PART 4Amendments relating to food contact materials

Amendment of Regulation (EC) No 1935/2004 of the European Parliament and of the Council on materials and articles intended to come into contact with food, etc.

regulation 11 + 11.—(1) Regulation (EC) No 1935/2004 of the European Parliament and of the Council on materials and articles intended to come into contact with food, etc.(1) is amended as follows.

(2) In Article 2(2), after point (g) insert—

“(h)‘specific measure’ means a measure under Article 5.”.

(3) In Article 5(1)—

regulation 11 3 a + (a)in point (a), for “a list of” substitute “provision regulating”;

regulation 11 3 b + (b)in point (b)—

regulation 11 3 b i + (i)for “list(s) of”, in the first place it occurs, substitute “provision regulating”;

regulation 11 3 b ii + (ii)in the second place it occurs, omit “list(s) of”;

regulation 11 3 b iii + (iii)omit “and, when necessary, special conditions of use for these substances”;

regulation 11 3 c + (c)omit points (c) and (d);

regulation 11 3 d + (d)in point (e) omit “specific”;

regulation 11 3 e + (e)in point (m)—

regulation 11 3 e i + (i)for “provisions requiring the appropriate authority to establish and maintain” substitute “provision relating to the establishment and maintenance of”;

regulation 11 3 e ii + (ii)after “Register” insert “or list”.

(4) In Article 8—

regulation 11 4 a + (a)for paragraph 1 substitute—

“1.  A person seeking an authorisation for a substance in accordance with a specific measure, where that substance has not yet been authorised by the appropriate authority, must submit an application in accordance with Article 9(1) and any relevant provisions in the specific measure concerned.”;

regulation 11 4 b + (b)in paragraph 2—

regulation 11 4 b i + (i)for “in the specific measures” substitute “out in the authorisation concerned”;

regulation 11 4 b ii + (ii)after “Article 4” insert “and any relevant specific measures”.

(5) In Article 11—

regulation 11 5 a + (a)in paragraph 1—

regulation 11 5 a i + (i)for “prescribed” substitute “determined”;

regulation 11 5 a ii + (ii)for “in light of” substitute “, having regard to”;

regulation 11 5 b + (b)after paragraph 1, insert—

“1A.  Where the appropriate authority determines that a substance is, or is not to be, authorised, the appropriate authority must:

(a)in the event of a determination to authorise the substance, specify the date on which the authorisation is to have effect; and

(b)communicate the determination to the Food Safety Authority.”.

(6) In Article 12—

regulation 11 6 a + (a)in paragraph 4, for “may prescribe amendments to the authorisation” substitute “determine whether the authorisation is to be modified, suspended or revoked”;

regulation 11 6 b + (b)after paragraph 4 insert(2)—

“4A.  Where the appropriate authority determines that an authorisation is, or is not, to be modified, suspended or revoked:

(a)the appropriate authority must:

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

(ii)communicate the determination to the Food Safety Authority;

(b)the Food Safety Authority must ensure that the domestic list referred to in Article 12A is updated accordingly.

4B.  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 substance, material or article concerned, and any products derived from it or containing it, may be placed on the market or used;

(b)the substance, material or article 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, material or article concerned, and any products derived from it or containing it, may continue to be applied.

4C.  The appropriate authority may prescribe other transitional measures not falling within paragraph 4B in relation to the modification, suspension or revocation of an authorisation.”.

(7) After Article 12, insert—

“Article 12ADomestic list of authorised substances

1.  The Food Safety Authority must establish and maintain a list (the “domestic list”) of substances authorised for use in materials and articles, including any restrictions or conditions specified by the appropriate authority under Article 11.

2.  The domestic list must be made available to the public.”.

(8) In Article 18(1), for “application of the provisions” substitute “the authorisation of the material or article”.