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You are here: BAILII >> Databases >> Statutory Instruments made by the National Assembly for Wales >> Rheoliadau Deunyddiau ac Eitemau Plastig mewn Cysylltiad â Bwyd (Diwygio) (Rhif 2) (Cymru) 2005 Rhif 1649 (Cy.130) URL: http://www.bailii.org/wales/legis/num_reg/2005/20051649w.html |
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Wedi'u gwneud | 21 Mehefin 2005 | ||
Yn dod i rym | 24 Mehefin 2005 |
4.
Yn rheoliad 4 (cyfyngiad ar ddefnyddio monomerau wrth weithgynhyrchu deunyddiau ac eitemau plastig)—
5.
Yn rheoliad 5 (cyfyngiad ar ddefnyddio ychwanegion wrth weithgynhyrchu deunyddiau ac eitemau plastig)—
(b) ym mharagraff (4)(b)(ii) ar ôl y gair "material" ym mhob achos mewnosoder y geiriau "or article".
6.
Ar ôl rheoliad 5A mewnosoder y rheoliad canlynol—
7.
Yn lle rheoliad 8 (labelu) rhodder y canlynol —
8.
Yn rheoliad 10 (tramgwyddau) —
9.
Yn Atodlen 1, Rhan 1—
(b) hepgorer Adrannau B a C.
10.
Yn Atodlen 1, Rhan II (atodol) paragraff 4—
11.
Yn Atodlen 2, Rhan I (rhestr anghyflawn o ychwanegion a ddefnyddir wrth weithgynhyrchu deunyddiau ac eitemau plastig) —
12.
Yn Atodlen 2, Rhan II (rhestr anghyflawn o ychwanegion a ddefnyddir wrth weithgynhyrchu deunyddiau ac eitemau plastig y mae paragraff 5 o Ran III o Atodlen 2 yn gymwys iddi) —
13.
Yn Atodlen 2, Rhan III (atodol) —
14.
Yn Atodlen 2A (cynhyrchion a gafwyd drwy eplesu bacterol) yn lle'r cofnod yn y golofn sy'n dwyn y pennawd "restrictions and specifications" rhodder y canlynol —
15.
Yn lle Atodlen 2B (manylebau) rhodder y tabl a nodir yn Atodlen 6 i'r Rheoliadau hyn.
16.
Yn lle paragraff 4(b) o Ran I (rheolau sylfaenol) o Atodlen 4 (profion ymfudo cyffredinol a phenodol gan ddefnyddio efelychwyr bwyd) rhodder —
Llofnodwyd ar ran Cynulliad Cenedlaethol Cymru o dan adran 66(1) o Ddeddf Llywodraeth Cymru 1998[10]
D. Elis-Thomas
Llywydd y Cynulliad Cenedlaethol
21 Mehefin 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 (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 (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 |
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 = 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 |
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 (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-diphenylacrylic acid, ethyl ester | SML = 0.05 mg/kg` |
69A | 46700 | — | 15,7-di-tert-Butyl-3-(3,4-and 2,3-di-methylphenyl)-3H-benzofuran-2-one containing: 3(a)5,7-di-tert-butyl-3-(3,4-dimethylphenyl)-3H-benzofuran-2-one (80-100% w/w); and 3(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 |
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) phosphate] | 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) |
101A | 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 |
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 | CH3 | |||||
CH3 | O | CH2 | O | |||
| | || | | | || | |||
(-O-CH-CH2-C-)m-(O-CH-CH2-C-)n | ||||||
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 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 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: — polyethyleneglycol (EO = 2—6) monoalkyl (C16—C18) ether (approximately 28% ) — fatty alcohols (C16—C18) (approximately 48% ) — 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 | ||||
Composition — 4,4'-Biphenylene-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] (CAS No. 38613-77-3) (36-46% w/w (1)) — 4,3'-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 [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 [0,0-bis (2,4-di-tert-butylphenyl) phosphonate-0,0-bis (2,4-di-tert-butylphenyl) phosphonite] (CAS No. 112949-970) (5% w/w ) Other specifications — Phosphor content of minimum 5.4% to 5.9% — Acid value of maximum 10 mg KOH per gram — Melt range of 85—110°C |
||||||
12 | 88640 |
Soyabean oil, epoxidized Oxirane < 8% , iodine number < 6 |
||||
13 | 95859 |
Waxes, refined, derived from petroleum based or synthetic hydrocarbon feedstocks The product has 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 |
||||
14 | 95883 |
White mineral oils, paraffinic, derived from petroleum hydrocarbon feedstocks The product has the following specifications: — Content of mineral hydrocarbons with carbon number less than 25: not more than 5% (w/w) — Viscosity note less than 8.5 × 10-6 m2/s (= 8.5 centistokes) at 100°C — Average molecular weight not less than 480 |
3.
Maent hefyd yn diwygio'r Atodlenni i Reoliadau 1998 drwy —
4.
Mae arfarniad rheoliadol yn unol ag adran 65 o Ddeddf Llywodraeth Cymru 1998 wedi'i baratoi ar gyfer y rheoliadau hyn a'i osod yn llyfrgell Cynulliad Cenedlaethol Cymru ynghyd â Nodyn Trosi sy'n nodi sut y trosir prif elfennau Cyfarwyddeb y Comisiwn 2004/19/EC yn y Rheoliadau hyn. Gellir cael copïau oddi wrth yr Asiantaeth Safonau Bwyd, Llawr 11, Southgate House, Wood Street, Caerdydd CF10 1EW.
[2] Trosglwyddwyd swyddogaethau'r Ysgrifennydd Gwladol o dan Ddeddf Diogelwch Bwyd 1990, i'r graddau yr oeddent yn arferadwy o ran Cymru, i Gynulliad Cenedlaethol Cymru gan Orchymyn Cynulliad Cenedlaethol Cymru (Trosglwyddo Swyddogaethau) 1999 (O.S. 1999/672).back
[3] OJ Rhif L31, 1.2.2002, t.1. Diwygiwyd y Rheoliad hwnnw ddiwethaf gan Reoliad (EC) Rhif 1642/2003 Senedd Ewrop a'r Cyngor (OJ Rhif L245, 29.9.2003, t.4).back
[4] O.S. 1998/1376, a ddiwygiwyd o ran Cymru gan O.S. 2001/1263 (Cy.70), O.S. 2002/2834 (Cy.272), O.S. 2003/302 (Cy.44) ac O.S. 2005/182 (Cy.15).back
[5] OJ Rhif L184, 15.7.88, t.61. Diwygiwyd y Gyfarwyddeb hon ddiwethaf gan Reoliad (EC) Rhif 1882/2003 Senedd Ewrop a'r Cyngor (OJ Rhif L284,31.10.2003, t.1.)back
[6] OJ Rhif L40, 11.2.89, t.27. Diwygiwyd y Gyfarwyddeb hon ddiwethaf gan Reoliad (EC) Rhif 1882/2003.back
[7] OJ Rhif L178, 28.7.95, t.1. Diwygiwyd y Gyfarwyddeb hon ddiwethaf gan Gyfarwyddeb y Comisiwn 2004/46 (OJ Rhif L114, 21.4.2004, t.15).back
[8] OJ Rhif L226, 22.9.95, t.1. Diwygiwyd y Gyfarwyddeb hon ddiwethaf gan Gyfarwyddeb y Comisiwn 2004/47 (OJ Rhif L113, 20.4.2004, t.24).back
[9] OJ Rhif L339, 30.12.96, t.1. Diwygiwyd y Gyfarwyddeb hon ddiwethaf gan Gyfarwyddeb y Comisiwn 2003/95 (OJ Rhif L283, 31.10.2003, t.71).back