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Commission Implementing Regulation (EU) 2017/2468 of 20 December 2017 laying down administrative and scientific requirements concerning traditional foods from third countries in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (Text with EEA relevance)
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1.A notification shall be submitted electronically to the Commission and shall consist of the following:
(a)a cover letter;
(b)a technical dossier;
(c)a summary of the dossier.
2.The cover letter referred to in paragraph 1(a) shall be drafted in accordance with the template provided in Annex I.
3.The technical dossier referred to in paragraph 1(b) shall contain:
(a)the administrative data as provided for in Article 5;
(b)the scientific data as provided for in Article 6.
4.Where the applicant submits a notification to modify the conditions of use, the specifications, specific labelling requirements or post-market monitoring requirements of an authorised traditional food from a third country, it may not be necessary for the applicant to provide all the data required under Article 6 where the applicant provides verifiable justification explaining that the proposed changes do not affect the results of the existing safety assessment.
5.The summary of the dossier referred to in paragraph 1(c) shall provide evidence that the use of a traditional food from a third country complies with the conditions laid down in Article 7 of Regulation (EU) 2015/2283.
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