Tag Archives: Psychotropic substance

Narcotic drugs and psychotropic substances: internal aspects

Outline of the Community (European Union) legislation about Narcotic drugs and psychotropic substances: internal aspects

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These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

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Narcotic drugs and psychotropic substances: internal aspects

1) Objective

To prevent the manufacture of narcotic drugs and psychotropic substances legitimately marketed in the Community from being diverted for illicit purposes.

2) Document or Iniciative

Council Directive 92/109/EEC of 14 December 1992 on the manufacture and the placing on the market of certain substances used in the illicit manufacture of narcotic drugs and psychotropic substances [Official Journal L 370, 19.12.1992].

3) Summary

The Directive distinguishes two types of precursor: those with limited use for licit purposes, and those of essential importance for legitimate commercial use.

The Directive defines “scheduled substance”, “placing on the market”, “operator”, “UN Convention” and “International Narcotics Control Board”.

The Directive lays down requirements in respect of documentation, records and labelling. It guarantees the competent authorities access to documents and records for verification purposes.

Member States must designate a competent authority in order to ensure proper application of the Directive. The Directive also requires intra-Community cooperation between the competent authorities.

Member States are to take all appropriate measures to encourage operators to notify the competent authorities of all unusual orders or transactions relating to scheduled substances which show that the substances which are to be placed on the market or manufactured are likely to be used in the illicit manufacture of narcotic drugs or psychotropic substances. Likewise, the Member States shall encourage all persons who suspect, from information obtained by reason of their professional duties, that scheduled substances which have been, or are about to be, placed on the market or manufactured are likely to be used for the illicit manufacture of narcotic drugs or psychotropic substances, to inform the competent authorities thereof.

With regard to the control measures, the Directive confers on the competent authorities powers of inspection, search and seizure. The competent authorities may prohibit the placing on the market or manufacture of scheduled substances if they believe that these substances are ultimately destined for the illegal manufacture of narcotic drugs or psychotropic substances.

An annual report drawn up by the Commission will be submitted to the International Narcotics Control Board. The report will provide information on the amounts of scheduled substances seized, the methods of diversion and illicit manufacture, any substances identified as having being used in illicit manufacture of narcotic drugs or psychotropic substances, and the nature and origin of processing equipment seized.

Act	Date of entry into force	Final date for implementation in the Member States
Directive 92/109/EEC	01.07.1993	01.07.1993

4) Implementing Measures

Regulation (EC) No 1485/96 [Official Journal L 188 of 27.7.1996]
Commission Regulation of 26 July 1996 setting out the conditions for implementing Council Directive 92/109/EEC with regard to customer declarations which specify the uses of certain substances used in the illicit manufacture of narcotic drugs and psychotropic substances.
According to this Regulation, a customer who purchases a classified substance falling within categories 1 or 2 in Annex I to Directive 92/109/EEC must complete a declaration on his supplier’s premises that specifies the use(s) of that substance. The Regulation also provides that a specific declaration shall be drawn up which covers multiple transactions in the substances falling within category 2.

This Regulation was amended by:

Commission Regulation No 1533/2000 of 13 July 2000 [Official Journal L 175 of 14.07.2000]

This Regulation amends the model declarations of use in respect of individual and multiple transactions, and establishes a uniform model for all operators so as to facilitate the monitoring of these declarations by the Member State authorities.

Recommendation [Official Journal C 114 of 15.05.2002]

Council Recommendation of 25 April 2002 on the need to enhance cooperation and exchanges of information between the various operational units specialising in combating trafficking in precursors in the Member States of the European Union.

Full text of the recommendation

Amendments to the Annexes to the Directive:

Directive 2003/101/EC [Official Journal L 286 of 04.11.2003]

This Directive replaces Annexes I and II of the basic directive on 1 January 2004.

5) Follow-Up Work

On 23 January 1998, the Commission presented a proposal for a European Parliament and Council Directive amending Council Directive 92/109/EEC on the manufacture and the placing on the market of certain substances used in the illicit manufacture of narcotic drugs and psychotropic substances [COM(98) 22 final – Official Journal C 108 of 07.04.1998].

Co-decision procedure (COD/1998/17)

First reading: on 20 November 1998, the European Parliament approved the Commission proposal subject to certain amendments. The Commission accepted most of these amendments.

The Commission presented an amended proposal on 28 April 1999. [COM(99) 202 final – Official Journal C 162 of 09.06.1999]

This proposal was withdrawn by the Commission and replaced by:

Proposal for a European Parliament and Council regulation on drug precursors [COM(2002) 494 final – Official Journal C 20 E of 28.01.2003].

This proposal aims to transform Directive 92/109/EEC into a Regulation, in order to simplify the legislation and make it more user-friendly both for economic operators and for the competent authorities in the Member States. The purpose of the new Regulation is to establish harmonised measures for controlling and monitoring certain chemical substances frequently used in the manufacture of illicit narcotic drugs. It contains rules on licensing, customer declarations and labelling. A monitoring procedure will prevent barriers to the free trade of these substances arising between Member States.

Co-decision procedure (COD/2002/0217)

On 26 February 2003, the Economic and Social Committee gave its opinion. [Official Journal C 95 of 23.04.2003]

On 11 March 2003, the European Parliament approved the Commission proposal subject to certain amendments. The Commission accepted some of these amendments.

On 19 May 2003, the Council reached a political agreement on its common position.

On 27 May 2003, la Commission adopted an amended proposal [COM(2003) 304 final – not yet published in the Official Journal].

On 29 September 2003, the Council adopted the common position [Official Journal L 277 E of 18.11.2003].

On 7 October 2003, the Commission stated its agreement with the Council’s common position.

The common position is currently before Parliament for its second reading.

Stronger control measures for the synthetic drug BZP

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Stronger control measures for the synthetic drug BZP

Outline of the Community (European Union) legislation about Stronger control measures for the synthetic drug BZP

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Justice freedom and security > Combating drugs

Stronger control measures for the synthetic drug BZP

Document or Iniciative

Council Decision 2008/206/JHA of 3 March 2008 on defining 1-benzylpiperazine (BZP) as a new psychoactive substance which is to be made subject to control measures and criminal provisions.

Summary

BZP (1-Benzylpiperazine) is a new psychoactive substance that acts as a stimulant on the central nervous system. It a purely recreational drug, with no established or recognised medical value, which is sold over the Internet and at ‘herbalists’ and ‘smart shops’.

The risks associated with the ingestion of this substance are still little known. That is why the Commission asked the Council – on the basis of a joint European Monitoring Centre for Drugs and Drug Addiction EMCDDA / Europol report – to measure its health and social risks via a risk assessment based on Council Decision 2005/387/JHA on the information exchange, risk-assessment and control of new psychoactive substances.

The BZP risk assessment exercise produced the following results: 13 Member States and Norway have reported seizures of BZP in quantities from 1 to 64 900 tablets. There is no evidence of an organised crime link.

BZP is a psychoactive substance. The risks associated with its use may include:

increased heart rate;
raised blood pressure;
restlessness and hyperactivity.

It may also have secondary effects, in the ‘down’ phase, that can last for up to 24 hours after the drug was taken. These can include:

vomiting and nausea;
headache and stomach ache;
loss of appetite;
anxiety and insomnia;
mood swings and irritability;
strange thoughts;
confusion;
palpitations and trembling.

The effects of using BZP are still largely unproven. Although clinical reports tend to establish a link between BZP and seizures, this conclusion is based on a very small number of cases, in which moreover the BZP was detected in post mortem specimens and its role in the death could not be determined since other factors were involved.

The risk assessment report reveals the lack of conclusive scientific proof establishing the global risks of this new substance. To be on the safe side, however, given that it does represent a health risk, it would be wise to make it subject to control and to take appropriate measures.

Final provisions

The Member States are required to make BZP subject to the control measures and criminal penalties provided under their national laws in accordance with the obligations imposed by the 1971 United Nations Convention on psychotropic substances.

Background

A number of initiatives have already been taken. The EMCDDA risk assessment concluded that the use of BZP can result in health problems whose long-term effects are still unknown. Based on this finding, the Commission wants to have BZP made subject to control measures, as provided by the UN Convention on psychotropic substances. This proposal also takes account of the data that have been collected as a result of the new psychoactive substances risk assessment procedure.

Council Decision 2005/387/JHA of 10 May 2005 provides for a three-step procedure for placing this type of substance under control. The first step is to draw up a report collating all available information on BZP. This assessment was carried out by the EMCDDA and Europol before being submitted to the Council on 22 February 2007. The Council responded by asking for a more extensive study of the risks associated with BZP, to be conducted by:

the extended scientific committee of the EMCDDA;
the Commission;
Europol;
the European Medicines Agency (EMEA).

References

Act	Entry into force – Date of expiry	Deadline for transposition in the Member States	Official Journal
Decision 2008/206/JHA	8.3.2008	–	OJ L 63 of 7.3.2008

Related Acts

Council Decision 2005/387/JHA of 10 May 2005 on the information exchange, risk-assessment and control of new psychoactive substances [Official Journal L 127 of 20.5.2005].

Drug precursors: external aspects

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Drug precursors: external aspects

Outline of the Community (European Union) legislation about Drug precursors: external aspects

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Internal market > Single Market for Goods > Single market for goods: external dimension

Drug precursors: external aspects

Document or Iniciative

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.

Summary

This regulation lays down rules for the monitoring of trade in precursor drugs between the European Union (EU) and non-EU countries. Drug precursors refer to substances used for the illicit manufacture of narcotic drugs and psychotropic substances. The regulation applies to imports, exports and transit of drug precursors with a view to preventing their diversion.

The aim of current legislation in this area is to apply Article 12 of the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, adopted in Vienna on 19 December 1988, which concerns trade in such substances.

Historically, the EU has been a significant exporter of precursors and an importer of illicitly manufactured drugs. Recently, the EU has also become one of the leading exporters of illicitly manufactured synthetic drugs and an importer of the precursors needed to manufacture them. Consequently, the provisions relating to the application for a licence to import or export drug precursors, the granting or refusal of such a licence and its suspension or revocation must be harmonised at EU level.

Given the magnitude of the trade in precursor drugs, current legislation in this area must be modernised. The new procedures are aimed at the most sensitive drug precursors so as not to place an excessive administrative burden on legitimate importers.

Trade monitoring

The purpose of this regulation is to:

introduce import and export authorisation requirements for the drug precursors concerned;
require all operators to label and properly document drug precursors;
require that all operators be licensed;
make sure that all drug precursor consignments are inspected in the EU;
strengthen import and export controls;
conduct special controls at EU level in areas where the risk of diversion is high, such as free zones and transhipment zones.

The import, export and transit of a substance listed in the annex to this regulation must be documented 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 the ultimate consignee. The operators concerned must keep records of all transactions for a period of three years.

These operators must be licensed and registered as such by the competent authorities of the country in which they are established.

EU countries are responsible for establishing cooperation between operators and the competent authorities to enable the latter to prevent diversions from occurring. To this end, operators must transmit to the competent authorities all relevant information and notify them of all transactions involving scheduled substances.

In addition, operators must lodge an application for an import or export authorisation in respect of each transaction with the competent authorities of the EU country in which the importer or exporter is established. Applications for authorisations must contain full information on the transport arrangements, the name and address of all operators involved, and the nature, quantity and weight of the substance. The competent authorities must reach a decision within 15 working days from the completion of the application file.

If there are grounds for suspecting that diversion might occur, the competent authorities may refuse the import or export of the substance.

A similar procedure applies to non-EU countries having requested the Commission to inform them of any export of substances that concerns them or that have concluded an agreement with the EU on the issuing of import authorisations. A specific procedure applies to countries identified as sensitive as regards the possible diversion of certain scheduled substances.

EU countries are responsible for providing their competent authorities with the means to obtain information and conduct enquiries in order to prevent diversion from occurring.

Mutual assistance and confidentiality between the administrations of EU countries is essential. EU countries determine appropriate penalties for infringements. Each year they communicate to the Commission the results of their monitoring measures, on the basis of which the Commission draws up an annual report to be submitted to the International Narcotics Control Board.

The Commission prepares guidelines for the chemical industry. These will include information on how to recognise and report suspicious transactions and an updated list of non-scheduled substances used to illicitly manufacture narcotic drugs and psychotropic substances.

Background

Following the adoption of the 2000-04 EU action plan on drugs, the Commission organised an assessment of the control system of trade in drug precursors. It considered it necessary to extend monitoring requirements to operators trading with non-EU countries, to introduce a common approach to procedures for granting licences and to strengthen customs monitoring requirements. Consequently, this regulation replaces Regulation (EEC) No 3677/90, which originally laid down measures to discourage the diversion of drug precursors.

References

Act	Entry into force	Deadline for transposition in the Member States	Official Journal
Regulation (EC) No 111/2005	15.2.2005	–	OJ L 22 of 26.1.2005

Related Acts

Report from the Commission to the Council and the European Parliament of 7 January 2010 pursuant to Article 16 of Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004 and to Article 32 of Council Regulation (EC) No 111/2005 on the implementation and functioning of the Community legislation on monitoring and control of trade in drug precursors [COM(2009) 709 final – Not published in the Official Journal].
This report evaluates the implementation as well as the functioning of Regulations (EC) Nos 111/2005 (above) and 273/2004.
Based on data received form EU countries, the Commission’s evaluation concludes that the legal framework for controlling trade generally provides measures that are proportionate for preventing the diversion of drug precursors without obstructing their legitimate trade. The well-functioning cooperation between operators and competent authorities has greatly contributed to this. Furthermore, the EU guidelines for the chemical industry, together with a new eLearning course for economic operators, complements well this legal framework.
EU countries have applied the common licensing system for category 1 precursors satisfactorily and it functions effectively for the competent authorities as well as for the industry. However, the registration requirement for category 2 precursors might have certain weak points for properly controlling, and preventing diversion in the trade of these substances. In addition, certain provisions (e.g. relating to customer declarations or criteria for determining mixtures) are interpreted differently by EU countries. Other difficulties concern the insufficient rate of reporting by operators to competent authorities and certain aspects of the legislation on external trade, such as inflexible time limits for pre-export notifications and lack of simplified authorisation procedures.
Consequently, the report makes the following recommendations:

enhance the harmonised application of the legislative framework by EU countries, especially by sharing best practice;
improve reporting, for example by increasing the frequency with which operators must report to competent authorities;
possibly modify existing legislation to strengthen controls on category 2 precursors;
strengthen controls on pharmaceutical preparations/medicinal products containing ephedrine or pseudo-ephedrine that transit through the EU;
modify the procedural requirements to achieve a level of controls that is proportionate to the risk of diversion.

Commission Regulation (EC) No 1277/2005 of 27 July 2005 laying down implementing rules for Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug precursors and for Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade in drug precursors between the Community and third countries [Official Journal L 202 of 03.08.2005].
The regulation lays down implementing rules concerning the responsible officer, the licensing and registration of operators, the provision of information, pre-export notifications and export and import authorisations in the area of drug precursors.

Information exchange, risk assessment and control of new psychoactive substances

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Information exchange, risk assessment and control of new psychoactive substances

Outline of the Community (European Union) legislation about Information exchange, risk assessment and control of new psychoactive substances

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Justice freedom and security > Combating drugs

Information exchange, risk assessment and control of new psychoactive substances

Document or Iniciative

Council Decision 2005/387/JHA of 10 May 2005 on the information exchange, risk-assessment and control of new psychoactive substances.

Summary

The decision establishes a mechanism for a rapid exchange of information on new psychoactive substances. It repeals Joint Action 97/396/JHA, which concerned only new synthetic drugs. The Commission’s evaluation of the joint action of 1997, provided for by the European Action Plan to Combat Drugs (2000-04), showed that it should be strengthened and given a new direction.

The decision takes note of the information on the suspected adverse reactions to be notified under the pharmacovigilance system established by Title IX of Directive 2001/83/CE. It also provides for an assessment of the risks which these new psychoactive substances contain, so that supervisory measures may be applied.

It applies to substances not currently listed in any of the schedules to the 1961 United Nations Single Convention on Narcotic Drugs, which may pose a comparable threat to public health as the substances listed in Schedule I or II or IV thereof, and the 1971 United Nations Convention on Psychotropic Substances, which may pose a comparable threat to public health as the substances listed in Schedule I or II or IV thereof.

Each European Union (EU) country shall ensure that its Europol National Unit and its representative in the European Information Network on Drugs and Drug Addiction (Reitox) provide information on the manufacture, traffic and use of new psychoactive substances and of preparations containing new psychoactive substances.

Europol and the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) collect the information received from EU countries through a reporting form and communicate this information immediately to each other and to the Europol national units, the EU countries’ representatives in the Reitox network, the European Commission and the European Agency for the Evaluation of Medicinal Products (EMEA).

If necessary, in light of the information supplied by EU countries, Europol and the EMCDDA may submit a joint report containing, among other things, information on the involvement of organised crime in the manufacture or trafficking of the new psychoactive substance, a first indication of the risks associated with the new psychoactive substance, including the health and social risks, and the characteristics of users, the date of notification of the new psychoactive substance to the EMCDDA or to Europol, etc.

The EMEA informs Europol and the EMCDDA whether in the EU or in any EU country:

the new psychoactive substance has obtained a marketing authorisation;
the substance is the subject of an application for a marketing authorisation;
a marketing authorisation that had been granted in respect of the new psychoactive substance has been suspended.

The Council, taking into account the advice of Europol and the EMCDDA, may request an assessment of the health and social risks caused by the use of, the manufacture of, and traffic in, a new psychoactive substance, the involvement of organised crime and the possible consequences of control measures.

The risk assessment report includes the physical and chemical description of the new psychoactive substance, the health and social risks associated with the new psychoactive substance and the chemical precursors that are used for the manufacture of the substance, etc.

No risk assessment is carried out on a new psychoactive substance in the absence of a Europol/EMCDDA joint report or where the new psychoactive substance concerned is at an advanced stage of assessment within the United Nations system, namely once the WHO expert committee on drug dependence has published its critical review together with a written recommendation. No assessment is carried out if the new psychoactive substance is used to manufacture a medicinal product that is the subject of an authorisation or an authorisation request. There is no assessment either if the new psychoactive substance is used to manufacture a medicinal product for which a marketing authorisation has been suspended.

Within six weeks from the date on which it received the risk assessment report, the Commission will present to the Council an initiative to have the new psychoactive substance subjected to control measures. If the Commission deems that it is not necessary to undertake this initiative, it may be presented to the Council by one or more EU countries.

If the Council decides to submit a new psychoactive substance to control measures, EU countries will endeavour to take the necessary measures to submit the new psychotropic drug to control measures and criminal penalties as provided under their legislation by virtue of their obligations under the 1971 United Nations Convention on Psychotropic Substances and the 1961 United Nations Single Convention on Narcotic Drugs.

The EMCDDA and Europol report annually to the European Parliament, the Council and the Commission on the efficacy and achievements of the system created by this decision.

EU countries and the EMEA ensure an appropriate exchange of information between the mechanism set up by means of this decision and the pharmacovigilance systems as defined and established under Title VII of Directive 2001/82/EC and Title IX of Directive 2001/83/EC.

References

Act	Entry into force	Deadline for transposition in the Member States	Official Journal
Decision 2005/387/JHA	10.5.2005	–	OJ L 127, 20.5.2005