Statutory Instrument 1998 No. 1376

The Plastic Materials and Articles in Contact with Food Regulations 1998

(The document as of February, 2008)

-- Back --

STATUTORY INSTRUMENTS

1998 No. 1376

FOOD

The Plastic Materials and Articles in Contact with Food Regulations 1998

	Made	1st June 1998
	Laid before Parliament	4th June 1998
	Coming into force	1st July 1998

The Minister of Agriculture, Fisheries and Food, the Secretary of State for Health and the Secretary of State for Wales, acting jointly in relation to England and Wales, and the Secretary of State for Scotland in relation to Scotland, in exercise of the powers conferred on them by sections 6(4), 16(2), 17(1), 26(1)(a) and (3), 31 and 48(1) of the Food Safety Act 1990[1], after consultation in accordance with section 48(4) with such organisations as appear to them to be representative of interests likely to be substantially affected by the Regulations; the Minister of Agriculture, Fisheries and Food and the Secretary of State, being Ministers designated[2] for the purposes of section 2(2) of the European Communities Act 1972[3] in relation to materials and articles in contact with food or drink or intended for such contact, acting jointly, in exercise of the powers conferred on them by the said section 2(2) in so far as these Regulations could not have been made under the powers hereinbefore mentioned; and in exercise of all other powers enabling the said Minister and aforesaid Secretaries of State in that behalf hereby make the following Regulations:

Title, commencement and extent
    1. - (1) These Regulations may be cited as the Plastic Materials and Articles in Contact with Food Regulations 1998 and shall come into force on 1st July 1998.

    (2) These Regulations apply in Great Britain.

Interpretation
    2. - (1) In these Regulations, unless the context otherwise requires - 

"the Act" means the Food Safety Act 1990;

"additive" means a substance, other than one which directly influences the formation of polymers, which is - 

(a) incorporated into a plastic material or article to achieve a technical effect in the finished product and is intended to be present in the finished product; or

(b) used to provide a suitable medium in which polymerisation occurs;

"business" has the same meaning as it has in the Act;

"capable" means capable as established under regulation 6;

"Council Directive 82/711" means Council Directive 82/711/EEC laying down the basic rules necessary for testing migration of the constituents of plastic materials and articles intended to come into contact with foodstuffs[4], as amended by Commission Directives 93/8/EEC[5] and 97/48/EC[6];

"the Directive" means Commission Directive (EEC) No. 90/128 relating to plastics materials and articles intended to come into contact with foodstuffs[7] (as corrected) and as amended by Commission Directives 92/39/EEC, 93/9/EEC, 95/3/EC and 96/11/EC[8];

"EEA Agreement" means the Agreement on the European Economic Area[9] signed at Oporto on 2nd May 1992 as adjusted by the Protocol[10] signed at Brussels on 17th March 1993;

"EEA State" means a State (other than the United Kingdom) which is a contracting party to the EEA Agreement;

"food" has the same meaning as it has in section 16(5) of the Act;

"good technical quality" means good technical quality as regards the purity criteria;

"human consumption" has the same meaning as it has in the Act;

"import" means import in the course of a business;

"monomer" means anything which is included for the purposes of the Directive among monomers and other starting substances;

"the 1987 Regulations" means the Materials and Articles in Contact with Food Regulations 1987[11];

"the 1992 Regulations" means the Plastic Materials and Articles in Contact with Food Regulations 1992[12];

"person charged" includes, in Scotland, the accused;

"plastic material or article" means anything which for the purposes of the Directive is included among those plastics materials and articles and parts thereof to which the Directive applies;

"preparation" has the same meaning as it has in the Act; and

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

    (2) For the purposes of these Regulations the supply of any plastic material or article, otherwise than on sale, in the course of a business shall be deemed to be a sale of the plastic material or article.

    (3) Any expression, other than one defined in paragraph (1) of this regulation, used both in these Regulations and in the Directive, Council Directive 82/711 or Council Directive 85/572/EEC laying down the list of simulants to be used for testing migration of constituents of plastic materials and articles intended to come into contact with foodstuffs13Y[13] has, in so far as the context admits, the same meaning as it bears in the Directive in which it appears.

    (4) Any reference in these Regulations to a numbered regulation or Schedule shall unless the context otherwise requires be construed as a reference to the regulation or Schedule bearing that number in these Regulations.

Restriction on the use, sale or importation of plastic materials and articles
    3. - (1) A plastic material or article which fails to meet the requisite standards shall not be - 

(a) used by any person in the course of a business in connection with the storage, preparation, packaging, sale or serving of food for human consumption;

(b) sold by any person for the purpose of its being used in connection with the storage, preparation, packaging, sale or serving of food for human consumption; or

(c) imported by any person from any place other than an EEA State for the purpose of its being used in connection with the storage, preparation, packaging, sale or serving of food for human consumption.

    (2) In any proceedings for an offence under these Regulations where it is alleged that a plastic material or article which fails to meet the requisite standards was used, sold or imported it shall be a defence for the person charged to prove that the plastic material or article in respect of which the offence is alleged to have been committed was intended for export to a country, other than an EEA State, which has legislation analogous to these Regulations and that the plastic material or article complies with such legislation.

    (3) In any proceedings for an offence under these Regulations where it is alleged that a plastic material or article which fails to meet the requisite standards was used, sold or imported it shall be a defence for the person charged to prove that the plastic material or article was manufactured - 

(a) before 1st July 1998; and

(b) in accordance with regulation 5 of the 1992 Regulations as that regulation applied when the plastic material or article was manufactured.

    (4) For the purposes of this regulation a plastic material or article fails to meet the requisite standards - 

(a) if - 


(i) it has been manufactured with a prohibited monomer as described in regulation 4(1) or a prohibited additive as described in regulation 5(1) or does not comply with regulation 4(5) or 7; and

(ii) no defence indicated in regulation 4(7), 5(2) or 7(5) would be available in proceedings for an offence under these Regulations relating to that manufacture or want of compliance; or



(b) if it has been manufactured outside Great Britain and sub-paragraph (a) above would have applied to it had it been manufactured in Great Britain.

Restriction on manufacture with monomers
    4. - (1) Subject to the following paragraphs of this regulation, no plastic material or article shall be manufactured by any person with any prohibited monomer, that is to say any monomer other than a monomer which is - 

(a) of good technical quality;

(b) identifed by PM/REF No., CAS No. (if any) and name respectively in columns 1, 2 and 3 of the relevant section of Part 1 of Schedule 1; and

(c) used in accordance with the restrictions (if any) specified in the corresponding entry in column 4 of the relevant section of that Part of that Schedule.

    (2) For the purposes of this regulation the relevant section of Part I of Schedule 1 is - 

(a) in the case of a plastic material or article manufactured before 1st January 1999, Section A, B or C;

(b) in the case of a plastic material or article manufactured after 31st December 1998 and before 1st January 2002, Section A or B; and

(c) in the case of a plastic material or article manufactured after 31st December 2001, Section A.

    (3) Paragraph (1) of this regulation does not apply to the use of a monomer in the manufacture of any - 

(a) surface coatings obtained from resinous or polymerised products in liquid, powder or dispersion form, including, but not limited to, varnishes, lacquers and paints;

(b) silicones;

(c) epoxy resins;

(d) products obtained by means of bacterial fermentation;

(e) adhesives and adhesion promoters; or

(f) printing inks.

    (4) Paragraph (1) of this regulation shall not be taken to prohibit the manufacture of any plastic material or article with any substance if the substance is a mixture which falls within paragraph 3(c) of Annex II to the Directive and does not contravene paragraph 4 of that Annex.

    (5) Subject to paragraph (6) of this regulation, where column 4 of the relevant section of Part I of Schedule 1 expresses a migration limit of mg/kg in relation to any monomer, no plastic material or article manufactured from that monomer shall be capable of transferring constituents of that monomer to food with which that plastic material or article may come into contact in quantities exceeding the appropriate limit, and for the purposes of this paragraph the appropriate limit is - 

(a) the number of milligrams expressed therein released per kilogram of food in the case of any plastic material or article other than one specified in sub-paragraph (b) below; and

(b) one sixth of the number of milligrams expressed therein per square decimetre of surface area of the plastic material or article if the plastic material or article comprises - 


(i) an article which is a container 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

(ii) sheet, film or other material which cannot be filled or for which it is impracticable to estimate the relationship between the surface area of that material and the quantity of food in contact with that surface area.

    (6) A plastic material or article manufactured from any monomer in respect of which column 4 of the relevant section of Part I of Schedule 1 expresses a migration limit of mg/kg shall not be considered capable of transferring constituents of that monomer to food with which that plastic material or article may come into contact in quantities exceeding the appropriate limit in paragraph (5) of this regulation if the only food which that plastic material or article may come into contact with is food to which regulation 7(3) applies.

    (7) In any proceedings for an offence under these Regulations where it is alleged that a plastic material or article does not comply with paragraph (1) of this regulation because it was manufactured with any monomer (whether or not of good technical quality) other than one identified in the relevant section of Part I of Schedule 1, it shall be a defence for the person charged to prove that - 

(a) each such monomer is present in the finished plastic material as an impurity, a reaction intermediate or a decomposition product which falls within paragraph 3(a) of Annex II to the Directive,

(b) each such monomer is an oligomer or a natural or synthetic macromolecular substance or a mixture thereof which falls within paragraph 3(b) of that Annex, or

(c) each such monomer falls within either sub-paragraph (a) or sub-paragraph (b) above,

and does not contravene paragraph 4 of that Annex.

    (8) Part II of Schedule 1 shall have effect to supplement this regulation and Part I of Schedule 1.

Restriction on manufacture with additives
    5. - (1) Subject to the following paragraphs of this regulation, no person shall use in the manufacture of plastic materials or articles any prohibited additive, that is to say an additive identified by PM/REF No., CAS No. (if any) and name respectively in columns 1, 2 and 3 of Part I of Schedule 2 which is not of good technical quality.

    (2) In any proceedings for an offence under these Regulations, where it is alleged that the commission of the offence is due to the manufacture of a plastic material or article with any additive identified in Part I of Schedule 2 which is not of good technical quality, it shall be a defence for the person charged to prove that each such additive is present in the finished plastic material or article as an impurity, a reaction intermediate or a decomposition product.

    (3) Part II of Schedule 2 shall have effect to supplement this regulation and Part I of Schedule 2.

---

Notes:

[1] 1990 c. 16; "the Ministers" is defined in section 4(1) of the Act; section 6(4)(a) was amended by paragraph 6 of Schedule 9 to the Deregulation and Contracting Out Act 1994 (c. 40).back

[2] S.I. 1976/2141.back

[3] 1972 c. 68.back

[4] OJ No. L297, 23.10.82, p.26.back

[5] OJ No. L90, 14.4.93, p.22.back

[6] OJ No. L222, 12.8.97, p.10.back

[7] OJ No. L75, 21.3.90, p.19.back

[8] Corrigendum in OJ No. L349, 13.12.90, p.26; amending Directives in OJ No. L168, 23.6.92, p.21, OJ No. L90, 14.3.93, p.26, OJ No. L41, 23.2.95, p.44 and OJ No. L61, 12.3.96, p.26.back

[9] OJ No. L1, 3.1.94, p.1.back

[10] OJ No. L1, 3.1.94, p.571.back

[11] S.I. 1987/1523; relevant amending instruments are S.I. 1990/2487 and 1994/979.back

[12] S.I. 1992/3145; amended by S.I. 1995/360, 1996/694 and 1996/2817.back

[13] OJ No. L372, 30.12.85, p.14.back

---