COMMISSION REGULATION (EC) No 1277/2005
of 27 July 2005
laying down implementing rules for Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug precursors and for Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Community and third countries in drug precursors
(Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004 on drug precursors (1), and in particular Article 14(a) and (f) thereof,
Having regard to Council Regulation (EC) No 111/2005 of 22 December 2004 laying down rules for the monitoring of trade between the Community and third countries in drug precursors (2), and in particular the third subparagraph of Article 6(1), Articles 7(2), 8(2) and 9(2), Article 11(1) and (3), the third subparagraph of Article 12(1) and Articles 19 and 28 thereof,
Whereas:
(1)
Council Regulation (EEC) No 3677/90 of 13 December 1990 laying down measures to be taken to discourage the diversion of certain substances to the illicit manufacture of narcotic drugs and psychotropic substances (3) which was implemented by Commission Regulation (EEC) No 3769/92 of 21 December 1992 implementing and amending Council Regulation (EEC) No 3677/90 laying down measures to be taken to discourage the diversion of certain substances to the illicit manufacture of narcotic drugs and psychotropic substances (4) has been replaced by Regulation (EC) No 111/2005. It is necessary to bring the implementing measures contained in Regulation (EEC) No 3769/92 in line with the new set of rules provided for in Regulation (EC) No 111/2005. Regulation (EEC) No 3769/92 should therefore be repealed.
(2)
Regulation (EC) No 273/2004 on drug precursors, which replaces Council Directive 92/109/EEC (5), harmonises the provisions concerning the placing on the market of certain substances used in the illicit manufacture of narcotic drugs and psychotropic substances within the Community. In order to enhance the smooth operation of the internal market, for the trade in drug precursors, the provisions for the application for a licence, the granting or refusal of the granting of a licence, its suspension or revocation, should be harmonised at Community level.
(3)
It is important to avoid the unauthorised removal of Category 1 substances, and therefore the business premises where these substances are stored or used should be secured against the unauthorised removal.
(4)
The types of operators engaged in intra-Community trade who may benefit from special licences and special registrations should be further determined. The cases where operators engaged in trade between the Community and third countries may be exempted from the licensing and registration requirement should be determined.
(5)
The provisions governing the licence conditions and the notification obligations of operators engaged in intra-Community trade and trade between the Community and third countries should to the extent possible be identical.
(6)
Provisions should be set up allowing to verify the licit purposes of all drug precursor consignments entering the Community customs territory, including, in particular, transit and transhipment consignments and sensitive areas such as Community free zones.
(7)
Specific import authorisation procedures are necessary to monitor individual import consignments of Category 1 substances in order to prevent diversion at an early stage and in particular to address the growing problem of amphetamine-type stimulants.
(8)
Detailed rules concerning pre-export notification should allow it to adapt the information transfer and the necessary type of response to the sensitivity of the export consignment. In order to fully exploit the pre-export notification and export authorisation system, efforts should in principle target high risk consignments. Detailed rules on the simplified use of pre-export notifications and the granting of export authorisations by simplified procedure should allow the easening of the administrative burden for mass chemicals with common licit uses.
(9)
In view of an efficient monitoring of trade Member States should enable the competent authorities to perform their tasks efficiently and to exchange information between themselves.
(10)
To improve the coordination of the monitoring of drug precursors it is appropriate that the Member States provide the Commission regularly with information on the prevention of the diversion of drug precursors.
(11)
This Regulation should apply from the same date as Regulation (EC) No 273/2004 and Regulation (EC) No 111/2005.
(12)
The measures provided for in this Regulation are in accordance with the opinion of the drug precursors committee,
HAS ADOPTED THIS REGULATION:
CHAPTER I
GENERAL PROVISIONS
Article 1
This Regulation lays down rules for the implementation of Regulations (EC) No 273/2004 and (EC) No 111/2005 as regards the responsible officer, the licensing and registration of operators, the provision of information, pre-export notifications and authorisation of exports and imports in the field of drug precursors.
Article 2
For the purposes of this Regulation, in addition to the definitions contained in regulations (EC) No 273/2004 and (EC) No 111/2005 ‘business premises’ shall mean building(s) together with the land occupied by an operator at a single location.
CHAPTER II
RESPONSIBLE OFFICER
Article 3
Operators engaged in import, export or intermediary activities referred to in Article 2 of Regulation (EC) No 111/2005 involving scheduled substances of Category 1 or 2, shall appoint an officer responsible for the trade in scheduled substances, notify the competent authorities of the name and contact details of that officer and notify them immediately of any subsequent modification of this information.
Article 4
The responsible officer referred to in Article 3 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.
CHAPTER III
LICENSING AND REGISTRATION OF OPERATORS
Article 5
1. In order to obtain a licence pursuant to Article 3(2) of Regulation (EC) No 273/2004 the operator concerned shall make an application in writing.
That application shall contain the following:
(a)
the full name and address of the applicant;
(b)
the full name of the responsible officer;
(c)
a description of the position and tasks of the responsible officer;
(d)
the full addresses of the business premises;
(e)
the description of all the places of storage, production, manufacture and processing of scheduled substances;
(f)
information showing that adequate measures have been taken against the unauthorised removal of scheduled substances from the places listed in point (e);
(g)
the name and the CN code of the scheduled substances as stated in Annex I to Regulation (EC) No 273/2004;
(h)
in the case of a mixture or natural product an indication of the following:
(i)
the name of the mixture or natural product;
(ii)
the name and CN code of the scheduled substances as stated in Annex I to Regulation (EC) No 273/2004 in the mixture or natural product;
(iii)
the maximum percentage of such scheduled substances in the mixture or natural product;
(i)
a description of the envisaged type of operations referred to in Article 3 of Regulation (EC) No 273/2004;
(j)
an authenticated copy of the Register of companies or activities, where appropriate;
(k)
a certificate of good conduct of the applicant and the responsible officer or a document showing that they offer the necessary guarantee for the proper conduct of the operations, as appropriate.
The applicant shall provide the competent authorities, upon their request, with access to relevant additional information and documents.
2. Paragraph 1 shall apply as regards licences referred to in Article 6(1) of Regulation (EC) No 111/2005.
For the purposes of point (e) of paragraph 1, the application shall contain a description of all places of storage, working, processing, usual forms of handling and use of scheduled substances.
For the purposes of point (g) and point (h)(ii) of paragraph 1 the name and CN code of the scheduled substances as stated in the Annex to Regulation (EC) No 111/2005 shall be given.
For the purposes of point (i) of paragraph 1, a description of the envisaged type of operations referred to in Article 6(1) of Regulation (EC) No 111/2005 shall be given.
Article 6
Operators shall take adequate measures to secure the business premises against the unauthorised removal of scheduled substances listed in Category 1.
Article 7
1. The competent authority shall take a decision on the application for the licences referred to in Article 5 within 60 working days from the date of receipt of that application.
In the case of a renewal of a licence, the decision shall be taken within 30 working days.
2. The competent authority may suspend the periods referred to in paragraph 1 to allow the applicant to provide any missing information. In that case the suspension shall begin on the day when the competent authority informs the applicant about the missing information.
3. The licence may cover the operations referred to in Regulation (EC) No 273/2004 and Regulation (EC) No 111/2005.
4. When granting the licence, the competent authorities shall use the model set out in Annex I.
5. The competent authorities may grant a licence in either of the following forms:
(a)
a licence which covers all scheduled substances and all operations per business premises;
(b)
a licence which covers all scheduled substances and all operations per Member State.
Article 8
1. Provided that measures adopted in accordance with Article 10 of Regulation (EC) No 273/2004 are not prejudiced, the competent authorities shall refuse the granting of the licence if the conditions set out in Article 5(1) 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.
2. Subject to Article 5(2), paragraph 1 of this Article shall apply in respect of applications under Regulation (EC) No 111/2005 and provided that measures adopted in accordance with Article 26(3) of that Regulation are not prejudiced.
Article 9
In the case of trade between the Community and third countries referred to in Regulation (EC) No 111/2005, the competent authorities 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 Regulation (EC) No 111/2005 shall not be affected.
Article 10
1. A licence shall not be transferable.
2. The licence holder shall, in accordance with Article 5, apply for a new licence where any of the following are envisaged:
(a)
the addition of a scheduled substance;
(b)
the start of a new operation;
(c)
the change of the location of the business premises where the operations take place.
In such cases, the existing licence shall cease to be valid on the earlier of the following dates:
(i)
the date of expiry of validity where a term of validity has been fixed in accordance with Article 9 of this Regulation or in accordance with Article 3(5) of Regulation (EC) No 273/2004;
(ii)
the date of commencement of validity of the new licence.
3. In cases of changes of the information provided in accordance with Article 5 other than those referred to in paragraph 2 of this Article, in particular the name of the responsible officer, the licence holder shall inform the competent authorities within 10 working days following such change.
Where, after the change, the conditions referred to in Article 5 continue to be fulfilled, the competent authorities shall amend the licence accordingly.
4. Licence holders shall return licences which are no longer valid to the competent authorities.
5. Paragraph 2 shall apply to licences issued before the date of application of Regulation (EC) No 273/2004 and Regulation (EC) No 111/2005.
Article 11
1. Provided that measures adopted in accordance with Article 10 of Regulation (EC) No 273/2004 are not prejudiced, the competent authorities may suspend or revoke a licence in the following cases:
(a)
the conditions set out in Article 5(1) of this Regulation are no longer fulfilled;
(b)
there are reasonable grounds for suspecting that the scheduled substances are intended for the illicit manufacture of narcotic drugs or psychotropic substances;
(c)
the licence holder has not used the licence for a period of three years.
2. Subject to Article 5(2), paragraph 1 of this Article shall apply in respect of licences under Regulation (EC) No 111/2005 and provided that measures adopted in accordance with Article 26(3) of that Regulation are not prejudiced.
Article 12
1. Articles 5 to 11 shall not apply to special licences referred to in Article 3(2) of Regulation (EC) No 273/2004.
2. 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.
Article 13
Pharmacies, dispensaries of veterinary medicine, customs, police, official laboratories of competent authorities and armed forces shall be exempted from the requirement of licensing and registration under Regulation (EC) No 111/2005 where these operators use drug precursors within the scope of their official duties, only.
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 of this Regulation.
Article 14
1. Operators engaged in the export of scheduled substances listed in Category 3 of the Annex to Regulation (EC) No 111/2005 shall be exempt from the registration requirement referred to in Article 7(1) of that Regulation 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 II to this Regulation.
When those amounts are exceeded within the current calendar year, the operator shall comply with the registration requirement immediately.
2. Operators engaged in export of mixtures containing scheduled substances listed in Category 3 of the Annex to Regulation (EC) No 111/2005, shall be exempt from the registration requirement referred to in Article 7(1) of that Regulation 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 II to this Regulation.
When those amounts are exceeded within the current calendar year, the operator shall comply with the registration requirement immediately.
Article 15
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 16
Where, pursuant to Article 8(1) of Regulation (EC) No 111/2005, the competent authorities request the licit purposes of the transaction to be demonstrated, the operator shall, using the model set out in Annex III to this Regulation, provide a written declaration allowing the competent authorities to satisfy themselves 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 (hereinafter the United Nations Convention).
However, the operator may also 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.
CHAPTER IV
PROVISION OF INFORMATION
Article 17
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.
The first paragraph shall apply to scheduled substances of Category 3, only upon request by the competent authorities.
Article 18
1. For the purposes of Article 9(2) of Regulation (EC) No 111/2005 operators holding a licence or registration 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 requiring an import authorisation or all cases where scheduled substances of Category 2 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.
2. The information referred to in point (a) of paragraph 1 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.
3. The information referred to in point (b) of paragraph 1 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.
4. The information referred to in point (c) of paragraph 1 shall be organised by making reference to the third countries involved by 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.
Article 19
The information referred to in Articles 17 and 18 shall be provided once a year before 15 February.
The operator shall also inform the competent authorities, where no operations have taken place.
The information shall be treated as confidential business information.
CHAPTER V
PRE-EXPORT NOTIFICATION
Article 20
Lists as referred to in Article 11(1) of Regulation (EC) No 111/2005 shall at least involve the following:
(a)
countries with whom the Community 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 United Nations Convention.
Such lists are set out in Annex IV.
Article 21
1. In the case of exports intended for the simplified export authorisation procedure referred to in Article 19 of Regulation (EC) No 111/2005 and Articles 25, 26 and 27 of this Regulation, the competent authorities may send a simplified pre-export notification covering several export operations carried out within a specific time period of either 6 or 12 months.
2. The competent authorities shall supply the information specified in Article 13(1) of Regulation (EC) No 111/2005 and indicate to the competent authorities of the third country of destination that the pre-export notification covers several export operations carried out within a specific time period of either 6 or 12 months.
3. The competent authorities shall send a pre-export notification to the country of destination using the ‘multilateral chemical reporting notification’ form set out in Annex V.
CHAPTER VI
EXPORT/IMPORT AUTHORISATION
Article 22
The countries of destination of exports of scheduled substances listed in Category 3 requiring an export authorisation are set out in Annex IV.
Article 23
1. Export and import authorisations shall be made out on the forms given in Annex VI and Annex VII respectively. The layout of the forms shall be binding.
An export or import authorisation may also be granted by electronic means. In that case Member States may adapt the box relating to the authorisation number.
2. An export authorisation shall be established in four copies numbered 1 to 4.
Copy No 1 shall be kept by the authority issuing the authorisation.
Copies No 2 and No 3 shall accompany the scheduled substances and be presented to the customs office where the customs export declaration is made and subsequently to the competent authorities at the point of exit from the customs territory of the Community. The competent authorities at the point of exit shall return Copy No 2 to the issuing authority. Copy No 3 shall accompany the scheduled substances to the competent authority of the importing country.
Copy No 4 shall be kept by the exporter.
3. The import authorisation shall be established in four copies numbered 1 to 4.
Copy No 1 shall be kept by the authority issuing the authorisation.
Copy No 2 shall be sent to the competent authority of the exporting country by the issuing authority.
Copy No 3 shall accompany the scheduled substances from the point of entry into the Community customs territory to the business premises of the importer, who sends this copy to the issuing authority.
Copy No 4 shall be kept by the importer.
4. An export or import authorisation shall not be granted for more than two scheduled substances.
Article 24
1. The authorisation forms shall be printed in one or more of the official languages of the Community.
2. The forms shall be A4 format. It shall have a printed guilloche pattern background making any falsification by mechanical or chemical means apparent to the eye.
3. Member States may reserve the right to print the authorisation forms themselves or may have them printed by printers approved by them. In the latter case, each authorisation form must include a reference of such approval. In addition, the authorisation form must bear the name and address of the printer or a mark by which the printer can be identified.
Article 25
On an application by the operator concerned the competent authority may grant an export authorisation by simplified procedure, as referred to in Article 19 of Regulation (EC) No 111/2005, in cases of frequent exports of one specific scheduled substance listed in Category 3 involving the same exporter established in the Community 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.
Article 26
1. The application for a simplified export authorisation referred to in Article 25 shall contain at least the following:
(a)
the names and addresses of the exporter, 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.
2. 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.
Article 27
1. An export authorisation granted by simplified procedure shall be established using copies No 1, 2 and 4 of the form set out in Annex VI.
Copy No 1 shall be kept by the authority issuing the authorisation.
Copy No 2 and Copy No 4 shall remain with the exporter.
The exporter shall indicate details of each export operation on the back side of Copy No 2, in particular the quantity of the scheduled substance of each export operation and the remaining quantity. Copy No 2 shall be presented to the customs office when the customs declaration is made. That customs office shall confirm the details and return the copy to the exporter.
2. The operator shall enter the authorisation number and the words ‘simplified export authorisation procedure’ on the customs declaration for each export operation.
Where the customs office of exit is not at the point of exit from the customs territory of the Community, the information referred to in the first subparagraph shall be provided on the documents accompanying the export consignment.
3. The exporter shall return Copy No 2 to the issuing authority at the latest 10 working days following the expiry of the period of validity of the export authorisation granted by simplified procedure.
CHAPTER VII
FINAL PROVISIONS
Article 28
1. Each Member State shall adopt the measures necessary to enable the competent authorities to perform their control and monitoring duties, including inspections to examine the suitability of the business premises.
2. The Member States shall ensure the exchange of information between all authorities involved.
Article 29
1. In the month following each calendar quarter, each Member State shall send the Commission a list providing information on the cases where the release of scheduled substances was suspended or the scheduled substances were detained.
That information shall include the following:
(a)
the of name of the scheduled substances; if known their origin, provenance and destination;
(b)
the quantity of the scheduled substances, their customs status and the means of transport used.
2. At the end of every calendar year, the Commission shall communicate to all Member States the information received pursuant to paragraph 1.
Article 30
Regulation (EEC) No 3769/92 is repealed with effect from 18 August 2005.
References to the repealed Regulation shall be construed as references to this Regulation.
Article 31
By 31 December 2005 at the latest, the competent authorities shall revoke open individual export authorisations granted pursuant to Articles 5(3) and 5a(3) of Regulation (EEC) No 3677/90. Such revocation shall not, however, affect scheduled substances which have been declared for export before 1 January 2006.
Article 32
This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.
It shall apply from the 18 August 2005.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 27 July 2005.