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The Plastic Materials and Articles in Contact with Food (Amendment) Regulations (Northern Ireland) 2005
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- 2005 No. 49
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Regulation 9(a)(i)
SCHEDULE 1(ENTRIES TO BE INSERTED IN SECTION A OF PART I OF SCHEDULE 1)
| 1 | 2 | 3 | 4 | |
|---|---|---|---|---|
| Item | PM/REF No. | CAS No. | Name | Restrictions and specifications |
| 6A | 10599/90A | 061788-89-4 | Acids, fatty, unsaturated (C18), dimers, distilled | QMA(T) = 0.05 mg/6 dm2 (27) |
| 6B | 10599/91 | 061788-89-4 | Acids, fatty, unsaturated | QMA(T) = 0.05 mg/6 |
| (C18), dimers, non-distilled | QMA(T) = 0.05 mg/6 dm2 (27) | |||
| 6C | 10599/92A | 068783-41-5 | Acids, fatty, unsaturated (C18), dimers, hydrogenated, distilled | QMA(T) = 0.05 mg/6 dm2 (27) |
| 6D | 10599/93 | 068783-41-5 | Acids, fatty, unsaturated (C18), dimers, hydrogenated, non-distilled | QMA(T) = 0.05 mg/6 dm2 (27) |
| 37A | 13323 | 000102-40-9 | 1,3-Bis(2-hydroxyethoxy) benzene | SML = 0.05 mg/kg |
| 68MA | 14800 | 003724-65-0 | Crotonic acid | QMA(T) = 0.05 mg/6 dm2 (33) |
| 87A | 16210 | 006864-37-5 | 3,3'-Dimethyl-4,4'-diaminodicyclohexylmethane | SML = 0.05 mg/kg(32). To be used only in polyamides. |
| 89A | 16540 | 000102-09-0 | Diphenyl carbonate | SML = 0.05 mg/kg |
| 101A | 17110 | 016219-75-3 | 5-Ethylidenebicyclo [2,2,1]hept-2-ene | QMA = 0.05 mg/6 dm2. The ratio surface/ quantity of food shall be lower than 2 dm2/kg |
| 118MA | 18700 | 000629-11-8 | 1,6-Hexanediol | SML = 0.05 mg/kg |
| 120ZA | 18896 | 001679-51-2 | 4-(Hydroxymethyl)-1-cyclohexene | SML = 0.05 mg/kg |
| 135BM | 20440 | 000097-90-5 | Methacrylic acid, diester with ethyleneglyco | SML = 0.05 mg/kg |
| 142A | 21400 | 054276-35-6 | Methacrylic acid, sulphopropyl ester | QMA = 0.05 mg/6 dm2 |
| 156XA | 22775 | 000144-62-7 | Oxalic acid | SML(T) = 6 mg/kg(29) |
| 161A | 23070 | 000102-39-6 | (1,3-Phenylenedioxy) diacetic acid | QMA = 0.05 mg/6 dm2 |
Regulation 9(a)(ii)
SCHEDULE 2(ENTRIES TO BE SUBSTITUTED FOR ENTRIES IN SECTION A OF PART I OF SCHEDULE 1)
| 1 | 2 | 3 | 4 | |
|---|---|---|---|---|
| Item | PM/REF No. | CAS No. | Name | Restrictions and specifications |
| 15A | 11530 | 00999-61-1 | Acrylic acid, 2-hydroxypropyl ester | QMA = 0.05 mg/6 dm2 for the sum of acrylic acid, 2-hydroxypropyl ester and acrylic acid, 2-hydroxyisopropyl ester and in compliance with the specifications laid down in Schedule 2B |
| 39 | 13480 | 000080-05-7 | 2,2-Bis(4-hydroxyphenyl) propane | SML(T) = 0.6 mg/kg (28) |
| 70 | 14950 | 003173-53-3 | Cyclohexyl isocyanate | QMT(T) = 1 mg/kg in FP (expressed as NCO) (26) |
| 120B | 18898 | 000103-90-2 | N-(4-Hydroxyphenyl) acetamide | SML = 0.05 mg/kg |
| 147 | 22150 | 000691-37-2 | 4-Methyl-1-pentene | SML = 0.05 mg/kg |
| 147A | 22331 | 025513-64-8 | Mixture of (35-45% w/w) 1,6-diamino-2,2,4-trimethylhexane and (55-65% w/w) 1,6-diamino-2,4,4-trimethylhexane | QMA = 5 mg/6 dm2 |
| 147B | 22332 | – | Mixture of (40% w/w) 2,2,4-trimethylhexane-1,6-diisocyanate and (60% w/w) 2,4,4-trimethylhexane-1,6-diisocyanate | QM(T) – 1 mg/kg (expressed as NCO) (26) |
| 188 | 24190 | 065997-05-9 | Rosin Wood |
Regulation 11(a)
SCHEDULE 3(ENTRIES TO BE INSERTED IN PART I OF SCHEDULE 2)
| 1 | 2 | 3 | 4 | |
|---|---|---|---|---|
| Item | PM/REF No. | CAS No. | Name | Restrictions and specifications |
| 18A | 34850 | 143925-92-2 | Amines, bis(hydrogenated tallow alkyl) oxidised | QM = For use only: (a) in polyolefines at 0.1% (w/w) but not in LDPE when it is in contact with foods for which the Directive 85/572/EEC establishes a reduction factor less than 3; (b) in PET at 0.25% (w/w) in contact with foods other than those for which the simulant D is laid down in Directive 85/572/EEC |
| 18B | 34895 | 000088-68-6 | 2-Aminobenzamide | SML = 0.05 mg/kg. To be used only for PET for water and beverages |
| 37AA | 39680 | 000080-05-7 | 2,2-Bis(4-hydroxyphenyl) propane | SML(T) = 0.6 mg/kg (28) |
| 51A | 42880 | 008001-79-4 | Castor oil | |
| 61A | 45600 | 003724-65-0 | Crotonic acid | QMA(T) = 0.05 mg/6 dm2 (33) |
| 61B | 45640 | 005232-99-5 | 2-Cyano-3,3 dipheneylacrylic acid, ethyl ester | SML = 0.05 mg/kg |
| 69A | 46700 | – | 5,7-di-tert-butyl-3-(3,4-and 2,3-di-methylphenyl)-3H-benzofuran-2-one containing: (a) 5,7-di-tert-butyl-3-(3,4-dimethylphenyl) 3H-benzofuran-2-one (80-100% w/w); and (b) 5,7-di-tert-butyl-3-(2,3-dimethylphenyl)-3H-benzofuran-2-one (0-20% w/w) | SML = 5 mg/kg |
| 69B | 46720 | 004130-42-1 | 2,6-Di-tert-butyl-4-ethylphenol | QMA = 4.8 mg/6 dm2 |
| 109A | 56535 | – | Glycerol, esters with nonanoic acid | |
| 131A | 59280 | 000100-97-0 | Hexamethylenetetramine | SML(T) = 15 mg/kg (21) (expressed as Formaldehyde) |
| 178A | 68078 | 027253-31-2 | Neodecanoic acid, cobalt salt | SML(T) = 0.05 mg/kg (expressed as Neodecanoic acid) and SML(T) = 0.05 mg/kg (13) (expressed as Cobalt). Not for use in polymers contacting foods for which simulant D is laid down in Directive 85/572/EEC |
| 182A | 69920 | 000144-62-7 | Oxalic acid | SML(T) = 6 mg/kg (29) |
| 195D | 76866 | – | Polyesters of 1,2-propanediol and/or 1,3- and/or 1,4-butanediol and/or polypropyleneglycol with adipic acid, which may be end-capped with acetic acid or fatty acids C12-C18 or n-octanol and/or n-decanol | SML = 30 mg/kg |
| 240ZA | 85601 | – | Silicates, natural (with the exception of asbestos) | |
| 280B | 95000 | 028931-67-1 | Trimethylolpropane trimethacrylatemethyl methacrylate copolymer |
Regulation 11(b)
SCHEDULE 4(ENTRIES TO BE SUBSTITUTED FOR THE ENTRIES IN PART I OF SCHEDULE 2)
| 1 | 2 | 3 | 4 | |
|---|---|---|---|---|
| Item | PM/REF No. | CAS No. | Name | Restrictions and specifications |
| 60A | 45450 | 068610-51-5 | p-Cresol-dicyclopentadiene isobutylene, copolymer | SML = 5 mg/kg |
| 198A | 77895 | 068439-49-6 | Polyethyleneglycol (EO = 2-6) monoalkyl (C16-C18) ether | SML = 0.05 mg/kg and in compliance with the specifications laid down in Schedule 2B |
Regulation 12(a)
SCHEDULE 5(ENTRIES TO BE INSERTED IN PART II OF SCHEDULE 2)
| 1 | 2 | 3 | 4 | |
|---|---|---|---|---|
| Item | PM/REF No. | CAS No. | Name | Restrictions and specifications |
| 4A | 34650 | 151841-65-5 | Aluminium hydroxybis [2,2'-methylenebis (4,6-di-tert-butylphenyl) phospate | SML = 5 mg/kg |
| 7A | 38000 | 000553-54-8 | Benzoic acid, lithium salt | SML(T) = 0.6 mg/kg (8) (expressed as Lithium) |
| 18A | 40720 | 025013-16-5 | tert-Butyl-4-hydroxyanisole (= BHA) | SML = 30 mg/kg |
| 27B | 46640 | 000128-37-0 | 2,6-Di-tert-butyl-p-cresol (= BHT) | SML = 3.0 mg/kg |
| 54A | 54880 | 000050-00-0 | Formaldehyde | SML(T) = 15 mg/kg (21) |
| 54B | 55200 | 001166-52-5 | Gallic acid, dodecyl ester | SML(T) = 30 mg/kg (34) |
| 54C | 55280 | 001034-01-1 | Gallic acid, octyl ester | SML(T) = 30 mg/kg (34) |
| 54D | 55360 | 000121-79-9 | Gallic acid, propyl ester | SML(T) = 30 mg/kg (34) |
| 79A | 67896 | 020336-96-3 | Myristic acid, lithium salt | SML(T) = 0.6 mg/kg (8) (expressed as Lithium) |
| 83A | 71935 | 007601-89-0 | Perchloric acid, sodium salt monohydrate | SML 0.05 mg/kg (31) |
| 88A | 76680 | 068132-00-3 | Polycyclopentadiene, hydrogenated | SML = 5 mg/kg (1) |
| 100A | 86480 | 007631-90-5 | Sodium bisulphite | SML(T) = 10 mg/kg (30) (expressed as S02) |
| 102A | 86920 | 007632-00-0 | Sodium nitrite | SML = 0.6 mg/kg |
| 102B | 86960 | 007757-83-7 | Sodium sulphite | SML(T) = 10 mg/kg (30) (expressed as S02) |
| 102C | 87120 | 007772-98-7 | Sodium thiosulphate | SML(T) = 10 mg/kg (30) (expressed as S02) |
| 110A | 94400 | 036443-68-2 | Triethyleneglycol bis[3-(3-tert-butyl-4-hydroxy-5-methylphenyl) propionate] | SML = 9 mg/kg |
Regulation 15
SCHEDULE 6(ENTRIES TO BE SUBSTITUTED FOR SCHEDULE 2B)
| Item | PM/REF No. | Specifications | |
|---|---|---|---|
| 1 | 11530 | Acrylic acid, 2-hydroxypropyl ester. It may contain up to 25% (m/m) of acrylic acid, 2-hydroxyisopropyl ester (CAS No. 002918-23-2) | |
| 2 | 16690 | Divinylbenzene It may contain up to 45% (m/m) of Ethylvinylbenzene | |
| 3 | 18888 | 3-Hydroxybutanoic acid-3-hydroxypentanoic acid, copolymer | |
| Definition | The 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 10422. 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-hydroxybutanoate-co-3-D-hydroxypentanoate) | ||
| CAS number | 080181-31-3 | ||
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-hydroxybutanoate-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 a chloroform or dichloromethane but practically insoluble in ethanol, aliphatic alkanes and water | |
| Restriction | QMA for crotonic acid is 0.05 mg/6 dm2 | ||
| 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 | ||
| 4 | 23547 | Polydimethylsiloxane (MW > 6800) Minimum viscosity 100 × 10−6 m2/s centistokes at 25°C | |
| 5 | 25385 | Triallylamine 40 mg/kg hydrogel at a ratio of 1 kg food to a maximum of 1.5 grams of hydrogel. For use only in hydrogels intended for non-direct food contact use. | |
| 6 | 38320 | 4-(2-Benzoxazolyl)-4'-(5-methyl-2-benzoxazolyl) stilbene Not more than 0.05% w/w (quantity of substance used/quantity of the formulation) | |
| 7 | 43680 | Chlorodifluoromethane Content of chlorofluoromethane less than 1 mg/kg of the substance | |
| 8 | 47210 | Dibutylthiostannoic acid polymer Molecular unit = (C8H18S3Sn2)n (n = 1, 5-2) | |
| 9 | 76721 | Polydimethylsiloxane (Mw > 6800) Minimum viscosity 100 × 10−6 m2/s (= 100 centistokes) at 25°C | |
| 10 | 77895 | Polyethyleneglycol (EO = 2–6) monoalkyl (C16-C18) ether The composition of this mixture is as follows:
| |
| 11 | 83595 | Reaction product of di-tert-butylphosphonite with biphenyl, obtained by condensation of 2,4-di-tert-butylphenol with Friedel Craft reaction product of phosphorus trichloride and biphenyl Composition
Other specifications
| |
| 12 | 88640 | Soybean oil, epoxidized Oxirane < 8%, iodine number < 6 | |
| 13 | 95859 | Waxes, refined, derived from petroleum based or synthetic hydrocarbon feedstocks The product shall have the following specifications:
| |
| 14 | 95883 | White mineral oils, paraffinic, derived from petroleum hydrocarbon feedstocks The product shall have the following specifications:
| |
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