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
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articles Not indexed
Reform history JSON API

Made: 5th June 2006

Coming into operation: 30th June 2006

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PART 1 — Preliminary

Citation and commencement

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Interpretation

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PART 2 — Requirements for Materials and Articles

Restriction on the use, sale or import of plastic materials and articles

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Restriction on the use of monomers in the manufacture of plastic materials and articles

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Restriction on the use of additives in the manufacture of plastic materials and articles

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Required standard for non-migration of constituents of monomers

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Required standard for non-migration of constituents of additives

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Required standard for products obtained by bacterial fermentation

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Required standards relating to overall migration limits

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Required standard for non-migration of primary aromatic amines

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Method of testing the capability of plastic materials or articles to transfer constituents, and methods of analysis

11

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Labelling

12

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Provisions relating to the use of certain epoxy derivatives (BADGE, BFDGE and NOGE)

13

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PART 3 — Execution and Enforcement

Enforcement

14

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Offences and Penalties

15

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General defences

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Transitional defences and savings

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Procedure where a sample is to be analysed

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Secondary analysis by the Government Chemist

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PART 4 — Application for Authorisation

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

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PART 5 — General and Supplementary

Application of provisions of the Order

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Amendment of the Food Safety (Sampling and Qualifications) Regulations (NI) 1991

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Amendments to the Materials and Articles in Contact with Food Regulations (Northern Ireland) 2005

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Revocations

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SCHEDULE 1

PART 1 — List of Monomers with Restrictions and Specifications

1 PM/REF No 2 CAS No 3 Name 4 Restrictions and specifications
1 10030 000514-10-3 Abietic acid
2 10060 00075-07-0 Acetaldehyde SML(T) = 6mg/kg (2)
3 10090 000064-19-7 Acetic acid
4 10120 000108-05-4 Acetic acid, vinyl ester The specific migration of this substance shall not exceed 12mg/kg
5 10150 000108-24-7 Acetic anhydride
6 10210 000074-86-2 Acetylene
6A 10599/90A 061788-89-4 Acids, fatty, unsaturated (C₁₈), dimers, distilled QMA(T) = 0.05 mg/6 dm² (²⁷)
6B 10599/91 061788-89-4 Acids, fatty, unsaturated (C₁₈), dimers, non distilled QMA(T) = 0.05 Mg/6 dm² (27)
6C 10599/92A 068783-41-5 Acids, fatty, unsaturated (C₁₈), dimers, hydrogenated, distilled QMA(T) = 0.05 Mg/6 dm² (27)
6D 10599/93 068783-41-5 Acids, fatty, unsaturated (C₁₈), dimers, hydrogenated, distilled QMA(T) = 0.05 mg/6 dm² (27)
7 10630 000079-06-1 Acrylamide The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.01 mg/kg)
8 10660 015214-89-8 2-Acrylamido-2-methylpropane sulphonic acid The specific migration of this substance shall not exceed 0.05 mg/kg
9 10690 000079-10-7 Acrylic acid
10 10750 002495-35-4 Acrylic acid. benzyl ester
11 10780 000141-32-2 Acrylic acid, n-butyl ester
12 10810 002998-08-5 Acrylic acid, sec-butyl ester
13 10840 001663-39-4 Acrylic acid, tert-butyl ester
13A 11000 050976-02-8 Acrylic acid, discyclopentaidien-yl ester The quantity of this substance in the finished plastic material or article shall not exceed 0.05 mg/6 m²
13B 11245 002156-97-0 Acrylic acid, dodecyl ester The specific migration of this substance shall not exceed 0.05 mg/kg (1)
14 11470 000140-88-5 Acrylic acid, ethyl ester
15 As item 19 000818-61-1 Acrylic acid, hydroxethyl ester
15A 11530 00999-61-1 Acrylic acid, 2-hydroxypropyl ester QMA = 0.05 mg/6 dm² for the sum of acrylic acid, 2-hydroxypropoyl ester and acrylic acid, 2-hydroxyisopropyl ester and in compliance with the specifications laid down in Schedule 4
16 11590 000106-63-8 Acrylic acid, asobutyl ester
17 11680 000689-12-3 Acrylic acid, isopropyl ester
18 11710 000096-33-3 Acrylic acid, methyl ester
19 11830 000818-61-1 Acrylic acid, monoester with ethylene gylcol
20 11890 002499-59-4 Acrylic acid, n-octyl ester
21 11980 000925-60-0 Acrylic acid, propyl ester
22 12100 000104-13-1 Acrylonitrile 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)
23 12130 000124-04-9 Adipic acid
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
24 12280 002035-75-8 Adipic anhydride
25 12310 – Albumin
26 12340 – Albumin, coagulated by formaldehyde
27 12375 – Alcohols, aliphatic, monohydric, saturated, linear, primary (C₄ – C₂₂)
28 12670 002855-13-2 1-Amino-3-aminomethyl-3, 5, 5-trimethylcyclohexane The specific migration of this substance shall not exceed 6 mg/kg
28A 12761 000693-57-2 12-Aminododecanoic acid The specific migration of this substance shall not exceed 0.05 mg/kg
28B 12763 00141-43-5 2-Aminoethanol SML = 0.05 mg/kg. Not for use in polymers contacting foods for which simulant D is laid down in Council Directive 85/572/EEC and for indirect food contact only, behind the PET layer
28C 12765 844354-12-8 N-(2-amionoethyl)-beta-alanine, sodium salt SML – 0.05 mg/kg]
29 12788 002432-99-7 11-Aminoundecanoic acid The specific migration of this substance shall not exceed 5mg/kg
30 12789 007664-41-7 Ammonia
31 12820 000123-99-9 Azelaic acid
32 12970 004196-95-6 Azelaic anhydride
33 13000 001477-55-0 1,3-Benzenedi-methanamine The specific migration of this substance shall not exceed 0.05 mg/kg
33A 13060 004422-95-1 1,3,5-Benzenetricarbo-xylic acid trichloride The quantity of this substance in the finished plastic material or article shall not exceed 0.05 mg/6 m² (measured as 1,3,5- benzenetricarboxylic acid)
33B 13075 00091-76-9 Benzoguanamine (see “2,4-Diamino-6- Phenyl-1,3,5- Triazine”
34 13090 000065-85-0 Benzoic acid
35 13150 000100-51-6 Benzyl alcohol
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
36 As item 79 000111-46-6 Bis (2-hydroxyethyl) ether As item 79
37 As item 217 000077-99-6 2,2-Bis (hydroxymethylbutan-1-ol) As item 217
37A 13323 000102-40-9 1,3-Bis (2-hydroxyethoxy) benzene SML = 0.05 mg/kg
38 13390 000105-08-8 1,4-Bis (hydroxymethyl) – cyclohexane
38A 13395 04767-03-7 2,2-Bis (hydroxymethyl) propionic acid QMA = 0.05 mg/6 dm²
39 13480 000080-05-7 2,2-Bis (4-hydroxyphenyl) propane SML(T) = 0.6 mg/kg (28)
40 13510 001675-54-3 2,2-Bis (4-hydroxyphenyl) propane bis (2,3-epoxypropyl) ether Use must be in accordance with Regulation 1895/2005
41 13530 038103-06-9 2,2-Bis (4-hydroxyphenyl) propane bis (phthalic anhydride) The specific migration of this substance shall not exceed 0.05 mg/kg
42 As item 93 000110-98-5 Bis (hydroxypropyl) ether
43 13560 005124-30-1 Bis(4-isocyanatocyclohexyl) methane As item 78
44 13600 047465-97-4 3,3-Bis (3-methyl-4-hydroxyphenyl) – indolin-2-one The specific migration of this substance shall not exceed 1.8 mg/kg
45 As item 39 000080-05-7 Bisphenol A As item 39
46 As item 40 001675-54-3 Bisphenol A bis (2,3-epoxypropyl) ether As item 40
47 13614 038103-06-9 Bisphenol A bis (phthalic anhydride) As item 41
47A 13617 00080-09-1 Bisphenol S As item 86A
47B 13620 10043-35-3 Boric acid SML(T) – 6 mg/kg (22) (expressed as boron) without prejudice to the provisions of Directive 98/93/EC on water for human consumption
48 13630 000106-99-9 Butadiene The quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg or the specific migration of this substance shall not be detectable (when measured by a method with a limit of detection of 0.02mg/kg, analytical tolerance included)
49 13690 000107-88-0 1,3 Butandiol
49A 13720 00110-63-4 1,4-Butanediol SML(T) = 0.05 mg/kg (23)
49B 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)
49C 13810 00505-65-7 1,4-Butanediol formal QMA = 0.05 mg/6dm²
50 13840 000071-36-3 Butan-1-ol
51 13870 000106-98-9 But-1-ene
52 13900 000107-01-7 Bit-2-ene
52A 13932 00598-32-3 3-Buten-2-ol QMA = ND (DL = 0.02 mg/6 dm²). To be used only as a co-monomer for the preparation of polymeric additive
52B 14020 000098-54-4 4-tert-Butylphenol The specific migration of this substance shall not exceed 0.05 mg/kg
53 14110 000123-72-8 Butyraldehyde
54 14140 000107-92-6 Butyric acid
55 14170 000106-31-0 Butyric acid anhydride
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)
58 14320 000124-07-2 Caprylic acid
59 14350 000630-80-0 Carbon monoxide
60 14380 000075-44-5 Carbonyl chloride The quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg
61 14411 008001-79-4 Caster oil
62 14500 009004-34-6 Cellulose
63 14530 007782-50-5 Chlorine
63A 14650 000079-38-9 Chlorotrifluorethylene QMA = 0.5 mg/6dm²
64 As item 94 000106-89-8 1-Chloro-2,3-epoxypropane As item 94
65 14680 000077-92-9 Citric acid
66 14710 000108-39-4 m-Cresol
67 14740 000095-48-7 o-Cresol
68 14770 000106-44-5 p-Cresol
68MA 14800 003724-65-0 Crotonic acid QMA(T) = 0.05 mg/6 dm²/ (33)
68A 14841 000599-64-4 4-Cumylphenol The specific migration of this substance shall not exceed 0.05 mg/kg
69 As item 38 000105-08-8 1,4-Cyclohexanedimethanol
70 14950 003173-53-3 Cyclohexyl isocyanate QM(T) = 1mg/kd in FP (expressed as NCO) (26)
70A 15030 00931-88-4 Cyclooctene SML = (0.05 mg/kg. For use only in polymers contacting foods for which simulant A is laid down in Council Directive 85/572/EEC
71 15070 001647-16-1 Dec-1, 9-diene The specific migration of this substance shall not exceed 0.05 mg/kg
72 15095 000334-48-5 Decanoic acid
73 15100 000112-30-1 Decan-1-ol
73A 15130 000872-05-9 1-Decene The specific migration of this substance shall not exceed 0.05 mg/kg
74 15250 000110-60-1 1,4-Diaminobutane
75 As item 97 000107-15-3 1,2-Diaminoethane As item 97
76 As item 116 000124-09-4 1,6-Diaminohexane As item 116
76A 15310 00091-76-9 2,4-Diamino-6-phenyl-1,3,5-triazine QMA = 5 mg/6²
77 15565 000106-46-7 1,4.-Dichlorobenzene The specific migration of this substance shall not exceed 12 mg/kg
77A 15610 00080-07-9 4,4'-Dichlorodiphenyl sulphone SML = 0.05 mg/kg
78 15700 005124-30-1 Dicyclohexylmethane-4,4' – diisocyanate QM(T) = 1mg/kg (expressed as NCO (25)
79 15760 000111-46-6 Diethylene glycol SML(T) = 30 mg/kg (3)
80 15790 000111-40-0 Diethylenetriamine The specific migration of this substance shall not exceed 5 mg/kg
81 15820 000345—92-6 4,4'-Difluorobenzophenone The specific migration of this substance shall not exceed 0.05 mg/kg
82 15880 000120-80-9 1,2-Dihydroxybenzene The specific migration of this substance shall not exceed 6 mg/kg
83 15910 000108-46-3 1,3-Dihydroxybenzene The specific migration of this shall not exceed 2.4 mg/kg
84 15940 000123-31-9 1,4-Dihydroxybenzene The specific migration of this shall not exceed 0.6 mg/kg
85 15970 000611-99-4 4,4'-Dihydroxybenzophenone (SML(T) – 6 mg/kg (14)
86 16000 000092-88-6 4,4'-Dihydroxybiphenyl The specific migration of this substance shall not exceed 6 mg/kg
86A 16090 00080-09-01 4,4'-Dihydroxydiphenyl sulphone SML = 0.05 mg/kg
87 16150 000108-01-0 Dimethylaminoethanol The specific migration of this substance shall not exceed 18 mg/kg
87A 16210 006864-37-5 3,3'-Dimethyl-4,4'-diaminodicyclohexyl methane SML = 0.05 mg/kg (32). To be used only in polyamides
88 16240 000091-97-4 3,3'-Dimethyl-4,4'-diisocyanatobiphenyl QM(T) = 1 mg/kg (expressed as NCO) (25)
88A 16360 000576-26-1 2,6-Dimethylphenol The specific migration of this substance shall not exceed 0.05 mg/kg
88B 16390 00126-30-7 2,2-Dimethyl-1,3-propanediol SML = 0.05 mg/kg
88C 16450 000646-06-0 1,3-Dioxolane The specific migration of this substance shall not exceed 0.05 mg/kg
89 16480 000126-58-9 Dipentaerythritol
89A 16540 000102-09-0 Diphenyl carbonate SML = 0.05 mg/kg
90 16570 004128-73-8 Diphenylether-4,4'-diisocyanate QM(T) = 1mg/kg (expressed as NCO) (25)
91 16660 005873-54-1 Diphenylmethane-2,4'-diisocyanate QM(T) = 1 mg/kg (expressed as NCO) (25)
92 16630 000101-68-8 Diphenylmethane-4,4'-diisocyanate QM(T) – 1 mg/kg (expressed as NCO) (25)
92A 16650 00127-63-9 Diphenyl sulphone SML(T) = 3 mg/kg (24)
93 16660 000110-98-5 Dipropyleneglycol
93A 16690 01321-74-0 Divinylbenzene QMA = 0.01 mg/6 dm2 of SML = ND (DL = 0.02 mg/kg, analytical tolerance included) for the sum of divinylbenzene and ethylvinylbenzene and in compliance with the specifications laid down in Schedule 4
93B 16694 013811-50-2 N,N'-Divinly-2-imidazolidinone The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg
93C 16697 00693-23-2 n-Dodecanedioic Acid
93D 16704 000112-41-4 1-Dodecene The specific migration of this substance shall not exceed 0.05 mg/kg
94 16750 000106-89-8 Epichlorohydrin The quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg
95 16780 000064-17-5 Ethanol
96 16950 000074-85-1 Ethylene
97 16960 000107-15-3 Ethylenediamine The specific migration of this substance shall not exceed 12 mg/kg
98 16990 000107-21-1 Ethylene glycol SML(T) = 30 mg/kg (3)
99 17005 000151-56-4 Ethyleneimine The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.01 mg/kg)
100 17020 000075-21-8 Ethylene oxide The quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg
101 17050 00104-76-7 2-Ethylhexan-1-ol The specific migration of this substance shall not exceed 30 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
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)
103 17170 061688-47-4 Fatty acids, coco
104 17200 068308-53-2 Fatty acids, soya
105 17230 061790-12-3 Fatty acids, tall oil
106 17260 000050-00-0 Formaldehyde SML(T) = 15mg/kg (21)
107 17290 000110-17-8 Fumaric acid
108 17530 000050-99-7 Glucose
109 18010 000110-94-1 Glutaric acid
110 18070 000108-55-4 Glutaric anhydride
111 18100 000056-81-5 Glycerol
111A 18220 068564-88-5 N-Heptylaminound-ecanoic acid The specific migration of this substance shall not exceed 0.05 mg/kg
112 18250 000115-28-6 Hexachloroendomethylene-tetrahydrophthalic acid The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.01 mg/kg)
113 18280 000115-27-5 Hexachloroendomethylene-tetrahydrophthalic anhydride The specific migration of this substance shall not be detectable (when measured by a method with a limit of detection of 0.01 mg/kg)
114 18310 036653-82-4 Hexadecan-1-ol
115 18430 000116-15-4 Hexafluoropropylene The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.01 mg/kg)
116 18460 000124-09-4 Hexamethylenediamine The specific migration of this substance shall not exceed 2.4 mg/kg
117 18640 000822-06-0 Hexamethylene diisocyanate QM(T) = 1 mg/kg (expressed as NCO) (25)
118 18670 000100-97-0 Hexamethylenetetramine SML(T) = 15 mg/kg (expressed as formaldehyde) (21)
118MA 18700 000629-11-8 1,6-Hexanediol SML = 0.05 mg/kg
118A 18820 000592-41-6 1-Hexene The specific migration of this substance shall not exceed 3 mg/kg
119 As item 84 000123-31-9 Hydroquinone As item 84
120 18880 000099-96-7 p-Hydroxybenzoic acid
120ZA 18896 001679-51-2 4-(Hydroxymethyl)-1-cyclohexene SML = 0.05 mg/kg
120A 18897 16712-64-4 6-Hydroxy-2-naphthalenecarboxylic acid SML = 0.05 mg/kg
120B 18898 000103-90-2 N-(4-Hydroxyphenyl) acetamide SML = 0.05 mg/kg
121 19000 000115-11-7 Isobutene
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
121B 19110 04098-71-9 1-Isocyanato-3-isocyanantomethyl-3,5,5-trimethylcyclohexane QM(T) = 1 mg/kg (expressed as NCO (25)
121C 19150 000121-91-5 Isophthalic acid The specific migration of this substance shall not exceed 5 mg/kg
122 19210 001459-93-4 Isophthalic acid, dimethyl ester The specific migration of this substance shall not exceed 0.05 mg/kg
122A 19243 000780-79-5 Isoprene As item 145A
123 19270 000097-65-4 Itaconic acid
124 19460 000050-21-5 Lactic acid
125 19470 000143-07-7 Lauric acid
126 19480 002146-71-6 Lauric acid, vinyl ester
126A 19490 00947-04-6 Laurolactam SML = 5 mg/kg
127 19510 011132-73-3 Lignocellulose
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)
130 As item 215 000108-78-1 Melamine As item 215
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)
131 20020 000079-41-4 Methacrylic acid
131A 20050 000096-05-9 Methacrylic acid, allyl ester The specific migration of this substance shall not exceed 0.05 mg/kg
132 20080 002495-37-6 Methacrylic acid, benzyl ester
133 20110 000097-88-1 Methacrylic acid, butyl ester
134 20140 002998-18-7 Methacrylic acid, sec-butyl ester
135 20170 000585-07-9 Methacrylic acid, tert-butyl ester
135A 20260 00101-43-9 Methacrylic acid, cyclohexyl ester SML = 0.05 mg.kg
135B 20410 02082-81-7 Methacrylic acid, diester with 1,4-butanediol SML = 0.05 mg/kg
135BM 20440 000097-90-5 Methacrylic acid, diester with ethylenegycol SML = 0.05 mg/kg
135C 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)
135D 20590 00106-91-2 Methacrylic acid, 2,3-epoxypropyl ester QMA = 0.02 mg/6 dm²
136 20890 000097-63-2 Methacrylic acid, ethyl ester
137 21010 000097-86-9 Methacrylic acid, isobutyl ester
138 21100 004655-34-9 Methacrylic acid, isopropyl ester
139 21130 000080-62-6 Methacrylic acid, methyl ester
140 21190 000868-77-9 Methacrylic acid, monoester with ethyleneglycol
141 21280 002177-70-0 Methacrylic acid, phenyl ester
142 21340 002210-28-8 Methacrylic acid, propyl ester
142A 21400 054276-35-6 Methacrylic acid, sulphopropyl ester QMA = 0.05 mg/6 dm²
143 21460 000760-93-0 Methacrylic anhydride
144 21490 000126-98-7 Methacrylonitrile 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)
144A 21520 01561-92-8 Methallylsulphonic acid, sodium salt SML = 5 mg/kg
145 21550 000067-56-1 Methanol
145A 21640 00078-79-5 2-Methyl-1,3-butadiene QM = 1 mg/kg in FP or SML = ND (DL = 0.02 mg/kg, analytical tolerance included)
145B 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
145C 21765 106246-33-7 4,4'-Methylenebis (3-chloro-2,6-diethylaniline) QMA = 0.05 mg/6dm²
145D 21821 00505-65-7 1,4-(Methylenedioxy) butane As item 49B
146 21940 000924-42-5 N-Methylolacrylamide The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.01 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 (26)
148 22350 000544-63-8 Myristic acid
148A 22360 01141-38-4 2,6- Naphthalenedicarboxylic acid SML = 5 mg/kg
149 22390 000840-65-3 2,6-Naphthalenedicarboxylic acid, dimethyl ester The specific migration of this substance shall not exceed 0.05 mg/kg
150 22420 003173-72-6 1,5-Naphthalene diisocyanate QM(T) = 1 mg/kg (expressed as NCO) (25)
150A 22437 00126-30-7 Neopentylgycol As item 88B
151 22450 009004-70-0 Nitrocellulose
152 22480 000143-08-8 Nonan-1-ol
152A 22550 000498-66-8 Norbornene The specific migration of this substance shall not exceed 0.05 mg/kg
153 22570 000112-96-9 Octadecyl isocyanate QM(T) = 1mg/kg (expressed as NCO) (25)
154 22600 000111-87-5 Octan-1-ol
155 22660 000111-66-0 Oct-1-ene The specific migration of this substance shall not exceed 15 mg/kg
156 22763 000112-80-1 Oleic acid
156XA 22775 000144-62-7 Oxalic acid SML(T) = 6 mg/kg (29)
156A 22778 07456-68-0 4,4'-Oxybis (benzenesulphonyl azide QMA = 0.05 mg/6 dm²
157 22780 000057-10-3 Palmitic acid
158 22840 000115-77-5 Pentaerythritol
159 22870 000071-41-0 Pentan-1-ol
159A 22900 00109-67-1 1-Pentene SML = 5 mg/kg
159B 22937 001623-05-8 Perfluoropropyl perfluorovinyl ether The specific migration of this substance shall not exceed 0.05 mg/kg
160 22960 000108-95-2 Phenol
161 23050 000108-45-2 1,3-Phenylenediamine SML = ND (DL = 0.02 mg/kg. Analytical tolerance included)
161A 23070 000102-39-6 (1,3-Phenylenedioxy) diacetic acid QMA = 0.05 mg/6 dm²
162 As item 60 000075-44-5 Phosgene As item 60
163 23170 007665-38-2 Phosphoric acid
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
164 As item 204 – Phthalic acid As item 204
165 23200 000088-99-3 o-Phthalic acid
166 23230 000131-17-9 Phthalic acid, diallyl ester The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.01 mg/kg)
167 23380 000085-44-9 Phthalic anhydride
168 23470 000080-56-8 Alpha-Pinene
169 23500 000127-91-3 Beta-Pinene
169A 23547 009016-00-6 063148-62-9 Polydimethylsiloxane (Mw >6800) In compliance with the specifications laid down in Schedule 4
170 23590 025322-68-3 Polyethylene glycol
171 23650 025322-69-4 Polypropylene glycol (molecular weight greater than 400)
172 23651 025322-69-4 Polypropyleneglycol
173 23740 000057-55-6 Propan-1,2-diol
173A 23770 000504-63-2 1,3-Propanediol The specific migration of this substance shall not exceed 0.05 mg/kg
174 23800 000071-23-8 Propan-1-ol
175 23830 000067-63-0 Propan-2-ol
176 23860 000123-38-6 Propionaldehyde
177 23890 000079-09-4 Propionic acid
177A 23920 000105-38-4 Propionic acid, vinyl ester SML(T) = 6 mg/kg (2) (expressed as acetaldehyde)
178 23950 000123-62-6 Propionic anhydride
179 23980 000115-07-1 Propylene
180 24010 000075-56-9 Propylene oxide The quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg
181 As item 82 000128-80-9 Pyrocatechol As item 82
182 24057 000089-32-7 Pyromellitic anhydride The specific migration of this substance shall not exceed 0.05 mg/kg (expressed as pyromellitic acid)
183 24070 073138-82-6 Resin acids and rosin acids
184 As item 83 000108-46-3 Resorcinol As item 83
184A 24073 000101-90-6 Resorcinol diglycidyl ether QMA = 0.005 mg/g dm². Not for use in polymers contacting foods for which simulant D is laid down in Council Directive 85/572/EEC and for indirect food contact only, behind the PET layer
185 24100 008050-09-7 Rosin
186 24130 008050-09-7 Rosin gum
187 24160 008052-10-6 Rosin tall oil
188 24190 065997-05-9 Rosin wood
189 24250 009006-04-6 Rubber, natural
190 24270 000069-72-7 Salicylic acid
191 24280 000111-20-6 Sebacic acid
192 24430 002561-88-8 Sebacic anhydride
193 24475 001313-82-2 Sodium sulphide
194 24490 000050-70-4 Sorbitol
195 24520 008001-22-7 Soybean oil
196 24540 009005-25-8 Starch, edible
197 24550 000057-11-4 Stearic acid
198 24610 000100-42-5 Styrene
198A 24760 026914-43-2 Styrenesulphonic acid The specific migration of this substance shall not exceed 0.05 mg/kg
199 24820 000110-15-6 Succinic acid
200 24850 000108-30-5 Succinic anhydride
201 24880 000057-50-1 Sucrose
202 24887 006362-79-4 5-Sulphoisophthalic acid, monosodium salt The specific migration of this substance shall not exceed 5 mg/kg
203 24888 003965-55-7 5-Sulphoisophthalic acid, monosodium salt, dimethyl ester The specific migration of this substance shall not exceed 0.05 mg/kg
204 24910 000100-21-0 Terephthalic acid The specific migration of this substance alone or together with item 205 shall not exceed a total of 7.5 mg/kg
205 24940 000100-20-9 Terephthalic acid dichloride The specific migration of this substance along or together with item 204 shall not exceed 7.5 mg/kg (expressed as terephthalic acid)
206 24970 000120-61-6 Terephthalic acid, dimethyl ester
206A 25080 001120-36-1 1-Tetradecene The specific migration of this substance shall not exceed 0.05 mg/kg
207 25090 000112-60-7 Tetraethylene glycol
208 25120 000116-14-3 Tetrafluoroethylene The specific migration of this substance shall not exceed 0.05 mg/kg
209 25150 000109-99-9 Tetrahydrofuran The specific migration of this substance shall not exceed 0.6 mg/kg
210 25180 000102-60-3 N,N,N'N'-Tetrakis (2-hydroxypropyl)- ethylenediamine
211 25210 000584-84-9 2,4-Toluene diisocyanate QM(T) = 1 mg/kg (expressed as NCO) (25)
212 25240 000091-08-7 2,6-Toluene diisocyanate QM(T) = 1 mg/kg (expressed as NCO) (25)
213 25270 026747-90-0 2,4-Toluene diisocyanate dimer QM(T) = 1 mg/kg (expressed as NCO) (25)
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)
214A 25380 Trialkyl acetic acid (C7 – C17), vinyl esters (= vinyl versatate) QMA = 0.05 mg/g dm²
214B 25385 000102-70-5 Triallylamine In compliance with the specifications laid down in Schedule 4
215 25420 000108-78-1 2,4,6-Triamino-1,3,5-triazine The specific migration of this substance shall not exceed 30 mg/kg
215A 25450 26896-48-0 Tricyclodecanedime-thanol SML = 0.05 mg/kg
216 25510 000112-27-6 Triethylene glycol
217 25600 000077-99-6 1,1,1-Trimethylolpropane The specific migration of this substance shall not exceed 6 mg/kg
217A 25840 03290-92-4 1,1,1-trimethylolpropane trimethacrylate SML = 0.05 mg/kg
217B 25900 00110-88-3 Trioxane SML = 0.05 mg/kg
218 25910 024800-44-0 Tripropylene glycol
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
219 25960 000057-13-6 Urea
220 26050 000075-01-4 Vinyl chloride The restrictions are those in regulation 6 (1) of the 2005 Regulations when analysed by the method referred to in regulation 7 of those Regulations
221 26110 000075-35-4 Vinylidene chloride The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg or the specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.05 mg/kg)
222 26140 000075-38-7 Vinylidene fluoride The specific migration of this substance shall not exceed 5 mg/kg
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
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
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

PART 2 — Supplementary

1

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2

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3

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4

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SCHEDULE 2

PART 1 — Incomplete List of Additives Used in the Manufacture of Plastic Materials and Articles (not being Additives to which Paragraph 5 of Part 3 of this Schedule Applies)

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)

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