# Commission Implementing Regulation (EU) No 307/2012 of 11 April 2012 establishing implementing rules for the application of Article 8 of Regulation (EC) No 1925/2006 of the European Parliament and of the Council on the addition of vitamins and minerals and of certain other substances to foods, Article 5: Substance included in Annex III, Part C

Extent: E+W+S+N.I.

1. To be considered valid, a file submitted by a food business operator or any other interested party to the expert committee in view of a safety assessment of the substance placed in Part C of Annex III to Regulation (EC) No 1925/2006, pursuant to the procedure provided under Article 8(4) of Regulation (EC) No 1925/2006, shall be based on relevant guidance documents adopted or endorsed by the expert committee.
In the case where it considers a file as not valid for the purpose of the first subparagraph, the expert committee shall inform the food business operator or interested party that has submitted the file and the appropriate authority, indicating the reasons why the file is not considered valid.
2. Only files submitted within 18 months from the entry into force of a decision that includes a substance to Part C of Annex III to Regulation (EC) No 1925/2006 pursuant to Article 8(2) of Regulation (EC) No 1925/2006 shall be taken into account by the expert committee as being a valid file for the purposes of a decision as laid down in paragraph 5 of Article 8 of Regulation (EC) No 1925/2006.

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Source: https://www.legislation.gov.uk/eur/2012/307/article/5 (the official version)
Page: https://openlegislation.uk/eu-regulation-2012-307/article-5
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.