2003 No. 302 (W.44)

FOOD, WALES

The Plastic Materials and Articles in Contact with Food (Amendment) (Wales) Regulations 2003
Made
13th February 2002
Coming into force
28th February 2003
In exercise of the powers conferred by sections 16(2), 17(1), 26(1)(a) and (3), 31 and 48(1) of the Food Safety Act 1990 which are now exercisable in relation to Wales by the National Assembly for Wales , the National Assembly for Wales 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 and in accordance with section 48(4) and (4B) of that Act, makes the following Regulations:

Title, extent and commencement
1
These Regulations may be cited as the Plastic Materials and Articles in Contact with Food (Amendment) (Wales) Regulations 2003 shall apply to Wales only and shall come into force on 28th February 2003.

Amendments to the Plastic Materials and Articles in Contact with Food Regulations 1998
2
The Plastic Materials and Articles in Contact with Food Regulations 1998 (“the principal Regulations”) shall be amended, in so far as they apply to Wales, in accordance with regulations 3 to 6.
3
In regulation 10 (offences), immediately after paragraph (20) there shall be added the following paragraphs —
21
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 manufactured or imported into the European Community before 1st March 2004 and the matter constituting the offence would not have constituted an offence under these Regulations if the amendments made to them by the provisions specified in paragraph (22) had not been in force at the time that matter occurred; or
b
the act constituting the offence was committed in relation to a plastic material or article which was manufactured or imported into the European Community before 1st March 2003, and the matter constituting the offence would not have constituted an offence under these Regulations if the amendments made to them by regulation 4(a)(i) and (b) (in so far as they relate to the monomer divinylbenzene) and 6 of the Plastic Materials and Articles in Contact with Food (Amendment) (Wales) Regulations 2003 had not been in force at the time that matter occurred.
22
The provisions referred to in paragraph (21)(a) of this regulation are the provisions of the Plastic Materials and Articles in Contact with Food (Amendment) (Wales) Regulations 2003, except in so far as they relate to the monomer divinylbenzene.
.
4
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) —
a
in Section A of Part I —
i
in the case of each monomer listed in Part I of Schedule 1 to these Regulations, the item number, PM/REF No. CAS No. name and restriction or specification specified for that monomer in that Part shall be inserted in the appropriate numerical position for that item number,
ii
in the case of each monomer named in the second column of Part II of Schedule 1 to these Regulations, for the item number for that monomer specified opposite to it in the column headed “Item” there shall be substituted the item number for it specified in the first column (item) of that Part,
iii
in the case of the monomer Bis (4-isocyanatocyclohexyl) methane (item 43), for the entry for that monomer specified in column 1 (PM/REF/No.) there shall be substituted the entry “13560”, and
iv
in the case of each monomer named in the first column of Part III of Schedule 1 to these Regulations, for the entry for that monomer specified opposite to it in column 4 (restrictions and specifications) there shall be substituted the entry for it specified in the second column (restrictions and specifications) of that Part;
b
in Section B of Part I, all the entries for the monomers named in Part IV of Schedule 1 to these Regulations shall be deleted; and
c
in Part II, at the end of paragraph 4 there shall be inserted the following provisions —
22
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. 13620, 36840, 40320 and 87040.
23
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. 13720 and 40580.
24
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. 16650 and 51570.
25
QM(T) in this case means that the restriction shall not be exceeded by the sum of the residual quantities of the substances having PM/REF/Nos. 14950, 15700, 16240, 16570, 16600, 16630, 18640, 19110, 22332, 22420, 22570, 25210, 25240 and 25270.
.
5
In Schedule 2 (additives and supplementary) —
a
in Part I —
i
in the case of each additive listed in Part I of Schedule 2 to these Regulations, the item number, PM/REF No. CAS No. name and restriction or specification specified for that additive in that Part shall be inserted in the appropriate numerical position for that item number,
ii
in the case of the additive Bis (polyethyleneglycol) hydroxymethylphosphonate, there shall be inserted in column 2 (CAS No.) the entry “68951 — 50 — 8”, and
iii
in the case of the additive named in the first column of Part II of Schedule 2 to these Regulations, for the entry for that additive specified opposite to it in column 4 (restrictions and specifications) there shall be substituted the entry for it specified in the second column (restrictions and specifications) of that Part; and
b
in Part II —
i
in the case of each additive listed in Part III of Schedule 2 to these Regulations, the item number, PM/REF/No. CAS No. name and restriction or specification specified for that additive in that Part shall be inserted in the appropriate numerical position for that item number, and
ii
in the case of each additive named in the first column of Part IV of Schedule 2 to these Regulations, for the entry for that additive specified opposite to it in column 4 (restrictions and specifications) there shall be substituted the entry for it specified in the second column (restrictions and specifications) of that Part; and
c
in Part III —
i
in note (11) of paragraph 4, after the figure “36800” there shall be inserted the figure “, 36840”, and
ii
at the end of that paragraph there shall be added the following provisions —
22
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. 13620, 36840, 40320 and 87040.
23
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. 13720 and 40580.
24
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. 16650 and 51570.
.
6
In Schedule 2B (specifications) in the case of the substance specified 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 and letter.

Amendment to the Food Safety (Sampling and Qualifications) Regulations 1990
7
In Schedule 1 to the Food Safety (Sampling and Qualifications) Regulations 1990 (provisions to which those Regulations do not apply) the reference in the second column, opposite the entry in the first column relating to the Plastic Materials and Articles in Contact with Food Regulations 1998, shall be amended in relation to Wales so as to read “S.I. 1998/1376 as amended by S.I. 2001/1263 (W.70) S.I. 2002/2834 (W.272) and S.I. 2003/302 (W.44)”.
Signed on behalf of the National Assembly for Wales under section 66(1) of the Government of Wales Act 1998 .
Rhodri Morgan
First Minister of the National Assembly for Wales
13th February 2003
SCHEDULE 1
Regulation 4(a)(i), (ii) and (iv) and (b)
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
33B | 13075 | 00091-76-9 | Benzoguanamine | see “2,4-Diamino-6-Phenyl-1,3,5-Triazine”
47B | 13620 | 10043--35-3 | Boric acid | SML(T) — 6 mg/kg (22) (expressed as boron) without prejudice to the provisions of Directive 98/83/EC on water for human consumption .
49A | 13720 | 00110-63-4 | 1,4-Butanediol | SML(T) = 0.05 mg/kg (23)
76A | 15310 | 00091-76-9 | 2,4-Diamino-6-phenyl-1,3,5-triazine | QMA = 5 mg/6 dm2
92A | 16650 | 00127-63-9 | Diphenyl sulphone | SML(T) = 3 mg/kg (24)
93A | 16690 | 01321-74-0 | Divinylbenzene | QMA = 0.01 mg/6 dm2 of SML = ND (DL = 0.02 mg/kg, analytical tolerance included) for the sum of divinylbenzene and ethylvinylbenzene and in compliance with the specifications laid down in Schedule 2B.
93C | 16697 | 00693-23-2 | n-Dodecanedioic Acid |
120A | 18897 | 16712-64-4 | 6-Hydroxy-2-naphthalenecarboxylic acid | SML = 0.05 mg/kg
120B | 18898 | 103-90-2 | N-(4-Hydroxyphenyl)acetamide | Only to be used in liquid crystals and behind a barrier layer in multi-layered plastics.
147B | 22332 | 28679-16-5 | Mixture of (40% w/w) 2,2,4-trimethylhexane-1,6-diisocyanate and (60% w/w) 2,4,4-trimethylhexane-1,6-diisocyanate | QM(T) = 1 mg/kg (expressed as NCO) (25)
217A | 25840 | 03290-92-4 | 1,1,1-trimethylolpropane trimethacrylate | 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 1 OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS IS TO BE AMENDED
Item | Name
49B | 1,4-Butanediol bis(2.3-epoxypropyl)ether
49C | 1,4-Butanediol formal
76B | 1,6-Diamino-2,2,4-trimethylhexane
76C | 1,6-Diamino-2,4,4-trimethylhexane
93B | N,N'-Divinyl-2-imidazolidone
93D | 1-Dodecene
217B | Trioxane
PART III

LIST OF MONOMERS FOR WHICH THE ENTRY CONTAINED IN COLUMN 4 (RESTRICTIONS) OF SECTION A OF PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS IS TO BE AMENDED
Name | Restrictions and specifications
Chlorotrifluoroethylene | QMA = 0.5 mg/6 dm2
Cyclohexyl isocyanate | QM(T ) = 1 mg/kg (expressed as NCO) (25)QM(T ) = 1 mg/kg (expressed as NCO) (25)
Dicyclohexylmethane-4,4'-diisocyanate | QM(T ) = 1 mg/kg (expressed as NCO) (25)
3,3'-Dimethyl-4,4'-diisocyanatobiphenyl | QM(T ) = 1 mg/kg (expressed as NCO) (25)
Diphenylether-4,4'-diisocyanate | QM(T ) = 1 mg/kg (expressed as NCO) (25)
Diphenylmethane-2,4'-diisocyanate | QM(T ) = 1 mg/kg (expressed as NCO) (25)
Diphenylmethane-4,4'-diisocyanate | QM(T ) = 1 mg/kg (expressed as NCO) (25)
Hexamethylene dissocyanate | QM(T ) = 1 mg/kg (expressed as NCO) (25)
1-isocyanato-3-isocyanatomethyl-3,5,5-trimethylcyclohexane | QM(T ) = 1 mg/kg (expressed as NCO) (25)
1,5-Naphthalene diisocyanate | QM(T ) = 1 mg/kg (expressed as NCO) (25)
Octadecyl isocyanate | QM(T ) = 1 mg/kg (expressed as NCO) (25)
2,4-Toluene diisocyanate | QM(T ) = 1 mg/kg (expressed as NCO) (25)
2,6-Toluene diisocyanate | QM(T ) = 1 mg/kg (expressed as NCO) (25)
2,4-Toluene diisocyanate dimer | QM(T ) = 1 mg/kg (expressed as NCO) (25)
PART IV

LIST OF MONOMERS FOR WHICH ALL THE ENTRIES CONTAINED IN SECTION B OF PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS ARE TO BE DELETED
- Benzoguanamine
- 1,4-Butanediol
- 2,4-Diamino-6-phenyl-1,3,5-triazine
- Divinylbenzene
- n-Dodecanedioic acid
- 1,1,1-Trimethylolpropane trimethacrylate
SCHEDULE 2
Regulation 5(a)(I) and (iii) and (b)
PART I

LIST OF ADDITIVES TO BE ADDED TO PART 1 OF SCHEDULE 2 TO THE PRINCIPAL REGULATIONS
Item | PM/REF No. | CAS No. | Name | Restrictions and specifications
27b | 36840 | 12007-55-5 | Barium tetraborate | SML(T) = 1 mg/kg expressed as barium (11) and SML(T) = 6 mg/kg (22) (expressed as boron) without prejudice to the provisions of Directive 98/83/EC on water for human consumption.
38C | 40320 | 10043-35-3 | Boric acid | SML(T) = 6 mg/kg (22) (expressed as boron) without prejudice to the provisions of Directive 98/83/EC on water for human consumption.
40A | 40580 | 00110-63-4 | 1,4-Butanediol | SML(T) = 0.05 mg/kg (23)
188B | 71670 | 178671-58-4 | Pentaerythritol tetrakis (2-cyano-3,3-diphenylacrylate) | SML(T) = 0.05 mg/kg
246A | 87040 | 01330-43-4 | Sodium tetraborate | SML(T) = 6 mg/kg (22) (expressed as boron) without prejudice to the provisions of Directive 98/83/EC on water for human consumption.
PART II

ADDITIVE 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
Bis(polyethyleneglycol) hydroxymethylphosphonate | SML = 0.6 mg/kg
PART III

LIST OF ADDITIVES TO BE ADDED TO PART II OF SCHEDULE 2 TO THE PRINCIPAL REGULATIONS
Item | PM/REF No. | CAS No. | Name | Restrictions and specifications
27A | 45650 | 6197-30-4 | 2-Cyano-3,3-diphenylacrylic acid, 2-ethylhexyl ester | SML = 0.05 mg/kg
82A | 68860 | 04724-48-5 | n-Octylphosphonic acid | SML = 0.05 mg/kg
111A | 95000 | 28931-67-1 | Trimethylolpropane trimethacrylate-methyl methacrylate copolymer |
PART IV

LIST OF ADDITIVES FOR WHICH THE ENTRY CONTAINED IN COLUMN 4 (RESTRICTIONS AND SPECIFICATIONS) OF PART II OF SCHEDULE 2 TO THE PRINCIPAL REGULATIONS IS TO BE AMENDED
Name | Restrictions and specifications
N,N-bis(2-hydroxyethyl)alkyl (C8-C18) amine hydrochlorides | SML(T) = 1.2 mg/kg (12) expressed as territory amine (expressed excluding HCl)
Diphenyl sulphone | SML(T) = 3 mg/kg (24)
SCHEDULE 3

SUBSTANCE TO BE ADDED TO SCHEDULE 2B TO THE PRINCIPAL REGULATIONS
Regulation 6
Item | PM/REF No. | Specifications
1 | 16690 | Divinylbenzene — must not contain more than 40% ethylvinylbenzene
(This note is not part of the Regulations)
1
These Regulations, which apply to Wales only, amend for the third time the Plastic Materials and Articles in Contact with Food Regulations 1998 (S.I. 1998/1376, “the 1998 Regulations”), in so far as they apply to Wales. These Regulations implement Commission Directive 2002/17/EC amending Directive 90/128/EEC relating to plastic materials and articles intended to come into contact with foodstuffs (OJ No. L58, 28.2.2002, p.19), except paragraph 1(a) of the Annex and paragraph 2(a)(ii) of the Annex in so far as it relates to the additives benzaldehyde and camphor, which were implemented by the Plastic Materials and Articles in Contact with Food (Amendment) (Wales) Regulations 2002 (S.I. 2002/2834 (W. 272)).
2
The Regulations amend the 1998 Regulations by —
a
adding a transitional provision in respect of proceedings for an offence under them (regulation 3);
b
adding new substances to the list of monomers which may be used in the manufacture of plastic materials or articles and amending the conditions of use of certain monomers used in such manufacture (regulation 4);
c
adding new substances to the non-exhaustive list of additives used in the manufacture of plastic materials or articles and amending the conditions of use of certain additives used in such manufacture (regulation 5);
d
adding certain substances to the list of substances whose specifications are set out in Schedule 2B to the 1998 Regulations (regulation 6); and
e
making a consequential amendment to the Food Safety (Sampling and Qualifications) Regulations 1990 (regulation 7).
1990 c. 16.
Functions of “the Secretary of State” so far as exercisable in relation to Wales were transferred to the National Assembly for Wales by S.I. 1999/672, as amended by s.40(3) of the Food Standards Act 1999 (1999 c. 28).
OJ No. L31, 1.2.2002, p.1.
S.I. 1998/1376, amended by S.I. 2001/1263 (W.70) and S.I. 2002/2834 (W.272).
S.I. 1990/2463. The relevant amending instruments are S.I. 1998/1376 and S.I. 2002/2834 (W.272).
1998 c. 38.
OJ No. L330, 5.12.1998, p.32.