REGULATION (EU) No 1259/2013 of the European Parliament and of the Council Regulation of 20 November 2013 amending Regulation (EC) No 111/2005 Laying down rules for the monitoring of trade between the Community and third countries in drug precursors.


REGULATION (EU) No 1258/2013 of the European Parliament and of the Council of 20 November 2013 amending Regulation (EC) No 273/2004 on drug precursors

Have been published in the Offical Journal of the European Union

The main changes will be :

  • The export of medicinal products listed in Category 4 of the Annex to Regulation (EC) No 111/2005, i.e. medicinal products and veterinary medicinal products containing ephedrine or its salts and medicinal products and veterinary medicinal products containing pseudo ephedrine or its salts, should be preceded by an export authorisation, and a pre‑export notification sent by the competent authorities in the Union to the competent authorities of the country of destination. It is not possible to grant a simplified export authorisation at the moment for these transactions.

  • The substance "alpha phenylacetoacetonitrile", better known as APAAN (with CN Code 2926 90 95 and CAS No 4468 48 8) shall be scheduled in Category 1 of the Annex to Regulation (EC) No 111/2005.
  • Acetic Anhydride (AA) will be included in the new subcategory 2A of Annex I to Regulation (EC) No 273/2004 to allow increased control of its trade. End-users of subcategory 2A substances will have to register. However, this new requirement will only become obligatory as of 30 June 2015 (transitional period of 18 months). It is important to point out that the current threshold for AA, set at 100 l over a period of one year in Annex II, will remain applicable for the obligation to register both for operators and end-users. At this stage, only AA is listed in subcategory 2A, but additions of other substances will be possible in the future through delegated acts.

  • In considering whether to grant a licence or a registration, the competent authority shall take into account the competence and integrity of the applicant, in particular the absence of any serious infringement or repeated infringements of legislation in the field of drug precursors and the absence of a record of any serious criminal offence.

  • The competent authorities of each Member State shall prohibit the introduction of consignments of non-scheduled substances into the customs territory of the Union or their departure from it where there is sufficient evidence that those substances are intended for the illicit manufacture of narcotic drugs or psychotropic substances.
  • The competent authority shall immediately inform the competent authorities of the other Member States and the Commission thereof, using the procedure referred to in Article 27 of Regulation (EC) No 111/2005. Those substances shall be considered as proposed for inclusion in the 'EU Voluntary Monitoring List'.
  • Additionally, each Member State may adopt the measures necessary to enable its competent authorities to control and monitor suspicious transactions involving non-scheduled substances, in particular:

(a) to obtain information on any orders for or operations involving non-scheduled substances;

(b) to enter business premises in order to obtain evidence of suspicious transactions involving non-scheduled substances.".

Of course, this enumeration of the main new provisions is only indicative; only the legislation as published in the Official Journal is binding. Additionally, further to these amendments Delegated and Implementing Acts will need to be adopted in the foreseeable future; these Acts will further supplement the concerned legislative framework on precursors in the EU and thus have an additional impact on the work of competent authorities.

The full legal text can be found here