Monitoring trade in drug precursors between the EU and non-EU countries

SUMMARY OF:

Regulation (EC) No 111/2005 — rules for the monitoring of trade between the EU and non-EU countries in drug precursors

WHAT IS THE AIM OF THE REGULATION?

It implements the EU’s obligations under the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, which requires measures to be taken to monitor the manufacture and distribution of drug precursors*.
It lays down measures to control and monitor trade between EU and non-EU countries.
It was amended by Regulation (EU) No 1259/2013, in particular to clarify certain definitions in the text, notably ‘scheduled substance’*, as well as the requirements of ‘users’* and ‘operators’*.
A related regulation, Regulation (EC) No 273/2004 (see summary), concerns the trade of drug precursors between EU countries.
Three delegated acts (Delegated Regulations (EU) 2015/1011, (EU) 2016/1443 and (EU) 2018/729) amending the regulation as well as one implementing act (Implementing Regulation (EU) 2015/1013) have been adopted.

KEY POINTS

The regulation distinguishes between scheduled and non-scheduled* substances.

There are 4 categories of scheduled substances in Annex I of the regulation.
- Category 1: the most sensitive substances, from which illicit drugs can be produced most easily (for example, 1-phenyl-2-propanone, piperonal).
- Category 2: less sensitive substances (subcategory 2A: acetic anhydride; subcategory 2B: phenylacetic acid, anthranilic acid, piperidine and potassium permanganate).
- Category 3: bulk chemicals which can have different types of uses in the manufacturing process (for example, acetone, hydrochloric acid).
- Category 4: since December 2013, substances covering medicinal products for human and veterinary use containing ephedrine or pseudoephedrine.

Obligations of operators

Operators must document the import, export and transit of a scheduled substance in such a way as to disclose:
- the name of the substance,
- its quantity and weight, and
- the name and address of the exporter, importer, distributor and ultimate consignee.
Operators must keep records of all transactions for a period of 3 years.

Licence for category 1 substances

Operators (other than customs agents and transporters) must obtain a licence from the competent authorities of the country in which they are established if they are engaged in import, export or intermediary activities involving category 1 substances.
Before granting a licence, the competent authorities must take into account the competence and integrity of the applicant in particular.
The licence may be suspended or revoked by the authorities whenever the conditions under which the licence was issued are no longer fulfilled or where there are reasonable grounds for suspecting that there is a risk of diversion of scheduled substances.

Registration for category 2 and category 3 substances

EU-based operators (other than customs agents and transporters) must obtain registration from the competent authorities of the EU country in which they are established if they are engaged in the import, export or intermediary activities involving category 2 substances or in the export of category 3 substances.

Notification of the authorities

Operators must:
- notify the competent authorities immediately of any circumstances, such as unusual orders or transactions involving scheduled substances, that suggest that such substances intended for import, export or intermediary activities might be diverted for the illicit manufacture of narcotic drugs or psychotropic substances;
- provide any available information allowing the competent authorities to verify the legitimacy of the abovementioned relevant order or transaction;
- provide the authorities with relevant information about their transactions involving scheduled substances, in the form of a summary.

Pre-export notification

All exports of categories 1 and 4 substances and all exports of category 2 and 3 substances to certain countries of destination require a pre-export notification to be sent from the competent authorities in the EU to the competent authorities of the country of destination, in accordance with the UN convention.
The country of destination has a period of 15 working days to reply, at the end of which the export operation may be authorised by the competent authorities of the EU country of export. This can only be if no advice from the competent authorities of the country of destination is received indicating that this export operation might be intended for the illicit manufacture of narcotic drugs or psychotropic substances.
Simplified pre-export notification procedures may be applied by the competent authorities where they are satisfied that this will not result in any risk of diversion of scheduled substances.

Export authorisation

Exports of scheduled substances that require a customs declaration must receive an export authorisation.
An authorisation is required where scheduled substances are re-exported within 10 days from the date of their placing into a suspensive procedure or under a free zone of control.
Category 3 substances are only subject to such an authorisation where pre-export notifications are required.
The regulation lists the details to be included in the application.

Import authorisation

Imports of category 1 substances require an import authorisation.
An authorisation may only be granted to an operator established in the EU.
The authorisation is issued by the competent authorities of the EU country where the importer is established.
The regulation lists the details required in the authorisation application.
The authorisation must accompany the consignment from the point of entry into the EU customs territory to the premises of the importer or ultimate consignee.

EU countries’ competent authorities — powers and obligations

EU countries must:

prohibit the introduction of scheduled substances and of consignments of non-scheduled substances into EU customs territory or their departure from it, where there is suspicion that such substances are intended for the illicit manufacture of narcotic drugs or psychotropic substances;
detain or suspend the release of the scheduled substances for the time necessary to verify their identification or compliance with this regulation;
adopt measures to enable their competent authorities, in particular:
- to obtain information on any orders for scheduled substances or operations involving scheduled substances
- to enter operators’ and users’ business premises in order to obtain evidence of irregularities
- to establish that a diversion or attempted diversion of scheduled substances has taken place;
ensure their competent authorities respect confidential business information;
lay down the rules on penalties applicable for infringing the rules and take all measures necessary to ensure that they are implemented — the penalties must be effective, proportionate and dissuasive.

European database

The European database on drug precursors set up under Regulation (EC) No 273/2004 serves to:
- simplify the procedure for EU countries to report seizures and stopped shipments;
- maintain a list of EU licensed or registered operators and users legally trading or using drug precursors;
- enable operators to provide competent authorities with information about their export, import or intermediary activities, in the form of a summary.

Implementing and delegated acts

Implementing Regulation (EU) 2015/1013 sets out rules as regards the licensing and registration of operators and users and their listing in the European database on drug precursors, the provision by operators of information required to monitor trade and the authorisation of exports and imports in the field of drug precursors.
Delegated Regulation (EU) 2015/1011:
- lays down conditions for granting licences and registrations;
- determines when a licence or registration are not required;
- establishes the criteria to demonstrate the legal/licit purpose of a transaction and for determining simplified procedures for pre-export notifications and for export authorisations;
- determines the information required to monitor trade; and
- specifies the requirements concerning the information to be provided on the implementation of the monitoring measures as regards trade in drug precursors.
Delegated Regulation (EU) 2016/1443 and Delegated Regulation (EU) 2018/729 extend the list of category 1 substances.

Repeal

The regulation repeals Regulation (EEC) No 3677/90.

FROM WHEN DOES THE REGULATION APPLY?

Regulation (EC) No 111/2005 has applied since 18 August 2005.
Amending Regulation (EU) No 1259/2013 has applied since 30 December 2013.

BACKGROUND

For more information, see:

Drug precursors control (European Commission).

KEY TERMS

Drug precursor: chemicals that are primarily used for the legitimate (legal) production of a wide range of products including medicines, plastics and cosmetics. These substances may also be misused for illegal/illicit purposes, such as the production of methamphetamines, heroin or cocaine.

Scheduled substance: any substance listed in Annex I of Regulation (EC) No 111/2005 that can be used for the illicit manufacture of narcotic drugs or psychotropic substances, including mixtures and natural products containing such substances. However, what is not included are 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 for humans as defined in Directive 2001/83/EC and veterinary medicinal products as defined in Directive 2001/82/EC.

User: a natural or legal person other than an operator (see next entry) 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.

Operator: any natural or legal person engaged in the placing on the market of scheduled substances.

Non-scheduled substance: any substance which, although not listed in Annex I of this regulation, is identified as having been used for the illicit manufacture of narcotic drugs or psychotropic substances.

MAIN DOCUMENT

Council Regulation (EC) No 111/2005 of 22 December 2004 laying down rules for the monitoring of trade between the Community and third countries in drug precursors (OJ L 22, 26.1.2005, pp. 1-10)

Successive amendments to Regulation (EC) No 111/2005 have been incorporated into the original text. This consolidated version is of documentary value only.