Offerynnau Statudol Cymru
2005 Rhif 1649 (Cy.130)
BWYD, CYMRU
Rheoliadau Deunyddiau ac Eitemau Plastig mewn Cysylltiad â Bwyd (Diwygio) (Rhif 2) (Cymru) 2005
Wedi'u gwneud
21 Mehefin 2005
Yn dod i rym
24 Mehefin 2005
Mae Cynulliad Cenedlaethol Cymru, drwy arfer y pwerau a roddwyd gan adrannau 16(2), 17(1), 26(1)(a) a (3) a 48(1) o Ddeddf Diogelwch Bwyd 1990(1) ac sydd bellach wedi'u breinio ynddo(2) ac wedi rhoi sylw yn unol ag adran 48(4A) o'r Ddeddf honno i gyngor perthnasol a roddwyd gan yr Asiantaeth Safonau Bwyd ac ar ôl ymgynghori fel sy'n ofynnol gan Erthygl 9 o Reoliad (EC) Rhif 178/2002 Senedd Ewrop a'r Cyngor, sy'n pennu egwyddorion cyffredinol a gofynion cyfraith bwyd, yn sefydlu Awdurdod Diogelwch Bwyd Ewrop ac yn pennu gweithdrefnau o ran materion diogelwch bwyd(3), yn gwneud y Rheoliadau a ganlyn:
Enwi, cymhwyso a chychwyn
1. Enw'r Rheoliadau hyn yw Rheoliadau Deunyddiau ac Eitemau Plastig mewn Cysylltiad â Bwyd (Diwygio) (Rhif 2) (Cymru) 2005 sy'n gymwys o ran Cymru a deuant i rym ar 24 Mehefin 2005.
Diwygiadau i Reoliadau Deunyddiau ac Eitemau Plastig mewn Cysylltiad â Bwyd 1998
2. Diwygir Rheoliadau Deunyddiau ac Eitemau Plastig mewn Cysylltiad â Bwyd 1998(4) i'r graddau y maent yn gymwys o ran Cymru yn unol â rheoliadau 3 i 16 o'r Rheoliadau hyn.
3. Yn rheoliad 2 (dehongli) —
(a)ym mharagraff (1)—
(i)yn lle'r diffiniad o “additive” rhodder ““additive” means a substance as defined in paragraph 1 of the general introduction to Annex III to the Directive as read with paragraph 3 of article 4 of the Directive;”;
(ii)yn y diffiniad o “Council Directive 82/711”, hepgorer y geiriau “as amended” hyd at y diwedd;
(iii)ar ôl y diffiniad o “Council Directive 82/711” mewnosoder y diffiniadau canlynol—
““Council Directive 88/388” means Council Directive 88/388/EEC on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production(5);
“Council Directive 89/107” means Council Directive 89/107/EEC on the approximation of the laws of the Member States concerning food additives authorised in foodstuffs intended for human consumption(6);”;
(iv)hepgorer y diffiniad o “EEA Agreement”;
(v)yn lle'r diffiniad o “EEA State” rhodder ““EEA State” means a Member State (other than the United Kingdom), Norway, Iceland and Liechtenstein;”;
(vi)ar ôl y diffiniad o “EEA State” mewnosoder y diffiniad canlynol —
““EFSA” means the European Food Safety Authority;”;
(vii)ar ôl y diffiniad o “preparation” mewnosoder y diffiniad canlynol—
““the purity Directives” means Commission Directive 95/31/EC laying down specific criteria of purity concerning sweeteners for use in foodstuffs(7), Commission Directive 95/45/EC laying down purity criteria concerning colours for use in foodstuffs(8) and Commission Directive 96/77/EC laying down specific purity criteria for food additives other than colours or sweeteners(9);”;
(b)ar ôl paragraff (5) ychwaneger—
“(6) Any reference in these Regulations to a Community instrument is to be construed as a reference to that instrument as amended at the time the Plastic Materials and Articles in Contact with Food (Amendment) (No. 2) (Wales) Regulations 2005 were made.”.
4. Yn rheoliad 4 (cyfyngiad ar ddefnyddio monomerau wrth weithgynhyrchu deunyddiau ac eitemau plastig)—
(a)ym mharagraff (2) hepgorer is-baragraffau (a) a (b);
(b)ym mharagraff (5)(b)(ii) ar ôl y gair “material” ym mhob achos mewnosoder y geiriau “or article”.
5. Yn rheoliad 5 (cyfyngiad ar ddefnyddio ychwanegion wrth weithgynhyrchu deunyddiau ac eitemau plastig)—
(a)ym mharagraff (1) ychwaneger ar ôl is-baragraff (d)—
“(e)any food additive authorised by Council Directive 89/107 or any flavouring authorised by Council Directive 88/388 that migrates into food —
(i)in a quantity that has a technological function in the final food product, or
(ii)where the food is of a type for which the use of any such food additive or flavouring is so authorised, in quantities exceeding the limits provided for in Council Directive 89/107 or Council Directive 88/388 as appropriate, or in Schedule 2 to these Regulations, whichever is the lower.”.
(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—
“Applications for inclusion of an additive in the Community list of authorised additives
5B.—(1) This regulation applies where a person wishes to make an application for the inclusion of an eligible additive in the Community list referred to in article 4 of the Directive.
(2) An application mentioned in paragraph (1) including supporting data must be made to EFSA before 1st January 2007.
(3) If, during examination of the data referred to in paragraph (2), EFSA calls for supplementary information, the eligible additive may, if permitted to be used under the laws of England and Wales, continue to be so used until EFSA has issued an opinion, provided such information is submitted within the time limits specified by EFSA.
(4) For the purposes of this regulation an eligible additive is one whose use is permitted in one or more Member States before 1st January 2007.”.
7. Yn lle rheoliad 8 (labelu) rhodder y canlynol —
“At marketing stages other than the retail stage a person who is in possession of any plastic material or article intended to come into contact with food is to ensure that the plastic material or article is accompanied by a written declaration which —
(a)attests that it complies with the legislation applicable to it; and
(b)provides, in respect of substances that are subject to a restriction on quantities migrating into food, information obtained from experimental data or theoretical calculation concerning —
(i)the levels of migration specific to those substances;
(ii)where appropriate, purity criteria in accordance with the purity Directives.”.
8. Yn rheoliad 10 (tramgwyddau) —
(a)ym mharagraff (1) yn lle'r ffigur “8(1)”, rhodder y ffigur “8”;
(b)ar ôl paragraff (24) ychwaneger —
“(25) In any proceedings for an offence under these Regulations it is a defence to prove that —
(a)the act constituting the offence was committed in relation to a plastic material or article which was manufactured or imported into the European Community before 1st March 2006; and
(b)the act constituting the offence would not have constituted an offence under these Regulations if the amendments made to them by the Plastic Materials and Articles in Contact with Food (Amendment) (No. 2) (Wales) Regulations 2005 had not been in force at the time that act occurred.”.
9. Yn Atodlen 1, Rhan 1—
(a)yn Adran A (monomerau a awdurdodwyd heb derfyn amser) —
(i)mewnosoder yn y drefn rifo briodol y cofnodion a nodir yn Atodlen 1 i'r Rheoliadau hyn;
(ii)yn lle eitemau 15A, 39, 70, 120B, 147, 147A, 147B a 188 rhodder y cofnodion a nodir yn Atodlen 2 i'r Rheoliadau hyn;
(iii)hepgorer eitemau 76B a 76C a'u cofnodion cyfatebol;
(b)hepgorer Adrannau B a C.
10. Yn Atodlen 1, Rhan II (atodol) paragraff 4—
(a)ar ddiwedd nodyn (21) yn lle “and 18670,” rhodder “,18670, 54880 a 59280”;
(b)ar ôl nodyn (25) ychwaneger y canlynol—
“(27) QMA(T) in this case means that the restriction is not to be exceeded by the sum of the residual quantities of the following substances having PM/REF Nos. 10599/90A, 10599/91, 10599/92A and 10599/93.
(28) SML(T) in this case means that the restriction is not to be exceeded by the sum of the migration levels of the following substances having PM/REF Nos. 13480 and 39680.
(29) SML(T) in this case means that the restriction is not to be exceeded by the sum of the migration levels of the following substances having PM/REF Nos. 22775 and 69920.
(32) Compliance testing when there is a fat contact should be performed using isoctane as substitute of simulant D (unstable).
(33) QMA(T) in this case means that the restriction is not to be exceeded by the sum of the residual quantities of the following substances having PM/REF Nos. 14800 and 45600.”
11. Yn Atodlen 2, Rhan I (rhestr anghyflawn o ychwanegion a ddefnyddir wrth weithgynhyrchu deunyddiau ac eitemau plastig) —
(a)mewnosoder yn y drefn rifo briodol y cofnodion a nodir yn Atodlen 3 i'r Rheoliadau hyn;
(b)yn lle eitemau 60A a 198A rhodder y cofnodion a nodir yn Atodlen 4 i'r Rheoliadau hyn;
(c)hepgorer eitemau 112, 173A, 195C a 240 gyda'u cofnodion cyfatebol.
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) —
(a)mewnosoder yn y drefn rifo briodol y cofnodion a nodir yn Atodlen 5 i'r Rheoliadau hyn;
(b)hepgorer eitemau 28, 80 a 111A gyda'u cofnodion cyfatebol.
13. Yn Atodlen 2, Rhan III (atodol) —
(a)ym mharagraff 4—
(i)yn nodyn (8), mewnosoder yn y drefn rifo briodol “38000” a “67896”;
(ii)yn nodyn (10), ar ôl “levels” mewnosoder “(expressed as iodine)”;
(iii)ar ddiwedd nodyn (21), yn lle “and 18670,” rhodder “, 18670, 54880 a 59280”;
(iv)ar ôl nodyn (24) ychwaneger y canlynol—
“(26) QMA(T) in this case means that the restriction is not to be exceeded by the sum of the residual quantities of the following substances mentioned as reference Nos. 14950, 15700, 16240, 16570, 16600, 16630, 18640, 19110, 22332, 22420, 22570, 25210, 25240 and 25270.
(27) QMA(T) in this case means that the restriction is not to be exceeded by the sum of the residual quantities of the following substances having PM/REF Nos. 10599/90A, 10599/91, 10599/92A and 10599/93.
(28) SML(T) in this case means that the restriction is not to be exceeded by the sum of the migration levels of the following substances having PM/REF Nos. 13480 and 39680.
(29) SML(T) in this case means that the restriction is not to be exceeded by the sum of the migration levels of the following substances having PM/REF Nos. 22775 and 69920.
(30) SML(T) in this case means that the restriction is not to be exceeded by the sum of the migration levels of the following substances having PM/REF Nos. 86480, 86960 and 87120.
(31) Compliance testing when there is a fat contact should be performed using saturated fatty food simulants as simulant D.
(32) Compliance testing when there is a fat contact should be performed using isoctane as substitute of stimulant D (unstable).
(33) QMA(T) in this case means that the restriction is not to be exceeded by the sum of the residual quantities of the following substances having PM/REF Nos. 14800 and 45600.
(34) SML(T) in this case means that the restriction is not to be exceeded by the sum of the migration levels of the following substances having PM/REF Nos. 55200, 55280 and 55360.”;
(b)ym mharagraff 5 yn lle “1st January 2004” rhodder “1st July 2006”.
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 —
“In compliance with specifications included in Schedule 2B”.
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 —
“(b)omit the migration, the substitute or the alternative tests where —
(i)there is conclusive proof that the migration limits cannot be exceeded in any foreseeable conditions of use of the material or article, or
(ii)the conditions for non-compulsory testing set out in article 8.2 and 8.3 of the Directive are met.”.
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
Rheoliad 9(a)(i)
ATODLEN 1(COFNODION I'W MEWNOSOD YN ADRAN A O RAN I O ATODLEN 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 (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 |
Rheoliad 9(a)(ii)
ATODLEN 2(COFNODION I'W RHOI YN LLE COFNODION YN ADRAN A O RAN I O ATOCLEN 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 = 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 |
Rheoliad 11(a)
ATODLEN 3(COFNODION I'W MEWNOSOD YN RAN I O ATODLEN 22)
1 | 2 | 3 | 4 | |
---|---|---|---|---|
Item | PM/REF No. | CAS No. | Name | Restrictions and specifications |
18A | 34850 | 143925-92-2 | Amines, bis(hydrogenated tallow alkyl) oxidised | QM = For use only: (a) in polyolefines at 0.1% (w/w) but not in LDPE when it is in contact with foods for which the Directive 85/572/EEC establishes a reduction factor less than 3; (b) in PET at 0.25% (w/w) in contact with foods other 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 |
Rheoliad 11(b)
ATODLEN 4(COFNODION I'W RHOI YN LLE COFNODION YN RAN I O ATODLEN 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 |
Rheoliad 12(a)
ATODLEN 5(COFNODION I'W MEWNOSOD YN RAN II O ATODLEN 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) 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 |
Rheoliad 15
ATODLEN 6(TABL I'W ROI YN LLE TABL YN ATODLEN 2B)
Item | PM/REF No. | Specifications | ||||
---|---|---|---|---|---|---|
1 | 11530 | Acrylic acid, 2-hydroxypropyl ester. It may contain up to 25% (m/m) of acrylic acid, 2-hydroxyisopropyl ester (CAS No. 002918-23-2) | ||||
2 | 16690 | Divinylbenzene It may contain up to 45% (m/m) of Ethylvinylbenzene | ||||
3 | 18888 | 3-Hydroxybutanoic acid-3-hydroxypentanoic acid, copolymer | ||||
Definition | The copolymers are produced by the controlled fermentation of Alcaligenes eutrophus using mixtures of glucose and propanoic acid as carbon sources. The organism used has not been genetically engineered and has been derived from a single wild-type organism Alcaligenes eutrophus strain H16 NCIMB 10422. Master stocks of the organism are stored as freeze-dried ampoules. A submaster / working stock is prepared from the master stock and stored in liquid nitrogen and used to prepare inocula for the fermenter. Fermenter samples will be examined daily both microscopically and for any changes in colonial morphology on a variety of agars at different temperatures. The copolymers are isolated from heat treatment bacteria by controlled digestion of the other cellular components, washing and drying. These copolymers are normally offered as formulated, melt formed granules containing additives such as nucleating agents, plasticisers, fillers, stabilisers and pigments which all conform to the general and individual specifications. | |||||
Chemical name | Poly(3-D-hydroxybutanoate-co-3-D-hydroxypentanoate) | |||||
CAS number | 080181-31-3 | |||||
Structural formula | 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:
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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
Other specifications
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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:
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14 | 95883 | White mineral oils, paraffinic, derived from petroleum hydrocarbon feedstocks The product has the following specifications:
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Nodyn Esboniadol
(Nid yw'r nodyn hwn yn rhan o'r Rheoliadau)
1. Mae'r Rheoliadau hyn sy'n gymwys o ran Cymru, yn diwygio ymhellach Reoliadau Deunyddiau ac Eitemau Plastig mewn Cysylltiad â Bwyd 1998 (O.S.1998/1376, “Rheoliadau 1998”), sy'n gymwys i Brydain Fawr gyfan. Mae'r Rheoliadau hyn yn gweithredu yng Nghymru Gyfarwyddeb y Comisiwn 2004/19/EC (OJ Rhif L71, 10.3.2004, t.8) sy'n diwygio Cyfarwyddeb y Comisiwn 2002/72/EC (OJ Rhif L220, 15.8.2002, t.18), (“y Gyfarwyddeb”) ynghylch deunyddiau ac eitemau plastig y bwriedir iddynt ddod i gysylltiad â bwydydd.
2. Mae'r Rheoliadau yn diwygio Rheoliadau 1998 drwy —
(a)diwygio'r diffiniad o “additive” er mwyn bod yn gyson â'r Gyfarwyddeb (rheoliad 3(a)(i));
(b)tynnu'r cyfeiriadau at restri o sylweddau y mae eu hawdurdodiad bellach wedi darfod (rheoliad 4(a));
(c)estyn i eitemau ddarpariaethau rheoliad 4(5) o Reoliadau 1998 a oedd cyn hynny'n gymwys i ddeunyddiau yn unig (rheoliad 4(b));
(ch)ychwanegu cyfyngiad at ddefnyddio ychwanegion wrth weithgynhyrchu deunyddiau ac eitemau plastig sy'n ymwneud â sylweddau a ddefnyddir hefyd fel ychwanegion neu gyflasynnau bwyd (rheoliad 5(a));
(d)estyn i eitemau ddarpariaethau rheoliad 5(4) o Reoliadau 1998 a oedd cyn hynny'n gymwys i ddeunyddiau yn unig (rheoliad 5(b));
(dd)gwneud darpariaeth am y weithdrefn sydd i'w dilyn a'r terfynau amser sydd i'w cadw gan unrhyw berson sy'n dymuno cynnwys ychwanegyn yn rhestr y Gymuned o ychwanegion awdurdodedig (rheoliad 6);
(e)diwygio'r gofynion labelu ar gyfer deunyddiau ac eitemau plastig yn y cyfnod cyn manwerthu er mwyn ei gwneud yn ofynnol i wybodaeth ychwanegol gael ei rhoi (rheoliad 7);
(f)gwneud diwygiad canlyniadol i reoliad 10 (tramgwyddau) a achoswyd oherwydd y diwygiad i'r gofynion labelu (rheoliad 8(a));
(ff)darparu amddiffyniad i doriad yn Rheoliadau 1998 fel y'u diwygiwyd ddiwethaf gan y Rheoliadau hyn o ran deunyddiau neu eitemau plastig a weithgynhyrchir neu a fewnforir i'r Gymuned Ewropeaidd cyn 1 Mawrth 2006 (rheoliad 8(b)).
3. Maent hefyd yn diwygio'r Atodlenni i Reoliadau 1998 drwy —
(a)mewnosod cofnodion newydd, a diwygio neu ddileu rhai o'r cofnodion presennol, yn y rhestr o fonomerau a awdurdodwyd heb derfyn amser yn adran A o Ran I o Atodlen 1 (rheoliad 9(a) ac Atodlenni 1 & 2);
(b)tynnu'r rhestr o gofnodion ar gyfer monomerau a awdurdodwyd gyda therfyn amser a ddaeth bellach i ben (rheoliad 9(b));
(c)ychwanegu manylebau atodol pellach at Ran II o Atodlen 1 (rheoliad 10);
(ch)mewnosod cofnodion newydd a diwygio neu dynnu rhai o'r cofnodion presennol yn y rhestr o ychwanegion a ddefnyddir wrth weithgynhyrchu deunyddiau ac eitemau plastig yn Rhan 1 o Atodlen 2 (rheoliad 11 ac Atodlenni 3 a 4);
(d)mewnosod cofnodion newydd a thynnu rhai o'r cofnodion presennol yn y rhestr o ychwanegion a ddefnyddir wrth weithgynhyrchu deunyddiau ac eitemau plastig a nodir yn Rhan II o Atodlen 2 (rheoliad 12 ac Atodlen 5);
(dd)ychwanegu manylebau atodol pellach at Ran III o Atodlen 2, ac estyn y terfyn amser sy'n gymwys i sylweddau a restrir yn Rhan II o'r Atodlen honno (rheoliad 13);
(e)diwygio'r cyfyngiadau a'r manylebau yn y cofnod yn Atodlen 2A ynghylch cynhyrchion a gafwyd drwy eplesu bacterol (rheoliad 14)
(f)mewnosod cofnodion newydd a diwygio neu dynnu rhai o'r cofnodion presennol yn y manylebau a nodir yn Atodlen 2B (rheoliad 15 ac Atodlen 6);
(ff)ychwanegu darpariaeth at y rheolau sylfaenol ar gyfer profion ymfudo cyffredinol a phenodol gan ddefnyddio efelychwyr bwyd a nodir yn Rhan 1 o Atodlen 4, i ganiatáu hepgor profion ymfudo yn yr amgylchiadau penodol y darperir ar eu cyfer yn y Gyfarwyddeb (rheoliad 16).
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.
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).
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).
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).
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.)
OJ Rhif L40, 11.2.89, t.27. Diwygiwyd y Gyfarwyddeb hon ddiwethaf gan Reoliad (EC) Rhif 1882/2003.
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).
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).
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).