Statutory Instruments of the Scottish Parliament

(a) for the purposes of regulations 5, 7 and 15(1)(b), on 1st August 2008, and

(b) for all other purposes, on 16th November 2007.

(a) Article 3 (general requirements);

(b) Article 4 (special requirements for active and intelligent materials and articles);

(c) Article 11(4) and (5) (provisions relating to Community authorisation);

(d) Article 15(1), (2), (3), (4), (7) and (8) (labelling);

(e) Article 16(1) (declaration of compliance); and

(f) Article 17(2) (traceability).

(a) must not contain vinyl chloride monomer in a quantity exceeding 1 milligram per kilogram of the material or article as measured by the method of analysis specified in regulation 9(1); and

(b) must be manufactured in such a way that they do not transfer to foods with which they are in contact any quantity of vinyl chloride exceeding 0.01 milligrams of vinyl chloride per kilogram of the food as measured by the method of analysis specified in regulation 9(2).

    (2) No person may–

(a) sell;

(b) import; or

(c) use in the course of a business in connection with the storage, preparation, packaging, selling or serving of food,

(a) constitutes a finished product in itself; or

(b) is part of a finished product containing other materials,

and is intended to come into contact with food, or by being used for that purpose does come into contact with food.

    (2) Except in paragraph (4), any reference in this regulation to Annex II is a reference to Annex II to Directive 2007/42/EC.

    (3) Subject to paragraph (5), no person may manufacture any regenerated cellulose film intended to come into contact with food using any substance or group of substances other than the substances named or described–

(a) in the first column (denominations) of Annex II in the case of–


(i) uncoated film; or

(ii) coated film where the coating is derived from cellulose;



(b) in the first column of the First Part of Annex II in the case of film to be coated, where the coating will consist of plastics;

and other than in accordance with the conditions and restrictions specified in the corresponding entry in the second column of the appropriate Part of Annex II, as read with the preamble to that Annex.

    (4) No person may manufacture any coating to be applied to film referred to in paragraph (3)(b) using any substance or group of substances, except those listed in Annexes II, III or IV to Directive 2002/72/EC, and other than in accordance with the appropriate requirements, restrictions and specifications contained in those Annexes and in the 2006 Regulations.

    (5) Substances other than those listed in Annex II may be used as colourants or adhesives in the manufacture of a film to which paragraph (3)(a) applies, provided that such film is manufactured in such a way that it does not transfer any colourant or adhesive to food in any detectable quantity.

    (6) Subject to regulation 12, no person may–

(a) sell;

(b) import; or

(c) use in the course of a business in connection with the storage, preparation, packaging, selling or serving of food,

any regenerated cellulose film which has been manufactured in contravention of the requirements of paragraphs (3), (4) or (5), or which fails to comply with paragraph (8).

    (7) No person may use in the course of a business in connection with the storage, preparation, packaging, serving or selling of food–

(a) where the food contains water physically free at the surface, any regenerated cellulose film containing bis(2-hydroxyethyl) ether, ethanediol or both these substances;

(b) any regenerated cellulose film in such a way that any printed surface of that film comes into contact with the food.

(a) contravenes the provisions of regulation 8(2), 10(3), (4), (6) or (7), or 11(1) or (3);

(b) intentionally obstructs any person acting in the execution of Regulation 1935/2004, Regulation 2023/2006 or these Regulations or without reasonable excuse fails to provide any assistance or information that that person may reasonably require; or

(c) in purported compliance with any requirement mentioned in sub paragraph (b), knowingly or recklessly supplies information that is false or misleading in any material particular,

is guilty of an offence.

    (2) Any person guilty of an offence under these Regulations is liable–

(a) on conviction on indictment to a fine or to imprisonment for a term not exceeding two years or to both;

(b) on summary conviction to a fine not exceeding the statutory maximum or to a term of imprisonment not exceeding 6 months or to both.

    (3) No prosecution for an offence under these Regulations shall be begun after the expiry of–

(a) three years from the commission of the offence; or

(b) one year from the date on which evidence sufficient in the opinion of the prosecutor to warrant proceedings comes to the knowledge of the prosecutor,

(a) provide that references to a certain EC instrument or specified parts of certain EC instruments are to be construed as references to the instrument or specified part of it as it may be amended from time to time (regulation 2(4));

(b) do not apply to materials or articles outside the scope of Regulation 1935/2004 (regulation 3);

(c) contain provisions which make it an offence to contravene certain requirements of Regulation 1935/2004 (Regulation 1935/2004 being the principal framework Regulation on materials and articles in contact with food) (regulation 4), and of Regulation 2023/2006 (regulation 5);

(d) provide for designation of the competent authorities for the various purposes identified in Regulations 1935/2004 and 2023/2006 (regulations 6 and 7);

(e) re-enact, without substantive amendments, the provisions of the 2005 Regulations relating to vinyl chloride (regulations 8 and 9);

(f) re-enact provisions of the 2005 Regulations relating to regenerated cellulose film ("RCF") with minor amendments to implement Directive 2007/42 (regulations 10 and 11).

(g) in regulation 10–


(i) control which substances may be used in the manufacture of RCF, which may vary according to whether or not it is coated with plastics (paragraph (3));

(ii) regulate which substances may be used to manufacture plastic coatings for RCF, and under what conditions (paragraph (4));

(iii) create a conditional derogation from paragraph (3) in respect of substances used as colourants or adhesives in the manufacture of non plastic coated RCF (paragraph (5));

(iv) create offences in relation to the sale, import or business use of non compliant RCF (paragraphs (6) and (7)); and

(v) create a requirement for RCF, when marketed prior to the retail stage, to be accompanied by a declaration of legislative compliance (paragraph (8)).



(h) in regulation 11–

     apply to plastic coated RCF the existing controls (derived from Commission Directive 2002/72/EC) on migration of constituents of plastic materials and articles into food, in particular by–



(i) specifying overall migration limits for plastic coated RCF (paragraphs (1) and (2));

(ii) applying to plastic coated RCF the specific migration limits applicable to certain substances used in the manufacture of plastic materials and articles (paragraphs (3) and (4)); and

(iii) applying the prescribed methods and procedures for checking compliance with migration limits (paragraphs (5) and (6)).



(i) include savings and transitional provisions which–



(i) preserve the defences available under the 2005 Regulations for any RCF manufactured before 29th April 1994 that may still be in circulation; and

(ii) preserve the defence in relation to RCF manufactured in or imported into the European Community before 29th January 2006 (regulation 12).



(j) contain general administrative and enforcement provisions which–



(i) penalise contravention of these Regulations or obstruction of those enforcing them (regulation 13);

(ii) provide for a defence of due diligence to an offence under these Regulations (regulation 14);

(iii) designate enforcement authorities for various functions under the Regulations (regulation 15);

(iv) specify the procedure to be followed when sending a sample for analysis (regulation 16);

(v) make provision for a sample to be analysed by the Government Chemist (regulation 17); and

(vi) apply certain provisions of the Food Safety Act 1990 (regulation 18).



(k) make amendments and revocations by–



(i) amending regulation 8(2) to the Ceramic Articles in Contact with Food (Scotland) Regulations 2006 (S.S.I. 2006/230) (regulation 19).

(ii) making consequential amendments to the Plastic Materials and Articles in Contact with Food (Scotland) (No. 2) Regulations 2006 (S.S.I. 2006/517) and the Food Safety (Sampling and Qualifications) Regulations 1990 (S.I. 1990/2463) (regulations 20 and 21); and

(iii) revoking the 2005 Regulations and subsequent amending legislation as well as a spent provision in the Food Safety Act 1990 (Consequential Modifications) (No. 2) (Great Britain) Order 1990 (S.I. 1990/2487) (regulation 22).

A full regulatory impact assessment of the effect that this instrument will have on business costs has been prepared and placed in the Scottish Parliament Information Centre. Copies may be obtained from the Food Standards Agency, 6th Floor, St Magnus House, 25 Guild Street, Aberdeen, AB11 6NJ.