
Article 1 
This Regulation establishes harmonised measures  in the United Kingdom for the  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 
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 regulation 2 (medicinal products) of the Human Medicines Regulations 2012  and veterinary medicinal products as defined in regulation 2 of the Veterinary Medicines Regulations 2013 ;
((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  United Kingdom; or the storage, manufacture, production, processing, trade, distribution or brokering of these substances for the purpose of supply in the  United Kingdom;
((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.
Article 3 

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 ... 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 ... 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 ... 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.
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8. The Secretary of State may prescribe by regulations  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) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .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.
Article 4 

1. Without prejudice to paragraph 4 of this Article, and to Articles 6 and 14, any operator established within the  United Kingdom  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  United Kingdom  and shall be presented on request to the authorities responsible for checking vehicle contents during transport operations.
4. The Secretary of State may prescribe by regulations requirements and conditions for obtaining and using customer declarations.
Article 5 

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 Secretary of State may prescribe by regulations requirements and conditions for the documentation of mixtures containing scheduled substances.
Article 6 
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 
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 Secretary of State may prescribe by regulations requirements and conditions for the labelling of mixtures containing scheduled substances.
Article 8 

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 Secretary of State may prescribe by regulations 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 

1. The Secretary of State must  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 
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Article 11 
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Article 12 
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Article 13 

1. To permit the necessary adjustments to the arrangements for monitoring trade in scheduled substances and non-scheduled substances, the Secretary of State must draw up a report annually summarising all relevant information on the implementation of the monitoring measures laid down in this Regulation, in particular as regards the 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 report mentioned in paragraph 1 must be submitted by the Secretary of State to the International Narcotics Control Board in accordance with article 12(12) of the United Nationals Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, adopted in Vienna on 19 December 1988.
Article 13a 
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Article 13b 

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2. Without prejudice to the Data Protection Act 2018, personal data obtained or processed pursuant to this Regulation shall be used solely for the purpose of preventing the diversion of scheduled substances.
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Article 14 
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Article 14a 
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Article 15 
The Secretary of State may make regulations to amend  Annexes I, II and III to new trends in diversion of drug precursors and to follow any amendment to the tables in the Annex to the United Nations Convention.
Article 15a 

1. A power of the Secretary of State to make regulations under this Regulation is to be exercised by statutory instrument which may not be made unless a draft of the instrument has been laid before, and approved by a resolution of, each House of Parliament.
2. Regulations may make different provision for different purposes and may include such incidental, supplemental, consequential, transitional, transitory or saving provision as the Secretary of State considers appropriate.
Article 16 
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Article 17 

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 
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.
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ANNEX I
Substance CN designation(if different) CN code CAS No
1-phenyl-2-propanone Phenylacetone 2914 31 00 103-79-7
Methyl alpha-phenylacetoacetate (MAPA)   2918 30 00 16648-44-5
Methyl 2-methyl-3-phenyloxirane-2-carboxylate(BMK methyl glycidate)  2918 99 90 80532-66-7
2-methyl-3-phenyloxirane-2-carboxylic acid(BMK glycidic acid)  2918 99 90 25547-51-7
N-acetylanthranilic acid 2-acetamidobenzoic acid 2924 23 00 89-52-1
Alpha-phenylacetoacetamide (APAA)   2924 29 70 4433-77-6
Alpha-phenylacetoacetonitrile (APAAN)
                             
                              2926 40 00 
                              4468-48-8
Isosafrol (cis + trans)  2932 91 00 120-58-1
3,4-methylenedioxyphenylpropan-2-one 1-(1,3-Benzodioxol-5-yl)propan-2-one 2932 92 00 4676-39-5
Piperonal  2932 93 00 120-57-0
Safrole  2932 94 00 94-59-7
Methyl 3-(1,3-benzodioxol-5-yl)-2-methyloxirane-2-carboxylate (PMK methyl glycidate   2932 99 00 13605-48-6
 3-(1,3-benzodioxol-5-yl)-2-methyloxirane-2-carboxylic acid (PMK glycidic acid)   2932 99 00 2167189-50-4
4-anilino-
                              
                                 N
                              
                              -phenethylpiperidine (ANPP)
                             
                              2933 39 99
                            
                              21409-26-7
                           

                                 N
                              
                              -phenethyl-4-piperidone (NPP)
                             
                              2933 39 99
                            
                              39742-60-4
Ephedrine  2939 41 00 299-42-3
Pseudoephedrine  2939 42 00 90-82-4
Norephedrine  2939 44 00 14838-15-4
Ergometrine  2939 61 00 60-79-7
Ergotamine  2939 62 00 113-15-5
Lysergic acid  2939 63 00 82-58-6
The stereoisomeric forms of the substances listed in this category not being cathine, whenever the existence of such forms is possible.
The salts of the substances listed in this category, whenever the existence of such salts is possible and not being the salts of cathine.
(1R,2S)-(-)-chloroephedrine
                             2939 79 90 
                              110925-64-9
                           

                              (1S,2R)-(+)-chloroephedrine
                             2939 79 90 
                              1384199-95-4
                           

                              (1S,2S)-(+)-chloropseudoephedrine
                             2939 79 90 
                              73393-61-0
                           

                              (1R,2R)-(-)-chloropseudoephedrine
                             2939 79 90 
                              771434-80-1





                                 SUBCATEGORY 2A
                              

                              Substance
                            
                              CN designation
                              (if different)
                            
                              CN code
                               
                              CAS No
                              

                              Acetic anhydride
                             
                              2915 24 00
                            
                              108-24-7
                           

                              The salts of the substances listed in this category, whenever the existence of such salts is possible.
                           

                                 SUBCATEGORY 2B
                              

                              Substance
                            
                              CN designation
                              (if different)
                            
                              CN code
                               
                              CAS No
                              

                              Phenylacetic acid
                             
                              2916 34 00
                            
                              103-82-2
                           

                              Anthranilic acid
                             ex 2922 43 00 
                              118-92-3
                           

                              Piperidine
                             
                              2933 32 00
                            
                              110-89-4
                           

                              Potassium permanganate
                             
                              2841 61 00
                            
                              7722-64-7
                           

                              The salts of the substances listed in this category, whenever the existence of such salts is possible.


Substance CN designation(if different) CN code CAS No
Hydrochloric acid Hydrogen chloride 2806 10 00 7647-01-0
Sulphuric acid  2807 00 00 7664-93-9
Toluene  2902 30 00 108-88-3
Ethyl ether Diethyl ether 2909 11 00 60-29-7
Acetone  2914 11 00 67-64-1
Methylethylketone Butanone 2914 12 00 78-93-3
The salts of the substances listed in this category, whenever the existence of such salts is possible and not being the salts of hydrochloric acid and sulphuric acid.


ANNEX II

Substance Threshold
Acetic anhydride 100 l
Potassium permanganate 100 kg
Anthranilic acid and its salts 1 kg
Phenylacetic acid and its salts 1 kg
Piperidine and its salts 0,5 kg
ANNEX III
1. 
2. 