Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2000 (S.I. No. 3162 of 2000)

Statutory Instrument 2000 No. 3162 file:///D/HTML/uk23153.htm[16.01.2025 11:29:45] Statutory Instrument 2000 No. 3162 The Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2000 © Crown Copyright 2000 The legislation contained on this web site is subject to Crown Copyright protection. It may be reproduced free of charge provided that it is reproduced accurately and that the source and copyright status of the material is made evident to users. It should be noted that the right to reproduce the text of Statutory Instruments does not extend to the Royal Arms and the Queen's Printer imprints. The text of this Internet version of the Statutory Instrument has been prepared to reflect the text as it was Made. The authoritative version is the Queen's Printer copy published by The Stationery Office Limited as the The Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2000, ISBN 0 11 018854 3. Purchase this item. 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STATUTORY INSTRUMENTS 2000 No. 3162 FOOD, ENGLAND The Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2000 Made 28th November 2000 Laid before Parliament 6th December 2000 Coming into force 31st December 2000 The Secretary of State, 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 of all other powers enabling him in that behalf, 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, hereby makes the following Regulations: Title, commencement and extent 1. - (1) These Regulations may be cited as the Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2000 and shall come into force on 31st December 2000. (2) These Regulations apply to England. Amendment of Regulations file:///bookstore.htm?AF=A10075&FO=38383&ACTION=AddItem&ProductID=0110188543 http://www.tso.co.uk/contacts/site.asp?FO=30883 Statutory Instrument 2000 No. 3162 file:///D/HTML/uk23153.htm[16.01.2025 11:29:45] 2. The Plastic Materials and Articles in Contact with Food Regulations 1998[2] ("the principal Regulations") shall be amended (in so far as they apply to England) as follows. 3. In regulation 2(1) (interpretation), in the definition of "the Directive" for the words "and 96/11/EC" there shall be substituted ", 96/11/EC and 1999/91/EC[3] (as corrected[4])". 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 1 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 inserted at the end the following paragraphs Statutory Instrument 2000 No. 3162 file:///D/HTML/uk23153.htm[16.01.2025 11:29:45] " (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 Schedule 1, 2 and 2A.". 9. In regulation 10 (offences) the following paragraph shall be inserted at the end Statutory Instrument 2000 No. 3162 file:///D/HTML/uk23153.htm[16.01.2025 11:29:45] " (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) (England) Regulations 2000 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 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 Schedulue 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 Statutory Instrument 2000 No. 3162 file:///D/HTML/uk23153.htm[16.01.2025 11:29:45] 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) shall 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 inserted 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 069158-41-4 " " " 054686-97-4 " " " 081541-12-0 " " ""; Statutory Instrument 2000 No. 3162 file:///D/HTML/uk23153.htm[16.01.2025 11:29:45] (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[5].". 12. After Schedule 2 there shall be inserted 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 by authority of the Secretary of State for Health. Gisela Stuart Parliamentary Under-Secretary of State, Department of Health Statutory Instrument 2000 No. 3162 file:///D/HTML/uk23153.htm[16.01.2025 11:29:45] 28th November 2000 SCHEDULE 1 Regulation 10 PART I LIST 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 001761 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 0.05mg/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 quanitity 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 Statutory Instrument 2000 No. 3162 file:///D/HTML/uk23153.htm[16.01.2025 11:29:45] 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/6dm2 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, triethyl ester 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 Statutory Instrument 2000 No. 3162 file:///D/HTML/uk23153.htm[16.01.2025 11:29:45] 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 Directive98/83/EC on the quality of water intended for human consumption[6] PART II LIST 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) = 6mg/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 1st 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- Maleic acid SML(T) = 30 mg/kg Statutory Instrument 2000 No. 3162 file:///D/HTML/uk23153.htm[16.01.2025 11:29:45] 16-7 (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 quanitity of this substance in the finished plastic material or article shall not exceed 1 mg/kg (expressed as epoxy group, molecular weight = 43) PART III LIST 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 0.01 mg/kg, analytical tolerance included) PART IV MONOMER TO BE ADDED TO SECTION B OF PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS Statutory Instrument 2000 No. 3162 file:///D/HTML/uk23153.htm[16.01.2025 11:29:45] Item 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 V LIST 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 050976 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 ester The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg. For use only as comonomer 12 33A 13060 004422 95-1 1,3,5 Benzenetricarboxylic acid trichloride The quantity of this substance in the finished plastic material or article shall not exceed 0.05 mg/6 dm2 (measured as 1,3,5 benzenetricarboxylic acid) 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 Statutory Instrument 2000 No. 3162 file:///D/HTML/uk23153.htm[16.01.2025 11:29:45] 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 0.05mg/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 Heptylaminoundecanoic 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- Methacrylic acid, 2- The specific Statutory Instrument 2000 No. 3162 file:///D/HTML/uk23153.htm[16.01.2025 11:29:45] 47-2 (dimethylamino)ethyl ester 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 2 Regulation 11 LIST 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- Acetic acid, copper salt SML(T) = 30 Statutory Instrument 2000 No. 3162 file:///D/HTML/uk23153.htm[16.01.2025 11:29:45] 12-5 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 migraton 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 1st January 2002 27A 36640 000123 77-3 Azodicarbonamide For use only as a blowing agent 31A 37360 000100 52-7 Benzaldehyde (10) 36A 38320 005242 49-9 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 Statutory Instrument 2000 No. 3162 file:///D/HTML/uk23153.htm[16.01.2025 11:29:45] 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 1st January 2002 44A 41680 000076 22-2 Camphor (10) 47A 42320 007492 68-4 Carbonic acid, copper salt SML(T) = 30 mg/kg (7) (expressed as copper) 57A 43515 - Chlorides of choline esters of coconut oil fatty acids The quantity of this substance in the finished Statutory Instrument 2000 No. 3162 file:///D/HTML/uk23153.htm[16.01.2025 11:29:45] 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 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 46-6 Diethyleneglycol SML(T) = 30 mg/kg (3) 73B 48460 000075 37-6 1,1-Difluoroethane 73C 49485 134701 20-5 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 054453 03-1 Ethylenediaminetetraacetic acid, copper salt SML(T) = 30 mg/kg (7) Statutory Instrument 2000 No. 3162 file:///D/HTML/uk23153.htm[16.01.2025 11:29:45] (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 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 (6) 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 to 100% 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) The specific Statutory Instrument 2000 No. 3162 file:///D/HTML/uk23153.htm[16.01.2025 11:29:45] 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 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 [7]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 191A 73720 0000115 96-8 Phosphoric acid, trichloroethyl 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 Statutory Instrument 2000 No. 3162 file:///D/HTML/uk23153.htm[16.01.2025 11:29:45] 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 laid down 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 Poly(zinc glycerolate) 210A 81760 - Powders, flakes and fibres of brass, bronze, copper, 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 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) Statutory Instrument 2000 No. 3162 file:///D/HTML/uk23153.htm[16.01.2025 11:29:45] (expressed as lithium) 244A 86285 - Silicon dioxide, silanated 259A 88640 008013 07-8 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 Thiodiethanolbis(5 methoxycarbonyl-2,6 dimethyl-1,4-dihydropri dine-3-carboxylate) The specific migration of this substance shall not exceed 6 mg/kg 280A 94960 000077 99-6 1,1,1-Trimethylolpropane The specific migration of this substance shall not exceed 6 mg/kg 281A 95725 110638 71-6 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 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, In compliance Statutory Instrument 2000 No. 3162 file:///D/HTML/uk23153.htm[16.01.2025 11:29:45] paraffinic, derived from petroleum based hydrocarbon feedstocks with the specifications laid down in Schedule 2B SCHEDULE 3 Regulation 12 " SCHEDULE 2A Regulation 5A PRODUCTS 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 crotonic acid (as impurity), and in compliance with the specifications laid down in Schedule 2B" SCHEDULE 4 Regulations 8 and 12 " SCHEDULE 2B Regulation 7A SPECIFICATIONS Item PM/REF No. Specifications 1 18888 3-HYDROXYBUTANOIC ACID-3-HYDROXYPENTANOIC ACID, COPOLYMER Definition These copolymers are produced by the controlled fermentation of Alcaligenes eutrophus using mixtures Statutory Instrument 2000 No. 3162 file:///D/HTML/uk23153.htm[16.01.2025 11:29:45] 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 Statutory Instrument 2000 No. 3162 file:///D/HTML/uk23153.htm[16.01.2025 11:29:45] 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 × 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 shall 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 × 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 shall 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 × 10-6 m2/s (=8.5 centistokes) at 100°C Average molecular weight not less than 480 " Statutory Instrument 2000 No. 3162 file:///D/HTML/uk23153.htm[16.01.2025 11:29:45] EXPLANATORY NOTE (This note is not part of the Regulations) 1. These Regulations amend, for England, 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 lists 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 mg per 6 dm2 of the surface in contact with 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 impact assessment, which includes a compliance cost assessment of the effect which these Regulations have on business costs, has been prepared and placed in the Library of each House of Parliament. Copies may be obtained from Branch 4 of the Chemical Safety and Toxicology Division of the Food Standards Agency, Ergon House, P.O. Box 31037, Horseferry Road, London SW1P 3WG. Notes: [1] 1990 c.16. Functions formerly exercisable by "the Ministers" are now exercisable in relation to England by the Secretary of State pursuant to paragraph 8 of Schedule 5 to the Food Standards Act 1999 (c. 28), and paragraphs 12 and 21 of that Schedule amend sections 17(1) and 48 of the 1990 Act. Functions of "the Ministers" so far as exercisable in relation to Wales were transferred to the National Assembly for Wales by the National Assembly for Wales (Transfer of Functions) Order 1999 (S.I. 1999/672) and those functions so far as exercisable in relation to Scotland were transferred to the Scottish Ministers by section 53 of the Scotland Act 1998 (c. 46). Regulation 13(4) of S.I. 2000/656 expressly authorises the Secretary of State to amend existing Regulations made by the Minister of Agriculture, Fisheries and Food (whether or not with others) under the Food Safety Act 1990.back [2] S.I. 1998/1376.back [3] OJ No. L310, 4.12.1999, p.41.back Statutory Instrument 2000 No. 3162 file:///D/HTML/uk23153.htm[16.01.2025 11:29:45] Other UK SIs | Home | National Assembly for Wales Statutory Instruments | Scottish Statutory Instruments | Statutory Rules of Northern Ireland | Her Majesty's Stationery Office We welcome your comments on this site © Crown copyright 2000 Prepared 6 December 2000 [4] OJ No. L249, 4.10.2000, p.26.back [5] S.I. 1987/1523, to which there are amendments not relevant to these Regulations.back [6] OJ No. L330, 5.12.1998, p.32.back [7] OJ No. L372, 31.12.85, p.14.back ISBN 0 11 018854 3 file:///stat.htm file:/// http://www.wales-legislation.hmso.gov.uk/legislation/wales/w-stat.htm http://www.scotland-legislation.hmso.gov.uk/legislation/scotland/s-stat.htm http://www.scotland-legislation.hmso.gov.uk/legislation/scotland/s-stat.htm http://www.northernireland-legislation.hmso.gov.uk/legislation/northernireland/ni-srni.htm http://www.hmso.gov.uk/ file:///hmsoform.htm