- Latest available (Revised) - English
- Latest available (Revised) - Welsh
- Original (As made) - English
- Original (As made) - Welsh
This is the original version (as it was originally made).
Regulation 10
ITEM | PM/REF No. | CAS No. | NAME | Restrictions and specifications |
---|---|---|---|---|
28A | 12761 | 000693-57-2 | 12-Aminododecanoic acid | The specific migration of this substance shall not exceed 0.05 mg/kg |
35A | 13180 | 000498-66-8 | Bicyclo [2.2.1] hept-2-ene (=norbornene) | The specific migration of this substance shall not exceed 0.05 mg/kg |
35B | 13210 | 00176-71-3 | Bis(4-aminocyclohexyl)methane | The specific migration of this substance shall not exceed 0.05 mg/kg |
63A | 14650 | 000079-38-9 | Chlorotrifluoroethylene | The quantity of this substance in the finished plastic material or article shall not exceed 0.05 mg/6 dm2 |
68A | 14841 | 000599-64-4 | 4-Cumylphenol | The specific migration of this substance shall not exceed 0.05 mg/kg |
93A | 16694 | 013811-50-2 | N,N'-Divinyl-2-imidazolidinone | The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg |
93B | 16704 | 000112-41-4 | 1-Dodecene | The specific migration of this substance shall not exceed 0.05 mg/kg |
147A | 22331 | 025513-64-8 | Mixture of (40% w/w) 1,6- diamino-2,2,4- trimethylhexane and (60% w/w) 1,6-diamino-2,4,4— trimethylhexane | The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/6 dm2 |
152A | 22550 | 000498-66-8 | Norbornene | The specific migration of this substance shall not exceed 0.05 mg/kg |
163A | 23175 | 000122-52-1 | Phosphorous acid, triethylester | The quantity of this substance in the finished plastic material or article shall be not detectable (when measured by a method with a detection limit of 1 mg/kg) |
169A | 23547 | 009016-00 6 063148-62-9 | Polydimethylsiloxane (MW>6800) | In compliance with the specifications laid down in Schedule 2B. |
206A | 25080 | 001120-36-1 | 1-Tetradecene | The specific migration of this substance shall not exceed 0.05 mg/kg |
214A | 25385 | 000102-70-5 | Triallylamine | In compliance with the specifications laid down in Schedule 2B. |
218A | 25927 | 027955-94-8 | 1,1,1-Tris(4-hydroxyphenyl)ethane | The quantity of this substance in the finished plastic material or article shall not exceed 0.5 mg/kg. For use only in polycarbonates |
223 | 26155 | 001072-63-5 | 1-Vinylimidazole | The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg |
225 | 26320 | 002768-02-7 | Vinyltrimethoxysilane | The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg |
226 | 26360 | 007732-18-5 | Water | In compliance with Directive 98/83/EC on the quality of water intended for human consumption (1). |
ITEM | PM/REF No. | CAS No. | Name | Restrictions and specifications |
---|---|---|---|---|
2 | 10060 | 000075-07-0 | Acetaldehyde | SML (T) = 6 mg/kg (2) |
40 | 13510 | 001675-54-3 | 2,2-Bis(4- hydroxyphenyl)propane bis(2,3-epoxypropyl) ether (=BADGE) | SML (T) = 1 mg/kg (9). Authorised only until 1 January 2005 |
56 | 14200 | 000105-60-2 | Caprolactam | SML (T) = 15 mg/kg (5) |
57 | 14230 | 002123-24-2 | Caprolactam, sodium salt | SML (T) = 15 mg/kg (5) (expressed as caprolactam) |
79 | 15760 | 000111-46-6 | Diethyleneglycol | SML (T) = 30 mg/kg (3) |
98 | 16990 | 000107-21-1 | Ethyleneglycol | SML (T) = 30 mg/kg (3) |
102 | 17160 | 000097-53-0 | Eugenol | The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.02 mg/kg, analytical tolerance included) |
128 | 19540 | 000110-16-7 | Maleic acid | SML (T) = 30 mg/kg (4) |
129 | 19960 | 000108-31-6 | Maleic anhydride | SML (T) = 30 mg/kg (4) (expressed as maleic acid) |
214 | 25360 | - | Trialkyl(C5-C15) acetic acid, 2,3-epoxypropyl ester | The quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg (expressed as epoxy group, molecular weight = 43) |
ITEM | PM/REF No | CAS/No. | Name | Restrictions |
---|---|---|---|---|
34 | 16690 | 001321-74-0 | Divinylbenzene | The quantity of this material in the finished plastic material or article shall not exceed 1 mg/kg or the specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.02 mg/kg, analytical tolerance included) |
56 | 20590 | 000106-91-2 | Methacrylic acid, 2,3-epoxypropyl ester | The quantity of this material in the finished plastic material or article shall not exceed 5 mg/kg (expressed as epoxy group, molecular weight = 43) |
68 | 22720 | 000140-66-9 | 4-tert-Octylphenol | The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.01mg/kg, analytical tolerance included) |
Items | PM/REF No. | CAS No. | Name | Restrictions |
---|---|---|---|---|
77A | 25185 | 000140-66-9 | 4-(1,1,3,3-Tetramethylbutyl) phenol (=4-tert-octylphenol) | As item 68 |
Item No. in Section B | Item No. For Section A | PM/REF No. | CAS No. | NAME | Restrictions and specifications |
---|---|---|---|---|---|
5 | 13A | 11000 | 05976-02-8 | Acrylic acid, dicyclopentadienyl ester | The quantity of this substance in the finished plastic material or article shall not exceed 0.05 mg/6 dm2 |
6 | 13B | 11245 | 002156-97-0 | Acrylic acid, dodecyl ester | The specific migration of this substance shall not exceed 0.05 mg/kg (1) |
9 | 23A | 12265 | 004074-90-2 | Adipic acid, divinyl dodecyl ester | The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg. For use only as a comonomer. |
12 | 33A | 13060 | 004422-95-1 | 1,3,5 - Benzenetricarboxylic acid trichloride | The quantity of this substance in the finished plastic material or artical shall not exceed 0.05 mg/6dm2 (measured as 1,3,5 — benzenetricarboxylic |
16 | 49A | 13780 | 002425-79-8 | 1,4-Butanediol bis(2,3- epoxypropyl) ether | The quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg (expressed as epoxy group, molecular weight equal to 43) |
19 | 52A | 14020 | 000098-54-4 | 4-tert-Butylphenol | The specific migration of this substance shall not exceed 0.05 mg/kg |
22 | 73A | 15130 | 000872-05-9 | 1-Decene | The specific migration of this substance shall not exceed 0.05 mg/kg |
30 | 88A | 16360 | 000576-26-1 | 2,6-Dimethylphenol | The specific migration of this substance shall not exceed 0.05 mg/kg |
32 | 88B | 16450 | 000646-06-0 | 1,3-Dioxolane | The specific migration of this substance shall not exceed 0.05 mg/kg |
37 | 111A | 18220 | 068564-88-5 | N-Heptylaminoundeca noic acid | The specific migration of this substance shall not exceed 0.05 mg/kg (1) |
41 | 118A | 18820 | 000592-41-6 | 1-Hexene | The specific migration of this substance shall not exceed 3 mg/kg |
42 | 121A | 19060 | 000109-53-5 | Isobutyl vinyl ether | The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg |
43 | 121B | 19150 | 000121-91-5 | Isophthalic acid | The specific migration of this substance shall not exceed 5 mg/kg |
49 | 130A | 19990 | 000079-39-0 | Methacrylamide | The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.02 mg/kg, analytical tolerance included) |
50 | 131A | 20050 | 000096-05-9 | Methacrylic acid, allyl ester | The specific migration of this substance shall not exceed 0.05 mg/kg |
55 | 135A | 20530 | 002867-47-2 | Methacrylic acid, 2-(dimethylamino) ethyl ester | The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.02 mg/kg, analytical tolerance included) |
61 | 145A | 21730 | 000563-45-1 | 3-Methyl-1-butene | The quantity of this substance in the finished plastic material or article shall not exceed 0.006 mg/6 dm2 For use only in polypropylene |
70 | 159A | 22937 | 001623-05-8 | Perfluoropropyl perfluorovinyl ether | The specific migration of this substance shall not exceed 0.05 mg/kg |
71 | 173A | 23770 | 000504-63-2 | 1,3-Propanediol | The specific migration of this substance shall not exceed 0.05 mg/kg |
72 | 177A | 23920 | 000105-38-4 | Propionic acid, vinyl ester | SML (T) = 6 mg/kg (2) (expressed as acetaldehyde) |
74 | 198A | 24760 | 026914-43-2 | Styrenesulphonic acid | The specific migration of this substance shall not exceed 0.05 mg/kg |
83 | 224 | 26170 | 003195-78-6 | N-Vinyl-N-methylacetamide | The quantity of this substance in the finished plastic material or article shall not exceed 2 mg/kg |
Regulation 11
ITEM | PM/REF No. | CAS No. | NAME | Restrictions and specifications |
---|---|---|---|---|
2A | 30080 | 004180-12-5 | Acetic acid, copper salt | SML (T) = 30 mg/kg (7) (expressed as copper) |
7A | 30610 | - | Acids C2-C24 aliphatic, linear monocarboxylic, from natural oils and fats and their mono-, di- and triglycerol esters (branched fatty acids at naturally occurring levels are included). | |
7B | 30612 | - | Acids C2-C24 aliphatic, linear, monocarboxylic, synthetic and their mono-, di— and triglycerol esters | |
9A | 31530 | 123968-25-2 | Acrylic acid, 2,4-di-tert- pentyl-6-[1(3,5-di-tert-pentyl- 2-hydroxyphenyl) ethyl] phenyl ester | The specific migration of this substance shall not exceed 5 mg/kg |
12A | 33801 | - | n-Alkyl (C10-C13) benzenesulphonic acid | The specific migration of this substance shall not exceed 30 mg/kg |
12B | 34240 | - | Alkyl(C10-C20) sulphonic acid, esters with phenols | The specific migration of this substance shall not exceed 6 mg/kg. Authorised only until 1 January 2002. |
27A | 36640 | 000123-77-3 | Azodicarbonamide | For use only as blowing agent. |
31A | 37360 | 000100-52-7 | Benzaldehyde | (10) |
36A | 38320 | 005242-49-6 | 4-(2-Benzoxazolyl)-4'-(5- methyl-2-benzoxazolyl) stilbene | In compliance with the specifications laid down in Schedule 2B |
36B | 38510 | 136504-96-6 | 1,2-Bis(3-aminopropyl) ethylenediamine, polymer with N-butyl-2,2,6,6- tetramethyl-4-piperidinamine and 2,4,6-trichloro-1,3,5— triazine | The specific migration of this substance shall not exceed 5 mg/kg |
36C | 38515 | 001533-45-5 | 4,4'-Bis(2-benzoxazolyl)stilbene | The specific migration of this substance shall not exceed 0.05 mg/kg (1) |
36D | 38810 | 080693-00-1 | Bis(2,6-di-tert-butyl-4-methylphenyl) pentaerythritol diphosphite | The specific migration of this substance shall not exceed 5 mg/kg (sum of phosphite and phosphate) |
36E | 38879 | 135861-56-2 | Bis(3,4— dimethylbenzylidene)sorbitol | |
37A | 39200 | 006200-40-4 | Bis (2-hydroxyethyl)-2-hydroxypropyl-3-(dodecyloxy) methylammonium chloride | The specific migration of this substance shall not exceed 1.8 mg/kg |
37B | 39815 | 182121-12-6 | 9,9 bis(methoxymethyl) fluorene | The quantity of this substance in the finished plastic material or article shall not exceed 0.05 mg/6 dm2 |
38A | 40120 | - | Bis(polyethyleneglycol) hydroxymethylphosphonate | The specific migration of this substance shall not exceed 0.6 mg/kg. Authorised only until 1 January 2002 |
44A | 41680 | 000076-22-2 | Camphor | (10) |
47A | 42320 | 007492-68- 4 | Carbonic acid, copper salt | SML (T) = 30 mg/kg (7) |
57A | 43515 | - | Chlorides of choline esters of coconut oil fatty acids | The quantity of this substance in the finished plastic material or article shall not exceed 0.9 mg/6 dm2 |
59A | 45195 | 007787-70-4 | Copper bromide | SML (T) = 30 mg/kg (7) (expressed as copper) |
59B | 45200 | 001335-23-5 | Copper iodide | SML (T) = 30 mg/kg (7) (expressed as copper) and the specific migration of this substance shall not exceed 1 mg/kg (expressed as iodine) |
60A | 45450 | 068610-51-5 | p-Cresol-dicyclopentadiene-isobutylene, copolymer | The specific migration of this substance shall not exceed 0.05 mg/kg (1) |
72A | 46880 | 065140-91-2 2 | 3,5-Di-tert-butyl-4-hydroxybenzyl phosphonic acid, monoethyl ester, calcium salt | The specific migration of this substance shall not exceed 6 mg/kg |
73A | 47680 | 000111-46-3 | Diethyleneglycol | SML (T) = 30 mg/kg (3) |
73B | 48460 | 000075-37-6 | 1,1-Difluoroethane | |
73C | 49485 | 134701-20-2 | 2,4-Dimethyl-6-(1-methylpentadecyl)phenol | The specific migration of this substance shall not exceed 1 mg/kg |
75A | 51700 | 147315-50-2 | 2-(4,6-Diphenyl-1,3,5-triazin-2-yl)-5-(hexyloxy) phenol | The specific migration of this substance shall not exceed 0.05 mg/kg |
86A | 53610 | 54453-03-1 | Ethylenediaminetetraacetic acid, copper salt | SML (T) = 30 mg/kg (7) (expressed as copper) |
86B | 53650 | 000107-21-1 | Ethyleneglycol | SML (T) = 30 mg/kg (3) |
90A | 54300 | 118337-09-0 | 2,2'-Ethylidenebis(4,6-di-tert-butyl-phenyl) fluorophosphonite | The specific migration of this substance shall not exceed 6 mg/kg |
92A | 54930 | 025359-91-5 | Formaldehyde-1-naphthol, copolymer [=poly (1-hydroxynaphthyl-methane)] | The specific migration of this substance shall not exceed 0.05 mg/kg |
125A | 57800 | 018641-57-1 | Glycerol tribehenate | |
140A | 60480 | 003864-99-1 | 2-(2-Hydroxy-3,5-di-tert-butylphenyl)-5-Chlorobenzo Chlorobenzotriazole | The specific migration of this substance shall not exceed 30 mg/kg |
169A | 66560 | 004066-02-8 | 2,2'-Methylenebis(4-methyl-6-cyclohexylphenol) | SML (T) = 3 mg/kg |
169B | 66580 | 000077-62-3 | 2,2'-Methylenebis [4-methyl-6-(1-methylcyclo-hexyl) phenol] | SML (T) = 3 mg/kg (6) |
172A | 66755 | 002682-20-4 | 2-Methyl-4-isothiazolin-3-one | The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.02 mg/kg analytical tolerance included) |
173A | 67170 | - | Mixture of (80 to100% w/w) 5,7-di-tert-butyl-3-(3,4- dimethylphenyl)-2(3H)- benzofuranone and (0-20% w/w) 5,7-di-tert-butyl-3-(2,3— di-methylphenyl)-2(3H)— benzofuranone | The specific migration of this substance shall not exceed 5 mg/kg |
173B | 67180 | - | Mixture of (50% w/w) phthalic acid n-decyl n-octyl ester, (25% w/w) phthalic acid di-n- decyl ester, and (25% w/w) phthalic acid di-n-octyl ester | The specific migration of this substance shall not exceed 5 mg/kg (1) |
179A | 68145 | 080410-33-9 | 2,2',2"-Nitrilo[triethyl tris(3,3',5,5'-tetra-tert-butyl-1- 1'-bi-phenyl-2,2'-diyl) phosphite] | The specific migration of this substance shall not exceed 5 mg/kg (sum of phosphite and phosphate) |
188A | 71635 | 025151-96-6 | Pentaerythritol dioleate | The specific migration of this substance shall not exceed 0.05 mg/kg. Not for use with foods for which simulant D is laid down in Directive 85/572/EEC laying down the list of simulants to be used for testing migration of constituents of plastic materials and articles intended to come into contact with foodstuffs (2). |
191A | 73720 | 000115-96-6 | Phosphoric acid, trichloroethyl ester | The specific migration of this substance shall not be detectable (when measured by a method with a limit of detection of 0.02 mg/kg, analytical tolerance included) |
191B | 74010 | 145650-60-8 | Phosphorous acid, bis(2,4-di-tert-butyl-6-methylphenyl) ethyl ester | The specific migration of this substance shall not exceed 5 mg/kg. (covering the sum of phosphite and phosphate) |
195A | 76721 | 009016-00-6 063148-62-9 | Polydimethylsiloxane (mw > 6800) | In compliance with the specifications mentioned in Schedule 2B. |
195B | 76865 | - | Polyesters of 1,2-propanediol and/or 1,3- and/or 1,4-butanediol and/or polypropyleneglycol with adipic acid, also end-capped with acetic acid or fatty acids C10-C18 or n-octanol and/or n-decanol | The specific migration of this substance shall not exceed 30 mg/kg |
198A | 77895 | 068439-49-6 | Polyethyleneglycol (EO = 2-6) monoalkyl (C16-C18) ether | The specific migration of this substance shall not exceed 0.05 mg/kg |
208A | 81515 | 087189-25-1 1 | Poly(zinc glycerolate) | |
210A | 81760 | - | Powders, flakes and fibres of stainless steel, tin and alloys of copper, tin and iron | SML (T) = 30 mg/kg (7) (expressed as copper); the specific migration of this substance shall not exceed 48 mg/kg (expressed as iron) |
239A | 85360 | 000109-43-3 3 | Sebacic acid, dibutyl ester | |
240A | 85610 | - | Silicates, natural, silanated (with the exception of asbestos) | |
240B | 85840 | 053320-86-8 | Silicic acid, lithium magnesium sodium salt | SML (T) = 0.6 mg/kg (8) (expressed as lithium) |
244A | 86285 | - | Silicon dioxide, silanated | |
259A | 88640 | 008013-07-8 8 | Soybean oil, epoxidized | In compliance with the specifications laid down in Schedule 2B |
263A | 89200 | 007617-31-4 | Stearic acid, copper salt | SML (T) = 30 mg/kg (7) (expressed as copper) |
263B | 89440 | - | Stearic acid, esters with ethyleneglycol | SML (T) = 30 mg/kg (3) |
270A | 92030 | 010124-44-4 | Sulphuric acid, copper salt | SML (T) = 30 mg/kg (7) (expressed as copper) |
276A | 92700 | 078301-43-6 | 2,2,4,4-Tetramethyl-20-(2,3- epoxypropyl)-7-oxa-3,20- diazadispiro-[5.1.11.2]- heneicosan-21-one, polymer | The specific migration of this substance shall not exceed 5 mg/kg |
276B | 92930 | 120218-34-0 0 | Thiodiethanolbis(5-methoxycarbonyl-2,6-dimethyl-1,4-dihydropyri-3 - Carboxylate- dine | The specific migration of this substance shall not exceed 6 mg/kg |
280A | 94960 | 000077-99-6 6 | 1,1,1-Trimethylolpropane | The specific migration of this substance shall not exceed 6 mg/kg |
281A | 95725 | 110638-71-6 6 | Vermiculite, reaction product with citric acid, lithium salt | SML (T) = 0.6 mg/kg (8) (expressed as lithium) |
281B | 95855 | 007732-18-5 | Water | In compliance with Directive 98/83/EC (i)(3). |
281C | 95859 | - | Waxes, refined, derived from petroleum based or synthetic hydrocarbon feedstocks | In compliance with the specifications laid down in Schedule 2B |
281D | 95883 | - | White mineral oils, paraffinic, derived from petroleum based hydrocarbon feedstocks | In compliance with the specifications laid down in Schedule 2B |
Regulation 12
Regulation 5A
ITEM | PM/REF No. | CAS No. | NAME | Restrictions and specifications |
---|---|---|---|---|
1 | 18888 | 80181-31-3 | 3-hydroxybutanoic acid-3-hydroxypentanoic acid, copolymer | The specific migration of this substance shall not exceed 0.05 mg/kg for croton acid (as impurity) and in compliance with the specifications laid down in Schedule 2B” |
Regulations 8, 13
Regulation 7A
ITEM | PM REF No | OTHER SPECIFICATIONS | |
---|---|---|---|
1 | 18888 | 3-HYDROXYBUTANOIC ACID-3-HYDROXYPENTANOIC ACID, COPOLYMER | |
Definition | These copolymers are produced by the controlled fermentation of Alcaligenes eutrophus using mixtures of glucose and propanoic acid as carbon sources. The organism used has not been genetically engineered and has been derived from a single wild-type organism Alcaligenes eutrophus strain H16 NCIMB 10442. Master stocks of the organism are stored as freeze-dried ampoules. A submaster/ working stock is prepared from the master stock and stored in liquid nitrogen and used to prepare inocula for the fermenter. Fermenter samples will be examined daily both microscopically and for any changes in colonial morphology on a variety of agars at different temperatures. The copolymers are isolated from heat treatment bacteria by controlled digestion of the other cellular components, washing and drying. These copolymers are normally offered as formulated, melt formed granules containing additives such as nucleating agents, plasticisers, fillers, stabilisers and pigments which all conform to the general and individual specifications. | ||
Chemical name | Poly (3-D-hydroxybutanoato-co-3-D-hydroxypentanoate). | ||
CAS number | 80181-31-3. | ||
Structural formula | where n/(m+n) greater than 0 and less or equal to 0.25 | ||
Average molecular weight | Not less than 150,000 Daltons (measured by gel permeation chromatography). | ||
Assay | Not less than 98% poly (3-D-hydroxybutanoato-co-3-D-hydroxypentanoate) analysed after hydrolysis as a mixture of 3-D-hydroxybutanoic and 3-D-hydroxypentanoic acids. | ||
Description | White to off-white powder after isolation. | ||
Characteristics | |||
Identification tests: | |||
Solubility | Soluble in chlorinated hydrocarbons such as chloroform or dichloromethane but practically insoluble in ethanol, aliphatic alkanes and water. | ||
Migration | The migration of crotonic acid should not exceed 0.05 mg/kg food. | ||
Purity | Prior to granulation the raw material copolymer powder must contain: | ||
—Nitrogen | Not more than 2,500 mg/kg of plastic | ||
—Zinc | Not more than 100 mg/kg of plastic | ||
—Copper | Not more than 5 mg/kg of plastic | ||
—Lead | Not more than 2 mg/kg of plastic | ||
—Arsenic | Not more than 1 mg/kg of plastic | ||
—Chromium | Not more than 1 mg/kg of plastic | ||
2 | 23547 | POLYDIMETHYLSILOXANE (MW> 6800)
| |
3 | 25385 | TRIALLYLAMINE
| |
4 | 38320 | 4-(2-BENZOXAZOLYL) -4'-(5-METHYL-2-BENZOXAZOLYL) STILBENE
| |
5 | 76721 | POLYDIMETHYLSILOXANE (Mw>6800)
| |
6 | 88640 | SOYBEAN OIL, EPOXIDIZED
| |
7 | 95859 | WAXES, REFINED DERIVED FROM PETROLEUM BASED OR SYNTHETIC HYDROCARBON FEEDSTOCKS
| |
8 | 95883 | WHITE MINERAL OILS, PARAFFINIC DERIVED FROM PETROLEUM BASED HYDROCARBON FEEDSTOCKS
|
OJ No. L330, 5.12.1998, p.32.
OJ No. L372, 31.12.85, p.14.
OJ No. L330, 5.12.1998, p.32.
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