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The European Union implements the 1988 UN Convention through two regulations of the European Parliament and of the Council. These are complemented with a number of Commission delegated and implementing regulations, which set out the provisions in detail. These regulations are directly applicable in the Member States. The delegated regulations may be amended after consulting the Group of Experts on Drug Precursors, which meets regularly and is composed of expert representatives from each EU Member State. The regulations implement the 1988 UN Convention and are established to prevent the diversion of substances into illicit channels. This is an important point, which will be further mentioned in the discussion. Trade in drug precursors between the European Union and third countries is regulated through Regulation (EC) No 111/2005, as amended by Regulation (EU) No 1259/2013 (see consolidated version). The trade between EU Member States is regulated by Regulation (EC) No 273/2004, amended by Regulation (EU) No 1258/2013 (see consolidated version). Each consolidated version contains an annex, listing the substances to which the regulations apply. European Commission delegated regulations place new substances under control measures by adding them directly to the regulations. Substances brought under control in this way include chloroephedrine and chloropseudoephedrine (precursors for methamphetamine) in 2016 and NPP and ANPP (precursors for fentanyl and derivatives) in 2018. In addition, the regulations are supplemented by additional practical tools, such as ‘Guidelines for economic operators’ and e-learning courses for such operators and for customs authorities.
These regulations set out the procedures, working arrangements and limits for economic operators trading in drug precursors. The provisions include rules for obtaining and checking licences and registrations, statutory reporting obligations, import and export procedures, and the identification of anomalies or irregularities (‘suspicious transactions’).
Certain terms are defined in the EU regulations, including ‘scheduled substance’ and ‘non-scheduled substance’. A scheduled substance is one that is contained in the annex of the regulations, including any mixtures or natural products (if the scheduled substance contained therein can be easily extracted), but excluding any medicinal products containing them (apart from those in category 4 of 111/2005). A non-scheduled substance is any substance which, although not listed in the annex, is identified as having been used for the illicit manufacture of narcotic drugs or psychotropic substances.
At international level, the 1988 UN Convention lists drug precursor chemicals in two tables. Table I contain substances which can be converted readily to controlled drugs or are essential for drug manufacturing, while Table II contains other chemicals such as solvents and reagents commonly used for drug processing. The substances listed in Table I are subject to more stringent controls than those in Table II. In the EU regulations, all of the chemicals in UN Tables I and II are broken down into four categories, described below. This four-tier categorization system allows a greater flexibility in the application of controls, checks and monitoring, tailored to the needs of the European Union.
Category 1
This category contains the substances that are readily convertible to controlled drugs, and are subject to the strictest controls. Many of these are contained in Table I of the 1988 UN Convention.
*(The stereoisomeric forms of the substances listed in this category not being cathine (also known as (+)-norpseudoephedrine), 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.)
Category 2
This category contains substances that are extensively used in the chemicals industry and which are also essential for drug processing (e.g. acetic anhydride and potassium permanganate for heroin and cocaine processing). These come from Table I or Table II of the 1988 Convention.
*(The salts of the substances listed in this category whenever the existence of such salts is possible. (a) In Regulation No 273/2004 of the European Parliament and of the Council of 11 February 2004 on drug precursors, Category 2 is split in two subcategories, with acetic anhydride appearing in Category 2A and the others listed in Category 2B.)
Category 3
This category contains the reagents and solvents typically used in drug processing found in Table II of the 1988 Convention.
*(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 sulfuric acid.)
Category 4
This category relates specifically to medicinal products and veterinary medicinal products containing ephedrine, pseudoephedrine or their salts.
( Category 4 only exists in Regulation 111/2005 relating to extra-EU trade.)
All of the substances contained on the UN lists are present in the EU lists, however, some additional chemicals are regulated in the European Union — these are chemicals not present in the UN lists that have been used in illegal drug manufacture in the European Union. Beyond the scheduled substance lists, the INCB maintains a limited international special surveillance list of non-scheduled substances. In the European Union, a ‘voluntary monitoring list’ is maintained by the European Commission. If necessary, the competent authorities of the EU Member States and the Commission may propose additions to the voluntary monitoring list in order to facilitate the identification of diversion attempts and respond rapidly to new trends.
The responsibilities of economic operators trading in drug precursors are summarised in a table of the ‘Guidelines for operators’ (see Figure) produced by the European Commission.
Economic operators play a key role in preventing the diversion of drug precursors and must facilitate the identification of suspicious transactions involving all scheduled substances; this is mandatory for categories 1 to 4, and voluntary and strongly recommended for non-scheduled substances. These provisions have proven to be effective in relation to scheduled substances, to the extent that the main substances used for making amphetamine and MDMA in the European Union (BMK and PMK) are rarely encountered. Voluntary cooperation offers the necessary flexibility to quickly respond to changing trends and patterns of diversion of drug precursors.
These regulations set out the procedures, working arrangements and limits for economic operators trading in drug precursors. The provisions include rules for obtaining and checking licences and registrations, statutory reporting obligations, import and export procedures, and the identification of anomalies or irregularities (‘suspicious transactions’).
Certain terms are defined in the EU regulations, including ‘scheduled substance’ and ‘non-scheduled substance’. A scheduled substance is one that is contained in the annex of the regulations, including any mixtures or natural products (if the scheduled substance contained therein can be easily extracted), but excluding any medicinal products containing them (apart from those in category 4 of 111/2005). A non-scheduled substance is any substance which, although not listed in the annex, is identified as having been used for the illicit manufacture of narcotic drugs or psychotropic substances.
At international level, the 1988 UN Convention lists drug precursor chemicals in two tables. Table I contain substances which can be converted readily to controlled drugs or are essential for drug manufacturing, while Table II contains other chemicals such as solvents and reagents commonly used for drug processing. The substances listed in Table I are subject to more stringent controls than those in Table II. In the EU regulations, all of the chemicals in UN Tables I and II are broken down into four categories, described below. This four-tier categorization system allows a greater flexibility in the application of controls, checks and monitoring, tailored to the needs of the European Union.
Category 1
This category contains the substances that are readily convertible to controlled drugs, and are subject to the strictest controls. Many of these are contained in Table I of the 1988 UN Convention.
Substance | UN Table | Typically used to make |
1-Phenyl-2-propanone (BMK, P-2-P) | I | Amphetamine |
3,4-Methylenedioxyphenylpro-pan-2-one (PMK, MD-P-2-P) | I | MDMA |
4-Anilino-N-phenethylpiperidine (ANPP) | I | Fentanyl derivatives |
Alpha-phenylacetoacetonitrile (APAAN) | I | Amphetamine |
Chloroephedrine | - | Methamphetamine |
Chloropseudoephedrine | - | Methamphetamine |
Ephedrine | I | Methamphetamine |
Ergometrine | I | LSD |
Ergotamine | I | LSD |
Isosafrol (cis + trans) | I | MDMA |
Lysergic acid | I | LSD |
N-acetylanthranilic acid | I | Methaqualone |
Norephedrine | I | Methamphetamine |
N-phenethyl-4-piperidone (NPP) | I | Fentanyl derivatives |
Piperonal | I | MDMA |
Pseudoephedrine | I | Methamphetamine |
Safrole | I | MDMA |
Category 2
This category contains substances that are extensively used in the chemicals industry and which are also essential for drug processing (e.g. acetic anhydride and potassium permanganate for heroin and cocaine processing). These come from Table I or Table II of the 1988 Convention.
Substance | UN Table | Typically used to produce |
Acetic anhydride (a) | I | Heroin |
Phenylacetic acid | I | Amphetamine |
Anthranilic acid | I I | Methaqualone |
Piperidine | I I | Phencyclidine |
Potassium permanganate | I | Cocaine |
Category 3
This category contains the reagents and solvents typically used in drug processing found in Table II of the 1988 Convention.
Substance | UN Table | Typical use |
Hydrochloric acid | II | Reagent |
Hydrogen chloride | - | Reagent |
Sulfuric acid | II | Reagent |
Toluene | II | Solvent |
Ethyl ether | II | Solvent |
Diethyl ether | - | Solvent |
Acetone | II | Solvent |
Methylethylketone | II | Solvent |
Category 4
This category relates specifically to medicinal products and veterinary medicinal products containing ephedrine, pseudoephedrine or their salts.
Substance | UN Table | |
Medicinal products and veterinary medicinal products containing ephedrine or its salts | - | Methamphetamine |
Medicinal products and veterinary medicinal products containing pseudoephedrine or its salts | - | Methamphetamine |
All of the substances contained on the UN lists are present in the EU lists, however, some additional chemicals are regulated in the European Union — these are chemicals not present in the UN lists that have been used in illegal drug manufacture in the European Union. Beyond the scheduled substance lists, the INCB maintains a limited international special surveillance list of non-scheduled substances. In the European Union, a ‘voluntary monitoring list’ is maintained by the European Commission. If necessary, the competent authorities of the EU Member States and the Commission may propose additions to the voluntary monitoring list in order to facilitate the identification of diversion attempts and respond rapidly to new trends.
The responsibilities of economic operators trading in drug precursors are summarised in a table of the ‘Guidelines for operators’ (see Figure) produced by the European Commission.
Economic operators play a key role in preventing the diversion of drug precursors and must facilitate the identification of suspicious transactions involving all scheduled substances; this is mandatory for categories 1 to 4, and voluntary and strongly recommended for non-scheduled substances. These provisions have proven to be effective in relation to scheduled substances, to the extent that the main substances used for making amphetamine and MDMA in the European Union (BMK and PMK) are rarely encountered. Voluntary cooperation offers the necessary flexibility to quickly respond to changing trends and patterns of diversion of drug precursors.
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