Legalize / United Kingdom / Northern Ireland / Ni-Statutory-Rule

The Plastic Materials and Articles in Contact with Food Regulations (Northern Ireland) 2006

Type Ni-Statutory-Rule

Publication 2006-06-05

Last updated 2006-11-19

State In force

Jurisdiction Northern Ireland

Department Government Printer for Northern Ireland

Source legislation.gov.uk

PDF Download

articles Not indexed

Reform history JSON API

Item	1 PM/REF No.	2 CAS No.	3 Name	4 Restrictions and specifications
1	30000	000064-19-7	Acetic acid
2	30045	000123-86-4	Acetic acid, butyl ester
2A	30080	004180-12-5	Acetic acid, copper salt	SML(T) = 30 mg/kg (7) (expressed as copper)
3	30140	000141-78-6	Acetic acid, ethyl ester
4	30280	000108-24-7	Acetic anhydride
5	30295	000067-64-1	Acetone
6	30370	–	Acetylacetic acid, salts
7	30400	–	Acetylated glycerides
7A	30610	–	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)
7B	30612	–	Acids C₂-C₂₄ aliphatic linear, monocarboxylic, synthetic and their mono-, di- and triglycerol esters
8	30960	–	Acids, aliphatic, monocarboxylic (C₆-C₂₂ ), esters with polyglycerol
9	31328	–	Acids, fatty, from animal or vegetable foods fats and oils
9A	31530	123968-25-2	Acrylic acid, 2,4-di-tert-pentyl-6[1(3,5-di-tert-pentyl-2- hydroxphenyl) ethyl] phenyl ester	The specific migration of this substance shall not exceed 5 mg/kg
10	31730	000124-04-9	Adipic acid
11	33120	–	Alcohol's, aliphatic, monohydric, saturated, linear, primary (C₄ -C₂₄ )
12	33350	009005-32-7	Algnic acid
12A	33801	–	n-Alkyl (C₁₀ -C₁₃) benzenesulphonic acid	The specific migration of this substance shall not exceed 30 mg/kg
13	34281	–	Alkyl (C₈-C₂₂ ) sulphuric acids, linear, primary, with an even number of carbon atoms
14	34475	–	Aluminium calcium hydroxide phosphite, hydrate
15	34480	–	Aluminium fibres, flakes and powders
16	34560	021645-51-2	Aluminium hydroxide
17	34690	010978-59-9	Aluminium magnesium carbonate hydroxide
18	34720	001344-28-1	Aluminium oxide
18A	34850	143925-92-2	Amines, bis (hydrogenated tallow alkyl) oxidised	QM = For use only: in polyolefines at 0.1% (w/w) not in LDPE when it is in contact with foods for which Directive 85/572/EEC establishes a reduction factor less than 3; 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 SML = 0.05 mg/kg
18B	34895	000088-68-6	2-Aminobenzamide	To be used only for PET for water and beverages
19	35120	013560-49-1	3-Aminocronic acid, diester with thiobis (2-hydroxyethyl) ether
19A	35160	006642-31-5	6-Amino-1,3-dimethyluracil	SML = 5 mg/kg
19B	35170	000141-53-5	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	000111-41-1	N-(2-aminoethyl) ethanolamine	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
20	35320	007664-41-7	Ammonia
21	35440	012124-97-9	Ammonium bromide
22	35600	001336-21-6	Ammonium hydroxide
23	35840	000506-30-9	Arachidic acid
24	35845	007771-44-0	Arachidonic acid
25	36000	000050-81-7	Ascorbic acid
26	36080	000137-66-6	Ascorbyl palmitate
27	36160	010605-09-1	Ascorbyl stearate
27B	36840	12007-55-5	Barium tetraborate	SML(T) = 1 mg/kg expressed as barium (11) and SML(T) = 6 mg/kg (22) (expressed as boron) without prejudice to the provisions of Directive 98/83/EC on water for human consumption
28	36880	008012-89-3	Beeswax
29	36960	003061-75-4	Behenamide
30	37040	000112-85-6	Behenic acid
31	37280	001302-78-9	Bentonite
31A	37360	000100-52-7	Benzaldehyde	(10)
32	37600	000065-85-0	Benzoic acid
33	37680	000136-60-7	Benzoic acid, butyl ester
34	37840	000093-89-0	Benzoic acid, ethyl ester
35	38080	000093-58-3	Benzoic acid, methyl ester
36	38160	002315-68-6	Benzoic acid, propyl ester
36A	38320	005242-49-9	4-(2-benzoxazolyl)-4'- (5-methyl-2-benzoxazolyl) stilbene	In compliance with the specifications laid down in Schedule 4
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	4,4'-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	38840	154862-43-8	Bis(-2,4-dicumylphenyl) pentaerythritoldiphosphite	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)
36F	38879	135861-56-2	Bis (3,4-dimethylbenzylidene) sorbitol
37	38950	079072-96-1	Bis(4-ethylbenzylidene) 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
37AA	39680	000080-05-7	2,2-Bis(4-hydroxyphenyl) propane	SML(T) = 0.6 mg/kg (28)
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
38	39890	087826-41-3	Bis(methylbenzylidene) sorbitol
		069158-41-4	“““““““““
		054686-97-4	“““““““““
		081541-12-0	“““““““““
38A	39925	129228-21-3	3,3-Bis (methoxymethyl)- 2,5-dimethyl hexane	SML = 0.05 mg./k
38B	40120	068951-50-8	Bis(polyethyleneglycol) hydroxymethylphosphonate	SML = 0.6 mg/kg
38C	40320	010043-35-3	Boric acid	SML(T) = 6 mg/kg (22) (expressed as boron) without prejudice to the provisions of Directive 98/83/EC on water for human consumption
39	40400	010043-11-5	Boron nitride
40	40570	000106-97-8	Butane
40A	40580	000110-63-4	1,4,-Butanediol	SML(T) = 0.05 mg/kg (23)
41	41040	005743-36-2	Calcium butyrate
41A	41120	010043-52-4	Calcium chloride
42	41280	001305-62-0	Calcium hydroxide
43	41520	001305-78-8	Calcium oxide
44	41600	012004-14-7	Calcium sulphoaluminate
		037293-22-4	““““““““
44A	41680	000076-22-2	Camphor	(10)
45	41760	0008006-44-8	Candelilla wax
45A	41840	00105-60-2	Caprolactam	SML(T) = 15 mg/kg (5)
46	41960	000124-07-2	Caprylic acid
47	42160	000124-38-9	Carbon dioxide
47A	42320	007492-68-4	Carbonic acid, copper salt	SMT(L) = 30 mg/kg (7) (expressed as copper)
48	42500	–	Carbonic acid, salts
49	42640	009000-11-7	Carboxymethylcellulose
50	42720	008015-86-9	Carnauba wax
51	42800	009000-71-9	Casein
51A	42880	008001-79-4	Castor oil
52	42960	064147-40-6	Castor oil, dehydrated
53	43200	–	Castor oil, mono- and diglycerides
54	43280	009004-34-6	Cellulose
55	43300	009004-36-8	Cellulose acetate butyrate
56	43360	068442-85-3	Cellulose, regenerated
57	43440	008001-75-0	Ceresin
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
58	44160	000077-92-9	Citric acid
59	44640	000077-93-0	Citric acid, triethyl ester
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 (10) (expressed as iodine)
60	45280	–	Cotton fibres
60A	45450	068610-51-5	p-Cresol-dicyclopentadiene- isobutylene, copolymer	SML = 5 mg/kg
61	45560	014464-46-1	Cristobalite
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
62	45760	000108-91-8	Cyclohexylamine
63	45920	009000-16-2	Dammar
64	45940	000334-48-5	n-Decanoic acid
65	46070	010016-20-3	Alpha-Dextrin
66	46080	007585-39-9	Beta-Dextrin
67	46375	061790-53-2	Diatomaceous earth
68	46380	068855-54-9	Diatomaceous earth. Soda ash flux-calcined
69	46480	032647-67-9	Dibenzylidene sorbitol
69A	46700	–	5,7-di-tert-Butyl-3- (3,4- and 2,3 –dimethylphenyl)-3H-benzofuran-2-one containing: 5,7-di-tert-butyl-3-(3,4-dimethylphenyl)-3H-benzofuran-2-one (80-100% w/w); and 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
70	46790	004221-80-1	3,5-Di-tert-butyl-4-hydroxybenzoic acid, 2,4-di-tert-butylphenyl ester
71	46800	067845-93-6	3,5-Di-tert-butyl-4-hydroxybenzoic acid, hexadecyl ester
72	46870	003135-18-0	3,5-Di-tert-butyl-4-hydroxybenzylphosphonic acid, dioctadecyl ester
72A	46880	065140-91-2	3,5-Di-tert-butyl-4-hydroxybenzyl phosphonic acid, moneothyl ester, calcium salt	The specific migration of this substance shall not exceed 6 mg/kg
72B	47210	26427-07-6	Dibutylthiostannoic acid polymer [= thiobis(butyl-tin sulphide), polymer]	In compliance with this specifications laid down in Schedule 4
73	47440	000461-58-5	Dicyanodiamide
73A	47540	027458-90-8	Di-tert-dodecyl disulfide	SML – 0.05 mg/kg
73B	47680	000111-46-6	Diethyleneglycol	SML(T) = 30 mg/kg (3)
73C	48460	000075-37-6	1,1-Difluoroethane]
73D	48620	000123-31-9	1,4-Dihydroxybenzene	SML = 0.6 mg/kg
73E	48720	000611-99-4	4,4'Dihydroxybenzophenone	SML(T) = 6 mg/kg (14)
73F	49485	134701-20-5	2,4-Dimethyl-6-(1-methylpentadecyl) phenol	The specific migration of this substance shall not exceed 1 mg/kg
74	49540	000067-68-5	Dimethyl sulphoxide
75	51200	000126-58-9	Dipentaerythritol
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
76	51760	025265-71-8	Dipropyleneglycol
		000110-98-5	““““““
77	52640	016389-88-1	Dolomite
77A	52645	010436-08-5	Cis-11-eicosenamide
78	52720	000112-84-5	Erucamide
79	52730	000112-86-7	Erucic acid
80	52800	000064-17-5	Ethanol
81	53270	037205-99-5	Ethylcarboxymethylcellulose
82	53280	009004-57-3	Ethylcellulose
83	53360	000110-31-6	N,N'-Ethylenebisoleamide
84	53440	005518-18-3	N,N'-Ethylenebispalmitamide
85	53520	000110-30-5	N,N'-Ethylenebisstearamide
86	53600	000060-00-4	Ethylenediaminetetraacetic acid
86A	53610	054453-03-1	Ethylenediaminetetraacetic acid, copper salt	SML(T) = 30 mg/kg (7) (expressed as copper) (3)
86B	53650	000107-21-1	Ethyleneglycol	SML(T) = 30 mg/kg
87	54005	005136-44-7	Ethylene-N-palmitamide-N'- stearamide
88	54260	009004-58-4	Ethylhydroxyethylcellulose
89	54270	–	Ethylhydroxymethylcellulose
90	54280	–	Ethylhydroxypropylcellulose
90A	54300	118337-09-0	2,2'-Ethylidenebis (4,6-di-tert-butylphenyl) fluorophosphonite	The specific migration of this substance shall not exceed 6 mg/kg
91	54450	–	Fats and oils, from animal or vegetable food sources
92	54480	–	Fats and oils, hydrogenated, from animal or vegetable food sources
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
93	55040	000064-18-6	Formic acid
94	55120	000110-17-8	Fumaric acid
95	55190	029204-02-2	Gadoleic acid
96	55440	009000-70-8	Gelatine
97	55520	–	Glass fibres
98	55600	–	Glass microballs
99	55680	000110-94-1	Glutaric acid
100	55920	000056-81-5	Glycerol
101	56020	099880-64-5	Glycerol dibehenate
102	56360	–	Glycerol, esters with acetic acid
103	56486	–	Glycerol, esters with acids, aliphatic, saturated, linear, with an even number of carbon atoms C₁₄-C₁₈) and with acids, aliphatic, unsaturated, linear, with even number of carbon atoms (C₁₆-C₁₈)
104	56487	–	Glycerol, esters with butyric acid
105	56490	–	Glycerol, esters with erucic acid
106	56495	–	Glycerol, esters with 12-hydroxystearic acid
107	56500	–	Glycerol, esters with lauric acid
108	56510	–	Glycerol, esters with linoleic acid
109	56520	–	Glycerol, esters with myristic acid
109A	56535	–	Glycerol, esters with nonanoic acid
110	56540	–	Glycerol, esters with oleic acid
111	56550	–	Glycerol, esters with palmitic acid
113	56570	–	Glycerol, esters with propionic acid
114	56580	–	Glycerol, esters with ricinoleic acid
115	56585	–	Glycerol, esters with stearic acid
116	56610	030233-64-8	Glycerol monobehenate
117	56720	026402-23-3	Glycerol monohexanoate
118	56800	030899-62-8	Glycerol monolaurate diacetate
119	56880	026402-26-6	Glycerol monooctanoate
120	57040	–	Glycerol monooleate, ester with ascorbic acid
121	57120	–	Glycerol monooleate, ester with citric acid
122	57200	–	Glycerol monopalmitate, ester with ascorbic acid
123	52780	–	Glycerol monopalmitate, ester with citric acid
124	57600	–	Glycerol monostearate, ester with ascorbic acid
125	57680	–	Glycerol monostearate, ester with citric acid
125A	57800	018641-57-1	Glycerol tribehenate
126	57920	000620-67-7	Glycerol triheptanoate
127	58300	–	Glycine, salts
128	58320	007782-42-5	Graphite
129	58400	009000-30-0	Guar gum
130	58480	009000-01-5	Gum arabic
131	58720	000111-14-8	Heptanoic acid
131A	59280	000100-97-0	Hexamethylenetetramine	SML(T) = 15 mg/kg (21) (expressed as Formaldehyde)
132	59360	000142-62-1	Hexanoic acid
133	59760	019569-21-2	Huntite
134	59990	007647-01-0	Hydrochloric acid
135	60030	012072-90-1	Hydromagnesite
136	60080	012304-65-3	Hydrotalcite
137	60160	000120-47-8	4-Hydroxybenzoic acid, ethyl ester
138	60180	004191-73-5	4-Hydroxybenzoic acid, isopropyl ester
139	60200	000099-76-3	4-Hydroxybenzoic acid, methyl ester
140	60240	000094-13-3	4-Hydroxybenzoic acid, propyl ester
140A	60480	003864-99-1	2-(2-Hydroxy-3,5,-di-tert-butylphenyl)-5- chlorobenzotriazole	SML(T) = 30 mg/kg (18)
141	60560	009004-62-0	Hydroxyethylcellulose
142	60880	009032-42-2	Hydroxyethylmethylcellulose
143	61120	009005-27-0	Hydroxyethyl starch
144	61390	037353-59-6	Hydroxymethylcellulose
145	61680	009004-64-2	Hydroxypropylcellulose
146	61800	009049-76-7	Hydroxypropyl starch
146	61840	000106-14-9	12-Hydroxystearic acid
148	62140	006303-21-5	Hypophosphorous acid
149	62240	001332-37-2	Iron oxide
150	62450	000078-78-4	Isopentane
151	62640	008001-39-6	Japan wax
152	62720	001332-58-7	Kaolin
153	62800	–	Kaolin, calcined
154	62960	000050-21-5	Lactic acid
155	63040	000138-22-7	Lactic acid, butyl ester
156	63280	000143-07-7	Lauric acid
157	63760	008002-43-5	Lecithin
158	63840	000123-76-2	Levulinic acid
159	63920	000557-59-5	Lignoceric acid
160	64015	000060-33-3	Linoleic acid
161	64150	028290-79-1	Linolenic acid
162	64500	–	Lysine, salts
163	64640	001309-42-8	Magnesium hydroxide
164	64720	001309-48-4	Magnesium oxide
164A	64800	00110-16-7	Maleic acid	SML(T) = 30 mg/kg(4)
165	65020	006915-15-7	Malic acid
166	65040	000141-82-2	Malonic acid
167	65520	000087-78-5	Mannitol
167A	65920	066822-60-4	N-methacryloyloxyethyl-N,N-dimethyl-N- carboxymethyl-ammonium chloride, sodium salt-octadecyl methacrylate- ethyl methacrylate –cyclohexyl methacrylate-N-vinyl-2-pyrrolidone, copolymers
168	66200	037206-01-2	Methylcarboxymethylcellulose
169	66240	009004-67-5	Methylcellulose
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)
170	66640	009004-59-5	Methylethylcellulose
171	66695	–	Methylhydroxymethylcellulose
172	66700	009004-65-3	Methylhydroxypropylcellulose
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
173	67120	012001-26-2	Mica
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)
174	67200	001317-33-5	Molybdenum disulphide
175	67840	–	Montanic acids and/or their esters with ethyleneglycol and/or with 1,3-butanediol and/or with glycerol
176	67850	008002-53-7	Montan wax
177	67891	000544-63-8	Myristic acid
178	68040	003333-62-8	7-(2H-Naphtho-(1,2-D) triazol-2-yl)-3-phenylcoumarin
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
179	68125	037244-96-5	Nepheline syenite
179A	68145	080410-33-9	2,2',2'-Nitrilo (triethyl tris (3,3',5,5'- tetra-tert-butyl-1-1'-bi-phenyl-2-2-diyl) phosphite)	The specific migration of this substance shall not exceed 5 mg/kg (sum of phosphite and phosphate)
180	68960	000301-02-0	Oleamide
181	69040	000112-80-1	Oleic acid
182	69760	000143-28-2	Oleyl alcohol
182A	69920	000144-62-7	Oxalic acid	SML(T) = 6 mg/kg (29)
183	70000	070331-94-1	2,2'-Oxamidobis(ethyl-3-(3,5-di-tert-butyl-4- hydroxyphenyl) propionate)
184	70240	012198-93-5	Ozokerite
185	70400	000057-10-3	Palmitic acid
186	71020	000373-49-9	Palmitoleic acid
187	71440	009000-69-5	Pectin
188	71600	000115-77-5	Pentaerythritol
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
188B	71670	178671-58-4	Pentaerythritol tetrakis (2-cyano-3,3-diphenylacrylate)	SML(T) = 0.05 mg/kg
189	71680	006683-19-8	Pentaerythritol tetrakis [-3-(3,5-di-tert-butyl-4- hydroxyphenyl) propionate]
190	71720	000109-66-0	Pentane
191	72640	007664-38-2	Phosphoric acid
191A	73160		Phosphoric acid, mono- and di-n-alkyl (C16 and C18) esters	SML(T) = 0.05 mg/kg
191B	73720	000115-96-8	Phosphoric acid, trichloroethyl	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
191C	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)
192	74240	031570-04-4	Phosphorous acid, tris (2,4-di-tert-butylphenyl) ester
193	74480	000088-99-3	o-Phthalic acid
194	76320	000085-44-9	Phthalic anhydride
195A	76721	009016-00-6 063148-62-9	Polydimethylsiloxane (Mw > 6800)	In compliance with the specifications laid down in Schedule 4
195B	76730		Polydimethylsiloxane, gamma-hydroxypropylated	SML = 6 mg/kg
195D	76865	–	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 or fatty acids C₁₂-C₁₈ or n-octanol and/or n-decanol	SML = 30 mg/kg
196	76960	025322-68-3	Polyethyleneglycol
197	77600	061788-85-0	Polyethyleneglycol ester of hydrogenated caster oil
198	77702	–	Polyethyleneglycol esters of aliphatic monocarboxylic acids (C₆-C₂₂ ), and their ammonium and sodium sulphates
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 4
199	79040	009005-64-5	Polyethyleneglycol sorbitan monolaurate
200	79120	009005-65-6	Polyethyleneglycol sorbitan monooleate
201	79200	009005-66-7	Polyethyleneglycol sorbitan monopalmitate
202	79280	009005-67-8	Polyethyleneglycol sorbitan monostearate
203	79360	009005-70-3	Polyethyleneglycol sorbitan trioleate
204	79440	009005-71-4	Polyethyleneglycol sorbitan tristearate
205	80240	029894-35-7	Polyglycerol ricinoleate
206	80640	–	Polyoxyalkyl (C₂-C₄ ) dimethylpolysiloxane
207	80720	008017-16-1	Polyphosphoric acids
208	80800	025322-69-4	Polypropyleneglycol
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-hexanedyl[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
208B	81515	087189-25-1	Poly (zinc glycerolate)]
209	81520	007758-02-3	Potassium bromide
210	81660	001310-58-3	Potassium hydroxide
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)
211	81840	000057-55-6	1,2-Propanediol
212	81882	000067-63-0	2-Propanol
213	82000	000079-09-4	Propionic acid
214	82080	009005-37-2	1,2-Propyleneglycol alginate
215	82240	022788-19-8	1,2-Propyleneglycol dilaurate
216	82400	000105-62-4	1,2-Propyleneglycol dioleate
217	82560	033587-20-1	1,2-Propyleneglycol dipalmitate
218	82720	006182-11-2	1,2-Propyleneglycol distearate
219	82800	027194-74-7	1,2-Propyleneglycol monolaurate
220	82960	001330-80-9	1,2-Propyleneglycol monooleate
221	83120	029013-28-3	1,2-Propyleneglycol monopalmitate
222	83300	001323-39-3	1,2-Propyleneglycol monostearate
223	83320	–	Propylhydroxyethylcellulose
224	83325	–	Propylhydroxymethylcellulose
225	83330	–	Propylhydroxypropylcellulose
226	83440	002466-09-3	Pyrophosphoric acid
227	83455	013445-56-2	Pyrophosphorous acid
228	83460	012269-78-2	Pyrophyllite
229	83470	014808-60-7	Quartz
229A	83599	068442-12-6	Reaction products of oleic acid, 2-mercaptoethyl ester, with dichlorodimethyltin, sodium sulphide and trichloromethyltin	SML(T) = 0.18 mg/kg (15) (expressed as tin)
230	83610	073138-82-6	Resin acids and rosin acids
231	83840	008050-09-6	Rosin
232	84000	008050-31-5	Rosin, ester with glycerol
233	84080	008050-26-8	Rosin, ester with pentaerythritol
234	84210	065997-06-0	Rosin, hydrogenated
235	84240	065997-13-9	Rosin, hydrogenated, ester with glycerol
236	84320	008050-15-5	Rosin, hydrogenated, ester with methanol
237	84400	064365-17-9	Rosin, hydrogenated, ester with pentaerythritol
238	84560	009006-04-6	Rubber, natural
239	84640	000069-72-7	Salicylic acid
239A	85360	000109-43-3	Sebacic acid, dibutyl ester
240A	85610	–	Silicates, natural, silanated (with the exception of asbestos)
240ZA	85601	–	Silicates, natural, (with the exception of asbestos)
240B	85680	001343-98-2	Silicic acid
240C	85840	053320-86-8	Silicic acid, lithium magnesium sodium salt	SML(T) = 0.6 mg/kg (8) (expressed as lithium)
242	86000	–	Silicic acid, silylated
243	86160	000409-21-2	Silicon carbide
244	86240	007631-86-9	Silicon dioxide
244A	86285	–	Silicon dioxide, silanated
245	86560	007647-15-6	Sodium bromide
246	86620	001310-73-2	Sodium hydroxide
246A	87040	001330-43-4	Sodium tetraborate	SML(T) = 6 mg/kg (22) (expressed as boron) without prejudice to the provisions of Directive 98/83/EC on water for human consumption
247	87200	000110-44-1	Sorbic acid
248	87280	029116-98-1	Sorbitan dioleate
249	87520	062568-11-0	Sorbitan monobehenate
250	87600	001338-39-2	Sorbitan monolaurate
251	87680	001338-43-8	Sorbitan monooleate
252	87760	026266-57-9	Sorbitan monopalmitate
253	87840	001338-41-6	Sorbitan monostearate
254	87920	061752-68-9	Sorbitan tetrastearate
255	88080	026266-58-0	Sorbitan trioleate
256	88160	054141-20-4	Sorbitan tripalmitate
257	88240	026658-19-5	Sorbitan tristearate
258	88320	000050-70-4	Sorbitol
259	88600	026836-47-5	Sorbitol monstearate
259A	88640	008013-07-8	Soybean oil, epoxidized	In compliance with the specifications laid down in Schedule 4
260	88800	009005-25-8	Starch, edible
261	88880	068412-29-3	Starch, hydrolysed
262	88960	000125-26-5	Stearamide
263	89040	000057-11-4	Stearic acid
263A	89200	007617-31-4	Stearic acid, copper salt	SML(T) = 30 mg/kg (7) (expressed as copper)
263B	89440	–	Stearic acid, esters with ethyleneglycol	SML(T) = 30 mg/kg (3)
264	90720	058446-52-9	Stearoylbenzoylmethane
265	90800	005793-94-2	Stearoyl-2-lactylic acid, calcium salt
266	90960	000110-15-6	Succinic acid
267	91200	000126-13-6	Sucrose acetate isobutyrate
268	91360	000126-14-7	Sucrose octaacetate
269	91840	007704-34-9	Sulphur
270	91920	007664-93-9	Sulphuric acid
270A	92030	010124-44-4	Sulphuric acid, copper salt	SML(T) = 30 mg/kg (7) (expressed as copper)
271	92080	014807-96-6	Talc
271A	92150	001401-55-4	Tannic acids	According to the JECFA specifications
272	92160	000087-69-4	Tartaric acid
273	92195	–	Taurine, salts
274	92205	057569-40-1	Terephthalic acid, diester with 2,2'-methylenebis (4-methyl-6-tert-butylphenol)
275	92350	000112-60-7	Tetraethyleneglycol
276	92640	000102-60-3	N,N,N',N'- Tetrakis (2-hydroxypropyl) ethylenediamine
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-dihydropridine-3-carboxylate)	The specific migration of this substance shall not exceed 6 mg/kg
277	93440	013463-67-7	Titanium dioxide
278	93520	000059-02-9 010191-41-0	alpha-Tocopherol ““““““
279	93680	009000-65-1	Tragacanth gum
279A	93720	000108-78-1	2,4,6-Triamino-1,3,5-triazine	SML = 30 mg/kg
280	94320	000112-27-6	Triethyleneglycol
280A	94960	000077-99-6	1,1,1-Trimethylolpropane	The specific migration of this substance shall not exceed 6 mg/kg
280B	95000	028931-67-1	Trimethylolpropane trimethacrylatemethyl methacrylate copolymer]
281	95200	001709-70-2	1,3,5-Trimethyl-2,4,6-tris (3,5-di-tert-butyl-4- hydroxybenzyl) benzene
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)
281B	95725	110638-71-6	Vermiculite, reaction product with citric acid, lithium salt	SML(T) = 0.6 mg/kg (8) (expressed as lithium)
281C	95855	007732-18-5	Water	In compliance with Directive 98/83/EC
281D	95859	–	Waxes, refined, derived from petroleum based or synthetic hydrocarbon feedstocks	In compliance with the specifications laid down in Schedule 4
281E	95883	–	White mineral oils, paraffinic, derived from petroleum based hydrocarbon deedstocks	In compliance with the specifications laid down in Schedule 4
282	95905	013983-17-0	Wollastonite
283	95920	–	Wood flour and fibres, untreated
284	95935	011138-66-2	Xanthan gum
285	91690	020427-58-1	Zinc hydroxide
286	96240	001314-13-2	Zinc oxide
287	96320	001314-98-3	Zinc sulphide

PART 2 — Incomplete List of Additives Used in the Manufacture of Plastic Materials and Articles (Being Additives to which Paragraphs 5 of Part 3 of this Schedule Applies)

Item	1 PM/REFNo.	2 CAS No	3 Name	4 Restrictions and specifications
1	30180	002180-18-9	Acetic acid, manganese salt	SML(T) = 0.6 mg/kg (9) (expressed as manganese)
2	31520	061167-58-6	Acrylic acid, 2-tert-butyl- 6-(3-tert- butyl- 2-hydroxy-5-methylbenzyl)-4-methylphenyl ester	SML = 6 mg/kg
3	31920	000103-23-1	Adipic acid, bis (2-ethylhexyl) ester	SML = 18 mg/kg (1)
4	34230		Alkyl (C₈-C₂₂ ) sulphonic acids	SML = 6 mg/kg
4A	34650	151841-65-5	Aluminium hydroxybis [2,2'-methylenebis (4,6-di-tert-butylphenyl) phospate	SML = 5 mg/kg
5	35760	001309-64-4	Antimony trioxide	SML = 0.02 mg/kg (expressed as anti-monium and analytical tolerance included)
6	36720	017194-00-2	Barium hydroxide	SML(T) = 1 mg/kg (11) (expressed as barium)
7	36800	010022-31-8	Barium nitrate	SML(T) = 1 mg/kg (11) (expressed as barium)
7A	38000	000553-54-8	Benzoic acid, lithium salt	SML(T) = 0.6 mg/kg (8) (expressed as lithium)
8	38240	000119-61-9	Benzophenone	SML = 0.6 mg/kg
9	38560	007128-64-5	2,5-Bis (5-tert-butyl-2-benzoxazolyl) thio-phene	SML = 0.6 mg/kg
10	38700	063397-60-4	Bis (2-carbobutoxyethyl) tin- bis (isooctylmercapto-acetate)	SML = 18 mg/kg
11	38800	032687-78-8	N,N'-Bis (3-(3,5-di-tert-butyl-4-hydroxyphenyl) pro-pionyl) hydrazide	SML = 15 mg/kg
12	38820	026741-53-7	Bis (2,4-di-tert-butylphenyl) pentaery-thritol diphosphite	SML = 0.6 mg/kg
13	39060	035958-30-6	1,1-Bis (2-hydroxy-3, 5-di-tert-butylphenyl) ethane	SML = 5 mg/kg
14	39090		N,N-bis (2-hydroxyethyl) alkyl (C₈-C₁₈) amine	SML(T) = 1.2 mg/kg (12)
15	39120		N,N-bis (2-hydroxyethyl)-alkyl (C₈-C₁₈) amine hydrochlorides	SML(T) = 1.2 mg/kg (12) expressed as tertiary amine (expressed excluding HCI)
16	40000	00991-84-4	2,4-Bis (octylmercapto) – 6- (4-hydroxy- 3,5,di-tert-butylanilino) – 1,3,5-triazine	SML = 30 mg/kg
17	40020	110553-27-0	2,4-Bis (octylthiomethyl) – 6- methylphenol	SML = 6 mg/kg
18	40160	61269-61-2	N,N'-bis (2,2,6,6-tetramethyl-4- piperidyl) hexamethy-lenediamine- 1,2- dibromoethane,copolymer	SML = 2.4 mg/kg
18A	40720	025013-16-5	Tert-butyl- 4-hydroxyanisole (= BHA)	SML = 30 mg/kg
19	40800	13003-12-8	4,4' – butylidene-bis (6-tert-butyl-3-methylphenyl-ditridecyl phosphite)	SML = 6 mg/kg
20	409080	19664-95-0	Butyric acid, manganese salt	SML(T) = 0.6 mg/kg (9) (expressed as manganese)
21	42000	63438-80-2	(2-carbobutoxyethyl) tin-tris (isooctylmercapto-acetate)	SML = 30 mg/kg
22	42400	010377-37-4	Carbonic acid, lithium salt	SML(T) = 0.6 mg/kg (8) (expressed as lithium)
23	42480	000584-09-8	Carbonic acid, rubidium salt	SML = 12 mg/kg
24	43600	004080-31-3	1- (3- Chloroallyl) – 3,5,7 – triaza-1-azoniaadamantane chloride	SML = 0.3 mg/kg
25	43680	000075-45-6	Chlorodifluoromethane	SML = 6 mg/kg and in compliance with the specifications laid down in Schedule 4
26	44960	011104-61-3	Cobalt oxide	SML(T) = 0.05 mg/kg (13) (expressed as cobalt)
27	45440	–	Cresols, butylated, styrenated	SML = 12 mg/kg
27A	45650	06197-30-4	2-Cyano-3,3-diphenylacrylic acid, 2-ethylhexyl ester	SML = 0.05 mg/kg
27B	46640	000128-37-0	2,6-di-tert-butyl-p-cresol (= BHT)	SML = 3.0 mg/kg
29	47600	084030-61-5	Di-n-dodecyltin bis (isooctyl mercaptoacetate)	SML = 12 mg/kg
30	48640	000131-56-6	2,4-Dihydroxybenzophenone	SML(T) = 6 mg/kg (14)
31	48800	000097-23-4	2,2'-Dihydroxy-5,5'-dichlorodiphenylmethane	SML = 12 mg/kg
32	48880	000131-53-3	2,2'Dihydroxy-4-methoxybenzophenone	SML(T) = 6 mg/kg (14)
33	49600	026636-01-1	Dimethyltin bis (isooctyl mercaptoaecetate)	SMT(T) 0.18 mg/kg (15) (expressed as tin)
34	49840	002500-88-1	Dioctadecyl disulphide	SMT = 3 mg/kg
35	50160		Di-n-octyltin bis(n-alkyl (C₁₀ -C₁₆) mercapto acetate)	SML(T) = 0.04 mg/kg (16) (expressed as tin)
36	50240	010039-33-5	Di-n-octyltin bis (2-ethylhexyl maleate)	SML(T) = 0.04 mg/kg (16) (expressed as tin)
37	50320	015571-58-1	Di-n-octyltin bis (2-ethylhexyl mercaptoaectate)	SML(T) = 0.04 mg/kg (16) (expressed as tin)
38	50360		Di-n-octyltin bis (ethyl maleate)	SML(T) = 0.04 mg/kg (16) (expressed as tin)
39	50400	033568-99-9	Di-n-octyltin bis (isooctyl maleate)	SML(T) = 0.04 mg/kg (16) (expressed as tin)
40	50480	026401-97-8	Di-n-octyltin bis (isooctyl mercaptoacetate)	SML(T) = 0.04 mg/kg (16) (expressed as tin)
41	50560		Di-n-octyltin 1,4-butanediol bis (mercaptoacetate)	SML(T) = 0.04 mg/kg (16) (expressed as tin)
42	50640	003648-18-8	Di-n-octyltin dilaurate	SML(T) = 0.04 mg/kg (16) (expressed as tin)
43	50720	015571-60-5	Di-n-octyltin dimaleate	SML(T) = 0.04 mg/kg (16) (expressed as tin)
44	50800		Di-n-octyltin dimaleate, esterified	SML(T) = 0.04 mg/kg (16) (expressed as tin)
45	50880		Di-n-octyltin dimaleate, polymers (n = 2-4)	SML(T) = 0.04 mg/kg (16) (expressed as tin)
46	50960	69226-44-4	Di-n0octyltin ethyleneglycol bis (mercaptoacetate)	SML(T) = 0.04 mg/kg (16) (expressed as tin)
47	51040	15535-79-2	Di-n-octyltin mercaptoacetate	SML(T) = 0.04 mg/kg (16) (expressed as tin)
48	51120		Di-n-octyltin thiobenzoate 2-ethyl-hexyl mercaptoacetate	SML(T) = 0.04 mg/kg (16) (expressed as tin)
49	51570	000127-63-9	Diphenyl sulphone	SML(T) = 3 mg/kg (24)
50	51680	000102-08-9	N,N'-diphenylthiourea	SML = 3 mg/kg
51	52000	027176-87-0	Dodecylbenzenesulphonic acid	SML = 30 mg/kg
52	52320	052047-59-3	2-(4-Dodecylphenyl) indole	SML = 0.06 mg/kg
53	52880	023676-09-7	4-Ethoxybenzoic acid, ethyl ester	SML = 3.6 mg/kg
54	53200	023949-66-8	2-Ethoxy-2'-ethyloxanilide	SML = 30 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 )
55	58960	000057-09-0	Hexadecyltrimethylammonium bromide	SML = 6 mg/kg
56	59120	023128-74-7	1,6-Hexamethylene-bis (3- (3,5-di-tert-butyl-4-hydroxyphenyl) propionamide)	SML = 45 mg/kg
57	59200	035074-77-2	1,6- Hexamethylene-bis (3- (3,5-di-tert-butyl-4-hydroxyphenyl) propionate	SML = 6 mg/kg
58	60320	070321-86-7	2- (2-Hydroxy-3,5-bis (1,1-dimethylbenzyl) phenyl) benzotriazole	SML = 1.5 mg/kg
59	60400	003896-11-5	2- (2'-Hydroxy-3'-tert-butyl- 5'-methylphenyl) –5-chlorobenzotriazole	SML(T) = 30 mg./kg (18)
60	60800	065447-77-0	1-(2- Hydroxyethyl) –4-hydroxy- 2,2, 6,6-tetramethyl, pipe ridine-succinic acid, dimethyl ester, copolymer	SML = 30 mg/kg
61	61280	003293-97-8	2-Hydroxy-4-n-hexyloxybenzophenone	SML(T) = 6 mg/kg (14)
62	61360	000131-57-7	2-Hydroxy-4-methoxybenzophenone	SML(T) = 6 mg/kg (14)
63	61440	002440-22-4	2-(2-Hydroxy-5-methylphenyl) benzotriazole	SML(T) = 30 mg/kg (18)
64	61600	001843-05-6	2-Hydroxy-4-n-octyloxybenzophenone	SML(T) = 6 mg/kg (14)
65	63200	051877-53-3	Lactic acid, manganese salt	SML(T) = 0.6 mg/kg (9) (expressed as manganese)
66	64320	010377-51-2	Lithium iodide	SML(T) = 1 mg/kg (10) (expressed as iodium) and SML(T) = 0.6 mg/kg (⁸ ) (expressed as lithium)
67	65120	007773-01-5	Manganese chloride	SML(T) = 0.6 mg/kg (9) (expressed as manganese)
68	65200	012626-88-9	Manganese hydroxide	SML(T) = 0.6 mg/kg (9) (expressed as manganese
69	65280	010043-84-2	Manganese hypophosphite	SML(T) = 0.6 mg/kg (9) (expressed as manganese
70	65360	011129-60-5	Manganese oxide	SML(T) = 0.6 mg/kg (9) (expressed as manganese
71	65440		Manganese pyrophosphite	SML(T) = 0.6 mg/kg (9) (expressed as manganese
72	66360	085209-91-2	2-2'-Methylene bis (4,6-di-tert-butylphenyl) sodium phosphate	SML = 5 mg/kg
73	66400	000088-24-4	2-2'-Methylenbis (4-ethyl-6-tert-butylphenol)	SML(T) = 1.5 mg/kg (19)
74	66480	000119-47-1	2-2'- Methylenbis (4-methyl-6-tert-butylphenol)	SML(T) = 1.5 mg/kg (19)
75	67360	067649-65-4	Mono-n-dodecyltin tris (isooctyl mercaptoacetate)	SML = 24 mg/kg
76	67520	054849-38-6	Monomethyltin tris (isooctyl mercaptoacetate)	SML(T) = 0.18 mg/kg (15) (expressed as tin)
77	67600		Mono-n-octyltin tris (alkyl (C₁₀ -C₁₆) – mercaptoacetate	SML(T) = 1.2 mg/kg (17) (expressed as tin)
78	67680	027107-89-7	Mono-n-octyltin tris (2-ethylhexyl mercaptoacetate	SML(T) = 1.2 mg/kg (17) (expressed as tin)
79	67760	026401-86-5	Mono-n-octyltin tris (isooctyl mercaptoacetate)	SML(T) = 1.2 mg/kg (17) (expressed as tin)
79A	67896	020336-96-3	Myristic acid, lithium salt	SML(T) = 0.6 mg/kg (8) (expressed as lithium)
81	68320	002082-79-3	Octadecyl 3- (3,5-di-tert-butyl-4- hydroxylphenyl) propionate	SML = 6 mg/kg
82	68400	010094-45-8	Octadecylerucamide	SML = 5 mg/kg
82A	68860	004724-48-5	n-Octylphosphonic acid	SML = 0.05 mg/kg
83	69840	016260-09-6	Oleylpalmitamide	SML = 5 mg/kg
83A	71935	007601-89-0	Perchloric acid, sodium salt monohydrate	SML = 0.05 mg/kg (31)
84	72160	000948-65-2	2-Phenylindole	SML = 15 mg/kg
85	72800	001241-94-7	Phosphoric acide, diphenyl 2-ethylhexyl ester	SML = 2.4 mg/kg
86	73040	013763-32-1	Phosphoric acid, lithium salts	SML(T) = 0.6 mg/kg (8) (expressed as lithium)
87	73120	010124-54-6	Phosphoric acid, manganese sale	SML(T) = 0.6 mg/kg (9) (expressed as manganese
88	74400		Phosphorous acid, tris (nonyl- and/or dinonylphenyl) ester	SML = 30 mg/kg
88A	76680	068132-00-3	Polycyclopentadiene, hydrogenated	SML = 5 mg/kg (1)
89	77440		Polyethyleneglycol diricinoleate	SML = 42 mg/kg
90	77520	061791-12-6	Polyethyleneglycol ester of caster oil	SML = 42 mg/kg
91	78320	009004-97-1	Polyethyleneglycol monoricinoleate	SML – 42 mg/kg
92	81200	071878-19-8	Poly [6- [1,1,3,3- tetramethylbutyl) – amino]- 1,3,5-triazine-2,4-diyl]- [(2,2,6,6-tetramethyl- 4-piperidyl)-imino] hexamethylene- [2,2,6,6-tetramethyl-4-piperidyl) imino]	SML = 3 mg/kg
93	81680	007681-11-0	Potassium iodide	SML(T) = 1 mg/kg (10) (expressed as iodium)
94	82020	019019-51-3	Propionic acid, cobalt salt	SML(T) = 0.05 mg/kg (13) (expressed as cobalt)
95	83595	119345-01-6	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	SML = 18 mg/kg and in compliance with the specifications in Schedule 4
96	83700	000141-22-0	Ricinoleic acid	SML = 42 mg/kg
97	84800	000087-18-3	Salicylic acid, 4-tert-butylphenyl ester	SML = 12 mg/kg
98	84880	000119-36-8	Salicylic acid, methyl ester	SML = 30 mg/kg
99	85760	012068-40-5	Silicic acid, lithium aluminium salt (2:1:1)	SML(T) = 0.6 mg/kg (8) (expressed as lithium)
100	85920	012627-14-4	Silicic acid, lithium salt	SML(T) = 0.6 mg/kg (8) (expressed as lithium)
100A	86480	007631-90-5	Sodium bisulphite	SML(T) = 10 mg/kg (30) (expressed as SO₂)
101	86800	007681-82-5	Sodium iodide	SML(T) = 1 mg/kg (10) (expressed as iodium)
102	86880		Sodium monoalkyl dialkylphenoxybenzenedi-sulphonate	SML = 9 mg/kg
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	07772-98-7	Sodium thiosulphate	SML(T) = 10 mg/kg (30) expressed as SO₂)
103	89170	013586-84-0	Stearic acid, cobalt salt	SML(T) = 0.05 mg/kg (13) expressed as cobalt)
104	92000	007727-43-7	Sulphuric acid, barium salt	SML(T) = 1 mg/kg (11) expressed as barium)
105	92320		Tetradecyl-polyethyleneglycol (EO = 3-8) ether of glycolic acid	SML = 15 mg/kg
106	92560	038613-77-3	Tetrakis (2,4- di-tert-butyl-phenyl) – 4-4' –biphenylylene diphosphonite	SML = 18 mg/kg
107	92800	000096-69-5	4,4'-Thiobis (6-tert-butyl- 3-methylphenol)	SML = 0.48 mg/kg
108	92880	041484-35-9	Thiodiethanol bis (3-(3-5-di-tert- butyl-4-hydroxyphenyl) propionate	SML = 2.4 mg/kg
109	93120	000123-28-4	Thiodipropionic acid, didodecyl ester	SML(T) = 5 mg/kg (20)
110	93280	000693-36-7	Thiodipropionic acid, dioctadecyl ester	SML(T) = 5 mg/kg (20)
110A	94400	036443-68-2	Triethyleneglycol bis[ 3-(3-tert-butyl- 4-hydroxy- 5-methylphenyl) propionate]	SML = 9 mg/kg
111	94560	000122-20-3	Triisopropanolamine	SML = 5 mg/kg
112	95280	040601-76-1	1,3,5- Tris (4-tert-butyl-3-hydroxy –2,6- dimethylbenzyl)- 1,3,5-triazine-2,4,6 (1H, 3H,5H)- trione	SML = 6 mg/kg
113	95360	27676-62-6	1,3,5 – Tris (3,5-di-tert-butyl-4 hydroxybenzyl)- 1,3,5-triazine –2,4,6 (1H, 3H, 5H) – trione	SML = 5 mg/kg
114	95600	01843-03-4	1,1,3- Tris (2-methyl-4-hydroxy-5-tert-butylphenyl) butane	SML = 5 mg/kg

PART 3 — Supplementary

1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SCHEDULE 3 — Products Obtained by Bacterial Fermentation

Item	1 PM/REF No	2 CAS No	3 Name	4 Restrictions and specifications
1	18888	080181-31-3	3-hydroxybutanoic acid— 3-hydroxypentanoic acid, copolymer	In compliance with specifications included in Schedule 4

SCHEDULE 4 — Specifications

SCHEDULE 5 — Provisions Applicable when Testing Compliance with the Migration Limits

General Provisions

1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Special provisions relating to overall migration

5

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SCHEDULE 6 — Overall and Specific Migration Testing Using Food Simulants

PART 1 — Basic Rules

1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 2 — Food Simulants to be Used in Migration Testing

5

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

8

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

9

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 3 — Selection of Food Simulants

Testing, reduction factors and definition of food types

10

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

11

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

12

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Selection of simulants for testing materials and articles intended for contact with all food types

13

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Selection of simulants for testing materials and articles which are already in contact with a known food

14

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Selection of simulants for testing materials and articles which are accompanied by a specific indication

15

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

16

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

17

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 4 — Selection of Food Simulants

18

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

19

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

20

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

21

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

22

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 5 — Migration Test Conditions (Times and Temperatures)

General criteria

23

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

24

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

25

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Volatile migrants

26

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Special cases

27

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

28

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

29

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

30

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 6 — Substitute Fat Test for Overall and Specific Migration

31

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

32

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

33

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

34

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

35

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

36

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 7 — Alternative Fat Tests for Overall and Specific Migration

37

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

38

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

39

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Signed

Sealed with the Official Seal of the Department of Health, Social Services and Public Safety on 5th June 2006.

Don Hill — A senior officer of the — Department of Health, Social Services and Public Safety

Explanatory note

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Footnotes

[^f00001]: Formerly the Department of Health and Social Services see S.I. 1999/283 (N.I.1) Article 3(6)

[^f00002]: S.I. 1991/762 (N.I.7) as amended by S.I. 1996/1663 (N.I.12), paragraphs 26 to 42 of Schedule 5 and Schedule 6 to the Food Standards Act 1999 c. 28 and S.R. 2004 Nos. 482 and 505

[^f00003]: 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)

[^f00004]: OJ No. L297, 23.10.1982, p.26

[^f00005]: OJ No. L222, 12.8.1997, p.10

[^f00006]: OJ No. L372, 31.12.1985, p.14

[^f00007]: OJ No. L184, 15.7.1988, p.61

[^f00008]: OJ No. L40, 11.2.1989, p. 27

[^f00009]: OJ No. L220, 15.8.2002, p.18

[^f00010]: OJ No. L71, 10.3.2004, p.8

[^f00011]: S.R. 1998 No. 264, as amended by S.R. 2000 No. 402, S.R. 2002 No. 316, S.R. 2003 No. 2, S.R. 2004 No. 493 and S.R. 2005 No. 49

[^f00012]: S.R. 2005 No. 210

[^f00013]: OJ No. L178, 28.7.97, p.1, as last amended by Commission Directive 2004/46, OJ No. L114, 21.4.2004, p.15

[^f00014]: OJ No. L226, 22.9.95, p.1, as last amended by Commission Directive 2004/47, OJ No. L113, 20.4.2004, p.24

[^f00015]: OJ No. L339, 30.12.96, p.1, as last amended by Commission Directive 2003/95, OJ No. L283, 31.10.2003, p.71

[^f00016]: OJ No. L302, 19.11.2005, p.28

[^f00017]: Regulation (EC) No 1935/2004 of the European Parliament and of the Council on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ No. L338, 13.11.2004, p.4)

[^f00018]: S.R. 1991 No. 198

[^f00019]: S.R. 2006 No.

[^f00020]: S.R. 2000 No. 402

[^f00021]: S.R. 2002 No. 316

[^f00022]: S.R. 2003 No. 2

[^f00023]: S.R. 2004 No. 493

[^f00024]: S.R. 2005 No. 49

[^f00025]: OJ No. L338, 13.11.2004, p.4

Editorial notes

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Reading this document does not replace reading the official text published on legislation.gov.uk. Contains public sector information licensed under the Open Government Licence v3.0. We assume no responsibility for any inaccuracies arising from the conversion of the original CLML XML to this format.

This text is published under legislation.gov.uk's own terms of reuse, not a Legalize or public-domain licence. legislation.gov.uk
Open Government Licence v3.0 (attribution required)
© Crown and database right. Derived from content available under the Open Government Licence v3.0 from legislation.gov.uk.

Item	1 PM/REF No	2 Specifications	2 Specifications
(1) Quantity of substance used/quantity of formulation	(1) Quantity of substance used/quantity of formulation	(1) Quantity of substance used/quantity of formulation	(1) Quantity of substance used/quantity of formulation
1	11530	Acrylic acid, 2-hydroxypropyl ester	Acrylic acid, 2-hydroxypropyl ester
		It may contain up to 25% (m/m) of acrylic acid, 2-hydroxyisopropyl ester (CAS No. 002918-23-2)	It may contain up to 25% (m/m) of acrylic acid, 2-hydroxyisopropyl ester (CAS No. 002918-23-2)
2	16690	Divinylbenzene	Divinylbenzene
		It may contain up to 45% (m/m) of Ethylvinylbenzene	It may contain up to 45% (m/m) of Ethylvinylbenzene
3	18888	3-Hydroxybutanoic acid – 3-hydroxypentanoic acid, copolymer	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	(This formula is currently unavailable. Please see the original.)
		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
		Solubility	Soluble in chlorinated hydrocarbons such as chloroform or dichloromethane but practically insoluable in ethanol, aliphatic alkanes and water
		Restriction	QMA for crotonic acid is 0.05 mg/6 dm²
		Purity	Prior to granulation of the raw material copolymer powder must contain:
		– nitrogen	Not more than 2 500 mg/g 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)	Polydimethylsiloxane (Mw > 6800)
		Minimum viscosity 100 × 10−6m²/s (= 100 centistokes) at 25°C	Minimum viscosity 100 × 10−6m²/s (= 100 centistokes) at 25°C
5	25385	Triallylamine	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.	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	4-(2-Benzoxazolyl)-4'- (5-methyl-2-benzoxazolyl) stilbene
		Not more than 0.05% w/w (quantity of substance used / quantity of the formulation)	Not more than 0.05% w/w (quantity of substance used / quantity of the formulation)
7	43680	Chlorodifluoromethane	Chlorodifluoromethane
		Content of chlorofluoromethane less than 1 mg/kg of the substance	Content of chlorofluoromethane less than 1 mg/kg of the substance
8	47210	Dibutylthiostannoic acid polymer	Dibutylthiostannoic acid polymer
		Molecular unit = (C₈H₁₈S₃Sn₂) n (n = 1.5-2)	Molecular unit = (C₈H₁₈S₃Sn₂) n (n = 1.5-2)
9	76721	Polydimethylsiloxane (Mw > 6800)	Polydimethylsiloxane (Mw > 6800)
		Minimum viscosity 100 × 10 −6m²/s (= 100 centistokes) at 25° C	Minimum viscosity 100 × 10 −6m²/s (= 100 centistokes) at 25° C
10	77895	Polyethyleneglycol (EO = 2-6) monoalkyl (C₁₆-C₁₈) ether	Polyethyleneglycol (EO = 2-6) monoalkyl (C₁₆-C₁₈) ether
		The composition of this mixture is as follows:	The composition of this mixture is as follows:
		–polyethyleneglycol (EO = 2-6) monoalkyl (C₁₆-C₁₈) ether approximately 28%)	–polyethyleneglycol (EO = 2-6) monoalkyl (C₁₆-C₁₈) ether approximately 28%)
		–fatty alcohols (C₁₆-C₁₈) (approximately 48%)	–fatty alcohols (C₁₆-C₁₈) (approximately 48%)
		–ethyleneglycol monoalkyl (C₁₆-C₁₈) ether (approximately 24%)	–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	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	Composition
		–4,4'-Biphenylene-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] (CAS No. 38613-77-3) (36-46% w/w)(¹)	–4,4'-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)[^f01000]	–4,3'-Biphenylene-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] (CAS No. 118421-00-4) (17-23% w/w)[^f01000]
		–3-3'-Biphenylene-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] CAS No. 118421-01-5) (1-5% w/w )[^f01000]	–3-3'-Biphenylene-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] CAS No. 118421-01-5) (1-5% w/w )[^f01000]
		–4-Biphenylene-0,0-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] (CAS No. 91362 – 37-7 (11-19% w/w)[^f01000]	–4-Biphenylene-0,0-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] (CAS No. 91362 – 37-7 (11-19% w/w)[^f01000]
		–Tris (2,4-di-tert-butylphenyl) phosphite (CAS No. 31570-04-4) (9-18% w/w)[^f01000]	–Tris (2,4-di-tert-butylphenyl) phosphite (CAS No. 31570-04-4) (9-18% w/w)[^f01000]
		–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 [^f01000])	–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 [^f01000])
		Other specifications	Other specifications
		–Phosphor content of minimum 5.4% to maximum 5.9%	–Phosphor content of minimum 5.4% to maximum 5.9%
		–Acid value of maximum 10 mg KOH per gram	–Acid value of maximum 10 mg KOH per gram
		–Melt range of 85-110°C	–Melt range of 85-110°C
12	88640	Soybean oil, epoxidized	Soybean oil, epoxidized
		Oxirane less than 8%, iodine number < 6	Oxirane less than 8%, iodine number < 6
13	95859	Waxes, refined, derived from petroleum based or synthetic hydrocarbon feedstocks. The product should have the following specifications:	Waxes, refined, derived from petroleum based or synthetic hydrocarbon feedstocks. The product should have the following specifications:
		Phosphor content of minimum 5.4% to maximum 5.9%	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)	–Content of mineral hydrocarbons with carbon number less than 25: not more than 5% (w/w)
		–Viscosity not less than 11 × 10 −6m²/s (= 11 centistokes) at 100°C	–Viscosity not less than 11 × 10 −6m²/s (= 11 centistokes) at 100°C
		–Average molecular weight not less than 500	–Average molecular weight not less than 500
14	95883	White mineral oils, paraffinic, derived from petroleum based hydrocarbon feedstocks	White mineral oils, paraffinic, derived from petroleum based hydrocarbon feedstocks
		The product shall have the following specifications:	The product shall have the following specifications:
		–Content of mineral hydrocarbons with carbon number less than 25: not more than 5% (w/w)	–Content of mineral hydrocarbons with carbon number less than 25: not more than 5% (w/w)
		–Viscosity not less than 8.5 × 10−6m²/s (= 8.5 centistokes) at 100°C	–Viscosity not less than 8.5 × 10−6m²/s (= 8.5 centistokes) at 100°C
		–Average molecular weight not less than 480	–Average molecular weight not less than 480