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

Amendment of Regulation (EC) No 1331/2008 of the European Parliament and of the Council establishing a common authorisation procedure for food additives, food enzymes and food flavourings

6.—(1) Regulation (EC) No 1331/2008 of the European Parliament and of the Council establishing a common authorisation procedure for food additives, food enzymes and food flavourings(1) is amended as follows.

(2) In Article 1—

(a)in paragraph 2—

(i)for “updating the lists” substitute “determining the authorisation status”;

(ii)for “the marketing of which is authorised pursuant to” substitute “for the purposes of”;

(b)in paragraph 3, for “included on the domestic list” to “Article 7” substitute “authorised”.

(3) In Article 2—

(a)for the heading, substitute “Definitions”;

(b)omit paragraphs 1 and 2;

(c)after paragraph 6, insert—

“7.  ‘Substance’ includes a flavouring substance under evaluation, within the meaning given in Regulation (EC) No 1334/2008.”.

(4) After Article 2, insert—

“Article 2ARequirement for appropriate authority to determine authorisation status

The appropriate authority must determine the authorisation status of substances in accordance with the sectoral food law concerned and this Regulation.

Article 2BDetermination of authorisation status

1.  For the purposes of this Regulation, determining the authorisation status of a substance is to consist of the appropriate authority determining whether or not to:

(a)authorise the placing on the market, or the use in or on food, of a substance;

(b)modify the authorisation of a substance, including modifying any conditions, restrictions or specifications associated with the authorisation concerned;

(c)revoke or suspend the authorisation of a substance.

2.  For the purposes of paragraph 1, a modification, suspension or revocation of an authorisation may specify a period of time, or different periods of time, within which—

(a)existing stocks of the substance concerned, and any products derived from it or containing it, may be placed on the market or used;

(b)the substance concerned, and any products derived from it or containing it, may continue to be produced, placed on the market or used;

(c)the labelling of the substance concerned, and any products derived from it or containing it, may continue to be applied.

3.  The appropriate authority may prescribe other transitional measures not falling within paragraph 2 in relation to the modification, suspension or revocation of an authorisation under the sectoral food law concerned and this Regulation.

4.  In this Article, “authorisation” includes the permission for a substance to be placed on the market or used in or on food under the sectoral food law concerned, and for this purpose includes food enzymes for which an application for initial authorisation has been entered in the Register under Regulation (EC) No 1332/2008 and flavouring substances under evaluation under Regulation (EC) No 1334/2008; and related terms are to be construed accordingly.

Article 2CDomestic list of substances

1.  The Authority must establish and maintain a list (the “domestic list”) of substances, the placing on the market, or the use in or on food, of which is permitted in accordance with the sectoral food law concerned and this Regulation.

2.  The Authority must make the domestic list available to the public.”.

(5) In Article 3—

(a)in paragraph 1, for “updating the domestic list” substitute “determining the authorisation status of a substance”;

(b)in paragraph 2, in the second subparagraph—

(i)for “the updates referred to in Article 2(2)(b) and (c)” substitute “a determination of the authorisation status of a substance described in Article 2B(1)(b) or (c)”;

(ii)for “the updates”, in the second place it occurs, substitute “any changes as a result of the determination”;

(c)in paragraph 3, for “prescribing the update” substitute “determining the authorisation status of the substance concerned”;

(d)in paragraph 4—

(i)in the first subparagraph, in the first sentence—

(aa)for “a planned update” substitute “determining the authorisation status of a substance”;

(bb)for “an update” substitute “a determination”;

(ii)in the second subparagraph, for “considering the update justified” substitute “determining the authorisation status of the substance concerned”.

(6) In Article 4(1), in the words before point (a), for “update the domestic list” substitute “determine the authorisation status of a substance”.

(7) In Article 7—

(a)for the heading, substitute “Determination of authorisation status and amendment of sectoral food laws”;

(b)in paragraph 1, for “take the decision whether to update the domestic list” substitute “determine the authorisation status of the substance concerned,”;

(c)after paragraph 1, insert—

“1A.  Where the appropriate authority makes a determination as to the authorisation status of a substance:

(a)the appropriate authority must:

(i)specify the date on which the authorisation, modification, suspension or revocation is to have effect; and

(ii)communicate the determination to the Authority;

(b)the Authority must update the domestic list referred to in Article 2C accordingly.”;

(d)in paragraph 3, for “decision”, in both places, substitute “determination”;

(e)in paragraph 4, for “removal of a substance from the domestic list” substitute “revocation of the authorisation of substances generally”;

(f)in paragraph 5—

(i)for “addition of a substance to the domestic list” substitute “authorisation of substances generally”;

(ii)for “adding, removing or changing” substitute “modifying”;

(iii)for “presence of the substance on the domestic list” substitute “authorisation of substances generally”.