Commission Delegated Regulation (EU) 2015/1011

law://eu/reg/2015/1011@2026-11-14

Contents

Article 1Subject matter#

This Regulation lays down conditions for granting licences and registrations, determines cases where a licence and a registration are not required, establishes the criteria to demonstrate the licit purpose of a transaction, determines the information required to monitor trade, fixes the conditions for determining the lists of the countries of destination for exports of scheduled substances of Categories 2 and 3, establishes the criteria for determining simplified procedures for pre-export notifications and for export authorisations and specifies the requirements concerning the information to be provided on the implementation of the monitoring measures as regards trade in drug precursors.

Article 2Definitions#

For the purposes of this Regulation, ‘business premises’ shall mean building(s) together with the land occupied by an operator at each single location.

Article 3Conditions for granting licences#

1.In order to obtain a licence pursuant to Article 6(1) of Regulation (EC) No 111/2005, the operator shall appoint an officer responsible for the trade in scheduled substances listed in Category 1 of the Annex to that Regulation, notify the competent authority of the name and contact details of that officer and notify them immediately of any subsequent modification of this information.The responsible officer shall ensure that import, export or intermediary activities take place in compliance with the pertinent legal provisions and shall be empowered to represent the operator and to take the decisions necessary for performing that task.

10.Paragraph 9 shall also apply to licences issued before the date of application of this Regulation.

11.Paragraphs 2 to 6 and 8, 9 and 10 shall also apply for the purpose of obtaining licences pursuant to Article 3(2) of Regulation (EC) No 273/2004, with the exception of special licences.

12.The public authorities referred to in Article 3(2) and (6) of Regulation (EC) No 273/2004 shall comprise customs, police and official laboratories of competent authorities.

2.The operator concerned shall fulfil all the following requirements and conditions:

(a)the operator shall take adequate measures against the unauthorised removal of scheduled substances of Category 1 of Annex I to Regulation (EC) No 273/2004 and of the Annex to Regulation (EC) No 111/2005 from the places of storage, production, manufacture and processing of scheduled substances and to secure business premises;

(b)the operator shall make an application containing the following:

(i)the full name, address, telephone and/or fax numbers and email address of the applicant;

(ii)the full name of the responsible officer and his/her contact details;

(iii)a description of the position and tasks of the responsible officer;

(iv)the full addresses of the business premises;

(v)the description of all the places where operations described under point (ix) take place;

(vi)information showing that the adequate measures referred to in paragraph 2(a) have been taken;

(vii)the name and the CN code of the scheduled substances as stated in Annex I to Regulation (EC) No 273/2004 and in the Annex to Regulation (EC) No 111/2005;

(viii)in the case of a mixture or natural product an indication of the following:

(a)the name of the mixture or natural product;

(b)the name and CN code of the scheduled substances as stated in Annex I to Regulation (EC) No 273/2004 and in the Annex to Regulation (EC) No 111/2005 contained in the mixture or natural product;

(c)the maximum percentage of such scheduled substances in the mixture or natural product;

(ix)a description of the envisaged type of operations referred to in Article 3 of Regulation (EC) No 273/2004 and in Article 6(1) of Regulation (EC) No 111/2005;

(x)an authenticated copy of the Register of companies or activities, where relevant;

(xi)a certificate of good conduct of the operator concerned and of the responsible officer or a document showing that they offer the necessary guarantee for the proper conduct of the operations or the information allowing the competent authority to obtain such document.

3.If the operator has already been granted the status of an Authorised Economic Operator in accordance with Article 5a of Council Regulation (EEC) No 2913/92^note; he may indicate the AEO certificate number when making the application for a licence for the purpose of the competent authority being able to take his AEO status into consideration.

4.Upon written request from the relevant competent authority, the applicant shall submit any relevant additional information.

5.Where the applicant is a natural person, points (ii) and (iii) of paragraphs 2(b) shall not apply, and point (iv) of paragraph 2(b) shall only apply where relevant.

6.Without prejudice to measures adopted in accordance with Article 10(1) of Regulation (EC) No 273/2004 and with Article 26(3) of Regulation (EC) No 111/2005, the competent authority shall refuse the granting of the licence if the conditions set out in Article 3(2)(b) of this Regulation are not fulfilled or if there are reasonable grounds for suspecting that the scheduled substances are intended for the illicit manufacture of narcotic drugs or psychotropic substances.

7.In the case of trade between the Union and third countries referred to in Regulation (EC) No 111/2005, the competent authority may either limit the validity of the licence to a period not exceeding three years or may require operators to demonstrate at intervals not exceeding three years that the conditions under which the licence was granted are still fulfilled.The validity of licences issued before the entry into force of this Regulation shall not be affected.

8.A licence shall not be transferable.

Article 4Cases where a licence is not required#

Pharmacies, dispensaries of veterinary medicine, customs, police, armed forces and official laboratories of competent authorities may be exempted from the requirement of licensing pursuant to Article 6(1) of Regulation (EC) No 111/2005 in so far as these operators use drug precursors within the scope of their official duties.The operators set out in the first paragraph are also exempted from the following:

(a)the provision of documentation referred to in Article 3 of Regulation (EC) No 111/2005;

(b)the obligation to appoint a responsible officer set out in Article 3(1) of this Regulation.

Article 5Conditions for granting registrations#

1.In order to obtain a registration pursuant to Article 7(1) of Regulation (EC) No 111/2005, the operator shall appoint an officer responsible for the trade in scheduled substances listed in Category 2 of the Annex to that Regulation, notify the competent authority of the name and contact details of that officer and notify them immediately of any subsequent modification of this information.The responsible officer shall ensure that import, export or intermediary activities take place in compliance with the pertinent legal provisions and shall be empowered to represent the operator and to take the decisions necessary for performing that task.

2.The operator of scheduled substances of Category 2 of the Annex to Regulation (EC) No 111/2005 shall make an application containing the information and documents as referred to in Article 3(2)(b) with the exception of points (vi), (x) and (xi).of Article 3(2)(b), unless so requested by the competent authority.The same applies to the operator engaged in the export of scheduled substances of Category 3 of the Annex to Regulation (EC) No 111/2005.

3.Article 3(3) and (4) shall also apply.

4.The first subparagraph of paragraph 2 and paragraph 3 shall apply mutatis mutandis to operators and users referred to in Article 3(6) of Regulation (EC) No 273/2004 in respect of scheduled substances of Category 2 of Annex I to that Regulation.

5.Users of scheduled substances of category 2A of Annex I to Regulation (EC) No 273/2004 shall also provide information on the use of the scheduled substances.

Article 6Cases where a registration is not required#

The following categories may be exempt from the registration requirement pursuant to Article 7(1) of Regulation (EC) No 111/2005:

(a)pharmacies, dispensaries of veterinary medicine, customs, police, official laboratories of competent authorities and armed forces, insofar as these operators use drug precursors within the scope of their official duties;

(b)operators engaged in the export of scheduled substances listed in Category 3 of the Annex to Regulation (EC) No 111/2005, if the sum of quantities concerned by their exports during the course of the preceding calendar year (1 January-31 December) does not exceed the amounts specified in Annex I to this Regulation. When those amounts are exceeded within the current calendar year, the operator shall comply with the registration requirement immediately;

(c)operators engaged in export of mixtures containing scheduled substances listed in Category 3 of the Annex to Regulation (EC) No 111/2005, if the amount of the scheduled substance contained in the mixtures does not exceed, during the course of the preceding calendar year, the amounts specified in Annex I to this Regulation. When those amounts are exceeded within the current calendar year, the operator shall comply with the registration requirement immediately.

Article 7Conditions for exemptions from certain requirements#

For the purposes of Article 6 of Regulation (EC) No 273/2004, customers shall inform their suppliers whether that Article is applicable to them.

Article 8Criteria for determining the licit purposes of a transaction#

1.The operator shall provide information that the consignment has left the country of export in accordance with the national provisions in force adopted pursuant to Article 12 of the Convention of the United Nations against illicit traffic in Narcotic Drugs and Psychotropic substances^note to demonstrate the licit purpose of his transaction pursuant to Article 8(1) of Regulation (EC) No 111/2005.

2.For that purpose, the operator shall either use the model set out in Annex II to this Regulation or present the import authorisation referred to in Article 20 of Regulation (EC) No 111/2005 or the customer declaration referred to in Article 4 of Regulation (EC) No 273/2004.

Article 9Information required to monitor trade#

1.For the purposes of Article 8(2) of Regulation (EC) No 273/2004 operators shall inform the competent authorities in a summary form of the quantities of scheduled substances used or supplied and, in the case of supply, of the quantity supplied to each third party.For scheduled substances of Category 3 of Annex I to Regulation (EC) No 273/2004, the first paragraph shall apply only upon request by the competent authorities.

2.For the purposes of Article 9(2) of Regulation (EC) No 111/2005, operators shall inform the competent authorities about the following:

(a)exports of scheduled substances subject to an export authorisation;

(b)all imports of scheduled substances of Category 1 of the Annex to Regulation (EC) No 111/2005 requiring an import authorisation or all cases where scheduled substances of Category 2 of the Annex to Regulation (EC) No 111/2005 are entered into a free zone of control type II, placed into a suspensive procedure other than transit, or released for free circulation;

(c)all intermediary activities involving scheduled substances of Categories 1 and 2 of the Annex to Regulation (EC) No 111/2005.

3.The information referred to in paragraph 2(a) shall be organised by making reference to the countries of destination, quantities exported and the reference numbers of the export authorisations as the case may be.

4.The information referred to in paragraph 2(b) shall be organised by making reference to the third country of export and the reference number of the import authorisations as the case may be.

5.The information referred to in paragraph 2(c) shall be organised by making reference to the third countries involved in these intermediary activities and the export or import authorisation as the case may be. Operators shall provide further information, upon request of the competent authorities.

6.The competent authorities shall treat the information referred to in this Article as confidential business information.

Article 10Conditions for determining the lists of the countries of destination for exports of scheduled substances of Categories 2 and 3#

The lists referred to in Article 11(1) of Regulation (EC) No 111/2005 shall include all of the following:

(a)third countries with whom the Union has concluded a specific agreement on drug precursors;

(b)third countries which have requested to receive pre-export notifications in accordance with Article 12(10) of the 1988 United Nations Convention against illicit traffic in narcotic drugs and psychotropic substances;

(c)third countries which have requested to receive pre-export notifications in accordance with Article 24 of the 1988 United Nations Convention against illicit traffic in narcotic drugs and psychotropic substances.

The lists of the specific countries of destination for export of scheduled substances listed in Categories 2 and 3 of the Annex referred to in points (a), (b) and (c) shall be published on the website of the Commission.

Article 11Criteria for determining simplified procedures for pre-export notifications#

1.Pursuant to Article 11(3) of Regulation (EC) No 111/2005, the competent authority may send a simplified pre-export notification covering several export operations carried out within a specific time period of either 6 or 12 months, in case of exports intended for the simplified export authorisation procedure.

2.The competent authority of the country of export shall supply the information specified in Article 13(1) of Regulation (EC) No 111/2005 to the competent authority of the third country of destination.

3.The competent authority shall inform the country of destination accordingly and use to that purpose the PEN-online system or the ‘Multilateral Chemical Reporting Notification’ set out in Annex III of this Regulation.

Article 12Criteria for determining simplified procedures for export authorisations#

1.Following an application by the operator concerned the competent authority may grant an export authorisation by simplified procedure pursuant to Article 19 of Regulation (EC) No 111/2005 in cases of frequent exports of one specific scheduled substance listed in Categories 3 and 4 of the Annex to that Regulation involving the same exporter established in the Union and the same importer in the same third country of destination covering a specific time period of either 6 or 12 months.Such simplified export authorisation may only be granted in the following cases:

(a)where during previous exports the operator has shown the capacity to fulfil all obligations in relation to those exports, and has not committed any offences against relevant legislation;

(b)where the competent authority can satisfy itself as to the licit purposes of those export operations.

2.The application for a simplified export authorisation shall contain at least the following:

(a)the names and addresses of the exporter, the importer in the third country, and the ultimate consignee;

(b)the name of the scheduled substance, as stated in the Annex to Regulation (EC) No 111/2005, or, in the case of a mixture or natural product, its name and CN code and the name of any scheduled substance, as stated in the Annex to Regulation (EC) No 111/2005, contained in the mixture or natural product;

(c)the maximum quantity of the scheduled substance intended for export;

(d)the intended specific time period for the export operations.

3.The competent authority shall take the decision on the application for simplified export authorisation within a period of 15 working days from the date on which it received the required information.

4.In case of emergency medical care, where the conditions under paragraph 1 (a) and (b) of this Article are fulfilled, the competent authority shall take the decision on the application for simplified export authorisation for exports of scheduled substances of Category 4 listed in the Annex to Regulation (EC) No 111/2005 immediately or at the latest within 3 working days after receipt of the application.

Article 13Conditions and requirements concerning the information to be provided on the implementation of the monitoring measures#

1.Member States shall submit the communications referred to in Article 32(1) of Regulation (EC) No 111/2005 and Article 13(1) of Regulation (EC) No 273/2004 to the Commission, in the month following each calendar quarter. The communications shall contain the information on all cases where the release of scheduled and non-scheduled substances was suspended or the scheduled and non-scheduled substances were detained.

2.That information shall include the following:

(a)the name of the substances;

(b)if known, the origin, provenance and destination of the substances;

(c)the quantity of the substances, their customs status and the means of transport used.

3.At the end of every calendar year, the Commission shall communicate to all Member States the information received pursuant to paragraph 1.

Article 14Repeal#

Regulation (EC) No 1277/2005 is repealed.

Article 15 #

This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.It shall apply from 1 July 2015.

Annex I

Substance	Quantity
Acetone^note	50 kg
Ethyl ether^note	20 kg
Methylethylketone^note	50 kg
Toluene^note	50 kg
Sulphuric acid	100 kg
Hydrochloric acid	100 kg

Annex II

European UnionDeclaration of the operator on the entry of the scheduled substances into the customs territory of the Union (Article 8 of Regulation (EC) No 111/2005)Article 12 of the United Nations’ Convention against illicit traffic in narcotic drugs and psychotropic substancesORIGINAL1. Operator (name, address, phone, fax, email)2.a. Country of export2.b. Transit country/countries2.c. Country of final destination3a. Exporter in the country of export (name, address, phone, fax, email)3b. Competent authority in country of export (name, address, phone, fax, email)4a. Importer in the country of destination (name, address, phone, fax, email)4b. Competent authority in the country import (name, address, phone, fax, email)5a. Scheduled Substance5a. CN Code5a. Net weight5a. % of mixture5b. Scheduled Substance5b. CN Code5b. Net weight5b. % of mixture6a. Bill of lading/Airway bill/or other transport document number of country of export6b. Reference number of the export authorisation of the exporter in the third country of export (optional)7. Declaration by the operator:Name: Representing: (operator) I hereby declare that — to my knowledge — the scheduled substances have left the country of export in accordance with the provisions in force adopted pursuant to Article 12 of the United Nations’ Convention against illicit traffic in narcotic drugs and psychotropic substances. The following supporting evidence is attached (optional):copy of export authorisation copy of licence/registrationSignature: Place: Date:

Notes1.The layout of the model is not binding.2.The order numbers and the text of the model are binding.3.Personal data protectionWhere the European Commission processes personal data contained in this document, Regulation (EC) No 45/2001 of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data by the Community Institutions and bodies and on the free movement of such data will apply.Where the competent authority of a Member State processes personal data contained in this document, the national provisions implementing Directive 95/46/EC will apply.The purpose of the processing of personal data is the monitoring of trade in drug precursors within the Union in accordance to Regulation (EC) No 273/2004 as amended by Regulation (EU) No 1258/2013, and between the Union and third countries in accordance with Regulation (EC) No 111/2005, as amended by Regulation (EU) No 1259/2013.The controller with respect to the processing of the data is the national competent authority where the present document has been submitted. The list of competent authorities is published on the website of the Commission:http://ec.europa.eu/taxation_customs/resources/documents/customs/customs_controls/drugs_precursors/legislation/national_competent_authorities.pdfIn accordance with Article 17 of Regulation (EC) No 111/2005 laying down rules for the monitoring of trade in drug precursors between the Union and third countries, without prejudice to applicable provisions on data protection in the Union and for the purpose of controlling and monitoring certain substances frequently used for the illicit manufacture of narcotic drugs or psychotropic substances, the Commission and the competent authorities of the Member States may share personal data and information contained in the present document with the relevant authorities in third countries.The data subject has a right of access to the personal data relating to him or her that will be processed and, where appropriate, the right to rectify erase or block personal data in accordance with Regulation (EC) No 45/2001 or the national laws implementing Directive 95/46/EC.All requests for the exercise of the right of access, rectification, erasure or blocking shall be submitted to and processed by the competent authorities where the present document was submitted.The legal basis for processing the personal data is Article 33 of Regulation (EC) No 111/2005 and Article 13b of Regulation (EC) No 273/2004.Personal data contained in the present document shall not be retained longer than necessary for the purposes for which it was collected.Complaints, in case of conflict, can be addressed to the relevant national data protection authority. The contact details of the national data protection authorities are available on the web-site of the European Commission, Directorate-General for Justice (http://ec.europa.eu/justice/data-protection/bodies/authorities/eu/index_en.htm#h2-1).Where the complaint concerns processing of personal data by the European Commission, it should be addressed to the European Data Protection Supervisor:(http://www.edps.europa.eu/EDPSWEB/).

III

MULTILATERAL CHEMICAL REPORTING NOTIFICATION1. ACTION ADDRESSEE2. Additional addressee3. Additional addressee4. Name5. Agency (name and address)6. Country7. Telephone8. Fax9. Email10. Signature and date11. This shipment WILL/ WILL NOT proceed if a reply is not received within … days.12. Does your office have any objection to this shipment? Yes No Further inquiries required If YES, please provide details and reasonsPART AThis multilateral chemical reporting notification covers:one export operation, orseveral export operations to be carried out within a specific time frame (Beginning: End: ).13. Name of scheduled substance14. Quantity and weight15. CN code16. Exporting country17. Point of exit18. Departure date19. Importing country20. Point of entry21. Estimated arrival date22. Transhipment route (including Free Zones, and Final Destination)23. Means of transport:24. Importer (name, address, telephone and fax)25. Import/export authorisation number26. Ultimate consignee (name, address, telephone and fax)27. Other remarksPART B28. Exporter, manufacturer or supplier (name, address, telephone and fax)29. Intermediaries (name, address, telephone and fax)30. Transit companies (name, address, telephone and fax)31. Transportation details (Flight No/vessel, etc.)

Notes1.The layout of the model is not binding.2.The order numbers and the text of the model are binding. The completion of the boxes marked in bold is mandatory.3.Further details of the boxes:

Box ‘Part A’: Indicate whether the MCRN covers one or several export operations. Where it covers several operations, indicate the intended time frame.

Box 14 (quantity and weight): In the case of a MCRN to cover several export operations, indicate the maximum quantity and weight.

Item 18 (Departure date): In the case of a MCRN to cover several export operations, this box must be filled out indicating the final estimated departure date.

4.Personal data protectionWhere the European Commission processes personal data contained in this document, Regulation (EC) No 45/2001 of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data by the Community Institutions and bodies and on the free movement of such data will apply.Where the competent authority of a Member State processes personal data contained in this document, the national provisions implementing Directive 95/46/EC will apply.The purpose of the processing of personal data is the monitoring of trade in drug precursors within the Union in accordance to Regulation (EC) No 273/2004 as amended by Regulation (EU) No 1258/2013, and between the Union and third countries in accordance with Regulation (EC) No 111/2005, as amended by Regulation (EU) No 1259/2013.The controller with respect to the processing of the data is the national competent authority where the present document has been submitted. The list of competent authorities is published on the website of the Commission:http://ec.europa.eu/taxation_customs/resources/documents/customs/customs_controls/drugs_precursors/legislation/national_competent_authorities.pdfIn accordance with Article 17 of Regulation (EC) No 111/2005 laying down rules for the monitoring of trade in drug precursors between the Union and third countries, without prejudice to applicable provisions on data protection in the Union and for the purpose of controlling and monitoring certain substances frequently used for the illicit manufacture of narcotic drugs or psychotropic substances, the Commission and the competent authorities of the Member States may share personal data and information contained in the present document with the relevant authorities in third countries.The data subject has a right of access to the personal data relating to him or her that will be processed and, where appropriate, the right to rectify erase or block personal data in accordance with Regulation (EC) No 45/2001 or the national laws implementing Directive 95/46/EC.All requests for the exercise of the right of access, rectification, erasure or blocking shall be submitted to and processed by the competent authorities where the present document was submitted.The legal basis for processing the personal data is Article 33 of Regulation (EC) No 111/2005 and Article 13b of Regulation (EC) No 273/2004.Personal data contained in the present document shall not be retained longer than necessary for the purposes for which it was collected.Complaints, in case of conflict, can be addressed to the relevant national data protection authority. The contact details of the national data protection authorities are available on the web-site of the European Commission, Directorate-General for Justice (http://ec.europa.eu/justice/data-protection/bodies/authorities/eu/index_en.htm#h2-1).Where the complaint concerns processing of personal data by the European Commission, it should be addressed to the European Data Protection Supervisor:(http://www.edps.europa.eu/EDPSWEB/).

Article 1Subject matter#

Article 2Definitions#

Article 3Conditions for granting licences#

Article 4Cases where a licence is not required#

Article 5Conditions for granting registrations#

Article 6Cases where a registration is not required#

Article 7Conditions for exemptions from certain requirements#

Article 8Criteria for determining the licit purposes of a transaction#

Article 9Information required to monitor trade#

Article 10Conditions for determining the lists of the countries of destination for exports of scheduled substances of Categories 2 and 3#

Article 11Criteria for determining simplified procedures for pre-export notifications#

Article 12Criteria for determining simplified procedures for export authorisations#

Article 13Conditions and requirements concerning the information to be provided on the implementation of the monitoring measures#

Article 14Repeal#

Defined terms · 1

Connections

History · 1 version

Key facts

Article 1Subject matter#

Article 2Definitions#

Article 3Conditions for granting licences#

Article 4Cases where a licence is not required#

Article 5Conditions for granting registrations#

Article 6Cases where a registration is not required#

Article 7Conditions for exemptions from certain requirements#

Article 8Criteria for determining the licit purposes of a transaction#

Article 9Information required to monitor trade#

Article 10Conditions for determining the lists of the countries of destination for exports of scheduled substances of Categories 2 and 3#

Article 11Criteria for determining simplified procedures for pre-export notifications#

Article 12Criteria for determining simplified procedures for export authorisations#

Article 13Conditions and requirements concerning the information to be provided on the implementation of the monitoring measures#

Article 14Repeal#