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Commission Implementing Regulation (EU) No 307/2012Show full title
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
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Article 4U.K.[F1Evidence required for the purposes of advice by an expert committee under Article 8 of Regulation 1925/2006]
1.[F2In preparing advice for the purpose of Article 8 of Regulation (EC) No 1925/2006, the Committee shall consider] the available and relevant generally accepted scientific evidence demonstrating that the conditions specified in Article 8(1) of Regulation (EC) No 1925/2006 are met [F3, including]:
(a)Evidence demonstrating the addition of the substance to food or use of the substance in the manufacture of food.
Such evidence shall include information on the current placing on the market of food products containing the substance as referred to in paragraph 1 of Article 3 of this Regulation.
(b)In cases referred to in Article 3(2)(a), evidence demonstrating that intake of the substance greatly exceeds normal conditions of consumption of a balanced and varied diet, as assessed in accordance with Article 3(3).
Such evidence shall include scientific data that represents actual dietary intake of the substance obtained from the most recently available dietary intake surveys or food consumption surveys. The inclusion of foods to which the substance has been added and/or food supplements containing the substance may be taken into account. F4...
(c)Evidence demonstrating a potential risk to consumers from consumption of the substance.
This evidence shall consist of relevant scientific data including unpublished validated reports, scientific opinions by a public risk assessment body or independent and peer-reviewed articles. A summary of the scientific data and the list of references of the scientific data shall be provided.
F52.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
[F63.Where an expert committee is asked to provide advice for the purposes of Article 8 of Regulation (EC) No 1925/2006, it shall make public the evidence referred to in paragraph 1.]
4.F7... The [F8expert committee] shall adopt a scientific opinion within a specified time limit as laid down by Article 29(3) of Regulation (EC) No 178/2002.
5.Interested parties may submit comments to the [F9appropriate authority] within 30 days from the publication by the [F10expert committee] of its opinion [F11, except in cases of urgency].
Textual Amendments
F1Art. 4 heading substituted (31.12.2020) by The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651), regs. 1(1), 43(4)(a); 2020 c. 1, Sch. 5 para. 1(1)
F2Words in Art. 4(1) substituted (31.12.2020) by The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651), regs. 1(1), 43(4)(b)(i); 2020 c. 1, Sch. 5 para. 1(1)
F3Words in Art. 4(1) substituted (31.12.2020) by The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651), regs. 1(1), 43(4)(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)
F4Words in Art. 4(1)(b) omitted (31.12.2020) by virtue of The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651), regs. 1(1), 43(4)(b)(iii); 2020 c. 1, Sch. 5 para. 1(1)
F5Art. 4(2) omitted (31.12.2020) by virtue of The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651), regs. 1(1), 43(4)(c); 2020 c. 1, Sch. 5 para. 1(1)
F6Art. 4(3) substituted (31.12.2020) by The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651), regs. 1(1), 43(4)(d); 2020 c. 1, Sch. 5 para. 1(1)
F7Words in Art. 4(4) omitted (31.12.2020) by virtue of The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651), regs. 1(1), 43(4)(e)(i); 2020 c. 1, Sch. 5 para. 1(1)
F8Words in Art. 4(4) substituted (31.12.2020) by The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651), regs. 1(1), 43(4)(e)(ii); 2020 c. 1, Sch. 5 para. 1(1)
F9Words in Art. 4(5) substituted (31.12.2020) by The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651), regs. 1(1), 43(4)(f)(i); 2020 c. 1, Sch. 5 para. 1(1)
F10Words in Art. 4(5) substituted (31.12.2020) by The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651), regs. 1(1), 43(4)(f)(ii); 2020 c. 1, Sch. 5 para. 1(1)
F11Words in Art. 4(5) inserted (31.12.2020) by The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651), regs. 1(1), 43(4)(f)(iii); 2020 c. 1, Sch. 5 para. 1(1)
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