Division 2.6.3 Methods of the analysis relating to the identity and characterisation of the additive

A description of the methods used for the determination of the characteristics listed under points 2.1.3, 2.1.4, 2.1.5, 2.2.2, 2.4.1, 2.4.2, 2.4.3, and 2.4.4 shall be provided by the applicant.

In accordance with Annex II of Regulation (EC) No 1831/2003 as amended by Regulation (EC) No 378/2005, the methods submitted under this section may also be evaluated if considered relevant by the, the F1Food Safety Authority or the F2appropriate authority for the assessment of the application.

It is recommended that the methods described under this section are internationally recognised. For those methods that are not internationally recognised, the methods have to be fully described. In those cases, studies shall be performed by accredited and independent laboratories and shall be documented according to appropriate quality standards (e.g. GLP in accordance with F3Annex I to Directive 2004/10/EC or ISO standards).

Methods for the identification and characterisation of the additive shall meet the same requirements as those for methods of analysis used for official control purposes as laid down in F4Regulation (EU) 2017/625, particularly where legal requirements are established (e.g. impurities, undesirable substances).