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Regulation of drug precursors in the European Union

HEISENBERG

Administrator
Staff member
ADMIN
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.

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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.
SubstanceUN TableTypically used to make
1-Phenyl-2-propanone (BMK, P-2-P)IAmphetamine
3,4-Methylenedioxyphenylpro-pan-2-one (PMK, MD-P-2-P)IMDMA
4-Anilino-N-phenethylpiperidine (ANPP)IFentanyl derivatives
Alpha-phenylacetoacetonitrile (APAAN)IAmphetamine
Chloroephedrine-Methamphetamine
Chloropseudoephedrine-Methamphetamine
EphedrineIMethamphetamine
ErgometrineILSD
ErgotamineILSD
Isosafrol (cis + trans)IMDMA
Lysergic acidILSD
N-acetylanthranilic acidIMethaqualone
NorephedrineIMethamphetamine
N-phenethyl-4-piperidone (NPP)IFentanyl derivatives
PiperonalIMDMA
PseudoephedrineIMethamphetamine
SafroleIMDMA
*(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.
SubstanceUN TableTypically used to produce
Acetic anhydride (a)IHeroin
Phenylacetic acidIAmphetamine
Anthranilic acidI IMethaqualone
PiperidineI IPhencyclidine
Potassium permanganateICocaine
*(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.
SubstanceUN TableTypical use
Hydrochloric acidIIReagent
Hydrogen chloride-Reagent
Sulfuric acidIIReagent
TolueneIISolvent
Ethyl etherIISolvent
Diethyl ether-Solvent
AcetoneIISolvent
MethylethylketoneIISolvent
*(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.
SubstanceUN 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
( 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.
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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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HEISENBERG

Administrator
Staff member
ADMIN
International cooperation

Drug precursors are produced all over the world. It is therefore essential that efficient and effective international cooperation is implemented to prevent their diversion to countries where drugs are produced. International cooperation on precursors is facilitated by two main online tools developed by the INCB. The first, known as the Pre-Export Notification Online (‘PEN Online’) system, was launched in March 2006 to facilitate the exchange of pre-export notifications by the country of export to the country of import. The second, launched in March 2012, is the Precursor Incident Communication System (PICS), which facilitates communication and information sharing on precursor incidents between national authorities in 110 countries. Around 35 000 pre-export notifications and 200-300 precursor incidents are communicated via these systems each year (INCB, 2019). Pre-export notifications may result in Member States preventing the supply of a chemical, if the competent authority in the receiving country is not convinced of the legitimacy of the order. This is known as a ‘stopped shipment’.
In addition to the international framework of cooperation enshrined in the 1988 UN Convention, the European Union has established closer cooperation with some third countries by concluding bilateral agreements to prevent drug precursors’ diversion through monitoring licit trade. At present, the European Union has agreements on ‘cooperation regarding the control of precursors and chemical substances frequently used in the illicit manufacture of narcotic drugs and psychotropic substances’ with 11 countries: Bolivia, Chile, China, Colombia, Ecuador, Mexico, Peru, Russia, Turkey, the United States and Venezuela. Another avenue exists in Europe for technical cooperation on the topic of drug precursors. The Council of Europe’s Pompidou Group hosts a drug precursors network, which meets on an annual basis. This network brings together experts from law enforcement, competent authorities, specialized magistrates and representatives of the European Chemical Industry Council.

Precursors for synthetic drugs produced in the European Union

The main synthetic drugs produced in the European Union — amphetamine, MDMA and methamphetamine — are produced from the scheduled precursors, BMK, PMK, ephedrine and pseudoephedrine. This section describes the alternative routes to these precursors that have been reported in the European Union.


Routes to BMK

The concept of using alternative chemicals to make scheduled drug precursors has been known for some time. In Poland, three clandestine facilities manufacturing BMK from phenylacetic acid for sale to amphetamine manufacturers were dismantled in the 2000s (Krawczyk et al., 2009). In the European Union, perhaps the first recorded example of an alternative chemical being used in an illicit laboratory was in the Netherlands in 2008, when the ‘bisulfite adduct’ of BMK was detected. Such was the importance of this finding that in its annual report on precursors of 2009, the INCB urged governments globally to exercise vigilance with regard to the possible ‘chemical masking’ of scheduled precursors for illicit purposes (INCB, 2009). Since then, the situation has been continuously evolving, with controls being introduced on new substances often followed by the emergence of alternative chemicals, presenting challenges for detection and identification and frustrating drug supply reduction efforts. Illicit laboratories converting APAAN into BMK were first detected in Europe in the 2009-11 period (Europol, 2011), with European seizures of APAAN amounting to well over 40 tonnes in 2013. APAAN was controlled in Europe in December 2013 and seizures for the next year fell to 11 tonnes. APAAN was subsequently placed in Table I of the 1988 UN Convention, effective from 6 October 2014. The response to this control was the emergence of APAA, a substance chemically related to APAAN (see Figure), which was first detected in Europe at the end of 2012 and found in so-called ‘conversion labs’ (places where precursor manufacture takes place) in the Netherlands in 2016. In 2017, a further development, possibly pre-empting the control of APAA was the appearance of MAPA (Figure). Between 2017 and August 2019 more than 10 tonnes of MAPA have been seized globally, mainly in the Netherlands. In March 2019, the Commission on Narcotic Drugs (CND) decided to add APAA to Table I of the 1988 Convention. In the same way APAA replaced APAAN to a certain degree when it was controlled, it is possible that MAPA could become the next alternative chemical of choice for producing BMK in Europe.
Whereas APAAN was rapidly brought under control in the European Union and then internationally, the glycidic derivatives of PMK and BMK, which emerged in 2010 and 2012 respectively (INCB, 2013), have not yet been subject to control measures. They have been detected in illicit drug laboratories in the European Union since 2015. It is worth noting that the glycidic derivatives of BMK are less commonly encountered than the PMK equivalents, perhaps due to the availability of APAAN, APAA and then MAPA (INCB, 2019). The scheduling of APAA in the European Union is expected in 2020.

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HEISENBERG

Administrator
Staff member
ADMIN
Routes to PMK

MDMA, commonly known as ‘ecstasy’ when found in the form of tablets, is produced primarily from PMK, which itself can be produced from piperonal and safrole (and safrole-rich oils). The global licit trade in PMK is almost non-existent. Legitimate trade of piperonal is known to be significant, whereas the licit trade in safrole and safrole-rich oils is considerably more limited. Since the 2000s, these chemicals have mainly been imported from Asia.

Seizures of safrole and safrole-rich oils and of PMK decreased considerably between 2008 and 2012, a period that coincided with the reduced availability of MDMA in Europe. While seizures of these substances in recent years have been uncommon, they have not completely disappeared; for example, more than 4 tonnes of PMK and almost 3 000 litres of safrole were seized in the Netherlands in 2017.

As mentioned earlier, PMK may be produced from alternative chemicals, such as glycidic derivatives of PMK and their salts and esters. Seizures of these substances were first detected in Europe in 2010, and for the first time found in illicit synthetic drug production laboratories in the Netherlands in 2015, perhaps as a result of the poor availability of safrole in the preceding years.

In 2014, during a survey by the INCB on the use of alternative chemicals, several governments mentioned a substance called ‘helional’ (2-methyl-3-(3,4-methylenedioxyphenyl)propanal), a precursor of MDMA and other similar substances. In May 2014, Dutch authorities reported a seizure of 800 litres of helional at a ‘clandestine warehouse’; more than 500 kilograms of APAAN was also seized from the same site (INCB, 2015), indicating that precursor developments continued to evolve and careful and continuous monitoring was essential.

Seizure data confirm that, as noted above, the glycidic derivatives of PMK are the most common alternative substances used to produce PMK in the European Union.

In 2017, a seizure of ‘3,4-methylenedioxyphenylacetonitrile’ was made in France. This substance is to PMK what APAAN is to BMK, clearly demonstrating the interplay between the alternative chemicals used to produce drug precursors for illicit drug manufacture.

The CND decided in March 2019 to add glycidic derivatives of PMK to Table I of the 1988 Convention (at the same time as the decision to control APAA).
 
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HEISENBERG

Administrator
Staff member
ADMIN
Routes to ephedrine

Ephedrine and pseudoephedrine and are internationally controlled drug precursors. They are the main precursors used for production of methamphetamine in Czech, Bulgaria, Germany, Poland and Slovakia. Production based on ephedrine and pseudoephedrine results in d-methamphetamine (‘crystal meth’ or ‘ice’). Ephedrine and pseudoephedrine can be extracted from medicines, and some EU Member States such as the Czech, and more recently Germany and Poland, have implemented national restrictions on the sale of such medicines. In these Member States, sales are restricted to small packet sizes sold under the supervision of a pharmacist. However, there is no harmonized approach to this at EU level, and the sale of medicines containing ephedrine or pseudoephedrine is not restricted in all Member States. This has given rise to the trafficking of such medicines from outside the European Union or from EU Member States with less restrictive sales regimes to Member States where methamphetamine production takes place.

In an apparently isolated case in Czech in 2014, ephedrine was found to be produced via a novel method using l-PAC, which can be synthesized relatively easily from a specially modified yeast, dextrose and benzaldehyde.

Chloroephedrine is also a precursor for the production of d-methamphetamine. Multi-tonne quantities of this precursor were discovered during law enforcement operations in Czech and Germany, also in 2014. Chloroephedrine is a chemical intermediate, produced as part of the methamphetamine synthesis process, and has no licit use. Since July 2016, both chloroephedrine and chloropseudoephedrine have been scheduled as drug precursors in the European Union.

The alternative chemicals used to produce ephedrine do not seem to have gained traction in methamphetamine production in Europe, perhaps due to the availability of alternative substances or the rapid response from the regulatory system. However, these developments strongly suggest that illicit synthetic drug producers perform their own research and development activities in order to keep ahead of the regulations.
 
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HEISENBERG

Administrator
Staff member
ADMIN
‘Precursor-free’ route

A recent and significant drug precursor development in the European Union is the use of non-scheduled substances that can be converted into illicit drugs without the need to involve the typical drug precursor at all. These are created by producing the drug and then making a derivative that is easily converted back to the drug. The number of these cases detected and reported to date has been low. Their existence, however, points to a concerning new and potentially important development in the precursor field. Although technically these substances may be considered as precursors, they are fundamentally different from all other precursors as they contain the full illicit drug molecule with a chemical group attached, rendering it a different chemical entity and therefore outside the international control regimes for illicit drugs and drug precursors. This is another example of innovative chemical development by illicit drug producers, using what are known in organic chemistry as protection/de-protection techniques. Using these techniques minimises the risks associated with the international trafficking of illicit drugs and drug precursors.

This method was first documented in Europe in December 2016, when N-t-BOC-MDMA and N-methoxycarbonyl-MDA were detected in the Netherlands. Using a rudimentary process of heating in acidic conditions for a relatively short time, these substances are readily converted to the illicit drugs MDMA and MDA, respectively. According to the INCB, the first detection of N-t-BOC-MDMA was in Australia in 2015. The corresponding methamphetamine derivative, N-t-BOC-methamphetamine was subsequently identified in China in 2015 and in New Zealand in January 2017, where it was found in a consignment imported from China (INCB, 2018). N-t-BOC-methamphetamine has not been detected in Europe (as of August 2019).
 
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