LegalizeCommission Implementing Regulation (EU) No 120/2014 of 7 February 2014 amending Regulation (EC) No 1981/2006 on detailed rules for the implementation of Article 32 of Regulation (EC) No 1829/2003 of the European Parliament and the Council as regards the Community reference laboratory for genetically modified organisms Text with EEA relevance
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (1), and in particular Article 32, second subparagraph and fifth subparagraph, thereof,
Whereas:
(1) Detailed rules for implementing Article 32 of Regulation (EC) No 1829/2003 were set out by Commission Regulation (EC) No 1981/2006 (2), as amended by Implementing Regulation (EU) No 503/2013 (3). It is necessary to update those rules, in particular regarding the financial contributions of applicants, in order to take into account changes in the costs incurred when testing and validating methods for detection, and changes in the allocation of tasks in the Member States.
(2) The Regulation should also take into account the growing number of GMOs containing stacked transformation events with an increasing combination of single transformation events.
(3) It is necessary to update the list of designated national reference laboratories to assist the Community Reference Laboratory referred to in in the first paragraph of Article 32 of Regulation (EC) No 1829/2003 (CRL) for testing and validation of detection methods in order to take account of changes of designation of national reference laboratories by Member States and to include those in the Member States which recently joined the Union.
(4) Transitional measures should be laid down to allow applicants who have received the acknowledgement of the application for an authorisation by the national competent authority according to Regulation (EC) No 1829/2003 before the entry into force of this Regulation to pay the financial contributions according to Regulation (EC) No 1981/2006.
(5) Due consideration should be given to public research institutions established in the EU applying for GMO authorisations related to projects mainly financed by the public sector, and a reduction of the amount of the financial contribution should therefore be foreseen in such cases.
(6) Regulation (EC) No 1981/2006 should therefore be amended accordingly.
(7) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food chain and Animal Health,
HAS ADOPTED THIS REGULATION:
Article 1
Regulation (EC) No 1981/2006 is amended as follows:
(6) In Article 6, paragraph 2 is replaced by the following paragraphs 2 and 3: ‘2. The national reference laboratories listed in Annex II shall be selected randomly for participation in an international collaborative validation trial and shall receive 2 400 EUR from the CRL as a contribution to the costs for their participation. In case of Article 4(1) this amount shall be proportionally reduced.
The CRL and those national reference laboratories listed in Annex II that participate in a validation study shall enter into a written agreement to define the relations between them, notably in financial matters.’
(8) Annex II is replaced by the Annex to this Regulation.
Article 2
Transitional measures
Articles 3 to 5 of Regulation (EC) No 1981/2006 on financial contributions shall continue to apply to applicants who have received the acknowledgement of the application for an authorisation by the national competent authority according to Regulation (EC) No 1829/2003 before the entry into force of this Regulation.
Article 3
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaties.
Done at Brussels, 7 February 2014.
For the Commission The President José Manuel BARROSO
(1) OJ L 268, 18.10.2003, p. 1.
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