PART 3Amendments relating to food additives, food enzymes and food flavourings

Amendment of Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives

regulation 8 + 8.—(1) Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives(1) is amended as follows.

(2) In Article 1, in the second subparagraph—

regulation 8 2 a + (a)for point (a), substitute—

“(a)the authorisation of food additives;”;

regulation 8 2 b + (b)in point (b)—

regulation 8 2 b i + (i)after “enzymes”, in the first place it occurs, insert “, food flavourings or nutrients,”;

regulation 8 2 b ii + (ii)omit “in food flavourings as covered by”;

regulation 8 2 b iii + (iii)omit “of the European Parliament and of the Council of 16 December 2008”.

(3) In Article 2(3), for “date of adoption of the domestic list of food enzymes in accordance with Article 17” substitute “start of the day after the day on which the appropriate authority has determined the authorisations status of all initial authorisation applications on the Register referred to in Article 17(3)”.

(4) In Article 3(2), after point (i) insert—

“(j)‘nutrients’ means vitamins, minerals and other substances added for nutritional purposes, as well as substances added for physiological purposes, in accordance with 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(2), the Food Supplements (Scotland) Regulations 2003(3), the Food Supplements (England) Regulations 2003(4), the Food Supplements (Wales) Regulations 2003(5) and Regulation (EU) No 609/2013 of the European Parliament and of the Council on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control, etc.(6), for the purposes of secondary use;

(k)‘primary use’ means the use of a food additive in food in accordance with the terms of its authorisation under Regulation (EC) No 1331/2008 and this Regulation;

(l)‘secondary use’ means the use of a food additive, including carriers, in food additives, food enzymes, food flavourings or nutrients in accordance with the terms of its authorisation under Regulation (EC) No 1331/2008 and this Regulation.”.

(5) Before Article 4, in the heading for Chapter II, for “DOMESTIC LISTS OF APPROVED” substitute “AUTHORISATION OF”.

(6) For Article 4, substitute—

“Article 4Requirement for authorisation

1.  Only food additives authorised for primary use may be placed on the market as such and used in foods under the conditions of use specified in the authorisation concerned.

2.  Only food additives authorised for secondary use may be used in food additives, food enzymes, food flavourings and in nutrients under the conditions of use specified in the authorisation concerned.

3.  Where a food additive is authorised for primary use, the authorisation must include the categories of food to which the additive may be added.

4.  Where a food additive is authorised for secondary use, the authorisation must include the food additives, food enzymes, food flavourings and nutrients or categories thereof to which the food additive may be added.

5.  Food additives must comply with the specifications referred to in Article 14.”.

(7) In Article 6—

regulation 8 7 a + (a)for the heading, substitute “General conditions for authorisation of food additives”;

regulation 8 7 b + (b)in paragraph 1, in the words before point (a), for “included in the domestic lists in Annexes II and III” substitute “authorised”;

regulation 8 7 c + (c)in paragraph 2, in the words before point (a), for “included in the domestic lists in Annexes II and III” substitute “authorised”;

regulation 8 7 d + (d)in paragraph 3, in the words before point (a), for “included in the domestic list in Annex II” substitute “authorised for primary use”.

(8) In Article 7, in the words before point (a), for “included in the domestic list in Annex II” substitute “authorised for primary use”.

(9) In Article 8, in the words before point (a), for “included in the domestic list in Annex II” substitute “authorised for primary use”.

(10) In Article 9(1), for “Food additives may be assigned in Annexes II and III” substitute “An authorisation may state that a food additive is assigned”.

(11) In Article 10—

regulation 8 11 a + (a)in the heading, for “the domestic lists” substitute “an authorisation”;

regulation 8 11 b + (b)in paragraph 1, for “included in:” to the end substitute “authorised.”;

regulation 8 11 c + (c)in paragraph 2—

regulation 8 11 c i + (i)in the words before point (a), for “entry for a food additive in the domestic lists in Annexes II and III” substitute “authorisation of a food additive”;

regulation 8 11 c ii + (ii)in point (b), after “the foods” insert “, food additives, food enzymes, food flavourings or nutrients or categories thereof”;

regulation 8 11 c iii + (iii)after point (d) insert—

“(e)any specifications concerned, in accordance with Article 14.”;

regulation 8 11 d + (d)omit paragraph 3.

(12) In Article 11—

regulation 8 12 a + (a)in paragraph 3, in the first sentence, for “Annex II” substitute “the authorisation for primary use concerned,”;

regulation 8 12 b + (b)in paragraph 4, for “Annex II” substitute “the authorisation for primary use concerned”.

(13) In Article 12—

regulation 8 13 a + (a)in the heading and in the text, in each place, for “included in a domestic list” substitute “authorised”;

regulation 8 13 b + (b)for “entry in the domestic lists or a change in the specifications” substitute “authorisation or a modification to the existing authorisation”.

(14) In Article 13—

regulation 8 14 a + (a)in paragraph 1, for “included in the domestic lists in Annexes II and III” substitute “authorised”;

regulation 8 14 b + (b)in paragraph 2, for “already included in the domestic list” substitute “that is already authorised”.

(15) In Article 14—

regulation 8 15 a + (a)for “adopted” substitute “set out in the authorisation concerned”;

regulation 8 15 b + (b)for “included in the domestic lists in Annexes II and III for the first time” substitute “authorised”.

(16) After Article 14, insert—

“Article 14AEthylene oxide: restrictions

1.  Ethylene oxide may not be used for sterilising purposes in food additives.

2.  Total residues of ethylene oxide (sum of ethylene oxide and 2-chloroethanol expressed as ethylene oxide (i.e. ethylene oxide + (0.55 x 2-chloroethanol))), irrespective of origin, in authorised food additives, or mixtures of those food additives, must not exceed 0.1 mg/kg.

Article 14BDetails to be included in the domestic list

The Authority must include the details described in Article 10(2) in the domestic list published and maintained under Regulation (EC) No 1331/2008.”.

(17) In Article 15—

regulation 8 17 a + (a)after “Food additives” insert “authorised for primary use”;

regulation 8 17 b + (b)for “Annex II” substitute “the authorisations concerned”.

(18) In Article 16—

regulation 8 18 a + (a)after “Food additives” insert “authorised for primary use”;

regulation 8 18 b + (b)for “Annex II to this Regulation” substitute “the authorisations concerned”.

(19) In Article 17, for “listed in Annex II to this Regulation may be used” substitute “that are authorised for primary use may be used, as provided for in the authorisations concerned,”.

(20) In Article 18—

regulation 8 20 a + (a)in paragraph 1(a), for “Annex II” substitute “an authorisation for primary use for the food additive concerned”;

regulation 8 20 b + (b)in paragraph 1(b), for “or food flavouring”, in each place it occurs, substitute “, food flavouring or nutrient”;

regulation 8 20 c + (c)in paragraph 3, for “or food enzyme”, in both places, substitute “, food enzyme or nutrient”;

regulation 8 20 d + (d)after paragraph 4, insert—

“5.  Paragraph 1(a) does not apply to foods listed in Table 1, as regards food additives in general, or in Table 2, as regards food colours, in Annex Ia.”.

(21) In Article 22(1)(a), for “in”, in the first place it occurs, substitute “under”.

(22) In Article 23(1)(a), for “in”, in the first place it occurs, substitute “under”.

(23) Omit Article 30.

(24) Omit Article 31.

(25) Omit Article 34.

(26) After Annex I, insert—

“ANNEX Ia

Carry-over principle: Article 18(1)(a) – exceptions”.

(27) Annex II is omitted, save that in Part A, in Section 2—

regulation 8 27 a + (a)Table 1 (foods in which the presence of an additive may not be permitted by virtue of the carry-over principle set out in Article 18(1)(a) of Regulation (EC) No 1333/2008); and

regulation 8 27 b + (b)Table 2 (foods in which the presence of a food colour may not be permitted by virtue of the carry-over principle set out in Article 18(1)(a) of Regulation (EC) No 1333/2008),

respectively, including their headings, become Table 1 and Table 2 following the heading in Annex Ia (as inserted by the previous paragraph of this regulation).

(28) Omit Annex III.