SECTION 1 — Documentation and labelling
All imports, exports or intermediary activities involving scheduled substances shall be documented by the operators by way of customs and commercial documents, such as summary declarations, customs declarations, invoices, cargo manifests, transport and other shipping documents.
Those documents shall contain the following information:
(a)
the name of the scheduled substance as stated in the Annex, or, in the case of a mixture or a natural product, its name and the name of any scheduled substance, as stated in the Annex, contained in the mixture or in the natural product, followed by the term ‘DRUG PRECURSORS’;
(b)
the quantity and weight of the scheduled substance and, in the case of a mixture or a natural product, the quantity, weight, and, if available, the percentage of any scheduled substance contained therein; and
(c)
the names and addresses of the exporter, the importer, the ultimate consignee and, where applicable, the person involved in the intermediary activities.
The documentation referred to in Article 3 shall be kept by the operators for a period of three years from the end of the calendar year in which the operation took place. The documentation shall be organised in such a way, electronically or in paper form, that it is readily available for inspection by the competent authorities upon request. The documentation may be provided via image medium or other data medium, provided that the data, when made readable, match the documentation in appearance and content, are available at all times, can be made readable without delay and can be analysed by automated means.
Operators shall ensure that labels are affixed on any packaging containing scheduled substances indicating their name as stated in the Annex, or, in the case of a mixture or a natural product, its name and the name of any scheduled substance, as stated in the Annex, contained in the mixture or in the natural product. Operators may, in addition, affix their customary labels.
SECTION 2 — Licensing and registration of operators
1. Operators established in the Community, other than customs agents and transporters when acting solely in that capacity, engaged in import, export or intermediary activities involving scheduled substances listed in Category 1 of the Annex, shall hold a licence. The licence shall be issued by the competent authority of the Member State in which the operator is established.
In considering whether to grant a licence, the competent authority shall take into account the competence and integrity of the applicant.
The committee procedure shall be used to lay down provisions determining cases where a licence is not required, setting out further conditions for the granting of licences and establishing a model for licences. These provisions shall guarantee a systematic and consistent control and monitoring of operators.
2. The licence may be suspended or revoked by the competent authorities whenever the conditions under which the licence was issued are no longer fulfilled or where there are reasonable grounds for suspecting that there is a risk of diversion of scheduled substances.
1. Operators established in the Community, other than customs agents and transporters when acting solely in that capacity, engaged in import, export or intermediary activities involving scheduled substances listed in Category 2 of the Annex, or in the export of scheduled substances listed in Category 3 of the Annex, shall register immediately and update as necessary the addresses of the premises at which they conduct those activities. This obligation shall be carried out with the competent authority in the Member State in which the operator is established.
2. The committee procedure shall be used to establish the conditions for exemption from the controls of certain categories of operators and of operators engaged in the export of small quantities of scheduled substances listed in Category 3. These conditions shall ensure that the risk of diversion of scheduled substances is minimised.
1. When the scheduled substances are entered into the customs territory of the Community for unloading or transhipment, for temporary storage, for their storage in a free zone of control type I or a free warehouse, or for their placing under the Community external transit procedure, the licit purposes must be demonstrated by the operator, upon request by the competent authorities.
2. The committee procedure shall be used to establish the criteria to determine how the licit purposes of the transaction may be demonstrated, in order to ensure that all movements of scheduled substances within the Community customs territory can be monitored by the competent authorities and the risk of diversion be minimised.
SECTION 3 — Provision of information
1. Operators established in the Community shall notify the competent authorities immediately of any circumstances, such as unusual orders and transactions involving scheduled substances, which suggest that such substances intended for import, export or intermediary activities might be diverted for the illicit manufacture of narcotic drugs or psychotropic substances.
2. Operators shall provide the competent authorities with information in summary form about their export, import or intermediary activities. The committee procedure shall be used to determine the information that is required by the competent authorities in order to allow them to monitor these activities.
1. In order to facilitate cooperation between the competent authorities of the Member States, operators established in the Community and the chemical industry, in particular as regards non-scheduled substances, the Commission shall, in consultation with the Member States, draw up and update guidelines.
2. These guidelines shall provide, in particular:
(a)
information on how to identify 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.
3. The competent authorities shall ensure that the guidelines are regularly disseminated in accordance with the objectives of these guidelines.
SECTION 4 — Pre-export notification
1. All exports of scheduled substances listed in Category 1 of the Annex and exports of scheduled substances listed in Categories 2 and 3 of the Annex to certain countries of destination, shall be preceded by a pre-export notification sent from the competent authorities in the Community to the competent authorities of the country of destination, in accordance with Article 12(10) of the United Nations Convention. The committee procedure shall be used to determine the list of the countries of destination in order to minimise the risk of diversion by ensuring systematic and consistent monitoring of exports of scheduled substances to these countries.
The country of destination shall be allowed a period of 15 working days to reply, at the end of which the export operation may be authorised by the competent authorities of the Member State of export, if no advice from the competent authorities of the country of destination is received indicating that this export operation might be intended for the illicit manufacture of narcotic drugs or psychotropic substances.
2. In the case of the scheduled substances to be notified in accordance with paragraph 1, the competent authorities of the Member State concerned shall, prior to the export of such substances, supply the information specified in Article 13(1) to the competent authorities of the country of destination.
The authority supplying such information shall require the authority in the third country receiving the information to keep confidential any trade, business, commercial or professional secret or any trade process referred to therein.
3. Simplified pre-export notification procedures may be applied by the competent authorities where they are satisfied that this will not result in any risk of diversion of scheduled substances. The committee procedure shall be used to determine such procedures and to establish the common criteria to be applied by the competent authorities.
SECTION 5 — Export authorisation
1. Exports of scheduled substances that require a customs declaration, including exports of scheduled substances leaving the customs territory from the Community following their storage in a free zone of control type I or free warehouse for a period of at least 10 days, shall be subject to an export authorisation.
Where scheduled substances are re-exported within 10 days from the date of their placing into a suspensive procedure or under a free zone of control type II, an export authorisation shall not be required.
However, exports of scheduled substances listed in Category 3 of the Annex shall only be subject to an export authorisation where pre-export notifications are required, or where these substances are exported to certain countries of destination to be determined in accordance with the committee procedure in order to ensure an appropriate level of control.
2. Export authorisations shall be issued by the competent authorities of the Member State where the exporter is established.
1. The application for export authorisations referred to in Article 12 shall contain at least the following:
(a)
the names and addresses of the exporter, the importer in the third country, any other operator involved in the export operation or shipment, and the ultimate consignee;
(b)
the name of the scheduled substance as stated in the Annex or, in the case of a mixture or a natural product, its name and eight-digit CN code and the name of any scheduled substance, as stated in the Annex, contained in the mixture or in the natural product;
(c)
the quantity and weight of the scheduled substance and, in the case of a mixture or a natural product, the quantity, weight, and, if available, the percentage of any scheduled substance contained therein;
(d)
details of the transport arrangements, such as the expected date of dispatch, method of transport, name of the customs office where the customs declaration is to be made and, where available at this stage, identification of the means of transport, itinerary, expected point of exit from Community customs territory and the point of entry into the importing country;
(e)
in the cases referred to in Article 17, a copy of the import authorisation issued by the country of destination; and
(f)
the number of the licence or registration referred to in Articles 6 and 7.
2. A decision on the application for an export authorisation shall be taken within a period of 15 working days from the date on which the competent authority considers the file to be complete.
That period shall be extended if, in the cases referred to in Article 17, the competent authorities are obliged to make further enquiries under the second subparagraph of that Article.
1. If the details of the itinerary and means of transport are not provided in the application, the export authorisation shall state that the operator must supply those details to the customs office of exit or other competent authorities at the point of exit from the Community customs territory before the physical departure of the consignment. In such cases the export authorisation shall be annotated accordingly at the time of issue.
Where the export authorisation is presented to a customs office in a Member State other than that of the issuing authority, the exporter shall make available any certified translation of parts or all of the information contained on the authorisation, upon request.
2. The export authorisation shall be presented to the customs office when the customs declaration is made, or in the absence of a customs declaration, at the customs office of exit or other competent authorities at the point of exit from the Community customs territory. The authorisation shall accompany the consignment to the third country of destination.
The customs office of exit or other competent authorities at the point of exit from the Community customs territory shall insert the necessary details referred to in Article 13(1)(d) in the authorisation and affix its stamp thereon.
Without prejudice to measures adopted in accordance with Article 26(3), the granting of the export authorisation shall be refused if:
(a)
details supplied in accordance with Article 13(1) are incomplete;
(b)
there are reasonable grounds for suspecting that the details supplied in accordance with Article 13(1) are false or incorrect;
(c)
in the cases referred to in Article 17, it is established that the import of the scheduled substances has not been authorised by the competent authorities of the country of destination, or
(d)
there are reasonable grounds for suspecting that the substances in question are intended for the illicit manufacture of narcotic drugs or psychotropic substances.
The competent authorities may suspend or revoke an export authorisation whenever there are reasonable grounds for suspecting that the substances are intended for the illicit manufacture of narcotic drugs or psychotropic substances.
Whenever, under an agreement between the Community and a third country, exports are not to be authorised unless an import authorisation has been issued by the competent authorities of that third country for the substances in question, the Commission shall communicate to the competent authorities of the Member States the name and address of the competent authority of the third country, together with any operational information obtained from it.
The competent authorities in the Member States shall satisfy themselves as to the authenticity of such import authorisation, if necessary by requesting confirmation from the competent authority of the third country.
The period of validity of the export authorisation within which the goods must have left the Community Customs territory shall not exceed six months from the date of issue of the export authorisation. Under exceptional circumstances, the period of validity may be extended, upon request.
Simplified procedures to grant an export authorisation may be applied by the competent authorities where they are satisfied that this will not result in any risk of diversion of scheduled substances. The committee procedure shall be used to determine such procedures and to establish the common criteria to be applied by the competent authorities.
SECTION 6 — Import authorisation
Imports of scheduled substances listed in Category 1 of the Annex shall be subject to an import authorisation. An import authorisation may only be granted to an operator established in the Community. The import authorisation shall be issued by the competent authorities of the Member State where the importer is established.
However, where the substances referred to in subparagraph 1 are unloaded or transhipped, under temporary storage, stored in a free zone of control type I or free warehouse, or placed into the Community transit procedure, such import authorisation shall not be required.
1. The application for the import authorisations referred to in Article 20 shall contain at least the following:
(a)
the names and addresses of the importer, the exporter of the third country, any other operator involved and the ultimate consignee;
(b)
the name of the scheduled substance as stated in the Annex or, in the case of a mixture or a natural product, its name and the eight-digit CN code and the name of any scheduled substance, as stated in the Annex, contained in the mixture or in the natural product;
(c)
the quantity and weight of the scheduled substance and, in the case of a mixture or a natural product, the quantity, weight, and, if available, the percentage of any scheduled substance contained therein;
(d)
if available, details of the transport arrangements, such as methods and means of transport, and date and place of envisaged import activities, and
(e)
the number of the licence or registration referred to in Articles 6 and 7.
2. A decision on the application for an import authorisation shall be taken within a period of 15 working days from the date on which the competent authority considers the file to be complete.
The import authorisation shall accompany the consignment from the point of entry into the Community customs territory to the premises of the importer or ultimate consignee.
The import authorisation shall be presented to the customs office when the scheduled substances are declared for a customs procedure.
Where the import authorisation is presented to a customs office in a Member State other than that of the issuing authority, the importer shall make available any certified translation of parts or all information contained on the authorisation, upon request.
Without prejudice to measures adopted in accordance with Article 26(3), the granting of the import authorisation shall be refused if:
(a)
details supplied in accordance with Article 21(1) are incomplete;
(b)
there are reasonable grounds for suspecting that the details supplied in accordance with Article 21(1) in the application are false or incorrect, or
(c)
there are reasonable grounds for suspecting that the scheduled substances are intended for the illicit manufacture of narcotic drugs or psychotropic substances.
The competent authorities may suspend or revoke the import authorisation whenever there are reasonable grounds for suspecting that the substances are intended for the illicit manufacture of narcotic drugs or psychotropic substances.
The period of validity of the import authorisation within which the scheduled substances must have been entered into the customs territory of the Community shall not exceed six months from the date of issue of the import authorisation. Under exceptional circumstances, the period of validity may be extended, upon request.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
