Statutory Instruments
FOOD
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:
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)
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 —
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)
| 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 |
Regulation 2(e)
| 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 |
Regulation 2(g)
| 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. |
Regulation 2(h)
| 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 |
(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.
1990 c. 16; "the Ministers" is defined in section 4(1) of the Act.
S.I. 1992/3145, amended by S.I. 1995/360 and S.I. 1996/694.
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.