Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2005 (S.I. No. 325 of 2005)

The Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2005 file:///D/HTML/uk60634.htm[16.01.2025 11:48:31] Statutory Instrument 2005 No. 325 The Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2005 © Crown Copyright 2005 Statutory Instruments printed from this website are printed under the superintendence and authority of the Controller of HMSO being the Queen's Printer of Acts of Parliament. 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 Queen's Printer imprints which should be removed from any copies of the Statutory Instrument which are issued or made available to the public. This includes reproduction of the Statutory Instrument on the Internet and on intranet sites. The Royal Arms may be reproduced only where they are an integral part of the original document. The text of this Internet version of the Statutory Instrument which is published by the Queen's Printer of Acts of Parliament has been prepared to reflect the text as it was Made. A print version is also available and is published by The Stationery Office Limited as the The Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2005, ISBN 0110723449. The print version may be purchased by clicking here. Braille copies of this Statutory Instrument can also be purchased at the same price as the print edition by contacting TSO Customer Services on 0870 600 5522 or e-mail: customer.services@tso.co.uk. Further information about the publication of legislation on this website can be found by referring to the Frequently Asked Questions. To ensure fast access over slow connections, large documents have been segmented into "chunks". Where you see a "continue" button at the bottom of the page of text, this indicates that there is another chunk of text available. This Statutory Instrument has been printed in substitution of the SI of the same number and is being issued free of charge to all known recipients of that Statutory Instrument. STATUTORY INSTRUMENTS 2005 No. 325 FOOD, ENGLAND The Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2005 http://www.opsi.gov.uk/bookstore.htm?AF=A10075&FO=38383&Action=AddItem&ProductID=0110723449 mailto:customer.services@tso.co.uk http://www.hmso.gov.uk/faqs.htm The Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2005 file:///D/HTML/uk60634.htm[16.01.2025 11:48:31] Made 9th February 2005 Laid before Parliament 1st March 2005 Coming into force 11th March 2005 The Secretary of State, in exercise of the powers conferred on him by sections 16(2), 17(1), 26(1)(a) and (3) and 48(1) of the Food Safety Act 1990[1] and now vested in him[2], having had regard, in accordance with section 48(4A) of that Act, to relevant advice given by the Food Standards Agency, and after consultation as required by Article 9 of Regulation (EC) No. 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety[3], makes the following Regulations: Title, application and commencement 1. These Regulations may be cited as the Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2005, shall apply in relation to England only and shall come into force on 11th March 2005. Amendments to the Plastic Materials and Articles in Contact with Food Regulations 1998 2. The Plastic Materials and Articles in Contact with Food Regulations 1998[4] are amended, in so far as they apply in relation to England, in accordance with regulations 3 to 16 of these Regulations. 3. In regulation 2 (interpretation) (a) in paragraph (1) (i) for the definition of "additive" substitute ""additive" means a substance as defined in paragraph 1 of the general introduction to Annex III to the Directive as read with paragraph 3 of Article 4 of the Directive;"; (ii) in the definition of "Council Directive 82/711", omit the words "as amended" to the end; (iii) after the definition of "Council Directive 82/711" insert the following definitions " "Council Directive 88/388" means Council Directive 88/388/EEC on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production[5]; "Council Directive 89/107" means Council Directive 89/107/EEC on the approximation of the laws of the Member States concerning food additives authorised in foodstuffs intended for human consumption[6];"; (iv) omit the definition of "EEA Agreement"; (v) for the definition of "EEA State" substitute ""EEA State" means a Member State (other than the United Kingdom), Norway, Iceland and Liechtenstein;"; http://www.opsi.gov.uk/si/si2005/20050325.htm#note1 http://www.opsi.gov.uk/si/si2005/20050325.htm#note2 http://www.opsi.gov.uk/si/si2005/20050325.htm#note3 http://www.opsi.gov.uk/si/si2005/20050325.htm#note4 http://www.opsi.gov.uk/si/si2005/20050325.htm#note5 http://www.opsi.gov.uk/si/si2005/20050325.htm#note6 The Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2005 file:///D/HTML/uk60634.htm[16.01.2025 11:48:31] (vi) after the definition of "EEA State" insert the following definition " "EFSA" means the European Food Safety Authority;"; (vii) after the definition of "preparation" insert the following definition " "the purity Directives" means Commission Directive 95/31/EC laying down specific criteria of purity concerning sweeteners for use in foodstuffs[7], Commission Directive 95/45/EC laying down purity criteria concerning colours for use in foodstuffs[8] and Commission Directive 96/77/EC laying down specific purity criteria for food additives other than colours or sweeteners[9];"; (b) after paragraph (5) add " (6) Any reference in these Regulations to a Community instrument shall be construed as a reference to that instrument as amended at the time the Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2005 were made.". 4. In regulation 4 (restriction on the use of monomers in the manufacture of plastic materials and articles) (a) in paragraph (2) omit sub-paragraphs (a) and (b); (b) in paragraph (5)(b)(ii) after the word "material" in each case insert the words "or article". 5. In regulation 5 (restriction on the use of additives in the manufacture of plastic materials and articles) (a) in paragraph (1) add after sub-paragraph (d) " (e) any food additive authorised by Council Directive 89/107 or any flavouring authorised by Council Directive 88/388 that migrates into food (i) i)in a quantity that has a technological function in the final food product, or (ii) where the food is of a type for which the use of any such food additive or flavouring is so authorised, in quantities exceeding the limits provided for in Council Directive 89/107 or Council Directive 88/388 as appropriate, or in Schedule 2 to these Regulations, whichever is the lower."; (b) in paragraph (4)(b)(ii) after the word "material" in each case insert the words "or article". http://www.opsi.gov.uk/si/si2005/20050325.htm#note7 http://www.opsi.gov.uk/si/si2005/20050325.htm#note8 http://www.opsi.gov.uk/si/si2005/20050325.htm#note9 The Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2005 file:///D/HTML/uk60634.htm[16.01.2025 11:48:31] 6. After regulation 5A insert the following regulation " Applications for inclusion of an additive in the Community list of authorised additives 5B. - (1) This regulation applies where a person wishes to make an application for the inclusion of an eligible additive in the Community list referred to in Article 4 of the Directive. (2) An application mentioned in paragraph (1) including supporting data must be made to EFSA before 1st January 2007. (3) If, during examination of the data referred to in paragraph (2), EFSA calls for supplementary information, the eligible additive may, if permitted to be used under English law, continue to be so used until EFSA has issued an opinion, provided such information is submitted within the time limits specified by EFSA. (4) For the purposes of this regulation an eligible additive is one whose use is permitted in one or more Member States before 1st January 2007.". 7. For regulation 8 (labelling) substitute the following " At marketing stages other than the retail stage a person who is in possession of any plastic material or article intended to come into contact with food shall ensure that the plastic material or article is accompanied by a written declaration which (a) attests that it complies with the legislation applicable to it; and (b) provides, in respect of substances that are subject to a restriction on quantities migrating into food, information obtained from experimental data or theoretical calculation concerning (i) i)the levels of migration specific to those substances; (ii) where appropriate, purity criteria in accordance with the purity Directives.". 8. In regulation 10 (offences) (a) in paragraph (1) for the figure "8(1)" substitute the figure "8"; (b) after paragraph (24) add " (25) In any proceedings for an offence under these Regulations it shall be a defence to prove that (a) the act constituting the offence was committed in relation to a plastic material or article which was manufactured or imported into the European Community before 1st March 2006; and The Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2005 file:///D/HTML/uk60634.htm[16.01.2025 11:48:31] (b) the act constituting the offence would not have constituted an offence under these Regulations if the amendments made to them by the Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2005 had not been in force at the time that act occurred.". 9. In Schedule 1, Part I (a) in Section A (monomers authorised without time limit) (i) insert in the appropriate numerical order the entries set out in Schedule 1 to these Regulations; (ii) for items 15A, 39, 70, 120B, 147, 147A, 147B and 188 substitute the entries set out in Schedule 2 to these Regulations; (iii) omit items 76B and 76C with their corresponding entries; (b) omit Sections B and C. 10. In Schedule 1, Part II (supplementary) paragraph 4 (a) at the end of note (21) for "and 18670," substitute ",18670, 54880 and 59280"; (b) after note (25) add the following " (27) QMA(T) in this case means that the restriction shall not be exceeded by the sum of the residual quantities of the following substances having PM/REF Nos. 10599/90A, 10599/91, 10599/92A and 10599/93. (28) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances having PM/REF Nos. 13480 and 39680. (29) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances having PM/REF Nos. 22775 and 69920. (32) Compliance testing when there is a fat contact should be performed using isooctane as substitute of simulant D (unstable). (33) QMA(T) in this case means that the restriction shall not be exceeded by the sum of the residual quantities of the following substances having PM/REF Nos. 14800 and 45600." 11. In Schedule 2, Part I (incomplete list of additives used in the manufacture of plastic materials and articles) (a) insert in appropriate numerical order the entries set out in Schedule 3 The Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2005 file:///D/HTML/uk60634.htm[16.01.2025 11:48:31] to these Regulations; (b) for items 60A and 198A substitute the entries set out in Schedule 4 to these Regulations; (c) omit items 112, 173A, 195C and 240 with their corresponding entries. 12. In Schedule 2, Part II (incomplete list of additives used in the manufacture of plastic materials and articles to which paragraph 5 of Part III of Schedule 2 applies) (a) insert in appropriate numerical order the entries set out in Schedule 5 to these Regulations; (b) omit items 28, 80 and 111A with their corresponding entries. 13. In Schedule 2, Part III (supplementary) (a) in paragraph 4 (i) in note (8), insert in the appropriate numerical order "38000" and "67896"; (ii) in note (10), after "levels" insert "(expressed as iodine)"; (iii) at the end of note (21), for "and 18670," substitute ",18670, 54880 and 59280"; (iv) after note (24) add the following " (26) QMA(T) in this case means that the restriction shall not be exceeded by the sum of the residual quantities of the following substances mentioned as reference Nos. 14950, 15700, 16240, 16570, 16600, 16630, 18640, 19110, 22332, 22420, 22570, 25210, 25240 and 25270. (27) QMA(T) in this case means that the restriction shall not be exceeded by the sum of the residual quantities of the following substances having PM/REF Nos. 10599/90A, 10599/91, 10599/92A and 10599/93. (28) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances having PM/REF Nos. 13480 and 39680. (29) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances having PM/REF Nos. 22775 and 69920. (30) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances having PM/REF Nos. 86480, 86960 and 87120. (31) Compliance testing when there is a fat contact should be performed using saturated fatty food simulants as simulant D. The Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2005 file:///D/HTML/uk60634.htm[16.01.2025 11:48:31] (32) Compliance testing when there is a fat contact should be performed using isooctane as substitute of simulant D (unstable). (33) QMA(T) in this case means that the restriction shall not be exceeded by the sum of the residual quantities of the following substances having PM/REF Nos. 14800 and 45600. (34) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances having PM/REF Nos. 55200, 55280 and 55360."; (b) in paragraph 5 for "1st January 2004" substitute "1st July 2006". 14. In Schedule 2A (products obtained by bacterial fermentation) for the entry in the column headed "restrictions and specifications" substitute the following "In compliance with specifications included in Schedule 2B". 15. For the table in Schedule 2B (specifications) substitute the table set out in Schedule 6 to these Regulations. 16. For paragraph 4(b) of Part I (basic rules) of Schedule 4 (overall and specific migration testing using food simulants) substitute the following " (b) omit the migration, the substitute or the alternative tests where (i) i)there is conclusive proof that the migration limits cannot be exceeded in any foreseeable conditions of use of the material or article, or (ii) the conditions for non-compulsory testing set out in article 8.2 or 8.3 of the Directive are met.". Signed by authority of the Secretary of State for Health Melanie Johnson Parliamentary Under Secretary of State Department of Health 9th February 2005 SCHEDULE 1 Regulation 9(a)(i) The Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2005 file:///D/HTML/uk60634.htm[16.01.2025 11:48:31] (ENTRIES TO BE INSERTED IN SECTION A OF PART I OF SCHEDULE 1) 1 2 3 4 Item PM/REF No. CAS No. Name Restrictions and specifications 6A 10599/90A 061788 89-4 Acids, fatty, unsaturated (C18), dimers, distilled QMA(T) = 0.05 mg/6 dm2 (27); 6B 10599/91 061788 89-4 Acids, fatty, unsaturated (C18), dimers, non distilled QMA(T) = 0.05 mg/6 dm2 (27); 6C 10599/92A 068783 41-5 Acids, fatty, unsaturated (C18), dimers, hydrogenated, distilled QMA(T) = 0.05 mg/6 dm2 (27); 6D 10599/93 068783 41-5 Acids, fatty, unsaturated (C18), dimers, hydrogenated, non distilled QMA(T) = 0.05 mg/6 dm2 (27); 37A 13323 000102 40-9 1,3-Bis(2-hydroxyethoxy) benzene SML = 0.05 mg/kg 68MA 14800 003724 65-0 Crotonic acid QMA(T) = 0.05 mg/6 dm2 (33); 87A 16210 006864 37-5 3,3'-Dimethyl-4,4' diaminodicyclohexylmethane SML = 0.05 mg/kg 2 (32);. To be used only in polyamides. 89A 16540 000102 09-0 Diphenyl carbonate SML = 0.05 mg/kg 101A 17110 016219 75-3 5 Ethylidenebicyclo[2,2,1]hept 2-ene QMA = 0.05 mg/6 dm2. The ratio surface / quantity of food shall be lower than 2 dm2/kg 118MA 18700 000629 11-8 1,6-Hexanediol SML = 0.05 mg/kg 120ZA 18896 001679 51-2 4-(Hydroxymethyl)-1 cyclohexene SML = 0.05 mg/kg 135BM 20440 000097 90-5 Methacrylic acid, diester with ethyleneglycol SML = 0.05 mg/kg 142A 21400 054276- Methacrylic acid, QMA = 0.05 The Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2005 file:///D/HTML/uk60634.htm[16.01.2025 11:48:31] 35-6 sulphopropyl ester mg/6 dm2 156XA 22775 000144 62-7 Oxalic acid SML(T) = 6 mg/kg(29) 161A 23070 000102 39-6 (1,3-Phenylenedioxy)diacetic acid QMA = 0.05 mg/6 dm2 SCHEDULE 2 Regulation 9(a)(ii) (ENTRIES TO BE SUBSTITUTED FOR ENTRIES IN SECTION A OF PART I OF SCHEDULE 1) 1 2 3 4 Item PM/REF No. CAS No. Name Restrictions and specifications 15A 11530 00999 61-1 Acrylic acid, 2 hydroxypropyl ester QMA = 0.05 mg/6 dm2 for the sum of acrylic acid, 2 hydroxypropyl ester and acrylic acid, 2 hydroxyisopropyl ester and in compliance with the specifications laid down in Schedule 2B 39 13480 000080 05-7 2,2-Bis(4 hydroxyphenyl) propane SML(T) = 0.6 mg/kg (28) 70 14950 003173 53-3 Cyclohexyl isocyanate QM(T) = 1 mg/kg in FP (expressed as NCO) (26) 120B 18898 000103 90-2 N-(4 Hydroxyphenyl) acetamide SML = 0.05 mg/kg 147 22150 000691 37-2 4-Methyl-1 pentene SML = 0.05 mg/kg 147A 22331 025513 64-8 Mixture of (35 45% w/w) 1,6 diamino-2,2,4 trimethylhexane and (55-65% w/w) 1,6 diamino-2,4,4 trimethylhexane QMA = 5 mg/6 dm2 147B 22332 - Mixture of (40% QM(T) = 1 mg/kg The Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2005 file:///D/HTML/uk60634.htm[16.01.2025 11:48:31] w/w) 2,2,4 trimethylhexane 1,6-diisocyanate and (60% w/w) 2,4,4 trimethylhexane 1,6-diisocyanate (expressed as NCO) (26) 188 24190 065997 05-9 Rosin Wood SCHEDULE 3 Regulation 11(a) (ENTRIES TO BE INSERTED IN PART I OF SCHEDULE 2) 1 2 3 4 Item PM/REF No. CAS No. Name Restrictions and specifications 18A 34850 143925 92-2 Amines, bis(hydrogenated tallow alkyl) oxidised QM = For use only: (a) in polyolefines at 0.1% (w/w) but not in LDPE when it is in contact with foods for which the Directive 85/572/EEC establishes a reduction factor less than 3; (b) in PET at 0.25% (w/w) in contact with foods other than those for which the simulant D is laid down in Directive 85/572/EEC The Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2005 file:///D/HTML/uk60634.htm[16.01.2025 11:48:31] 18B 34895 000088 68-6 2-Aminobenzamide SML = 0.05 mg/kg. To be used only for PET for water and beverages 37AA 39680 000080 05-7 2,2-Bis(4 hydroxyphenyl) propane SML(T) = 0.6 mg/kg (28) 51A 42880 008001 79-4 Castor oil 61A 45600 003724 65-0 Crotonic acid QMA(T) = 0.05 mg/6 dm2 (33) 61B 45640 005232 99-5 2-Cyano-3,3 dipheneylacrylic acid, ethyl ester SML = 0.05 mg/kg 69A 46700 - 5,7-di-tert-Butyl-3-(3,4 and 2,3-di methylphenyl)-3H benzofuran-2-one containing: SML = 5 mg/kg (a) 5,7-di-tert-butyl-3 (3,4 dimethylphenyl)-3H benzofuran-2-one (80 100% w/w); and (b) 5,7-di-tert-butyl-3 (2,3 dimethylphenyl)-3H benzofuran-2-one (0 20% w/w) 69B 46720 004130 42-1 2,6-Di-tert-butyl-4 ethylphenol QMA = 4.8 mg/6 dm2 109A 56535 - Glycerol, esters with nonanoic acid 131A 59280 000100 97-0 Hexamethylenetetramine SML(T) = 15 mg/kg (21) (expressed as Formaldehyde) 178A 68078 027253 31-2 Neodecanoic acid, cobalt salt SML(T) = 0.05 mg/kg (expressed as Neodecanoic acid) and SML(T) = 0.05 mg/kg (13) (expressed as Cobalt). Not The Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2005 file:///D/HTML/uk60634.htm[16.01.2025 11:48:31] for use in polymers contacting foods for which simulant D is laid down in Directive 85/572/EEC 182A 69920 000144 62-7 Oxalic acid SML(T) = 6 mg/kg (29) 195D 76866 - Polyesters of 1,2 propanediol and/or 1,3 and/or 1,4-butanediol and/or polypropyleneglycol with adipic acid, which may be end-capped with acetic acid or fatty acids C12-C18 or n-octanol and / or n-decanol SML = 30 mg/kg 240ZA 85601 - Silicates, natural (with the exception of asbestos) 280B 95000 028931 67-1 Trimethylolpropane trimethacrylatemethyl methacrylate copolymer SCHEDULE 4 Regulation 11(b) (ENTRIES TO BE SUBSTITUTED FOR ENTRIES IN PART I OF SCHEDULE 2) 1 2 3 4 Item PM/REF No. CAS No. Name Restrictions and specifications 60A 45450 068610 51-5 p-Cresol dicyclopentadiene isobutylene, copolymer SML = 5 mg/kg 198A 77895 068439 49-6 Polyethyleneglycol (EO = 2-6) monoalkyl (C16 C18) ether SML = 0.05 mg/kg and in compliance with the specifications laid down in Schedule 2B The Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2005 file:///D/HTML/uk60634.htm[16.01.2025 11:48:31] SCHEDULE 5 Regulation 12(a) (ENTRIES TO BE INSERTED IN PART II OF SCHEDULE 2) 1 2 3 4 Item PM/REF No. CAS No. Name Restrictions and specifications 4A 34650 151841 65-5 Aluminium hydroxybis [2,2'-methylenebis (4,6 di-tert-butylphenyl) phospate SML = 5 mg/kg 7A 38000 000553 54-8 Benzoic acid, lithium salt SML(T) = 0.6 mg/kg (8) (expressed as Lithium) 18A 40720 025013 16-5 tert-Butyl-4 hydroxyanisole (= BHA) SML = 30 mg/kg 27B 46640 000128 37-0 2,6-Di-tert-butyl-p cresol (= BHT) SML = 3.0 mg/kg 54A 54880 000050 00-0 Formaldehyde SML(T) = 15 mg/kg (21) 54B 55200 001166 52-5 Gallic acid, dodecyl ester SML(T) = 30 mg/kg (34) 54C 55280 001034 01-1 Gallic acid, octyl ester SML(T) = 30 mg/kg (34) 54D 55360 000121 79-9 Gallic acid, propyl ester SML(T) = 30 mg/kg (34) 79A 67896 020336 96-3 Myristic acid, lithium salt SML(T) = 0.6 mg/kg (8) (expressed as Lithium) 83A 71935 007601 89-0 Perchloric acid, sodium salt monohydrate SML 0.05 mg/kg (31) 88A 76680 068132 00-3 Polycyclopentadiene, hydrogenated SML = 5 mg/kg (1) 100A 86480 007631 90-5 Sodium bisulphite SML(T) = 10 mg/kg (30) (expressed as SO ) The Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2005 file:///D/HTML/uk60634.htm[16.01.2025 11:48:31] 2 102A 86920 007632 00-0 Sodium nitrite SML = 0.6 mg/kg 102B 86960 007757 83-7 Sodium sulphite SML(T) = 10 mg/kg (30) (expressed as SO2 102C 87120 007772 98-7 Sodium thiosulphate SML(T) = 10 mg/kg (30) (expressed as SO2 110A 94400 036443 68-2 Triethyleneglycol bis[3 (3-tert-butyl-4-hydroxy 5-methylphenyl) propionate] SML = 9 mg/kg SCHEDULE 6 Regulation 15 (ENTRIES TO BE SUBSTITUTED FOR SCHEDULE 2B) Item PM/REF No. Specifications 11530 Acrylic acid, 2-hydroxypropyl ester. It may contain up to 25% (m/m) of acrylic acid, 2 hydroxyisopropyl ester (CAS No. 002918-23-2) 2 16690 Divinylbenzene It may contain up to 45% (m/m) of Ethylvinylbenzene 3 18888 3-Hydroxybutanoic acid-3-hydroxypentanoic acid, copolymer Definition The copolymers are produced by the controlled fermentation of Alcaligenes eutrophus using mixtures of glucose and propanoic acid as carbon sources. The organism used has not been genetically engineered and has been derived from a single wild-type organism Alcaligenes eutrophus strain H16 NCIMB 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 The Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2005 file:///D/HTML/uk60634.htm[16.01.2025 11:48:31] nitrogen and used to prepare inocula for the fermenter. Fermenter samples will be examined daily both microscopically and for any changes in colonial morphology on a variety of agars at different temperatures. The copolymers are isolated from heat treatment bacteria by controlled digestion of the other cellular components, washing and drying. These copolymers are normally offered as formulated, melt formed granules containing additives such as nucleating agents, plasticisers, fillers, stabilisers and pigments which all conform to the general and individual specifications. Chemical name Poly(3-D-hydroxybutanoate-co-3 D-hydroxypentanoate) CAS number 080181-31-3 Structural formula CH3 | CH3 O CH2 O | || | || (-O-CH-CH2-C-)m-(O-CH-CH2-C )n where n / (m + n) greater than 0 and less or equal to 0.2 Average molecular weight Not less than 150 000 Daltons (measured by gel permeation chromatography) Assay Not less than 98% poly(3-D hydroxybutanoate-co-3-D hydroxypentanoate) analysed after hydrolysis as a mixture of 3-D hydroxybutanoic and 3-D hydroxypentanoic acids Description White to off-white powder after isolation Characteristics Identification tests: Solubility Soluble in chlorinated hydrocarbons such as chloroform or The Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2005 file:///D/HTML/uk60634.htm[16.01.2025 11:48:31] dichloromethane but practically insoluble in ethanol, aliphatic alkanes and water Restriction QMA for crotonic acid is 0.05 mg/6 dm2 Purity Prior to granulation the raw material copolymer powder must contain: nitrogen Not more than 2 500 mg/kg of plastic zinc Not more than 100 mg/kg of plastic copper Not more than 5 mg/kg of plastic lead Not more than 2 mg/kg of plastic arsenic Not more than 1 mg/kg of plastic chromium Not more than 1 mg/kg of plastic 4 23547 Polydimethylsiloxane (Mw > 6800) Minimum viscosity 100 x 10-6 m2/s (= 100 centistokes) at 25°C 5 25385 Triallylamine 40 mg/kg hydrogel at a ratio of 1 kg food to a maximum of 1.5 grams of hydrogel. For use only in hydrogels intended for non-direct food contact use. 6 38320 4-(2-Benzoxazolyl)-4'-(5-methyl-2-benzoxazolyl) stilbene Not more than 0.05% w/w (quantity of substance used / quantity of the formulation) 7 43680 Chlorodifluoromethane Content of chlorofluoromethane less than 1 mg/kg of the substance 8 47210 Dibutylthiostannoic acid polymer Molecular unit = (C8H18S3Sn2)n (n = 1.5-2) 9 76721 Polydimethylsiloxane (Mw > 6800) Minimum viscosity 100 x 10&sup-;6 m2/s (= 100 centistokes) at 25°C 10 77895 Polyethyleneglycol (EO = 2-6) monoalkyl (C16-C18) ether The composition of this mixture is as follows: polyethyleneglycol (EO = 2-6) monoalkyl (C16 C18) ether (approximately 28%) fatty alcohols (C16-C18>) (approximately 48%) The Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2005 file:///D/HTML/uk60634.htm[16.01.2025 11:48:31] ethyleneglycol monoalkyl (C16-C18) ether (approximately 24%) 11 83595 Reaction product of di-tert-butylphosphonite with biphenyl, obtained by condensation of 2,4-di-tert butylphenol with Friedel Craft reaction product of phosphorus trichloride and biphenyl Composition 4,4'-Biphenylene-bis [0,0-bis (2,4-di-tert butylphenyl) phosphonite] (CAS No. 38613-77 3) (36-46% w/w (1)) 4,3'-Biphenylene-bis [0,0-bis (2,4-di-tert butylphenyl) phosphonite] (CAS No. 118421-00 4) (17-23% w/w(1)) 3,3'-Biphenylene-bis [0,0-bis (2,4-di-tert butylphenyl) phosphonite] (CAS No. 118421-01 5) (1-5% w/w(1)) 4-Biphenylene-0,0-bis [0,0-bis (2,4-di-tert butylphenyl) phosphonite] (CAS No. 91362-37 7) (11-19% w/w(1)) Tris (2,4-di-tert-butylphenyl) phosphite (CAS No. 31570-04-4) (9-18% w/w(1)) 4,4'-Biphenylene-0,0-bis (2,4-di-tert butylphenyl) phosphonate-0,0-bis (2,4-di-tert butylphenyl) phosphonite (CAS No. 112949-97 0) (<5% w/w((1)) Other specifications Phosphor content of minimum 5.4% to maximum 5.9% Acid value of maximum 10 mg KOH per gram Melt range of 85-110°C 12 88640 Soybean oil, epoxidized Oxirane < 8%, iodine number < 6 13 95859 Waxes, refined, derived from petroleum based or synthetic hydrocarbon feedstocks Phosphor content of minimum 5.4% to maximum 5.9% Content of mineral hydrocarbons with carbon number less than 25: not more than 5% (w/w) Viscosity not less than 11 x 10&sup-;6 m2/s (= 11 centistokes) at 100°C Average molecular weight not less than 500 14 95883 White mineral oils, paraffinic, derived from The Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2005 file:///D/HTML/uk60634.htm[16.01.2025 11:48:31] petroleum 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 x 10&sup-;6 m2/s (= 8.5 centistokes) at 100°C Average molecular weight not less than 480 EXPLANATORY NOTE (This note is not part of the Regulations) 1. These Regulations, which apply in relation to England only, further amend the Plastic Materials and Articles in Contact with Food Regulations 1998 (S.I. 1998/1376, "the 1998 Regulations"), which extend to the whole of Great Britain. These Regulations implement in England Commission Directive 2004/19/EC amending Commission Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with foodstuffs (OJ No. L220, 15.8.2002, p.18), ("the Directive"). 2. The Regulations amend the 1998 Regulations by (a) amending the definition of "additive" to maintain consistency with the Directive (regulation 3(a)(i)); (b) removing references to lists of substances whose authorisations are now spent (regulation 4(a)); (c) extending to articles the provisions of regulation 4(5) of the 1998 Regulations that formerly only applied to materials (regulation 4(b)); (d) adding a restriction on the use of additives in the manufacture of plastic materials and articles which relates to substances also used as food additives or flavourings (regulation5(a)) ; (e) extending to articles the provisions of regulation 5(4) of the 1998 Regulations that formerly only applied to materials (regulation 5(b)); (f) making provision for the procedure to be followed and the time limits to be observed by any person wishing to have an additive included in the Community list of authorised additives (regulation 6); (g) amending the labelling requirements for plastic materials and articles at the pre-retail stage so as to require additional information to be given (regulation 7); (h) making a consequential amendment to regulation 10 (offences) brought about by the amendment to the labelling requirements (regulation 8(a)); (i) providing a defence to breach of the 1998 Regulations as last amended The Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2005 file:///D/HTML/uk60634.htm[16.01.2025 11:48:31] by these Regulations in respect of plastic materials or articles manufactured or imported into the European Community before 1st March 2006 (regulation 8(b)). 3. They also amend the Schedules to the 1998 Regulations by (a) inserting new entries, and amending or removing some existing ones, in the list of monomers authorised without time limit in Section A of Part I of Schedule 1 (regulation9(a) and Schedules 1 & 2); (b) removing the lists of entries for monomers authorised with a time limit that has now expired (regulation 9(b)); (c) adding further supplementary specifications in Part II of Schedule 1 (regulation 10); (d) inserting new entries and amending or removing some existing entries in the list of additives used in the manufacture of plastic materials articles in Part I of Schedule 2 (regulation 11 and Schedules 3 & 4); (e) inserting new entries and removing some existing entries in the list of additives used in the manufacture of plastic materials and articles set out I Part II of Schedule 2 (regulation12 and Schedule 5); (f) adding further supplementary specifications to Part III of Schedule 2, and extending the time limit applicable to substances listed in Part II of that Schedule (regulation 13); (g) amending the restrictions and specifications in the entry in Schedule 2A relating to products obtained by bacterial fermentation (regulation 14); (h) inserting new entries and amending or removing some existing ones in the specifications set out in Schedule 2B (regulation 15 and Schedule 6); (i) adding a provision to the basic rules for overall and specific migration testing using food simulants set out in Part I of Schedule 4, to allow for migration testing to be omitted in the specific circumstances provided for in the Directive (regulation 16). 4. A regulatory impact assessment has been prepared for these Regulations and has been placed in the Library of each House of Parliament, together with a transposition note setting out how the main elements of Commission Directive 2004/19/EC are transposed into domestic law by these Regulations. Copies may be obtained from the Chemical Safety Division of the Food Standards Agency, Aviation House, 125 Kingsway, London WC2B 6NH. Notes: [1] 1990 c. 16.back [2] Functions formerly exercisable by "the Ministers" (being, in relation to England and Wales and acting jointly, the Minister of Agriculture, Fisheries and Food and the Secretaries of State respectively concerned with health in England http://www.opsi.gov.uk/si/si2005/20050325.htm#n1 The Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2005 file:///D/HTML/uk60634.htm[16.01.2025 11:48:31] 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 2005 Prepared 7 March 2005 and food and health in Wales and, in relation to Scotland, the Secretary of State) 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 (1999 c. 28). Those functions, so far as exercisable in relation to Wales, were transferred to the National Assembly for Wales by S.I. 1999/672 as read with section 40(3) of the 1999 Act. Those functions, so far as exercisable in relation to Scotland, were transferred to the Scottish Ministers by section 53 of the Scotland Act 1998 (1998 c. 46) as read with section 40(2) of the 1999 Act. Section 17(1) was amended by paragraph 12(a), and section 48 by paragraph 21, of Schedule 5 to the 1999 Act. 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 [3] OJ No. L31, 1.2.2002, p.1. That Regulation was last amended by Regulation (EC) No. 1642/2003 of the European Parliament and of the Council (OJ No. L245, 29.9.2003, p.4).back [4] S.I. 1998/1376, amended in relation to England by S.I. 2000/3162, S.I. 2002/2364, S.I. 2002/3008 and S.I. 2004/3113.back [5] OJ No. L184, 15.7.88, p.61. This Directive was last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Commission (OJ No. L284, 31.10.2003, p.1).back [6] OJ No. L40, 11.2.89, p.27. This Directive was last amended by Regulation (EC) No 1882/2003.back [7] OJ No. L178, 28.7.95, p.1. This Directive was last amended by Commission Directive 2004/46 (OJ No. L114, 21.4.2004, p.15).back [8] OJ No. L226, 22.9.95, p.1. This Directive was last amended by Commission Directive 2004/47 (OJ No. L113, 20.4.2004, p.24).back [9] OJ No. L339, 30.12.96, p.1. This Directive was last amended by Commission Directive 2003/95 (OJ No. L283, 31.10.2003, p.71).back ISBN 0 11 072344 9 http://www.opsi.gov.uk/stat.htm http://www.opsi.gov.uk/stat.htm http://www.opsi.gov.uk/ http://www.wales-legislation.hmso.gov.uk/legislation/wales/w-stat.htm 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.scotland-legislation.hmso.gov.uk/legislation/scotland/s-stat.htm http://www.northernireland-legislation.hmso.gov.uk/legislation/northernireland/ni-srni.htm http://www.northernireland-legislation.hmso.gov.uk/legislation/northernireland/ni-srni.htm http://www.hmso.gov.uk/ http://www.hmso.gov.uk/ http://www.hmso.gov.uk/contact/comments.htm http://www.opsi.gov.uk/si/si2005/20050325.htm#n2 http://www.opsi.gov.uk/si/si2005/20050325.htm#n3 http://www.opsi.gov.uk/si/si2005/20050325.htm#n4 http://www.opsi.gov.uk/si/si2005/20050325.htm#n5 http://www.opsi.gov.uk/si/si2005/20050325.htm#n6 http://www.opsi.gov.uk/si/si2005/20050325.htm#n7 http://www.opsi.gov.uk/si/si2005/20050325.htm#n8 http://www.opsi.gov.uk/si/si2005/20050325.htm#n9