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The Plastic Materials and Articles in Contact with Food (Amendment) (Scotland) Regulations 2003

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Scottish Statutory Instruments

2003 No. 9

FOOD

The Plastic Materials and Articles in Contact with Food (Amendment) (Scotland) Regulations 2003

Made

9th January 2003

Laid before the Scottish Parliament

10th January 2003

Coming into force

28th February 2003

The Scottish Ministers, in exercise of the powers conferred by sections 6(4), 16(2), 17(1), 26(1)(a) and (3), 31 and 48(1) of the Food Safety Act 1990(1) and of all other powers enabling them in that behalf, having had regard, in accordance with section 48(4A)(2) of that Act, to relevant advice given by the Food Standards Agency, and after consultation in accordance with section 48(4) and (4B)(3) of that Act, hereby make the following Regulations:

Citation, commencement and extent

1.—(1) These Regulations may be cited as the Plastic Materials and Articles in Contact with Food (Amendment) (Scotland) Regulations 2003 and shall come into force on 28th February 2003.

(2) These Regulations shall extend to Scotland only.

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(4) (“the principal Regulations”) shall be amended in accordance with regulations 3 to 6.

3.—(1) In regulation 10 (offences), after paragraph (20) there shall be inserted–

(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 intended to come into contact with food which was manufactured in or imported into the European Community before 1st March 2004, and that 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 intended to come into contact with food which was manufactured in or imported into the European Community before 1st March 2003, and that 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 regulation 6 of the Plastic Materials and Articles in Contact with Food (Amendment) (Scotland) Regulations 2003 had not been in force at the time that matter occurred.

(22) The provisions referred to in paragraph (21)(a) are all the provisions of the Plastic Materials and Articles in Contact with Food (Amendment) (Scotland) 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 and letter, PM/REF No. , CAS No. , name and restriction or specification (if any) specified for that monomer in Part I of Schedule 1 to these Regulations shall be inserted in the appropriate numerical position for that item number and letter;

(ii)in the case of each monomer listed in the third column of Part II of Schedule 1 to these Regulations, for the item number and letter for that monomer specified opposite to it in the first column of section A of Part I of Schedule 1 to the principal Regulations (item) there shall be substituted the item number and letter for it specified in the second column (new item) of Part II of Schedule 1 to these Regulations;

(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 listed 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 of section A of Part I of Schedule 1 to the principal Regulations (restrictions and specifications) there shall be substituted the entry for it specified in the second column (restrictions and specifications) of Part III of Schedule 1 to these Regulations;

(b)in Section B of Part I, all the entries for the monomers listed in Part IV of Schedule 1 to these Regulations shall be omitted; and

(c)in Part II, there shall be inserted at the end of paragraph 4–

(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 and letter, PM/REF No. , CAS No. , name and restriction or specification specified for that additive in Part I of Schedule 2 to these Regulations shall be inserted in the appropriate numerical position for that item number and letter;

(ii)in the case of the entry at item number 38B for the additive Bis (polyethyleneglycol) hydroxymethylphosphonate, there shall be inserted in column 2 of that Part (CAS No. ) the entry “68951 – 50 – 8”; and

(iii)in the case of the additive listed of Part II of Schedule 2 to these Regulations, for the entry for that additive in Part I of Schedule 2 to the principal Regulations there shall be substituted the entry for it specified in Part II of Schedule 2 to these Regulations;

(b)in Part II–

(i)in the case of each additive listed in Part III of Schedule 2 to these Regulations, the item number and letter, PM/REF/No. , CAS No. , name and restriction or specification (if any) specified for that additive in Part III of Schedule 2 to these Regulations shall be inserted in the appropriate numerical position for that item number and letter; and

(ii)in the case of each additive listed 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 of Part II of Schedule 2 to the principal Regulations (restrictions and specifications) there shall be substituted the entry for it specified in the second column (restrictions and specifications) of Part IV of Schedule 2 to these Regulations; and

(c)in Part III–

(i)in note (11) of paragraph 4, after “36800” there shall be inserted “, 36840”; and

(ii)at the end of paragraph 4, there shall be inserted–

(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 and letter, PM/REF No. and specification set out for that substance shall be inserted in the appropriate numerical position for that item number and letter.

MARY MULLIGAN

Authorised to sign by the Scottish Ministers

St Andrew’s House, Edinburgh

9th January 2003

Regulation 4(a)(i), (ii) and (iv) and (b)

SCHEDULE 1

PART ILIST OF MONOMERS TO BE ADDED TO SECTION A OF PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS

ItemPM/REF No. CAS No. NameRestrictions and Specifications
33B1307500091–76–9BenzoguanamineAs item 76A
47B1362010043–-35–3Boric acidSML(T) – 6 mg/kg (22) (expressed as boron) without prejudice to the provisions of Directive 98/83/EC on water for human consumption(5)
49A1372000110–63–41,4-ButanediolSML(T) = 0.05 mg/kg (23)
76A1531000091–76–92,4-Diamino-6-phenyl-1,3,5-triazineQMA = 5 mg/6 dm2
92A1665000127–63–9Diphenyl sulphoneSML(T) = 3 mg/kg (24)
93A1669001321–74–0DivinylbenzeneQMA = 0.01 mg/6 dm2 or 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
93C1669700693–23–2n-Dodecanedioic Acid
120A1889716712–64–46-Hydroxy-2-naphthalenecarboxylic acidSML = 0.05 mg/kg
120B18898103–90–2N-(4-Hydroxyphenyl) acetamideOnly to be used in liquid crystals and behind a barrier layer in multi-layered plastics
147B2233228679–16–5Mixture of (40% w/w) 2,2,4-trimethylhexane-1,6-diisocyanate and (60% w/w) 2,4,4-trimethylhexane-1,6-diisocyanateQM(T) = 1 mg/kg (expressed as NCO) (25)
217A2584003290–92–41,1,1-trimethylolpropane trimethacrylateSML = 0.05 mg/kg

PART IILIST 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

Previous ItemItemName
49A49B1,4-Butanediol bis(2,3- epoxypropyl)ether
49B49C1,4-Butanediol formal
76A76B1,6-Diamino-2,2,4-trimethylhexane
76B76C1,6-Diamino-2,4,4-trimethylhexane
93A93BN,N'-Divinyl-2-imidazolidone
93B93D1-Dodecene
217A217BTrioxane

PART IIILIST 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

NameRestrictions and specifications
ChlorotrifluoroethyleneQMA = 0.5 mg/6 dm2
Cyclohexyl isocyanateQM(T) = 1 mg/kg (expressed as NCO) (25)
Dicyclohexylmethane-4,4'-diisocyanateQM(T) = 1 mg/kg (expressed as NCO) (25)
3,3'-Dimethyl-4,4'-diisocyanatobiphenylQM(T) = 1 mg/kg (expressed as NCO) (25)
Diphenylether-4,4'-diisocyanateQM(T) = 1 mg/kg (expressed as NCO) (25)
Diphenylmethane-2,4'-diisocyanateQM(T) = 1 mg/kg (expressed as NCO) (25)
Diphenylmethane-4,4'-diisocyanateQM(T) = 1 mg/kg (expressed as NCO) (25)
Hexamethylene diisocyanateQM(T) = 1 mg/kg (expressed as NCO) (25)
1-Isocyanato-3-isocyanatomethyl-3,5,5-trimethylcyclohexaneQM(T) = 1 mg/kg (expressed as NCO) (25)
1,5-Naphthalene diisocyanateQM(T) = 1 mg/kg (expressed as NCO) (25)
Octadecyl isocyanateQM(T) = 1 mg/kg (expressed as NCO) (25)
2,4-Toluene diisocyanateQM(T) = 1 mg/kg (expressed as NCO) (25)
2,6-Toluene diisocyanateQM(T) = 1 mg/kg (expressed as NCO) (25)
2,4-Toluene diisocyanate dimerQM(T ) = 1 mg/kg (expressed as NCO) (25)

PART IVLIST OF MONOMERS FOR WHICH THE ENTRIES CONTAINED IN SECTION B OF PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS ARE TO BE DELETED

ItemName
7Benzoguanamine
81,4-Butanediol
112,4-Diamino 6 phenyl 1,3,5 triazine
14Divinylbenzene
15Dodecanedioic acid
251,1,1-Trimethylolpropane trimethacrylate

Regulation 5(a)(i) and (iii) and (b)

SCHEDULE 2

PART ILIST OF ADDITIVES TO BE ADDED TO PART I OF SCHEDULE 2 TO THE PRINCIPAL REGULATIONS

ItemPM/REF No. CAS No. NameRestrictions and Specifications
27B3684012007–55–5Barium tetraborateSML(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
38C4032010043–35–3Boric acidSML(T) = 6 mg/kg (22) (expressed as boron) without prejudice to the provisions of Directive 98/83/EC on water for human consumption
40A4058000110–63–41,4-ButanediolSML(T) = 0.05 mg/kg (23)
188B71670178671–58–4Pentaerythritol tetrakis (2-cyano-3,3-diphenylacrylate)SML(T) = 0.05 mg/kg
246A8704001330–43–4Sodium tetraborateSML(T) = 6 mg/kg (22) (expressed as boron) without prejudice to the provisions of Directive 98/83/EC on water for human consumption

PART IIADDITIVE FOR WHICH THE ENTRY CONTAINED IN PART I OF SCHEDULE 2 TO THE PRINCIPAL REGULATIONS IS TO BE SUBSTITUTED

ItemPM/REF No. CAS No. NameRestrictions and specifications
38B4012068951-50 8Bis (polyethyleneglycol) hydroxymethylphosphonateSML = 0.6 mg/kg

PART IIILIST OF ADDITIVES TO BE ADDED TO PART II OF SCHEDULE 2 TO THE PRINCIPAL REGULATIONS

ItemPM/REF No. CAS No. NameRestrictions and specifications
27A456506197–30–42-Cyano-3,3-diphenylacrylic acid, 2-ethylhexyl esterSML = 0.05 mg/kg
82A6886004724–48–5n-Octylphosphonic acidSML = 0.05 mg/kg
111A9500028931–67–1Trimethylolpropane trimethacrylate-methyl methacrylate copolymer

PART IVLIST 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

ItemNameRestrictions and specifications
15N,N-bis(2-hydroxyethyl)alkyl (C8-C18) amine hydrochloridesSML(T) = 1.2 mg/kg (12) expressed as tertiary amine (expressed excluding HCl)
49Diphenyl sulphoneSML(T) = 3 mg/kg (24)

Regulation 6

SCHEDULE 3SUBSTANCE TO BE ADDED TO SCHEDULE 2B TO THE PRINCIPAL REGULATIONS

ItemPM/REF No. Specifications
116690

DIVINYLBENZENE

It may contain up to 40% of Ethylvinylbenzene

Explanatory Note

(This note is not part of the Regulations)

These Regulations, which extend to Scotland only, amend for the third time the Plastic Materials and Articles in Contact with Food Regulations 1998 (S.I. 1998/1376, “the 1998 Regulations”).

The 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 (O.J. No. L58, 28.2.2002, p.19) (in so far as it is not already implemented in relation to camphor and benzaldehyde by the Plastic Materials and Articles in Contact with Food (Amendment) (Scotland) Regulations 2002).

The Regulations amend the 1998 Regulations by–

(a)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);

(b)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);

(c)adding one substance to the list of substances whose specifications are set out in Schedule 2B to the 1998 Regulations (regulation 6); and

(d)inserting a transitional provision in relation to offences which may be committed under the 1998 Regulations (regulation 3).

A Regulatory Impact Assessment, which includes a compliance cost assessment of the effect which these Regulations are likely to have on business costs, has been prepared and placed in the Scottish Parliament Information Centre. Copies may be obtained from the Food Standards Agency, 6th Floor, St Magnus House, 25 Guild Street, Aberdeen AB11 6NJU.

(1)

1990 c. 16; section 6(4) was amended by paragraph 6 of Schedule 9 to the Deregulation and Contracting Out Act 1994 (c. 40) and by paragraph 10(3) of Schedule 5 to the Food Standards Act 1999 (c. 28) (“the 1999 Act”); sections 16(2) and 48(1) were amended by paragraph 8 of Schedule 5 to the 1999 Act; section 17(1) was amended by paragraphs 8 and 12 of Schedule 5 to the 1999 Act; section 26(3) was amended by Schedule 6 to the 1999 Act; amendments made by Schedule 5 to the 1999 Act which extend to Scotland shall be taken as pre-commencement enactments for the purposes of the Scotland Act 1998 (c. 46) by virtue of section 40(2) of the 1999 Act. The functions of the Secretary of State were transferred to the Scottish Ministers by virtue of section 53 of the Scotland Act 1998.

(2)

Section 48(4A) was inserted by paragraph 21 of Schedule 5 to the Food Standards Act 1999.

(3)

Section 48(4B) was inserted by paragraph 21 of Schedule 5 to the Food Standards Act 1999.

(4)

S.I. 1998/1376, amended by S.S.I. 2000/431 and 2002/498.

(5)

O.J. No. L 330, 5.12.1998, p.32.

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