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

1 For the purposes of this Regulation, the following definitions apply: (1)‘Precision — Relative Repeatability Standard Deviation (RSDr)’The relative standard deviation of test results obtained under repeatability conditions. Repeatability conditions are conditions where test results are obtained with the same method, on identical test items, in the same laboratory, by the same operator, using the same equipment within short intervals of time;(2)‘Minimum Required Performance Limit (MRPL)’the lowest amount or concentration of analyte in a sample that has to be reliably detected and confirmed by official laboratories;(3)‘GM material’material which contains, consists of or is produced from GMOs.

2 The definitions set out in Article 2 of Regulation (EC) No 1829/2003 and in Annex I to Regulation (EC) No 152/2009 apply.

This Regulation shall apply to the official control of feed with respect to the presence of the following material: (a) GM material authorised for commercialisation in a third country and for which a valid application has been submitted under Article 17 of Regulation (EC) No 1829/2003 and for which the authorisation procedure has been pending for more than 3 months provided that: (i) it has not been identified by EFSA as susceptible to have adverse effects on health or the environment when present under the MRPL; (ii) the quantitative method requested under that Article has been validated and published by the European Union Reference Laboratory; and (iii) that the certified reference material fulfils the conditions set out in Article 3; (b) after 25 April 2012, GM material notified under Article 20 of Regulation (EC) No 1829/2003 of which the authorisation has expired and for which a quantitative method has been validated and published by the European Union Reference Laboratory provided that certified reference material fulfils the conditions set out in Article 3; and (c) GM material for which the authorisation has expired due to the fact that no application for renewal in accordance with Article 23 of Regulation (EC) No 1829/2003 has been submitted provided that certified reference material fulfils the conditions set out in Article 3.

1 Certified reference material must be available to Member States and any third party.

2 Certified reference material shall be produced and certified in accordance with ISO guides 30 to 35.

3 The information accompanying the certified reference material shall include information on the breeding of the plant which has been used for the production of the certified reference material and on the zygosity of the insert(s). The certified value of the GMO content shall be given in mass fraction and, where available, in copy number per haploid genome equivalent.

Samples for the official control of feed as regards the presence of the GM material referred to in Article 2, shall comply with the methods of sampling, as set out in Annex I.

The preparation of laboratory samples, the methods of analysis and the interpretation of results shall comply with the requirements set out in Annex II.

1 Where results of analytical tests indicate the presence of GM material referred to in Article 2 are at or above the MRPL as defined in accordance with the rules of interpretation set out in Annex II Part B, the feed shall be considered as non-compliant with Regulation (EC) No 1829/2003. Member States shall immediately notify this information through the RASFF in accordance with Article 50 of Regulation (EC) No 178/2002.

2 Where results of analytical tests indicate the presence of GM material referred to in Article 2 is below the MRPL as defined in accordance with the rules of interpretation set out in Annex II Part B, Member States shall record this information and notify the Commission and the other Member States by 30 June of each year. Recurrent findings over a period of time of 3 months shall be notified without delay.

3 The Commission shall or a Member State may, where appropriate, adopt emergency measures in accordance with Articles 53 and 54 of Regulation (EC) No 178/2002.

The Commission shall publish the list of GM material complying with the conditions set out in Article 2 on its website. The list shall include information as to the place where the certified reference material can be accessed as required by Article 17(3)(j) of Regulation (EC) No 1829/2003 and, if applicable, information on the measures adopted in accordance with paragraph 3 of Article 6 of this Regulation.

The Commission shall monitor the application of this Regulation and its impact on the internal market as well as on feed, livestock and other operators, and, if necessary, bring forward proposals to review this Regulation.

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.