# 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 3: Conditions to be met for the request

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

1. In assessing 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 parts of Great Britain of the food product to which the substance has been added shall be taken into account.
2. The 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.
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Source: https://www.legislation.gov.uk/eur/2012/307/article/3 (the official version)
Page: https://openlegislation.uk/eu-regulation-2012-307/article-3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.