7Article 8 of Regulation (EC) No 1925/2006, as amended by Commission Regulation (EU) 2019/650 of 24 April 2019 (OJ 2019 L 110, p. 21), entitled ‘Substances prohibited, restricted or under Community scrutiny’, provides, in paragraphs 1 and 2 thereof: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.2. 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 [European Food Safety] Authority [(EFSA)], 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. ……’
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