Commission Implementing Regulation (EU) No 503/2013Show full title

Article 11 Amendments to Regulation (EC) No 1981/2006

Regulation (EC) No 1981/2006 is amended as follows:

(1)

in Article 2, point (a) is replaced by the following:

‘(a)

“full validation procedure” means:

(i)

the assessment through a ring trial involving national reference laboratories of the method performance criteria set by the applicant as compliant with the document entitled “Definition of minimum performance requirements for analytical methods of GMO testing” referred to:

• in the case of genetically modified plants for food or feed uses, food or feed containing or consisting of genetically modified plants and food produced from or containing ingredients produced from genetically modified plants or feed produced from genetically modified plants, in point 3.1.C.4 of Annex III to Commission Implementing Regulation (EU) No 503/2013(1),

• in all other cases, in point 1(B) of Annex I to Regulation (EC) No 641/2004;

and

(ii)

the assessment of the precision and trueness of the method provided by the applicant.’;

(2)

in Article 3(2), the first and second subparagraphs are replaced by the following:

‘2. The CRL shall request the applicant to pay an additional contribution of EUR 60 000 where a full validation procedure of a method of detection and identification for a single GMO event according to the requirements laid down in the following provisions is required:

(a) Annex III to Implementing Regulation (EU) No 503/2013, when the application is related to:

(i)

genetically modified plants for food or feed uses;

(ii)

food or feed containing or consisting of genetically modified plants;

(iii)

food produced from or containing ingredients produced from genetically modified plants or feed produced from such plants; or

(b) point 1(B) of Annex I to Regulation (EC) No 641/2004, in all other cases.

That amount shall be multiplied by the number of GMO events to be fully validated.’.

(1)

OJ L 157, 8.6.2013, p. 1.’;