1.The procedure provided for in this Article shall be followed where a substance other than vitamins or minerals, or an ingredient containing a substance other than vitamins or minerals, is added to foods or used in the manufacture of foods under conditions that would result in the ingestion of amounts of this substance greatly exceeding those reasonably expected to be ingested under normal conditions of consumption of a balanced and varied diet and/or would otherwise represent a potential risk to consumers.
[F12. On its own initiative or on the basis of information provided by Member States, the Commission may take a decision designed to amend non-essential elements of this Regulation, following in each case an assessment of available information by the Authority, in accordance with the regulatory procedure with scrutiny referred to in Article 14(3), to include, if necessary, the substance or ingredient in Annex III. In particular:
(a) if a harmful effect on health has been identified, the substance and/or the ingredient containing the substance shall:
be placed in Annex III, Part A, and its addition to foods or its use in the manufacture of foods shall be prohibited; or
be placed in Annex III, Part B, and its addition to foods or its use in the manufacture of foods shall only be allowed under the conditions specified therein;
(b) if the possibility of harmful effects on health is identified but scientific uncertainty persists, the substance shall be placed in Annex III, Part C.
On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 14(4) in order to include the substance or the ingredient in Annex III, Part A or B.]
3.Community provisions applicable to specified foods may provide for restrictions or prohibitions on the use of certain substances in addition to those laid down in this Regulation.
4.Food business operators, or any other interested parties, may at any time submit for evaluation to the Authority a file containing the scientific data demonstrating the safety of a substance listed in Annex III, Part C, under the conditions of its use in a food or in a category of foods and explaining the purpose of that use. The Authority shall inform without delay the Member States and the Commission of the submission and shall make the file available to them.
[F15. Within four years from the date a substance has been listed in Annex III, Part C, a decision designed to amend non-essential elements of this Regulation shall be taken in accordance with the regulatory procedure with scrutiny referred to in Article 14(3) and taking into account the opinion of the Authority on any files submitted for evaluation as mentioned in paragraph 4 of this Article, to generally allow the use of a substance listed in Annex III, Part C, or to list it in Annex III, Part A or B, as appropriate.
On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 14(4) in order to include the substance or the ingredient in Annex III, Part A or B.]
6.The Commission shall establish, in accordance with the procedure referred to in Article 14(2), implementing rules for the application of this Article, including rules concerning the submission referred to in paragraph 4 of this Article.