Division 1.4.2 Testing of new constituents other than proteins

The applicant shall provide a risk assessment of identified new constituents other than proteins. This shall include, on a case-by-case basis, an evaluation of their toxic potency and of the need of toxicological testing as well as a determination of their concentration in the genetically modified food and feed. To establish the safety of new constituents having no history of safe use for consumption in food and feed, the applicant shall provide information F1in accordance with food additives guidance available from the Food Safety Authority and Commission Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives^f1. This shall include the submission of information on a core set of studies such as on metabolism/toxicokinetics, subchronic toxicity, genotoxicity, chronic toxicity, carcinogenicity and reproduction and developmental toxicity, accompanied by any other appropriate type of study. For specific guidelines for animal tests, see Table 1 of Section 1.7 of this Annex. Genotoxicity test protocols are provided for in Table 2 of Section 1.7 of this Annex.