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

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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- 41-3Bis(methylbenzylidene) sorbitol
069158- 41-1Bis(methylbenzylidene) sorbitol
054686- 97-4Bis(methylbenzylidene) sorbitol
081541- 12-0Bis(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

ITEMPM/REF No.CAS No.NAMERestrictions and specifications
28A12761000693-57-212-Aminododecanoic acidThe specific migration of this substance shall not exceed 0.05 mg/kg
35A13180000498-66-8Bicyclo [2.2.1] hept-2-ene (=norbornene)The specific migration of this substance shall not exceed 0.05 mg/kg
35B1321000176-71-3Bis(4-aminocyclohexyl)methaneThe specific migration of this substance shall not exceed 0.05 mg/kg
63A14650000079-38-9ChlorotrifluoroethyleneThe quantity of this substance in the finished plastic material or article shall not exceed 0.05 mg/6 dm2
68A14841000599-64-44-CumylphenolThe specific migration of this substance shall not exceed 0.05 mg/kg
93A16694013811-50-2N,N'-Divinyl-2-imidazolidinoneThe quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg
93B16704000112-41-41-DodeceneThe specific migration of this substance shall not exceed 0.05 mg/kg
147A22331025513-64-8Mixture of (40% w/w) 1,6- diamino-2,2,4- trimethylhexane and (60% w/w) 1,6-diamino-2,4,4— trimethylhexaneThe quantity of this substance in the finished plastic material or article shall not exceed 5 mg/6 dm2
152A22550000498-66-8NorborneneThe specific migration of this substance shall not exceed 0.05 mg/kg
163A23175000122-52-1Phosphorous acid, triethylesterThe 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)
169A23547009016-00 6 063148-62-9Polydimethylsiloxane (MW>6800)In compliance with the specifications laid down in Schedule 2B.
206A25080001120-36-11-TetradeceneThe specific migration of this substance shall not exceed 0.05 mg/kg
214A25385000102-70-5TriallylamineIn compliance with the specifications laid down in Schedule 2B.
218A25927027955-94-81,1,1-Tris(4-hydroxyphenyl)ethaneThe quantity of this substance in the finished plastic material or article shall not exceed 0.5 mg/kg. For use only in polycarbonates
22326155001072-63-51-VinylimidazoleThe quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg
22526320002768-02-7VinyltrimethoxysilaneThe quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg
22626360007732-18-5WaterIn 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 COLUMNRESTRICTIONS AND SPECIFICATIONSIS MODIFIED

ITEMPM/REF No.CAS No.NameRestrictions and specifications
210060000075-07-0AcetaldehydeSML (T) = 6 mg/kg (2)
4013510001675-54-32,2-Bis(4- hydroxyphenyl)propane bis(2,3-epoxypropyl) ether (=BADGE)SML (T) = 1 mg/kg (9). Authorised only until 1 January 2005
5614200000105-60-2CaprolactamSML (T) = 15 mg/kg (5)
5714230002123-24-2Caprolactam, sodium saltSML (T) = 15 mg/kg (5) (expressed as caprolactam)
7915760000111-46-6DiethyleneglycolSML (T) = 30 mg/kg (3)
9816990000107-21-1EthyleneglycolSML (T) = 30 mg/kg (3)
10217160000097-53-0EugenolThe 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)
12819540000110-16-7Maleic acidSML (T) = 30 mg/kg (4)
12919960000108-31-6Maleic anhydrideSML (T) = 30 mg/kg (4) (expressed as maleic acid)
21425360-Trialkyl(C5-C15) acetic acid, 2,3-epoxypropyl esterThe 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 COLUMNRESTRICTIONSIS MODIFIED

ITEMPM/REF NoCAS/No.NameRestrictions
3416690001321-74-0DivinylbenzeneThe 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)
5620590000106-91-2Methacrylic acid, 2,3-epoxypropyl esterThe quantity of this material in the finished plastic material or article shall not exceed 5 mg/kg (expressed as epoxy group, molecular weight = 43)
6822720000140-66-94-tert-OctylphenolThe 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

ItemsPM/REF No.CAS No.NameRestrictions
77A25185000140-66-94-(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 BItem No. For Section APM/REF No.CAS No.NAMERestrictions and specifications
513A1100005976-02-8Acrylic acid, dicyclopentadienyl esterThe quantity of this substance in the finished plastic material or article shall not exceed 0.05 mg/6 dm2
613B11245002156-97-0Acrylic acid, dodecyl esterThe specific migration of this substance shall not exceed 0.05 mg/kg (1)
923A12265004074-90-2Adipic acid, divinyl dodecyl esterThe quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg. For use only as a comonomer.
1233A13060004422-95-11,3,5 - Benzenetricarboxylic acid trichlorideThe quantity of this substance in the finished plastic material or artical shall not exceed 0.05 mg/6dm2 (measured as 1,3,5 — benzenetricarboxylic
1649A13780002425-79-81,4-Butanediol bis(2,3- epoxypropyl) etherThe 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)
1952A14020000098-54-44-tert-ButylphenolThe specific migration of this substance shall not exceed 0.05 mg/kg
2273A15130000872-05-91-DeceneThe specific migration of this substance shall not exceed 0.05 mg/kg
3088A16360000576-26-12,6-DimethylphenolThe specific migration of this substance shall not exceed 0.05 mg/kg
3288B16450000646-06-01,3-DioxolaneThe specific migration of this substance shall not exceed 0.05 mg/kg
37111A18220068564-88-5N-Heptylaminoundeca noic acidThe specific migration of this substance shall not exceed 0.05 mg/kg (1)
41118A18820000592-41-61-HexeneThe specific migration of this substance shall not exceed 3 mg/kg
42121A19060000109-53-5Isobutyl vinyl etherThe quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg
43121B19150000121-91-5Isophthalic acidThe specific migration of this substance shall not exceed 5 mg/kg
49130A19990000079-39-0MethacrylamideThe 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)
50131A20050000096-05-9Methacrylic acid, allyl esterThe specific migration of this substance shall not exceed 0.05 mg/kg
55135A20530002867-47-2Methacrylic acid, 2-(dimethylamino) ethyl esterThe 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)
61145A21730000563-45-13-Methyl-1-buteneThe quantity of this substance in the finished plastic material or article shall not exceed 0.006 mg/6 dm2 For use only in polypropylene
70159A22937001623-05-8Perfluoropropyl perfluorovinyl etherThe specific migration of this substance shall not exceed 0.05 mg/kg
71173A23770000504-63-21,3-PropanediolThe specific migration of this substance shall not exceed 0.05 mg/kg
72177A23920000105-38-4Propionic acid, vinyl esterSML (T) = 6 mg/kg (2) (expressed as acetaldehyde)
74198A24760026914-43-2Styrenesulphonic acidThe specific migration of this substance shall not exceed 0.05 mg/kg
8322426170003195-78-6N-Vinyl-N-methylacetamideThe 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

ITEMPM/REF No.CAS No.NAMERestrictions and specifications
2A30080004180-12-5Acetic acid, copper saltSML (T) = 30 mg/kg (7) (expressed as copper)
7A30610-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).
7B30612-Acids C2-C24 aliphatic, linear, monocarboxylic, synthetic and their mono-, di— and triglycerol esters
9A31530123968-25-2Acrylic acid, 2,4-di-tert- pentyl-6-[1(3,5-di-tert-pentyl- 2-hydroxyphenyl) ethyl] phenyl esterThe specific migration of this substance shall not exceed 5 mg/kg
12A33801-n-Alkyl (C10-C13) benzenesulphonic acidThe specific migration of this substance shall not exceed 30 mg/kg
12B34240-Alkyl(C10-C20) sulphonic acid, esters with phenolsThe specific migration of this substance shall not exceed 6 mg/kg. Authorised only until 1 January 2002.
27A36640000123-77-3AzodicarbonamideFor use only as blowing agent.
31A37360000100-52-7Benzaldehyde(10)
36A38320005242-49-64-(2-Benzoxazolyl)-4'-(5- methyl-2-benzoxazolyl) stilbeneIn compliance with the specifications laid down in Schedule 2B
36B38510136504-96-61,2-Bis(3-aminopropyl) ethylenediamine, polymer with N-butyl-2,2,6,6- tetramethyl-4-piperidinamine and 2,4,6-trichloro-1,3,5— triazineThe specific migration of this substance shall not exceed 5 mg/kg
36C38515001533-45-54,4'-Bis(2-benzoxazolyl)stilbeneThe specific migration of this substance shall not exceed 0.05 mg/kg (1)
36D38810080693-00-1Bis(2,6-di-tert-butyl-4-methylphenyl) pentaerythritol diphosphiteThe specific migration of this substance shall not exceed 5 mg/kg (sum of phosphite and phosphate)
36E38879135861-56-2Bis(3,4— dimethylbenzylidene)sorbitol
37A39200006200-40-4Bis (2-hydroxyethyl)-2-hydroxypropyl-3-(dodecyloxy) methylammonium chlorideThe specific migration of this substance shall not exceed 1.8 mg/kg
37B39815182121-12-69,9 bis(methoxymethyl) fluoreneThe quantity of this substance in the finished plastic material or article shall not exceed 0.05 mg/6 dm2
38A40120-Bis(polyethyleneglycol) hydroxymethylphosphonateThe specific migration of this substance shall not exceed 0.6 mg/kg. Authorised only until 1 January 2002
44A41680000076-22-2Camphor(10)
47A42320007492-68- 4Carbonic acid, copper saltSML (T) = 30 mg/kg (7)
57A43515-Chlorides of choline esters of coconut oil fatty acidsThe quantity of this substance in the finished plastic material or article shall not exceed 0.9 mg/6 dm2
59A45195007787-70-4Copper bromideSML (T) = 30 mg/kg (7) (expressed as copper)
59B45200001335-23-5Copper iodideSML (T) = 30 mg/kg (7) (expressed as copper) and the specific migration of this substance shall not exceed 1 mg/kg (expressed as iodine)
60A45450068610-51-5p-Cresol-dicyclopentadiene-isobutylene, copolymerThe specific migration of this substance shall not exceed 0.05 mg/kg (1)
72A46880065140-91-2 23,5-Di-tert-butyl-4-hydroxybenzyl phosphonic acid, monoethyl ester, calcium saltThe specific migration of this substance shall not exceed 6 mg/kg
73A47680000111-46-3DiethyleneglycolSML (T) = 30 mg/kg (3)
73B48460000075-37-61,1-Difluoroethane
73C49485134701-20-22,4-Dimethyl-6-(1-methylpentadecyl)phenolThe specific migration of this substance shall not exceed 1 mg/kg
75A51700147315-50-22-(4,6-Diphenyl-1,3,5-triazin-2-yl)-5-(hexyloxy) phenolThe specific migration of this substance shall not exceed 0.05 mg/kg
86A5361054453-03-1Ethylenediaminetetraacetic acid, copper saltSML (T) = 30 mg/kg (7) (expressed as copper)
86B53650000107-21-1EthyleneglycolSML (T) = 30 mg/kg (3)
90A54300118337-09-02,2'-Ethylidenebis(4,6-di-tert-butyl-phenyl) fluorophosphoniteThe specific migration of this substance shall not exceed 6 mg/kg
92A54930025359-91-5Formaldehyde-1-naphthol, copolymer [=poly (1-hydroxynaphthyl-methane)]The specific migration of this substance shall not exceed 0.05 mg/kg
125A57800018641-57-1Glycerol tribehenate
140A60480003864-99-12-(2-Hydroxy-3,5-di-tert-butylphenyl)-5-Chlorobenzo ChlorobenzotriazoleThe specific migration of this substance shall not exceed 30 mg/kg
169A66560004066-02-82,2'-Methylenebis(4-methyl-6-cyclohexylphenol)SML (T) = 3 mg/kg
169B66580000077-62-32,2'-Methylenebis [4-methyl-6-(1-methylcyclo-hexyl) phenol]SML (T) = 3 mg/kg (6)
172A66755002682-20-42-Methyl-4-isothiazolin-3-oneThe 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)
173A67170-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)— benzofuranoneThe specific migration of this substance shall not exceed 5 mg/kg
173B67180-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 esterThe specific migration of this substance shall not exceed 5 mg/kg (1)
179A68145080410-33-92,2',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)
188A71635025151-96-6Pentaerythritol dioleateThe 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).
191A73720000115-96-6Phosphoric acid, trichloroethyl esterThe 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)
191B74010145650-60-8Phosphorous acid, bis(2,4-di-tert-butyl-6-methylphenyl) ethyl esterThe specific migration of this substance shall not exceed 5 mg/kg. (covering the sum of phosphite and phosphate)
195A76721009016-00-6 063148-62-9Polydimethylsiloxane (mw > 6800)In compliance with the specifications mentioned in Schedule 2B.
195B76865-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-decanolThe specific migration of this substance shall not exceed 30 mg/kg
198A77895068439-49-6Polyethyleneglycol (EO = 2-6) monoalkyl (C16-C18) etherThe specific migration of this substance shall not exceed 0.05 mg/kg
208A81515087189-25-1 1Poly(zinc glycerolate)
210A81760-Powders, flakes and fibres of stainless steel, tin and alloys of copper, tin and ironSML (T) = 30 mg/kg (7) (expressed as copper); the specific migration of this substance shall not exceed 48 mg/kg (expressed as iron)
239A85360000109-43-3 3Sebacic acid, dibutyl ester
240A85610-Silicates, natural, silanated (with the exception of asbestos)
240B85840053320-86-8Silicic acid, lithium magnesium sodium saltSML (T) = 0.6 mg/kg (8) (expressed as lithium)
244A86285-Silicon dioxide, silanated
259A88640008013-07-8 8Soybean oil, epoxidizedIn compliance with the specifications laid down in Schedule 2B
263A89200007617-31-4Stearic acid, copper saltSML (T) = 30 mg/kg (7) (expressed as copper)
263B89440-Stearic acid, esters with ethyleneglycolSML (T) = 30 mg/kg (3)
270A92030010124-44-4Sulphuric acid, copper saltSML (T) = 30 mg/kg (7) (expressed as copper)
276A92700078301-43-62,2,4,4-Tetramethyl-20-(2,3- epoxypropyl)-7-oxa-3,20- diazadispiro-[5.1.11.2]- heneicosan-21-one, polymerThe specific migration of this substance shall not exceed 5 mg/kg
276B92930120218-34-0 0Thiodiethanolbis(5-methoxycarbonyl-2,6-dimethyl-1,4-dihydropyri-3 - Carboxylate- dineThe specific migration of this substance shall not exceed 6 mg/kg
280A94960000077-99-6 61,1,1-TrimethylolpropaneThe specific migration of this substance shall not exceed 6 mg/kg
281A95725110638-71-6 6Vermiculite, reaction product with citric acid, lithium saltSML (T) = 0.6 mg/kg (8) (expressed as lithium)
281B95855007732-18-5WaterIn compliance with Directive 98/83/EC (i)(11).
281C95859-Waxes, refined, derived from petroleum based or synthetic hydrocarbon feedstocksIn compliance with the specifications laid down in Schedule 2B
281D95883-White mineral oils, paraffinic, derived from petroleum based hydrocarbon feedstocksIn compliance with the specifications laid down in Schedule 2B

Regulation 12

SCHEDULE 3

Regulation 5A

SCHEDULE 2APRODUCTS OBTAINED BY BACTERIAL FERMENTATION

ITEMPM/REF No.CAS No.NAMERestrictions and specifications
11888880181-31-33-hydroxybutanoic acid-3-hydroxypentanoic acid, copolymerThe 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

ITEMPM REF NoOTHER SPECIFICATIONS
1188883-HYDROXYBUTANOIC ACID-3-HYDROXYPENTANOIC ACID, COPOLYMER
DefinitionThese 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 namePoly (3-D-hydroxybutanoato-co-3-D-hydroxypentanoate).
CAS number80181-31-3.
Structural formula

where n/(m+n) greater than 0 and less or equal to 0.25

Average molecular weightNot less than 150,000 Daltons (measured by gel permeation chromatography).
AssayNot 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.
DescriptionWhite to off-white powder after isolation.
Characteristics
Identification tests:
SolubilitySoluble in chlorinated hydrocarbons such as chloroform or dichloromethane but practically insoluble in ethanol, aliphatic alkanes and water.
MigrationThe migration of crotonic acid should not exceed 0.05 mg/kg food.
PurityPrior to granulation the raw material copolymer powder must contain:
—NitrogenNot more than 2,500 mg/kg of plastic
—ZincNot more than 100 mg/kg of plastic
—CopperNot more than 5 mg/kg of plastic
—LeadNot more than 2 mg/kg of plastic
—ArsenicNot more than 1 mg/kg of plastic
—ChromiumNot more than 1 mg/kg of plastic
223547

POLYDIMETHYLSILOXANE (MW> 6800)

  • Minimum viscosity 100 centistokes at 25°C

325385

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.

438320

4-(2-BENZOXAZOLYL) -4'-(5-METHYL-2-BENZOXAZOLYL) STILBENE

  • Not more than 0.05% w/w (quantity of substance used/quantity of the formulation)

576721

POLYDIMETHYLSILOXANE (Mw>6800)

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

688640

SOYBEAN OIL, EPOXIDIZED

  • Oxirane <8%, iodine number < 6

795859

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

895883

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

Explanatory Note

(This note does not form part of the Regulations)

1.  These Regulations amend, in relation to Wales, the Plastic Materials and Articles in Contact with Food Regulations 1998 (“the 1998 Regulations”), which apply to Great Britain. These Regulations implement Commission Directive 1999/91/EC amending Directive 90/128/EEC relating to plastic materials and articles intended to come into contact with foodstuffs.

2.  These Regulations—

(a)update the list of monomers and additives which can be used in the manufacture of plastic materials and articles intended to come into contact with food (regulations 10 and 11 and Schedules 1 and 2);

(b)impose restrictions and specifications in respect of some of those monomers and additives (regulations 5(a), 6, 8, 10, 11 and 12 and Schedules 1, 2 and 4); in particular, a new type of restriction is introduced (maximum permitted quantity of the substance in the finished material or article expressed as milligrammes per 6 square decimetres of the surface in contact with the food);

(c)bring products obtained by bacterial fermentation within the scope of the 1998 Regulations and impose restrictions and specifications for such products (regulations 4, 5(b), 7 and 12 and Schedule 3);

(d)include a transitional provision (regulation 9); and

(e)make some consequential amendments (regulations 3 and 13(a)) and correct two errors in the 1998 Regulations (regulations 10(d) and 13(b)).

3.  A regulatory appraisal for these Regulations has been prepared pursuant to section 65 of the Government of Wales Act 1998 and placed in the library of the National Assembly for Wales. Copies may be obtained from the Food Standards Agency, 1st Floor, Southgate House, Cardiff CF10 1EN.

(2)

The National Assembly for Wales (Transfer of Functions) Order 1999 (SI 1999/672)

(3)

S.I. 1998/1376.

(4)

OJ No. L161, 12.3.96, p.26.

(5)

OJ No. L310, 4.12.99, p.41.(f) OJ No. L249, 4.10.2000, p.26.

(6)

OJ No. L249, 4.10.2000, p.26.

(7)

SI 1987/1523, to which there are amendments not relevant to these Regulations.

(9)

OJ No. L330, 5.12.1998, p.32.

(10)

OJ No. L372, 31.12.85, p.14.

(11)

OJ No. L330, 5.12.1998, p.32.

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