Office of Public Sector Information

PART 4 Application for Authorisation

Applications for inclusion of an additive in the Community list of authorised additives

25.—(1) This regulation applies where a person has made an application for the inclusion of an eligible additive in the Community list referred to in Article 4 of the Directive.

(2) The application mentioned in paragraph (1), including supporting data, must have been made to EFSA before 1 January 2007.

(3) If during examination of the data referred to in paragraph (2), EFSA calls for supplementary information, the eligible additive may, if otherwise permitted to be used under the law of England and Wales, continue to be so used until EFSA has issued an opinion, provided the supplementary opinion is submitted within the time limits specified by EFSA.

(4) For the purposes of this regulation, an eligible additive is one whose use is permitted in one or more Member States before 1 January 2007.

PART 5 General and Supplementary

Application of provisions of the Act

26.  The following provisions of the Act must apply for the purposes of these Regulations as they apply for the purposes of the Act —

(a) section 3 (presumption that food is intended for human consumption);

(b) section 30(8) (relating to documentary evidence);

(c) section 44 (protection of officers acting in good faith).

Amendment of the Food Safety (Sampling and Qualifications) Regulations 1990

27.  In the Food Safety (Sampling and Qualifications) Regulations 1990(24), in Schedule 1 (provisions to which those Regulations do not apply) for the title and reference of the Plastic Materials and Articles in Contact with Food (Wales) Regulations 2008 substitute the title and reference of these Regulations.

Amendments to the Materials and Articles in Contact with Food (Wales) Regulations 2007

28.—(1) The 2007 Regulations are amended in accordance with paragraphs (2) to (3).

(2) In regulation 2(1) —

(a) omit the definition of “the 2008 Regulations”;

(b) insert the following definition in the appropriate place—

““the 2008 Regulations” (“Rheoliadau 2008”) means the Plastic Materials and Articles in Contact with Food (Wales) (No. 2) Regulations 2008(25);”.

(3) In paragraph (5) of regulation 11 (migration limits for regenerated cellulose film coated with plastics), for the expression “as read with regulation 11” substitute “as read with regulation 13”.

Amendment of the Plastic Materials and Articles in Contact with Food (Lid Gaskets) (Wales) Regulations 2008

29.  In regulation 2 (interpretation) of the Plastic Materials and Articles in Contact with Food (Lid Gaskets) (Wales) Regulations 2008(26), for the definition of “the Commission Regulation” substitute the following definition —

““the Commission Regulation” (“Rheoliad y Comisiwn”) means Commission Regulation (EC) No. 372/2007 laying down transitional migration limits for plasticisers in gaskets in lids intended to come into contact with foods as amended by Commission Regulation (EC) No. 597/2008(27);”.

Revocations

30.  The following Regulations or parts thereof are revoked —

(a) Regulation 29(c) of the Plastic Materials and Articles in Contact with Food (Wales) Regulations 2008(28);

(b) The Plastic Materials and Articles in Contact with Food (Wales) Regulations 2008; and

(c) Regulation 24 of the 2007 Regulations.

Regulations 4 and 5

SCHEDULE 1 Supplementary provisions relating to Annexes II and III

1.  In Sections A and B of Annexes II and III (for the purposes of this Schedule referred to together as “the Annexes”) —

(a) the PM/REF number. of any substance is its EEC packaging material reference number;

(b) the CAS number of any substance is its CAS (Chemical Abstracts Service) Registry Number;

(c) the name of any substance is its chemical name, and to the extent that there is any inconsistency between the CAS number and the name, the name must take precedence over the CAS number; and

(d) references to specific migration are to be taken to mean specific migration as measured in accordance with Schedules 2 and 3.

2.  If a substance appearing in the Annexes as an individual compound also falls within a generic term which appears therein, any restriction applying to that substance must be that indicated for the individual compound and the entry applying to the generic term must be treated as varied to such extent as is necessary.

3.—(1) The items identified in Section A or B of Annex II must be taken to include—

(a) substances undergoing polymerisation (including polycondensation, polyaddition or any other similar process) to manufacture macromolecules;

(b) natural or synthetic macromolecular substances used in the manufacture of modified macromolecules, if the monomers required to synthesise them are not so identified; and

(c) substances used to modify existing natural or synthetic macromolecular substances.

(2) Salts (including double salts and acid salts) of aluminium, ammonium, calcium, iron, magnesium, potassium and sodium of authorised acids, phenols or alcohols are not included in the lists in the Annexes even if they are authorised and intentionally used; however names containing “...acid(s), salts” do appear in the lists if the corresponding free acid(s) is not or are not mentioned.

(3) Salts (including double salts and acid salts) of zinc of authorised acids, phenols or alcohols are not included in the lists in the Annexes even if they are authorised and intentionally used. For these salts a Group SML = 25/mg/kg (expressed as Zn) applies. The same restriction for Zn applies to —

(a) substances whose name contains “ ... ... ... ...acid(s), salts” which appear in the lists, if the corresponding free acid(s) is not or are not mentioned; and

(b) substances referred to in note 38 of Annex VI.

4.  In the case of substances listed in Section B of Annex III, the specific migration limits specified in column 4 must have effect where the verification of compliance is carried out in Simulant D or in test media of substitute tests as prescribed in Directive 82/711/EEC and 85/572/EEC.

5.  Where an entry in column 4 of the Annexes (restrictions and specifications) includes a bracketed number, that entry is subject to a note relating to that number as set out in Annex VI.