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Plastic Materials and Articles in Contact with Food (Amendment) Regulations (Northern Ireland) 2002

Type Ni-Statutory-Rule
Publication 2002-10-11
State In force
Jurisdiction Northern Ireland
Department Government Printer for Northern Ireland
Source legislation.gov.uk
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articles Not indexed
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Made: 11th October 2002

Coming into operation: 30th November 2002

The Department of Health, Social Services and Public Safety[^f00001], in exercise of the powers conferred on it by Articles 15(2), 16(1), 25(1)(a) and (3), 32 and 47(2) of the Food Safety (Northern Ireland) Order 1991[^f00002], 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[^f00003], and in accordance with Article 47(3) and (3B) of the said Order, hereby makes the following Regulations:

Citation and commencement

1

These Regulations may be cited as the Plastic Materials and Articles in Contact with Food (Amendment) Regulations (Northern Ireland) 2002 and shall come into operation on 30th November 2002.

Amendments to the Plastic Materials and Articles in Contact with Food Regulations (Northern Ireland) 1998

2

The Plastic Materials and Articles in Contact with Food Regulations (Northern Ireland) 1998[^f00004] (“the principal Regulations”) shall be amended in accordance with regulations 3 to 18.

3

Immediately after regulation 1 (citation and commencement) there shall be inserted the following regulation –

(1A) Notwithstanding the title to these Regulations – (a) regulations 3 and 9 to 12 apply also in relation to adhesives and to materials or articles covered by surface coatings; and (b) regulations 8A and 8B apply only in relation to adhesives and to materials or articles covered by surface coatings.

4

In regulation 2 (interpretation) –

  • “adhesive” means anything which, for the purposes of Commission Directive 2002/16, is included among the adhesives to which that Directive applies;
  • “BADGE” means 2,2-bis(4-hydroxyphenyl) propane bis(2,3-epoxypropyl) ether;
  • “BFDGE” means bis(hydroxyphenyl) methane bis(2,3-epoxypropyl) ethers;
  • “capable” means capable as established – in relation to any plastic material or article, under regulation 6; and in relation to any adhesive or material or article covered by a surface coating, under regulation 8B;
  • “Commission Directive 2001/62” means Commission Directive 2001/62/EC amending Directive 90/128/EEC relating to plastic materials and articles intended to come into contact with foodstuffs[^f00005];
  • “Commission Directive 2002/16” means Commission Directive 2002/16/EC on the use of certain epoxy derivatives in materials and articles intended to come into contact with foodstuffs[^f00006],
  • “the Directive” means Commission Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with foodstuffs[^f00007];
  • “material or article covered by a surface coating” means anything which, for the purposes of Commission Directive 2002/16, is included among the materials and articles covered by surface coatings to which that Directive applies;
  • “NOGE” means novolac glycidyl ethers not covered by Article 1(a) or (b) of Commission Directive 2002/16;
  • “QMA” has the same meaning as it bears in the first sentence of the sub-division relating to that term in paragraph 8 of Annex ll to the Directive;

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

; and

(5) The provisions referred to in the definition of “plastic material or article” in paragraph (1) are regulations 3, 4, 4A, 5, 6, 10, 11 and 12 and Schedules 3 and 4.

5

In regulation 3 (restriction on the use, sale or importation of plastic materials and articles) –

Restriction on the use, sale or importation of plastic materials and articles, adhesives and materials and articles covered by surface coatings

(iv) it does not comply with regulation 4(5), (5A) or (5B), 4A(4), (5) or (6), 5(4), (4A), (4B) or (4C), 7 or 7A(1), or

(v) it has been manufactured in contravention of a prohibition contained in regulation 4A(1), (2) or (3),

; and

(5) For the purposes of this regulation, an adhesive or a material or article covered by a surface coating fails to meet the requisite standards if – (i) it has been manufactured in contravention of a prohibition contained in regulation 8A(1), (2) or (3), or (ii) it does not comply with regulation 8A(4), (5) or (6).

6

In regulation 4 (restriction on manufacture with monomers) –

(1) Subject to the following paragraphs, no person shall use in the manufacture of any plastic material or article any prohibited monomer, that is to say – (a) any monomer (not being one to which sub-paragraph (b) or (c) relates) which is not – (i) of good technical quality; (ii) identified by PM/REF No. , CAS No. (if any) and name in columns 1, 2 and 3 respectively of the relevant section of Part I of Schedule 1, and (iii) used in accordance with the restrictions and specifications (if any) for that monomer set out or referred to in the corresponding entry in column 4 of that section; (b) BFDGE to the extent that they are used in such manufacture – (i) on or after 1st January 2005, or (ii) prior to that date in contravention of the restriction specified in paragraph 1 of Annex II to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of that Annex; or (c) NOGE to the extent that it is used in such manufacture – (i) on or after 1st January 2005, or (ii) prior to that date but on or after 1st March 2003, in contravention of the restriction specified in the first sentence of Article 4 of Commission Directive 2002/16.

(b) in the case of a plastic material or article manufactured on or after 30th November 2002 and before 1st January 2005, Section A or B; and (c) in the case of a plastic material or article manufactured on or after 1st January 2005, Section A.

(3) Paragraph (1)(a) 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) epoxy resins; (c) adhesives and adhesion promoters; or (d) printing inks.

(5A) No plastic material or article manufactured using BFDGE as a 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 specified in paragraph 1 of Annex II to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of that Annex. (5B) On or after 1st March 2003, no plastic material or article manufactured using NOGE as a monomer shall fail to comply with the requirements of the first sentence of Article 4 of Commission Directive 2002/16.

; and

7

Immediately after regulation 4 there shall be inserted the following regulation –

(4A) (1) No person shall use BADGE in the manufacture of any plastic material or article, where the use is not as a monomer or an additive – (a) on or after 1st January 2005; or (b) prior to that date in contravention of the restriction specified in paragraph 1 of Annex 1 to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of that Annex. (2) No person shall use BFDGE in the manufacture of any plastic material or article, where the use is not as a monomer or an additive – (a) on or after 1st January 2005; or (b) prior to that date in contravention of the restriction specified in paragraph 1 of Annex II to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of that Annex. (3) No person shall use NOGE in the manufacture of any plastic material or article, where the use is not as a monomer or additive – (a) on or after 1st January 2005; or (b) prior to that date but on or after 1st March 2003, in contravention of the restriction specified in the first sentence of Article 4 of Commission Directive 2002/16. (4) No plastic material or article manufactured using BADGE other than as a monomer or an additive shall be capable of transferring constituents of BADGE to food with which the plastic material or article may come into contact, in quantities exceeding the appropriate limit specified in paragraph 1 of Annex I to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of that Annex. (5) No plastic material or article manufactured using BFDGE other than as a monomer or an additive shall be capable of transferring constituents of BFDGE to food with which the plastic material or article may come into contact, in quantities exceeding the appropriate limit specified in paragraph 1 of Annex II to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of that Annex. (6) On or after 1st March 2003, no plastic material or article manufactured using NOGE other than as a monomer or an additive shall fail to comply with the requirements of the first sentence of Article 4 of Commission Directive 2002/16.

8

In regulation 5 (restriction on manufacture with additives) –

(1) Subject to the following paragraphs, no person shall use in the manufacture of any plastic material or article any prohibited additive, that is to say – (a) any additive identified by PM/REF No. , CAS No. (if any) and name in columns 1, 2 and 3 respectively of Part I of Schedule 2 or columns 1, 2 and 3 respectively of Part II of that Schedule, which – (i) is not of good technical quality, or (ii) is not used in accordance with the restrictions and specifications (if any) for that additive set out in the corresponding entry in column 4 of Part I or Part II, as appropriate; (b) BADGE to the extent that it is used in such manufacture – (i) on or after 1st January 2005, or (ii) prior to that date in contravention of the restriction specified in paragraph 1 of Annex I to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of that Annex; (c) BFDGE to the extent that they are used in such manufacture – (i) on or after 1st January 2005, or (ii) prior to that date in contravention of the restriction specified in paragraph 1 of Annex II to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of that Annex; or (d) NOGE to the extent that it is used in such manufacture – (i) on or after 1st January 2005, or (ii) prior to that date but on or after 1st March 2003, in contravention of the restriction specified in the first sentence of Article 4 of Commission Directive 2002/16.

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

(4A) No plastic material or article manufactured using BADGE as an additive shall be capable of transferring constituents of that additive to food with which the plastic material or article may come into contact, in quantities exceeding the appropriate limit specified in paragraph 1 of Annex I to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of that Annex. (4B) No plastic material or article manufactured using BFDGE as an additive shall be capable of transferring constituents of that additive to food with which the plastic material or article may come into contact, in quantities exceeding the appropriate limit specified in paragraph 1 of Annex II to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of that Annex. (4C) On or after 1st March 2003, no plastic material or article manufactured using NOGE as an additive shall fail to comply with the requirements of the first sentence of Article 4 of Commission Directive 2002/16.

; and

9

In regulation 6 (method of testing capability of transferring constituents) –

(1) For the purposes of these Regulations, a plastic material or article shall be treated as being capable of transferring constituents other than NOGE to food with which it may come into contact to the extent that such capability is established – (a) in any case other than one to which sub-paragraph (b) relates, and subject to Article 8.4 of the Directive (which may be applied on compliance with the conditions stated therein), by the verification methods specified in Schedules 3 and 4;

; and

(4) The specific migration of a constituent from a plastic material or article shall, where applicable, be determined in the manner specified in the relevant sub-paragraph of paragraph 8 of Annex ll to the Directive. (5) The specific migration from a plastic material or article of the substances listed in paragraph 1 of Annex I to Commission Directive 2002/16 shall be determined in the manner specified in paragraph 3 of that Annex. (6) The specific migration from a plastic material or article of the substances listed in paragraph 1 of Annex II to Commission Directive 2002/16 shall be determined in the manner specified in paragraph 3 of that Annex. (7) Whether or not the detection requirement specified in Article 4 of Commission Directive 2002/16 is complied with in relation to a plastic material or article shall be determined in the manner specified in the second sentence of that Article. (8) The quantity of a constituent in a plastic material or article shall, where applicable, be determined in the manner specified in the sub-paragraph of paragraph 8 of Annex II to the Directive relating to the term “QM(T)” or, as the case may be, the sub-paragraph of that paragraph relating to the term “QMA”,

10

For regulation 7A (specifications) there shall be substituted the following regulation –

(7A) (1) Subject to paragraph (3), no plastic material or article manufactured using isocyanates or colourants prepared by diazo-coupling shall be capable of transferring in a detectable quantity primary aromatic amines (expressed as aniline), not being primary aromatic amines listed in these Regulations, to food with which that plastic material or article may come into contact. (2) Schedule 2B shall have effect for the purpose of prescribing, for certain items listed in Part I of Schedule 1, Part I or II of Schedule 2 or Schedule 2A, the specifications for those items which are referred to in column 4 of the Part or, as the case may be, Schedule concerned. (3) For the purposes of paragraph (1), “detectable quantity” means a quantity of at least DL0.02 milligrams per kilogram of food or food simulant (analytical tolerance included).

11

Immediately after regulation 8 (labelling) there shall be inserted the following regulations –

(8A) (1) No person shall (in any case not covered by Article 1(2) of Commission Directive 2002/16) use BADGE in the manufacture of any – (a) adhesive; or (b) material or article covered by a surface coating, on or after 1st January 2005 or, prior to that date, in contravention of the restriction specified in paragraph 1 of Annex 1 to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of that Annex. (2) No person shall (in any case not covered by Article 1.2 of Commission Directive 2002/16) use BFDGE in the manufacture of any – (a) adhesive; or (b) material or article covered by a surface coating, on or after 1st January 2005 or, prior to that date, in contravention of the restriction specified in paragraph 1 of Annex II to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of that Annex. (3) No person shall (in any case not covered by Article 1(2) of Commission Directive 2002/16) use NOGE in the manufacture of any – (a) adhesive; or (b) material or article covered by a surface coating, on or after 1st January 2005 or, prior to that date but on or after 1st March 2003, in contravention of the restriction specified in the first sentence of Article 4 of Commission Directive 2002/16. (4) No adhesive or material or article covered by a surface coating, manufactured using BADGE and not covered by Article 1(2) of Commission Directive 2002/16, shall be capable of transferring constituents of BADGE to food with which the adhesive or, as the case may be, material or article may come into contact, in quantities exceeding the appropriate limit specified in paragraph 1 of Annex 1 to that Directive, as read with the second sentence of paragraph 2 of that Annex. (5) No adhesive or material or article covered by a surface coating, manufactured using BFDGE and not covered by Article 1(2) of Commission Directive 2002/16, shall be capable of transferring constituents of BFDGE to food with which the adhesive or, as the case may be, material or article may come into contact, in quantities exceeding the appropriate limit specified in paragraph 1 of Annex II to that Directive, as read with the second sentence of paragraph 2 of that Annex. (6) On or after 1st March 2003, no adhesive or material or article covered by a surface coating, manufactured using NOGE and not covered by Article 1(2) of Commission Directive 2002/16, shall fail to comply with the requirements of the first sentence of Article 4 of that Directive. (8B) (1) Subject to paragraphs (2) and (3), for the purposes of regulation 8A(1), (2), (4) and (5), an adhesive or material or article covered by a surface coating shall be treated as being capable of transferring BADGE or, as the case may be, BFDGE to food with which the adhesive or material or article may come into contact to the extent that such capability is established by the verification methods specified in Section A of Schedule 3 and in Schedule 4. (2) Subject to paragraph (3), in Section A of Schedule 3 and in Schedule 4, references to migration or release of a substance shall be construed as references to the transfer of constituents to the simulant representing the food or, as the case may be, the food with which the substance may come into contact. (3) For the purposes of paragraphs (1) and (2), Schedules 3 and 4 shall have effect as if – (a) the references in Section A of Schedule 3 and in Schedule 4 to “plastic material or article” were references to “adhesive or material or article covered by a surface coating”; (b) the references in paragraph 4(3) and (4) of Section A of Schedule 3 to “a migration limit specified in regulation 7, Schedule 1 or Schedule 2” were references to “a migration limit referred to in regulation 8A(4) or (5)”; and (c) the reference in paragraph 5 of Part II of Schedule 4 and paragraph 2(1)(b) of Part III of that Schedule to “regulation 7 or Schedule 1” were a reference to “regulation 8A(4) or (5)”. (4) The specific migration from an adhesive or a material or article covered by a surface coating of the substances listed in paragraph 1 of Annex I to Commission Directive 2002/16 shall be determined in the manner specified in paragraph 3 of that Annex. (5) The specific migration from an adhesive or a material or article covered by a surface coating of the substances listed in paragraph 1 of Annex II to Commission Directive 2002/16 shall be determined in the manner specified in paragraph 3 of that Annex. (6) Whether or not the detection requirement specified in Article 4 of Commission Directive 2002/16 is complied with in relation to an adhesive or a material or article covered by a surface coating shall be determined in the manner specified in the second sentence of that Article.

12

In regulation 10 (offences) –

(14) Subject to paragraph (16), in any proceedings for an offence under these Regulations it shall be a defence to prove that – (a) the act constituting the offence was committed in relation to a plastic material or article which was put into free circulation in the European Community before 30th November 2002; and (b) the matter constituting the offence would not have constituted an offence under these Regulations if the amendments made to them by the provisions referred to in paragraph (15) had not been in operation at the time that matter occurred. (15) The provisions referred to in paragraph (14) are regulations 5(d), 6(b), 8(a), (b) and (d), 10, 12(a) and 15 to 17 of the Plastic Materials and Articles in Contact with Food (Amendment) Regulations (Northern Ireland) 2002, to the extent that they implement those requirements of Commission Directive 2001/62 to which Article 2 of that Directive applies. (16) For the purposes of paragraph (14), “free circulation” shall have the same meaning as in Article 2 of Commission Directive 2001/62. (17) In any proceedings for an offence under these Regulations it shall be a defence to prove that – (a) the act constituting the offence was the sale of an adhesive or a material or article covered by a surface coating – (i) which was brought into contact with food before 28th February 2003, (ii) on which (in the case of a material or article covered by a surface coating) the date of filling of the material or article concerned appeared at the time of the sale, and (iii) the labelling or marking of which at the time of sale (in the case of a material or article covered by a surface coating) complied with the requirement as regards labelling relating to durability contained in Article 2.1(a) of Directive 2000/13/EC of the European Parliament and the Council on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs[^f00008]; and (b) the sale would not have constituted an offence under these Regulations if the amendments made to them by the provisions referred to in paragraph (18) had not been in operation at the time of sale. (18) The provisions referred to in paragraph (17) are regulations 5(b) and (f), 11 and 12(a) of the Plastic Materials and Articles in Contact with Food (Amendment) Regulations (Northern Ireland) 2002.

13

In regulation 11 (presumption as to food with which a plastic material or article is to come into contact) and the heading to it, immediately after “plastic material or article”, wherever it occurs, there shall be inserted “, adhesive or material or article covered by a surface coating”.

14

In regulation 12 (application of other provisions) –

15

In Schedule 1 (monomers authorised without time limit, monomers authorised up to the end of 2001, monomers authorised up to the end of 1998 and supplementary) –

(4) Where an entry in column 4 of Part I (restrictions and specifications) includes a bracketed number, that entry shall be subject to a note relating to that number as follows, the following bracketed numbers corresponding with those appearing in that Part: (1) Warning: there is a risk that the specific migration limit could be exceeded in fatty food simulants. (2) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 10060 and 23920. (3) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 15760, 16990, 47680, 53650 and 89440. (4) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 19540, 19960 and 64800. (5) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 14200, 14230 and 41840. (14) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 15970, 48640, 48720, 48880, 61280, 61360 and 61600. (21) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 17260 and 18670.

16

In Schedule 2 (additives and supplementary) –

(4) Where an entry in column 4 of Part I or Part II (in each case restrictions and specifications) includes a bracketed number, that entry shall be subject to a note relating to that number as follows, the following bracketed numbers corresponding with those appearing in those Parts : (1) Warning: there is a risk that the SML could be exceeded in fatty food simulants. (2) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 10060 and 23920. (3) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 15760, 16990, 47680, 53650 and 89440. (4) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 19540, 19960 and 64800. (5) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 14200, 14230 and 41840. (6) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 66560 and 66580. (7) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 30080, 42320, 45195, 45200, 53610, 81760, 89200 and 92030. (8) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 42400, 64320, 73040, 85760, 85840, 85920 and 95725. (9) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 30180, 40980, 63200, 65120, 65200, 65280, 65360, 65440 and 73120. (10) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 45200, 64320, 81680 and 86800. (11) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 36720, 36800 and 92000. (12) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 39090 and 39120. (13) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 44960, 68078, 82020 and 89170. (14) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 15970, 48640, 48720, 48880, 61280, 61360 and 61600. (15) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 49600, 67520 and 83599. (16) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 50160, 50240, 50320, 50360, 50400, 50480, 50560, 50640, 50720, 50800, 50880, 50960, 51040 and 51120. (17) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 67600, 67680 and 67760. (18) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 60400, 60480 and 61440. (19) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 66400 and 66480. (20) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 93120 and 93280. (21) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 17260 and 18670.

; and

(5) In the case of the substances listed in Part II, the specific migration limits specified in column 4 of that Part (restrictions and specifications) shall have effect with effect from 1st January 2004 where the verification of compliance is carried out in simulant D or in test media of substitute tests as prescribed in Council Directive 82/711/EEC[^f00009] and Council Directive 85/572/EEC[^f00010].

17

In Schedule 2B (specifications) in the case of each substance listed in Schedule 3 to these Regulations, the item number, PM/REF No. and specification set out for that substance in that Schedule shall be inserted in the appropriate numerical position for that item number.

18

In Schedule 3 (provisions applicable when testing compliance with the migration limits) –

(b) 12 mg/kg or, as the case may be, 2 milligrams per square decimeter in migration tests using other simulants referred to in Schedule 4.

SCHEDULE 1

PART I — list of monomers to be added to section a of part i of schedule 1 to the principal regulations

Item PM/REF No. CAS No. Name Restrictions and specifications
15A 11530 00999-61-1 Acrylic acid, 2-hydroxypropyl ester QMA = 0.05 mg/6 dm²
28B 12763 00141-43-5 2-Aminoethanol SML = 0.05 mg/kg. Not for use in polymers contacting foods for which simulant D is laid down in Council Directive 85/572/EEC and for indirect food contact only, behind the PET layer
28C 12765 84434-12-8 N-(2-aminoethyl)-beta-alanine, sodium salt SML = 0.05 mg/kg
38A 13395 04767-03-7 2,2-Bis(hydroxymethyl) propionic acid QMA = 0.05 mg/6 dm²
47A 13617 00080-09-1 Bisphenol S As item 86A
49B 13810 00505-65-7 1,4-Butanediol formal QMA = 0.05 mg/6 dm²
52A 13932 00598-32-3 3-Buten-2-ol QMA = ND (DL = 0.02 mg/6 dm²). To be used only as a co-monomer for the preparation of polmeric additive
70A 15030 00931-88-4 Cyclooctene SML = 0.05 mg/kg. For use only in polymers contacting foods for which simulant A is laid down in Council Directive 85/572/EEC
76A 15370 03236-53-1 1,6-Diamino-2,2,4-trimethylhexane QMA = 5 mg/6 dm²
76B 15400 03236-54-2 1,6-Diamino-2,4,4-trimethylhexane QMA = 5 mg/6 dm²
77A 15610 00080-07-9 4,4'-Dichlorodiphenyl sulphone SML = 0.05 mg/kg
86A 16090 00080-09-01 4,4'-Dihydroxydiphenyl sulphone SML = 0.05 mg/kg
88B 16390 00126-30-7 2,2-Dimethyl-1,3-propanediol SML = 0.05 mg/kg
121B 19110 04098-71-9 1-Isocyanato-3-isocyanatomethyl-3,5,5-trimethylcyclohexane QM(T) = 1 mg/kg in FP (as NCO)
122A 19243 00078-79-5 Isoprene As item 145A
126A 19490 00947-04-6 Laurolactam SML = 5 mg/kg
135A 20260 00101-43-9 Methacrylic acid, cyclohexyl ester SML = 0.05 mg/kg
135B 20410 02082-81-7 Methacrylic acid, diester with 1,4-butanediol SML = 0.05 mg/kg
135D 20590 00106-91-2 Methacrylic acid, 2,3-epoxypropyl ester QMA = 0.02 mg/6 dm²
144A 21520 01561-92-8 Methallylsulphonic acid, sodium salt SML = 5 mg/kg
145A 21640 00078-79-5 2-Methyl-1,3-butadiene QM = 1 mg/kg in FP or SML = ND (DL = 0.02 mg/kg, analytical tolerance included)
145C 21765 106246-33-7 4,4'-Methylenebis(3-chloro-2,6-diethylaniline) QMA = 0.05 mg/6 dm²
145D 21821 00505-65-7 1,4-(Methylenedioxy)butane As item 49B
148A 22360 01141-38-4 2,6-Naphthalenedicarboxylic acid SML = 5 mg/kg
150A 22437 00126-30-7 Neopentylglycol As item 88B
156A 22778 07456-68-0 4,4'-Oxybis(benzenesulphonyl azide) QMA = 0.05 mg/6 dm²
159A 22900 00109-67-1 1-Pentene SML = 5 mg/kg
184A 24073 000101-90-6 Resorcinol diglycidyl ether QMA = 0.005 mg/g dm². Not for use in polymers contacting foods for which simulant D is laid down in Council Directive 85/572/EEC and for indirect food contact only, behind the PET layer.
214A 25380 Trialkyl acetic acid (C7-C17), vinyl esters (= vinyl versatate) QMA = 0.05 mg/g dm²
215A 25450 26896-48-0 Tricyclodecanedimethanol SML = 0.05 mg/kg
217A 25900 00110-88-3 Trioxane SML = 0.05 mg/kg

PART II — list of monomers for which the entry contained in the first column (item) of section a of part i of schedule 1 to the principal regulations is to be amended

Item Name
52B 4-tert-Butylphenol
88C 1.3 Dioxolane
121C Isophthalic acid
135C Methacrylic acid, 2-(dimethylamino) ethyl ester
145B 3-Methyl-1-butene
159B Perfluoropropyl perfluorovinyl ether
214B Triallylamine

PART III — list of monomers for which the entry contained in column 4 (restrictions and specifications) of section a of part i of schedule 1 to the principal regulations is to be amended

Name Restrictions and specifications
2,2-Bis(4-hydroxyphenyl) propane bis(2,3-epoxypropyl) ether (= BADGE) Use must be before 1st January 2005 and prior to that date be as specified in paragraph 1 of Annex I to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of that Annex
4,4'-Dihydroxybenzophenone SML(T) = 6 mg/kg (14)
Formaldehyde SML(T) = 15 mg/kg (21)
Hexamethylenetetramine SML(T) = 15 mg/kg (expressed as formaldehyde (21)
1,3-Phenylenediamine SML = ND (DL = 0.02 mg/kg, analytical tolerance included)

PART IV — provisions substituted for section b of part i of schedule 1 to the principal regulations

SCHEDULE 2

PART I — list of additives to be added to part i of schedule 2 to the principal regulations

Item PM/REF No. CAS No. Name Restrictions and specifications
19A 35160 06642-31-5 6-Amino-1,3-dimethyluracil SML = 5 mg/kg
19B 35170 00141-43-5 2-Aminoethanol SML = 0.05 mg/kg. Not for use in polymers contacting foods for which simulant D is laid down in Council Directive 85/572/EEC and for indirect food contact only, behind the PET layer
19C 35284 00111-41-1 N-(2-aminoethyl)ethanolamine SML = 0.05 mg/kg. Not for use in polymers contacting foods for which simulant D is laid down in Council Directive 85/572/EEC and for indirect food contact only, behind the PET layer
36E 38840 154862-43-8 Bis(-2,4-dicumylphenyl) pentaerythritoldiphosphite SML = 5 mg/kg (as sum of the substance itself, its oxidised form bis(2,4-dicumylphenyl)pentaerythritol-phosphate and its hydrolysis product (2,4-dicumylphenol)
38A 39925 129228-21-3 3,3-Bis(methoxymethyl)-2,5-dimethyl hexane SML = 0.05 mg/kg
41A 41120 10043-52-4 Calcium chloride
45A 41840 00105-60-2 Caprolactam SML(T) = 15 mg/kg (5)
72B 47210 26427-07-6 Dibutylthiostannoic acid polymer [= thiobis(butyl-tin sulphide), polymer] In compliance with the specifications laid down in Schedule 2B
73A 47540 27458-90-8 Di-tert-dodecyl disulfide SML = 0.05 mg/kg
73D 48620 00123-31-9 1,4-Dihydroxybenzene SML = 0.6 mg/kg
73E 48720 00611-99-4 4,4'-Dihydroxybenzophenone SML(T) = 6 mg/kg (14)
77A 52645 10436-08-5 Cis-11-eicosenamide
164A 64800 00110-16-7 Maleic acid SML(T) = 30 mg/kg (4)
167A 65920 66822-60-4 [N-methacryloyloxyethyl-N,N-dimethyl-N-carboxymethyl-ammonium chloride, sodium salt-octadecyl methacrylate-ethyl methacrylate-cyclohexyl methacrylate-N-vinyl-2-pyrrolidone, copolymers
191A 73160 – Phosphoric acid, mono-and di-n-alkyl (C16 and C18) esters SML = 0.05 mg/kg
195B 76730 – Polydimethylsiloxane, gamma-hydroxypropylated SML = 6 mg/kg
208A 81220 192268-64-7 Poly-[[6-[N-(2,2,6,6-tetramethyl-4-piperidinyl)-n-butylamino]-1,3,5-triazine-2,4-diyl][2,2,6,6-tetramethyl- 4-piperidinyl)imino]-1,6-hexanediyl [2,2,6,6-tetramethyl-4-piperidinyl) imino]]-alpha-[N,N,N',N'-tetrabutyl- N" "-(2,2,6,6-tetramethyl-4-piperidinyl)-N"-[6,2,2,6,6-tetramethyl (-4-piperidinylamino)-hexyl][1,3,5- triazine-2,4,6-triamine]-omega-N,N, N',N'-tetrabutyl-1,3,5-triazine-2,4-diamine] SML = 5 mg/kg
229A 83599 68442-12-6 Reaction products of oleic acid, 2-mercaptoethyl ester, with dichlorodimethyltin, sodium sulphide and trichloromethyltin SML(T) = 0.18 mg/kg (15) (expressed as tin)
240B 85680 01343-98-2 Silicic acid
271A 92150 01401-55-4 Tannic acids According to the JECFA specifications
279A 93270 00108-78-1 2,4,6-Triamino-1,3,5-triazine SML = 30 mg/kg
281A 95270 161717-32-4 2,4,6-Tris(tert-butyl)phenyl 2-butyl-2-ethyl-1,3-propanediol phosphite SML = 2 mg/kg (as sum of phosphite, phosphate and the hydrolysis product = TTBP)

PART II — list of additives for which the entry contained in the first column (item) of part i of schedule 2 to the principal regulations is to be amended

Item Name
36F Bis(3-4-dimethylbenzylidene)sorbitol
38B Bis(polyethyleneglycol)hydroxymethyl-phosphonate
73B Diethyleneglycol
73C 1,1-Difluoroethane
73F 2,4-Dimethyl-6-(1-methylpentadecyl)phenol
191B Phosphoric acid, trichloroethyl ester
195C Polyesters of 1,2-propanediol and/or 1,3-and/or polypropyleneglycol with adipic acid, also end-capped with acetic acid or fatty acids C10-C18 or n-octanol and or n-decanol
208B Poly (zinc glycerolate)
240C Silicic acid, lithium, magnesium, sodium salt
281B Vermiculite, reaction product with citric acid, lithium salt
281C Water
281D Waxes, refined, derived from petroleum based or synthetic hydrocarbon feed stocks
281E White mineral oils, paraffinic, derived from petroleum based hydrocarbon feed stocks

PART III — list of additives for which the entry contained in column 4 (restrictions and specifications) of part i of schedule 2 to the principal regulations is to be amended

Name Restrictions and specifications
Benzaldehyde In compliance with regulation 4(2) of the 1987 Regulations
Bis(polyethyleneglycol)hydroxymethyl-phosphonate SML = 0.6 mg/kg. Authorised until 1st January 2004
Camphor In compliance with regulation 4(2) of the 1987 Regulations
Copper iodide SML(T) = 30 mg/kg (7) (expressed as copper) and the specific migration of this substance shall not exceed 1 mg/kg (10) (expressed as iodine)
2'-(2-Hydroxy-3,5'-di-tert-butylphenyl)-5-chlorobenzotriazole SML(T) = 30 mg/kg (18)

PART IV — provisions inserted after part i of schedule 2 to the principal regulations

SCHEDULE 3 — LIST OF SUBSTANCES TO BE ADDED TO SCHEDULE 2B TO THE PRINCIPAL REGULATIONS

Item PM/REF No. Specifications
4A 43680 CHLORODIFLUOROMETHANE
– Content of chlorofluoromethane less than 1 mg/kg of the substance
4B 47210 DIBUTYLTHIOSTANNOIC ACID POLYMER
– Molecular unit = (C₈H₁₈S₃Sn₂)n (n = 1,5-2)
5A 83595 REACTION PRODUCT OF DI-TERT-BUTYLPHOSPHONITE WITH BIPHENYL, OBTAINED BY CONDENSATION OF 2,4-DI-TERT-BUTYLPHENOL WITH FRIEDEL CRAFT REACTION PRODUCT OF PHOSPHORUS TRICHLORIDE AND BIPHENYL Composition 4,4'-Biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS No. 38613-77-3) (36–46% w/w (1)) 4,3'-Biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS No. 118421-00-4) (17–23% w/w) 3,3'-Biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS No. 118421-01-5) (1–5% w/w) 4-Biphenylene-0,0-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS No. 91362-37-7) (11–19% w/w) Tris(2,4-di-tert-butylphenyl)phosphite (CAS No. 31570-04-4) (9–18% w/w) 4,4'-Biphenylene-0,0-bis(2,4-di-tert-butylphenyl)phosphonate-0,0-bis(2,4-di-tert-butylphenyl)phosphonite (CAS No. 112949-970) < 5% w/w) Other specifications Phosphor content of minimum 5.4% to 5.9% Acid value of maximum 10 mg KOH per gram Melt range of 85–110°C

Signed

Sealed with the Official Seal of the Department of Health, Social Services and Public Safety on 11th October 2002.

David Finnegan — A Senior Officer of the — Department of Health, Social Services and Public Safety

Explanatory note

(This note is not part of the Regulations.)

These Regulations amend for the second time the Plastic Materials and Articles in Contact with Food Regulations (Northern Ireland) 1998 (S.R. 1998 No. 264, “the 1998 Regulations”). The Regulations implement –

The Regulations also reflect the revocation, with effect from 4th September 2002, of Directive 90/128/EEC relating to plastic materials and articles intended to come into contact with foodstuffs (O.J. No. L75, 21.3.1990) as amended and its re-enactment in consolidated form by Commission Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with foodstuffs (O.J.No. L220 15.8.2002, p. 18).

The Regulations amend the 1998 Regulations by –

Footnotes

[^f00001]: Formerly the Department of Health and Social Services: see S.I. 1999/283 (N.I. 1) Article 3(6)

[^f00002]: S.I. 1991/762 (N.I. 7) as amended by S.I. 1996/1633 (N.I. 12) and paragraphs 26 to 42 of Schedule 5 and Schedule 6 to the Food Standards Act 1999 c. 28

[^f00003]: O.J. No. L31, 1.2.2002, p. 1

[^f00004]: S.R. 1998 No. 264, as amended by S.R. 2000 No. 402

[^f00005]: O.J. No. L221, 17.8.2001, p. 18

[^f00006]: O.J. No. L51, 22.2.2002, p. 27

[^f00007]: O.J. No. L220, 15.8.2002, p. 18

[^f00008]: O.J. No. L109, 6.5.2000, p. 29

[^f00009]: O.J. No. L297, 23.10.82, p. 26, last amended by Commission Directive 97/48/EC (O.J. No. L222, 12.8.97, p.10)

[^f00010]: O.J. No. L372, 31.12.85, p. 14

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