PART 4Amendments relating to food contact materials

Amendment of Commission Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food

regulation 13 + 13.—(1) Commission Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food(1) is amended as follows.

(2) In Article 3, after paragraph (19) insert—

“(20) ‘appropriate authority’ and ‘Food Safety Authority’ have the meanings given in Regulation (EC) No 1935/2004.”.

(3) In Article 5—

regulation 13 3 a + (a)for the heading, substitute “Requirement for authorisation”;

regulation 13 3 b + (b)for paragraph 1 substitute—

“1.  Only substances of a type falling within paragraph 2 and which are authorised by the appropriate authority in accordance with the procedure in Regulation (EC) 1935/2004 may be intentionally used in the manufacture of plastic layers in plastic materials and articles.”;

regulation 13 3 c + (c)in paragraph 2, in the words before point (a), for “The list shall contain:” substitute “For the purposes of paragraph 1, the types of substances that may be authorised are:”;

regulation 13 3 d + (d)omit paragraph 3.

(4) Omit Article 5A.

(5) In Article 6—

regulation 13 5 a + (a)in the heading, for “not included in the list” substitute “that are not authorised”;

regulation 13 5 b + (b)in paragraph 1, for “included in the list” substitute “that are authorised”;

regulation 13 5 c + (c)in paragraph 3, for “not included in the list are authorised” substitute “, if not otherwise authorised, are nevertheless deemed to be authorised,”;

regulation 13 5 d + (d)in paragraph 4, for “not included in the list” substitute “, if not otherwise authorised,”;

regulation 13 5 e + (e)in paragraph 5—

regulation 13 5 e i + (i)for “not included in the list” substitute “that were not authorised”;

regulation 13 5 e ii + (ii)for “to include or not to include them in the list” substitute “on whether or not they are to be authorised,”.

(6) In Article 7—

regulation 13 6 a + (a)in paragraph 1, for “regularly prescribe” substitute “determine whether there are to be”;

regulation 13 6 b + (b)in paragraph 2—

regulation 13 6 b i + (i)in point (a), for “included in the list set out in Annex 1” substitute “authorised”;

regulation 13 6 b ii + (ii)in point (b), for “include it in the list” substitute “authorise it”;

regulation 13 6 c + (c)after paragraph 2, insert—

“3.  Where the appropriate authority determines that there is to be an update to the provisional list, the appropriate authority must:

(a)specify the date on which the update is to have effect; and

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

4.  The Food Safety Authority must publish and maintain the provisional list, and where the Food Safety Authority is informed by the appropriate authority that there is to be an update to the provisional list, the Food Safety Authority must publish the update.”.

(7) In Article 9—

regulation 13 7 a + (a)in paragraph 1—

regulation 13 7 a i + (i)in point (c)—

regulation 13 7 a i aa + (aa)for “the” substitute “any”;

regulation 13 7 a i bb + (bb)for “column 10 of Table 1 of point 1 of Annex I” substitute “the authorisations for the substances concerned”;

regulation 13 7 a ii + (ii)in point (d)—

regulation 13 7 a ii aa + (aa)for “the” substitute “any”;

regulation 13 7 a ii bb + (bb)for “in point 4 of Annex I” substitute “the authorisations for the substances concerned”;

regulation 13 7 b + (b)in paragraph 2, for “in Annex I” substitute “concerned”.

(8) In Article 11—

regulation 13 8 a + (a)in paragraph 1, for “Annex I” substitute “the authorisations for the substances concerned”;

regulation 13 8 b + (b)in paragraph 3(a), for “in Regulation (EC) No 1333/2008 or in Regulation (EC) No 1334/2008 or in Annex I to this Regulation” substitute “pursuant to Regulation (EC) No 1333/2008, Regulation (EC) No 1334/2008 or this Regulation”;

regulation 13 8 c + (c)in paragraph 3(b), for “Annex I to this Regulation” substitute “the authorisations for the substances concerned”.

(9) In Article 13—

regulation 13 9 a + (a)in paragraph 2—

regulation 13 9 a i + (i)in point (a)—

regulation 13 9 a i aa + (aa)after “set out in” insert “, or pursuant to,”;

regulation 13 9 a i bb + (bb)for “Annex I” substitute “the authorisation for the substance concerned”;

regulation 13 9 a ii + (ii)in point (b), for “not listed in the list or” substitute “that are not authorised or not listed”;

regulation 13 9 b + (b)in paragraph 4, omit “not listed in the list or provisional list”.

(10) In Article 14—

regulation 13 10 a + (a)in paragraph 2, for “not listed in the list or” substitute “that are not authorised or in”;

regulation 13 10 b + (b)in paragraph 3, in the words before point (a), omit “not listed in the list or provisional list”;

regulation 13 10 c + (c)in paragraph 5, for “Annex I to this Regulation” substitute “the authorisation for the substance concerned”.

(11) In Article 19—

regulation 13 11 a + (a)in the heading, for “not included in the list” substitute “that are not authorised”;

regulation 13 11 b + (b)in the text, for “covered by an inclusion in Annex I to this Regulation” substitute “authorised substances”.

(12) In Article 22, omit paragraph 4.

(13) Omit Annex I.

(14) In Annex II—

regulation 13 14 a + (a)in note (2) to Table 1, omit “The note in Annex I, Table 1, FCM No 398 applies:”;

regulation 13 14 b + (b)after the notes to Table 1, in paragraph 2 (which begins with the words “Primary aromatic amines”)—

regulation 13 14 b i + (i)for “Table 1 of Annex I” substitute “an authorisation for the substance concerned”;

regulation 13 14 b ii + (ii)for “Annex I”, in the second place it occurs, substitute “the authorisation concerned”.

(15) In Annex IV, in point (6), for “Annex I and” substitute “the authorisation for the substance concerned and in Annex”.

(16) In Annex V—

regulation 13 16 a + (a)in Chapter 2, in point 2.1.8., for “Annex I” substitute “the authorisation for the substance concerned”;

regulation 13 16 b + (b)in Chapter 4, in point 4.1., in the first sentence—

regulation 13 16 b i + (i)omit “in Annex I”;

regulation 13 16 b ii + (ii)for “column 7” substitute “the authorisation for the substance concerned”.