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

Type Statutory-Instrument
Publication 1996-11-07
State In force
Department Queen's Printer of Acts of Parliament
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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[^f00001], 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[^f00002] for the purposes of section 2(2) of the European Communities Act 1972[^f00003] 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

Amendment of the principal Regulations

2

The principal Regulations shall be amended as follows:

(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.

SCHEDULE 1 — ADDITIONAL MONOMERS AUTHORISED WITHOUT TIME LIMIT

1 2 3 4
Item PM/REF No. CAS No. Name Restrictions
110C 19460 000050-21-5 Lactic-acid
111A 19480 002146-71-6 Lauric acid, vinyl ester
153A 23651 025322-69-4 Polypropyleneglycol

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

1 2 3 4
Item PM/REF No. CAS No. Name Restrictions
1 15280 000542-02-9 Acetoguanamine
2 10599/90A 061788-89-4 Acids, fatty, unsaturated (C18), dimers, distilled
3 10599/91 061788-89-4 Acids, fatty, unsaturated (C18), dimers, non-distilled
4 10599/92A 068783-41-5 Acids, fatty, unsaturated (C18), dimers, hydrogenated, distilled
5 10599/93 068783-41-5 Acids, fatty, unsaturated (C18), dimers, hydrogenated, non-distilled
6 11000 050976-02-8 Acrylic acid, dicyclopentadienyl ester
7 11245 002156-97-0 Acrylic acid, dodecyl ester
8 11500 000103-11-7 Acrylic acid, 2-ethylhexyl ester
9 11530 000999-61-1 Acrylic acid, 2-hydroxypropyl ester
10 12265 004074-90-2 Adipic acid, divinyl ester
11 12910 001732-10-1 Azelaic acid, dimethyl ester
12 As item 81 000528-44-9 1,2,4-Benzenetricarboxylic acid
13 13060 004422-95-1 1,3,5-Benzenetricarboxylic acid trichloride As item 81
14 As item 25 000091-76-9 Benzoguanamine
15 As item 30 000080-09-1 Bisphenol S
16 13720 000110-63-4 Butan-1,4-diol
17 13780 002425-79-8 Butan-1,-diol bis(2,3- epoxypropyl) ether The 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)
18 13810 000505-65-7 Butan-1,4-diol formal
19 13932 000598-32-3 But-3-en 2-ol
20 14020 000098-54-4 4-tert-Butylphenol
21 14260 000502-44-3 Caprolactone
22 As item 101 Section A 000115-28-6 Chlorendic acid As item 101, Section A
23 14800 003724-65-0 Crotonic acid
24 15130 000872-05-9 Dec-1-ene
25 15310 000091-76-9 2,4-Diamino-6-phenyl-1,3,5,-triazine
26 15370 003236-53-1 1,6-Diamino-2,2,4- trimethylhexane
27 15400 003236-54-2 1,6-Diamino-2,2,4- trimethylhexane
28 15610 000080-07-9 4,4'-Dichlorodiphenyl sulphone
29 15730 000077-73-6 Dicyclopentadiene
30 16090 000080-09-1 4,4'-Dihydroxydiphenyl sulphone
31 16210 006864-37-5 3,3'-Dimethyl-4,4'-diamino- dicyclohexylmethane
32 16360 000576-26-1 2,6-Dimethylphenol
33 16390 000126-30-7 2,2-Dimethylpropan-1,3-diol
34 16450 000646-06-0 1,3-Dioxolane
35 16540 000102-09-0 Diphenyl carbonate
36 16690 001321-74-0 Divinylbenzene
37 16697 000693-23-2 Dodecanedioic acid
38 17110 016219-75-3 5-Ethylidenebicyclo- [2 2 1]hept-2-ene
39 18220 068564-88-5 N-Heptylaminoundecanoic acid
40 18370 000592-45-0 Hexa-1,4-diene
41 18441 000085-42-7 Hexahydrophthalic anhydride
42 18700 000629-11-8 Hexan-1,6-diol
43 18820 000592-41-6 Hex-1-ene
44 19060 000109-53-5 Isobutyl vinyl ether
45 19150 000121-91-5 Isophthalic acid
46 19180 000099-63-8 Isophthalic acid dichloride
47 As item 62 000078-79-5 Isoprene
48 19490 000947-04-6 Laurolactam
49 19570 000999-21-3 Maleic acid, diallyl ester
50 19600 000105-76-0 Maleic acid, dibutyl ester
51 19990 000079-39-0 Methacrylamide
52 20050 000096-05-9 Methacrylic acid, allyl ester
53 20260 000101-43-9 Methacrylic acid, cyclohexyl ester
54 20380 001189-08-8 Methacrylic acid, diester with butan-1,3-diol
55 20410 002082-81-7 Methacrylic acid, diester with butan-1,4-diol
56 20440 000097-90-5 Metacrylic acid, diester with ethyleneglycol
57 20530 002867-47-2 Methacrylic acid, 2- (dimethylamino)-ethyl ester
58 20590 000106-91-2 Methacrylic acid, 2,3- epoxypropyl ester As item 17
59 21370 010595-80-9 Methacrylic acid, 2- sulphoethyl ester
60 21400 054276-35-6 Methacrylic acid, sulphopropyl ester
61 21520 001561-92-8 Methallysulphonic acid, sodium salt The quantity of this substance in the finished plastic material or article shall not exceed 5mg/kg
62 21640 000078-79-5 2-Methylbut-1,3-diene
63 21730 000563-45-1 3-Methylbut-1-ene
64 As item 18 000505-65-7 1,4-(Methylene-dioxy)butane
65 21970 000923-02-4 N-Methylolmethacrylamide
66 22210 000098-83-9 alpha-Methylstyrene
67 22360 001141-38-4 2,6-Naphthalene-dicarboxylic acid
68 As item 33 000126-30-7 Neopentylglycol
69 22428 051000-52-3 Neodecanoic acid, vinyl ester
70 13180 (also used for bicyclo[2.2.1]hept- 2-ene) 000498-66-8 Norbornene As item 39, Section C
71 22720 000140-66-9 4-tert.-Octylphenol
72 22900 000109-67-1 Pent-1-ene
73 22937 001623-05-8 Perfluoropropyl perfluorovinyl; ether
74 23770 000504-63-2 Propan-1,3-diol
75 23920 000105-38-4 Propionic acid, vinyl ester
76 24370 000106-79-6 Sebacic acid, dimethyl ester
77 24760 026914-43-2 Styrenesulphonic acid
78 25380 Trialkyl(C5-C15) acetic acid, vinyl ester (=vinyl versatate)
79 25390 000101-37-1 Triallyl cyanurate
80 25450 026896-48-0 Tricyclodecanedimethanol
81 25540 000528-44-9 Trimellitic acid The quantity of this substance alone or together with item 82 in the finished plastic material or article shall not exceed 5mg/kg
82 25550 000552-30-7 Trimellitic anhydride The 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)
83 25810 015625-89-5 1,1,1-Trimethylolpropane triacrylate
84 25840 003290-92-4 1,1,1-Trimethylolpropane trimethacrylate
85 25900 000110-88-3 Trioxane
86 25480 000102-71-6 Tris(2-hydroxyethyl)amine
87 26170 003195-78-6 N-Vinyl-N-methyl- acetamide The quantity of this substance in the finished plastic material or article shall not exceed 5mg/kg
88 26230 000088-12-0 Vinylpyrrolidone
89 22240 000622-97-9 p-Vinyltoluene
90 16300 000105-67-9 m-Xylenol
91 16270 000526-75-0 o-Xylenol
92 16330 000095-87-4 p-Xylenol

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

1 2 3 4
Item PM/REF No. CAS No. Name Restrictions
1 10160 002206-94-2 alpha-Acetoxystyrene
2 10162 010521-96-7 beta-Acetoxystyrene
3 10480 — Acids, aliphatic, monocarboxylic, saturated (C2-C24)
4 10510 — Acids, aliphatic, monocarboxylic, unsaturated (C3-C24)
5 10599/70 — Acids, fatty, unsaturated (C18)
6 10930 003066-71-5 Acrylic acid, cylohexyl ester
7 11050 001070-70-8 Acrylic acid, diester with 1,4-butanediol
8 11180 017831-71-9 Acrylic acid, diester with tetraethylenglycol
9 11195 068901-05-3 Acrylic acid, diester with triprophyleneglycol
10 11520 002918-23-2 Acrylic acid, 2- hydroxisopropyl ester (= acrylic acid, 2-hydroxy-l- methylethyl ester)
11 11560 005888-33-5 Acrylic acid, isobornyl ester
12 11620 001330-61-6 Acrylic acid, isodecyl ester
13 11650 029590-42-9 Acrylic acid, isooctyl ester
14 11695 003121-61-7 Acrylic acid, 2-methoxyethyl ester
15 11740 010095-13-3 Acrylic acid, monoester with 1,3-butanediol
16 11770 002478-10-6 Acrylic acid, monoester with 1,4-butanediol
17 11800 013533-05-6 Acrylic acid, monoester with diethyleneglycol
18 12010 040074-09-7 Acrylic acid, 2-sulphoethyl ester
19 12040 039121-78-3 Acrylic acid, sulphopropyl ester
20 12055 094160-26-6 Acrylic acid, triester with glycerol tris(2- hydroxypropyl) ether
21 12062 075577-70-7 Acrylic acid, triester with 1,1,1-trimethylolpropane tris(2-hydroxyxethyl) ether
22 12160 002998-04-1 Adipic acid, diallyl ester
23 12190 000105-97-5 Adipic acid, didecyl ester
24 12220 027178-16-1 Adipic acid, diisodecyl ester
25 12250 000123-79-5 Adipic acid, dioctyl ester
26 12370 — Alcohols, aliphatic, monohydric, saturated, linear, secondary or tertiary (C4-C22)
27 12610 000107-18-6 Allyl alcohol
28 12700 000150-13-0 p-Aminobenzoic acid
29 12790 000080-46-6 p-tert-Amylphenol
30 12850 029602-44-6 Azelaic acid, bis(2- hydroxyethyl) ester
31 13328 000104-38-1 Bis(-2 hydroxyethyl) ether of hydroquinone
32 13660 000584-03-2 1,2-Butanediol
33 13750 000513-85-9 2,3-Butanediol
34 13960 001852-16-0 N-(Butoxymethyl) acrylamide
35 15020 002182-55-0 Cyclohexyl vinyl ether
36 15280 000542-02-9 2,4-Diamino-6-methyl-1,3,5- triazine
37 15340 000109-76-2 1,3-Diaminopropane
38 15490 002215-89-6 4,4'-Dicarboxydiphenyl ether
39 15580 001653-19-6 2,3-Dichloro-1,3-butadiene
40 16270 000526-75-0 2,3-Dimethylphenol
41 16300 000105-67-9 2,4-Dimethylphenol
42 16330 000095-87-4 2,5-Dimethylphenol
43 17040 000149-57-5 2-Ethylhexanoic acid
44 17350 000105-75-9 Fumaric acid, dibutyl ester
45 18400 000592-42-7 1,5-Hexadiene
46 18905 002628-17-3 4-Hydroxystyrene
47 18970 000078-83-1 Isobutanol
48 19030 016669-59-3 N-(Isobutoxymethyl) acrylamide
49 19090 000078-84-2 Isobutyraldehyde
50 19120 025339-17-7 Isodecanol
51 19130 026896-18-4 Isononanoic acid
52 19936 007423-42-9 Maleic acid, mono(2- ethylhexyl)ester
53 20470 025852-47-5 Methacrylic acid, diester with polyethyleneglycol
54 20740 039670-09-2 Methacrylic acid, ester with ethoxytriethylene-glycol
55 20950 000923-26-2 Methacrylic acid, 2-hydroxypropyl ester
56 21115 000816-74-0 Methacrylic acid, methallyl ester
57 21220 032360-05-7 Methacrylic acid, octadecyl ester
58 21760 000694-91-7 5-Methylenebicyclo [2.2.1]hept-2-ene
59 21837 001116-90-1 4-Methyl-1,4-hexadiene The specific migration of this substance shall not be detectable (when measured by a method with a limit of detection of 0.05 mg/kg).
60 22240 000622-97-9 p-Methylstyrene
61 22270 000107-25-5 Methyl vinyl ether
62 22540 000104-40-5 4-Nonylphenol
63 22585 003710-30-3 1,7-Octadiene
64 22932 001187-93-5 Perfluoromethyl perfluorovinyl ether
65 23530 025190-06-1 Poly(1,4-butyleneglycol) (Molecular weight greater than 1000)
66 23650 025322-69-4 Polypropyleneglycol (Molecular weight greater than 400)
67 24560 000111-63-7 Stearic acid, vinyl ester
68 25030 016646-44-9 Tetra(allyloxy)ethane
69 25161 000085-43-8 1,2,3,6-Tetrahydrophtalic anhydride
70 25300 000088-19-7 o-Toluenesulphonamide
71 25480 000102-71-6 Triethanolamine
72 26290 025013-15-4 Vinyltoluene
73 26320 002768-02-7 Vinyltrimethoxysilane The quantity of this substance in the finished material or article shall not exceed 5mg/kg.

SCHEDULE 4 — ADDITIONAL ADDITIVES

1 2 3 4
Item PM/REF No. CAS No. Name
12A 34281 — Alkyl (C8-C22) sulphoric acids, linear, primary, with an even number of carbon atoms
12B 34475 — Aluminium calcium hydroxide phosphite, hydrate
65A 46380 068855-54-9 Diatomaceous earth, soda ash flux-calcined
74A 52720 000112-84-5 Erucamide
92A 55520 — Glass fibers
92B 55600 — Glass microballs
96A 56486 — 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)
172A 68960 000301-02-0 Oleamide
199A 80800 025322-69-4 Polypropyleneglycol
252A 88960 000124-26-5 Stearamide

Signed

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, — 7th November 1996

Signed by authority of the Secretary of State for Wales

Gwilym Jones — Parliamentary Under Secretary of State, — 5th November 1996

Lindsay — Parliamentary Under Secretary of State, — 4th November 1996

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 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.

Footnotes

[^f00001]: 1990 c. 16; "the Ministers" is defined in section 4(1) of the Act.

[^f00002]: S.I. 1976/2141.

[^f00003]: 1972 c. 68.

[^f00004]: S.I. 1992/3145, amended by S.I. 1995/360 and S.I. 1996/694.

[^f00005]: 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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