1.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.
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 [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.
Textual Amendments
F1Words in Art. 5 substituted (31.12.2020) by The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651), regs. 1(1), 43(5)(a); 2020 c. 1, Sch. 5 para. 1(1)
F2Words in Art. 5 substituted (31.12.2020) by The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651), regs. 1(1), 43(5)(b); 2020 c. 1, Sch. 5 para. 1(1)