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Statutory Instruments of the Scottish Parliament |
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You are here: BAILII >> Databases >> Statutory Instruments of the Scottish Parliament >> The Plastic Materials and Articles in Contact with Food Amendment (Scotland) Regulations 2005 No. 92 URL: http://www.bailii.org/scot/legis/num_reg/2005/20050092.html |
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Made | 1st March 2005 | ||
Laid before the Scottish Parliament | 1st March 2005 | ||
Coming into force | 24th March 2005 |
(c) at the end of the definition of "the Directive" insert "and Commission Directive 2004/19/EC"[9];
(d) omit the definition of "EEA Agreement";
(e) for the definition of "EEA State" substitute ""EEA State" means a Member State (other than the United Kingdom), Norway, Iceland or Liechtenstein;";
(f) after the definition of "EEA State" insert-
"EFSA" means the European Food Safety Authority;";
(g) after the definition of "preparation" insert-
4.
In regulation 4 (restriction on manufacture with monomers)-
5.
In regulation 5 (restriction on the use of additives in the manufacture of plastic materials and articles)-
(b) in paragraph (4)(b)(ii) after "material" wherever it appears, insert "or article"."
6.
After regulation 5A insert-
7.
For regulation 8 (labelling) substitute-
sufficient to enable the user of those materials and articles to comply with the legislation applicable to food.".
8.
In regulation 10 (offences)-
9.
In Schedule 1, Part I-
(b) omit Sections B and C.
10.
In Schedule 1, Part II (supplementary) paragraph 4-
11.
In Schedule 2, Part I (incomplete list of additives used in the manufacture of plastic materials and articles)-
12.
In Schedule 2, Part II (incomplete list of additives used in the manufacture of plastic materials and articles being additives to which paragraph 5 of Part III of Schedule 2 applies) -
13.
In Schedule 2, Part III (supplementary)-
14.
In Schedule 2A (products obtained by bacterial fermentation)-
15.
For Schedule 2B (specifications) substitute the contents of Schedule 6 to these Regulations.
16.
For paragraph 4(b) of Part I (basic rules) of Schedule 4 (overall and specific migration testing using food simulants) substitute-
RHONA BRANKIN
Authorised to sign by the Scottish Ministers
St Andrew's House, Edinburgh
1st March 2005
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 (26) |
6B | 10599/91 | 061788-89-4 | Acids, fatty, unsaturated (C18), dimers, non distilled | QMA(T) = 0.05 mg/6 dm2 (26) |
6C | 10599/92A | 068783-41-5 | Acids, fatty, unsaturated (C18), dimers, hydrogenated, distilled | QMA(T) = 0.05 mg/6 dm2 (26) |
6D | 10599/93 | 068783-41-5 | Acids, fatty, unsaturated (C18), dimers, hydrogenated, non distilled | QMA(T) = 0.05 mg/6 dm2 (26) |
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 (32) |
87A | 16210 | 006864-37-5 | 3,3'-Dimethyl-4,4'-diaminodicyclohexylmethane | SML = 0.05 mg/kg (31). 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 |
|
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(28) |
161A | 23070 | 000102-39-6 | (1,3-Phenylenedioxy)diacetic acid" | QMA = 0.05 mg/6 dm2 |
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 (27) |
70 | 14950 | 003173-53-3 | Cyclohexyl isocyanate | QM(T) = 1 mg/kg in FP (expressed as NCO) (25) |
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) (25) |
188 | 24190 | 065997-05-9 | Rosin Wood" |
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:
(b) in PET at 0.25% (w/w) in contact with foods other of 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 (27) |
51A | 42880 | 008001-79-4 | Castor oil | |
61A | 45600 | 003724-65-0 | Crotonic acid | QMA(T) = 0.05 mg/6 dm2 (32) |
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:
(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 (28) |
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" |
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" |
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 (33) |
54C | 55280 | 001034-01-1 | Gallic acid, octyl ester | SML(T) = 30 mg/kg (33) |
54D | 55360 | 000121-79-9 | Gallic acid, propyl ester | SML(T) = 30 mg/kg (33) |
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 0.0 5 mg/kg (30) |
88A | 76680 | 068132-00-3 | Polycyclopentadiene, hydrogenated | SML = 5 mg/kg (1) |
100A | 86480 | 007631-90-5 | Sodium bisulphite | SML(T) = 10 mg/kg (29) (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 (29) (expressed as S02) |
102C | 87120 | 007772-98-7 | Sodium thiosulphate | SML(T) = 10 mg/kg (29) (expressed as S02) |
110A | 94400 | 036443-68-2 | Triethyleneglycol bis[3-(3-tert-butyl-4-hydroxy-5-methylphenyl) propionate]" | SML = 9 mg/kg |
1 | 2 | |||||
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) |
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2 | 16690 |
Divinylbenzene It may contain up to 45% (m/m) of Ethylvinylbenzene |
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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 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 |
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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 (= 100 centistokes) at 25°C |
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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. |
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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) |
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7 | 43680 |
Chlorodifluoromethane Content of chlorofluoromethane less than 1 mg/kg of the substance |
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8 | 47210 |
Dibutylthiostannoic acid polymer Molecular unit = (C8H18S3Sn2)n (n = 1.5-2) |
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9 | 76721 |
Polydimethylsiloxane (Mw > 6800) Minimum viscosity 100 × 10-6 m2/s (= 100 centistokes) at 25°C |
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10 | 77895 |
Polyethyleneglycol (EO = 2-6) monoalkyl (C16-C18) ether The composition of this mixture is as follows: - polyethyleneglycol (EO = 2-6) monoalkyl (C16-C18) ether (approximately 28%) - fatty alcohols (C16-C18) (approximately 48%) - ethyleneglycol monoalkyl (C16-C18) ether (approximately 24%) |
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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 - 4,4'-Biphenylene-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] (CAS No. 38613-77-3) (36-46% w/w (*)) - 4,3'-Biphenylene-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] (CAS No. 118421-00-4) (17-23% w/w (*)) - 3,3'-Biphenylene-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] (CAS No. 118421-01-5) (1-5% w/w (*)) - 4-Biphenylene-0,0-bis (2,4-di-tert-butylphenyl) phosphonite (CAS No. 91362-37-7) (11-19% w/w (*)) - Tris (2,4-di-tert-butylphenyl) phosphite (CAS No. 31570-04-4) (9-18% w/w (*)) - 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 (*)) Other specifications - Phosphor content of minimum 5.4% to maximum 5.9% - Acid value of maximum 10 mg KOH per gram - Melt range of 85-110°C |
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12 | 88640 |
Soyabean oil, epoxidized Oxirane < 8%, iodine number < 6 |
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13 | 95859 |
Waxes, refined, derived from petroleum based or synthetic hydrocarbon feedstocks The product shall have the following specifications: - 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 - Average molecular weight not less than 500 |
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14 | 95883 |
White mineral oils, paraffinic derived from petroleum hydrocarbon feedstocks The product shall have the following specifications: - 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 - Average molecular weight not less than 480" |
They also amend the Schedules to the 1998 Regulations by-
A Regulatory Impact Assessment, which includes a compliance cost assessment of the effect which these Regulations are likely to have on business costs, has been prepared and has been placed in the Scottish Parliament Information Centre. Copies may be obtained from the Food Standards Agency, 6th Floor, St Magnus House, 25 Guild Street, Aberdeen AB11 6NJ.
[2] Section 48(4A) was inserted by the 1999 Act, Schedule 5, paragraph 21.back
[3] S.I. 1998/1376, relevantly amended by S.S.I. 2000/431, S.S.I. 2002/498, S.S.I. 2003/9 and S.S.I. 2004/524.back
[4] O.J. No. L 184, 15.7.88, p.61.back
[5] O.J. No. L 345, 14.12.88, p.29.back
[6] O.J. No. L 42, 15.2.91, p.25.back
[7] O.J. No. L 140, 11.2.89, p.27.back
[8] O.J. No. L 237, 10.9.94, p.1.back
[9] O.J. No. L 71, 10.3.04, p.8.back
[10] O.J. No. L 178, 28.7.95, p.1.back
[11] O.J. No. L257, 19.9.98, p. 35.back
[12] O.J. No. L 198, 4.8.00, p.41.back
[13] O.J. No. L 190, 12.7.01, p.18.back
[14] O.J. No. L 114, 21.4.04, p.15.back
[15] O.J. No. L 226, 22.9.95, p.1.back
[16] O.J. No. L 206, 5.8.99, p.19.back
[17] O.J. No. L 190, 12.7.01, p.14.back
[18] O.J. No. L 113, 20.4.04, p.24.back
[19] O.J. No. L 339, 30.12.96, p.1.back
[20] O.J. No. L 334, 9.12.98, p.1.back
[21] O.J. No. L 277, 30.10.00, p.1.back
[22] O.J. No. L 146, 31.5.01, p.1.back
[23] O.J. No. L 292, 28.10.02, p.1.back
[24] O.J. No. L 283, 31.10.03, p.71.back