Plastic Materials and Articles in Contact with Food (Amendment) Regulations (Northern Ireland) 2000

Regulation 10

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
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 0.05 mg/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,N9-Divinyl-2-imidazolidinone	The quantity 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 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/6 dm2
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 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 Directive 98/83/EC on the quality of water intended for human consumption(1)

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) = 6 mg/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	000110-16-7	Maleic acid	SML(T) = 30 mg/kg (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 quantity 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 and Specifications” is modified

Item	PM/REF No.	CAS No.	Name	Restrictions and specifications
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 0.01mg/kg, analytical tolerance included)

Part IV Monomer to be added to Section B of Part I of Schedule 1 to the Principal Regulations

Item	PM/REF No.	CAS No.	Name	Restrictions and specifications
77AA	2518255	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 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 0.05 mg/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-Heptylaminound ecanoic 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	002867-47-2	Methacrylic acid, 2- (dimethylamino) ethyl 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 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

Regulation 11

SCHEDULE 2 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 7A	30080 30610	004180-12-5 —	Acetic acid, copper salt 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)	SML(T) = 30 mg/kg (7) (expressed as copper)
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 migration 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)-49-(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
36C	38515	001533-45-5	4,49-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 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) (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 to100% 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) 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	The specific migration of this substance shall not exceed 5 mg/kg (1)
179A	68145	080410-33-9	2,2',2"-Nitrilo[triethyl tris(3,39,5,59-tetra-tert-butyl- 1-19-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	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(2)
191A	73720	000115-96-8	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 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 polypropy- leneglycol 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) (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 263B	89200 89440	007617-31-4 —	Stearic acid, copper salt Stearic acid, esters with ethyleneglycol	SML(T) = 30 mg/kg (7) (expressed as copper) 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-dihydropyri- 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, paraffinic, derived from petroleum based hydrocarbon feedstocks	In compliance with the specifications laid down in Schedule 2B

Regulation 12

SCHEDULE 3

Regulation 5A

“SCHEDULE 2A 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”

Regulations 8 and 12

SCHEDULE 4

Regulation 7A

“SCHEDULE 2B 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 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
		– 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”

(1)

O.J. No. L330, 5.12.1998, p. 32

(2)

O.J. No. L372, 31.12.85, p. 14