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 (1). |
| 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)(2). |
| 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 |
OJ No. L372, 31.12.85, p.14.
OJ No. L330, 5.12.1998, p.32.