CHAPTER III

ADDITION OF CERTAIN OTHER SUBSTANCES

Substances prohibited, restricted or under ... scrutiny
Article 8
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
Following an assessment of available evidence by an expert committee, the appropriate authority may make regulations
, 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:
1. be placed in Annex III, Part A, and its addition to foods or its use in the manufacture of foods shall be prohibited; or
2. 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.
...
3
Enactments 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 to the appropriate 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 appropriate authority shall submit the file to an expert committee for evaluation and shall inform the other relevant authorities of the submission and shall make the file available to them.
5
Within four years from the date a substance has been listed in Annex III, Part C, the appropriate authority must consider, in consultation with the other relevant authorities and taking into account the opinion of the expert committee on any files submitted for evaluation as mentioned in paragraph 4 of this Article, whether to make regulations 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.
6
The appropriate authority may by regulations amend Commission Implementing Regulation (EU) No 307/2012 in order to modify the implementing rules for the application of this Article.
Substituted by Regulation (EC) No 108/2008 of the European Parliament and of the Council of 15 January 2008 amending Regulation (EC) No 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods.
Word in Art. 8 heading omitted (E.W.S.) (31.12.2020) by virtue of The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651), regs. 1(1), 18(9)(a); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 8(2) substituted (E.W.S.) (31.12.2020) by The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651), regs. 1(1), 18(9)(b)(i); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 8(2) omitted (E.W.S.) (31.12.2020) by virtue of The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651), regs. 1(1), 18(9)(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)
Word in Art. 8(3) substituted (E.W.S.) (31.12.2020) by The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651), regs. 1(1), 18(9)(c); 2020 c. 1, Sch. 5 para. 1(1)
Art. 8(4) substituted (E.W.S.) (31.12.2020) by The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651), regs. 1(1), 18(9)(d); 2020 c. 1, Sch. 5 para. 1(1)
Art. 8(5) substituted (E.W.S.) (31.12.2020) by The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651), regs. 1(1), 18(9)(e); 2020 c. 1, Sch. 5 para. 1(1)
Art. 8(6) substituted (E.W.S.) (31.12.2020) by The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651), regs. 1(1), 18(9)(f); 2020 c. 1, Sch. 5 para. 1(1)