PART 4Amendments relating to food contact materials

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(1) 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(2).”.

(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”.