Division C

The applicant shall demonstrate that the method fulfils the following requirements.

1. 1..

   The method shall be event-specific and thus must only be functional with the GMO or GM based product considered and shall not be functional if applied to other events already authorised; otherwise the method cannot be applied for unequivocal detection/identification/quantification. This shall be demonstrated with a selection of non-target transgenic authorised events and conventional counterparts, in the case of GM plants. This testing shall include closely related events, where relevant, and cases where the limits of the detection are truly tested. The same specificity principle must be applied for products that consist of or contain GMOs other than plants.

2. 2..

   The method shall be applicable to samples of the food or feed, to the control samples and to the reference material, which is referred to in Articles 5(3)(j) and 17(3)(j) of Regulation (EC) No 1829/2003.

3. 3..

   The method shall be developed taking the following documents in consideration as appropriate:

   • General requirements and definitions: draft European standard prEN ISO 24276:2002,

   • Nucleic acid extraction prEN ISO 21571:2002,

   • Quantitative nucleic acid based methods: draft European standard prEN ISO 21570:2002,

   • Protein based methods: adopted European standard EN ISO 21572:2002,

   • Qualitative nucleic acid based methods: draft European standard prEN ISO 21569:2002.