name and CN code, or, in the case of a mixture or a natural product, its name and the name of any drug precursor contained in the mixture or in the natural product. Operators may, in addition, affix their customary labels.
Notification on suspicious transactions. Operators handling drug precursors must notify the State Agency of Medicines of any suspicious transactions concerning drug precursors, including unusual orders and other types of transactions that may indicate that drug precursors may be diverted from the legal supply chain in order to produce illicit drugs. In case of suspicion, please submit at least the name and the quantity and weight of the drug precursor and other relevant details of the transaction.
Annual reports on the handling of category 1 and 2 drug precursors must be submitted by 15th of February each calendar year. Please submit the annual reports in electronic form and signed digitally to email address [email protected].
Last updated: 03.11.2022