Welsh Statutory Instruments
2001 No. 1263 (W.70)

FOOD, WALES
The Plastic Materials and Articles in Contact with Food (Amendment) (Wales) Regulations 2001

Made
20th March 2001

Coming into force
1st April 2001

In exercise of the powers conferred by sections 16(2), 17(1), 26(1)(a) and 48(1) of the Food Safety Act 1990(1) and now vested in the National Assembly for Wales(2), the National Assembly for Wales, having had regard in accordance with section 48(4A) of that Act to relevant advice given by the Food Standards Agency and after consultation in accordance with section 48(4) and (4B) of that Act, makes the following Regulations:

Title, commencement and application

1.—(1) These Regulations may be cited as the Plastic Materials and Articles in Contact with Food (Amendment) (Wales) Regulations 2001 and shall come into force on 1st April 2001.

(2) These Regulations apply to Wales only.

Amendment of Regulations

2.  The Plastic Materials and Articles in Contact with Food Regulations 1998(3) (“the principal Regulations”) shall be amended (in so far as they apply to Wales) as follows.

3.  In regulation 2 (interpretation), in the definition of “the Directive” for the words “and 96/11/EC(4)” there shall be substituted “, 96/11/EC and 1999/91/EC(5) as corrected (6)”.

4.  For paragraph (4)(a) of regulation 3 (restriction on the use, sale or importation of plastic materials and articles) there shall be substituted—

“(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.  In regulation 4 (restriction on manufacture with monomers)—

(a)in paragraph (1)(c), for the words “restrictions (if any) specified” there shall be substituted the words “restrictions and specifications (if any) set out”; and

(b)paragraph (3)(d) shall be deleted.

6.  In regulation 5 (restriction on manufacture with additives)—

(a)for paragraph (1) there shall be substituted—

“(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.”; and

(b)there shall be added at the end the following paragraphs—

“(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.  After regulation 5 there shall be inserted the following regulation—

“Products obtained by bacterial fermentation

5A.  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.  After regulation 7 (transfer of constituents) there shall be inserted the following regulation—

“Specifications

7A.  Schedule 2B shall have effect for the purpose of giving the specifications referred to in column 4 in Schedules 1, 2 and 2A.”.

9.  In regulation 10 (offences) the following paragraph shall be added at the end—

“(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.  In Schedule 1 (monomers)—

(a)in Part I, in section A in column 4, for the heading “Restrictions” there shall be substituted “Restrictions and/or specifications”;

(b)the item number and letter, PM/REF No., CAS No., name, restriction and specification (if any) for each monomer identified in Part I of Schedule 1 to these Regulations shall be inserted in Section A of Part I of Schedule 1 to the principal Regulations at the place corresponding to the number and letter (if any) specified for that monomer in the column headed “item” in that Part of that Schedule to these Regulations;

(c)in Part I, in Section A for the entries in column 4 (restrictions and specifications), opposite to and corresponding to the items listed in Part II of Schedule 1 to these Regulations there shall be substituted the corresponding entries specified in the said Part II;

(d)in Part I, in Section A, in item 196 the entry in column 4 (restrictions and specifications) shall be deleted;

(e)in Part I, in Section B, item 67 and the entries for it shall be deleted;

(f)in Part I, in Section B, for the entries in column 4 (restrictions), opposite to and corresponding to the items listed in Part III of Schedule 1 to these Regulations there shall be substituted the corresponding entries specified in Part III of Schedule 1 to these Regulations;

(g)in Part I, in Section B, after the entries relating to item 77 there shall be inserted the item number and letter, PM/REF No., CAS No., name and restriction for the monomer identified in Part IV of Schedule 1 to these Regulations;

(h)in Part I, the items in Section B which are listed in Part V of Schedule 1 to these Regulations, and the entries for those items in that Section, shall be deleted and there shall be inserted in Section A at the place corresponding to the number and letter (if any) specified for each item in the column headed “Item No. for Section A” in Part V of Schedule 1 to these Regulations the entries relating to that item in the said Part V; and

(i)in Part II there shall be inserted at the end the following paragraph—

“4.  Where an entry in column 4 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.

(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.  In Schedule 2 (additives)—

(a)in Part I there shall be added an extra column, numbered “4” and headed “Restrictions and specifications”;

(b)the item number and letter, PM/REF No., CAS No., name restriction and specification (if any) for each additive identified in Schedule 2 to these Regulations shall be inserted in Part I of Schedule 2 to the principal Regulations at the place corresponding to the number and letter specified for that additive in the column headed “Item” in Schedule 2 to these Regulations;

(c)in Part I, for the entries in column 2 (CAS No.) and column 3 (name) for item 38 there shall be substituted the following—

087826- 41-3
Bis(methylbenzylidene) sorbitol

069158- 41-1
Bis(methylbenzylidene) sorbitol

054686- 97-4
Bis(methylbenzylidene) sorbitol

081541- 12-0
Bis(methylbenzylidene) sorbitol

(d)in Part I, for the entry in column 2 (CAS No.) for item 179 there shall be substituted the entry “037244-96-5”;

(e)In Part I, item 195 and the entries for it shall be deleted; and

(f)in Part II, there shall be inserted at the end the following paragraph—

“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 1987 (7).”.

12.  After Schedule 2 there shall be added as Schedules 2A and 2B the contents of Schedules 3 and 4 to these Regulations.

13.  In Schedule 3 (provisions applicable when testing compliance with the migration limits)—

(a)in paragraph 4(3) and (4), for “regulation 7 or Schedule 1” in each case there shall be substituted “regulation 7, Schedule 1 or Schedule 2”; and

(b)in paragraph 7(2)(c) for “M1 and M2” there shall be substituted “M2 and M3”.

Signed on behalf of the National Assembly for Wales under section 66(1) of the Government of Wales Act 1998(8)

D.Elis Thomas
The Presiding Officer of the National Assembly
20th March 2001

Regulation 10
SCHEDULE 1

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

Regulation 11

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

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

Regulation 12
SCHEDULE 3

Regulation 5A

“SCHEDULE 2APRODUCTS OBTAINED BY BACTERIAL FERMENTATION

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”

Regulations 8, 13
SCHEDULE 4

Regulation 7A

“SCHEDULE 2BSPECIFICATIONS

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

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