LegalizeThe Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2005
Made: 9th February 2005
Laid before Parliament: 1st March 2005
Coming into force: 11th March 2005
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Title, application and commencement
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Amendments to the Plastic Materials and Articles in Contact with Food Regulations 1998
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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 (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 2 (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 ethyleneglycol | 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 |
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 | QM(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 |
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: |
| ain 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; | ||||
| bin 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: | SML = 5 mg/kg |
| a5,7–di–tert–butyl–3–(3,4–dimethylphenyl)–3H–benzofuran–2–one (80–100% w/w); and | ||||
| b5,7–di–tert–butyl–3–(2,3–dimethylphenyl)–3H–benzofuran–2–one (0–20% w/w) | ||||
| 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 |
SCHEDULE 4 — (ENTRIES TO BE SUBSTITUTED FOR 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 |
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 SO₂) |
| 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 | 007772–98–7 | Sodium thiosulphate | SML(T) = 10 mg/kg (30) (expressed as SO₂ |
| 110A | 94400 | 036443–68–2 | Triethyleneglycol bis[3–(3–tert–butyl–4–hydroxy–5–methylphenyl) propionate] | SML = 9 mg/kg |
SCHEDULE 6 — (ENTRIES TO BE SUBSTITUTED FOR SCHEDULE 2B)
| Item | PM/REF No. | Specifications | Specifications | Specifications | Specifications | Specifications | Specifications |
|---|---|---|---|---|---|---|---|
| 11530 | Acrylic acid, 2–hydroxypropyl ester. | Acrylic acid, 2–hydroxypropyl ester. | Acrylic acid, 2–hydroxypropyl ester. | Acrylic acid, 2–hydroxypropyl ester. | 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) | 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) | 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 | Divinylbenzene | Divinylbenzene | Divinylbenzene | Divinylbenzene |
| It may contain up to 45% (m/m) of Ethylvinylbenzene | It may contain up to 45% (m/m) of Ethylvinylbenzene | It may contain up to 45% (m/m) of Ethylvinylbenzene | It may contain up to 45% (m/m) of Ethylvinylbenzene | 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 | 3–Hydroxybutanoic acid–3–hydroxypentanoic acid, copolymer | 3–Hydroxybutanoic acid–3–hydroxypentanoic acid, copolymer | 3–Hydroxybutanoic acid–3–hydroxypentanoic acid, copolymer | 3–Hydroxybutanoic acid–3–hydroxypentanoic acid, copolymer |
| Definition | 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. | 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. | 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. | 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 | Chemical name | Poly(3–D–hydroxybutanoate–co–3–D–hydroxypentanoate) | Poly(3–D–hydroxybutanoate–co–3–D–hydroxypentanoate) | Poly(3–D–hydroxybutanoate–co–3–D–hydroxypentanoate) | Poly(3–D–hydroxybutanoate–co–3–D–hydroxypentanoate) | ||
| CAS number | CAS number | 080181–31–3 | 080181–31–3 | 080181–31–3 | 080181–31–3 | ||
| Structural formula | Structural formula | CH₃ | |||||
| | | |||||||
| CH₃ | O | CH₂ | O | ||||
| | | || | | | || | ||||
| (–O–CH–CH₂–C–)m–(O–CH–CH₂–C–)n | (–O–CH–CH₂–C–)m–(O–CH–CH₂–C–)n | (–O–CH–CH₂–C–)m–(O–CH–CH₂–C–)n | (–O–CH–CH₂–C–)m–(O–CH–CH₂–C–)n | ||||
| where n / (m + n) greater than 0 and less or equal to 0.2 | where n / (m + n) greater than 0 and less or equal to 0.2 | where n / (m + n) greater than 0 and less or equal to 0.2 | where n / (m + n) greater than 0 and less or equal to 0.2 | ||||
| Average molecularweight | Average molecularweight | Not less than 150 000 Daltons (measured by gel permeation chromatography) | Not less than 150 000 Daltons (measured by gel permeation chromatography) | Not less than 150 000 Daltons (measured by gel permeation chromatography) | Not less than 150 000 Daltons (measured by gel permeation chromatography) | ||
| Assay | 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 | 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 | 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 | 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 | Description | White to off–white powder after isolation | White to off–white powder after isolation | White to off–white powder after isolation | White to off–white powder after isolation | ||
| Characteristics | Characteristics | ||||||
| Identification tests: | Identification tests: | ||||||
| Solubility | Solubility | Soluble in chlorinated hydrocarbons such as chloroform or dichloromethane but practically insoluble in ethanol, aliphatic alkanes and water | Soluble in chlorinated hydrocarbons such as chloroform or dichloromethane but practically insoluble in ethanol, aliphatic alkanes and water | Soluble in chlorinated hydrocarbons such as chloroform or dichloromethane but practically insoluble in ethanol, aliphatic alkanes and water | Soluble in chlorinated hydrocarbons such as chloroform or dichloromethane but practically insoluble in ethanol, aliphatic alkanes and water | ||
| Restriction | Restriction | QMA for crotonic acid is 0.05 mg/6 dm² | QMA for crotonic acid is 0.05 mg/6 dm² | QMA for crotonic acid is 0.05 mg/6 dm² | QMA for crotonic acid is 0.05 mg/6 dm² | ||
| Purity | Purity | Prior to granulation the raw material copolymer powder must contain: | Prior to granulation the raw material copolymer powder must contain: | Prior to granulation the raw material copolymer powder must contain: | Prior to granulation the raw material copolymer powder must contain: | ||
| — | nitrogen | Not more than 2 500 mg/kg of plastic | Not more than 2 500 mg/kg of plastic | Not more than 2 500 mg/kg of plastic | Not more than 2 500 mg/kg of plastic | ||
| — | zinc | Not more than 100 mg/kg of plastic | Not more than 100 mg/kg of plastic | Not more than 100 mg/kg of plastic | Not more than 100 mg/kg of plastic | ||
| — | copper | Not more than 5 mg/kg of plastic | Not more than 5 mg/kg of plastic | Not more than 5 mg/kg of plastic | Not more than 5 mg/kg of plastic | ||
| — | lead | Not more than 2 mg/kg of plastic | Not more than 2 mg/kg of plastic | Not more than 2 mg/kg of plastic | Not more than 2 mg/kg of plastic | ||
| — | arsenic | Not more than 1 mg/kg of plastic | Not more than 1 mg/kg of plastic | Not more than 1 mg/kg of plastic | Not more than 1 mg/kg of plastic | ||
| — | chromium | Not more than 1 mg/kg of plastic | Not more than 1 mg/kg of plastic | Not more than 1 mg/kg of plastic | Not more than 1 mg/kg of plastic | ||
| 4 | 23547 | Polydimethylsiloxane (Mw > 6800) | Polydimethylsiloxane (Mw > 6800) | Polydimethylsiloxane (Mw > 6800) | Polydimethylsiloxane (Mw > 6800) | Polydimethylsiloxane (Mw > 6800) | Polydimethylsiloxane (Mw > 6800) |
| Minimum viscosity 100 × 10–6 m2/s (= 100 centistokes) at 25°C | Minimum viscosity 100 × 10–6 m2/s (= 100 centistokes) at 25°C | Minimum viscosity 100 × 10–6 m2/s (= 100 centistokes) at 25°C | Minimum viscosity 100 × 10–6 m2/s (= 100 centistokes) at 25°C | Minimum viscosity 100 × 10–6 m2/s (= 100 centistokes) at 25°C | Minimum viscosity 100 × 10–6 m2/s (= 100 centistokes) at 25°C | ||
| 5 | 25385 | Triallylamine | Triallylamine | Triallylamine | Triallylamine | 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. | 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. | 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 | 4–(2–Benzoxazolyl)–4'–(5–methyl–2–benzoxazolyl) stilbene | 4–(2–Benzoxazolyl)–4'–(5–methyl–2–benzoxazolyl) stilbene | 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) | 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) | 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 | Chlorodifluoromethane | Chlorodifluoromethane | Chlorodifluoromethane | Chlorodifluoromethane |
| Content of chlorofluoromethane less than 1 mg/kg of the substance | Content of chlorofluoromethane less than 1 mg/kg of the substance | Content of chlorofluoromethane less than 1 mg/kg of the substance | Content of chlorofluoromethane less than 1 mg/kg of the substance | 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 | Dibutylthiostannoic acid polymer | Dibutylthiostannoic acid polymer | Dibutylthiostannoic acid polymer | Dibutylthiostannoic acid polymer |
| Molecular unit = (C₈H₁₈S₃Sn₂)n (n = 1.5–2) | Molecular unit = (C₈H₁₈S₃Sn₂)n (n = 1.5–2) | Molecular unit = (C₈H₁₈S₃Sn₂)n (n = 1.5–2) | Molecular unit = (C₈H₁₈S₃Sn₂)n (n = 1.5–2) | Molecular unit = (C₈H₁₈S₃Sn₂)n (n = 1.5–2) | Molecular unit = (C₈H₁₈S₃Sn₂)n (n = 1.5–2) | ||
| 9 | 76721 | Polydimethylsiloxane (Mw > 6800) | Polydimethylsiloxane (Mw > 6800) | Polydimethylsiloxane (Mw > 6800) | Polydimethylsiloxane (Mw > 6800) | Polydimethylsiloxane (Mw > 6800) | Polydimethylsiloxane (Mw > 6800) |
| Minimum viscosity 100 × 10−6 m²/s (= 100 centistokes) at 25°C | Minimum viscosity 100 × 10−6 m²/s (= 100 centistokes) at 25°C | Minimum viscosity 100 × 10−6 m²/s (= 100 centistokes) at 25°C | Minimum viscosity 100 × 10−6 m²/s (= 100 centistokes) at 25°C | Minimum viscosity 100 × 10−6 m²/s (= 100 centistokes) at 25°C | Minimum viscosity 100 × 10−6 m²/s (= 100 centistokes) at 25°C | ||
| 10 | 77895 | Polyethyleneglycol (EO = 2–6) monoalkyl (C₁₆–C₁₈) ether | Polyethyleneglycol (EO = 2–6) monoalkyl (C₁₆–C₁₈) ether | Polyethyleneglycol (EO = 2–6) monoalkyl (C₁₆–C₁₈) ether | Polyethyleneglycol (EO = 2–6) monoalkyl (C₁₆–C₁₈) ether | 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: | The composition of this mixture is as follows: | The composition of this mixture is as follows: | 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%) | polyethyleneglycol (EO = 2–6) monoalkyl (C₁₆–C₁₈) ether (approximately 28%) | 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%) | fatty alcohols (C₁₆–C₁₈) (approximately 48%) | 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%) | ethyleneglycol monoalkyl (C₁₆–C₁₈) ether (approximately 24%) | 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 | 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 | 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 | Composition | Composition | 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⁾) | 4,4'–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⁾) | 4,4'–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⁽¹⁾) | 4,3'–Biphenylene–bis [0,0–bis (2,4–di–tert–butylphenyl) phosphonite] (CAS No. 118421–00–4) (17–23% 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⁽¹⁾) | 4,3'–Biphenylene–bis [0,0–bis (2,4–di–tert–butylphenyl) phosphonite] (CAS No. 118421–00–4) (17–23% 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⁽¹⁾) | ||
| — | 3,3'–Biphenylene–bis [0,0–bis (2,4–di–tert–butylphenyl) phosphonite] (CAS No. 118421–01–5) (1–5% w/w⁽¹⁾) | 3,3'–Biphenylene–bis [0,0–bis (2,4–di–tert–butylphenyl) phosphonite] (CAS No. 118421–01–5) (1–5% w/w⁽¹⁾) | 3,3'–Biphenylene–bis [0,0–bis (2,4–di–tert–butylphenyl) phosphonite] (CAS No. 118421–01–5) (1–5% w/w⁽¹⁾) | 3,3'–Biphenylene–bis [0,0–bis (2,4–di–tert–butylphenyl) phosphonite] (CAS No. 118421–01–5) (1–5% w/w⁽¹⁾) | 3,3'–Biphenylene–bis [0,0–bis (2,4–di–tert–butylphenyl) phosphonite] (CAS No. 118421–01–5) (1–5% w/w⁽¹⁾) | ||
| — | 4–Biphenylene–0,0–bis [0,0–bis (2,4–di–tert–butylphenyl) phosphonite] (CAS No. 91362–37–7) (11–19% w/w⁽¹⁾) | 4–Biphenylene–0,0–bis [0,0–bis (2,4–di–tert–butylphenyl) phosphonite] (CAS No. 91362–37–7) (11–19% w/w⁽¹⁾) | 4–Biphenylene–0,0–bis [0,0–bis (2,4–di–tert–butylphenyl) phosphonite] (CAS No. 91362–37–7) (11–19% w/w⁽¹⁾) | 4–Biphenylene–0,0–bis [0,0–bis (2,4–di–tert–butylphenyl) phosphonite] (CAS No. 91362–37–7) (11–19% w/w⁽¹⁾) | 4–Biphenylene–0,0–bis [0,0–bis (2,4–di–tert–butylphenyl) phosphonite] (CAS No. 91362–37–7) (11–19% w/w⁽¹⁾) | ||
| — | Tris (2,4–di–tert–butylphenyl) phosphite (CAS No. 31570–04–4) (9–18% w/w⁽¹⁾) | Tris (2,4–di–tert–butylphenyl) phosphite (CAS No. 31570–04–4) (9–18% w/w⁽¹⁾) | Tris (2,4–di–tert–butylphenyl) phosphite (CAS No. 31570–04–4) (9–18% w/w⁽¹⁾) | Tris (2,4–di–tert–butylphenyl) phosphite (CAS No. 31570–04–4) (9–18% w/w⁽¹⁾) | Tris (2,4–di–tert–butylphenyl) phosphite (CAS No. 31570–04–4) (9–18% w/w⁽¹⁾) | ||
| — | 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(⁽¹⁾) | 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(⁽¹⁾) | 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(⁽¹⁾) | 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(⁽¹⁾) | 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(⁽¹⁾) | ||
| Other specifications | Other specifications | Other specifications | Other specifications | Other specifications | Other specifications | ||
| — | Phosphor content of minimum 5.4% to maximum 5.9% | Phosphor content of minimum 5.4% to maximum 5.9% | Phosphor content of minimum 5.4% to maximum 5.9% | 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 | Acid value of maximum 10 mg KOH per gram | 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 | Melt range of 85–110°C | Melt range of 85–110°C | Melt range of 85–110°C | ||
| 12 | 88640 | Soybean oil, epoxidized | Soybean oil, epoxidized | Soybean oil, epoxidized | Soybean oil, epoxidized | Soybean oil, epoxidized | Soybean oil, epoxidized |
| Oxirane < 8%, iodine number < 6 | Oxirane < 8%, iodine number < 6 | Oxirane < 8%, iodine number < 6 | Oxirane < 8%, iodine number < 6 | Oxirane < 8%, iodine number < 6 | Oxirane < 8%, iodine number < 6 | ||
| 13 | 95859 | Waxes, refined, derived from petroleum based or synthetic hydrocarbon feedstocks | Waxes, refined, derived from petroleum based or synthetic hydrocarbon feedstocks | Waxes, refined, derived from petroleum based or synthetic hydrocarbon feedstocks | Waxes, refined, derived from petroleum based or synthetic hydrocarbon feedstocks | Waxes, refined, derived from petroleum based or synthetic hydrocarbon feedstocks | Waxes, refined, derived from petroleum based or synthetic hydrocarbon feedstocks |
| Phosphor content of minimum 5.4% to maximum 5.9% | Phosphor content of minimum 5.4% to maximum 5.9% | Phosphor content of minimum 5.4% to maximum 5.9% | Phosphor content of minimum 5.4% to maximum 5.9% | 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) | 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) | Content of mineral hydrocarbons with carbon number less than 25: not more than 5% (w/w) | ||
| — | Viscosity not less than 11 × 10−6 m²/s (= 11 centistokes) at 100°C | Viscosity not less than 11 × 10−6 m²/s (= 11 centistokes) at 100°C | Viscosity not less than 11 × 10−6 m²/s (= 11 centistokes) at 100°C | Viscosity not less than 11 × 10−6 m²/s (= 11 centistokes) at 100°C | Viscosity not less than 11 × 10−6 m²/s (= 11 centistokes) at 100°C | ||
| — | Average molecular weight not less than 500 | Average molecular weight not less than 500 | Average molecular weight not less than 500 | Average molecular weight not less than 500 | Average molecular weight not less than 500 | ||
| 14 | 95883 | White mineral oils, paraffinic, derived from petroleum hydrocarbon feedstocks | White mineral oils, paraffinic, derived from petroleum hydrocarbon feedstocks | White mineral oils, paraffinic, derived from petroleum hydrocarbon feedstocks | White mineral oils, paraffinic, derived from petroleum hydrocarbon feedstocks | White mineral oils, paraffinic, derived from petroleum hydrocarbon feedstocks | White mineral oils, paraffinic, derived from petroleum hydrocarbon feedstocks |
| The product shall have the following specifications: | The product shall have the following specifications: | The product shall have the following specifications: | The product shall have the following specifications: | 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) | 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) | Content of mineral hydrocarbons with carbon number less than 25: not more than 5% (w/w) | ||
| — | Viscosity not less than 8.5 × 10−6 m²/s (= 8.5 centistokes) at 100°C | Viscosity not less than 8.5 × 10−6 m²/s (= 8.5 centistokes) at 100°C | Viscosity not less than 8.5 × 10−6 m²/s (= 8.5 centistokes) at 100°C | Viscosity not less than 8.5 × 10−6 m²/s (= 8.5 centistokes) at 100°C | Viscosity not less than 8.5 × 10−6 m²/s (= 8.5 centistokes) at 100°C | ||
| — | Average molecular weight not less than 480 | Average molecular weight not less than 480 | Average molecular weight not less than 480 | Average molecular weight not less than 480 | Average molecular weight not less than 480 |
Signed
Signed by authority of the Secretary of State for Health
Melanie Johnson — Parliamentary Under Secretary of State — Department of Health — 9th February 2005
Explanatory note
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Footnotes
[^f00001]: 1990 c. 16.
[^f00002]: Functions formerly exercisable by “the Ministers” (being, in relation to England and Wales and acting jointly, the Minister of Agriculture, Fisheries and Food and the Secretaries of State respectively concerned with health in England and food and health in Wales and, in relation to Scotland, the Secretary of State) are now exercisable, in relation to England, by the Secretary of State pursuant to paragraph 8 of Schedule 5 to the Food Standards Act 1999 (1999 c. 28). Those functions, so far as exercisable in relation to Wales, were transferred to the National Assembly for Wales by S.I. 1999/672 as read with section 40(3) of the 1999 Act. Those functions, so far as exercisable in relation to Scotland, were transferred to the Scottish Ministers by section 53 of the Scotland Act 1998 (1998 c. 46) as read with section 40(2) of the 1999 Act. Section 17(1) was amended by paragraph 12(a), and section 48 by paragraph 21, of Schedule 5 to the 1999 Act. Regulation 13(4) of S.I. 2000/656 expressly authorises the Secretary of State to amend existing Regulations made by the Minister of Agriculture, Fisheries and Food (whether or not with others) under the Food Safety Act 1990.
[^f00003]: 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).
[^f00004]: S.I. 1998/1376, amended in relation to England by S.I. 2000/3162, S.I. 2002/2364, S.I. 2002/3008 and S.I. 2004/3113.
[^f00005]: OJ No. L184, 15.7.88, p.61. This Directive was last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Commission (OJ No. L284, 31.10.2003, p.1).
[^f00006]: OJ No. L40, 11.2.89, p.27. This Directive was last amended by Regulation (EC) No 1882/2003.
[^f00007]: OJ No. L178, 28.7.95, p.1. This Directive was last amended by Commission Directive 2004/46 (OJ No. L114, 21.4.2004, p.15).
[^f00008]: OJ No. L226, 22.9.95, p.1. This Directive was last amended by Commission Directive 2004/47 (OJ No. L113, 20.4.2004, p.24).
[^f00009]: OJ No. L339, 30.12.96, p.1. This Directive was last amended by Commission Directive 2003/95 (OJ No. L283, 31.10.2003, p.71).
Editorial notes
[^key-21eabee30cc2d2d3c75ec7fc138e3e9a]: Regulations revoked (30.6.2006) by The Plastic Materials and Articles in Contact with Food (England) Regulations 2006 (S.I. 2006/1401), regs. 1, 24(f)
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