Commission Directive 2002/72/EC (repealed)Show full title

[X1 ANNEX V U.K. SPECIFICATIONS

Editorial Information

X1 Substituted by Corrigendum to Commission Directive 2002/72/EC of 6 August 2002 relating to plastic materials and articles intended to come into contact with foodstuffs (Official Journal of the European Communities L 220 of 15 August 2002).

[F1 [X2 Part A: U.K. General specifications

Plastic material and articles shall not release primary aromatic amines in a detectable quantity (DL = 0,01 mg/kg of food or food simulant). The migration of the primary aromatic amines appearing in the lists in Annex II and III is excluded from this restriction.] ]

Editorial Information

X2 Substituted by Corrigendum to Commission Directive 2007/19/EC of 30 March 2007 amending Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with food and Council 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 (Official Journal of the European Union L 91 of 31 March 2007).

Textual Amendments

F1 Substituted by Commission Directive 2007/19/EC of 30 March 2007 amending Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with food and Council 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 (Text with EEA relevance).

Part B: U.K. Other specifications

a Quantity of substance used /quantity of formulation
b [F2 [X3 OJ L 339, 30.12.1996, p. 1 .] ] ]
Ref. No	OTHER SPECIFICATIONS
[F3 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)]
[F4 16690	Divinylbenzene It may contain up to 45 % (m/m) of Ethylvinylbenzene
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 HI6 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-hydroxybutanoate-co-3-D-hydroxypentanoate)
	CAS number	080181-31-3
	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-hydroxybutanoate-co-3-D-hydoxypentanoate) 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
	Restriction	QMA for crotonic acid is 0.05 mg/6 dm 2
	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]
23547	Polydimethylsiloxane (Mw >  6 800 )
	Minimum viscosity 100 × 10 –6 m 2 /s (= 100 centistokes) at 25 °C
[F5 24903	Syrups, hydrolysed starch, hydrogenated
	In compliance with the purity criteria for maltitol syrup E 965(ii) (Commission Directive 95/31/EC ( OJ L 178, 28.7.1995, p. 1 ) as last amended by 2004/46/EC ( OJ L 114, 21.04.2004, p. 15 ))]
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.
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)
[F2 [X3 42080	Carbon black Specifications: Toluene extractables: maximum 0,1 %, determined according to ISO method 6209. UV absorption of cyclohexane extract at 386 nm: < 0,02 AU for a 1 cm cell or < 0,1 AU for a 5 cm cell, determined according to a generally recognised method of analysis. Benzo(a)pyrene content: max 0,25 mg/kg carbon black. Maximum use level of carbon black in the polymer: 2,5 % w/w] ]
[F5 43480	Charcoal, activated
	To be used only in PET at maximum 10 mg/kg of polymer. Same purity requirements as for Vegetable Carbon (E 153) set out by Commission Directive 95/45/EC (( OJ L 226, 22.9.1995, p. 1 ). Directive as last amended by Directive 2004/47/EC ( OJ L 113, 20.4.2004, p. 24 )) with exception of ash content which can be up to 10 % (w/w)]
43680	Chlorodifluoromethane
	Content of chlorofluoromethane less than 1 mg/kg of the substance
47210	Dibutylthiostannoic acid polymer
	Molecular unit = (C 8 H 18 S 3 Sn 2 )n (n = 1,5-2)
[F6 60025	Specifications: Minimum viscosity (at 100 °C) = 3,8 cSt Average Mw > 450]
[F5 64990	Maleic anhydride-styrene, copolymer, sodium salt
	MW fraction <  1 000 is less than 0,05 % (w/w)
67155	Mixture of 4-(2-Benzoxazolyl)-4'-(5-methyl-2-benzoxazolyl)stilbene, 4,4'-bis(2-benzoxazolyl) stilbene and 4,4'-bis(5-methyl-2-benzoxazolyl)stilbene
	Mixture obtained from the manufacturing process in the typical ratio of (58-62 %):(23-27 %): (13-17 %)]
[F2 [X3 72081/10	Petroleum hydrocarbon resins (hydrogenated) Specifications: Petroleum hydrocarbon resins, hydrogenated are produced by the catalytic or thermal polymerisation of dienes and olefins of the aliphatic, alicyclic and/or monobenzenoid arylalkene types from distillates of cracked petroleum stocks with a boiling range not greater than 220 °C, as well as the pure monomers found in these distillation streams, subsequently followed by distillation, hydrogenation and additional processing. Properties: Viscosity: > 3 Pa.s at 120 °C Softening point: > 95 °C as determined by ASTM Method E 28-67 Bromine number: < 40 (ASTM D1159) The colour of a 50 % solution in toluene < 11 on the Gardner scale Residual aromatic monomer ≤ 50 ppm] ]
76721	Polydimethylsiloxane (Mw >  6 800 )
	Minimum viscosity 100 × 10 –6 m 2 /s (= 100 centistokes) at 25 °C
[F6 76723	Specifications: The fraction with molecular weight below 1 000 should not exceed 1,5 % w/w
76725	Specifications: The fraction with molecular weight below 1 000 should not exceed 1 % w/w]
[F1 [X2 76845	Polyester of 1,4-butanediol with caprolactone MW fraction < 1 000 is less than 0,5 % (w/w)] ]
[F5 76815	Polyester of adipic acid with glycerol or pentaerythritol, esters with even numbered, unbranched C12-C22 fatty acids
	MW fraction <  1 000 is less than 5 % (w/w)]
[F3 77895	Polyethyleneglycol (E0 = 2-6) monoalkyl (C 16 -C 18 ) ether The composition of this mixture is as follows: polyethyleneglycol (E0 = 2-6)monoalkyl (C 16 -C 18 ) ether (approximately 28 %) fatty alcohols (C 16 -C 18 ) (approximately 48 %) ethyleneglycol monoalkyl (C 16 -C 18 ) ether (approximately 24 %)]
[F5 79600	Polyethyleneglycol tridecyl ether phosphate
	Polyethyleneglycol (EO ≤ 11) tridecyl ether phosphate (mono-and dialkyl ester) with a maximum 10 % content of polyethyleneglycol (EO ≤ 11) tridecylether]
[F2 [X3 81500	Polyvinylpyrrolidone The substance shall meet the purity criteria established in Commission Directive 96/77/EC] ] b
83595	Reaction product of di-tert-butylphosphonite with biphenyl, obtained by condensation of 2,4-di-tert-butylphenol with Friedel Craft reaction product of phosphorous 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  a ), 4,3′-Biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS.No 118421-00-4 (17-23 % w/w  a ), 3,3′-Biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS.No 118421-01-5) (1-5 % w/w  a ), 4-Biphenylene-0,0-bis(2,4-di-tert-butylphenyl)phosphonite (CAS.No 91362-37-7) (11-19 % w/w  a ), Tris(2,4-di-tert-butylphenyl)phosphite (CAS.No 31570-04-4) (9-18 % w/w  a ), 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  a ).
	Other specifications: Phosphor content of min. 5,4 % to max. 5,9 % Acid value of max. 10 mg KOH per gram Melt range of 85-110 °C
[F1 [X2 88640	Soybean oil, epoxidized Oxirane < 8 %, iodine number < 6] ]
[F6 95858	Specifications: Average molecular weight not less than 350 Viscosity at 100 °C min 2,5 cSt Content of hydrocarbons with carbon number less than 25, not more than 40 % w/w]
95859	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 × 10 –6 m 2 /s (= 11 centistokes) at 100 °C Average molecular weight not less than 500.
95883	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 × 10 –6 m 2 /s (= 8,5 centistokes) at 100 °C Average molecular weight not less than 480

Editorial Information

X3 Inserted by Corrigendum to Commission Directive 2007/19/EC of 30 March 2007 amending Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with food and Council 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 (Official Journal of the European Union L 91 of 31 March 2007).

Textual Amendments

F2 Inserted by Commission Directive 2007/19/EC of 30 March 2007 amending Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with food and Council 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 (Text with EEA relevance).

F3 Inserted by Commission Directive 2004/19/EC of 1 March 2004 amending Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with foodstuffs (Text with EEA relevance).

F4 Substituted by Commission Directive 2004/19/EC of 1 March 2004 amending Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with foodstuffs (Text with EEA relevance).

F5 Inserted by Commission Directive 2005/79/EC of 18 November 2005 amending Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with food (Text with EEA relevance).

F6 Inserted by Commission Directive 2008/39/EC of 6 March 2008 amending Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with food (Text with EEA relevance).