25.6.2011 Official Journal of the European Union L 166/9 COMMISSION REGULATION (EU) No 619/2011 of 24 June 2011 laying down the methods of sampling and analysis for the official control of feed as regards presence of genetically modified material for which an authorisation procedure is pending or the authorisation of which has expired (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 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (1), and in particular Article 11(4) thereof, Whereas: ( ( ( Y ’) ’) Commission Regulation (EC) No 152/2009 of 27 January 2009 laying down the methods of sampling and analysis for the official control of feed (?) does not provide for special rules for the control of material which contains, consists of or is produced from GMOs (GM material) for which an EU authorisation procedure is pending or GM material the authorisation of which has expired. Experience has shown that in the absence of such rules, the official laboratories and the competent authorities apply different methods of sampling and different rules for the interpretation of the results of the analytical tests. This may lead to different conclusions as regards the compliance of a product with Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (). As a result of the lack of harmonised rules, economic operators are faced with legal uncertainty and there is a risk that the functioning of the internal market will be affected. Different international information exchange mechanisms providing information on the safety assessments performed by countries authorising the commercial- isation of GMOs are in place. In accordance with the Cartagena Protocol on Biosafety to the Convention on Biological Diversity of which all Member States are 165, 30.4.2004, p. 1. 0] L 0] L 54, 26.2.2009, p. 1. 0J L 268, 18.10.2003, p. 1. ) Parties, Parties to the Protocol have to inform the other Parties through the Biosafety Clearing House (BCH) on any final decision regarding domestic use, including placing on the market, of a GMO that may be subject to transboundary movement for direct use as food or feed or for processing. This information shall contain, inter alia, a risk assessment report. Countries which are not Parties to the Protocol may also provide such information on a voluntary basis. International information exchange mechanisms regarding the authori- sation of GMOs and their safety assessments are also provided by FAO and OECD. The EU imports significant quantities of commodities produced in third countries where GMO cultivation is widespread. While these imported commodities are used both in the production of food and feed, the majority of the commodities likely to contain GMOs are destined for the feed sector thereby entailing a higher risk of trade disruption for that sector in cases where Member States apply different rules for official controls. It appears therefore appropriate to limit the scope of this Regulation to the feed sector which, in comparison with other sectors related to the production of foodstuffs, has a higher likelihood for GM presence. Regulation (EC) No 1829/2003 provides that the placing on the market of genetically modified feed is subject to an authorisation procedure. The authorisation procedure includes the publication of an EFSA opinion of which the main component is a safety assessment. In giving its opinion, EFSA consults Member States upon receipt of a valid application and Member States have 3 months to make their opinions known. The opinion of EFSA has also to include a method for detection validated by the European Union Reference Laboratory (EU-RL). In practice, the validation by the European Union Reference Laboratory (EU-RL) is carried out inde- pendently of the other elements provided for in the auth- orisation procedure. Generally the method is validated and published before all of the other elements are fulfilled for completing the EFSA opinion. These methods are published on the website of the EU-RL and are available to the competent authorities as well as to any interested parties.