The Plastic Materials and Articles in Contact with Food (Amendment) (No. 2) Regulations 1996 No. 2817


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Statutory Instruments

1996 No. 2817

FOOD

The Plastic Materials and Articles in Contact with Food (Amendment) (No. 2) Regulations 1996

Made

7th November 1996

Laid before Parliament

18th November 1996

Coming into force

1st January 1997

The Minister of Agriculture, Fisheries and Food, the Secretary of State for Health and the Secretary of State for Wales, acting jointly, in relation to England and Wales, and the Secretary of State for Scotland in relation to Scotland, in exercise of the powers conferred on them 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; the Minister of Agriculture, Fisheries and Food and the Secretary of State being Ministers designated(2) for the purposes of section 2(2) of the European Communities Act 1972(3) in relation to materials and articles in contact with food or drink or intended for such contact, acting jointly, in exercise of the powers conferred on them by the said section 2(2) and of all other powers enabling them in that behalf; and after consultation in accordance with section 48(4) of the said Act of 1990 with such organisations as appear to them to be representative of interests likely to be substantially affected by the Regulations (in so far as the Regulations are made in exercise of the powers conferred by that Act), hereby make the following Regulations:

Title, commencement and interpretation

1.-(1) These Regulations may be cited as the Plastic Materials and Articles in Contact with Food (Amendment) (No. 2) Regulations 1996 and shall come into force on 1st January 1997.

(2) In these Regulations "the principal Regulations" means the Plastic Materials and Articles in Contact with Food Regulations 1992.(4)

Amendment of the principal Regulations

2. The principal Regulations shall be amended as follows:

(a)in the definition of "the Directive" in regulation 2(1), for the words "as amended" there shall be substituted the words ", (as corrected) and as amended by Commission Directives 92/39/EEC, 93/9/EEC, 95/3/EC and 96/11/EC";(5)

(b)in regulation 5 (monomers) -

(i)in paragraph (1) -

(A)after the words "the following paragraphs of this regulation" there shall be inserted the words "and regulation 14A",

(B)in sub-paragraph (a), for the date "1st January 1997" there shall be substituted the date "1st January 2002", and

(C)in sub-paragraph (b), for the date "31st December 1996" there shall be substituted the date "31st December 2001";

(ii)in paragraphs (3), (4), (5) and (6), after the words "the relevant fraction of"(wherever they occur) there shall be added the words ", or section F of,";

(c)after regulation 14 there shall be inserted the following regulation -

"Manufacture until 1st January l999

14A. Notwithstanding regulation 5(1),until lst January 1999 a plastic material or article may be manufactured using one or more of the monomers identified by PM/REF No., CAS No. (if any) and name respectively in columns 1, 2, 3 of Section F of Part I of Schedule l, if any such monomer is of good technical quality and is used in accordance with the restrictions (if any) specified in the corresponding entry in column 4 thereof.";

(d)the Item number and letter, PM/REF No., CAS No. and name for each monomer identified in Schedule 1 to these Regulations shall be inserted in Section A of Part 1 of Schedule 1 (monomers authorised without time limit) at the place corresponding to the number and letter specified for that monomer in the column headed "Item" in Schedule l to these Regulations;

(e)the contents of Schedule 2 to these Regulations shall be substituted for Section B of Part 1 of Schedule 1;

(f)in Section D of Part 1 of Schedule l (monomers authorised until 1st April 1996), in Item 16, for the figures "51" and "115" in column 4 (restrictions) there shall be substituted the figures "17" and "58" respectively;

(g)the contents of Schedule 3 to these Regulations shall be inserted after Section E of Part 1 of Schedule 1; and

(h)the Item number and letter, PM/REF No., CAS No. (if any) and name for each additive identified in Schedule 4 to these Regulations shall be inserted in Part I of Schedule 3 (additives) at the place corresponding to the number and letter specified for that additive in the column headed "Item" in Schedule 4 to these Regulations.

Angela Browning

Parliamentary Secretary, Ministry of Agriculture, Fisheries and Food

5th November 1996

Signed by authority of the Secretary of State for Health

Cumberlege

Parliamentary Under Secretary of State,

Department of Health

7th November 1996

Signed by authority of the Secretary of State for Wales

Gwilym Jones

Parliamentary Under Secretary of State,

Welsh Office

5th November 1996

Lindsay

Parliamentary Under Secretary of State,

Scottish Office

4th November 1996

Regulation 2(d)

SCHEDULE 1ADDITIONAL MONOMERS AUTHORISED WITHOUT TIME LIMIT

1234
ItemPM/REF No.CAS No.NameRestrictions
110C19460000050-21-5Lactic-acid
111A19480002146-71-6Lauric acid, vinyl ester
153A23651025322-69-4Polypropyleneglycol

Regulation 2(e)

SCHEDULE 2NEW SECTION B SUBSTITUTED IN PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS

"SECTION B

Monomers authorised up to the end of 2001"

1234
ItemPM/REF No.CAS No.NameRestrictions
115280000542-02-9Acetoguanamine
210599/90A061788-89-4Acids, fatty, unsaturated (C18), dimers, distilled
310599/91061788-89-4Acids, fatty, unsaturated (C18), dimers, non-distilled
410599/92A068783-41-5Acids, fatty, unsaturated (C18), dimers, hydrogenated, distilled
510599/93068783-41-5Acids, fatty, unsaturated (C18), dimers, hydrogenated, non-distilled
611000050976-02-8Acrylic acid, dicyclopentadienyl ester
711245002156-97-0Acrylic acid, dodecyl ester
811500000103-11-7Acrylic acid, 2-ethylhexyl ester
911530000999-61-1Acrylic acid, 2-hydroxypropyl ester
1012265004074-90-2Adipic acid, divinyl ester
1112910001732-10-1Azelaic acid, dimethyl ester
12As item 81000528-44-91,2,4-Benzenetricarboxylic acid
1313060004422-95-11,3,5-Benzenetricarboxylic acid trichlorideAs item 81
14As item 25000091-76-9Benzoguanamine
15As item 30000080-09-1Bisphenol S
1613720000110-63-4Butan-1,4-diol
1713780002425-79-8Butan-1,-diol bis(2,3- epoxypropyl) etherThe quantity in the finished plastic material or article of any substance within, or any combination of substances within, items 17 and 58 (and 16 and 20 of section D) shall not exceed 5mg/kg (expressed as epoxy)
1813810000505-65-7Butan-1,4-diol formal
1913932000598-32-3But-3-en 2-ol
2014020000098-54-44-tert-Butylphenol
2114260000502-44-3Caprolactone
22As item 101 Section A000115-28-6Chlorendic acidAs item 101, Section A
2314800003724-65-0Crotonic acid
2415130000872-05-9Dec-1-ene
2515310000091-76-92,4-Diamino-6-phenyl-1,3,5,-triazine
2615370003236-53-11,6-Diamino-2,2,4- trimethylhexane
2715400003236-54-21,6-Diamino-2,2,4- trimethylhexane
2815610000080-07-94,4'-Dichlorodiphenyl sulphone
2915730000077-73-6Dicyclopentadiene
3016090000080-09-14,4'-Dihydroxydiphenyl sulphone
3116210006864-37-53,3'-Dimethyl-4,4'-diamino- dicyclohexylmethane
3216360000576-26-12,6-Dimethylphenol
3316390000126-30-72,2-Dimethylpropan-1,3-diol
3416450000646-06-01,3-Dioxolane
3516540000102-09-0Diphenyl carbonate
3616690001321-74-0Divinylbenzene
3716697000693-23-2Dodecanedioic acid
3817110016219-75-35-Ethylidenebicyclo- [2 2 1]hept-2-ene
3918220068564-88-5N-Heptylaminoundecanoic acid
4018370000592-45-0Hexa-1,4-diene
4118441000085-42-7Hexahydrophthalic anhydride
4218700000629-11-8Hexan-1,6-diol
4318820000592-41-6Hex-1-ene
4419060000109-53-5Isobutyl vinyl ether
4519150000121-91-5Isophthalic acid
4619180000099-63-8Isophthalic acid dichloride
47As item 62000078-79-5Isoprene
4819490000947-04-6Laurolactam
4919570000999-21-3Maleic acid, diallyl ester
5019600000105-76-0Maleic acid, dibutyl ester
5119990000079-39-0Methacrylamide
5220050000096-05-9Methacrylic acid, allyl ester
5320260000101-43-9Methacrylic acid, cyclohexyl ester
5420380001189-08-8Methacrylic acid, diester with butan-1,3-diol
5520410002082-81-7Methacrylic acid, diester with butan-1,4-diol
5620440000097-90-5Metacrylic acid, diester with ethyleneglycol
5720530002867-47-2Methacrylic acid, 2- (dimethylamino)-ethyl ester
5820590000106-91-2Methacrylic acid, 2,3- epoxypropyl esterAs item 17
5921370010595-80-9Methacrylic acid, 2- sulphoethyl ester
6021400054276-35-6Methacrylic acid, sulphopropyl ester
6121520001561-92-8Methallysulphonic acid, sodium saltThe quantity of this substance in the finished plastic material or article shall not exceed 5mg/kg
6221640000078-79-52-Methylbut-1,3-diene
6321730000563-45-13-Methylbut-1-ene
64As item 18000505-65-71,4-(Methylene-dioxy)butane
6521970000923-02-4N-Methylolmethacrylamide
6622210000098-83-9alpha-Methylstyrene
6722360001141-38-42,6-Naphthalene-dicarboxylic acid
68As item 33000126-30-7Neopentylglycol
6922428051000-52-3Neodecanoic acid, vinyl ester
7013180 (also used for bicyclo[2.2.1]hept- 2-ene)000498-66-8NorborneneAs item 39, Section C
7122720000140-66-94-tert.-Octylphenol
7222900000109-67-1Pent-1-ene
7322937001623-05-8Perfluoropropyl perfluorovinyl; ether
7423770000504-63-2Propan-1,3-diol
7523920000105-38-4Propionic acid, vinyl ester
7624370000106-79-6Sebacic acid, dimethyl ester
7724760026914-43-2Styrenesulphonic acid
7825380Trialkyl(C5-C15) acetic acid, vinyl ester (=vinyl versatate)
7925390000101-37-1Triallyl cyanurate
8025450026896-48-0Tricyclodecanedimethanol
8125540000528-44-9Trimellitic acidThe quantity of this substance alone or together with item 82 in the finished plastic material or article shall not exceed 5mg/kg
8225550000552-30-7Trimellitic anhydrideThe quantity of this substance alone or together with item 81 in the finished plastic material or article shall not exceed 5mg/kg (expressed as trimellitic acid)
8325810015625-89-51,1,1-Trimethylolpropane triacrylate
8425840003290-92-41,1,1-Trimethylolpropane trimethacrylate
8525900000110-88-3Trioxane
8625480000102-71-6Tris(2-hydroxyethyl)amine
8726170003195-78-6N-Vinyl-N-methyl- acetamideThe quantity of this substance in the finished plastic material or article shall not exceed 5mg/kg
8826230000088-12-0Vinylpyrrolidone
8922240000622-97-9p-Vinyltoluene
9016300000105-67-9m-Xylenol
9116270000526-75-0o-Xylenol
9216330000095-87-4p-Xylenol

Regulation 2(g)

SCHEDULE 3NEW SECTION F INSERTED IN PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS

"SECTION F

Monomers authorised until 1st January 1999"

1234
ItemPM/REF No.CAS No.NameRestrictions
110160002206-94-2alpha-Acetoxystyrene
210162010521-96-7beta-Acetoxystyrene
310480-Acids, aliphatic, monocarboxylic, saturated (C2-C24)
410510-Acids, aliphatic, monocarboxylic, unsaturated (C3-C24)
510599/70-Acids, fatty, unsaturated (C18)
610930003066-71-5Acrylic acid, cylohexyl ester
711050001070-70-8Acrylic acid, diester with 1,4-butanediol
811180017831-71-9Acrylic acid, diester with tetraethylenglycol
911195068901-05-3Acrylic acid, diester with triprophyleneglycol
1011520002918-23-2Acrylic acid, 2- hydroxisopropyl ester (= acrylic acid, 2-hydroxy-l- methylethyl ester)
1111560005888-33-5Acrylic acid, isobornyl ester
1211620001330-61-6Acrylic acid, isodecyl ester
1311650029590-42-9Acrylic acid, isooctyl ester
1411695003121-61-7Acrylic acid, 2-methoxyethyl ester
1511740010095-13-3Acrylic acid, monoester with 1,3-butanediol
1611770002478-10-6Acrylic acid, monoester with 1,4-butanediol
1711800013533-05-6Acrylic acid, monoester with diethyleneglycol
1812010040074-09-7Acrylic acid, 2-sulphoethyl ester
1912040039121-78-3Acrylic acid, sulphopropyl ester
2012055094160-26-6Acrylic acid, triester with glycerol tris(2- hydroxypropyl) ether
2112062075577-70-7Acrylic acid, triester with 1,1,1-trimethylolpropane tris(2-hydroxyxethyl) ether
2212160002998-04-1Adipic acid, diallyl ester
2312190000105-97-5Adipic acid, didecyl ester
2412220027178-16-1Adipic acid, diisodecyl ester
2512250000123-79-5Adipic acid, dioctyl ester
2612370-Alcohols, aliphatic, monohydric, saturated, linear, secondary or tertiary (C4-C22)
2712610000107-18-6Allyl alcohol
2812700000150-13-0p-Aminobenzoic acid
2912790000080-46-6p-tert-Amylphenol
3012850029602-44-6Azelaic acid, bis(2- hydroxyethyl) ester
3113328000104-38-1Bis(-2 hydroxyethyl) ether of hydroquinone
3213660000584-03-21,2-Butanediol
3313750000513-85-92,3-Butanediol
3413960001852-16-0N-(Butoxymethyl) acrylamide
3515020002182-55-0Cyclohexyl vinyl ether
3615280000542-02-92,4-Diamino-6-methyl-1,3,5- triazine
3715340000109-76-21,3-Diaminopropane
3815490002215-89-64,4'-Dicarboxydiphenyl ether
3915580001653-19-62,3-Dichloro-1,3-butadiene
4016270000526-75-02,3-Dimethylphenol
4116300000105-67-92,4-Dimethylphenol
4216330000095-87-42,5-Dimethylphenol
4317040000149-57-52-Ethylhexanoic acid
4417350000105-75-9Fumaric acid, dibutyl ester
4518400000592-42-71,5-Hexadiene
4618905002628-17-34-Hydroxystyrene
4718970000078-83-1Isobutanol
4819030016669-59-3N-(Isobutoxymethyl) acrylamide
4919090000078-84-2Isobutyraldehyde
5019120025339-17-7Isodecanol
5119130026896-18-4Isononanoic acid
5219936007423-42-9Maleic acid, mono(2- ethylhexyl)ester
5320470025852-47-5Methacrylic acid, diester with polyethyleneglycol
5420740039670-09-2Methacrylic acid, ester with ethoxytriethylene-glycol
5520950000923-26-2Methacrylic acid, 2-hydroxypropyl ester
5621115000816-74-0Methacrylic acid, methallyl ester
5721220032360-05-7Methacrylic acid, octadecyl ester
5821760000694-91-75-Methylenebicyclo [2.2.1]hept-2-ene
5921837001116-90-14-Methyl-1,4-hexadieneThe specific migration of this substance shall not be detectable (when measured by a method with a limit of detection of 0.05 mg/kg).
6022240000622-97-9p-Methylstyrene
6122270000107-25-5Methyl vinyl ether
6222540000104-40-54-Nonylphenol
6322585003710-30-31,7-Octadiene
6422932001187-93-5Perfluoromethyl perfluorovinyl ether
6523530025190-06-1Poly(1,4-butyleneglycol) (Molecular weight greater than 1000)
6623650025322-69-4Polypropyleneglycol (Molecular weight greater than 400)
6724560000111-63-7Stearic acid, vinyl ester
6825030016646-44-9Tetra(allyloxy)ethane
6925161000085-43-81,2,3,6-Tetrahydrophtalic anhydride
7025300000088-19-7o-Toluenesulphonamide
7125480000102-71-6Triethanolamine
7226290025013-15-4Vinyltoluene
7326320002768-02-7VinyltrimethoxysilaneThe quantity of this substance in the finished material or article shall not exceed 5mg/kg.

Regulation 2(h)

SCHEDULE 4ADDITIONAL ADDITIVES

1234
ItemPM/REF No.CAS No.Name
12A34281-Alkyl (C8-C22) sulphoric acids, linear, primary, with an even number of carbon atoms
12B34475-Aluminium calcium hydroxide phosphite, hydrate
65A46380068855-54-9Diatomaceous earth, soda ash flux-calcined
74A52720000112-84-5Erucamide
92A55520-Glass fibers
92B55600-Glass microballs
96A56486-Glycerol, esters with acids, aliphatic, saturated, linear, with an even number of carbon atoms (C14-C18) and with acids, aliphatic, unsaturated, linear with an even number of carbon atoms (C16-C18)
172A68960000301-02-0Oleamide
199A80800025322-69-4Polypropyleneglycol
252A88960000124-26-5Stearamide

Explanatory Note

(This note is not part of the Regulations)

These Regulations, which extend to Great Britain, amend the Plastic Materials and Articles in Contact with Food Regulations 1992, as amended ("the principal Regulations") and implement Commission Directive 96/11/EC (OJ No. L61, 12.3.96, p.26), amending Directive 90/128/EEC (OJ No. L75, 21.3.90, p.19,) as read with the corrigendum in OJ No. L349, 13.12.90, p.26) relating to plastic materials and articles intended to come into contact with foodstuffs.

The Regulations -

(a)modify the prohibition in regulation 5(1) of the principal Regulations on manufacture of plastic materials and articles before and after specified dates, using monomers other than those specified, by substituting later dates (regulation 2(b)(i)(B) and (C));

(b)permit, until 1st January 1999, the manufacture of plastic materials and articles, using monomers specified in Section F (as inserted by regulation 2(g) and Schedule 3 into Part 1 of Schedule 1 to the principal Regulations), (regulation 2(c));

(c)add specified monomers to those monomers authorised without time limit specified in Section A of Part I of Schedule 1 to the principal Regulations (regulation 2(d) and Schedule 1);

(d)substitute for the list of monomers in Section B of Part I of Schedule 1 to the principal Regulations (monomers authorised up to the end of 1996) an amended list, omitting certain monomers previously included, those remaining being authorised up to the end of 2001 (regulation 2(e) and Schedule 2);

(e)add specified additives to those which are specified in Part I of Schedule 3 to the principal Regulations, and which it is prohibited to use, if they are not of good technical quality, in the manufacture of plastic materials and articles, (regulation 2(h) and Schedule 4); and

(f)make consequential amendments to the principal Regulations (regulation 2(a), 2(b)(i)(A) and (ii), and (f)).

A compliance cost assessment of the effect that this Instrument would have on the cost of business, is available from Food Contaminants Division B of the Ministry of Agriculture, Fisheries and Food, Ergon House, 17 Smith Square, London SW1P 3JR.

(1)

1990 c. 16; "the Ministers" is defined in section 4(1) of the Act.

(2)

S.I. 1976/2141.

(4)

S.I. 1992/3145, amended by S.I. 1995/360 and S.I. 1996/694.

(5)

Corrigendum in OJ No. L349, 13.12.90, p.26; amending Directives in OJ No. L168, 23.6.92, p.21, OJ No. L90, 14.3.93, p.26, OJ No. L41, 23.2.95, p.44 and OJ No. L61, 12.3.96, p.26.


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