ANNEX IISupplementary provisions
ANNEX II Template cover letter accompanying an application for traditional food from a third country following the requirements of Article 16 of Regulation (EU) 2015/2283 EUROPEAN COMMISSION Directorate General Directorate Unit Date: … Subject: Application for authorisation of a traditional food from a third country following the requirements of Article 16 of Regulation (EU) 2015/2283 The Applicant(s) or their Representative(s) within the European Union (name(s), address(es)…) … … … submit(s) this application in order to update the Union list on novel foods. Identity of the traditional food: … … Confidentiality ( 1 ) . Where appropriate, state whether the application includes confidential data in accordance with Article 23 of Regulation (EU) 2015/2283 ☐ Yes ☐ No Food categories, conditions of use and labelling requirements Food category Specific conditions of use Additional specific labelling requirement Yours sincerely, Signature … Enclosures: ☐ Complete application ☐ Summary of the application ☐ List of the parts of the application requested to be treated as confidential and verifiable justification for such claims ☐ Documented data relating to the duly reasoned safety objections ☐ Copy of administrative data of applicant(s) ( 1 ) Applicants should use the format established in Annex III to indicate the information they wish to have treated as confidential and should provide all necessary details to substantiate the request for confidentiality.