The Materials and Articles in Contact with Food (England) Regulations 2005
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The Secretary of State, in exercise of the powers conferred on him by sections 16(2), 17(1) and (2), 26(1)(a) and (3), 31 and 48(1) of the Food Safety Act 1990[1] and now vested in him[2], having had regard, in accordance with section 48(4A) of that Act, to relevant advice given by the Food Standards Agency, and after consultation as required by Article 9 of Regulation (EC) No. 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety[3], makes the following Regulations: Title, application and commencement 1. These Regulations may be cited as the Materials and Articles in Contact with Food (England) Regulations 2005, apply in relation to England only and come into force on 29th April 2005. Interpretation 2. - (1) In these Regulations -
(2) Any reference in these Regulations to a
numbered Article is a reference to the Article bearing that number in
Regulation 1935/2004. Enforcement of Regulation 1935/2004 4. Subject to the provisions of Article 27 (transitional arrangements), any person who contravenes any of the following provisions of Regulation 1935/2004 is guilty of an offence -
(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); (f) on or after 27th October 2006, Article 17(2) (traceability). Competent authorities for the purposes of Regulation
1935/2004
(b) in respect of Articles 16(1) and 17(2), the Agency and the authority having responsibility for enforcement pursuant to regulation 12(1).
Limits and migration limits 6. - (1) Materials and articles which are manufactured with vinyl chloride polymers or copolymers -
(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 food as measured by the method of analysis specified in regulation 7(2). (2) No person may -
(b) import; or (c) use in the course of a business in connection with the storage, preparation, packaging, selling or serving of food, any such material or article that does not comply with this
regulation. Controls and limits 8. - (1) This Part applies to regenerated cellulose film which -
(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.
(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.
(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) or (4), or which
fails to comply with paragraph (8).
(b) any regenerated cellulose film in such a way that any printed surface of that film comes into contact with the food. (8) Any material or article made of
regenerated cellulose film, unless by its nature clearly intended to
come into contact with food, at a marketing stage other than the
retail stage must be accompanied by a written declaration attesting
that it complies with the legislation applicable to
it.
(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
-
(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.
(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 -
(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.
(b) the act constituting the offence would not have constituted an offence under the Materials and Articles in Contact with Food Regulations 1987 immediately before the coming into force of these Regulations. (3) In any proceedings for an offence under
these Regulations it shall be a defence 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 which has legislation
analogous to these Regulations and that the material or article
complies with that legislation. Offences and penalties 11. - (1) Any person who contravenes the provisions of regulation 6(2), 8(3), (4), (6) or (7), or 9(1) or (3) is guilty of an offence. (2) Any person guilty of an offence under paragraph (1) or under regulation 4 is liable -
(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. Enforcement
(b) these Regulations. (2) The Agency shall also execute and
enforce the provisions of Articles 16(1) and 17(2).
(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 paid by the
prosecutor or the person charged as the court may
order.
(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) (punishment of offences) in so far as it relates to offences under section 33(1) as applied by paragraph (3) below; (f) section 35(2) and (3) in so far as it relates to offences under section 33(2) as applied by paragraph (3) below; (g) section 36 (offences by bodies corporate); (h) 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 Regulation
1935/2004.
(b) section 33(1) (obstruction etc. of officers); (c) section 33(2), with the modification that the reference to "any such requirement as is mentioned in subsection (1)(b) above" shall be deemed to be a reference to any such requirement as is mentioned in that subsection as applied by sub-paragraph (b); (d) section 44 (protection of officers acting in good faith). (4) Section 34 of the Act (time limit for
prosecutions) applies to offences under these Regulations as it
applies to offences punishable under section 35(2) of the
Act.
(b) after the definition of "the 1992 Regulations" insert the following definition -
(3) In paragraph (1)(b) of regulation 6
(method of testing the capability of plastic materials or articles to
transfer constituents and methods of analysis) for "regulation 14(2)
of the 1987 Regulations" substitute "regulation 7(2) of the 2005
Regulations".
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 -
(b) section 30(8) (relating to documentary evidence); (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
(b) Regulation 3 of The Food Safety (Export) Regulations 1991[14]; (c) The Materials and Articles in Contact with Food (Amendment) Regulations 1994[15].
(This note is not part of the Regulations) 1. These Regulations revoke the Materials and Articles in Contact with Food Regulations 1987 (S.I. 1987/1523, as amended) ("the 1987 Regulations") in so far as they apply in relation to England, and re-enact or re-enact with amendments certain provisions contained in those Regulations. These Regulations also provide for the enforcement of 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 ("Regulation 1935/2004"). 2. These Regulations do not apply to materials or articles outside the scope of Regulation 1935/2004 (regulation 3). The materials identified in that Regulation as being outside its scope are materials and articles supplied as antiques, covering or coating materials forming part of the food and which may be consumed with it, and fixed public or private water supply equipment. 3. Part 2 of these Regulations contains provision for the enforcement of Regulation 1935/2004, (regulation 4). Regulation 1935/2004 is a framework Regulation on materials and articles in contact with food, and replaces Directives 80/590/EEC and 89/109/EEC, which were implemented by the 1987 Regulations. This Part also provides for designation of the competent authorities for the various purposes identified in Regulation 1935/2004 (regulation 5). 4. Part 3 contains regulations which re-enact, without substantive amendments, the provisions of the 1987 Regulations relating to vinyl chloride (regulations 6 & 7). 5. Part 4 contains regulations that re-enact provisions of the 1987 Regulations relating to regenerated cellulose film ("RCF"), amended as necessary to implement the requirements of Commission Directive 2004/14/EC amending Directive 93/10/EC (regulations 8 & 9). 6. In particular regulation 8 of these Regulations -
(b) regulates what substances may be used to manufacture plastic coatings for RCF, and under what conditions (paragraph (4)); (c) creates 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)); (d) creates offences in relation to the sale, import or business use of non-compliant RCF (paragraphs (6) & (7)); and (e) creates a conditional requirement for RCF, when marketed prior to the retail stage, to be accompanied by a declaration of legislative compliance (paragraph (8)). 7. Regulation 9 applies
to plastic coated RCF the existing controls (derived from Commission
Directive 2002/72 and implemented by the Plastic Materials and
Articles in Contact with Food Regulations 1998, S.I. 1998/1376 as
amended) on migration of constituents of plastic materials and
articles into food, in particular by -
(b) applying to plastic coated RCF the specific migration limits applicable to certain substances used in the manufacture of plastic materials and articles (paragraphs (3) & (4)); and (c) applying the prescribed methods and procedures for checking compliance with migration limits (paragraphs (5) & (6)). 8. Regulation 10 contains
savings and transitional provisions which -
(b) create a defence in relation to RCF manufactured in or imported into the European Community before 29th January 2006; (c) provide for a defence in relation to exports. 9. Part 5 of these
Regulations contains general administrative and enforcement provisions
which -
(b) designate enforcement authorities (regulation 12); (c) provide that the courts may direct that substances should be submitted to the Government Chemist for analysis (regulation 13); (d) apply certain provisions of the Food Safety Act 1990 (regulation 14); (e) make consequential amendments to the Plastic Materials and Articles in Contact with Food Regulations 1998 (S.I. 1998/1376, as amended) (regulation 15); (f) revoke the 1987 Regulations and subsequent amending legislation (regulation 16). 10. A regulatory impact
assessment has been prepared for these Regulations and has been placed
in the library of each House of Parliament, together with a
transposition note setting out how the main elements of Commission
Directive 2004/14/EC have been transposed into domestic law by these
Regulations. Copies may be obtained from the Chemical Safety Division
of the Food Standards Agency, Aviation House, 125 Kingsway, London
WC2B 6NH. Notes: [1] 1990 c. 16. Section 1(1) and (2) (definition of "food") was substituted by S.I. 2004/2990.back [2] Functions formerly exercisable by "the Ministers" (being, in relation to England and Wales and acting jointly, the Minister of Agriculture, Fisheries and Food and the Secretaries of State respectively concerned with health in England and food and health in Wales and, in relation to Scotland, the Secretary of State) are now exercisable in relation to England by the Secretary of State pursuant to paragraph 8 of Schedule 5 to the Food Standards Act 1999 (1999 c.28) and paragraphs 12 and 21 of that Schedule amend respectively sections 17(2) and 48 of the 1990 Act. Section 48 was also amended by the Food Safety Act (Amendment) Regulations 2004 (S.I. 2004/2990). Functions of "the Ministers" so far as exercisable in relation to Wales were transferred to the National Assembly for Wales by the National Assembly for Wales (Transfer of Functions) Order 1999 (S.I. 1999/672) as read with section 40(3) of the 1999 Act and those functions so far as exercisable in relation to Scotland were transferred to the Scottish Ministers by section 53 of the Scotland Act 1998 (1998 c.46) as read with section 40(2) of the 1999 Act.back [3] OJ No. L31, 1.2.2002, p.1. That Regulation was last amended by Regulation (EC) No. 1642/2003 of the European Parliament and of the Council (OJ No. L245, 29.9.2003, p.4).back [4] OJ No. L93, 17.4.93, p.27, as last amended by Commission Directive 2004/14/EC (OJ No. L27, 30.1.2004, p.48).back [5] OJ No. L220, 15.8.2002, p.18, as last amended by Commission Directive 2004/19/EC (OJ No. L71, 10.3.2004, p.8).back [6] S.I. 1998/1376, as amended in relation to England by S.I. 2000/3162, S.I. 2002/2364, S.I. 2004/3113 and S.I. 2005/325.back [7] OJ No. L338, 13.11.2004, p.4.back [8] OJ No. L213, 16.8.90, p.42.back [9] OJ No. L167, 24.6.81, p.6.back [10] S.I. 1987/1523, as amended by S.I. 1991/1476 and S.I. 1994/979.back [12] OJ No. L338, 13.11.2004, p.4.back
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