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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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1.In [F1assessing] the conditions under which the concerned substance is added to foods or used in the manufacture of foods, as laid down in paragraph 1 of Article 8 of Regulation (EC) No 1925/2006, the placing on the market in one or more [F2parts of Great Britain] of the food product to which the substance has been added shall be taken into account.
2.[F3The power to make regulations under Article 8 of Regulation (EC) No 1925/2006 may be exercised where the assessment referred to in paragraph 1] shows at least one of the following:
(a)a potential risk to consumers is associated with the ingestion of amounts of the substance that greatly exceed those reasonably expected under normal conditions of consumption of a balanced and varied diet, due to the conditions under which the substance is added to food or used in the manufacture of food;
(b)a potential risk to consumers is associated with the consumption of this substance by the general adult population or other specified population group for which a potential risk has been identified.
3.For the purposes of this Regulation those conditions that would result in the ingestion of amounts of a substance greatly exceeding those reasonably expected to be ingested under normal conditions of consumption of a balanced and varied diet shall occur under actual circumstances and shall be assessed on a case-by-case basis in comparison with the average intake of the concerned substance by the general adult population or other specified population group for which health concerns have been raised.
F44.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F1Word in Art. 3(1) substituted (31.12.2020) by The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651), regs. 1(1), 43(3)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)
F2Words in Art. 3(1) substituted (31.12.2020) by The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651), regs. 1(1), 43(3)(a)(ii) (as amended by S.I. 2020/1476, regs. 1(2), 6(5)); 2020 c. 1, Sch. 5 para. 1(1)
F3Words in Art. 3(2) substituted (31.12.2020) by The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651), regs. 1(1), 43(3)(b); 2020 c. 1, Sch. 5 para. 1(1)
F4Art. 3(4) omitted (31.12.2020) by virtue of The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651), regs. 1(1), 43(3)(c); 2020 c. 1, Sch. 5 para. 1(1)
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