PART 7Amendments relating to smoke flavourings
Amendment of Regulation (EC) No 2065/2003
20.—(1) Regulation (EC) No 2065/2003 is amended as follows.
(2) In Article 1(2)—
(a)in point (a), at the end, insert “, and their conditions of use in or on foods”;
(b)omit point (b).
(3) In Article 3, omit paragraph 8.
(4) In Article 4(2), for “Article 6” substitute “this Regulation”.
(5) In Article 6—
(a)for the heading, substitute “Content of authorisations”;
(b)omit paragraph 1;
(c)in paragraph 2, for “list referred to in paragraph 1 shall give” substitute “authorisation must include”;
(d)omit paragraph 3.
(6) After Article 6, insert—
“Article 6ADomestic list of authorised smoke flavouring primary products
1. The Authority must establish and maintain a list (the “domestic list”) of primary products for use as such in or on foods or for the production of derived smoke flavourings, which have been authorised in accordance with this Regulation, including the details described in Article 6(2).
2. The Authority must make the domestic list available to the public.”.
(7) In Article 7(1)—
(a)for “inclusion” substitute “authorisation”;
(b)omit “in the list referred to in Article 6(1)”.
(8) In Article 9—
(a)in paragraph 1—
(i)in the first sentence; for “include a primary product in the list referred to in Article 6(1)” substitute “authorise the primary product”;
(ii)in the second sentence, for “inform the” substitute “specify the date on which the authorisation (if it is a decision to authorise) is to have effect, and inform the Authority and the”;
(b)omit paragraphs 2 and 3.
(9) After Article 9 insert—
“Article 9ASupervision
1. This Article applies where the Authority receives, or becomes aware of, any information which might affect the assessment of the safety of an authorised primary product or derived smoke flavouring.
2. Where the Authority receives, or becomes aware of, information under paragraph 1, the Authority must consider whether it is necessary to issue an opinion under Article 11(2).
3. The Authority may ask a relevant person to provide, within a specified period, such other information as the Authority considers necessary for the purposes of deciding whether to issue an opinion under Article 11(2).
4. The Authority may extend the period of time described in paragraph 3.
5. Where the Authority makes a request under paragraph 3 and the relevant person fails to provide the information requested within the specified period (including any extension of that period), the Authority must consider whether it is necessary to issue an opinion under Article 11(2) based on such information as the Authority has which might affect the assessment of the safety of the authorised primary product or derived smoke flavouring concerned.
6. In this Article, “relevant person” means any person who is—
(a)the authorisation holder of the authorised primary product or derived smoke flavouring concerned;
(b)a producer or manufacturer of the authorised primary product or derived smoke flavouring concerned; or
(c)any food business placing on the market or using the authorised primary product or derived smoke flavouring concerned.”.
(10) In Article 11—
(a)for paragraph 2 substitute—
“2. An opinion on whether an authorisation or the requested modification is still in accordance with this Regulation, following the procedure laid down in Article 8, where applicable:
(a)may be delivered by the Authority of its own initiative to the appropriate authority; or
(b)must be delivered by the Authority to the appropriate authority:
(i)following an application under paragraph 1, but only where the modification could affect the safety assessment of the authorised primary product; or
(ii)following a request to do so from the appropriate authority.”;
(b)in paragraph 3, for “the entry for that authorisation” substitute “, suspend or revoke the authorisation”;
(c)for paragraph 4 substitute—
“4. Where the appropriate authority decides to modify, suspend or revoke an authorisation, the appropriate authority must specify the date on which the modification, suspension or revocation is to have effect and communicate the decision to the Authority, and the Authority must update the domestic list referred to in Article 6A accordingly.
4A. For the purposes of this Article, 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 product concerned, and any products derived from it or containing it, may be placed on the market or used;
(b)the product 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 product concerned, and any products derived from it or containing it, may continue to be applied.
4B. The appropriate authority may prescribe other transitional measures not falling within paragraph 4A in relation to the modification, suspension or revocation of an authorisation.”.
(11) Omit Article 12.
(12) In Article 13(1)—
(a)in the words before point (a), omit “specified in the list referred to in Article 6(1)”;
(b)in point (a), omit “as given in the list referred to in Article 6(1)”;
(c)in point (b), omit “as set out in the list referred to in Article 6(1)”;
(d)in point (c), for “set out in the list referred to in Article 6(1)” substitute “for that product”.
(13) In Article 18—
(a)in the heading, after “Amendments” insert “to the Annexes”;
(b)omit the “and” at the end of point (a);
(c)omit point (b).
(14) Omit Article 20.