LegalizeThe Plastic Materials and Articles in Contact with Food Regulations (Northern Ireland) 2006
| Item | 1 PM/REFNo. | 2 CAS No | 3 Name | 4 Restrictions and specifications |
|---|---|---|---|---|
| 1 | 30180 | 002180-18-9 | Acetic acid, manganese salt | SML(T) = 0.6 mg/kg (9) (expressed as manganese) |
| 2 | 31520 | 061167-58-6 | Acrylic acid, 2-tert-butyl- 6-(3-tert- butyl- 2-hydroxy-5-methylbenzyl)-4-methylphenyl ester | SML = 6 mg/kg |
| 3 | 31920 | 000103-23-1 | Adipic acid, bis (2-ethylhexyl) ester | SML = 18 mg/kg (1) |
| 4 | 34230 | Alkyl (C₈-C₂₂ ) sulphonic acids | SML = 6 mg/kg | |
| 4A | 34650 | 151841-65-5 | Aluminium hydroxybis [2,2'-methylenebis (4,6-di-tert-butylphenyl) phospate | SML = 5 mg/kg |
| 5 | 35760 | 001309-64-4 | Antimony trioxide | SML = 0.02 mg/kg (expressed as anti-monium and analytical tolerance included) |
| 6 | 36720 | 017194-00-2 | Barium hydroxide | SML(T) = 1 mg/kg (11) (expressed as barium) |
| 7 | 36800 | 010022-31-8 | Barium nitrate | SML(T) = 1 mg/kg (11) (expressed as barium) |
| 7A | 38000 | 000553-54-8 | Benzoic acid, lithium salt | SML(T) = 0.6 mg/kg (8) (expressed as lithium) |
| 8 | 38240 | 000119-61-9 | Benzophenone | SML = 0.6 mg/kg |
| 9 | 38560 | 007128-64-5 | 2,5-Bis (5-tert-butyl-2-benzoxazolyl) thio-phene | SML = 0.6 mg/kg |
| 10 | 38700 | 063397-60-4 | Bis (2-carbobutoxyethyl) tin- bis (isooctylmercapto-acetate) | SML = 18 mg/kg |
| 11 | 38800 | 032687-78-8 | N,N'-Bis (3-(3,5-di-tert-butyl-4-hydroxyphenyl) pro-pionyl) hydrazide | SML = 15 mg/kg |
| 12 | 38820 | 026741-53-7 | Bis (2,4-di-tert-butylphenyl) pentaery-thritol diphosphite | SML = 0.6 mg/kg |
| 13 | 39060 | 035958-30-6 | 1,1-Bis (2-hydroxy-3, 5-di-tert-butylphenyl) ethane | SML = 5 mg/kg |
| 14 | 39090 | N,N-bis (2-hydroxyethyl) alkyl (C₈-C₁₈) amine | SML(T) = 1.2 mg/kg (12) | |
| 15 | 39120 | N,N-bis (2-hydroxyethyl)-alkyl (C₈-C₁₈) amine hydrochlorides | SML(T) = 1.2 mg/kg (12) expressed as tertiary amine (expressed excluding HCI) | |
| 16 | 40000 | 00991-84-4 | 2,4-Bis (octylmercapto) – 6- (4-hydroxy- 3,5,di-tert-butylanilino) – 1,3,5-triazine | SML = 30 mg/kg |
| 17 | 40020 | 110553-27-0 | 2,4-Bis (octylthiomethyl) – 6- methylphenol | SML = 6 mg/kg |
| 18 | 40160 | 61269-61-2 | N,N'-bis (2,2,6,6-tetramethyl-4- piperidyl) hexamethy-lenediamine- 1,2- dibromoethane,copolymer | SML = 2.4 mg/kg |
| 18A | 40720 | 025013-16-5 | Tert-butyl- 4-hydroxyanisole (= BHA) | SML = 30 mg/kg |
| 19 | 40800 | 13003-12-8 | 4,4' – butylidene-bis (6-tert-butyl-3-methylphenyl-ditridecyl phosphite) | SML = 6 mg/kg |
| 20 | 409080 | 19664-95-0 | Butyric acid, manganese salt | SML(T) = 0.6 mg/kg (9) (expressed as manganese) |
| 21 | 42000 | 63438-80-2 | (2-carbobutoxyethyl) tin-tris (isooctylmercapto-acetate) | SML = 30 mg/kg |
| 22 | 42400 | 010377-37-4 | Carbonic acid, lithium salt | SML(T) = 0.6 mg/kg (8) (expressed as lithium) |
| 23 | 42480 | 000584-09-8 | Carbonic acid, rubidium salt | SML = 12 mg/kg |
| 24 | 43600 | 004080-31-3 | 1- (3- Chloroallyl) – 3,5,7 – triaza-1-azoniaadamantane chloride | SML = 0.3 mg/kg |
| 25 | 43680 | 000075-45-6 | Chlorodifluoromethane | SML = 6 mg/kg and in compliance with the specifications laid down in Schedule 4 |
| 26 | 44960 | 011104-61-3 | Cobalt oxide | SML(T) = 0.05 mg/kg (13) (expressed as cobalt) |
| 27 | 45440 | – | Cresols, butylated, styrenated | SML = 12 mg/kg |
| 27A | 45650 | 06197-30-4 | 2-Cyano-3,3-diphenylacrylic acid, 2-ethylhexyl ester | SML = 0.05 mg/kg |
| 27B | 46640 | 000128-37-0 | 2,6-di-tert-butyl-p-cresol (= BHT) | SML = 3.0 mg/kg |
| 29 | 47600 | 084030-61-5 | Di-n-dodecyltin bis (isooctyl mercaptoacetate) | SML = 12 mg/kg |
| 30 | 48640 | 000131-56-6 | 2,4-Dihydroxybenzophenone | SML(T) = 6 mg/kg (14) |
| 31 | 48800 | 000097-23-4 | 2,2'-Dihydroxy-5,5'-dichlorodiphenylmethane | SML = 12 mg/kg |
| 32 | 48880 | 000131-53-3 | 2,2'Dihydroxy-4-methoxybenzophenone | SML(T) = 6 mg/kg (14) |
| 33 | 49600 | 026636-01-1 | Dimethyltin bis (isooctyl mercaptoaecetate) | SMT(T) 0.18 mg/kg (15) (expressed as tin) |
| 34 | 49840 | 002500-88-1 | Dioctadecyl disulphide | SMT = 3 mg/kg |
| 35 | 50160 | Di-n-octyltin bis(n-alkyl (C₁₀ -C₁₆) mercapto acetate) | SML(T) = 0.04 mg/kg (16) (expressed as tin) | |
| 36 | 50240 | 010039-33-5 | Di-n-octyltin bis (2-ethylhexyl maleate) | SML(T) = 0.04 mg/kg (16) (expressed as tin) |
| 37 | 50320 | 015571-58-1 | Di-n-octyltin bis (2-ethylhexyl mercaptoaectate) | SML(T) = 0.04 mg/kg (16) (expressed as tin) |
| 38 | 50360 | Di-n-octyltin bis (ethyl maleate) | SML(T) = 0.04 mg/kg (16) (expressed as tin) | |
| 39 | 50400 | 033568-99-9 | Di-n-octyltin bis (isooctyl maleate) | SML(T) = 0.04 mg/kg (16) (expressed as tin) |
| 40 | 50480 | 026401-97-8 | Di-n-octyltin bis (isooctyl mercaptoacetate) | SML(T) = 0.04 mg/kg (16) (expressed as tin) |
| 41 | 50560 | Di-n-octyltin 1,4-butanediol bis (mercaptoacetate) | SML(T) = 0.04 mg/kg (16) (expressed as tin) | |
| 42 | 50640 | 003648-18-8 | Di-n-octyltin dilaurate | SML(T) = 0.04 mg/kg (16) (expressed as tin) |
| 43 | 50720 | 015571-60-5 | Di-n-octyltin dimaleate | SML(T) = 0.04 mg/kg (16) (expressed as tin) |
| 44 | 50800 | Di-n-octyltin dimaleate, esterified | SML(T) = 0.04 mg/kg (16) (expressed as tin) | |
| 45 | 50880 | Di-n-octyltin dimaleate, polymers (n = 2-4) | SML(T) = 0.04 mg/kg (16) (expressed as tin) | |
| 46 | 50960 | 69226-44-4 | Di-n0octyltin ethyleneglycol bis (mercaptoacetate) | SML(T) = 0.04 mg/kg (16) (expressed as tin) |
| 47 | 51040 | 15535-79-2 | Di-n-octyltin mercaptoacetate | SML(T) = 0.04 mg/kg (16) (expressed as tin) |
| 48 | 51120 | Di-n-octyltin thiobenzoate 2-ethyl-hexyl mercaptoacetate | SML(T) = 0.04 mg/kg (16) (expressed as tin) | |
| 49 | 51570 | 000127-63-9 | Diphenyl sulphone | SML(T) = 3 mg/kg (24) |
| 50 | 51680 | 000102-08-9 | N,N'-diphenylthiourea | SML = 3 mg/kg |
| 51 | 52000 | 027176-87-0 | Dodecylbenzenesulphonic acid | SML = 30 mg/kg |
| 52 | 52320 | 052047-59-3 | 2-(4-Dodecylphenyl) indole | SML = 0.06 mg/kg |
| 53 | 52880 | 023676-09-7 | 4-Ethoxybenzoic acid, ethyl ester | SML = 3.6 mg/kg |
| 54 | 53200 | 023949-66-8 | 2-Ethoxy-2'-ethyloxanilide | SML = 30 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 ) |
| 55 | 58960 | 000057-09-0 | Hexadecyltrimethylammonium bromide | SML = 6 mg/kg |
| 56 | 59120 | 023128-74-7 | 1,6-Hexamethylene-bis (3- (3,5-di-tert-butyl-4-hydroxyphenyl) propionamide) | SML = 45 mg/kg |
| 57 | 59200 | 035074-77-2 | 1,6- Hexamethylene-bis (3- (3,5-di-tert-butyl-4-hydroxyphenyl) propionate | SML = 6 mg/kg |
| 58 | 60320 | 070321-86-7 | 2- (2-Hydroxy-3,5-bis (1,1-dimethylbenzyl) phenyl) benzotriazole | SML = 1.5 mg/kg |
| 59 | 60400 | 003896-11-5 | 2- (2'-Hydroxy-3'-tert-butyl- 5'-methylphenyl) –5-chlorobenzotriazole | SML(T) = 30 mg./kg (18) |
| 60 | 60800 | 065447-77-0 | 1-(2- Hydroxyethyl) –4-hydroxy- 2,2, 6,6-tetramethyl, pipe ridine-succinic acid, dimethyl ester, copolymer | SML = 30 mg/kg |
| 61 | 61280 | 003293-97-8 | 2-Hydroxy-4-n-hexyloxybenzophenone | SML(T) = 6 mg/kg (14) |
| 62 | 61360 | 000131-57-7 | 2-Hydroxy-4-methoxybenzophenone | SML(T) = 6 mg/kg (14) |
| 63 | 61440 | 002440-22-4 | 2-(2-Hydroxy-5-methylphenyl) benzotriazole | SML(T) = 30 mg/kg (18) |
| 64 | 61600 | 001843-05-6 | 2-Hydroxy-4-n-octyloxybenzophenone | SML(T) = 6 mg/kg (14) |
| 65 | 63200 | 051877-53-3 | Lactic acid, manganese salt | SML(T) = 0.6 mg/kg (9) (expressed as manganese) |
| 66 | 64320 | 010377-51-2 | Lithium iodide | SML(T) = 1 mg/kg (10) (expressed as iodium) and SML(T) = 0.6 mg/kg (⁸ ) (expressed as lithium) |
| 67 | 65120 | 007773-01-5 | Manganese chloride | SML(T) = 0.6 mg/kg (9) (expressed as manganese) |
| 68 | 65200 | 012626-88-9 | Manganese hydroxide | SML(T) = 0.6 mg/kg (9) (expressed as manganese |
| 69 | 65280 | 010043-84-2 | Manganese hypophosphite | SML(T) = 0.6 mg/kg (9) (expressed as manganese |
| 70 | 65360 | 011129-60-5 | Manganese oxide | SML(T) = 0.6 mg/kg (9) (expressed as manganese |
| 71 | 65440 | Manganese pyrophosphite | SML(T) = 0.6 mg/kg (9) (expressed as manganese | |
| 72 | 66360 | 085209-91-2 | 2-2'-Methylene bis (4,6-di-tert-butylphenyl) sodium phosphate | SML = 5 mg/kg |
| 73 | 66400 | 000088-24-4 | 2-2'-Methylenbis (4-ethyl-6-tert-butylphenol) | SML(T) = 1.5 mg/kg (19) |
| 74 | 66480 | 000119-47-1 | 2-2'- Methylenbis (4-methyl-6-tert-butylphenol) | SML(T) = 1.5 mg/kg (19) |
| 75 | 67360 | 067649-65-4 | Mono-n-dodecyltin tris (isooctyl mercaptoacetate) | SML = 24 mg/kg |
| 76 | 67520 | 054849-38-6 | Monomethyltin tris (isooctyl mercaptoacetate) | SML(T) = 0.18 mg/kg (15) (expressed as tin) |
| 77 | 67600 | Mono-n-octyltin tris (alkyl (C₁₀ -C₁₆) – mercaptoacetate | SML(T) = 1.2 mg/kg (17) (expressed as tin) | |
| 78 | 67680 | 027107-89-7 | Mono-n-octyltin tris (2-ethylhexyl mercaptoacetate | SML(T) = 1.2 mg/kg (17) (expressed as tin) |
| 79 | 67760 | 026401-86-5 | Mono-n-octyltin tris (isooctyl mercaptoacetate) | SML(T) = 1.2 mg/kg (17) (expressed as tin) |
| 79A | 67896 | 020336-96-3 | Myristic acid, lithium salt | SML(T) = 0.6 mg/kg (8) (expressed as lithium) |
| 81 | 68320 | 002082-79-3 | Octadecyl 3- (3,5-di-tert-butyl-4- hydroxylphenyl) propionate | SML = 6 mg/kg |
| 82 | 68400 | 010094-45-8 | Octadecylerucamide | SML = 5 mg/kg |
| 82A | 68860 | 004724-48-5 | n-Octylphosphonic acid | SML = 0.05 mg/kg |
| 83 | 69840 | 016260-09-6 | Oleylpalmitamide | SML = 5 mg/kg |
| 83A | 71935 | 007601-89-0 | Perchloric acid, sodium salt monohydrate | SML = 0.05 mg/kg (31) |
| 84 | 72160 | 000948-65-2 | 2-Phenylindole | SML = 15 mg/kg |
| 85 | 72800 | 001241-94-7 | Phosphoric acide, diphenyl 2-ethylhexyl ester | SML = 2.4 mg/kg |
| 86 | 73040 | 013763-32-1 | Phosphoric acid, lithium salts | SML(T) = 0.6 mg/kg (8) (expressed as lithium) |
| 87 | 73120 | 010124-54-6 | Phosphoric acid, manganese sale | SML(T) = 0.6 mg/kg (9) (expressed as manganese |
| 88 | 74400 | Phosphorous acid, tris (nonyl- and/or dinonylphenyl) ester | SML = 30 mg/kg | |
| 88A | 76680 | 068132-00-3 | Polycyclopentadiene, hydrogenated | SML = 5 mg/kg (1) |
| 89 | 77440 | Polyethyleneglycol diricinoleate | SML = 42 mg/kg | |
| 90 | 77520 | 061791-12-6 | Polyethyleneglycol ester of caster oil | SML = 42 mg/kg |
| 91 | 78320 | 009004-97-1 | Polyethyleneglycol monoricinoleate | SML – 42 mg/kg |
| 92 | 81200 | 071878-19-8 | Poly [6- [1,1,3,3- tetramethylbutyl) – amino]- 1,3,5-triazine-2,4-diyl]- [(2,2,6,6-tetramethyl- 4-piperidyl)-imino] hexamethylene- [2,2,6,6-tetramethyl-4-piperidyl) imino] | SML = 3 mg/kg |
| 93 | 81680 | 007681-11-0 | Potassium iodide | SML(T) = 1 mg/kg (10) (expressed as iodium) |
| 94 | 82020 | 019019-51-3 | Propionic acid, cobalt salt | SML(T) = 0.05 mg/kg (13) (expressed as cobalt) |
| 95 | 83595 | 119345-01-6 | 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 | SML = 18 mg/kg and in compliance with the specifications in Schedule 4 |
| 96 | 83700 | 000141-22-0 | Ricinoleic acid | SML = 42 mg/kg |
| 97 | 84800 | 000087-18-3 | Salicylic acid, 4-tert-butylphenyl ester | SML = 12 mg/kg |
| 98 | 84880 | 000119-36-8 | Salicylic acid, methyl ester | SML = 30 mg/kg |
| 99 | 85760 | 012068-40-5 | Silicic acid, lithium aluminium salt (2:1:1) | SML(T) = 0.6 mg/kg (8) (expressed as lithium) |
| 100 | 85920 | 012627-14-4 | Silicic acid, lithium salt | SML(T) = 0.6 mg/kg (8) (expressed as lithium) |
| 100A | 86480 | 007631-90-5 | Sodium bisulphite | SML(T) = 10 mg/kg (30) (expressed as SO₂) |
| 101 | 86800 | 007681-82-5 | Sodium iodide | SML(T) = 1 mg/kg (10) (expressed as iodium) |
| 102 | 86880 | Sodium monoalkyl dialkylphenoxybenzenedi-sulphonate | SML = 9 mg/kg | |
| 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 SO₂) |
| 102C | 87120 | 07772-98-7 | Sodium thiosulphate | SML(T) = 10 mg/kg (30) expressed as SO₂) |
| 103 | 89170 | 013586-84-0 | Stearic acid, cobalt salt | SML(T) = 0.05 mg/kg (13) expressed as cobalt) |
| 104 | 92000 | 007727-43-7 | Sulphuric acid, barium salt | SML(T) = 1 mg/kg (11) expressed as barium) |
| 105 | 92320 | Tetradecyl-polyethyleneglycol (EO = 3-8) ether of glycolic acid | SML = 15 mg/kg | |
| 106 | 92560 | 038613-77-3 | Tetrakis (2,4- di-tert-butyl-phenyl) – 4-4' –biphenylylene diphosphonite | SML = 18 mg/kg |
| 107 | 92800 | 000096-69-5 | 4,4'-Thiobis (6-tert-butyl- 3-methylphenol) | SML = 0.48 mg/kg |
| 108 | 92880 | 041484-35-9 | Thiodiethanol bis (3-(3-5-di-tert- butyl-4-hydroxyphenyl) propionate | SML = 2.4 mg/kg |
| 109 | 93120 | 000123-28-4 | Thiodipropionic acid, didodecyl ester | SML(T) = 5 mg/kg (20) |
| 110 | 93280 | 000693-36-7 | Thiodipropionic acid, dioctadecyl ester | SML(T) = 5 mg/kg (20) |
| 110A | 94400 | 036443-68-2 | Triethyleneglycol bis[ 3-(3-tert-butyl- 4-hydroxy- 5-methylphenyl) propionate] | SML = 9 mg/kg |
| 111 | 94560 | 000122-20-3 | Triisopropanolamine | SML = 5 mg/kg |
| 112 | 95280 | 040601-76-1 | 1,3,5- Tris (4-tert-butyl-3-hydroxy –2,6- dimethylbenzyl)- 1,3,5-triazine-2,4,6 (1H, 3H,5H)- trione | SML = 6 mg/kg |
| 113 | 95360 | 27676-62-6 | 1,3,5 – Tris (3,5-di-tert-butyl-4 hydroxybenzyl)- 1,3,5-triazine –2,4,6 (1H, 3H, 5H) – trione | SML = 5 mg/kg |
| 114 | 95600 | 01843-03-4 | 1,1,3- Tris (2-methyl-4-hydroxy-5-tert-butylphenyl) butane | SML = 5 mg/kg |
PART 3 — Supplementary
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SCHEDULE 3 — Products Obtained by Bacterial Fermentation
| Item | 1 PM/REF No | 2 CAS No | 3 Name | 4 Restrictions and specifications |
|---|---|---|---|---|
| 1 | 18888 | 080181-31-3 | 3-hydroxybutanoic acid— 3-hydroxypentanoic acid, copolymer | In compliance with specifications included in Schedule 4 |
SCHEDULE 4 — Specifications
| Item | 1 PM/REF No | 2 Specifications | 2 Specifications |
|---|---|---|---|
| (1) Quantity of substance used/quantity of formulation | (1) Quantity of substance used/quantity of formulation | (1) Quantity of substance used/quantity of formulation | (1) Quantity of substance used/quantity of formulation |
| 1 | 11530 | Acrylic acid, 2-hydroxypropyl ester | Acrylic acid, 2-hydroxypropyl ester |
| It may contain up to 25% (m/m) of acrylic acid, 2-hydroxyisopropyl ester (CAS No. 002918-23-2) | It may contain up to 25% (m/m) of acrylic acid, 2-hydroxyisopropyl ester (CAS No. 002918-23-2) | ||
| 2 | 16690 | Divinylbenzene | Divinylbenzene |
| It may contain up to 45% (m/m) of Ethylvinylbenzene | It may contain up to 45% (m/m) of Ethylvinylbenzene | ||
| 3 | 18888 | 3-Hydroxybutanoic acid – 3-hydroxypentanoic acid, copolymer | 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 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-hydroxybutanoate-co-3-D-hydroxypentanoate) | ||
| CAS number | 080181-31-3 | ||
| Structural formula | (This formula is currently unavailable. Please see the original.) | ||
| 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 | ||
| Solubility | Soluble in chlorinated hydrocarbons such as chloroform or dichloromethane but practically insoluable in ethanol, aliphatic alkanes and water | ||
| Restriction | QMA for crotonic acid is 0.05 mg/6 dm² | ||
| Purity | Prior to granulation of the raw material copolymer powder must contain: | ||
| – nitrogen | Not more than 2 500 mg/g 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) | Polydimethylsiloxane (Mw > 6800) |
| Minimum viscosity 100 × 10−6m²/s (= 100 centistokes) at 25°C | Minimum viscosity 100 × 10−6m²/s (= 100 centistokes) at 25°C | ||
| 5 | 25385 | Triallylamine | 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. | 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 | 4-(2-Benzoxazolyl)-4'- (5-methyl-2-benzoxazolyl) stilbene |
| Not more than 0.05% w/w (quantity of substance used / quantity of the formulation) | Not more than 0.05% w/w (quantity of substance used / quantity of the formulation) | ||
| 7 | 43680 | Chlorodifluoromethane | Chlorodifluoromethane |
| Content of chlorofluoromethane less than 1 mg/kg of the substance | Content of chlorofluoromethane less than 1 mg/kg of the substance | ||
| 8 | 47210 | Dibutylthiostannoic acid polymer | Dibutylthiostannoic acid polymer |
| Molecular unit = (C₈H₁₈S₃Sn₂) n (n = 1.5-2) | Molecular unit = (C₈H₁₈S₃Sn₂) n (n = 1.5-2) | ||
| 9 | 76721 | Polydimethylsiloxane (Mw > 6800) | Polydimethylsiloxane (Mw > 6800) |
| Minimum viscosity 100 × 10 −6m²/s (= 100 centistokes) at 25° C | Minimum viscosity 100 × 10 −6m²/s (= 100 centistokes) at 25° C | ||
| 10 | 77895 | Polyethyleneglycol (EO = 2-6) monoalkyl (C₁₆-C₁₈) ether | Polyethyleneglycol (EO = 2-6) monoalkyl (C₁₆-C₁₈) ether |
| The composition of this mixture is as follows: | The composition of this mixture is as follows: | ||
| –polyethyleneglycol (EO = 2-6) monoalkyl (C₁₆-C₁₈) ether approximately 28%) | –polyethyleneglycol (EO = 2-6) monoalkyl (C₁₆-C₁₈) ether approximately 28%) | ||
| –fatty alcohols (C₁₆-C₁₈) (approximately 48%) | –fatty alcohols (C₁₆-C₁₈) (approximately 48%) | ||
| –ethyleneglycol monoalkyl (C₁₆-C₁₈) ether (approximately 24%) | –ethyleneglycol monoalkyl (C₁₆-C₁₈) ether (approximately 24%) | ||
| 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 | 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 | Composition | ||
| –4,4'-Biphenylene-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] (CAS No. 38613-77-3) (36-46% w/w)(¹) | –4,4'-Biphenylene-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] (CAS No. 38613-77-3) (36-46% w/w)(¹) | ||
| –4,3'-Biphenylene-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] (CAS No. 118421-00-4) (17-23% w/w)[^f01000] | –4,3'-Biphenylene-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] (CAS No. 118421-00-4) (17-23% w/w)[^f01000] | ||
| –3-3'-Biphenylene-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] CAS No. 118421-01-5) (1-5% w/w )[^f01000] | –3-3'-Biphenylene-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] CAS No. 118421-01-5) (1-5% w/w )[^f01000] | ||
| –4-Biphenylene-0,0-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] (CAS No. 91362 – 37-7 (11-19% w/w)[^f01000] | –4-Biphenylene-0,0-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] (CAS No. 91362 – 37-7 (11-19% w/w)[^f01000] | ||
| –Tris (2,4-di-tert-butylphenyl) phosphite (CAS No. 31570-04-4) (9-18% w/w)[^f01000] | –Tris (2,4-di-tert-butylphenyl) phosphite (CAS No. 31570-04-4) (9-18% w/w)[^f01000] | ||
| –4,4'-Biphenylene-0,0-bis (2,4-di-tert-butylphenyl) phosphonate-0,0-bis (2,4-di-tert-butylphenyl) phosphonite (CAS No. 112949–97-0) (<5% w/w [^f01000]) | –4,4'-Biphenylene-0,0-bis (2,4-di-tert-butylphenyl) phosphonate-0,0-bis (2,4-di-tert-butylphenyl) phosphonite (CAS No. 112949–97-0) (<5% w/w [^f01000]) | ||
| Other specifications | Other specifications | ||
| –Phosphor content of minimum 5.4% to maximum 5.9% | –Phosphor content of minimum 5.4% to maximum 5.9% | ||
| –Acid value of maximum 10 mg KOH per gram | –Acid value of maximum 10 mg KOH per gram | ||
| –Melt range of 85-110°C | –Melt range of 85-110°C | ||
| 12 | 88640 | Soybean oil, epoxidized | Soybean oil, epoxidized |
| Oxirane less than 8%, iodine number < 6 | Oxirane less than 8%, iodine number < 6 | ||
| 13 | 95859 | Waxes, refined, derived from petroleum based or synthetic hydrocarbon feedstocks. The product should have the following specifications: | Waxes, refined, derived from petroleum based or synthetic hydrocarbon feedstocks. The product should have the following specifications: |
| Phosphor content of minimum 5.4% to maximum 5.9% | Phosphor content of minimum 5.4% to maximum 5.9% | ||
| –Content of mineral hydrocarbons with carbon number less than 25: not more than 5% (w/w) | –Content of mineral hydrocarbons with carbon number less than 25: not more than 5% (w/w) | ||
| –Viscosity not less than 11 × 10 −6m²/s (= 11 centistokes) at 100°C | –Viscosity not less than 11 × 10 −6m²/s (= 11 centistokes) at 100°C | ||
| –Average molecular weight not less than 500 | –Average molecular weight not less than 500 | ||
| 14 | 95883 | White mineral oils, paraffinic, derived from petroleum based hydrocarbon feedstocks | White mineral oils, paraffinic, derived from petroleum based hydrocarbon feedstocks |
| The product shall have the following specifications: | The product shall have the following specifications: | ||
| –Content of mineral hydrocarbons with carbon number less than 25: not more than 5% (w/w) | –Content of mineral hydrocarbons with carbon number less than 25: not more than 5% (w/w) | ||
| –Viscosity not less than 8.5 × 10−6m²/s (= 8.5 centistokes) at 100°C | –Viscosity not less than 8.5 × 10−6m²/s (= 8.5 centistokes) at 100°C | ||
| –Average molecular weight not less than 480 | –Average molecular weight not less than 480 |
SCHEDULE 5 — Provisions Applicable when Testing Compliance with the Migration Limits
General Provisions
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Special provisions relating to overall migration
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SCHEDULE 6 — Overall and Specific Migration Testing Using Food Simulants
PART 1 — Basic Rules
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PART 2 — Food Simulants to be Used in Migration Testing
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PART 3 — Selection of Food Simulants
Testing, reduction factors and definition of food types
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Selection of simulants for testing materials and articles intended for contact with all food types
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Selection of simulants for testing materials and articles which are already in contact with a known food
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Selection of simulants for testing materials and articles which are accompanied by a specific indication
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PART 4 — Selection of Food Simulants
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PART 5 — Migration Test Conditions (Times and Temperatures)
General criteria
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Volatile migrants
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Special cases
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PART 6 — Substitute Fat Test for Overall and Specific Migration
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PART 7 — Alternative Fat Tests for Overall and Specific Migration
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Signed
Sealed with the Official Seal of the Department of Health, Social Services and Public Safety on 5th June 2006.
Don Hill — A senior officer of the — Department of Health, Social Services and Public Safety
Explanatory note
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Footnotes
Formerly the Department of Health and Social Services see S.I. 1999/283 (N.I.1) Article 3(6)
S.I. 1991/762 (N.I.7) as amended by S.I. 1996/1663 (N.I.12), paragraphs 26 to 42 of Schedule 5 and Schedule 6 to the Food Standards Act 1999 c. 28 and S.R. 2004 Nos. 482 and 505
OJ No. L31, 1.2.2002, p.1. That Regulation was last amended by Regulation (EC) No. 1642/2003 of the European Parliament and of the Council (OJ No. L245, 29.9.2003, p.4)
OJ No. L297, 23.10.1982, p.26
OJ No. L222, 12.8.1997, p.10
OJ No. L372, 31.12.1985, p.14
OJ No. L184, 15.7.1988, p.61
OJ No. L40, 11.2.1989, p. 27
OJ No. L220, 15.8.2002, p.18
OJ No. L71, 10.3.2004, p.8
S.R. 1998 No. 264, as amended by S.R. 2000 No. 402, S.R. 2002 No. 316, S.R. 2003 No. 2, S.R. 2004 No. 493 and S.R. 2005 No. 49
OJ No. L178, 28.7.97, p.1, as last amended by Commission Directive 2004/46, OJ No. L114, 21.4.2004, p.15
OJ No. L226, 22.9.95, p.1, as last amended by Commission Directive 2004/47, OJ No. L113, 20.4.2004, p.24
OJ No. L339, 30.12.96, p.1, as last amended by Commission Directive 2003/95, OJ No. L283, 31.10.2003, p.71
OJ No. L302, 19.11.2005, p.28
Regulation (EC) No 1935/2004 of the European Parliament and of the Council on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ No. L338, 13.11.2004, p.4)
S.R. 2006 No.
OJ No. L338, 13.11.2004, p.4
Editorial notes
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