To be considered valid, a file submitted by a food business operator or any other interested party to the F1expert 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 F1expert committee.

In the case where it considers a file as not valid for the purpose of the first subparagraph, the F1expert committee shall inform the food business operator or interested party that has submitted the file and the F2appropriate authority, indicating the reasons why the file is not considered valid.

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 F1expert 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.