2001 Rhif 1263 (Cy.70)

BWYD, CYMRU

Rheoliadau Deunyddiau ac Eitemau Plastig mewn Cysylltiad â Bwyd (Diwygio) (Cymru) 2001

Wedi'u gwneud

Yn dod i rym

Drwy arfer y pwerau a roddir gan adrannau 16(2), 17(1), 26(1)(a) a 48(1) o Ddeddf Diogelwch Bwyd 19901 ac sydd bellach wedi'u breinio yng Nghynulliad Cenedlaethol Cymru2, mae Cynulliad Cenedlaethol Cymru, ar ôl 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 yn unol ag adran 48(4) a (4B) o'r Ddeddf honno, yn gwneud y Rheoliadau canlynol:

Enwi, cychwyn a chymhwyso1

1

Enw'r Rheoliadau hyn yw Rheoliadau Deunyddiau Plastig ac Eitemau mewn Cysylltiad â Bwyd (Diwygio) (Cymru) 2001 a deuant i rym ar 1 Ebrill 2001.

2

Mae'r Rheoliadau hyn yn gymwys i Gymru yn unig.

Diwygio Rheoliadau

2

Diwygir Rheoliadau Deunyddiau Plastig ac Eitemau sy'n Dod i Gysylltiad â Bwyd 19983 (“y prif Reoliadau”) (i'r graddau y maent yn gymwys i Gymru) fel a ganlyn.

3

Yn rheoliad 2 (dehongli), yn y diffiniad o “the Directive” yn lle'r geiriau “and 96/11/EC4)” rhoddir “, 96/11/EC and 1999/91/EC5 as corrected 6)”.

4

Yn lle paragraff (4)(a) o reoliad 3 (cyfyngu ar ddefnyddio, gwerthu neu fewnforio deunyddiau ac eitemau plastig) rhoddir—

a

if—

i

it has been manufactured with a prohibited monomer as described in regulation 4(1);

ii

it has been manufactured with a prohibited additive as described in regulation 5(1);

iii

being a product obtained by bacterial fermentation, it does not comply with regulation 5A; or

iv

it does not comply with regulation 4(5), 5(4) or 7,

and no defence indicated in regulation 4(7), 5(2) or 7(5) would be available in proceedings for an offence under these Regulations relating to that manufacture or want of compliance; or

5

Yn rheoliad 4 (cyfyngu ar weithgynhyrchu â monomerau)—

a

ym mharagraff (1)(c), yn lle'r geiriau “restrictions (if any) specified” rhoddir y geiriau “restrictions and specifications (if any) set out”; a

b

dilëir paragraff (3)(d).

6

Yn rheoliad 5 (cyfyngu ar weithgynhyrchu ag ychwanegion)—

a

yn lle paragraff (1) rhoddir—

1

Subject to the following paragraphs of this regulation, no person shall use in the manufacture of plastic materials or articles any prohibited additive, that is to say an additive identified by PM/REF No., CAS No. (if any) and name respectively in columns 1, 2 and 3 of Part I of Schedule 2 which—

a

is not of good technical quality, or

b

is not used in accordance with the restrictions and specifications (if any) set out in the corresponding entry in column 4 of the relevant section of that Part of that Schedule.

b

ychwanegir y paragraffau canlynol ar y diwedd—

4

Subject to paragraph (5) of this regulation, where column 4 of Part I of Schedule 2 expresses a migration limit of mg/kg in relation to any additive, no plastic material or article manufactured containing that additive shall be capable of transferring constituents of that additive to food with which that plastic material or article may come into contact in quantities exceeding the appropriate limit, and for the purposes of this paragraph the appropriate limit is—

a

the number of milligrams expressed therein released per kilogram of food in the case of any plastic material or article other than one specified in sub–paragraph (b) below; and

b

one sixth of the number of milligrams expressed therein per square decimetre of surface area of the plastic material or article if the plastic material or article comprises—

i

an article which is a container or is comparable to a container or which can be filled, with a capacity of less than 500 millilitres or more than 10 litres, or

ii

sheet, film or other material which cannot be filled or for which it is impracticable to estimate the relationship between the surface area of that material and the quantity of food in contact with that surface area.

5

A plastic material or article manufactured containing an additive in respect of which column 4 of Part I of Schedule 2 expresses a migration limit of mg/kg shall not be considered capable of transferring constituents of that additive to food with which that plastic material or article may come into contact in quantities exceeding the appropriate limit in paragraph (4) of this regulation if the only food which that plastic material or article may come into contact with is food to which regulation 7(3) applies.

7

Ar ôl rheoliad 5 mewnosodir y rheoliad canlynol—

Products obtained by bacterial fermentation5A

A product obtained by bacterial fermentation complies with this regulation if it is—

a

of good technical quality;

b

identified by PM/REF No., CAS No. and name respectively in columns 1, 2 and 3 of Schedule 2A; and

c

in compliance with the restrictions and specifications set out in column 4 of that Schedule.

8

Ar ôl rheoliad 7 (trosglwyddo cyfansoddion) mewnosodir y rheoliad canlynol—

Specifications7A

Schedule 2B shall have effect for the purpose of giving the specifications referred to in column 4 in Schedules 1, 2 and 2A.

9

Yn rheoliad 10 (tramgwyddo) ychwanegir y paragraff canlynol ar y diwedd—

15

In any proceedings for an offence under these Regulations it shall be a defence to prove that—

a

the act was committed in relation to a plastic material or article intended to come into contact with food which was manufactured in the European Community, or imported into the European Community, before 1st January 2003, and

b

the matters constituting the offence would not have constituted an offence under these Regulations before the amendments made by the Plastic Materials and Articles in Contact with Food (Amendment) (Wales) Regulations 2001 came into force.

10

Yn Atodlen 1 (monomerau)—

a

yn Rhan I, yn adran A yng ngholofn 4, yn lle'r pennawd “Restrictions” rhoddir “Restrictions and/or specifications”;

b

mewnosodir rhif a llythyren yr eitem, Rhif PM/REF, Rhif CAS, enw, cyfyngiad a manyleb (os oes un) ar gyfer pob monomer a enwir yn Rhan I o Atodlen 1 i''r Rheoliadau hyn yn Adran A o Ran I o Atodlen 1 i'r prif Reoliadau yn y lle sy'n cyfateb i'r rhif a'r llythyren (os oes un) a bennir ar gyfer y monomer hwnnw yn y golofn o dan y pennawd “item” yn y Rhan honno o'r Atodlen honno i'r Rheoliadau hyn;

c

yn Rhan I, yn Adran A yn lle'r cofnodion yng ngholofn 4 (cyfyngiadau a manylebau), gyferbyn â'r eitemau ac yn cyfateb i'r eitemau a restrir yn Rhan II o Atodlen 1 i'r Rheoliadau hyn mewnosodir y cofnodion cyfatebol a bennir yn y Rhan II a enwyd;

ch

yn Rhan I, yn Adran A, yn eitem 196 dilëir y cofnod yng ngholofn 4 (cyfyngiadau a manylebau);

d

yn Rhan I, yn Adran B, dilëir eitem 67 a'r cofnodion ar ei chyfer;

dd

yn Rhan I, yn Adran B, yn lle'r cofnodion yng ngholofn 4 (cyfyngiadau), gyferbyn â'r eitemau ac yn cyfateb i'r eitemau a restrir yn Rhan III o Atodlen 1 i'r Rheoliadau hyn rhoddir y cofnodion cyfatebol a bennir yn Rhan III o Atodlen 1 i'r Rheoliadau hyn;

e

yn Rhan I, yn Adran B, ar ôl y cofnodion sy'n ymwneud ag eitem 77 mewnosodir rhif a llythyren yr eitem, Rhif PM/REF, Rhif CAS, enw a chyfyngiad ar gyfer y monomer a enwir yn Rhan IV o Atodlen 1 i''r Rheoliadau hyn;

f

yn Rhan I, dilëir yr eitemau a restrir yn Rhan V o Atodlen 1 i'r Rheoliadau hyn, a'r cofnodion ar gyfer yr eitemau hynny yn yr Adran honno, a mewnosodir yn Adran A yn y lle sy'n cyfateb i'r rhif hwnnw a'r llythyren honno yn y golofn o dan y pennawd “Item No. for Section A” yn Rhan V o Atodlen 1 i'r Rheoliadau hyn y cofnodion sy'n ymwneud â'r eitem honno yn y Rhan V a enwyd; ac

ff

yn Rhan II mewnosodir y paragraff canlynol ar y diwedd—

4

Where an entry in column 4 in Part I of this Scheduleincludes a bracketed number, that entry shall be subject to the note relating to that number as follows:

1

Warning: there is a risk that the specific migration limit could be exceeded in fatty food simulants.

2

SML (T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as PM/REF Nos: 10060 and 23920.

3

SML (T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as PM/REF Nos: 15760, 16990, 47680, 53650, 89440.

4

SML (T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as PM/REF Nos: 19540, 19960.

5

SML (T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as PM/REF Nos: 14200, 14230.

9

SML (T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances:

a

Badge (=2,2-bis(4-hydroxyphenyl)) propane bis (2,3-epoxypropyl) ether

b

Badge.H2O

d

Badge.HCi

e

Badge.2HCi

f

Badge.H2O.HCi

However in aqueous food simulants, the SML (T) should also include Badge.2H2O(c) unless the material or article is labelled for use in contact only with those foods and beverages for which it has been demonstrated that the sum of the migration levels of the five above mentioned substances (a)(b)(d)(e)(f) cannot exceed 1 mg/kg.

11

Yn Atodlen 2 (ychwanegion)—

a

yn Rhan I ychwanegir colofn ychwanegol, yn dwyn y rhif “4” a'r pennawd “Restrictions and specifications”;

b

mewnosodir rhif a llythyren yr eitem, Rhif PM/REF, Rhif CAS, enw, cyfyngiad a manyleb (os oes un) ar gyfer pob ychwanegyn a enwir yn Atodlen 2 i''r Rheoliadau hyn yn Rhan I o Atodlen 2 i'r prif Reoliadau yn y lle sy'n cyfateb i'r rhif a'r llythyren a bennir ar gyfer yr ychwanegyn hwnnw yn y golofn o dan y pennawd “Item” yn Atodlen 2 i'r Rheoliadau hyn;

c

yn Rhan I, yn lle'r cofnodion yng ngholofn 2 (Rhif CAS) a cholofn 3 (enw) ar gyfer eitem 38 rhoddir y canlynol—

087826- 41-3

Bis(methylbenzylidene) sorbitol

069158- 41-1

Bis(methylbenzylidene) sorbitol

054686- 97-4

Bis(methylbenzylidene) sorbitol

081541- 12-0

Bis(methylbenzylidene) sorbitol

ch

yn Rhan I, yn lle'r cofnod yng ngholofn 2 (Rhif CAS) ar gyfer eitem 179 rhoddir y cofnod “037244-96-5”;

d

yn Rhan I, dilëir eitem 195 a'r cofnodion ar ei chyfer; ac

dd

yn Rhan II, mewnosodir y paragraff canlynol ar y diwedd—

4

Where an entry in column 4 (Restrictions and specifications) in Part I of this Schedule includes a bracketed number, that entry shall be subject to the note relating to that number as follows:

1

Warning : there is a risk that the specific migration limit could be exceeded in fatty food simulants.

3

SML (T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as PM/REF Nos.: 15760, 16990, 47680, 53650, 89440.

6

SML (T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as PM/REF/Nos.: 66560 and 66580.

7

SML (T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as PM/REF Nos.: 30080, 42320, 45195, 45200, 53610, 81760, 89200, 92030.

8

SML (T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as PM/REF Nos.: 85840 and 95725.

10

Warning: there is a risk that the migration of the substance deteriorates the organoleptic characteristics of the food in contact and then, that the finished product does not comply with regulation 4(2) of the Materials and Articles in Contact with Food Regulations 19877.

12

Ar ôl Atodlen 2 ychwanegir cynnwys Atodlenni 3 a 4 i'r Rheoliadau hyn fel Atodlenni 2A a 2B.

13

Yn Atodlen 3 (darpariaethau sy'n gymwys wrth brofi a ydy yn cydymffurfio â'r terfynau ymfudo)—

a

ym mharagraff 4(3) a (4), yn lle “regulation 7 or Schedule 1” ym mhob achos mewnosodir “regulation 7, Schedule 1 or Schedule 2”; a

b

ym mharagraff 7(2)(c) yn lle “M1 and M2” rhoddir “M2 and M3”.

Llofnodwyd ar ran Cynulliad Cenedlaethol Cymru o dan adran 66(1) o Ddeddf Llywodraeth Cymru 19988.

D.Elis ThomasLlywydd y Cynulliad Cenedlaethol

SCHEDULE 1

Regulation 10

PART ILIST OF MONOMERS TO BE ADDED TO SECTION A OF PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS

ITEM

PM/REF No.

CAS No.

NAME

Restrictions and specifications

28A

12761

000693-57-2

12-Aminododecanoic acid

The specific migration of this substance shall not exceed 0.05 mg/kg

35A

13180

000498-66-8

Bicyclo [2.2.1] hept-2-ene (=norbornene)

The specific migration of this substance shall not exceed 0.05 mg/kg

35B

13210

00176-71-3

Bis(4-aminocyclohexyl)methane

The specific migration of this substance shall not exceed 0.05 mg/kg

63A

14650

000079-38-9

Chlorotrifluoroethylene

The quantity of this substance in the finished plastic material or article shall not exceed 0.05 mg/6 dm2

68A

14841

000599-64-4

4-Cumylphenol

The specific migration of this substance shall not exceed 0.05 mg/kg

93A

16694

013811-50-2

N,N'-Divinyl-2-imidazolidinone

The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg

93B

16704

000112-41-4

1-Dodecene

The specific migration of this substance shall not exceed 0.05 mg/kg

147A

22331

025513-64-8

Mixture of (40% w/w) 1,6- diamino-2,2,4- trimethylhexane and (60% w/w) 1,6-diamino-2,4,4— trimethylhexane

The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/6 dm2

152A

22550

000498-66-8

Norbornene

The specific migration of this substance shall not exceed 0.05 mg/kg

163A

23175

000122-52-1

Phosphorous acid, triethylester

The quantity of this substance in the finished plastic material or article shall be not detectable (when measured by a method with a detection limit of 1 mg/kg)

169A

23547

009016-00 6 063148-62-9

Polydimethylsiloxane (MW>6800)

In compliance with the specifications laid down in Schedule 2B.

206A

25080

001120-36-1

1-Tetradecene

The specific migration of this substance shall not exceed 0.05 mg/kg

214A

25385

000102-70-5

Triallylamine

In compliance with the specifications laid down in Schedule 2B.

218A

25927

027955-94-8

1,1,1-Tris(4-hydroxyphenyl)ethane

The quantity of this substance in the finished plastic material or article shall not exceed 0.5 mg/kg. For use only in polycarbonates

223

26155

001072-63-5

1-Vinylimidazole

The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg

225

26320

002768-02-7

Vinyltrimethoxysilane

The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg

226

26360

007732-18-5

Water

In compliance with Directive 98/83/EC on the quality of water intended for human consumption 9.

PART IILIST OF MONOMERS IN SECTION A OF PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS FOR WHICH THE CONTENT OF THE COLUMN “RESTRICTIONS AND SPECIFICATIONS” IS MODIFIED

ITEM

PM/REF No.

CAS No.

Name

Restrictions and specifications

2

10060

000075-07-0

Acetaldehyde

SML (T) = 6 mg/kg (2)

40

13510

001675-54-3

2,2-Bis(4- hydroxyphenyl)propane bis(2,3-epoxypropyl) ether (=BADGE)

SML (T) = 1 mg/kg (9). Authorised only until 1 January 2005

56

14200

000105-60-2

Caprolactam

SML (T) = 15 mg/kg (5)

57

14230

002123-24-2

Caprolactam, sodium salt

SML (T) = 15 mg/kg (5) (expressed as caprolactam)

79

15760

000111-46-6

Diethyleneglycol

SML (T) = 30 mg/kg (3)

98

16990

000107-21-1

Ethyleneglycol

SML (T) = 30 mg/kg (3)

102

17160

000097-53-0

Eugenol

The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.02 mg/kg, analytical tolerance included)

128

19540

000110-16-7

Maleic acid

SML (T) = 30 mg/kg (4)

129

19960

000108-31-6

Maleic anhydride

SML (T) = 30 mg/kg (4) (expressed as maleic acid)

214

25360

-

Trialkyl(C5-C15) acetic acid, 2,3-epoxypropyl ester

The quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg (expressed as epoxy group, molecular weight = 43)

PART IIILIST OF MONOMERS IN SECTION B OF PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS FOR WHICH THE CONTENT OF THE COLUMN “RESTRICTIONS” IS MODIFIED

ITEM

PM/REF No

CAS/No.

Name

Restrictions

34

16690

001321-74-0

Divinylbenzene

The quantity of this material in the finished plastic material or article shall not exceed 1 mg/kg or the specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.02 mg/kg, analytical tolerance included)

56

20590

000106-91-2

Methacrylic acid, 2,3-epoxypropyl ester

The quantity of this material in the finished plastic material or article shall not exceed 5 mg/kg (expressed as epoxy group, molecular weight = 43)

68

22720

000140-66-9

4-tert-Octylphenol

The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.01mg/kg, analytical tolerance included)

PART IVMONOMER TO BE ADDED TO SECTION B OF PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS

Items

PM/REF No.

CAS No.

Name

Restrictions

77A

25185

000140-66-9

4-(1,1,3,3-Tetramethylbutyl) phenol (=4-tert-octylphenol)

As item 68

PART VLIST OF MONOMERS TRANSFERRED FROM SECTION B TO SECTION A OF PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS

Item No. in Section B

Item No. For Section A

PM/REF No.

CAS No.

NAME

Restrictions and specifications

5

13A

11000

05976-02-8

Acrylic acid, dicyclopentadienyl ester

The quantity of this substance in the finished plastic material or article shall not exceed 0.05 mg/6 dm2

6

13B

11245

002156-97-0

Acrylic acid, dodecyl ester

The specific migration of this substance shall not exceed 0.05 mg/kg (1)

9

23A

12265

004074-90-2

Adipic acid, divinyl dodecyl ester

The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg. For use only as a comonomer.

12

33A

13060

004422-95-1

1,3,5 - Benzenetricarboxylic acid trichloride

The quantity of this substance in the finished plastic material or artical shall not exceed 0.05 mg/6dm2 (measured as 1,3,5 — benzenetricarboxylic

16

49A

13780

002425-79-8

1,4-Butanediol bis(2,3- epoxypropyl) ether

The quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg (expressed as epoxy group, molecular weight equal to 43)

19

52A

14020

000098-54-4

4-tert-Butylphenol

The specific migration of this substance shall not exceed 0.05 mg/kg

22

73A

15130

000872-05-9

1-Decene

The specific migration of this substance shall not exceed 0.05 mg/kg

30

88A

16360

000576-26-1

2,6-Dimethylphenol

The specific migration of this substance shall not exceed 0.05 mg/kg

32

88B

16450

000646-06-0

1,3-Dioxolane

The specific migration of this substance shall not exceed 0.05 mg/kg

37

111A

18220

068564-88-5

N-Heptylaminoundeca noic acid

The specific migration of this substance shall not exceed 0.05 mg/kg (1)

41

118A

18820

000592-41-6

1-Hexene

The specific migration of this substance shall not exceed 3 mg/kg

42

121A

19060

000109-53-5

Isobutyl vinyl ether

The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg

43

121B

19150

000121-91-5

Isophthalic acid

The specific migration of this substance shall not exceed 5 mg/kg

49

130A

19990

000079-39-0

Methacrylamide

The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.02 mg/kg, analytical tolerance included)

50

131A

20050

000096-05-9

Methacrylic acid, allyl ester

The specific migration of this substance shall not exceed 0.05 mg/kg

55

135A

20530

002867-47-2

Methacrylic acid, 2-(dimethylamino) ethyl ester

The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.02 mg/kg, analytical tolerance included)

61

145A

21730

000563-45-1

3-Methyl-1-butene

The quantity of this substance in the finished plastic material or article shall not exceed 0.006 mg/6 dm2 For use only in polypropylene

70

159A

22937

001623-05-8

Perfluoropropyl perfluorovinyl ether

The specific migration of this substance shall not exceed 0.05 mg/kg

71

173A

23770

000504-63-2

1,3-Propanediol

The specific migration of this substance shall not exceed 0.05 mg/kg

72

177A

23920

000105-38-4

Propionic acid, vinyl ester

SML (T) = 6 mg/kg (2) (expressed as acetaldehyde)

74

198A

24760

026914-43-2

Styrenesulphonic acid

The specific migration of this substance shall not exceed 0.05 mg/kg

83

224

26170

003195-78-6

N-Vinyl-N-methylacetamide

The quantity of this substance in the finished plastic material or article shall not exceed 2 mg/kg

SCHEDULE 2LIST OF ADDITIVES TO BE INSERTED IN PART I OF SCHEDULE 2 TO THE PRINCIPAL REGULATIONS

Regulation 11

ITEM

PM/REF No.

CAS No.

NAME

Restrictions and specifications

2A

30080

004180-12-5

Acetic acid, copper salt

SML (T) = 30 mg/kg (7) (expressed as copper)

7A

30610

-

Acids C2-C24 aliphatic, linear monocarboxylic, from natural oils and fats and their mono-, di- and triglycerol esters (branched fatty acids at naturally occurring levels are included).

7B

30612

-

Acids C2-C24 aliphatic, linear, monocarboxylic, synthetic and their mono-, di— and triglycerol esters

9A

31530

123968-25-2

Acrylic acid, 2,4-di-tert- pentyl-6-[1(3,5-di-tert-pentyl- 2-hydroxyphenyl) ethyl] phenyl ester

The specific migration of this substance shall not exceed 5 mg/kg

12A

33801

-

n-Alkyl (C10-C13) benzenesulphonic acid

The specific migration of this substance shall not exceed 30 mg/kg

12B

34240

-

Alkyl(C10-C20) sulphonic acid, esters with phenols

The specific migration of this substance shall not exceed 6 mg/kg. Authorised only until 1 January 2002.

27A

36640

000123-77-3

Azodicarbonamide

For use only as blowing agent.

31A

37360

000100-52-7

Benzaldehyde

(10)

36A

38320

005242-49-6

4-(2-Benzoxazolyl)-4'-(5- methyl-2-benzoxazolyl) stilbene

In compliance with the specifications laid down in Schedule 2B

36B

38510

136504-96-6

1,2-Bis(3-aminopropyl) ethylenediamine, polymer with N-butyl-2,2,6,6- tetramethyl-4-piperidinamine and 2,4,6-trichloro-1,3,5— triazine

The specific migration of this substance shall not exceed 5 mg/kg

36C

38515

001533-45-5

4,4'-Bis(2-benzoxazolyl)stilbene

The specific migration of this substance shall not exceed 0.05 mg/kg (1)

36D

38810

080693-00-1

Bis(2,6-di-tert-butyl-4-methylphenyl) pentaerythritol diphosphite

The specific migration of this substance shall not exceed 5 mg/kg (sum of phosphite and phosphate)

36E

38879

135861-56-2

Bis(3,4— dimethylbenzylidene)sorbitol

37A

39200

006200-40-4

Bis (2-hydroxyethyl)-2-hydroxypropyl-3-(dodecyloxy) methylammonium chloride

The specific migration of this substance shall not exceed 1.8 mg/kg

37B

39815

182121-12-6

9,9 bis(methoxymethyl) fluorene

The quantity of this substance in the finished plastic material or article shall not exceed 0.05 mg/6 dm2

38A

40120

-

Bis(polyethyleneglycol) hydroxymethylphosphonate

The specific migration of this substance shall not exceed 0.6 mg/kg. Authorised only until 1 January 2002

44A

41680

000076-22-2

Camphor

(10)

47A

42320

007492-68- 4

Carbonic acid, copper salt

SML (T) = 30 mg/kg (7)

57A

43515

-

Chlorides of choline esters of coconut oil fatty acids

The quantity of this substance in the finished plastic material or article shall not exceed 0.9 mg/6 dm2

59A

45195

007787-70-4

Copper bromide

SML (T) = 30 mg/kg (7) (expressed as copper)

59B

45200

001335-23-5

Copper iodide

SML (T) = 30 mg/kg (7) (expressed as copper) and the specific migration of this substance shall not exceed 1 mg/kg (expressed as iodine)

60A

45450

068610-51-5

p-Cresol-dicyclopentadiene-isobutylene, copolymer

The specific migration of this substance shall not exceed 0.05 mg/kg (1)

72A

46880

065140-91-2 2

3,5-Di-tert-butyl-4-hydroxybenzyl phosphonic acid, monoethyl ester, calcium salt

The specific migration of this substance shall not exceed 6 mg/kg

73A

47680

000111-46-3

Diethyleneglycol

SML (T) = 30 mg/kg (3)

73B

48460

000075-37-6

1,1-Difluoroethane

73C

49485

134701-20-2

2,4-Dimethyl-6-(1-methylpentadecyl)phenol

The specific migration of this substance shall not exceed 1 mg/kg

75A

51700

147315-50-2

2-(4,6-Diphenyl-1,3,5-triazin-2-yl)-5-(hexyloxy) phenol

The specific migration of this substance shall not exceed 0.05 mg/kg

86A

53610

54453-03-1

Ethylenediaminetetraacetic acid, copper salt

SML (T) = 30 mg/kg (7) (expressed as copper)

86B

53650

000107-21-1

Ethyleneglycol

SML (T) = 30 mg/kg (3)

90A

54300

118337-09-0

2,2'-Ethylidenebis(4,6-di-tert-butyl-phenyl) fluorophosphonite

The specific migration of this substance shall not exceed 6 mg/kg

92A

54930

025359-91-5

Formaldehyde-1-naphthol, copolymer [=poly (1-hydroxynaphthyl-methane)]

The specific migration of this substance shall not exceed 0.05 mg/kg

125A

57800

018641-57-1

Glycerol tribehenate

140A

60480

003864-99-1

2-(2-Hydroxy-3,5-di-tert-butylphenyl)-5-Chlorobenzo Chlorobenzotriazole

The specific migration of this substance shall not exceed 30 mg/kg

169A

66560

004066-02-8

2,2'-Methylenebis(4-methyl-6-cyclohexylphenol)

SML (T) = 3 mg/kg

169B

66580

000077-62-3

2,2'-Methylenebis [4-methyl-6-(1-methylcyclo-hexyl) phenol]

SML (T) = 3 mg/kg (6)

172A

66755

002682-20-4

2-Methyl-4-isothiazolin-3-one

The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.02 mg/kg analytical tolerance included)

173A

67170

-

Mixture of (80 to100% w/w) 5,7-di-tert-butyl-3-(3,4- dimethylphenyl)-2(3H)- benzofuranone and (0-20% w/w) 5,7-di-tert-butyl-3-(2,3— di-methylphenyl)-2(3H)— benzofuranone

The specific migration of this substance shall not exceed 5 mg/kg

173B

67180

-

Mixture of (50% w/w) phthalic acid n-decyl n-octyl ester, (25% w/w) phthalic acid di-n- decyl ester, and (25% w/w) phthalic acid di-n-octyl ester

The specific migration of this substance shall not exceed 5 mg/kg (1)

179A

68145

080410-33-9

2,2',2"-Nitrilo[triethyl tris(3,3',5,5'-tetra-tert-butyl-1- 1'-bi-phenyl-2,2'-diyl) phosphite]

The specific migration of this substance shall not exceed 5 mg/kg (sum of phosphite and phosphate)

188A

71635

025151-96-6

Pentaerythritol dioleate

The specific migration of this substance shall not exceed 0.05 mg/kg. Not for use with foods for which simulant D is laid down in Directive 85/572/EEC laying down the list of simulants to be used for testing migration of constituents of plastic materials and articles intended to come into contact with foodstuffs 10.

191A

73720

000115-96-6

Phosphoric acid, trichloroethyl ester

The specific migration of this substance shall not be detectable (when measured by a method with a limit of detection of 0.02 mg/kg, analytical tolerance included)

191B

74010

145650-60-8

Phosphorous acid, bis(2,4-di-tert-butyl-6-methylphenyl) ethyl ester

The specific migration of this substance shall not exceed 5 mg/kg. (covering the sum of phosphite and phosphate)

195A

76721

009016-00-6 063148-62-9

Polydimethylsiloxane (mw > 6800)

In compliance with the specifications mentioned in Schedule 2B.

195B

76865

-

Polyesters of 1,2-propanediol and/or 1,3- and/or 1,4-butanediol and/or polypropyleneglycol with adipic acid, also end-capped with acetic acid or fatty acids C10-C18 or n-octanol and/or n-decanol

The specific migration of this substance shall not exceed 30 mg/kg

198A

77895

068439-49-6

Polyethyleneglycol (EO = 2-6) monoalkyl (C16-C18) ether

The specific migration of this substance shall not exceed 0.05 mg/kg

208A

81515

087189-25-1 1

Poly(zinc glycerolate)

210A

81760

-

Powders, flakes and fibres of stainless steel, tin and alloys of copper, tin and iron

SML (T) = 30 mg/kg (7) (expressed as copper); the specific migration of this substance shall not exceed 48 mg/kg (expressed as iron)

239A

85360

000109-43-3 3

Sebacic acid, dibutyl ester

240A

85610

-

Silicates, natural, silanated (with the exception of asbestos)

240B

85840

053320-86-8

Silicic acid, lithium magnesium sodium salt

SML (T) = 0.6 mg/kg (8) (expressed as lithium)

244A

86285

-

Silicon dioxide, silanated

259A

88640

008013-07-8 8

Soybean oil, epoxidized

In compliance with the specifications laid down in Schedule 2B

263A

89200

007617-31-4

Stearic acid, copper salt

SML (T) = 30 mg/kg (7) (expressed as copper)

263B

89440

-

Stearic acid, esters with ethyleneglycol

SML (T) = 30 mg/kg (3)

270A

92030

010124-44-4

Sulphuric acid, copper salt

SML (T) = 30 mg/kg (7) (expressed as copper)

276A

92700

078301-43-6

2,2,4,4-Tetramethyl-20-(2,3- epoxypropyl)-7-oxa-3,20- diazadispiro-[5.1.11.2]- heneicosan-21-one, polymer

The specific migration of this substance shall not exceed 5 mg/kg

276B

92930

120218-34-0 0

Thiodiethanolbis(5-methoxycarbonyl-2,6-dimethyl-1,4-dihydropyri-3 - Carboxylate- dine

The specific migration of this substance shall not exceed 6 mg/kg

280A

94960

000077-99-6 6

1,1,1-Trimethylolpropane

The specific migration of this substance shall not exceed 6 mg/kg

281A

95725

110638-71-6 6

Vermiculite, reaction product with citric acid, lithium salt

SML (T) = 0.6 mg/kg (8) (expressed as lithium)

281B

95855

007732-18-5

Water

In compliance with Directive 98/83/EC (i)11.

281C

95859

-

Waxes, refined, derived from petroleum based or synthetic hydrocarbon feedstocks

In compliance with the specifications laid down in Schedule 2B

281D

95883

-

White mineral oils, paraffinic, derived from petroleum based hydrocarbon feedstocks

In compliance with the specifications laid down in Schedule 2B

SCHEDULE 3

Regulation 12

SCHEDULE 2APRODUCTS OBTAINED BY BACTERIAL FERMENTATION

Regulation 5A

ITEM

PM/REF No.

CAS No.

NAME

Restrictions and specifications

1

18888

80181-31-3

3-hydroxybutanoic acid-3-hydroxypentanoic acid, copolymer

The specific migration of this substance shall not exceed 0.05 mg/kg for croton acid (as impurity) and in compliance with the specifications laid down in Schedule 2B

SCHEDULE 4

Regulations 8, 13

SCHEDULE 2BSPECIFICATIONS

Regulation 7A

ITEM

PM REF No

OTHER SPECIFICATIONS

1

18888

3-HYDROXYBUTANOIC ACID-3-HYDROXYPENTANOIC ACID, COPOLYMER

Definition

These 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-hydroxybutanoato-co-3-D-hydroxypentanoate).

CAS number

80181-31-3.

Structural formula

Image_r00000

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-hydroxybutanoato-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 chloroform or dichloromethane but practically insoluble in ethanol, aliphatic alkanes and water.

Migration

The migration of crotonic acid should not exceed 0.05 mg/kg food.

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

2

23547

POLYDIMETHYLSILOXANE (MW> 6800)

  • Minimum viscosity 100 centistokes at 25°C

3

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.

4

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)

5

76721

POLYDIMETHYLSILOXANE (Mw>6800)

  • Minimum viscosity 100 x 10-6 m2/s (=100 centistokes) at 25°C

6

88640

SOYBEAN OIL, EPOXIDIZED

  • Oxirane <8%, iodine number < 6

7

95859

WAXES, REFINED DERIVED FROM PETROLEUM BASED OR SYNTHETIC HYDROCARBON FEEDSTOCKS

  • The product should 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 x 10−6 m2/ s (=11 centistokes) at 100°C

    • Average molecular weight not less than 500

8

95883

WHITE MINERAL OILS, PARAFFINIC DERIVED FROM PETROLEUM BASED HYDROCARBON FEEDSTOCKS

  • The product should 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 x 10−6 m2/ s (=8.5 centistokes) at 100°C

    • Average molecular weight not less than 480

(Nid yw'r nodyn hwn yn rhan o'r Rheoliadau)

1

Mae'r Rheoliadau hyn yn diwygio, mewn perthynas â Chymru, Reoliadau Deunyddiau ac Eitemau Plastig mewn Cysylltiad â Bwyd 1998 (“Rheoliadau 1998”), sy'n gymwys i Brydain Fawr. Mae'r Rheoliadau hyn yn gweithredu Cyfarwyddeb y Comisiwn 1999/91/EC sy'n diwygio Cyfarwyddeb 90/128/EEC ynghylch deunyddiau ac eitemau plastig y bwriedir iddynt ddod i gysylltiad â bwydydd.

2

Mae'r Rheoliadau hyn—

a

yn diweddaru'r rhestr o fonomerau ac ychwanegion a all gael eu defnyddio wrth weithgynhyrchu deunyddiau ac eitemau plastig i ddod i gysylltiad â bwyd (rheoliadau 10 ac 11 ac Atodlenni 1 a 2);

b

yn gosod cyfyngiadau a manylebau mewn perthynas â rhai o'r monomerau a'r ychwanegion hyn (rheoliadau 5(a), 6, 8, 10, 11 a 12 ac Atodlenni 1, 2 a 4); yn benodol, mae math newydd o gyfyngiad yn cael ei gyflwyno (y swm mwyaf o'r sylwedd a ganiateir yn y deunydd neu'r eitem orffenedig wedi'i fynegi mewn miligramau am bob 6 decimetr sgwâr o'r arwynebedd sydd mewn cysylltiad â'r bwyd);

c

yn dod â chynhyrchion a geir drwy eplesu â bacteria o fewn cwmpas Rheoliadau 1998 ac yn gosod cyfyngiadau a manylebau ar gyfer cynhyrchion o'r fath (rheoliadau 4, 5(b), 7 a 12 ac Atodlen 3);

ch

yn cynnwys darpariaeth drosiannol (rheoliad 9); a

d

yn gwneud rhai diwygiadau canlyniadol (rheoliadau 3 a 13(a)) ac yn cywiro dau wall yn Rheoliadau 1998 (rheoliadau 10(ch) a 13(b)).

3

Mae arfarniad rheoleiddiol ar gyfer y Rheoliadau hyn wedi'i baratoi yn unol ag adran 65 o Ddeddf Llywodraeth Cymru 1998 ac wedi'i osod yn llyfrgell Cynulliad Cenedlaethol Cymru. Gellir cael copïau oddi wrth yr Asiantaeth Safonau Bwyd, Llawr 1, Southgate House, Caerdydd CF10 1EN.