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	Statutory Instruments of the Scottish Parliament
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"plastics" means those materials and articles to which Commission Directive 2002/72/EC relating to plastic materials intended to come into contact with foodstuffs[3], as corrected by a corrigendum published on 13th February 2002[4] and as amended by Commission Directive 2004/1/EC[5] and Commission Directive 2004/19/EC[6] applies;

"preparation" in relation to food includes manufacture and any form of treatment or process;

"regenerated cellulose film" means a thin sheet material obtained from refined cellulose derived from unrecycled wood or cotton, with or without the addition of suitable substances, either in the mass or on one or both surfaces, but does not include synthetic casings of regenerated cellulose;

"the 1998 Regulations" means the Plastic Materials and Articles in Contact with Food Regulations 1998[7];

"the Community Regulation" means Regulation (EC) No. 1935/2004 of the European Parliament and of the Council on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC[8]; and

"sell" includes offer or expose for sale or have in possession for sale, and "sale" and "sold" shall be construed accordingly.

    (2) Any reference in these Regulations to a numbered Article is a reference to the Article bearing that number in the Community Regulation.

    (3) Expressions used both in these Regulations and the Community Regulation have the same meaning in these Regulations as they have in the Community Regulation.

Scope
     3. These Regulations do not apply to those materials and articles specified in Article 1.3.

Competent authorities for the purposes of the Community Regulation
     5. The competent authority for the purposes of-

(a) Article 9 shall be the Agency; and

(b) Articles 16.1 and 17.2 shall be the Agency and the authority having responsibility for enforcement pursuant to regulation 12(1).

any such material or article that does not comply with this regulation.

Methods of analysis
     7.  - (1) The method used in analysing any sample for the purpose of establishing the quantity of vinyl chloride monomer present in the material or article in order to determine whether it complies with regulation 6(1)(a) shall be the method specified in the Annex to Commission Directive No. 80/766/EEC laying down the Community method of analysis for the official control of the vinyl chloride monomer level in materials and articles which are intended to come into contact with foodstuffs[9].

    (2) The method used in analysing any food for the purpose of establishing the quantity of vinyl chloride present in the food in order to determine whether a material or article which is or has been in contact with the food complies with regulation 6(1)(b) shall be the method specified in the Annex to Commission Directive No. 81/432/EEC laying down the Community method of analysis for the official control of vinyl chloride released by material and articles into foodstuffs[10].

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

    (2) Any reference in this regulation to Annex II is a reference to Annex II to Directive 93/10/EEC relating to materials and articles made of regenerated cellulose film intended to come into contact with food[11] as amended by Commission Directive 93/111/EC[12] and Commission Directive 2004/14/EC[13].

    (3) Subject to paragraph (5) no person shall 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; or



(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 shall manufacture any coating to be applied to film referred to in paragraph (3)(b) using any substance or group of substances other than the substances listed in Schedules 1, 2 or 2A to the 1998 Regulations and other than in accordance with the appropriate requirements, restrictions and specifications contained in those Regulations and in the Schedules thereto.

    (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 of those substances to food in any detectable quantity.

    (6) No person shall-

(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 paragraphs (3), (4) or (5) or which does not comply with paragraph (8).

    (7) No person shall 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 which contains 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 food.

    (8) Any material or article made of regenerated cellulose film, unless by its nature clearly intended to come into contact with food, shall be accompanied at a marketing stage other than the retail stage by a written declaration attesting that it complies with the legislation applicable to it.

Migration limits for regenerated cellulose film coated with plastics
     9.  - (1) Subject to paragraph (2) no person shall manufacture or import any material or article made with regenerated cellulose film coated with plastics which-

(a) is intended to come into contact with food; and

(b) is capable of transferring its constituents to food in quantities exceeding an overall migration limit of 10 milligrams per square decimetre of the surface of the material or article in contact with food.

    (2) In the case of any material or article made with regenerated cellulose film coated with plastics which-

(a) is or is comparable to a container or which can be filled, with a capacity of not less than 500 millilitres and not more than 10 litres;

(b) can be filled and for which it is impracticable to estimate the surface area in contact with food; or

(c) is a cap, gasket, stopper or similar device for sealing,

the overall migration limit shall be 60 milligrams of constituents transferred per kilogram of food.

    (3) No person shall manufacture or import any material or article made with regenerated cellulose film coated with plastics manufactured with any substance listed in Part I of Schedule 1 to the 1998 Regulations (authorised monomers) which-

(a) is intended to come into contact with food; and

(b) is capable of transferring its constituents to food in quantities exceeding the specific migration limits set out in column 4 of that Part as read with Part II of that Schedule.

    (4) Where the migration limit for a substance mentioned in paragraph (3) is expressed in milligrams per kilogram, in the case of regenerated cellulose film coated with plastics which-

(a) is or is comparable to a container or which can be filled, with a capacity of less than 500 millilitres or more than 10 litres; or

(b) cannot be filled or for which it is impracticable to estimate the relationship between the surface area of the film and the quantity of food in contact with it,

the migration limit shall be divided by the conversion factor of 6 in order to express it in milligrams of constituents transferred per square decimetre of the material or article in contact with food.

    (5) Subject to paragraph (6), the verification of compliance with migration limits shall be conducted in accordance with the provisions of Schedules 3 and 4 of the 1998 Regulations as read with regulation 6 of those Regulations and for the purposes of this paragraph any reference in those provisions to a plastic material or article shall be construed as a reference to regenerated cellulose film coated with plastics.

    (6) Paragraph (5) shall not apply in any circumstances to which regulation 7(1) or (2) is applicable.

Saving and transitional provisions
     10.  - (1) Notwithstanding the revocations in regulation 16, regulation 6A of the Materials and Articles in Contact with Food Regulations 1987[14] shall apply to offences under these Regulations as it applied to offences under the equivalent provisions of those Regulations.

    (2) In any proceedings for an offence under regulation 8(3), (4) or (6) or regulation 9(1) or (3) it shall be a defence to prove that-

(a) the act constituting the offence was committed in relation to regenerated cellulose film which was manufactured or imported into the European Community before 29th January 2006; and

(b) the act constituting the offence would not have constituted an offence under the 1987 Regulations as they were in force immediately before the coming into force of these Regulations.

whichever is the earlier.

    (4) For the purposes of paragraph (3), a certificate signed by or on behalf of the prosecutor, and stating the date on which evidence sufficient in the prosecutor's opinion to warrant the proceedings came to the knowledge of the prosecutor, shall be conclusive evidence of that fact.

    (5) A certificate stating that matter and purporting to be so signed shall be deemed to be so signed unless the contrary is proved.

    (6) In any proceedings for an offence of contravening or failing to comply with these Regulations it shall be a defence for the accused to prove that the material or article in respect of which the offence is alleged to have been committed was intended for export to a country that is not a member State and that the material or article could lawfully be exported there in the circumstances provided for in relation to food and feed in Article 12 of Regulation (EC) No. 178/2002[15].

Enforcement
     12.  - (1) Subject to paragraph (2) it shall be the duty of each food authority to enforce and execute these Regulations and the provisions of the Community Regulation mentioned in paragraphs (a) to (f) of regulation 4 within its area.

    (2) In addition, the Agency may, if it considers it appropriate to do so, enforce and execute Articles 16.1 and 17.2.

Analysis by Government Chemist
     13.  - (1) The sheriff before whom any criminal proceedings are taken under these Regulations shall, on the application of either the prosecutor or the accused, cause-

(a) any material or article which is the subject of the proceedings and which, if it has already been tested is capable of being further tested; or

(b) any food which has been in contact with any such material or article,

to be sent to the Government Chemist who shall carry out such testing as is appropriate and transmit to the court a certificate of the result and the costs of the testing shall be borne by the prosecutor or the accused as the sheriff may order.

    (2) Any certificate of the results of testing transmitted by the Government Chemist under this regulation shall be signed by or on behalf of the Government Chemist, and the testing may be carried out by any person under the direction of the person who signs the certificate.

    (3) Any certificate transmitted by the Government Chemist in accordance with paragraph (2) shall be taken as sufficient evidence of the facts stated therein unless any party to the proceedings requests that the person by whom the certificate is signed be called as a witness.

    (4) In this regulation "testing" includes examination and analysis, and "tested" shall be construed accordingly.

Application of various provisions of the Act
     14.  - (1) The following provisions of the Act apply for the purposes of these Regulations with the modification that any reference in those provisions to the Act or Part thereof shall be construed as a reference to these Regulations-

(a) section 2 (extended meaning of "sale" etc.);

(b) section 20 (offences due to fault of another person);

(c) section 21 (defence of due diligence) with the modification that in subsection (4) the references to "sale" shall be deemed to include references to "placing on the market";

(d) section 30(8) (which relates to documentary evidence);

(e) section 35(1) to (3) (punishment of offences) in so far as it relates to offences under section 33(1) and (2) as applied by paragraph (3)(b);

(f) section 36 (offences by bodies corporate); and

(g) section 36A (offences by Scottish partnerships).

    (2) In the application of section 32 of the Act (powers of entry) for the purposes of these Regulations, the reference in subsection (1) to the Act shall be construed as including a reference to the Community Regulation.

    (3) The following provisions of the Act apply for the purposes of these Regulations with the modification that any reference in those provisions to the Act shall be construed as including a reference to the Community Regulation and these Regulations-

(a) section 3 (presumptions that food intended for human consumption) with the modifications that the references to "sold" and "sale" shall be deemed to include references to "placed on the market" and "placing on the market" respectively;

(b) section 33 (obstruction etc. of officers); and

(c) section 44 (protection of officers acting in good faith) with the modification that references to "a food authority" shall include "the Agency".

Amendments to the 1998 Regulations
     15.  - (1) The 1998 Regulations are amended in accordance with paragraphs (2) to (6).

    (2) In regulation 2 (interpretation)-

(a) omit the definition of "the 1987 Regulations";

(b) after the definition of "the 1992 Regulations" insert-

"the 2005 Regulations" means the Materials and Articles in Contact with Food (Scotland) Regulations 2005;?CQ?[16].

    (3) In regulation 6(1)(b) (method of testing the capability of plastic materials or articles to transfer constituents and methods of analysis)[17] for "regulation 14(2) of the 1987 Regulations" substitute "regulation 7(2) of the 2005 Regulations".

    (4) In regulation 9(1) (enforcement) for "the 1987 Regulations" substitute "the 2005 Regulations".

    (5) In regulation 11 (presumption as to food with which a plastic material or article, adhesive or material or article covered by a surface coating is to come into contact) for "the 1987 Regulations" substitute "Regulation (EC) No. 1935/2004 of the European Parliament and of the Council"[18].

    (6) For regulation 12 (application of other provisions)[19] substitute-

" Application of other provisions
     12.  - (1) The following provisions of the Act shall apply for the purposes of these Regulations as they apply for the purposes of the Act-


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

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

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



    (2) Regulation 13 of the 2005 Regulations shall apply in relation to proceedings taken under these Regulations as it does to proceedings taken under those Regulations.".

Revocations
     16. The following Regulations or parts thereof are revoked-

(a) the Materials and Articles in Contact with Food Regulations 1987[20];

(b) regulation 3 of the Food Safety (Export) Regulations 1991[21];

(c) The Materials and Articles in Contact with Food (Amendment) Regulations 1994[22].

RHONA BRANKIN
Authorised to sign by the Scottish Ministers

St Andrew's House, Edinburgh
28th April 2005

[2] Section 48(4A) was inserted by paragraph 21 of Schedule 5 to the 1999 Act.back

[3] O.J. No. L 39, 13.2.03, p.1.back

[4] O.J. No. L 220, 15.8.02, p.18.back

[5] O.J. No. L 7, 13.1.04, p.45.back

[6] O.J. No. L 71, 10.3.04, p.8.back

[7] S.I. 1998/1376, as amended by S.S.I. 2000/431, 2002/498, 2003/9, 2004/524 and 2005/92.back

[8] O.J. No. L 338, 13.11.04, p.4.back

[9] O.J. No. L 213, 16.8.80, p.42.back

[10] O.J. No. L 167, 24.6.81, p.6.back

[11] O.J. No. L 93, 17.4.93, p.27.back

[12] O.J. No. L 310, 14.12.93, p.41.back

[13] O.J. No L 27, 30.1.04, p.48.back

[14] S.I. 1987/1523; as amended by S.I. 1990/2487, 1991/1476 and 1994/979; regulation 6A was inserted by S.I. 1994/979.back

[15] O.J. No. L 31, 1.2.02, p.1.back

[16] S.S.I. 2005/ 243 .back

[17] Regulation 6(1) was inserted by S.S.I. 2002/498.back

[18] O.J. No. L 338, 13.11.04, p.4.back

[19] Regulation 12 was amended by S.S.I. 2002/498.back

[20] S.I. 1987/1523, amended by S.I. 1990/2487, 1991/1476 and 1994/979.back

[21] S.I. 1991/1476.back

[22] S.I. 1994/979.back

 © Crown copyright 2005