
Article 1 
This Regulation establishes implementing rules for the application of Article 8 of Regulation (EC) No 1925/2006 and in particular:

((a)) the conditions for the use of the procedure referred to in paragraphs 1 and 2 of Article 8 of Regulation (EC) No 1925/2006; and
((b)) the procedure referred to in paragraphs 4 and 5 of Article 8 of Regulation (EC) No 1925/2006 concerning substances listed in Annex III, Part C thereto.
Article 2 
For the purpose of this Regulation the following definitions shall apply:

((a)) ...
((b)) ‘file’ means a file as referred to in paragraphs 4 and 5 of Article 8 of Regulation (EC) No 1925/2006 that is submitted by a food business operator or interested party to  an expert committee;
((c)) ‘placing on the market’ as defined by Article 3(8) of Regulation (EC) No 178/2002.
((d)) ‘appropriate authority’ and  ‘expert committee’ have the same meaning as in Regulation (EC) 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to food.
Article 3 

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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Article 4 

1. In 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  , 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. ...
(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.
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3. 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. ... The  expert 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  appropriate authority  within 30 days from the publication by the  expert committee  of its opinion , except in cases of urgency.
Article 5 

1. To be considered valid, a file submitted by a food business operator or any other interested party to the  expert 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 expert committee.In the case where it considers a file as not valid for the purpose of the first subparagraph, the expert committee shall inform the food business operator or interested party that has submitted the file and the  appropriate 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 expert 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.
Article 6 

1. The expert committee shall give its opinion on files referred to in Article 5(1) of this Regulation within nine months from the date of receipt of a valid file. The expert committee shall assess the validity of the file within 30 days from receipt of the file.
2. The expert committee may request the food business operator or interested party to supplement the data or information submitted in a file within a specified time limit. When the expert committee seeks supplementary information from the food business operator or any other interested party, the time limit referred to in paragraph 1 shall be extended only once by up to three months and shall include the time needed by the food business operator or any interested party to provide this supplementary information. The food business operator or interested party shall submit the requested information within 15 days from the date of receipt of the  expert committee's  request.
Article 7 
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...Done at Brussels, 11 April 2012.
For the Commission
The President
José Manuel BARROSO