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.

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)—

(a)in point (a), for “a list of” substitute “provision regulating”;

(b)in point (b)—

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

(ii)in the second place it occurs, omit “list(s) of”;

(iii)omit “and, when necessary, special conditions of use for these substances”;

(c)omit points (c) and (d);

(d)in point (e) omit “specific”;

(e)in point (m)—

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

(ii)after “Register” insert “or list”.

(4) In Article 8—

(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.”;

(b)in paragraph 2—

(i)for “in the specific measures” substitute “out in the authorisation concerned”;

(ii)after “Article 4” insert “and any relevant specific measures”.

(5) In Article 11—

(a)in paragraph 1—

(i)for “prescribed” substitute “determined”;

(ii)for “in light of” substitute “, having regard to”;

(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—

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

(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”.

Amendment of Commission Regulation (EC) No 450/2009 on active and intelligent materials and articles intended to come into contact with food

12.—(1) Commission Regulation (EC) No 450/2009 on active and intelligent materials and articles intended to come into contact with food(3) is amended as follows.

(2) In Article 3, for point (g) substitute—

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

(h)‘registered substance’ means a substance that was entered in the Register immediately before IP completion day;

(i)‘Register’ means the “Register of substances for which a valid application for authorisation was submitted under Regulation (EC) No 450/2009” published by the European Commission, dated 14 June 2012, version 1.1, as it had effect in the European Union immediately before IP completion day(4).”.

(3) Before Article 5, for the heading for “Section 1”, substitute “Authorised substances”.

(4) In Article 5—

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

(b)for paragraph 1 substitute—

“1.  Only substances that are authorised by the appropriate authority in accordance with the procedure in Regulation (EC) No 1935/2004 may be used in components of active and intelligent materials and articles.”;

(c)in paragraph 2, in the words before point (a), for “included in the list” substitute “authorised”.

(5) In Article 6—

(a)in the heading, for “inclusion of substances in the list” substitute “authorisation”;

(b)in the text, for “included in the list” substitute “authorised”.

(6) In Article 7—

(a)in the heading, for “the list” substitute “an authorisation”;

(b)in the words before point (a), for “The list” substitute “An authorisation”.

(7) For Article 8, substitute—

“Article 8ARegistered substances

1.  The Food Safety Authority may ask a person (“the applicant”) who applied for a registered substance to be entered in the Register to provide, within a specified period, such supplementary information or additional data as the Food Safety Authority considers necessary to evaluate that substance for the purpose of delivering its opinion to the appropriate authority prior to the determination of the authorisation status of that substance.

2.  The Food Safety Authority may extend the period of time described in paragraph 1.

3.  Where the Food Safety Authority makes a request under paragraph 1 and the applicant fails to provide the information or data requested within the specified period (including any extension of that period), the substance shall cease to be treated as a registered substance after the end of the day on which the applicant was required to provide the requested information but failed to do so.

4.  Before determining the authorisation status of all registered substances (which, under Article 14, would cause Article 4(e) and 5 to begin to apply), the appropriate authority must:

(a)have regard to substances (“unregistered substances”) other than registered substances lawfully placed on the market; and

(b)consider the time that may reasonably be needed by a person to apply for an unregistered substance to be authorised in accordance with Regulation (EC) No 1935/2004 and this Regulation.

Article 8BDetermination of authorisation status: registered substances

1.  For the purposes of Article 8A, determining the authorisation status of a registered substance is to consist of the appropriate authority determining whether the registered substance is:

(a)to be authorised for placing on the market or for use in contact with food;

(b)to cease to be permitted to be placed on the market or used in contact with food, and to cease to be a registered substance.

2.  A determination of a type falling within paragraph 1(b) may specify a period of time, or different periods of time, within which:

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

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

3.  Where the appropriate authority makes a determination as to the authorisation status of a registered substance, 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.”.

(8) Before Article 9, in the heading for “Section 2”, for “not to be included in the list” substitute “referred to in Article 5(2)”.

(9) In Article 14—

(a)in the second paragraph, for “of application of the Community list” substitute “that the appropriate authority determines the authorisation status of all registered substances in the Register pursuant to Article 8A and 8B”;

(b)in the final paragraph—

(i)for “of application of the Community list,” substitute “described in the second paragraph of this Article, registered substances and other”;

(ii)for “authorised” substitute “permitted to be placed on the market”;

(iii)in the second place it occurs, omit “Community”.

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(5) 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”.