The Plastic Materials and Articles in Contact with Food Amendment (Scotland) Regulations 2005

Applications for inclusion of an additive in the Community list of authorised additives5B

1

This regulation applies to any person who 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 otherwise lawful, 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.

8

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

the levels of migration specific to those substances;

ii

where appropriate, purity criteria in accordance with the purity Directives

sufficient to enable the user of those materials and articles to comply with the legislation applicable to food.

b

omit the migration, the substitute or the alternative tests where–

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.

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Item	PM/REF No.	CASNo.	Name	Restrictions and specifications
6A	10599/90A	061788–89–4	Acids, fatty, unsaturated (C18), dimers, distilled	QMA(T) = 0.05 mg/6 dm2 (26)
6B	10599/91	061788–89–4	Acids, fatty, unsaturated (C18), dimers, non distilled	QMA(T) = 0.05 mg/6 dm2 (26)
6C	10599/92A	068783–41–5	Acids, fatty, unsaturated (C18), dimers, hydrogenated, distilled	QMA(T) = 0.05 mg/6 dm2 (26)
6D	10599/93	068783–41–5	Acids, fatty, unsaturated (C18), dimers, hydrogenated, non distilled	QMA(T) = 0.05 mg/6 dm2 (26)
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 (32)
87A	16210	006864–37–5	3,3'-Dimethyl-4,4'-diaminodicyclohexylmethane	SML = 0.05 mg/kg (31). 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	054276–35–6	Methacrylic acid, sulphopropyl ester	QMA = 0.05 mg/6 dm2
156XA	22775	000144–62–7	Oxalic acid	SML(T) = 6 mg/kg(28)
161A	23070	000102–39–6	(1,3-Phenylenedioxy)diacetic acid	QMA = 0.05 mg/6 dm2

	1	2	3	4
Item	PM/REF No.	CASNo.	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(27)
70	14950	003173–53–3	Cyclohexyl isocyanate	QM(T) = 1 mg/kg in FP (expressed as NCO) (25)
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% w/w) 2,2,4-trimethylhexane-1,6-diisocyanate and (60% w/w) 2,4,4-trimethylhexane-1,6-diisocyanate	QM(T)= 1 mg/kg (expressed as NCO) (25)
188	24190	065997–05–9	Rosin Wood

	1	2	3	4
Item	PM/REF No.	CASNo.	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 of those for which the simulant D is laid down in Directive 85/572/EEC
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(27)
51A	42880	008001–79–4	Castor oil
61A	45600	003724–65–0	Crotonic acid	QMA(T) = 0.05 mg/6 dm2 (32)
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: 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)	SML = 5 mg/kg
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 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(28)
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

	1	2	3	4
Item	PM/REF No.	CASNo.	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

	1	2	3	4
Item	PM/REF No.	CASNo.	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(33)
54C	55280	001034–01–1	Gallic acid, octyl ester	SML(T) = 30 mg/kg(33)
54D	55360	000121–79–9	Gallic acid, propyl ester	SML(T) = 30 mg/kg(33)
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 0.0 5 mg/kg(30)
88A	76680	068132–00–3	Polycyclopentadiene, hydrogenated	SML = 5 mg/kg(1)
100A	86480	007631–90–5	Sodium bisulphite	SML(T) = 10 mg/kg(29) (expressed as S02)
102A	86920	007632–00–0	Sodium nitrite	SML = 0.6 mg/kg
102B	86960	007757–83–7	Sodium sulphite	SML(T) = 10 mg/kg(29) (expressed as S02)
102C	87120	007772–98–7	Sodium thiosulphate	SML(T) = 10 mg/kg(29) (expressed as S02)
110A	94400	036443–68–2	Triethyleneglycol bis[3-(3-tert-butyl-4-hydroxy-5-methylphenyl) propionate]	SML = 9 mg/kg

SCHEDULE 2BSPECIFICATIONS

Regulation 7A

	1	2
Item	PM/REF No.	Specifications
1	11530	Acrylic acid, 2-hydroxypropyl ester. It may contain up to 25% (m/m) of acrylic acid, 2-hydroxyisopropyl ester (CASNo. 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 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-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 a chloroform or 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 × 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 × 10−6 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%) 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] (CASNo. 38613–77–3) (36–46% w/w (*)) 4,3'-Biphenylene-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] (CASNo. 118421–00–4) (17–23% w/w (*)) 3,3'-Biphenylene-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] (CASNo. 118421–01–5) (1–5% w/w (*)) 4-Biphenylene-0,0-bis (2,4-di-tert-butylphenyl) phosphonite (CASNo. 91362–37–7) (11–19% w/w (*)) Tris (2,4-di-tert-butylphenyl) phosphite (CASNo. 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 (CASNo. 112949–97-0) (<5% w/w (*)) 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	Soyabean oil, epoxidized Oxirane < 8%, iodine number < 6
13	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
14	95883	White mineral oils, paraffinic derived from 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 × 10−6 m2/s (= 8.5 centistokes) at 100°C Average molecular weight not less than 480
Note:–
(*) Quantity of substance used/quantity of formulation.