L 343/140 Official Journal of the European Union 23.12.2011 COMMISSION IMPLEMENTING DECISION of 22 December 2011 on emergency measures regarding unauthorised genetically modified rice in rice products originating from China and repealing Decision 2008/289/EC (Text with EEA relevance) (2011/884/EU) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety ('), and in particular Article 53(1) thereof, Whereas: (") ¢ Articles 4(2) and 16(2) of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (%) provide that no genetically modified food or feed is to be placed on the Union market unless it is covered by an authorisation granted in accordance with that Regulation. Articles 4(3) and 16(3) of the same Regulation lay down that no genetically modified food and feed may be authorised unless it has been adequately and sufficiently demonstrated that it does not have adverse effects on human health, animal health or the environment, that it does not mislead the consumer or the user, and that it does not differ from the food or feed it is intended to replace to such an extent that its normal consumption would be nutritionally disadvantageous for humans or animals. In September 2006, rice products originating in or consigned from China, contaminated with the unauth- orised genetically modified rice Bt 63, were discovered in the United Kingdom, France and Germany and were notified to the Rapid Alert System for Food and Feed (RASFF). Notwithstanding the measures announced by the Chinese authorities to control the presence of that unauthorised Genetically Modified Organism (GMO), several other alerts concerning the presence of the unauthorised genetically modified rice Bt 63 were subsequently reported. 31, 1.2.2002, p. 1. oJ L 0] L 268, 18.10.2003, p. 1. G) Considering the continuing alerts and the lack of sufficient guarantees from the Chinese competent authorities concerning the absence of the unauthorised genetically modified rice Bt 63 in products originating in or consigned from China, Commission Decision 2008/289/EC (}) was adopted which introduced emergency measures regarding the unauthorised GMO Bt 63 in rice products. That Decision required that prior to placing on the market, operators should submit an analytical report to the relevant Member State competent authorities demonstrating that the consignment of rice products was not contaminated with genetically modified rice Bt 63. Additionally, that Decision provided for Member States to take appropriate measures, including random sampling and analysis carried out using a specific method described therein, concerning products presented for importation or already on the market. In March 2010, Germany notified the RASFF with regard to the presence of new rice varieties carrying unauth- orised genetic elements encoding insect resistance which had characteristics similar to the GMO Kefeng 6. Subsequently, several additional similar alerts were notified, which in addition to Kefeng 6, also included the presence of another insect resistant rice line which contained genetic elements similar to the GMO Kemingdao 1 (KMD1). Kefeng 6 and KMD1 are not auth- orised either in the Union or China. All RASFF notifications were notified to the relevant Chinese authorities and additionally the Commission wrote to the authorities both in June 2010 and February 2011 requesting action to address the increasing number of alerts. The Food and Veterinary Office conducted an inspection in China in October 2008 with the objective of evaluating the implementation of Decision 2008/289/EC, which was subsequently followed up with another mission in March 2011. The conclusions of the 2008 mission and the initial findings of the 2011 mission indicated uncertainty as to the level, type and number of genetically modified rice varieties which may have contaminated rice products originating in or consigned from China, and that therefore there was a high risk of further introductions of unauthorised GMOs in such rice products. () O] L 96, 9.4.2008, p. 29.