The Materials and Articles in Contact with Food Regulations (Northern Ireland) 2005 No. 210

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STATUTORY RULES OF NORTHERN IRELAND

2005 No. 210
FOOD
The Materials and Articles in Contact with Food Regulations (Northern Ireland) 2005

	Made	12th April 2005
	Coming into operation	23rd May 2005

ARRANGEMENT OF REGULATIONS

PART 1
PRELIMINARIES

1.	Citatation and commencement

2.	Interpretation

Scope

PART 2
GENERAL REQUIREMENTS FOR MATERIALS AND ARTICLES

4.	Enforcement of Regulation 1935/2004

5.	Competent Authorities for the purposes of Regulation 1935/2004

PART 3
REQUIREMENTS FOR VINYL CHLORIDE

6.	Limits and Migration Limits

7.	Methods of Analysis

PART 4
REQUIREMENTS FOR REGENERATED CELLULOSE FILM

8.	Controls and Limits

9.	Migration limits for regenerated cellulose film coated with plastics

10.	Transitional provisions

PART 5
GENERAL

11.	Offences and penalties

12.	Enforcement

13.	Analysis by Government Chemist

14.	Application of various provisions of the Order

15.	Amendments to the 1998 Regulations

16.	Revocations

The Department of Health, Social Services and Public Safety[1], in exercise of the powers conferred on it by Articles 15(2), 16(1) and (2), 25(1)(a) and (3), 32 and 47(3) of the Food Safety (Northern Ireland) Order 1991[2] and of all other powers enabling it in that behalf, having had regard, in accordance with Article 47(3A) of the said Order, 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] and in accordance with Article 47(3) and (3B) of the said Order, hereby makes the following Regulations:

PART 1
PRELIMINARIES
Citation and commencement
1. These Regulations may be cited as the Materials and Articles in Contact with Food Regulations (Northern Ireland) 2005, and shall come into operation on 23rd May 2005.

Interpretation
2. - (1) "the Agency" means the Food Standards Agency;

"Directive 93/10/EEC" means Commission Directive 93/10/EEC relating to materials and articles made of regenerated cellulose film intended to come into contact with food[

"import" means import in the course of a business from a place other than a Member State;

"the Order" means the Food Safety (Northern Ireland) Order 1991;

"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;

    (2) Any reference in these Regulations to a numbered Article or Annex is, unless otherwise indicated, a reference to the Article or Annex bearing that number in Regulation 1935/2004.

    (3) Expressions used in these Regulations and in Regulation 1935/2004 have the same meaning in these Regulations as in that Regulation.

Scope
     3. The provisions of these Regulations do not apply to those materials and articles specified in sub-paragraphs (a), (b) and (c) of Article 1(3).

PART 2
GENERAL REQUIREMENTS FOR MATERIALS AND ARTICLES
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 -

Competent authorities for the purposes of Regulation 1935/2004
5. The following bodies are designated as the competent authorities for the purposes of the provisions of Regulation 1935/2004 as specified below -

(a) in respect of Articles 9 and 13, the Agency;

(b) in respect of Articles 16(1) and 17(2), the Agency and the authority having responsibility for enforcement pursuant to regulation 12(1).

PART 3
REQUIREMENTS FOR VINYL CHLORIDE
Limits and migration limits
6. - (1) Materials and articles which are manufactured with vinyl chloride polymers or copolymers -

(2) No person may -

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 (which lays 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)[8].

(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 (which lays down the Community method of analysis for the official control of vinyl chloride released by material and articles into foodstuffs)[9].

PART 4
REQUIREMENTS FOR REGENERATED CELLULOSE FILM
Controls and Limits
8. - (1) This Part applies to regenerated cellulose film which -

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.

(3) Subject to paragraph (5) no person may manufacture any regenerated cellulose film using any substance or group of substances other than the substances named or described -

(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 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 regenerated cellulose film to which this paragraph applies 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 10 no person may -

any regenerated cellulose film which has been manufactured in contravention of the requirements of paragraphs (4) and (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 -

    (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.

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 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; or

(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 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 plastic.

    (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, in relation to regenerated cellulose film manufactured before 29th April 1994 the defences in regulation 6A of the Materials and Articles in Contact with Food Regulations (Northern Ireland) 1987[10] shall apply in relation to offences under these Regulations in like manner as they applied to offences under the equivalent provisions in those Regulations.

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

PART 5
GENERAL
Offences and penalties
11. - (1) Any person who contravenes the provisions of regulations 6, 8 or 9, as read with regulation 10, is guilty of an offence.

(2) Any person guilty of an offence under paragraph (1) or under regulation 4 is liable -

Enforcement
12. - (1) Each district council in its district shall execute and enforce -

(a) the provisions of Regulation 1935/2004 mentioned in regulation 4, and

(b) these Regulations.

(2) The Agency shall also execute and enforce the provisions of Article 16(1) and 17(2).

Analysis by Government Chemist
13. - (1) The court before which any proceedings are taken under these Regulations may, if it thinks fit for the purposes of the proceedings, 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 paid by the prosecutor or the person charged as the court may order.

    (2) If in a case where an appeal is brought no action has been taken under paragraph (1), the provisions of that paragraph shall apply in relation to the court by which the appeal is heard.

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

    (4) Any certificate transmitted by the Government Chemist in accordance with paragraph (3) shall be taken as 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.

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

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

(a) Article 2(4) (extended meaning of "sale" etc);

(b) Article 19 (offences due to fault of another person);

(c) Article 20 (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) Article 30(8) (which relates to documentary evidence);

(e) Article 36(1) (punishment of offences) in so far as it relates to offences under Article 34(1) as applied by paragraph (3);

(f) Article 36(2) and (3) in so far as it relates to offences under Article 33(2) as applied by paragraph (3).

(2) In the application of Article 33 of the Order (powers of entry) for the purposes of these Regulations, the reference in subsection (1) to the Order shall be construed as including a reference to Regulation 1935/2004.

(3) The following provisions of the Order apply for the purposes of these Regulations with the modification that any reference in those provisions to the Order shall be construed as including a reference to Regulation 1935/2004 and these Regulations -

(a) Article 4 (presumptions that food is 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) Article 34(1) (obstruction etc. of officers);

(c) Article 34(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).

    (4) Article 35 of the Order (time limit for prosecutions) applies to offences under these Regulations as it applies to offences punishable under Article 36(2) of the Order.

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 1993 Regulations" insert the following -

" "the 2005 Regulations" means the Materials and Articles in Contact with Food Regulations (Northern Ireland) 2005[

    (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".

    (4) 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[12]".

    (5) For regulation 12 (application of other provisions) substitute -

Application of other provisions

12.

- (1) The following provisions of the Order shall apply for the purposes of these Regulations as they apply for the purposes of the Order -

(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.".

Revocation
16. The following Regulations or Parts thereof are revoked -

(a) the Materials and Articles in Contact with Food Regulations (Northern Ireland) 1987[

Sealed with the Official Seal of the Department of Health, Social Services and Public Safety on

12th April 2005.

L.S.

D. C. Gowdy
A senior officer of the Department of Health, Social Services and Public Safety

EXPLANATORY NOTE

(This note is not part of the Regulations)

     1. These Regulations revoke the Materials and Articles in Contact with Food Regulations (Northern Ireland) 1987 (S.R. 1987 No. 432, as amended) ("the 1987 Regulations"), 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, (regulation 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 -

paragraph (3)

paragraph (4)

paragraph (5)

paragraphs (6) & (7)

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 (Northern Ireland) 1998, S.R. 1998 No. 264 as amended) on migration of constituents of plastic materials and articles into food, in particular by -

(a) specifying overall migration limits for plastic coated RCF (paragraphs (1) & (2));

(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 -

(a) preserve the defences available under the 1987 Regulations for any RCF manufactured before 29th April 1994 that may still be in circulation, and

(b) create a defence in relation to RCF manufactured in or imported into the European Community before 29th January 2006.

9. Part 5 of these Regulations contains general administrative and enforcement provisions which:

(a) penalise contravention of these Regulations or of Regulation 1935/2004 (regulation 11);

(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 (Northern Ireland) Order 1991 (regulation 14);

(e) make consequential amendments to the Plastic Materials and Articles in Contact with Food Regulations 1998 (S.R. 1998 No. 264, as amended) (regulation 15); and

(f) revoke the 1987 Regulations and subsequent amending legislation (regulation 16).

Notes:

[1] Formerly the Department of Health and Social Services; see S.I. 1999/283 (N.I. 1) Article 3(6)back

[2] S.I. 1991/762 (N.I. 7) as amended by S.I. 1996/1663 (N.I. 12) and paragraphs 26 to 42 of Schedule 5 and Schedule 6 to the Food Standards Act 1999 c. 28 and S.R. 2004 No. 482 back

[3] O.J. 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 (O.J. No. L245, 29.9.2003, p. 4)back

[4] O.J. No. L93, 17.4.93, p.27, as last amended by Commission Directive 2004/14/EC (O.J. No. L27, 30.1.2004, p. 48)back

[5] O.J. No. L220, 15.8.2002, p. 18, as last amended by Commission Directive 2004/19/EC (O.J. No. L71, 10.3.2004, p. 8)back

[6] S.R. 1998 No. 264 as amended by S.R. 2000 No. 402, S.R. 2002 No. 316, S.R. 2004 No. 493 and S.R. 2005 No. 49 back

[7] O.J. No. L338, 13.11.2004, p. 4 back

[8] O.J. No. L213, 16.8.90, p. 42 back

[9] O.J. No. L167, 24.6.81, p. 6 back

[10] S.R. 1987 No. 432 as amended by S.R. 1991 No. 344 and S. R. 1994 No. 174 back

[11] S.R. 2005 No. 210 back

[12] O.J. No. L338, 13.11.2004, p. 4 back

[13] S.R. 1987 No. 432 back

[14] S.R. 1991 No. 344 back

[15] S.R. 1994 No. 174 back

ISBN 0 337 95975 7

Prepared 28 April 2005

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