
Article 1 

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.
Article 2 
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.
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.
Article 4 
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.
Article 5 
The preparation of laboratory samples, the methods of analysis and the interpretation of results shall comply with the requirements set out in Annex II.
Article 6 

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.
Article 7 
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.
Article 8 
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.
Article 9 
This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 24 June 2011.
For the Commission
The President
José Manuel BARROSO
ANNEX I
1. For the purpose of applying Annex I to Regulation (EC) No 152/2009, GM material shall be considered as a substance likely to be distributed non-uniformly throughout the feed.

2. 
The mass equivalent of 10 000 grains/seeds is provided in Table 1 below.


Plant Mass, in grams, corresponding to 10 000 grain/seed
Barley, Millet, Oat, Rice, Rye, Wheat 400
Maize 3 000
Soybean 2 000
Rape seed 40

ANNEX II
In order to detect the presence in feed of the GM material referred to in Article 2, the official laboratories shall use the methods of analysis and control requirements described in this Annex.

A. 
In addition to the requirements of Annex II Part A to Regulation (EC) No 152/2009, the following provisions shall apply.
 1. 
Official laboratories shall use the standard EN ISO 24276, ISO 21570, ISO 21569 and ISO 21571 that indicate strategies for the homogenisation of the final sample (also designated as the ‘laboratory sample’ in the ISO standards), the reduction of the final sample to the sample for analysis, the preparation of the test sample and the extraction and the analysis of target analyte.
 2. 
The sample for analysis shall be of a size which ensures the quantification of GM material at a presence corresponding to the MRPL with a statistical degree of confidence of 95 %.

B. 
By derogation from Part C of Annex II to Regulation (EC) No 152/2009, the following rules for the application of methods of analysis and expression of results shall apply.
 1. 
Official laboratories shall comply with the requirements of ISO 17025 and use quantitative methods of analysis that have been validated by the European Union Reference Laboratory in collaboration with the European Network of GMO Laboratories. They shall ensure that, considering the whole analytical method starting with the treatment of the laboratory sample of feed, they are in position to carry out the analysis at the level of 0,1 % related to mass fraction of GM material in feed with an adequate precision (relative repeatability standard deviation less than or equal to 25 %).
 2. 
To ensure a level of confidence of approximately 95 %, the outcome of the analysis shall be reported as x +/– U whereby x is the analytical result for one measured transformation event and U is the appropriate expanded measurement uncertainty.

U shall be specified by the official laboratory for the whole analytical method and confirmed as described in the guidance document on Measurement Uncertainty for GMO testing laboratories developed by JRC.

A feed material, feed additive or, in the case of compound feed each of the feed material and feed additive of which it is composed shall be considered as non-compliant with Regulation (EC) No 1829/2003 when the analytical result (x) for one measured transformation event minus the expanded measurement uncertainty (U) equals or exceeds the level of 0,1 % related to mass fraction of GM material. When results are primarily expressed as GM-DNA copy numbers in relation to target taxon specific DNA copy numbers calculated in terms of haploid genomes, they shall be translated into mass fraction in accordance with the information provided in each validation report of the EU-RL.
