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The Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2002

Type Statutory-Instrument
Publication 2002-09-16
State In force
Department King's Printer of Acts of Parliament
Source legislation.gov.uk
Reform history JSON API PDF

Made: 16th September 2002

Laid before Parliament: 16th September 2002

Coming into force: 30th November 2002

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Amendments to the Plastic Materials and Articles in Contact with Food Regulations 1998

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Amendment of the Food Safety (Sampling and Qualifications) Regulations 1990

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SCHEDULE 1

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
15A 11530 00999-61-1 Acrylic acid, 2-hydroxypropyl ester QMA = 0.05 mg/6 dm²
28B 12763 00141-43-5 2-Aminoethanol SML = 0.05 mg/kg. Not for use in polymers contacting foods for which simulant D is laid down in Council Directive 85/572/EEC and for indirect food contact only, behind the PET layer
28C 12765 84434-12-8 N-(2-aminoethyl)-beta-alanine, sodium salt SML = 0.05 mg/kg
38A 13395 04767-03-7 2,2-Bis(hydroxymethyl) propionic acid QMA = 0.05 mg/6 dm²
47A 13617 00080-09-1 Bisphenol S As item 86A
49B 13810 00505-65-7 1,4-Butanediol formal QMA = 0.05 mg/6 dm²
52A 13932 00598-32-3 3-Buten-2-ol QMA = ND (DL = 0.02 mg/6 dm²). To be used only as a co-monomer for the preparation of polmeric additive
70A 15030 00931-88-4 Cyclooctene SML = 0.05 mg/kg. For use only in polymers contacting foods for which simulant A is laid down in Council Directive 85/572/EEC
76A 15370 03236-53-1 1,6-Diamino-2,2,4-trimethylhexane QMA = 5 mg/6 dm²
76B 15400 03236-54-2 1,6-Diamino-2,4,4-trimethylhexane QMA = 5 mg/6 dm²
77A 15610 00080-07-9 4,4'-Dichlorodiphenyl sulphone SML = 0.05 mg/kg
86A 16090 00080-09-01 4,4'-Dihydroxydiphenyl sulphone SML = 0.05 mg/kg
88B 16390 00126-30-7 2,2-Dimethyl-1,3-propanediol SML = 0.05 mg/kg
121B 19110 04098-71-9 1-Isocyanato-3-isocyanatomethyl-3,5,5-trimethylcyclohexane QM(T) = 1 mg/kg in FP (as NCO)
122A 19243 00078-79-5 Isoprene As item 145A
126A 19490 00947-04-6 Laurolactam SML = 5 mg/kg
135A 20260 00101-43-9 Methacrylic acid, cyclohexyl ester SML = 0.05 mg/kg
135B 20410 02082-81-7 Methacrylic acid, diester with 1,4-butanediol SML = 0.05 mg/kg
135D 20590 00106-91-2 Methacrylic acid, 2,3-epoxypropyl ester QMA = 0.02 mg/6 dm²
144A 21520 01561-92-8 Methallylsulphonic acid, sodium salt SML = 5 mg/kg
145A 21640 00078-79-5 2-Methyl-1,3-butadiene QM = 1 mg/kg in FP or SML = ND (DL = 0.02 mg/kg, analytical tolerance included)
145C 21765 106246-33-7 4,4'-Methylenebis(3-chloro-2,6-diethylaniline) QMA = 0.05 mg/6 dm²
145D 21821 00505-65-7 1,4-(Methylenedioxy) butane As item 49B
148A 22360 01141-38-4 2,6-Naphthalenedicar- boxylic acid SML = 5 mg/kg
150A 22437 00126-30-7 Neopentylglycol As item 88B
156A 22778 07456-68-0 4,4'-Oxybis(benzenesul- phonyl azide) QMA = 0.05 mg/6 dm²
159A 22900 00109-67-1 1-Pentene SML = 5 mg/kg
184A 24073 000101-90-6 Resorcinol diglycidyl ether QMA = 0.005 mg/g dm². Not for use in polymers contacting foods for which simulant D is laid down in Council Directive 85/572/EEC and for indirect food contact only, behind the PET layer.
214A 25380 Trialkyl acetic acid (C7-C17), vinyl esters (= vinyl versatate) QMA = 0.05 mg/g dm²
215A 25450 26896-48-0 Tricyclodecanedime- thanol SML = 0.05 mg/kg
217A 25900 00110-88-3 Trioxane SML = 0.05 mg/kg

PART II — LIST OF MONOMERS FOR WHICH THE ENTRY CONTAINED IN THE FIRST COLUMN (ITEM) OF SECTION A OF PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS IS TO BE AMENDED

Item Name
52B 4-tert-Butylphenol
88C 1.3 Dioxolane
121C Isophthalic acid
135C Methacrylic acid, 2-(dimethylamino) ethyl ester
145B 3-Methyl-1-butene
159B Perfluoropropyl perfluorovinyl ether
214B Triallylamine

PART III — LIST OF MONOMERS FOR WHICH THE ENTRY CONTAINED IN COLUMN 4 (RESTRICTIONS AND SPECIFICATIONS) OF SECTION A OF PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS IS TO BE AMENDED

Name Restrictions and specifications
2,2-Bis(4-hydroxyphenyl) propane bis(2,3-epoxypropyl) ether (= BADGE) Use must be before 1st January 2005 and prior to that date be as specified in paragraph 1 of Annex I to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of that Annex
4,4'-Dihydroxybenzophenone SML(T) = 6 mg/kg (14)
Formaldehyde SML(T) = 15 mg/kg (21)
Hexamethylenetetramine SML(T) = 15 mg/kg (expressed as formaldehyde (21)
1,3-Phenylenediamine SML = ND (DL = 0.02 mg/kg, analytical tolerance included)

PART IV — PROVISIONS SUBSTITUTED FOR SECTION B OF PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS

SCHEDULE 2

PART I — LIST OF ADDITIVES TO BE ADDED TO PART I OF SCHEDULE 2 TO THE PRINCIPAL REGULATIONS

Item PM/REF No. CAS No. Name Restrictions and specifications
19A 35160 06642-31-5 6-Amino-1,3-dimethyluracil SML = 5 mg/kg
19B 35170 00141-43-5 2-Aminoethanol SML = 0.05 mg/kg. Not for use in polymers contacting foods for which simulant D is laid down in Council Directive 85/572/EEC and for indirect food contact only, behind the PET layer
19C 35284 00111-41-1 N-(2-aminoethyl)ethano- lamine SML = 0.05 mg/kg. Not for use in polymers contacting foods for which simulant D is laid down in Council Directive 85/572/EEC and for indirect food contact only, behind the PET layer
36E 38840 154862-43-8 Bis(-2,4-dicumylphenyl) pentaerythritoldiphos- phite SML = 5 mg/kg (as sum of the substance itself, its oxidised form bis(2,4-dicumylphenyl)pen- taerythritol-phosphate and its hydrolysis product (2,4-dicumylphenol)
38A 39925 129228-21-3 3,3-Bis(methoxymethyl)-2,5-dimethyl hexane SML = 0.05 mg/kg
41A 41120 10043-52-4 Calcium chloride
45A 41840 00105-60-2 Caprolactam SML(T) = 15 mg/kg (⁵)
72B 47210 26427-07-6 Dibutylthiostannoic acid polymer [= thiobis(butyl-tin sulphide), polymer] In compliance with the specifications laid down in Schedule 2B
73A 47540 27458-90-8 Di-tert-dodecyl disulfide SML = 0.05 mg/kg
73D 48620 00123-31-9 1,4-Dihydroxybenzene SML = 0.6 mg/kg
73E 48720 00611-99-4 4,4'-Dihydroxybenzophe- none SML(T) = 6 mg/kg (¹⁴)
77A 52645 10436-08-5 Cis-11-eicosenamide
164A 64800 00110-16-7 Maleic acid SML(T) = 30 mg/kg (⁴)
167A 65920 66822-60-4 [N-methacryloyloxyethyl-N,N-dimethyl-N-carboxymethyl-ammonium chloride, sodium salt-octadecyl methacrylate-ethyl methacrylate-cyclohexyl methacrylate-N-vinyl-2-pyrrolidone, copolymers
191A 73160 Phosphoric acid, mono- and di-n-alkyl (C16 and C18) esters SML = 0.05 mg/kg
195B 76730 Polydimethylsiloxane, gamma-hydroxypropylated SML = 6 mg/kg
208A 81220 192268-64-7 Poly-[[6-[N-(2,2,6,6-tetramethyl-4-piperidinyl)-n-butylamino]-1,3,5-triazine-2,4-diyl][2,2,6,6-tetramethyl-4-piperidinyl)imino]-1,6-hexanediyl[2,2,6,6-tetramethyl-4-piperidinyl)imino]]-alpha-[N,N,N',N'-tetrabutyl-N""-(2,2,6,6-tetramethyl-4-piperidinyl)-N"-[6,2,2,6,6-tetramethyl(-4-piperidinylamino)-hexyl][1,3,5-triazine-2,4,6-triamine]-omega-N,N,N',N'-tetrabutyl-1,3,5-triazine-2,4-diamine] SML = 5 mg/kg
229A 83599 68442-12-6 Reaction products of oleic acid, 2-mercaptoethyl ester, with dichlorodimethyltin, sodium sulphide and trichloromethyltin SML(T) = 0.18 mg/kg (¹⁵) (expressed as tin)
240B 85680 01343-98-2 Silicic acid
271A 92150 01401-55-4 Tannic acids According to the JECFA specifications
279A 93270 00108-78-1 2,4,6-Triamino-1,3,5-triazine SML = 30 mg/kg
281A 95270 161717-32-4 2,4,6-Tris(tert-butyl)phenyl 2-butyl-2-ethyl-1,3-propanediol phosphite SML = 2 mg/kg (as sum of phosphite, phosphate and the hydrolysis product = TTBP)

PART II — LIST OF ADDITIVES FOR WHICH THE ENTRY CONTAINED IN THE FIRST COLUMN (ITEM) OF PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS IS TO BE AMENDED

Item Name
36F Bis(3-4-dimethylbenzylidene)sorbitol
38B Bis(polyethyleneglycol)hydroxymethyl-phosphonate
73B Diethyleneglycol
73C 1,1-Difluoroethane
73F 2,4-Dimethyl-6-(1-methylpentadecyl)phenol
191B Phosphoric acid, trichloroethyl ester
195C Polyesters of 1,2-propanediol and/or 1,3-and/or polypropyleneglycol with adipic acid, also end-capped with acetic acid or fatty acids C10-C18 or n-octanol and or n-decanol
208B Poly (zinc glycerolate)
240C Silicic acid, lithium, magnesium, sodium salt
281B Vermiculite, reaction product with citric acid, lithium salt
281C Water
281D Waxes, refined, derived from petroleum based or synthetic hydrocarbon feed stocks
281E White mineral oils, paraffinic, derived from petroleum based hydrocarbon feed stocks

PART III — LIST OF ADDITIVES FOR WHICH THE ENTRY CONTAINED IN COLUMN 4 (RESTRICTIONS AND SPECIFICATIONS) OF PART I OF SCHEDULE 2 TO THE PRINCIPAL REGULATIONS IS TO BE AMENDED

Name Restrictions and specifications
Benzaldehyde In compliance with regulation 4(2) of the 1987 Regulations
Bis(polyethyleneglycol)hydroxymethyl-phosphonate SML = 0.6 mg/kg. Authorised until 1st January 2004
Camphor In compliance with regulation 4(2) of the 1987 Regulations
Copper iodide SML(T) = 30 mg/kg (⁷) (expressed as copper) and the specific migration of this substance shall not exceed 1 mg/kg (¹⁰) (expressed as iodine)
2'-(2-Hydroxy-3,5'-di-tert-butylphenyl)-5-chlorobenzotriazole SML(T) = 30 mg/kg (¹⁸)

PART IV — PROVISIONS INSERTED AFTER PART I OF SCHEDULE 2 TO THE PRINCIPAL REGULATIONS

SCHEDULE 3 — LIST OF SUBSTANCES TO BE ADDED TO SCHEDULE 2B IN THE PRINCIPAL REGULATIONS

Item PM/REF No. Specifications
4A 43680 CHLORODIFLUOROMETHANE
– Content of chlorofluoromethane less than 1 mg/kg of the substance
4B 47210 DIBUTYLTHIOSTANNOIC ACID POLYMER
– Molecular unit = (C₈H₁₈S₃Sn₂)n (n = 1,5-2)
5A 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-bis0,0-bis(2,4-di-tert-butylphenyl)phosphonite (36-46% w/w (¹)) 4,3'-Biphenylene-bis0,0-bis(2,4-di-tert-butylphenyl)phosphonite (17-23% w/w) 3,3'-Biphenylene-bis0,0-bis(2,4-di-tert-butylphenyl)phosphonite (1-5% w/w) 4-Biphenylene-0,0-bis0,0-bis(2,4-di-tert- butylphenyl)phosphonite (11-19% w/w) Tris(2,4-di-tert-butylphenyl)phosphite(CAS No. 31570-04-4) (9-18% w/w) 4,4'-Biphenylene-0,0-bis(2,4-di-tert-butylphenyl)phosphonate-0,0-bis(2,4-di-tert-butylphenyl)phosphonite(CAS No. 112949-970) (5% w/w) Other specifications Phosphor content of minimum 5.4% to 5.9% Acid value of maximum 10 mg KOH per gram Melt range of 85-110°C

Signed

Signed by authority of the Secretary of State for Health

Hazel Blears — Parliamentary Under-Secretary of State, — Department of Health — 16th September 2002

Explanatory note

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Footnotes

[^f00001]: 1990 c. 16.

[^f00002]: 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 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.

[^f00003]: OJ No. L31, 1.2.2002, p.1.

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