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

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—

(a)for the heading, substitute “Requirement for authorisation”;

(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.”;

(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:”;

(d)omit paragraph 3.

(4) Omit Article 5A.

(5) In Article 6—

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

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

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

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

(e)in paragraph 5—

(i)for “not included in the list” substitute “that were not authorised”;

(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—

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

(b)in paragraph 2—

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

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

(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—

(a)in paragraph 1—

(i)in point (c)—

(aa)for “the” substitute “any”;

(bb)for “column 10 of Table 1 of point 1 of Annex I” substitute “the authorisations for the substances concerned”;

(ii)in point (d)—

(aa)for “the” substitute “any”;

(bb)for “in point 4 of Annex I” substitute “the authorisations for the substances concerned”;

(b)in paragraph 2, for “in Annex I” substitute “concerned”.

(8) In Article 11—

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

(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”;

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

(9) In Article 13—

(a)in paragraph 2—

(i)in point (a)—

(aa)after “set out in” insert “, or pursuant to,”;

(bb)for “Annex I” substitute “the authorisation for the substance concerned”;

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

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

(10) In Article 14—

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

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

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

(11) In Article 19—

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

(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—

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

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

(i)for “Table 1 of Annex I” substitute “an authorisation for the substance concerned”;

(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—

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

(b)in Chapter 4, in point 4.1., in the first sentence—

(i)omit “in Annex I”;

(ii)for “column 7” substitute “the authorisation for the substance concerned”.