Article 1 Scope and objectives
This Regulation establishes harmonised measures for the intra-Community control and monitoring of certain substances frequently used for the illicit manufacture of narcotic drugs or psychotropic substances with a view to preventing the diversion of such substances.
Amendment rationale: CONTEXT OF THE PROPOSAL General Context Many chemicals are used in a wide variety of important industrial processes (e.g. in the synthesis of plastics, pharmaceuticals, cosmetics, perfumes, detergents and aromas) and they are traded for these licit uses on regional and global markets. Some of these chemicals can, however, be misused for the illicit manufacture of narcotic drugs and psychotropic substances. The chemicals produced for a licit purpose which can be misused in the illegal drug production are called drug precursors. Drug precursors are rarely produced by the criminals that intend to use them in the illicit manufacture of drugs, as their production often requires important industrial infrastructure. Therefore, criminals try to divert these substances from the licit trade. The trade in drug precursors is not in itself prohibited because of their important legitimate uses. However, in order to prevent their diversion to illicit drug production, a specific regulatory framework has been set up on international level through Article 12 of the United Nations Convention against the Illicit Traffic in Narcotic Drugs and Psychotropic Substances (hereafter referred as UN 1988 Convention). The European Union is a Party to the Convention and has implemented its obligations through Regulation (EC) No 273/2004 governing the monitoring of the intra-EU trade in drug precursors and Regulation (EC) No 111/2005 governing the external trade. The Union regulatory framework provides for the monitoring and control of the legitimate trade in drug precursors. Operators, i.e. manufacturers, distributors, brokers, importers, exporters and wholesalers of chemicals engaged in the legitimate trade of drug precursors are required to take measures against theft, check their customers, detect suspicious transactions and notify the authorities thereof. This industry-authority partnership is key to the well functioning of the regulatory framework. Public authorities monitor that companies dealing with drug precursors properly exercise their obligations under the legislation by conducting on-site inspections and via administrative procedures such as granting licences and registrations. Grounds for and objectives of the proposal Traffickers purchase the drug precursors they need from different regions of the world and exploit weaknesses of control to their benefit. This proposal aims to address a specific weakness which has been detected in the European Union, when large quantities of acetic anhydride ("AA"), the main drug precursor for heroin, were diverted from the EU-internal trade: in 2008, 75% of the global seizures of AA happened in the EU. Heroin use has been contributing to public health problems in Europe since the 1970s. It still accounts for the greatest share of morbidity and mortality-related drug use in the European Union. Even though the quantities of AA seized in the EU have decreased very substantially since 2008, the INCB[1] continues to mention in its annual reports that the European legislative control measures are not sufficiently strict to prevent the diversion of the main heroin precursor from the intra-EU trade. On 7 January 2010, the European Commission adopted a Report on the implementation and functioning of the existing EU legislation on drug precursors[2] which concluded that the legislation is overall functioning well but also identified some weaknesses and made recommendations how to address these[3]. This proposal addresses, by amending Regulation (EC) No 273/2004, the recommendation of the Commission Report to improve the prevention of the diversion from the EU-internal trade of AA, the main drug precursor for heroin, by extending the registration requirement, which so far applies only to operators placing AA on the market, to also include users of the substance and by enhancing the harmonised registration provisions to achieve a more robust level playing field preserving the internal market and avoiding adoption of divergent national measures.
Revised version (Article 1 Scope and objectives):
This Regulation establishes harmonised measures for the intra-Union control and monitoring of certain substances frequently used for the illicit manufacture of narcotic drugs or psychotropic substances with a view to preventing the diversion of such substances.
Article 2 Definitions
For the purposes of this Regulation the following definitions shall apply: (a) ‘scheduled substance’ means any substance listed in Annex I, including mixtures and natural products containing such substances. This excludes medicinal products as defined by Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use ( 13 ), pharmaceutical preparations, mixtures, natural products and other preparations containing scheduled substances that are compounded in such a way that they cannot be easily used or extracted by readily applicable or economically viable means; (b) ‘non-scheduled substance’ means any substance which, although not listed in Annex I, is identified as having been used for the illicit manufacture of narcotic drugs or psychotropic substances; (c) ‘placing on the market’ means any supply, whether in return for payment or free of charge, of scheduled substances in the Community; or the storage, manufacture, production, processing, trade, distribution or brokering of these substances for the purpose of supply in the Community; (d) ‘operator’ means any natural or legal person engaged in the placing on the market of scheduled substances; (e) ‘International Narcotics Control Board’ means the Board established by the Single Convention on Narcotic Drugs, 1961, as amended by the 1972 Protocol; (f) ‘special licence’ means a licence that is granted to a particular type of operator; (g) ‘special registration’ means a registration that is made for a particular type of operator.
Amendment rationale: CONTEXT OF THE PROPOSAL General Context Many chemicals are used in a wide variety of important industrial processes (e.g. in the synthesis of plastics, pharmaceuticals, cosmetics, perfumes, detergents and aromas) and they are traded for these licit uses on regional and global markets. Some of these chemicals can, however, be misused for the illicit manufacture of narcotic drugs and psychotropic substances. The chemicals produced for a licit purpose which can be misused in the illegal drug production are called drug precursors. Drug precursors are rarely produced by the criminals that intend to use them in the illicit manufacture of drugs, as their production often requires important industrial infrastructure. Therefore, criminals try to divert these substances from the licit trade. The trade in drug precursors is not in itself prohibited because of their important legitimate uses. However, in order to prevent their diversion to illicit drug production, a specific regulatory framework has been set up on international level through Article 12 of the United Nations Convention against the Illicit Traffic in Narcotic Drugs and Psychotropic Substances (hereafter referred as UN 1988 Convention). The European Union is a Party to the Convention and has implemented its obligations through Regulation (EC) No 273/2004 governing the monitoring of the intra-EU trade in drug precursors and Regulation (EC) No 111/2005 governing the external trade. The Union regulatory framework provides for the monitoring and control of the legitimate trade in drug precursors. Operators, i.e. manufacturers, distributors, brokers, importers, exporters and wholesalers of chemicals engaged in the legitimate trade of drug precursors are required to take measures against theft, check their customers, detect suspicious transactions and notify the authorities thereof. This industry-authority partnership is key to the well functioning of the regulatory framework. Public authorities monitor that companies dealing with drug precursors properly exercise their obligations under the legislation by conducting on-site inspections and via administrative procedures such as granting licences and registrations. Grounds for and objectives of the proposal Traffickers purchase the drug precursors they need from different regions of the world and exploit weaknesses of control to their benefit. This proposal aims to address a specific weakness which has been detected in the European Union, when large quantities of acetic anhydride ("AA"), the main drug precursor for heroin, were diverted from the EU-internal trade: in 2008, 75% of the global seizures of AA happened in the EU. Heroin use has been contributing to public health problems in Europe since the 1970s. It still accounts for the greatest share of morbidity and mortality-related drug use in the European Union. Even though the quantities of AA seized in the EU have decreased very substantially since 2008, the INCB[1] continues to mention in its annual reports that the European legislative control measures are not sufficiently strict to prevent the diversion of the main heroin precursor from the intra-EU trade. On 7 January 2010, the European Commission adopted a Report on the implementation and functioning of the existing EU legislation on drug precursors[2] which concluded that the legislation is overall functioning well but also identified some weaknesses and made recommendations how to address these[3]. This proposal addresses, by amending Regulation (EC) No 273/2004, the recommendation of the Commission Report to improve the prevention of the diversion from the EU-internal trade of AA, the main drug precursor for heroin, by extending the registration requirement, which so far applies only to operators placing AA on the market, to also include users of the substance and by enhancing the harmonised registration provisions to achieve a more robust level playing field preserving the internal market and avoiding adoption of divergent national measures.
Revised version (Article 2 Definitions):
For the purposes of this Regulation the following definitions shall apply: (a) ‘scheduled substance’ means any substance listed in Annex I that can be used for the illicit manufacture of narcotic drugs or psychotropic substances, including mixtures and natural products containing such substances but excluding 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 as defined in point 2 of Article 1 of Directive 2001/83/EC of the European Parliament and of the Council ( 13 ) and veterinary medicinal products as defined in point 2 of Article 1 of Directive 2001/82/EC of the European Parliament and of the Council ( 14 ); (b) ‘non-scheduled substance’ means any substance which, although not listed in Annex I, is identified as having been used for the illicit manufacture of narcotic drugs or psychotropic substances; (c) ‘placing on the market’ means any supply, whether in return for payment or free of charge, of scheduled substances in the Union; or the storage, manufacture, production, processing, trade, distribution or brokering of these substances for the purpose of supply in the Union; (d) ‘operator’ means any natural or legal person engaged in the placing on the market of scheduled substances; (e) ‘International Narcotics Control Board’ means the Board established by the Single Convention on Narcotic Drugs, 1961, as amended by the 1972 Protocol; (f) ‘special licence’ means a licence that is granted to a particular type of operator; (g) ‘special registration’ means a registration that is made for a particular type of operator; (h) ‘user’ means a natural or legal person other than an operator 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; (i) ‘natural product’ means an organism or a part thereof, in any form, or any substances which occur in nature as defined in point 39 of Article 3 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council ( 15 ).
Article 3 Requirements for the placing on the market of scheduled substances
1. Operators wishing to place on the market scheduled substances of categories 1 and 2 of Annex I shall be required to appoint an officer responsible for the trade in scheduled substances, to notify the competent authorities of the name and contact details of that officer and to notify them immediately of any subsequent modification of this information. The officer shall ensure that the trade in scheduled substances conducted by the operator takes place in compliance with this Regulation. The officer shall be empowered to represent the operator and to take the decisions necessary for performing the tasks specified above. 2. Operators shall be required to obtain a licence from the competent authorities before they may possess or place on the market scheduled substances of category 1 of Annex I. Special licences may be granted by the competent authorities to pharmacies, dispensaries of veterinary medicine, certain types of public authorities or armed forces. Such special licences shall only be valid for the use of precursors within the scope of the official duties of the operators concerned. 3. Any operator holding a licence referred to in paragraph 2 shall supply scheduled substances of category 1 of Annex I only to natural or legal persons who hold such a licence and have signed a customer declaration as provided for in Article 4(1). 4. When considering whether to grant a licence, the competent authorities shall take into account in particular the competence and integrity of the applicant. The licence is to be refused if there are reasonable grounds for doubting the suitability and reliability of the applicant or of the officer responsible for the trade in scheduled substances. The licence may be suspended or revoked by the competent authorities whenever there are reasonable grounds for believing that the holder is no longer a fit and proper person to hold a licence, or that the conditions under which the licence was granted are no longer fulfilled. 5. Without prejudice to Article 14, the competent authorities may either limit the validity of the licence to a period not exceeding three years or may oblige the operators to demonstrate at intervals not exceeding three years that the conditions under which the licence was granted are still fulfilled. The licence shall mention the operation or operations for which it is valid, as well as the substances concerned. Special licences within the meaning of paragraph 2 shall be granted in principle for an unlimited duration but may be suspended or revoked by the competent authorities under the conditions of paragraph 4, third sentence. 6. Without prejudice to Article 6, operators engaged in the placing on the market of scheduled substances of category 2 of Annex I shall be required to register and update with the competent authorities without delay the addresses of the premises at which they manufacture or from which they trade in these substances, before placing them on the market. Pharmacies, dispensaries of veterinary medicine, certain types of public authorities or the armed forces may be made subject to a special registration. Such registrations shall be considered valid only for the use of precursors within the scope of the official duties of the operators concerned. 7. The competent authorities may require operators to pay a fee for the application for a licence or a registration. Such fees shall be levied in a non-discriminatory way and shall not exceed the cost of processing the application.
Amendment rationale: CONTEXT OF THE PROPOSAL General Context Many chemicals are used in a wide variety of important industrial processes (e.g. in the synthesis of plastics, pharmaceuticals, cosmetics, perfumes, detergents and aromas) and they are traded for these licit uses on regional and global markets. Some of these chemicals can, however, be misused for the illicit manufacture of narcotic drugs and psychotropic substances. The chemicals produced for a licit purpose which can be misused in the illegal drug production are called drug precursors. Drug precursors are rarely produced by the criminals that intend to use them in the illicit manufacture of drugs, as their production often requires important industrial infrastructure. Therefore, criminals try to divert these substances from the licit trade. The trade in drug precursors is not in itself prohibited because of their important legitimate uses. However, in order to prevent their diversion to illicit drug production, a specific regulatory framework has been set up on international level through Article 12 of the United Nations Convention against the Illicit Traffic in Narcotic Drugs and Psychotropic Substances (hereafter referred as UN 1988 Convention). The European Union is a Party to the Convention and has implemented its obligations through Regulation (EC) No 273/2004 governing the monitoring of the intra-EU trade in drug precursors and Regulation (EC) No 111/2005 governing the external trade. The Union regulatory framework provides for the monitoring and control of the legitimate trade in drug precursors. Operators, i.e. manufacturers, distributors, brokers, importers, exporters and wholesalers of chemicals engaged in the legitimate trade of drug precursors are required to take measures against theft, check their customers, detect suspicious transactions and notify the authorities thereof. This industry-authority partnership is key to the well functioning of the regulatory framework. Public authorities monitor that companies dealing with drug precursors properly exercise their obligations under the legislation by conducting on-site inspections and via administrative procedures such as granting licences and registrations. Grounds for and objectives of the proposal Traffickers purchase the drug precursors they need from different regions of the world and exploit weaknesses of control to their benefit. This proposal aims to address a specific weakness which has been detected in the European Union, when large quantities of acetic anhydride ("AA"), the main drug precursor for heroin, were diverted from the EU-internal trade: in 2008, 75% of the global seizures of AA happened in the EU. Heroin use has been contributing to public health problems in Europe since the 1970s. It still accounts for the greatest share of morbidity and mortality-related drug use in the European Union. Even though the quantities of AA seized in the EU have decreased very substantially since 2008, the INCB[1] continues to mention in its annual reports that the European legislative control measures are not sufficiently strict to prevent the diversion of the main heroin precursor from the intra-EU trade. On 7 January 2010, the European Commission adopted a Report on the implementation and functioning of the existing EU legislation on drug precursors[2] which concluded that the legislation is overall functioning well but also identified some weaknesses and made recommendations how to address these[3]. This proposal addresses, by amending Regulation (EC) No 273/2004, the recommendation of the Commission Report to improve the prevention of the diversion from the EU-internal trade of AA, the main drug precursor for heroin, by extending the registration requirement, which so far applies only to operators placing AA on the market, to also include users of the substance and by enhancing the harmonised registration provisions to achieve a more robust level playing field preserving the internal market and avoiding adoption of divergent national measures.
Revised version (Article 3 Requirements for the placing on the market of scheduled substances):
1. Operators wishing to place on the market scheduled substances of categories 1 and 2 of Annex I shall be required to appoint an officer responsible for the trade in scheduled substances, to notify the competent authorities of the name and contact details of that officer and to notify them immediately of any subsequent modification of this information. The officer shall ensure that the trade in scheduled substances conducted by the operator takes place in compliance with this Regulation. The officer shall be empowered to represent the operator and to take the decisions necessary for performing the tasks specified above. 2. Operators and users shall obtain a licence from the competent authorities of the Member State in which they are established before they may possess or place on the market scheduled substances of category 1 of Annex I. The competent authorities may grant special licences to pharmacies, dispensaries of veterinary medicine, certain types of public authorities or armed forces. Such special licences shall be valid only for the use of scheduled substances of category 1 of Annex I within the scope of the official duties of the operators concerned. 3. Any operator holding a licence shall supply scheduled substances of category 1 of Annex I only to operators or users who also hold a licence and have signed a customer declaration as provided for in Article 4(1). 4. When considering whether to grant a licence, the competent authorities shall take into account in particular the competence and integrity of the applicant. The licence is to be refused if there are reasonable grounds for doubting the suitability and reliability of the applicant or of the officer responsible for the trade in scheduled substances. The licence may be suspended or revoked by the competent authorities whenever there are reasonable grounds for believing that the holder is no longer a fit and proper person to hold a licence, or that the conditions under which the licence was granted are no longer fulfilled. 5. Without prejudice to paragraph 8, the competent authorities may either limit the validity of the licence to a period not exceeding three years or may oblige the operators and users to demonstrate at intervals not exceeding three years that the conditions under which the licence was granted are still fulfilled. The licence shall mention the operation or operations for which it is valid, as well as the scheduled substances concerned. The competent authorities shall, in principle, grant special licences for an unlimited duration but may suspend or revoke them where there are reasonable grounds for believing that the holder is no longer a fit and proper person to hold a licence, or that the conditions under which the licence was granted are no longer fulfilled. 6. Operators shall obtain registration from the competent authorities of the Member State in which they are established before placing on the market scheduled substances of category 2 of Annex I. From 1 July 2015 users shall obtain a registration from the competent authorities of the Member State in which they are established before possessing scheduled substances of subcategory 2A of Annex I. The competent authorities may grant special registrations to pharmacies, dispensaries of veterinary medicine, certain types of public authorities or the armed forces. Such special registrations shall be considered valid only for the use of scheduled substances of category 2 of Annex I within the scope of the official duties of the operators or users concerned. 6a. Any operator holding a registration shall supply scheduled substances of subcategory 2A of Annex I only to other operators or users who also hold a registration and have signed a customer declaration as provided for in Article 4(1). 6b. When considering whether to grant registration, the competent authorities shall take into account, in particular, the competence and integrity of the applicant. They shall refuse registration if there are reasonable grounds for doubting the suitability and reliability of the applicant or of the officer responsible for the trade in scheduled substances. They may suspend or revoke registration where there are reasonable grounds for believing that the holder is no longer a fit and proper person to hold a registration, or that the conditions under which registration was granted are no longer fulfilled. 6c. The competent authorities may require operators and users to pay a fee for the application for a licence or for registration. Where a fee is levied, competent authorities shall consider adjusting the level of the fee depending on the size of the enterprise. Such a fee shall be levied in a non-discriminatory manner and shall not exceed the cost of processing the application. 7. The competent authorities shall list the operators and users that have obtained a licence or a registration in the European database referred to in Article 13a. 8. The Commission shall be empowered to adopt delegated acts in accordance with Article 15a concerning the requirements and conditions for: (a) granting the licence, including, where relevant, the categories of personal data to be provided; (b) granting registration, including where relevant the categories of personal data to be provided; (c) listing operators and users in the European database referred to in Article 13a, in accordance with paragraph 7 of this Article. The categories of personal data referred to in points (a) and (b) of the first subparagraph of this paragraph shall not include special categories of data as referred to in Article 8(1) of Directive 95/46/EC of the European Parliament and of the Council ( 16 ).
Article 4 Customer declaration
1. Without prejudice to Articles 6 and 14, any operator established within the Community who supplies a customer with a scheduled substance of categories 1 or 2 of Annex I shall obtain a declaration from the customer which shows the specific use or uses of the scheduled substances. A separate declaration shall be required for each scheduled substance. This declaration shall conform to the model set out in point 1 of Annex III. In the case of legal persons, the declaration shall be made on headed notepaper. 2. As an alternative to the above declaration for an individual transaction, an operator who regularly supplies a customer with a scheduled substance of category 2 of Annex I may accept a single declaration in respect of a number of transactions involving this scheduled substance over a period not exceeding one year, provided that the operator is satisfied that the following criteria have been met: (a) the customer has been supplied by the operator with the substance on at least three occasions in the preceding 12 months; (b) the operator has no reason to suppose that the substance will be used for illicit purposes; (c) the quantities ordered are consistent with the usual consumption for that customer. This declaration shall conform to the model set out in point 2 of Annex III. In the case of legal persons, the declaration shall be made on headed notepaper. 3. An operator supplying scheduled substances of category 1 of Annex I shall stamp and date a copy of the declaration, certifying it to be a true copy of the original. Such copy must always accompany category 1 substances being moved within the Community and must be presented on request to the authorities responsible for checking vehicle contents during transport operations.
Amendment rationale: CONTEXT OF THE PROPOSAL General Context Many chemicals are used in a wide variety of important industrial processes (e.g. in the synthesis of plastics, pharmaceuticals, cosmetics, perfumes, detergents and aromas) and they are traded for these licit uses on regional and global markets. Some of these chemicals can, however, be misused for the illicit manufacture of narcotic drugs and psychotropic substances. The chemicals produced for a licit purpose which can be misused in the illegal drug production are called drug precursors. Drug precursors are rarely produced by the criminals that intend to use them in the illicit manufacture of drugs, as their production often requires important industrial infrastructure. Therefore, criminals try to divert these substances from the licit trade. The trade in drug precursors is not in itself prohibited because of their important legitimate uses. However, in order to prevent their diversion to illicit drug production, a specific regulatory framework has been set up on international level through Article 12 of the United Nations Convention against the Illicit Traffic in Narcotic Drugs and Psychotropic Substances (hereafter referred as UN 1988 Convention). The European Union is a Party to the Convention and has implemented its obligations through Regulation (EC) No 273/2004 governing the monitoring of the intra-EU trade in drug precursors and Regulation (EC) No 111/2005 governing the external trade. The Union regulatory framework provides for the monitoring and control of the legitimate trade in drug precursors. Operators, i.e. manufacturers, distributors, brokers, importers, exporters and wholesalers of chemicals engaged in the legitimate trade of drug precursors are required to take measures against theft, check their customers, detect suspicious transactions and notify the authorities thereof. This industry-authority partnership is key to the well functioning of the regulatory framework. Public authorities monitor that companies dealing with drug precursors properly exercise their obligations under the legislation by conducting on-site inspections and via administrative procedures such as granting licences and registrations. Grounds for and objectives of the proposal Traffickers purchase the drug precursors they need from different regions of the world and exploit weaknesses of control to their benefit. This proposal aims to address a specific weakness which has been detected in the European Union, when large quantities of acetic anhydride ("AA"), the main drug precursor for heroin, were diverted from the EU-internal trade: in 2008, 75% of the global seizures of AA happened in the EU. Heroin use has been contributing to public health problems in Europe since the 1970s. It still accounts for the greatest share of morbidity and mortality-related drug use in the European Union. Even though the quantities of AA seized in the EU have decreased very substantially since 2008, the INCB[1] continues to mention in its annual reports that the European legislative control measures are not sufficiently strict to prevent the diversion of the main heroin precursor from the intra-EU trade. On 7 January 2010, the European Commission adopted a Report on the implementation and functioning of the existing EU legislation on drug precursors[2] which concluded that the legislation is overall functioning well but also identified some weaknesses and made recommendations how to address these[3]. This proposal addresses, by amending Regulation (EC) No 273/2004, the recommendation of the Commission Report to improve the prevention of the diversion from the EU-internal trade of AA, the main drug precursor for heroin, by extending the registration requirement, which so far applies only to operators placing AA on the market, to also include users of the substance and by enhancing the harmonised registration provisions to achieve a more robust level playing field preserving the internal market and avoiding adoption of divergent national measures.
Revised version (Article 4 Customer declaration):
1. Without prejudice to paragraph 4 of this Article, and to Articles 6 and 14, any operator established within the Union who supplies a customer with a scheduled substance of category 1 or 2 of Annex I shall obtain a declaration from the customer which shows the specific use or uses of the scheduled substances. The operator shall obtain a separate declaration for each scheduled substance. That declaration shall conform to the model set out in point 1 of Annex III. In the case of legal persons, the declaration shall be made on headed notepaper. 2. As an alternative to the above declaration for an individual transaction, an operator who regularly supplies a customer with a scheduled substance of category 2 of Annex I may accept a single declaration in respect of a number of transactions involving this scheduled substance over a period not exceeding one year, provided that the operator is satisfied that the following criteria have been met: (a) the customer has been supplied by the operator with the substance on at least three occasions in the preceding 12 months; (b) the operator has no reason to suppose that the substance will be used for illicit purposes; (c) the quantities ordered are consistent with the usual consumption for that customer. This declaration shall conform to the model set out in point 2 of Annex III. In the case of legal persons, the declaration shall be made on headed notepaper. 3. An operator supplying scheduled substances of category 1 of Annex I shall stamp and date a copy of the declaration, certifying it to be a true copy of the original. Such copy shall always accompany those substances being moved within the Union and shall be presented on request to the authorities responsible for checking vehicle contents during transport operations. 4. The Commission shall be empowered to adopt delegated acts in accordance with Article 15a concerning the requirements and conditions for obtaining and using customer declarations.
Article 5 Documentation
1. Without prejudice to Article 6, operators shall ensure that all transactions leading to the placing on the market of scheduled substances of categories 1 and 2 of Annex I are properly documented in accordance with paragraphs 2 to 5 below. This obligation shall not apply to those operators who hold special licences or are subject to special registration pursuant to Article 3(2) and (6) respectively. 2. Commercial documents such as invoices, cargo manifests, administrative documents, transport and other shipping documents shall contain sufficient information to identify positively: (a) the name of the scheduled substance as given in categories 1 and 2 of Annex I; (b) the quantity and weight of the scheduled substance and, where a mixture or natural product is concerned, the quantity and weight, if available, of the mixture or natural product as well as the quantity and weight, or the percentage by weight, of any substance or substances of categories 1 and 2 of Annex I which are contained in the mixture; (c) the name and address of the supplier, distributor, consignee, and, if possible, of other operators directly involved in the transaction, as referred to in Article 2(c) and (d). 3. The documentation must also contain a customer declaration as referred to in Article 4. 4. Operators shall keep such detailed records of their activities as are required to comply with their obligations under paragraph 1. 5. The documentation and records referred to in paragraphs 1 to 4 shall be kept for at least three years from the end of the calendar year in which the transaction referred to in paragraph 1 took place, and must be readily available for inspection by the competent authorities upon request. 6. The documentation may also be kept in the form of reproductions on an image medium or other data media. It must be ensured that the data stored: (a) match the documentation in appearance and content when made readable, and (b) are readily available at all times, can be made readable without delay and can be analysed by automated means for the duration of the period specified in paragraph 5.
Amendment rationale: CONTEXT OF THE PROPOSAL General Context Many chemicals are used in a wide variety of important industrial processes (e.g. in the synthesis of plastics, pharmaceuticals, cosmetics, perfumes, detergents and aromas) and they are traded for these licit uses on regional and global markets. Some of these chemicals can, however, be misused for the illicit manufacture of narcotic drugs and psychotropic substances. The chemicals produced for a licit purpose which can be misused in the illegal drug production are called drug precursors. Drug precursors are rarely produced by the criminals that intend to use them in the illicit manufacture of drugs, as their production often requires important industrial infrastructure. Therefore, criminals try to divert these substances from the licit trade. The trade in drug precursors is not in itself prohibited because of their important legitimate uses. However, in order to prevent their diversion to illicit drug production, a specific regulatory framework has been set up on international level through Article 12 of the United Nations Convention against the Illicit Traffic in Narcotic Drugs and Psychotropic Substances (hereafter referred as UN 1988 Convention). The European Union is a Party to the Convention and has implemented its obligations through Regulation (EC) No 273/2004 governing the monitoring of the intra-EU trade in drug precursors and Regulation (EC) No 111/2005 governing the external trade. The Union regulatory framework provides for the monitoring and control of the legitimate trade in drug precursors. Operators, i.e. manufacturers, distributors, brokers, importers, exporters and wholesalers of chemicals engaged in the legitimate trade of drug precursors are required to take measures against theft, check their customers, detect suspicious transactions and notify the authorities thereof. This industry-authority partnership is key to the well functioning of the regulatory framework. Public authorities monitor that companies dealing with drug precursors properly exercise their obligations under the legislation by conducting on-site inspections and via administrative procedures such as granting licences and registrations. Grounds for and objectives of the proposal Traffickers purchase the drug precursors they need from different regions of the world and exploit weaknesses of control to their benefit. This proposal aims to address a specific weakness which has been detected in the European Union, when large quantities of acetic anhydride ("AA"), the main drug precursor for heroin, were diverted from the EU-internal trade: in 2008, 75% of the global seizures of AA happened in the EU. Heroin use has been contributing to public health problems in Europe since the 1970s. It still accounts for the greatest share of morbidity and mortality-related drug use in the European Union. Even though the quantities of AA seized in the EU have decreased very substantially since 2008, the INCB[1] continues to mention in its annual reports that the European legislative control measures are not sufficiently strict to prevent the diversion of the main heroin precursor from the intra-EU trade. On 7 January 2010, the European Commission adopted a Report on the implementation and functioning of the existing EU legislation on drug precursors[2] which concluded that the legislation is overall functioning well but also identified some weaknesses and made recommendations how to address these[3]. This proposal addresses, by amending Regulation (EC) No 273/2004, the recommendation of the Commission Report to improve the prevention of the diversion from the EU-internal trade of AA, the main drug precursor for heroin, by extending the registration requirement, which so far applies only to operators placing AA on the market, to also include users of the substance and by enhancing the harmonised registration provisions to achieve a more robust level playing field preserving the internal market and avoiding adoption of divergent national measures.
Revised version (Article 5 Documentation):
1. Without prejudice to Article 6, operators shall ensure that all transactions leading to the placing on the market of scheduled substances of categories 1 and 2 of Annex I are properly documented in accordance with paragraphs 2 to 5 below. This obligation shall not apply to those operators who hold special licences or are subject to special registration pursuant to Article 3(2) and (6) respectively. 2. Commercial documents such as invoices, cargo manifests, administrative documents, transport and other shipping documents shall contain sufficient information to identify positively: (a) the name of the scheduled substance as given in categories 1 and 2 of Annex I; (b) the quantity and weight of the scheduled substance and, where a mixture or natural product is concerned, the quantity and weight, if available, of the mixture or natural product as well as the quantity and weight, or the percentage by weight, of any substance or substances of categories 1 and 2 of Annex I which are contained in the mixture; (c) the name and address of the supplier, distributor, consignee, and, if possible, of other operators directly involved in the transaction, as referred to in Article 2(c) and (d). 3. The documentation must also contain a customer declaration as referred to in Article 4. 4. Operators shall keep such detailed records of their activities as are required to comply with their obligations under paragraph 1. 5. The documentation and records referred to in paragraphs 1 to 4 shall be kept for at least three years from the end of the calendar year in which the transaction referred to in paragraph 1 took place, and must be readily available for inspection by the competent authorities upon request. 6. The documentation may also be kept in the form of reproductions on an image medium or other data media. It must be ensured that the data stored: (a) match the documentation in appearance and content when made readable, and (b) are readily available at all times, can be made readable without delay and can be analysed by automated means for the duration of the period specified in paragraph 5. 7. The Commission shall be empowered to adopt delegated acts in accordance with Article 15a concerning the requirements and conditions for the documentation of mixtures containing scheduled substances.
Article 6 Exemptions
The obligations according to Articles 3, 4 and 5 shall not apply to transactions involving scheduled substances of category 2 of Annex I where the quantities involved do not exceed those indicated in Annex II over a period of one year.
Article 7 Labelling
Operators shall ensure that labels are affixed to scheduled substances of categories 1 and 2 of Annex I before they are supplied. The labels must show the names of the substances as given in Annex I. Operators may in addition affix their customary labels.
Amendment rationale: CONTEXT OF THE PROPOSAL General Context Many chemicals are used in a wide variety of important industrial processes (e.g. in the synthesis of plastics, pharmaceuticals, cosmetics, perfumes, detergents and aromas) and they are traded for these licit uses on regional and global markets. Some of these chemicals can, however, be misused for the illicit manufacture of narcotic drugs and psychotropic substances. The chemicals produced for a licit purpose which can be misused in the illegal drug production are called drug precursors. Drug precursors are rarely produced by the criminals that intend to use them in the illicit manufacture of drugs, as their production often requires important industrial infrastructure. Therefore, criminals try to divert these substances from the licit trade. The trade in drug precursors is not in itself prohibited because of their important legitimate uses. However, in order to prevent their diversion to illicit drug production, a specific regulatory framework has been set up on international level through Article 12 of the United Nations Convention against the Illicit Traffic in Narcotic Drugs and Psychotropic Substances (hereafter referred as UN 1988 Convention). The European Union is a Party to the Convention and has implemented its obligations through Regulation (EC) No 273/2004 governing the monitoring of the intra-EU trade in drug precursors and Regulation (EC) No 111/2005 governing the external trade. The Union regulatory framework provides for the monitoring and control of the legitimate trade in drug precursors. Operators, i.e. manufacturers, distributors, brokers, importers, exporters and wholesalers of chemicals engaged in the legitimate trade of drug precursors are required to take measures against theft, check their customers, detect suspicious transactions and notify the authorities thereof. This industry-authority partnership is key to the well functioning of the regulatory framework. Public authorities monitor that companies dealing with drug precursors properly exercise their obligations under the legislation by conducting on-site inspections and via administrative procedures such as granting licences and registrations. Grounds for and objectives of the proposal Traffickers purchase the drug precursors they need from different regions of the world and exploit weaknesses of control to their benefit. This proposal aims to address a specific weakness which has been detected in the European Union, when large quantities of acetic anhydride ("AA"), the main drug precursor for heroin, were diverted from the EU-internal trade: in 2008, 75% of the global seizures of AA happened in the EU. Heroin use has been contributing to public health problems in Europe since the 1970s. It still accounts for the greatest share of morbidity and mortality-related drug use in the European Union. Even though the quantities of AA seized in the EU have decreased very substantially since 2008, the INCB[1] continues to mention in its annual reports that the European legislative control measures are not sufficiently strict to prevent the diversion of the main heroin precursor from the intra-EU trade. On 7 January 2010, the European Commission adopted a Report on the implementation and functioning of the existing EU legislation on drug precursors[2] which concluded that the legislation is overall functioning well but also identified some weaknesses and made recommendations how to address these[3]. This proposal addresses, by amending Regulation (EC) No 273/2004, the recommendation of the Commission Report to improve the prevention of the diversion from the EU-internal trade of AA, the main drug precursor for heroin, by extending the registration requirement, which so far applies only to operators placing AA on the market, to also include users of the substance and by enhancing the harmonised registration provisions to achieve a more robust level playing field preserving the internal market and avoiding adoption of divergent national measures.
Revised version (Article 7 Labelling):
Operators shall ensure that labels are affixed to scheduled substances of categories 1 and 2 of Annex I before they are supplied. The labels must show the names of the substances as given in Annex I. Operators may in addition affix their customary labels. The Commission shall be empowered to adopt delegated acts in accordance with Article 15a concerning the requirements and conditions for the labelling of mixtures containing scheduled substances.
Article 8 Notification of the competent authorities
1. Operators shall notify the competent authorities immediately of any circumstances, such as unusual orders or transactions involving scheduled substances to be placed on the market, which suggest that such substances might be diverted for the illicit manufacture of narcotic drugs or psychotropic substances. 2. Operators shall provide the competent authorities in summary form with such information about their transactions involving scheduled substances as is specified in implementing measures adopted pursuant to Article 14.
Amendment rationale: CONTEXT OF THE PROPOSAL General Context Many chemicals are used in a wide variety of important industrial processes (e.g. in the synthesis of plastics, pharmaceuticals, cosmetics, perfumes, detergents and aromas) and they are traded for these licit uses on regional and global markets. Some of these chemicals can, however, be misused for the illicit manufacture of narcotic drugs and psychotropic substances. The chemicals produced for a licit purpose which can be misused in the illegal drug production are called drug precursors. Drug precursors are rarely produced by the criminals that intend to use them in the illicit manufacture of drugs, as their production often requires important industrial infrastructure. Therefore, criminals try to divert these substances from the licit trade. The trade in drug precursors is not in itself prohibited because of their important legitimate uses. However, in order to prevent their diversion to illicit drug production, a specific regulatory framework has been set up on international level through Article 12 of the United Nations Convention against the Illicit Traffic in Narcotic Drugs and Psychotropic Substances (hereafter referred as UN 1988 Convention). The European Union is a Party to the Convention and has implemented its obligations through Regulation (EC) No 273/2004 governing the monitoring of the intra-EU trade in drug precursors and Regulation (EC) No 111/2005 governing the external trade. The Union regulatory framework provides for the monitoring and control of the legitimate trade in drug precursors. Operators, i.e. manufacturers, distributors, brokers, importers, exporters and wholesalers of chemicals engaged in the legitimate trade of drug precursors are required to take measures against theft, check their customers, detect suspicious transactions and notify the authorities thereof. This industry-authority partnership is key to the well functioning of the regulatory framework. Public authorities monitor that companies dealing with drug precursors properly exercise their obligations under the legislation by conducting on-site inspections and via administrative procedures such as granting licences and registrations. Grounds for and objectives of the proposal Traffickers purchase the drug precursors they need from different regions of the world and exploit weaknesses of control to their benefit. This proposal aims to address a specific weakness which has been detected in the European Union, when large quantities of acetic anhydride ("AA"), the main drug precursor for heroin, were diverted from the EU-internal trade: in 2008, 75% of the global seizures of AA happened in the EU. Heroin use has been contributing to public health problems in Europe since the 1970s. It still accounts for the greatest share of morbidity and mortality-related drug use in the European Union. Even though the quantities of AA seized in the EU have decreased very substantially since 2008, the INCB[1] continues to mention in its annual reports that the European legislative control measures are not sufficiently strict to prevent the diversion of the main heroin precursor from the intra-EU trade. On 7 January 2010, the European Commission adopted a Report on the implementation and functioning of the existing EU legislation on drug precursors[2] which concluded that the legislation is overall functioning well but also identified some weaknesses and made recommendations how to address these[3]. This proposal addresses, by amending Regulation (EC) No 273/2004, the recommendation of the Commission Report to improve the prevention of the diversion from the EU-internal trade of AA, the main drug precursor for heroin, by extending the registration requirement, which so far applies only to operators placing AA on the market, to also include users of the substance and by enhancing the harmonised registration provisions to achieve a more robust level playing field preserving the internal market and avoiding adoption of divergent national measures.
Revised version (Article 8 Notification of the competent authorities):
1. Operators shall notify the competent authorities immediately of any circumstances, such as unusual orders or transactions involving scheduled substances to be placed on the market, which suggest that such substances might be diverted for the illicit manufacture of narcotic drugs or psychotropic substances. To that end, operators shall provide any available information allowing the competent authorities to verify the legitimacy of the relevant order or transaction. 2. Operators shall provide the competent authorities with relevant information in summary form about their transactions involving scheduled substances. 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 15a concerning the requirements and conditions for operators to provide information as referred to in paragraph 2 of this Article including, where relevant, the categories of personal data to be processed for that purpose and the safeguards for processing such personal data. 4. Operators shall not disclose any personal data collected pursuant to this Regulation other than to the competent authorities.
Article 9 Guidelines
1. In order to facilitate cooperation between the competent authorities, the operators, and the chemical industry, in particular as regards non-scheduled substances, the Commission shall, in accordance with the procedure referred to in Article 15(2), draw up and update guidelines to assist the chemical industry. 2. The guidelines shall provide in particular: (a) information on how to recognise and notify suspect transactions; (b) a regularly updated list of non-scheduled substances to enable the industry to monitor on a voluntary basis the trade in such substances; (c) other information which may be deemed useful. 3. The competent authorities shall ensure that the guidelines and the list of non-scheduled substances are regularly disseminated in a manner deemed appropriate by the competent authorities in accordance with the objectives of the guidelines.
Amendment rationale: CONTEXT OF THE PROPOSAL General Context Many chemicals are used in a wide variety of important industrial processes (e.g. in the synthesis of plastics, pharmaceuticals, cosmetics, perfumes, detergents and aromas) and they are traded for these licit uses on regional and global markets. Some of these chemicals can, however, be misused for the illicit manufacture of narcotic drugs and psychotropic substances. The chemicals produced for a licit purpose which can be misused in the illegal drug production are called drug precursors. Drug precursors are rarely produced by the criminals that intend to use them in the illicit manufacture of drugs, as their production often requires important industrial infrastructure. Therefore, criminals try to divert these substances from the licit trade. The trade in drug precursors is not in itself prohibited because of their important legitimate uses. However, in order to prevent their diversion to illicit drug production, a specific regulatory framework has been set up on international level through Article 12 of the United Nations Convention against the Illicit Traffic in Narcotic Drugs and Psychotropic Substances (hereafter referred as UN 1988 Convention). The European Union is a Party to the Convention and has implemented its obligations through Regulation (EC) No 273/2004 governing the monitoring of the intra-EU trade in drug precursors and Regulation (EC) No 111/2005 governing the external trade. The Union regulatory framework provides for the monitoring and control of the legitimate trade in drug precursors. Operators, i.e. manufacturers, distributors, brokers, importers, exporters and wholesalers of chemicals engaged in the legitimate trade of drug precursors are required to take measures against theft, check their customers, detect suspicious transactions and notify the authorities thereof. This industry-authority partnership is key to the well functioning of the regulatory framework. Public authorities monitor that companies dealing with drug precursors properly exercise their obligations under the legislation by conducting on-site inspections and via administrative procedures such as granting licences and registrations. Grounds for and objectives of the proposal Traffickers purchase the drug precursors they need from different regions of the world and exploit weaknesses of control to their benefit. This proposal aims to address a specific weakness which has been detected in the European Union, when large quantities of acetic anhydride ("AA"), the main drug precursor for heroin, were diverted from the EU-internal trade: in 2008, 75% of the global seizures of AA happened in the EU. Heroin use has been contributing to public health problems in Europe since the 1970s. It still accounts for the greatest share of morbidity and mortality-related drug use in the European Union. Even though the quantities of AA seized in the EU have decreased very substantially since 2008, the INCB[1] continues to mention in its annual reports that the European legislative control measures are not sufficiently strict to prevent the diversion of the main heroin precursor from the intra-EU trade. On 7 January 2010, the European Commission adopted a Report on the implementation and functioning of the existing EU legislation on drug precursors[2] which concluded that the legislation is overall functioning well but also identified some weaknesses and made recommendations how to address these[3]. This proposal addresses, by amending Regulation (EC) No 273/2004, the recommendation of the Commission Report to improve the prevention of the diversion from the EU-internal trade of AA, the main drug precursor for heroin, by extending the registration requirement, which so far applies only to operators placing AA on the market, to also include users of the substance and by enhancing the harmonised registration provisions to achieve a more robust level playing field preserving the internal market and avoiding adoption of divergent national measures.
Revised version (Article 9 Guidelines):
1. The Commission shall draw up, and keep up to date, guidelines to facilitate cooperation between the competent authorities, the operators, and the chemical industry, in particular as regards non-scheduled substances. 2. The guidelines shall provide in particular: (a) information on how to recognise and notify suspect transactions; (b) a regularly updated list of non-scheduled substances to enable the industry to monitor on a voluntary basis the trade in such substances; (c) other information which may be deemed useful. 3. The competent authorities shall ensure that the guidelines and the list of non-scheduled substances are regularly disseminated in a manner deemed appropriate by the competent authorities in accordance with the objectives of the guidelines.
Article 10 Powers and obligations of competent authorities
1. In order to ensure the correct application of Articles 3 to 8, each Member State shall adopt the measures necessary to enable its competent authorities to perform their control and monitoring duties, and in particular: (a) to obtain information on any orders for scheduled substances or operations involving scheduled substances; (b) to enter operators' business premises in order to obtain evidence of irregularities; (c) where necessary, to detain consignments that fail to comply with this Regulation. 2. The competent authorities shall respect confidential business information.
Amendment rationale: CONTEXT OF THE PROPOSAL General Context Many chemicals are used in a wide variety of important industrial processes (e.g. in the synthesis of plastics, pharmaceuticals, cosmetics, perfumes, detergents and aromas) and they are traded for these licit uses on regional and global markets. Some of these chemicals can, however, be misused for the illicit manufacture of narcotic drugs and psychotropic substances. The chemicals produced for a licit purpose which can be misused in the illegal drug production are called drug precursors. Drug precursors are rarely produced by the criminals that intend to use them in the illicit manufacture of drugs, as their production often requires important industrial infrastructure. Therefore, criminals try to divert these substances from the licit trade. The trade in drug precursors is not in itself prohibited because of their important legitimate uses. However, in order to prevent their diversion to illicit drug production, a specific regulatory framework has been set up on international level through Article 12 of the United Nations Convention against the Illicit Traffic in Narcotic Drugs and Psychotropic Substances (hereafter referred as UN 1988 Convention). The European Union is a Party to the Convention and has implemented its obligations through Regulation (EC) No 273/2004 governing the monitoring of the intra-EU trade in drug precursors and Regulation (EC) No 111/2005 governing the external trade. The Union regulatory framework provides for the monitoring and control of the legitimate trade in drug precursors. Operators, i.e. manufacturers, distributors, brokers, importers, exporters and wholesalers of chemicals engaged in the legitimate trade of drug precursors are required to take measures against theft, check their customers, detect suspicious transactions and notify the authorities thereof. This industry-authority partnership is key to the well functioning of the regulatory framework. Public authorities monitor that companies dealing with drug precursors properly exercise their obligations under the legislation by conducting on-site inspections and via administrative procedures such as granting licences and registrations. Grounds for and objectives of the proposal Traffickers purchase the drug precursors they need from different regions of the world and exploit weaknesses of control to their benefit. This proposal aims to address a specific weakness which has been detected in the European Union, when large quantities of acetic anhydride ("AA"), the main drug precursor for heroin, were diverted from the EU-internal trade: in 2008, 75% of the global seizures of AA happened in the EU. Heroin use has been contributing to public health problems in Europe since the 1970s. It still accounts for the greatest share of morbidity and mortality-related drug use in the European Union. Even though the quantities of AA seized in the EU have decreased very substantially since 2008, the INCB[1] continues to mention in its annual reports that the European legislative control measures are not sufficiently strict to prevent the diversion of the main heroin precursor from the intra-EU trade. On 7 January 2010, the European Commission adopted a Report on the implementation and functioning of the existing EU legislation on drug precursors[2] which concluded that the legislation is overall functioning well but also identified some weaknesses and made recommendations how to address these[3]. This proposal addresses, by amending Regulation (EC) No 273/2004, the recommendation of the Commission Report to improve the prevention of the diversion from the EU-internal trade of AA, the main drug precursor for heroin, by extending the registration requirement, which so far applies only to operators placing AA on the market, to also include users of the substance and by enhancing the harmonised registration provisions to achieve a more robust level playing field preserving the internal market and avoiding adoption of divergent national measures.
Revised version (Article 10 Powers and obligations of competent authorities):
1. In order to ensure the correct application of Articles 3 to 8, each Member State shall adopt the measures necessary to enable its competent authorities to perform their control and monitoring duties, and in particular: (a) to obtain information on any orders for scheduled substances or operations involving scheduled substances; (b) to enter operators’ and users’ business premises in order to obtain evidence of irregularities; (c) where necessary, to detain and seize consignments that fail to comply with this Regulation. 2. Each Member State may adopt the measures necessary to enable its competent authorities to control and monitor suspicious transactions involving non-scheduled substances, and in particular: (a) to obtain information on any orders for non-scheduled substances or operations involving non-scheduled substances; (b) to enter business premises in order to obtain evidence of suspicious transactions involving non-scheduled substances; (c) where necessary, to detain and seize consignments to prevent the use of specific non-scheduled substances for the illicit manufacture of narcotic drugs or psychotropic substances. 3. The competent authorities shall respect confidential business information.
Article 11 Cooperation between the Member States and the Commission
1. Each Member State shall designate the competent authority or authorities responsible for ensuring the application of this Regulation and shall inform the Commission thereof. 2. For the purposes of applying this Regulation and without prejudice to Article 15, the provisions of Council Regulation (EC) No 515/97 of 13 March 1997 on mutual assistance between the administrative authorities of the Member States and cooperation between the latter and the Commission to ensure the correct application of the law on customs and agricultural matters ( 14 ), and in particular those on confidentiality, shall apply mutatis mutandis . The competent authority or authorities designated under paragraph 1 of this Article shall act as competent authorities within the meaning of Article 2(2) of Regulation (EC) No 515/97.
Article 12 Penalties
The Member State shall lay down the rules on penalties applicable for infringement of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive.
Article 13 Communications from Member States
1. To permit any necessary adjustments to the arrangements for monitoring trade in scheduled substances and non-scheduled substances, the competent authorities in each Member State shall each year communicate to the Commission all information on the implementation of the monitoring measures laid down in this Regulation, in particular as regards substances frequently used for the illicit manufacture of narcotic drugs or psychotropic substances and methods of diversion and illicit manufacture. 2. A summary of the communications made pursuant to paragraph 1 shall be submitted by the Commission to the International Narcotics Control Board in accordance with Article 12(12) of the United Nations Convention and in consultation with the Member States.
Amendment rationale: CONTEXT OF THE PROPOSAL General Context Many chemicals are used in a wide variety of important industrial processes (e.g. in the synthesis of plastics, pharmaceuticals, cosmetics, perfumes, detergents and aromas) and they are traded for these licit uses on regional and global markets. Some of these chemicals can, however, be misused for the illicit manufacture of narcotic drugs and psychotropic substances. The chemicals produced for a licit purpose which can be misused in the illegal drug production are called drug precursors. Drug precursors are rarely produced by the criminals that intend to use them in the illicit manufacture of drugs, as their production often requires important industrial infrastructure. Therefore, criminals try to divert these substances from the licit trade. The trade in drug precursors is not in itself prohibited because of their important legitimate uses. However, in order to prevent their diversion to illicit drug production, a specific regulatory framework has been set up on international level through Article 12 of the United Nations Convention against the Illicit Traffic in Narcotic Drugs and Psychotropic Substances (hereafter referred as UN 1988 Convention). The European Union is a Party to the Convention and has implemented its obligations through Regulation (EC) No 273/2004 governing the monitoring of the intra-EU trade in drug precursors and Regulation (EC) No 111/2005 governing the external trade. The Union regulatory framework provides for the monitoring and control of the legitimate trade in drug precursors. Operators, i.e. manufacturers, distributors, brokers, importers, exporters and wholesalers of chemicals engaged in the legitimate trade of drug precursors are required to take measures against theft, check their customers, detect suspicious transactions and notify the authorities thereof. This industry-authority partnership is key to the well functioning of the regulatory framework. Public authorities monitor that companies dealing with drug precursors properly exercise their obligations under the legislation by conducting on-site inspections and via administrative procedures such as granting licences and registrations. Grounds for and objectives of the proposal Traffickers purchase the drug precursors they need from different regions of the world and exploit weaknesses of control to their benefit. This proposal aims to address a specific weakness which has been detected in the European Union, when large quantities of acetic anhydride ("AA"), the main drug precursor for heroin, were diverted from the EU-internal trade: in 2008, 75% of the global seizures of AA happened in the EU. Heroin use has been contributing to public health problems in Europe since the 1970s. It still accounts for the greatest share of morbidity and mortality-related drug use in the European Union. Even though the quantities of AA seized in the EU have decreased very substantially since 2008, the INCB[1] continues to mention in its annual reports that the European legislative control measures are not sufficiently strict to prevent the diversion of the main heroin precursor from the intra-EU trade. On 7 January 2010, the European Commission adopted a Report on the implementation and functioning of the existing EU legislation on drug precursors[2] which concluded that the legislation is overall functioning well but also identified some weaknesses and made recommendations how to address these[3]. This proposal addresses, by amending Regulation (EC) No 273/2004, the recommendation of the Commission Report to improve the prevention of the diversion from the EU-internal trade of AA, the main drug precursor for heroin, by extending the registration requirement, which so far applies only to operators placing AA on the market, to also include users of the substance and by enhancing the harmonised registration provisions to achieve a more robust level playing field preserving the internal market and avoiding adoption of divergent national measures.
Revised version (Article 13 Communications from Member States):
1. To permit any necessary adjustments to the arrangements for monitoring trade in scheduled substances and non-scheduled substances, the competent authorities in each Member State shall communicate to the Commission in electronic form via the European database referred to in Article 13a in a timely manner all relevant information on the implementation of the monitoring measures laid down in this Regulation, in particular as regards substances used for the illicit manufacture of narcotic drugs or psychotropic substances and methods of diversion and illicit manufacture, and their licit trade. 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 15a specifying the conditions and requirements concerning the information to be provided under paragraph 1 of this Article. 3. A summary of the communications made pursuant to paragraph 1 of this Article shall be submitted by the Commission to the International Narcotics Control Board in accordance with Article 12(12) of the United Nations Convention and in consultation with the Member States.
Article 14 Implementation
Where necessary, the Commission shall adopt implementing measures concerning the following: The measures referred to in points (a) to (e) of the first paragraph, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 15(3). The measures referred to in point (f) of the first paragraph shall be adopted in accordance with the management procedure referred to in Article 15(2). (a) determination of the requirements and conditions for the granting of the licence as provided for in Article 3 and the details pertaining to the licence; (b) determination, whenever necessary, of the conditions which shall apply to the documentation and labelling of mixtures and preparations containing substances listed in Annex I, as provided for in Articles 5 to 7; (c) any amendments to Annex I made necessary by amendments to the tables in the Annex to the United Nations Convention; (d) amendments to the thresholds set in Annex II; (e) determination of the requirements and conditions for customer declarations referred to in Article 4, as well as the detailed rules concerning their use. This shall include rules on how to provide customer declarations in electronic form, where appropriate; (f) other measures needed for the efficient implementation of this Regulation.
Amendment rationale: CONTEXT OF THE PROPOSAL General Context Many chemicals are used in a wide variety of important industrial processes (e.g. in the synthesis of plastics, pharmaceuticals, cosmetics, perfumes, detergents and aromas) and they are traded for these licit uses on regional and global markets. Some of these chemicals can, however, be misused for the illicit manufacture of narcotic drugs and psychotropic substances. The chemicals produced for a licit purpose which can be misused in the illegal drug production are called drug precursors. Drug precursors are rarely produced by the criminals that intend to use them in the illicit manufacture of drugs, as their production often requires important industrial infrastructure. Therefore, criminals try to divert these substances from the licit trade. The trade in drug precursors is not in itself prohibited because of their important legitimate uses. However, in order to prevent their diversion to illicit drug production, a specific regulatory framework has been set up on international level through Article 12 of the United Nations Convention against the Illicit Traffic in Narcotic Drugs and Psychotropic Substances (hereafter referred as UN 1988 Convention). The European Union is a Party to the Convention and has implemented its obligations through Regulation (EC) No 273/2004 governing the monitoring of the intra-EU trade in drug precursors and Regulation (EC) No 111/2005 governing the external trade. The Union regulatory framework provides for the monitoring and control of the legitimate trade in drug precursors. Operators, i.e. manufacturers, distributors, brokers, importers, exporters and wholesalers of chemicals engaged in the legitimate trade of drug precursors are required to take measures against theft, check their customers, detect suspicious transactions and notify the authorities thereof. This industry-authority partnership is key to the well functioning of the regulatory framework. Public authorities monitor that companies dealing with drug precursors properly exercise their obligations under the legislation by conducting on-site inspections and via administrative procedures such as granting licences and registrations. Grounds for and objectives of the proposal Traffickers purchase the drug precursors they need from different regions of the world and exploit weaknesses of control to their benefit. This proposal aims to address a specific weakness which has been detected in the European Union, when large quantities of acetic anhydride ("AA"), the main drug precursor for heroin, were diverted from the EU-internal trade: in 2008, 75% of the global seizures of AA happened in the EU. Heroin use has been contributing to public health problems in Europe since the 1970s. It still accounts for the greatest share of morbidity and mortality-related drug use in the European Union. Even though the quantities of AA seized in the EU have decreased very substantially since 2008, the INCB[1] continues to mention in its annual reports that the European legislative control measures are not sufficiently strict to prevent the diversion of the main heroin precursor from the intra-EU trade. On 7 January 2010, the European Commission adopted a Report on the implementation and functioning of the existing EU legislation on drug precursors[2] which concluded that the legislation is overall functioning well but also identified some weaknesses and made recommendations how to address these[3]. This proposal addresses, by amending Regulation (EC) No 273/2004, the recommendation of the Commission Report to improve the prevention of the diversion from the EU-internal trade of AA, the main drug precursor for heroin, by extending the registration requirement, which so far applies only to operators placing AA on the market, to also include users of the substance and by enhancing the harmonised registration provisions to achieve a more robust level playing field preserving the internal market and avoiding adoption of divergent national measures.
Article 15 Committee procedure
1. The Commission shall be assisted by the Committee set up by Article 30 of Council Regulation (EC) No 111/2005 ( 15 ). 2. Where reference is made to this paragraph, Articles 4 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 4(3) of Decision 1999/468/EC shall be set at three months. 3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
Amendment rationale: CONTEXT OF THE PROPOSAL General Context Many chemicals are used in a wide variety of important industrial processes (e.g. in the synthesis of plastics, pharmaceuticals, cosmetics, perfumes, detergents and aromas) and they are traded for these licit uses on regional and global markets. Some of these chemicals can, however, be misused for the illicit manufacture of narcotic drugs and psychotropic substances. The chemicals produced for a licit purpose which can be misused in the illegal drug production are called drug precursors. Drug precursors are rarely produced by the criminals that intend to use them in the illicit manufacture of drugs, as their production often requires important industrial infrastructure. Therefore, criminals try to divert these substances from the licit trade. The trade in drug precursors is not in itself prohibited because of their important legitimate uses. However, in order to prevent their diversion to illicit drug production, a specific regulatory framework has been set up on international level through Article 12 of the United Nations Convention against the Illicit Traffic in Narcotic Drugs and Psychotropic Substances (hereafter referred as UN 1988 Convention). The European Union is a Party to the Convention and has implemented its obligations through Regulation (EC) No 273/2004 governing the monitoring of the intra-EU trade in drug precursors and Regulation (EC) No 111/2005 governing the external trade. The Union regulatory framework provides for the monitoring and control of the legitimate trade in drug precursors. Operators, i.e. manufacturers, distributors, brokers, importers, exporters and wholesalers of chemicals engaged in the legitimate trade of drug precursors are required to take measures against theft, check their customers, detect suspicious transactions and notify the authorities thereof. This industry-authority partnership is key to the well functioning of the regulatory framework. Public authorities monitor that companies dealing with drug precursors properly exercise their obligations under the legislation by conducting on-site inspections and via administrative procedures such as granting licences and registrations. Grounds for and objectives of the proposal Traffickers purchase the drug precursors they need from different regions of the world and exploit weaknesses of control to their benefit. This proposal aims to address a specific weakness which has been detected in the European Union, when large quantities of acetic anhydride ("AA"), the main drug precursor for heroin, were diverted from the EU-internal trade: in 2008, 75% of the global seizures of AA happened in the EU. Heroin use has been contributing to public health problems in Europe since the 1970s. It still accounts for the greatest share of morbidity and mortality-related drug use in the European Union. Even though the quantities of AA seized in the EU have decreased very substantially since 2008, the INCB[1] continues to mention in its annual reports that the European legislative control measures are not sufficiently strict to prevent the diversion of the main heroin precursor from the intra-EU trade. On 7 January 2010, the European Commission adopted a Report on the implementation and functioning of the existing EU legislation on drug precursors[2] which concluded that the legislation is overall functioning well but also identified some weaknesses and made recommendations how to address these[3]. This proposal addresses, by amending Regulation (EC) No 273/2004, the recommendation of the Commission Report to improve the prevention of the diversion from the EU-internal trade of AA, the main drug precursor for heroin, by extending the registration requirement, which so far applies only to operators placing AA on the market, to also include users of the substance and by enhancing the harmonised registration provisions to achieve a more robust level playing field preserving the internal market and avoiding adoption of divergent national measures.
Revised version (Article 14a Committee procedure):
1. The Commission shall be assisted by the Drug Precursors Committee established by Article 30 of Council Regulation (EC) No 111/2005 ( 19 ). That committee shall be a committee within the meaning of Regulation (EU) No 182/2011 of the European Parliament and of the Council ( 20 ). 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
Article 16 Information about measures adopted by Member States
Each Member State shall inform the Commission of the measures it adopts pursuant to this Regulation, and in particular of the measures adopted pursuant to Articles 10 and 12. They shall also notify any subsequent amendments thereof. The Commission shall communicate this information to the other Member States. It shall evaluate the implementation of the Regulation three years after its entry into force.
Amendment rationale: CONTEXT OF THE PROPOSAL General Context Many chemicals are used in a wide variety of important industrial processes (e.g. in the synthesis of plastics, pharmaceuticals, cosmetics, perfumes, detergents and aromas) and they are traded for these licit uses on regional and global markets. Some of these chemicals can, however, be misused for the illicit manufacture of narcotic drugs and psychotropic substances. The chemicals produced for a licit purpose which can be misused in the illegal drug production are called drug precursors. Drug precursors are rarely produced by the criminals that intend to use them in the illicit manufacture of drugs, as their production often requires important industrial infrastructure. Therefore, criminals try to divert these substances from the licit trade. The trade in drug precursors is not in itself prohibited because of their important legitimate uses. However, in order to prevent their diversion to illicit drug production, a specific regulatory framework has been set up on international level through Article 12 of the United Nations Convention against the Illicit Traffic in Narcotic Drugs and Psychotropic Substances (hereafter referred as UN 1988 Convention). The European Union is a Party to the Convention and has implemented its obligations through Regulation (EC) No 273/2004 governing the monitoring of the intra-EU trade in drug precursors and Regulation (EC) No 111/2005 governing the external trade. The Union regulatory framework provides for the monitoring and control of the legitimate trade in drug precursors. Operators, i.e. manufacturers, distributors, brokers, importers, exporters and wholesalers of chemicals engaged in the legitimate trade of drug precursors are required to take measures against theft, check their customers, detect suspicious transactions and notify the authorities thereof. This industry-authority partnership is key to the well functioning of the regulatory framework. Public authorities monitor that companies dealing with drug precursors properly exercise their obligations under the legislation by conducting on-site inspections and via administrative procedures such as granting licences and registrations. Grounds for and objectives of the proposal Traffickers purchase the drug precursors they need from different regions of the world and exploit weaknesses of control to their benefit. This proposal aims to address a specific weakness which has been detected in the European Union, when large quantities of acetic anhydride ("AA"), the main drug precursor for heroin, were diverted from the EU-internal trade: in 2008, 75% of the global seizures of AA happened in the EU. Heroin use has been contributing to public health problems in Europe since the 1970s. It still accounts for the greatest share of morbidity and mortality-related drug use in the European Union. Even though the quantities of AA seized in the EU have decreased very substantially since 2008, the INCB[1] continues to mention in its annual reports that the European legislative control measures are not sufficiently strict to prevent the diversion of the main heroin precursor from the intra-EU trade. On 7 January 2010, the European Commission adopted a Report on the implementation and functioning of the existing EU legislation on drug precursors[2] which concluded that the legislation is overall functioning well but also identified some weaknesses and made recommendations how to address these[3]. This proposal addresses, by amending Regulation (EC) No 273/2004, the recommendation of the Commission Report to improve the prevention of the diversion from the EU-internal trade of AA, the main drug precursor for heroin, by extending the registration requirement, which so far applies only to operators placing AA on the market, to also include users of the substance and by enhancing the harmonised registration provisions to achieve a more robust level playing field preserving the internal market and avoiding adoption of divergent national measures.
Revised version (Article 16 Information about measures adopted by Member States):
1. Member States shall inform the Commission of the measures they adopt pursuant to this Regulation, and in particular of the measures adopted pursuant to Articles 10 and 12. They shall also notify any subsequent amendments thereof. 2. The Commission shall communicate that information to the other Member States. 3. The Commission shall, by 31 December 2019, submit a report to the European Parliament and to the Council on the implementation and functioning of this Regulation, and in particular on the possible need for additional action to monitor and control suspicious transactions with non-scheduled substances.
Article 17 Repeals
1. Council Directive 92/109/EEC, Commission Directives 93/46/EEC, 2001/8/EC and 2003/101/EC and Commission Regulations (EC) No 1485/96 and (EC) No 1533/2000 are hereby repealed. 2. References to the repealed directives or regulations shall be construed as being made to this Regulation. 3. The validity of any register established, any licences granted and any customer declarations issued under the repealed directives or regulations shall not be affected.
Article 18 Entry into force
This Regulation shall enter into force on 18 August 2005, except for Articles 9, 14 and 15, which shall enter into force on the day of publication of this Regulation in the Official Journal of the European Union , in order to permit the adoption of the measures provided for in those Articles. Such measures shall enter into force at the earliest on 18 August 2005. This Regulation shall be binding in its entirety and directly applicable in all Member States.