ANNEX ISubstances
1.Union list of authorised monomers, other starting substances, macromolecules obtained from microbial fermentation, additives and polymer production aids
Table 1 contains the following information:
Column 1 (FCM substance No): the unique identification number of the substance
Column 2 (Ref. No): the EEC packaging material reference number
Column 3 (CAS No): the Chemical Abstracts Service (CAS) registry number
Column 4 (Substance Name): the chemical name
Column 5 (Use as additive or polymer production aid (PPA) (yes/no)): an indication if the substance is authorised to be used as additive or polymer production aid (yes) or if the substance is not authorised to be used as additive or polymer production aid (no). If the substance is only authorised as PPA it is indicated (yes) and in the specifications the use is restricted to PPA.
Column 6 (Use as monomer or other starting substance or macromolecule obtained from microbial fermentation (yes/no)): an indication if the substance is authorised to be used as monomer or other starting substance or macromolecule obtained from microbial fermentation (yes) or if the substance is not authorised to be used as monomer or other starting substance or macromolecule obtained from microbial fermentation (no). If the substance is authorised as macromolecule obtained from microbial fermentation it is indicated (yes) and in the specifications it is indicated that the substance is a macromolecule obtained from microbial fermentation.
Column 7 (FRF applicable (yes/no)): an indication if for the substance the migration results can be corrected by the Fat Consumption Reduction Factor (FRF) (yes) or if they cannot be corrected by the FRF (no).
Column 8 (SML [mg/kg]): the specific migration limit applicable for the substance. It is expressed in mg substance per kg food. It is indicated ND if the substance shall not migrate in detectable quantities.
Column 9 (SML(T) [mg/kg] (group restriction No)): contains the identification number of the group of substances for which the group restriction in Column 1 in Table 2 of this Annex applies.
Column 10 (Restrictions and specifications): contains other restrictions than the specific migration limit specifically mentioned and it contains specifications related to the substance. In case detailed specifications are set out a reference to Table 4 is included.
Column 11 (Notes on verification of compliance): contains the Notes number which refers to the detailed rules applicable for verification of compliance for this substance included in Column 1 in Table 3 of this Annex.
If a substance appearing on the list as an individual compound is also covered by a generic term, the restrictions applying to this substance shall be those indicated for the individual compound.
If in Column 8 the specific migration limit is non-detectable (ND) a detection limit of 0,01 mg substance per kg food is applicable unless specified differently for an individual substance.
(1) | (2) | (3) | (4) | (5) | (6) | (7) | (8) | (9) | (10) | (11) |
FCM substance No | Ref. No | CAS No | Substance name | Use as additive or polymer production aid(yes/no) | Use as monomer or other starting substance or macromolecule obtained from microbial fermentation(yes/no) | FRF applicable(yes/no) | SML[mg/kg] | SML(T)[mg/kg](Group restriction No) | Restrictions and specifications | Notes on verification of compliance |
---|---|---|---|---|---|---|---|---|---|---|
1 | 12310 | 0266309-43-7 | albumin | no | yes | no | ||||
2 | 12340 | — | albumin, coagulated by formaldehyde | no | yes | no | ||||
3 | 12375 | — | alcohols, aliphatic, monohydric, saturated, linear, primary (C4-C22) | no | yes | no | ||||
4 | 22332 | — | mixture of (40 % w/w) 2,2,4-trimethylhexane-1,6-diisocyanate and (60 % w/w) 2,4,4-trimethylhexane-1,6-diisocyanate | no | yes | no | (17) | 1 mg/kg in final product expressed as isocyanate moiety. | (10) | |
5 | 25360 | — | trialkyl(C5-C15)acetic acid, 2,3-epoxypropyl ester | no | yes | no | ND | 1 mg/kg in final product expressed as epoxygroup. Molecular weight is 43 Da. | ||
6 | 25380 | — | trialkyl acetic acid (C7-C17), vinyl esters | no | yes | no | 0,05 | (1) | ||
7 | 30370 | — | acetylacetic acid, salts | yes | no | no | ||||
8 | 30401 | — | acetylated mono- and diglycerides of fatty acids | yes | no | no | (32) | |||
9 | 30610 | — | acids, C2-C24, aliphatic, linear, monocarboxylic from natural oils and fats, and their mono-, di- and triglycerol esters (branched fatty acids at naturally occuring levels are included) | yes | no | no | ||||
10 | 30612 | — | acids, C2-C24, aliphatic, linear, monocarboxylic, synthetic and their mono-, di- and triglycerol esters | yes | no | no | ||||
11 | 30960 | — | acids, aliphatic, monocarboxylic (C6-C22), esters with polyglycerol | yes | no | no | ||||
12 | 31328 | — | acids, fatty, from animal or vegetable food fats and oils | yes | no | no | ||||
13 | 33120 | — | alcohols, aliphatic, monohydric, saturated, linear, primary (C4-C24) | yes | no | no | ||||
14 | 33801 | — | n-alkyl(C10-C13)benzenesulphonic acid | yes | no | no | 30 | |||
15 | 34130 | — | alkyl, linear with even number of carbon atoms (C12-C20) dimethylamines | yes | no | yes | 30 | |||
16 | 34230 | — | alkyl(C8-C22)sulphonic acids | yes | no | no | 6 | |||
17 | 34281 | — | alkyl(C8-C22)sulphuric acids, linear, primary with an even number of carbon atoms | yes | no | no | ||||
18 | 34475 | — | aluminium calcium hydroxide phosphite, hydrate | yes | no | no | ||||
19 | 39090 | — | N,N-bis(2-hydroxyethyl)alkyl(C8-C18)amine | yes | no | no | (7) | |||
20 | 39120 | — | N,N-bis(2-hydroxyethyl)alkyl(C8-C18)amine hydrochlorides | yes | no | no | (7) | SML(T) expressed excluding HCl | ||
21 | 42500 | — | carbonic acid, salts | yes | no | no | ||||
22 | 43200 | — | castor oil, mono- and diglycerides | yes | no | no | ||||
23 | 43515 | — | chlorides of choline esters of coconut oil fatty acids | yes | no | no | 0,9 | (1) | ||
24 | 45280 | — | cotton fibers | yes | no | no | ||||
25 | 45440 | — | cresols, butylated, styrenated | yes | no | no | 12 | |||
26 | 46700 | — | 5,7-di-tert-butyl-3-(3,4- and 2,3-dimethylphenyl)-3H-benzofuran-2-one containing: a) 5,7-di-tert-butyl-3-(3,4-dimethylphenyl)-3H-benzofuran-2-one (80 to 100 % w/w) and b) 5,7-di-tert-butyl-3-(2,3-dimethylphenyl)-3H-benzofuran-2-one (0 to 20 % w/w) | yes | no | no | 5 | |||
27 | 48960 | — | 9,10-dihydroxy stearic acid and its oligomers | yes | no | no | 5 | |||
28 | 50160 | — | di-n-octyltin bis(n-alkyl(C10-C16) mercaptoacetate) | yes | no | no | (10) | |||
29 | 50360 | — | di-n-octyltin bis(ethyl maleate) | yes | no | no | (10) | |||
30 | 50560 | — | di-n-octyltin 1,4-butanediol bis(mercaptoacetate) | yes | no | no | (10) | |||
31 | 50800 | — | di-n-octyltin dimaleate, esterified | yes | no | no | (10) | |||
32 | 50880 | — | di-n-octyltin dimaleate, polymers (n = 2-4) | yes | no | no | (10) | |||
33 | 51120 | — | di-n-octyltin thiobenzoate 2-ethylhexyl mercaptoacetate | yes | no | no | (10) | |||
34 | 54270 | — | ethylhydroxymethylcellulose | yes | no | no | ||||
35 | 54280 | — | ethylhydroxypropylcellulose | yes | no | no | ||||
36 | 54450 | — | fats and oils, from animal or vegetable food sources | yes | no | no | ||||
37 | 54480 | — | fats and oils, hydrogenated, from animal or vegetable food sources | yes | no | no | ||||
38 | 55520 | — | glass fibers | yes | no | no | ||||
39 | 55600 | — | glass microballs | yes | no | no | ||||
40 | 56360 | — | glycerol, esters with acetic acid | yes | no | no | ||||
41 | 56486 | — | glycerol, esters with acids, aliphatic, saturated, linear, with an even number of carbon atoms (C14-C18) and with acids, aliphatic, unsaturated, linear, with an even number of carbon atoms (C16-C18) | yes | no | no | ||||
42 | 56487 | — | glycerol, esters with butyric acid | yes | no | no | ||||
43 | 56490 | — | glycerol, esters with erucic acid | yes | no | no | ||||
44 | 56495 | — | glycerol, esters with 12-hydroxystearic acid | yes | no | no | ||||
45 | 56500 | — | glycerol, esters with lauric acid | yes | no | no | ||||
46 | 56510 | — | glycerol, esters with linoleic acid | yes | no | no | ||||
47 | 56520 | — | glycerol, esters with myristic acid | yes | no | no | ||||
48 | 56535 | — | glycerol, esters with nonanoic acid | yes | no | no | ||||
49 | 56540 | — | glycerol, esters with oleic acid | yes | no | no | ||||
50 | 56550 | — | glycerol, esters with palmitic acid | yes | no | no | ||||
51 | 56570 | — | glycerol, esters with propionic acid | yes | no | no | ||||
52 | 56580 | — | glycerol, esters with ricinoleic acid | yes | no | no | ||||
53 | 56585 | — | glycerol, esters with stearic acid | yes | no | no | ||||
54 | 57040 | — | glycerol monooleate, ester with ascorbic acid | yes | no | no | ||||
55 | 57120 | — | glycerol monooleate, ester with citric acid | yes | no | no | ||||
56 | 57200 | — | glycerol monopalmitate, ester with ascorbic acid | yes | no | no | ||||
57 | 57280 | — | glycerol monopalmitate, ester with citric acid | yes | no | no | ||||
58 | 57600 | — | glycerol monostearate, ester with ascorbic acid | yes | no | no | ||||
59 | 57680 | — | glycerol monostearate, ester with citric acid | yes | no | no | ||||
60 | 58300 | — | glycine, salts | yes | no | no | ||||
62 | 64500 | — | lysine, salts | yes | no | no | ||||
63 | 65440 | — | manganese pyrophosphite | yes | no | no | ||||
64 | 66695 | — | methylhydroxymethylcellulose | yes | no | no | ||||
65 | 67155 | — | mixture of 4-(2-benzoxazolyl)-4′-(5-methyl-2-benzoxazolyl)stilbene, 4,4′-bis(2-benzoxazolyl) stilbene and 4,4′-bis(5-methyl-2-benzoxazolyl)stilbene | yes | no | no | Not more than 0,05 % (w/w) (quantity of substance used/quantity of the formulation). Mixture obtained from the manufacturing process in the typical ratio of (58-62 %):(23-27 %):(13-17 %). | |||
66 | 67600 | — | mono-n-octyltin tris(alkyl(C10-C16) mercaptoacetate) | yes | no | no | (11) | |||
67 | 67840 | — | montanic acids and/or their esters with ethyleneglycol and/or with 1,3-butanediol and/or with glycerol | yes | no | no | ||||
68 | 73160 | — | phosphoric acid, mono- and di-n-alkyl (C16 and C18) esters | yes | no | yes | 0,05 | |||
69 | 74400 | — | phosphorous acid, tris(nonyl-and/or dinonylphenyl) ester | yes | no | yes | 30 | |||
70 | 76463 | — | polyacrylic acid, salts | yes | no | no | (22) | |||
71 | 76730 | — | polydimethylsiloxane, γ-hydroxypropylated | yes | no | no | 6 | |||
72 | 76815 | — | polyester of adipic acid with glycerol or pentaerythritol, esters with even numbered, unbranched C12-C22 fatty acids | yes | no | no | (32) | The fraction with molecular weight below 1 000 Da should not exceed 5 % (w/w) | ||
73 | 76866 | — | polyesters of 1,2-propanediol and/or 1,3- and/or 1,4-butanediol and/or polypropyleneglycol with adipic acid, which may be end-capped with acetic acid or fatty acids C12-C18 or n-octanol and/or n-decanol | yes | no | yes | (31) (32) | |||
74 | 77440 | — | polyethyleneglycol diricinoleate | yes | no | yes | 42 | |||
75 | 77702 | — | polyethyleneglycol esters of aliph. monocarb. acids (C6-C22) and their ammonium and sodium sulphates | yes | no | no | ||||
76 | 77732 | — | polyethylene glycol (EO = 1-30, typically 5) ether of butyl 2-cyano 3-(4-hydroxy-3-methoxyphenyl) acrylate | yes | no | no | 0,05 | Only for use in PET | ||
77 | 77733 | — | polyethyleneglycol (EO = 1-30, typically 5) ether of butyl-2-cyano-3-(4-hydroxyphenyl) acrylate | yes | no | no | 0,05 | Only for use in PET | ||
78 | 77897 | — | polyethyleneglycol (EO = 1-50) monoalkylether (linear and branched, C8-C20) sulphate, salts | yes | no | no | 5 | |||
79 | 80640 | — | polyoxyalkyl (C2-C4) dimethylpolysiloxane | yes | no | no | ||||
80 | 81760 | — | powders, flakes and fibres of brass, bronze, copper, stainless steel, tin, iron and alloys of copper, tin and iron | yes | no | no | ||||
81 | 83320 | — | propylhydroxyethylcellulose | yes | no | no | ||||
82 | 83325 | — | propylhydroxymethylcellulose | yes | no | no | ||||
83 | 83330 | — | propylhydroxypropylcellulose | yes | no | no | ||||
84 | 85601 | — | silicates, natural (with the exception of asbestos) | yes | no | no | ||||
85 | 85610 | — | silicates, natural, silanated (with the exception of asbestos) | yes | no | no | ||||
86 | 86000 | — | silicic acid, silylated | yes | no | no | ||||
87 | 86285 | — | silicon dioxide, silanated | yes | no | no | ||||
88 | 86880 | — | sodium monoalkyl dialkylphenoxybenzenedisulphonate | yes | no | no | 9 | |||
89 | 89440 | — | stearic acid, esters with ethyleneglycol | yes | no | no | (2) | |||
90 | 92195 | — | taurine, salts | yes | no | no | ||||
91 | 92320 | — | tetradecyl-polyethyleneglycol(EO = 3-8) ether of glycolic acid | yes | no | yes | 15 | |||
92 | 93970 | — | tricyclodecanedimethanol bis(hexahydrophthalate) | yes | no | no | 0,05 | |||
93 | 95858 | — | waxes, paraffinic, refined, derived from petroleum based or synthetic hydrocarbon feedstocks, low viscosity | yes | no | no | 0,05 | Not to be used for articles in contact with fatty foods for which simulant D is laid down. Average molecular weight not less than 350 Da. Viscosity at 100 °C not less than 2,5 cSt (2,5 × 10-6 m2/s). Content of hydrocarbons with Carbon number less than 25, not more than 40 % (w/w). | ||
94 | 95859 | — | waxes, refined, derived from petroleum based or synthetic hydrocarbon feedstocks, high viscosity | yes | no | no | Average molecular weight not less than 500 Da. Viscosity at 100 °C not less than 11 cSt (11 × 10-6 m2/s). Content of mineral hydrocarbons with Carbon number less than 25, not more than 5 % (w/w). | |||
95 | 95883 | — | white mineral oils, paraffinic, derived from petroleum based hydrocarbon feedstocks | yes | no | no | Average molecular weight not less than 480 Da. Viscosity at 100 °C not less than 8,5 cSt (8,5 × 10-6 m2/s). Content of mineral hydrocarbons with Carbon number less than 25, not more than 5 % (w/w). | |||
96 | 95920 | — | wood flour and fibers, untreated | yes | no | no | ||||
97 | 72081/10 | — | petroleum hydrocarbon resins (hydrogenated) | yes | no | no | Petroleum hydrocarbon resins, hydrogenated are produced by the catalytic or thermalpolymerisation of dienes and olefins of the aliphatic, alicyclic and/or monobenzenoidarylalkene types from distillates of cracked petroleum stocks with a boiling range not greater than 220 °C, as well as the pure monomers found in these distillation streams, subsequently followed by distillation, hydrogenation and additional processing. Properties:
| |||
98 | 17260 | 0000050-00-0 | formaldehyde | yes | yes | no | (15) | |||
54880 | ||||||||||
99 | 19460 | 0000050-21-5 | lactic acid | yes | yes | no | ||||
62960 | ||||||||||
100 | 24490 | 0000050-70-4 | sorbitol | yes | yes | no | ||||
88320 | ||||||||||
101 | 36000 | 0000050-81-7 | ascorbic acid | yes | no | no | ||||
102 | 17530 | 0000050-99-7 | glucose | no | yes | no | ||||
103 | 18100 | 0000056-81-5 | glycerol | yes | yes | no | ||||
55920 | ||||||||||
104 | 58960 | 0000057-09-0 | hexadecyltrimethylammonium bromide | yes | no | no | 6 | |||
105 | 22780 | 0000057-10-3 | palmitic acid | yes | yes | no | ||||
70400 | ||||||||||
106 | 24550 | 0000057-11-4 | stearic acid | yes | yes | no | ||||
89040 | ||||||||||
107 | 25960 | 0000057-13-6 | urea | no | yes | no | ||||
108 | 24880 | 0000057-50-1 | sucrose | no | yes | no | ||||
109 | 23740 | 0000057-55-6 | 1,2-propanediol | yes | yes | no | ||||
81840 | ||||||||||
110 | 93520 | 0000059-02-9 0010191-41-0 | α-tocopherol | yes | no | no | ||||
111 | 53600 | 0000060-00-4 | ethylenediaminetetraacetic acid | yes | no | no | ||||
112 | 64015 | 0000060-33-3 | linoleic acid | yes | no | no | ||||
113 | 16780 | 0000064-17-5 | ethanol | yes | yes | no | ||||
52800 | ||||||||||
114 | 55040 | 0000064-18-6 | formic acid | yes | no | no | ||||
115 | 10090 | 0000064-19-7 | acetic acid | yes | yes | no | ||||
30000 | ||||||||||
116 | 13090 | 0000065-85-0 | benzoic acid | yes | yes | no | ||||
37600 | ||||||||||
117 | 21550 | 0000067-56-1 | methanol | no | yes | no | ||||
118 | 23830 | 0000067-63-0 | 2-propanol | yes | yes | no | ||||
81882 | ||||||||||
119 | 30295 | 0000067-64-1 | acetone | yes | no | no | ||||
120 | 49540 | 0000067-68-5 | dimethyl sulphoxide | yes | no | no | ||||
121 | 24270 | 0000069-72-7 | salicylic acid | yes | yes | no | ||||
84640 | ||||||||||
122 | 23800 | 0000071-23-8 | 1-propanol | no | yes | no | ||||
123 | 13840 | 0000071-36-3 | 1-butanol | no | yes | no | ||||
124 | 22870 | 0000071-41-0 | 1-pentanol | no | yes | no | ||||
125 | 16950 | 0000074-85-1 | ethylene | no | yes | no | ||||
126 | 10210 | 0000074-86-2 | acetylene | no | yes | no | ||||
127 | 26050 | 0000075-01-4 | vinyl chloride | no | yes | no | ND | 1 mg/kg in final product | ||
128 | 10060 | 0000075-07-0 | acetaldehyde | no | yes | no | (1) | |||
129 | 17020 | 0000075-21-8 | ethylene oxide | no | yes | no | ND | 1 mg/kg in final product | (10) | |
130 | 26110 | 0000075-35-4 | vinylidene chloride | no | yes | no | ND | (1) | ||
131 | 48460 | 0000075-37-6 | 1,1-difluoroethane | yes | no | no | ||||
132 | 26140 | 0000075-38-7 | vinylidene fluoride | no | yes | no | 5 | |||
133 | 14380 | 0000075-44-5 | carbonyl chloride | no | yes | no | ND | 1 mg/kg in final product | (10) | |
23155 | ||||||||||
134 | 43680 | 0000075-45-6 | chlorodifluoromethane | yes | no | no | 6 | Content of chlorofluoromethane less than 1 mg/kg of the substance | ||
135 | 24010 | 0000075-56-9 | propylene oxide | no | yes | no | ND | 1 mg/kg in final product | ||
136 | 41680 | 0000076-22-2 | camphor | yes | no | no | (3) | |||
137 | 66580 | 0000077-62-3 | 2,2′-methylenebis(4-methyl-6-(1-methylcyclohexyl)phenol) | yes | no | yes | (5) | |||
138 | 93760 | 0000077-90-7 | tri-n-butyl acetyl citrate | yes | no | no | (32) | |||
139 | 14680 | 0000077-92-9 | citric acid | yes | yes | no | ||||
44160 | ||||||||||
140 | 44640 | 0000077-93-0 | citric acid, triethyl ester | yes | no | no | (32) | |||
141 | 13380 | 0000077-99-6 | 1,1,1-trimethylolpropane | yes | yes | no | 6 | |||
25600 | ||||||||||
94960 | ||||||||||
142 | 26305 | 0000078-08-0 | vinyltriethoxysilane | no | yes | no | 0,05 | Only to be used as a surface treatment agent | (1) | |
143 | 62450 | 0000078-78-4 | isopentane | yes | no | no | ||||
144 | 19243 | 0000078-79-5 | 2-methyl-1,3-butadiene | no | yes | no | ND | 1 mg/kg in final product | ||
21640 | ||||||||||
145 | 10630 | 0000079-06-1 | acrylamide | no | yes | no | ND | |||
146 | 23890 | 0000079-09-4 | propionic acid | yes | yes | no | ||||
82000 | ||||||||||
147 | 10690 | 0000079-10-7 | acrylic acid | no | yes | no | (22) | |||
148 | 14650 | 0000079-38-9 | chlorotrifluoroethylene | no | yes | no | ND | (1) | ||
149 | 19990 | 0000079-39-0 | methacrylamide | no | yes | no | ND | |||
150 | 20020 | 0000079-41-4 | methacrylic acid | no | yes | no | (23) | |||
151 | 13480 | 0000080-05-7 | 2,2-bis(4-hydroxyphenyl)propane | no | yes | no | 0,6 | F2Not to be used for the manufacture of polycarbonate infant24 feeding bottles25. | ||
13607 | ||||||||||
152 | 15610 | 0000080-07-9 | 4,4′-dichlorodiphenyl sulphone | no | yes | no | 0,05 | |||
153 | 15267 | 0000080-08-0 | 4,4′-diaminodiphenyl sulphone | no | yes | no | 5 | |||
154 | 13617 | 0000080-09-1 | 4,4′-dihydroxydiphenyl sulphone | no | yes | no | 0,05 | |||
16090 | ||||||||||
155 | 23470 | 0000080-56-8 | α-pinene | no | yes | no | ||||
156 | 21130 | 0000080-62-6 | methacrylic acid, methyl ester | no | yes | no | (23) | |||
157 | 74880 | 0000084-74-2 | phthalic acid, dibutyl ester | yes | no | no | 0,3 | (32) | Only to be used as:
| (7) |
158 | 23380 | 0000085-44-9 | phthalic anhydride | yes | yes | no | ||||
76320 | ||||||||||
159 | 74560 | 0000085-68-7 | phthalic acid, benzyl butyl ester | yes | no | no | 30 | (32) | Only to be used as:
| (7) |
160 | 84800 | 0000087-18-3 | salicylic acid, 4-tert-butylphenyl ester | yes | no | yes | 12 | |||
F4161 | 92160 | 000087-69-4 | L-(+)-tartaric acid | yes | no | no | ||||
162 | 65520 | 0000087-78-5 | mannitol | yes | no | no | ||||
163 | 66400 | 0000088-24-4 | 2,2′-methylene bis(4-ethyl-6-tert-butylphenol) | yes | no | yes | (13) | |||
164 | 34895 | 0000088-68-6 | 2-aminobenzamide | yes | no | no | 0,05 | Only for use in PET for water and beverages | ||
165 | 23200 | 0000088-99-3 | o-phthalic acid | yes | yes | no | ||||
74480 | ||||||||||
166 | 24057 | 0000089-32-7 | pyromellitic anhydride | no | yes | no | 0,05 | |||
167 | 25240 | 0000091-08-7 | 2,6-toluene diisocyanate | no | yes | no | (17) | 1 mg/kg in final product expressed as isocyanate moiety | (10) | |
168 | 13075 | 0000091-76-9 | 2,4-diamino-6-phenyl-1,3,5-triazine | no | yes | no | 5 | (1) | ||
15310 | ||||||||||
169 | 16240 | 0000091-97-4 | 3,3′-dimethyl-4,4′-diisocyanatobiphenyl | no | yes | no | (17) | 1 mg/kg in final product expressed as isocyanate moiety | (10) | |
170 | 16000 | 0000092-88-6 | 4,4′-dihydroxybiphenyl | no | yes | no | 6 | |||
171 | 38080 | 0000093-58-3 | benzoic acid, methyl ester | yes | no | no | ||||
172 | 37840 | 0000093-89-0 | benzoic acid, ethyl ester | yes | no | no | ||||
173 | 60240 | 0000094-13-3 | 4-hydroxybenzoic acid, propyl ester | yes | no | no | ||||
174 | 14740 | 0000095-48-7 | o-cresol | no | yes | no | ||||
175 | 20050 | 0000096-05-9 | methacrylic acid, allyl ester | no | yes | no | 0,05 | |||
176 | 11710 | 0000096-33-3 | acrylic acid, methyl ester | no | yes | no | (22) | |||
177 | 16955 | 0000096-49-1 | ethylene carbonate | no | yes | no | 30 | SML expressed as ethyleneglycol. Residual content of 5 mg ethylene carbonate per kg of hydrogel with max 10 g of hydrogel in contact with 1 kg of food. | ||
178 | 92800 | 0000096-69-5 | 4,4′-thiobis(6-tert-butyl-3-methylphenol) | yes | no | yes | 0,48 | |||
179 | 48800 | 0000097-23-4 | 2,2′-dihydroxy-–5,5′-dichlorodiphenylmethane | yes | no | yes | 12 | |||
F5180 | 17160 | 0000097-53-0 | eugenol | no | yes | no | (33) | |||
181 | 20890 | 0000097-63-2 | methacrylic acid, ethyl ester | no | yes | no | (23) | |||
182 | 19270 | 0000097-65-4 | itaconic acid | no | yes | no | ||||
183 | 21010 | 0000097-86-9 | methacrylic acid, isobutyl ester | no | yes | no | (23) | |||
184 | 20110 | 0000097-88-1 | methacrylic acid, butyl ester | no | yes | no | (23) | |||
185 | 20440 | 0000097-90-5 | methacrylic acid, diester with ethyleneglycol | no | yes | no | 0,05 | |||
186 | 14020 | 0000098-54-4 | 4-tert-butylphenol | no | yes | no | 0,05 | |||
187 | 22210 | 0000098-83-9 | α-methylstyrene | no | yes | no | 0,05 | |||
188 | 19180 | 0000099-63-8 | isophthalic acid dichloride | no | yes | no | (27) | |||
189 | 60200 | 0000099-76-3 | 4-hydroxybenzoic acid, methyl ester | yes | no | no | ||||
190 | 18880 | 0000099-96-7 | p-hydroxybenzoic acid | no | yes | no | ||||
191 | 24940 | 0000100-20-9 | terephthalic acid dichloride | no | yes | no | (28) | |||
192 | 23187 | — | phthalic acid | no | yes | no | (28) | |||
193 | 24610 | 0000100-42-5 | styrene | no | yes | no | ||||
194 | 13150 | 0000100-51-6 | benzyl alcohol | no | yes | no | ||||
195 | 37360 | 0000100-52-7 | benzaldehyde | yes | no | no | (3) | |||
196 | 18670 | 0000100-97-0 | hexamethylenetetramine | yes | yes | no | (15) | |||
59280 | ||||||||||
197 | 20260 | 0000101-43-9 | methacrylic acid, cyclohexyl ester | no | yes | no | 0,05 | |||
198 | 16630 | 0000101-68-8 | diphenylmethane-4,4′-diisocyanate | no | yes | no | (17) | 1 mg/kg in final product expressed as isocyanate moiety | (10) | |
199 | 24073 | 0000101-90-6 | resorcinol diglycidyl ether | no | yes | no | ND | Not to be used for articles in contact with fatty foods for which simulant D is laid down. For indirect food contact only, behind a PET layer. | (8) | |
200 | 51680 | 0000102-08-9 | N,N′-diphenylthiourea | yes | no | yes | 3 | |||
201 | 16540 | 0000102-09-0 | diphenyl carbonate | no | yes | no | 0,05 | |||
202 | 23070 | 0000102-39-6 | (1,3-phenylenedioxy)diacetic acid | no | yes | no | 0,05 | (1) | ||
203 | 13323 | 0000102-40-9 | 1,3-bis(2-hydroxyethoxy)benzene | no | yes | no | 0,05 | |||
204 | 25180 | 0000102-60-3 | N,N,N′,N′-tetrakis(2-hydroxypropyl)ethylenediamine | yes | yes | no | ||||
92640 | ||||||||||
205 | 25385 | 0000102-70-5 | triallylamine | no | yes | no | 40 mg/kg hydrogel at a ratio of 1 kg food to a maximum of 1,5 grams of hydrogel. Only to be used in hydrogels intended for non-direct food contact use. | |||
206 | 11500 | 0000103-11-7 | acrylic acid, 2-ethylhexyl ester | no | yes | no | 0,05 | |||
207 | 31920 | 0000103-23-1 | adipic acid, bis(2-ethylhexyl) ester | yes | no | yes | 18 | (32) | (2) | |
208 | 18898 | 0000103-90-2 | N-(4-hydroxyphenyl) acetamide | no | yes | no | 0,05 | |||
209 | 17050 | 0000104-76-7 | 2-ethyl-1-hexanol | no | yes | no | 30 | |||
210 | 13390 | 0000105-08-8 | 1,4-bis(hydroxymethyl)cyclohexane | no | yes | no | ||||
14880 | ||||||||||
211 | 23920 | 0000105-38-4 | propionic acid, vinyl ester | no | yes | no | (1) | |||
212 | 14200 | 0000105-60-2 | caprolactam | yes | yes | no | (4) | |||
41840 | ||||||||||
213 | 82400 | 0000105-62-4 | 1,2-propyleneglycol dioleate | yes | no | no | ||||
214 | 61840 | 0000106-14-9 | 12-hydroxystearic acid | yes | no | no | ||||
215 | 14170 | 0000106-31-0 | butyric anhydride | no | yes | no | ||||
216 | 14770 | 0000106-44-5 | p-cresol | no | yes | no | ||||
217 | 15565 | 0000106-46-7 | 1,4-dichlorobenzene | no | yes | no | 12 | |||
218 | 11590 | 0000106-63-8 | acrylic acid, isobutyl ester | no | yes | no | (22) | |||
219 | 14570 | 0000106-89-8 | epichlorohydrin | no | yes | no | ND | 1 mg/kg in final product | (10) | |
16750 | ||||||||||
220 | 20590 | 0000106-91-2 | methacrylic acid, 2,3-epoxypropyl ester | no | yes | no | 0,02 | (10) | ||
221 | 40570 | 0000106-97-8 | butane | yes | no | no | ||||
222 | 13870 | 0000106-98-9 | 1-butene | no | yes | no | ||||
223 | 13630 | 0000106-99-0 | butadiene | no | yes | no | ND | 1 mg/kg in final product | ||
224 | 13900 | 0000107-01-7 | 2-butene | no | yes | no | ||||
225 | 12100 | 0000107-13-1 | acrylonitrile | no | yes | no | ND | |||
226 | 15272 | 0000107-15-3 | ethylenediamine | no | yes | no | 12 | |||
16960 | ||||||||||
227 | 16990 | 0000107-21-1 | ethyleneglycol | yes | yes | no | (2) | |||
53650 | ||||||||||
228 | 13690 | 0000107-88-0 | 1,3-butanediol | no | yes | no | ||||
229 | 14140 | 0000107-92-6 | butyric acid | no | yes | no | ||||
230 | 16150 | 0000108-01-0 | dimethylaminoethanol | no | yes | no | 18 | |||
231 | 10120 | 0000108-05-4 | acetic acid, vinyl ester | no | yes | no | 12 | |||
232 | 10150 | 0000108-24-7 | acetic anhydride | yes | yes | no | ||||
30280 | ||||||||||
233 | 24850 | 0000108-30-5 | succinic anhydride | no | yes | no | ||||
234 | 19960 | 0000108-31-6 | maleic anhydride | no | yes | no | (3) | |||
235 | 14710 | 0000108-39-4 | m-cresol | no | yes | no | ||||
236 | 23050 | 0000108-45-2 | 1,3-phenylenediamine | no | yes | no | ND | |||
237 | 15910 | 0000108-46-3 | 1,3-dihydroxybenzene | no | yes | no | 2,4 | |||
24072 | ||||||||||
238 | 18070 | 0000108-55-4 | glutaric anhydride | no | yes | no | ||||
F6239 | 19975 | 0000108-78-1 | 2,4,6-triamino-1,3,5-triazine | yes | yes | no | 2,5 | |||
25420 | ||||||||||
93720 | ||||||||||
240 | 45760 | 0000108-91-8 | cyclohexylamine | yes | no | no | ||||
F4241 | 22960 | 0000108-95-2 | phenol | no | yes | no | 3 | |||
242 | 85360 | 0000109-43-3 | sebacic acid, dibutyl ester | yes | no | no | (32) | |||
243 | 19060 | 0000109-53-5 | isobutyl vinyl ether | no | yes | no | 0,05 | (10) | ||
244 | 71720 | 0000109-66-0 | pentane | yes | no | no | ||||
245 | 22900 | 0000109-67-1 | 1-pentene | no | yes | no | 5 | |||
246 | 25150 | 0000109-99-9 | tetrahydrofuran | no | yes | no | 0,6 | |||
247 | 24820 | 0000110-15-6 | succinic acid | yes | yes | no | ||||
90960 | ||||||||||
248 | 19540 | 0000110-16-7 | maleic acid | yes | yes | no | (3) | |||
64800 | ||||||||||
249 | 17290 | 0000110-17-8 | fumaric acid | yes | yes | no | ||||
55120 | ||||||||||
250 | 53520 | 0000110-30-5 | N,N′-ethylenebisstearamide | yes | no | no | ||||
251 | 53360 | 0000110-31-6 | N,N′-ethylenebisoleamide | yes | no | no | ||||
252 | 87200 | 0000110-44-1 | sorbic acid | yes | no | no | ||||
253 | 15250 | 0000110-60-1 | 1,4-diaminobutane | no | yes | no | ||||
254 | 13720 | 0000110-63-4 | 1,4-butanediol | yes | yes | no | (30) | |||
40580 | ||||||||||
255 | 25900 | 0000110-88-3 | trioxane | no | yes | no | 5 | |||
256 | 18010 | 0000110-94-1 | glutaric acid | yes | yes | no | ||||
55680 | ||||||||||
F5257 | 13550 | 0000110-98-5 | dipropyleneglycol | yes | yes | no | ||||
16660 | 0025265-71-8 | |||||||||
51760 | ||||||||||
258 | 70480 | 0000111-06-8 | palmitic acid, butyl ester | yes | no | no | ||||
259 | 58720 | 0000111-14-8 | heptanoic acid | yes | no | no | ||||
260 | 24280 | 0000111-20-6 | sebacic acid | no | yes | no | ||||
261 | 15790 | 0000111-40-0 | diethylenetriamine | no | yes | no | 5 | |||
262 | 35284 | 0000111-41-1 | N-(2-aminoethyl)ethanolamine | yes | no | no | 0,05 | Not to be used for articles in contact with fatty foods for which simulant D is laid down. For indirect food contact only, behind a PET layer. | ||
263 | 13326 | 0000111-46-6 | diethyleneglycol | yes | yes | no | (2) | |||
15760 | ||||||||||
47680 | ||||||||||
264 | 22660 | 0000111-66-0 | 1-octene | no | yes | no | 15 | |||
265 | 22600 | 0000111-87-5 | 1-octanol | no | yes | no | ||||
266 | 25510 | 0000112-27-6 | triethyleneglycol | yes | yes | no | ||||
94320 | ||||||||||
267 | 15100 | 0000112-30-1 | 1-decanol | no | yes | no | ||||
268 | 16704 | 0000112-41-4 | 1-dodecene | no | yes | no | 0,05 | |||
269 | 25090 | 0000112-60-7 | tetraethyleneglycol | yes | yes | no | ||||
92350 | ||||||||||
270 | 22763 | 0000112-80-1 | oleic acid | yes | yes | no | ||||
69040 | ||||||||||
271 | 52720 | 0000112-84-5 | erucamide | yes | no | no | ||||
272 | 37040 | 0000112-85-6 | behenic acid | yes | no | no | ||||
273 | 52730 | 0000112-86-7 | erucic acid | yes | no | no | ||||
274 | 22570 | 0000112-96-9 | octadecyl isocyanate | no | yes | no | (17) | 1 mg/kg in final product expressed as isocyanate moiety | (10) | |
275 | 23980 | 0000115-07-1 | propylene | no | yes | no | ||||
276 | 19000 | 0000115-11-7 | isobutene | no | yes | no | ||||
277 | 18280 | 0000115-27-5 | hexachloroendomethylenetetrahydrophthalic anhydride | no | yes | no | ND | |||
278 | 18250 | 0000115-28-6 | hexachloroendomethylenetetrahydrophthalic acid | no | yes | no | ND | |||
279 | 22840 | 0000115-77-5 | pentaerythritol | yes | yes | no | ||||
71600 | ||||||||||
280 | 73720 | 0000115-96-8 | phosphoric acid, trichloroethyl ester | yes | no | no | ND | |||
281 | 25120 | 0000116-14-3 | tetrafluoroethylene | no | yes | no | 0,05 | |||
282 | 18430 | 0000116-15-4 | hexafluoropropylene | no | yes | no | ND | |||
283 | 74640 | 0000117-81-7 | phthalic acid, bis(2-ethylhexyl) ester | yes | no | no | 1,5 | (32) | Only to be used as:
| (7) |
284 | 84880 | 0000119-36-8 | salicylic acid, methyl ester | yes | no | no | 30 | |||
285 | 66480 | 0000119-47-1 | 2,2′-methylene bis(4-methyl-6-tert-butylphenol) | yes | no | yes | (13) | |||
286 | 38240 | 0000119-61-9 | benzophenone | yes | no | yes | 0,6 | |||
287 | 60160 | 0000120-47-8 | 4-hydroxybenzoic acid, ethyl ester | yes | no | no | ||||
288 | 24970 | 0000120-61-6 | terephthalic acid, dimethyl ester | no | yes | no | ||||
289 | 15880 | 0000120-80-9 | 1,2-dihydroxybenzene | no | yes | no | 6 | |||
24051 | ||||||||||
290 | 55360 | 0000121-79-9 | gallic acid, propyl ester | yes | no | no | (20) | |||
291 | 19150 | 0000121-91-5 | isophthalic acid | no | yes | no | (27) | |||
292 | 94560 | 0000122-20-3 | triisopropanolamine | yes | no | no | 5 | |||
293 | 23175 | 0000122-52-1 | phosphorous acid, triethyl ester | no | yes | no | ND | 1 mg/kg in final product | (1) | |
294 | 93120 | 0000123-28-4 | thiodipropionic acid, didodecyl ester | yes | no | yes | (14) | |||
295 | 15940 | 0000123-31-9 | 1,4-dihydroxybenzene | yes | yes | no | 0,6 | |||
18867 | ||||||||||
48620 | ||||||||||
296 | 23860 | 0000123-38-6 | propionaldehyde | no | yes | no | ||||
297 | 23950 | 0000123-62-6 | propionic anhydride | no | yes | no | ||||
298 | 14110 | 0000123-72-8 | butyraldehyde | no | yes | no | ||||
299 | 63840 | 0000123-76-2 | levulinic acid | yes | no | no | ||||
300 | 30045 | 0000123-86-4 | acetic acid, butyl ester | yes | no | no | ||||
301 | 89120 | 0000123-95-5 | stearic acid, butyl ester | yes | no | no | ||||
302 | 12820 | 0000123-99-9 | azelaic acid | no | yes | no | ||||
303 | 12130 | 0000124-04-9 | adipic acid | yes | yes | no | ||||
31730 | ||||||||||
304 | 14320 | 0000124-07-2 | caprylic acid | yes | yes | no | ||||
41960 | ||||||||||
305 | 15274 | 0000124-09-4 | hexamethylenediamine | no | yes | no | 2,4 | |||
18460 | ||||||||||
306 | 88960 | 0000124-26-5 | stearamide | yes | no | no | ||||
307 | 42160 | 0000124-38-9 | carbon dioxide | yes | no | no | ||||
308 | 91200 | 0000126-13-6 | sucrose acetate isobutyrate | yes | no | no | ||||
309 | 91360 | 0000126-14-7 | sucrose octaacetate | yes | no | no | ||||
310 | 16390 | 0000126-30-7 | 2,2-dimethyl-1,3-propanediol | no | yes | no | 0,05 | |||
22437 | ||||||||||
311 | 16480 | 0000126-58-9 | dipentaerythritol | yes | yes | no | ||||
51200 | ||||||||||
312 | 21490 | 0000126-98-7 | methacrylonitrile | no | yes | no | ND | |||
313 | 16650 | 0000127-63-9 | diphenyl sulphone | yes | yes | no | 3 | |||
51570 | ||||||||||
314 | 23500 | 0000127-91-3 | β-pinene | no | yes | no | ||||
315 | 46640 | 0000128-37-0 | 2,6-di-tert-butyl-p-cresol | yes | no | no | 3 | |||
316 | 23230 | 0000131-17-9 | phthalic acid, diallyl ester | no | yes | no | ND | |||
317 | 48880 | 0000131-53-3 | 2,2′-dihydroxy-4-methoxybenzophenone | yes | no | yes | (8) | |||
318 | 48640 | 0000131-56-6 | 2,4-dihydroxybenzophenone | yes | no | no | (8) | |||
319 | 61360 | 0000131-57-7 | 2-hydroxy-4-methoxybenzophenone | yes | no | yes | (8) | |||
320 | 37680 | 0000136-60-7 | benzoic acid, butyl ester | yes | no | no | ||||
321 | 36080 | 0000137-66-6 | ascorbyl palmitate | yes | no | no | ||||
322 | 63040 | 0000138-22-7 | lactic acid, butyl ester | yes | no | no | ||||
323 | 11470 | 0000140-88-5 | acrylic acid, ethyl ester | no | yes | no | (22) | |||
324 | 83700 | 0000141-22-0 | ricinoleic acid | yes | no | yes | 42 | |||
325 | 10780 | 0000141-32-2 | acrylic acid, n-butyl ester | no | yes | no | (22) | |||
326 | 12763 | 0000141-43-5 | 2-aminoethanol | yes | yes | no | 0,05 | Not to be used for articles in contact with fatty foods for which simulant D is laid down. For indirect food contact only, behind a PET layer. | ||
35170 | ||||||||||
327 | 30140 | 0000141-78-6 | acetic acid, ethyl ester | yes | no | no | ||||
328 | 65040 | 0000141-82-2 | malonic acid | yes | no | no | ||||
329 | 59360 | 0000142-62-1 | hexanoic acid | yes | no | no | ||||
330 | 19470 | 0000143-07-7 | lauric acid | yes | yes | no | ||||
63280 | ||||||||||
331 | 22480 | 0000143-08-8 | 1-nonanol | no | yes | no | ||||
332 | 69760 | 0000143-28-2 | oleyl alcohol | yes | no | no | ||||
333 | 22775 | 0000144-62-7 | oxalic acid | yes | yes | no | 6 | |||
69920 | ||||||||||
334 | 17005 | 0000151-56-4 | ethyleneimine | no | yes | no | ND | |||
335 | 68960 | 0000301-02-0 | oleamide | yes | no | no | ||||
336 | 15095 | 0000334-48-5 | n-decanoic acid | yes | yes | no | ||||
45940 | ||||||||||
337 | 15820 | 0000345-92-6 | 4,4′-difluorobenzophenone | no | yes | no | 0,05 | |||
338 | 71020 | 0000373-49-9 | palmitoleic acid | yes | no | no | ||||
339 | 86160 | 0000409-21-2 | silicon carbide | yes | no | no | ||||
F7340 | 47440 | 0000461-58-5 | dicyanodiamide | yes | no | no | 60 | |||
341 | 13180 | 0000498-66-8 | bicyclo[2.2.1]hept-2-ene | no | yes | no | 0,05 | |||
22550 | ||||||||||
342 | 14260 | 0000502-44-3 | caprolactone | no | yes | no | (29) | |||
343 | 23770 | 0000504-63-2 | 1,3-propanediol | no | yes | no | 0,05 | |||
F4344 | 13810 | 0000505-65-7 | 1,4-butanediol formal | no | yes | no | 0,05 | 15 30 | (21) | |
21821 | ||||||||||
345 | 35840 | 0000506-30-9 | arachidic acid | yes | no | no | ||||
346 | 10030 | 0000514-10-3 | abietic acid | no | yes | no | ||||
347 | 13050 | 0000528-44-9 | trimellitic acid | no | yes | no | (21) | |||
25540 | ||||||||||
348 | 22350 | 0000544-63-8 | myristic acid | yes | yes | no | ||||
67891 | ||||||||||
349 | 25550 | 0000552-30-7 | trimellitic anhydride | no | yes | no | (21) | |||
350 | 63920 | 0000557-59-5 | lignoceric acid | yes | no | no | ||||
351 | 21730 | 0000563-45-1 | 3-methyl-1-butene | no | yes | no | ND | Only to be used in polypropylene | (1) | |
352 | 16360 | 0000576-26-1 | 2,6-dimethylphenol | no | yes | no | 0,05 | |||
353 | 42480 | 0000584-09-8 | carbonic acid, rubidium salt | yes | no | no | 12 | |||
354 | 25210 | 0000584-84-9 | 2,4-toluene diisocyanate | no | yes | no | (17) | 1 mg/kg in final product expressed as isocyanate moiety | (10) | |
355 | 20170 | 0000585-07-9 | methacrylic acid, tert-butyl ester | no | yes | no | (23) | |||
356 | 18820 | 0000592-41-6 | 1-hexene | no | yes | no | 3 | |||
357 | 13932 | 0000598-32-3 | 3-buten-2-ol | no | yes | no | ND | Only to be used as a co-monomer for the preparation of polymeric additive | (1) | |
358 | 14841 | 0000599-64-4 | 4-cumylphenol | no | yes | no | 0,05 | |||
359 | 15970 | 0000611-99-4 | 4,4′-dihydroxybenzophenone | yes | yes | no | (8) | |||
48720 | ||||||||||
360 | 57920 | 0000620-67-7 | glycerol triheptanoate | yes | no | no | ||||
361 | 18700 | 0000629-11-8 | 1,6-hexanediol | no | yes | no | 0,05 | |||
362 | 14350 | 0000630-08-0 | carbon monoxide | no | yes | no | ||||
363 | 16450 | 0000646-06-0 | 1,3-dioxolane | no | yes | no | 5 | |||
F4364 | 15404 | 0000652-67-5 | 1,4:3,6-dianhydrosorbitol | no | yes | no | 5 | Only to be used as:
Polyesters made using dianhydrosorbitol together with 1,4-bis(hydroxymethyl)cyclohexane shall not be used in contact with foods containing more than 15 % alcohol. | ||
365 | 11680 | 0000689-12-3 | acrylic acid, isopropyl ester | no | yes | no | (22) | |||
366 | 22150 | 0000691-37-2 | 4-methyl-1-pentene | no | yes | no | 0,05 | |||
367 | 16697 | 0000693-23-2 | n-dodecanedioic acid | no | yes | no | ||||
368 | 93280 | 0000693-36-7 | thiodipropionic acid, dioctadecyl ester | yes | no | yes | (14) | |||
369 | 12761 | 0000693-57-2 | 12-aminododecanoic acid | no | yes | no | 0,05 | |||
370 | 21460 | 0000760-93-0 | methacrylic anhydride | no | yes | no | (23) | |||
371 | 11510 | 0000818-61-1 | acrylic acid, monoester with ethyleneglycol | no | yes | no | (22) | |||
11830 | ||||||||||
372 | 18640 | 0000822-06-0 | hexamethylene diisocyanate | no | yes | no | (17) | 1 mg/kg in final product expressed as isocyanate moiety | (10) | |
373 | 22390 | 0000840-65-3 | 2,6-naphthalenedicarboxylic acid, dimethyl ester | no | yes | no | 0,05 | |||
374 | 21190 | 0000868-77-9 | methacrylic acid, monoester with ethyleneglycol | no | yes | no | (23) | |||
375 | 15130 | 0000872-05-9 | 1-decene | no | yes | no | 0,05 | |||
F6376 | 66905 | 0000872-50-4 | N-methylpyrrolidone | yes | no | no | 60 | |||
377 | 12786 | 0000919-30-2 | 3-aminopropyltriethoxysilane | no | yes | no | 0,05 | Residual extractable content of 3-aminopropyltriethoxysilane to be less than 3 mg/kg filler when used for the reactive surface treatment of inorganic fillers. SML = 0,05 mg/kg when used for the surface treatment of materials and articles. | ||
378 | 21970 | 0000923-02-4 | N-methylolmethacrylamide | no | yes | no | 0,05 | |||
379 | 21940 | 0000924-42-5 | N-methylolacrylamide | no | yes | no | ND | |||
380 | 11980 | 0000925-60-0 | acrylic acid, propyl ester | no | yes | no | (22) | |||
381 | 15030 | 0000931-88-4 | cyclooctene | no | yes | no | 0,05 | Only to be used in polymers contacting foods for which simulant A is laid down | ||
382 | 19490 | 0000947-04-6 | laurolactam | no | yes | no | 5 | |||
383 | 72160 | 0000948-65-2 | 2-phenylindole | yes | no | yes | 15 | |||
384 | 40000 | 0000991-84-4 | 2,4-bis(octylmercapto)-6-(4-hydroxy-3,5-di-tert-butylanilino)-1,3,5-triazine | yes | no | yes | 30 | |||
385 | 11530 | 0000999-61-1 | acrylic acid, 2-hydroxypropyl ester | no | yes | no | 0,05 | SML expressed as the sum of acrylic acid, 2-hydroxypropyl ester and acrylic acid, 2-hydroxyisopropyl ester. It may contain up to 25 % (m/m) of acrylic acid, 2-hydroxyisopropyl ester (CAS No 0002918-23-2). | (1) | |
386 | 55280 | 0001034-01-1 | gallic acid, octyl ester | yes | no | no | (20) | |||
387 | 26155 | 0001072-63-5 | 1-vinylimidazole | no | yes | no | 0,05 | (1) | ||
388 | 25080 | 0001120-36-1 | 1-tetradecene | no | yes | no | 0,05 | |||
389 | 22360 | 0001141-38-4 | 2,6-naphthalenedicarboxylic acid | no | yes | no | 5 | |||
390 | 55200 | 0001166-52-5 | gallic acid, dodecyl ester | yes | no | no | (20) | |||
391 | 22932 | 0001187-93-5 | perfluoromethyl perfluorovinyl ether | no | yes | no | 0,05 | Only to be used in anti-stick coatings | ||
392 | 72800 | 0001241-94-7 | phosphoric acid, diphenyl 2-ethylhexyl ester | yes | no | yes | 2,4 | |||
393 | 37280 | 0001302-78-9 | bentonite | yes | no | no | ||||
394 | 41280 | 0001305-62-0 | calcium hydroxide | yes | no | no | ||||
395 | 41520 | 0001305-78-8 | calcium oxide | yes | no | no | ||||
396 | 64640 | 0001309-42-8 | magnesium hydroxide | yes | no | no | ||||
397 | 64720 | 0001309-48-4 | magnesium oxide | yes | no | no | ||||
398 | 35760 | 0001309-64-4 | antimony trioxide | yes | no | no | 0,04 | SML expressed as antimony | (6) | |
399 | 81600 | 0001310-58-3 | potassium hydroxide | yes | no | no | ||||
400 | 86720 | 0001310-73-2 | sodium hydroxide | yes | no | no | ||||
401 | 24475 | 0001313-82-2 | sodium sulphide | no | yes | no | ||||
402 | 96240 | 0001314-13-2 | zinc oxide | yes | no | no | ||||
403 | 96320 | 0001314-98-3 | zinc sulphide | yes | no | no | ||||
404 | 67200 | 0001317-33-5 | molybdenum disulphide | yes | no | no | ||||
405 | 16690 | 0001321-74-0 | divinylbenzene | no | yes | no | ND | SML expressed as the sum of divinylbenzene and ethylvinylbenzene. It may contain up to 45 % (m/m) of ethylvinylbenzene. | (1) | |
406 | 83300 | 0001323-39-3 | 1,2-propyleneglycol monostearate | yes | no | no | ||||
407 | 87040 | 0001330-43-4 | sodium tetraborate | yes | no | no | (16) | |||
408 | 82960 | 0001330-80-9 | 1,2-propyleneglycol monooleate | yes | no | no | ||||
409 | 62240 | 0001332-37-2 | iron oxide | yes | no | no | ||||
F4410 | 62720 | 0001332-58-7 | kaolin | yes | no | no | Particles can be thinner than 100 nm only if incorporated at a quantity of less than 12 % w/w in an ethylene vinyl alcohol copolymer (EVOH) inner layer of a multi-layer structure, in which the layer in direct contact with the food provides a functional barrier preventing migration of particles into the food. | |||
411 | 42080 | 0001333-86-4 | carbon black | yes | no | no | Primary particles of 10 – 300 nm which are aggregated to a size of 100 – 1 200 nm which may form agglomerates within the size distribution of 300 nm – mm. Toluene extractables: maximum 0,1 %, determined according to ISO method 6209. UV absorption of cyclohexane extract at 386 nm: < 0,02 AU for a 1 cm cell or < 0,1 AU for a 5 cm cell, determined according to a generally recognised method of analysis. Benzo(a)pyrene content: max 0,25 mg/kg carbon black. Maximum use level of carbon black in the polymer: 2,5 % w/w. | |||
412 | 45200 | 0001335-23-5 | copper iodide | yes | no | no | (6) | |||
413 | 35600 | 0001336-21-6 | ammonium hydroxide | yes | no | no | ||||
414 | 87600 | 0001338-39-2 | sorbitan monolaurate | yes | no | no | ||||
415 | 87840 | 0001338-41-6 | sorbitan monostearate | yes | no | no | ||||
416 | 87680 | 0001338-43-8 | sorbitan monooleate | yes | no | no | ||||
417 | 85680 | 0001343-98-2 | silicic acid | yes | no | no | ||||
418 | 34720 | 0001344-28-1 | aluminium oxide | yes | no | no | ||||
419 | 92150 | 0001401-55-4 | tannic acids | yes | no | no | According to the JECFA specifications | |||
420 | 19210 | 0001459-93-4 | isophthalic acid, dimethyl ester | no | yes | no | 0,05 | |||
F7421 | 13000 | 0001477-55-0 | 1,3-benzenedimethanamine | no | yes | no | (34) | |||
422 | 38515 | 0001533-45-5 | 4,4′-bis(2-benzoxazolyl)stilbene | yes | no | yes | 0,05 | (2) | ||
423 | 22937 | 0001623-05-8 | perfluoropropylperfluorovinyl ether | no | yes | no | 0,05 | |||
424 | 15070 | 0001647-16-1 | 1,9-decadiene | no | yes | no | 0,05 | |||
425 | 10840 | 0001663-39-4 | acrylic acid, tert-butyl ester | no | yes | no | (22) | |||
426 | 13510 | 0001675-54-3 | 2,2-bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ether | no | yes | no | In compliance with Commission Regulation (EC) No 1895/200519 | |||
13610 | ||||||||||
427 | 18896 | 0001679-51-2 | 4-(hydroxymethyl)-1-cyclohexene | no | yes | no | 0,05 | |||
428 | 95200 | 0001709-70-2 | 1,3,5-trimethyl-2,4,6-tris(3,5-di-tert-butyl-4-hydroxybenzyl)benzene | yes | no | no | ||||
429 | 13210 | 0001761-71-3 | bis(4-aminocyclohexyl)methane | no | yes | no | 0,05 | |||
430 | 95600 | 0001843-03-4 | 1,1,3-tris(2-methyl-4-hydroxy-5-tert-butylphenyl) butane | yes | no | yes | 5 | |||
431 | 61600 | 0001843-05-6 | 2-hydroxy-4-n-octyloxybenzophenone | yes | no | yes | (8) | |||
432 | 12280 | 0002035-75-8 | adipic anhydride | no | yes | no | ||||
433 | 68320 | 0002082-79-3 | octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate | yes | no | yes | 6 | |||
434 | 20410 | 0002082-81-7 | methacrylic acid, diester with 1,4-butanediol | no | yes | no | 0,05 | |||
435 | 14230 | 0002123-24-2 | caprolactam, sodium salt | no | yes | no | (4) | |||
436 | 19480 | 0002146-71-6 | lauric acid, vinyl ester | no | yes | no | ||||
437 | 11245 | 0002156-97-0 | acrylic acid, dodecyl ester | no | yes | no | 0,05 | (2) | ||
F6438 | 13303 | 0002162-74-5 | bis(2,6-diisopropylphenyl) carbodiimide | no | yes | no | 0,05 | Expressed as the sum of bis(2,6-diisopropylphenyl)carbodiimide and its hydrolysis product 2,6-diisopropylaniline | ||
439 | 21280 | 0002177-70-0 | methacrylic acid, phenyl ester | no | yes | no | (23) | |||
440 | 21340 | 0002210-28-8 | methacrylic acid, propyl ester | no | yes | no | (23) | |||
441 | 38160 | 0002315-68-6 | benzoic acid, propyl ester | yes | no | no | ||||
442 | 13780 | 0002425-79-8 | 1,4-butanediol bis(2,3-epoxypropyl)ether | no | yes | no | ND | Residual content = 1 mg/kg in final product expressed as epoxygroup. Molecular weight is 43 Da. | (10) | |
443 | 12788 | 0002432-99-7 | 11-aminoundecanoic acid | no | yes | no | 5 | |||
444 | 61440 | 0002440-22-4 | 2-(2′-hydroxy-5′-methylphenyl)benzotriazole | yes | no | no | (12) | |||
445 | 83440 | 0002466-09-3 | pyrophosphoric acid | yes | no | no | ||||
446 | 10750 | 0002495-35-4 | acrylic acid, benzyl ester | no | yes | no | (22) | |||
447 | 20080 | 0002495-37-6 | methacrylic acid, benzyl ester | no | yes | no | (23) | |||
448 | 11890 | 0002499-59-4 | acrylic acid, n-octyl ester | no | yes | no | (22) | |||
F5449 | 49840 | 0002500-88-1 | dioctadecyl disulphide | yes | no | yes | 0,05 | |||
450 | 24430 | 0002561-88-8 | sebacic anhydride | no | yes | no | ||||
451 | 66755 | 0002682-20-4 | 2-methyl-4-isothiazolin-3-one | yes | no | no | 0,5 | Only to be used in aqueous polymer dispersions and emulsions | ||
F6452 | 38885 | 0002725-22-6 | 2,4-bis(2,4-dimethylphenyl)-6-(2-hydroxy-4-n-octyloxyphenyl)-1,3,5-triazine | yes | no | no | 5 | |||
453 | 26320 | 0002768-02-7 | vinyltrimethoxysilane | no | yes | no | 0,05 | (10) | ||
454 | 12670 | 0002855-13-2 | 1-amino-3-aminomethyl-3,5,5-trimethylcyclohexane | no | yes | no | 6 | |||
455 | 20530 | 0002867-47-2 | methacrylic acid, 2-(dimethylamino)-ethyl ester | no | yes | no | ND | |||
456 | 10810 | 0002998-08-5 | acrylic acid, sec-butyl ester | no | yes | no | (22) | |||
457 | 20140 | 0002998-18-7 | methacrylic acid, sec-butyl ester | no | yes | no | (23) | |||
458 | 36960 | 0003061-75-4 | behenamide | yes | no | no | ||||
459 | 46870 | 0003135-18-0 | 3,5-di-tert-butyl-4-hydroxybenzylphosphonic acid, dioctadecyl ester | yes | no | no | ||||
460 | 14950 | 0003173-53-3 | cyclohexyl isocyanate | no | yes | no | (17) | 1 mg/kg in final product expressed as isocyanate moiety | (10) | |
461 | 22420 | 0003173-72-6 | 1,5-naphthalene diisocyanate | no | yes | no | (17) | 1 mg/kg in final product expressed as isocyanate moiety | (10) | |
462 | 26170 | 0003195-78-6 | N-vinyl-N-methylacetamide | no | yes | no | 0,02 | (1) | ||
463 | 25840 | 0003290-92-4 | 1,1,1-trimethylolpropane trimethacrylate | no | yes | no | 0,05 | |||
464 | 61280 | 0003293-97-8 | 2-hydroxy-4-n-hexyloxybenzophenone | yes | no | yes | (8) | |||
465 | 68040 | 0003333-62-8 | 7-[2H-naphtho-(1,2-D)triazol-2-yl]-3-phenylcoumarin | yes | no | no | ||||
466 | 50640 | 0003648-18-8 | di-n-octyltin dilaurate | yes | no | no | (10) | |||
467 | 14800 | 0003724-65-0 | crotonic acid | yes | yes | no | 0,05 | (1) | ||
45600 | ||||||||||
468 | 71960 | 0003825-26-1 | perfluorooctanoic acid, ammonium salt | yes | no | no | Only to be used in repeated use articles, sintered at high temperatures | |||
469 | 60480 | 0003864-99-1 | 2-(2′-hydroxy-3,5′-di-tert-butylphenyl)-5-chlorobenzotriazole | yes | no | yes | (12) | |||
470 | 60400 | 0003896-11-5 | 2-(2′-hydroxy-3′-tert-butyl-5′-methylphenyl)-5-chlorobenzotriazole | yes | no | yes | (12) | |||
471 | 24888 | 0003965-55-7 | 5-sulphoisophthalic acid, monosodium salt, dimethyl ester | no | yes | no | 0,05 | |||
472 | 66560 | 0004066-02-8 | 2,2′-methylenebis(4-methyl-6-cyclohexylphenol) | yes | no | yes | (5) | |||
473 | 12265 | 0004074-90-2 | adipic acid, divinyl ester | no | yes | no | ND | 5 mg/kg in final product. Only to be used as co-monomer. | (1) | |
474 | 43600 | 0004080-31-3 | 1-(3-chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride | yes | no | no | 0,3 | |||
475 | 19110 | 0004098-71-9 | 1-isocyanato-3-isocyanatomethyl-3,5,5-trimethylcyclohexane | no | yes | no | (17) | 1 mg/kg in final product expressed as isocyanate moiety | (10) | |
476 | 16570 | 0004128-73-8 | diphenylether-4,4′-diisocyanate | no | yes | no | (17) | 1 mg/kg in final product expressed as isocyanate moiety | (10) | |
477 | 46720 | 0004130-42-1 | 2,6-di-tert-butyl-4-ethylphenol | yes | no | yes | 4,8 | (1) | ||
478 | 60180 | 0004191-73-5 | 4-hydroxybenzoic acid, isopropyl ester | yes | no | no | ||||
479 | 12970 | 0004196-95-6 | azelaic anhydride | no | yes | no | ||||
480 | 46790 | 0004221-80-1 | 3,5-di-tert-butyl-4-hydroxybenzoic acid, 2,4-di-tert-butylphenyl ester | yes | no | no | ||||
481 | 13060 | 0004422-95-1 | 1,3,5-benzenetricarboxylic acid trichloride | no | yes | no | 0,05 | SML expressed as 1,3,5-benzenetricarboxylic acid | (1) | |
482 | 21100 | 0004655-34-9 | methacrylic acid, isopropyl ester | no | yes | no | (23) | |||
483 | 68860 | 0004724-48-5 | n-octylphosphonic acid | yes | no | no | 0,05 | |||
484 | 13395 | 0004767-03-7 | 2,2-bis(hydroxymethyl)propionic acid | no | yes | no | 0,05 | (1) | ||
485 | 13560 | 0005124-30-1 | dicyclohexylmethane-4,4′-diisocyanate | no | yes | no | (17) | 1 mg/kg in final product expressed as isocyanate moiety | (10) | |
15700 | ||||||||||
486 | 54005 | 0005136-44-7 | ethylene-N-palmitamide-N′-stearamide | yes | no | no | ||||
487 | 45640 | 0005232-99-5 | 2-cyano-3,3-diphenylacrylic acid, ethyl ester | yes | no | no | 0,05 | |||
488 | 53440 | 0005518-18-3 | N,N′-ethylenebispalmitamide | yes | no | no | ||||
489 | 41040 | 0005743-36-2 | calcium butyrate | yes | no | no | ||||
490 | 16600 | 0005873-54-1 | diphenylmethane-2,4′-diisocyanate | no | yes | no | (17) | 1 mg/kg in final product expressed as isocyanate moiety | (10) | |
491 | 82720 | 0006182-11-2 | 1,2-propyleneglycol distearate | yes | no | no | ||||
492 | 45650 | 0006197-30-4 | 2-cyano-3,3-diphenylacrylic acid, 2-ethylhexyl ester | yes | no | no | 0,05 | |||
493 | 39200 | 0006200-40-4 | bis(2-hydroxyethyl)-2-hydroxypropyl-3-(dodecyloxy)methylammonium chloride | yes | no | no | 1,8 | |||
494 | 62140 | 0006303-21-5 | hypophosphorous acid | yes | no | no | ||||
495 | 35160 | 0006642-31-5 | 6-amino-1,3-dimethyluracil | yes | no | no | 5 | |||
496 | 71680 | 0006683-19-8 | pentaerythritol tetrakis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)-propionate] | yes | no | no | ||||
497 | 95020 | 0006846-50-0 | 2,2,4-trimethyl-1,3-pentanediol diisobutyrate | yes | no | no | 5 | Only to be used in single-use gloves | ||
498 | 16210 | 0006864-37-5 | 3,3′-dimethyl-4,4′-diaminodicyclohexylmethane | no | yes | no | 0,05 | Only to be used in polyamides | (5) | |
499 | 19965 | 0006915-15-7 | malic acid | yes | yes | no | In case of use as a monomer only to be used as a co-monomer in aliphatic polyesters up to maximum level of 1 % on a molar basis | |||
65020 | ||||||||||
500 | 38560 | 0007128-64-5 | 2,5-bis(5-tert-butyl-2-benzoxazolyl)thiophene | yes | no | yes | 0,6 | |||
501 | 34480 | — | aluminium fibers, flakes and powders | yes | no | no | ||||
502 | 22778 | 0007456-68-0 | 4,4′-oxybis(benzenesulphonyl azide) | no | yes | no | 0,05 | (1) | ||
503 | 46080 | 0007585-39-9 | β-dextrin | yes | no | no | ||||
504 | 86240 | 0007631-86-9 | silicon dioxide | yes | no | no | For synthetic amorphous silicon dioxide: primary particles of 1 – 100 nm which are aggregated to a size of 0,1 – 1 μm which may form agglomerates within the size distribution of 0,3 μm to the mm size. | |||
505 | 86480 | 0007631-90-5 | sodium bisulphite | yes | no | no | (19) | |||
506 | 86920 | 0007632-00-0 | sodium nitrite | yes | no | no | 0,6 | |||
507 | 59990 | 0007647-01-0 | hydrochloric acid | yes | no | no | ||||
508 | 86560 | 0007647-15-6 | sodium bromide | yes | no | no | ||||
509 | 23170 | 0007664-38-2 | phosphoric acid | yes | yes | no | ||||
72640 | ||||||||||
510 | 12789 | 0007664-41-7 | ammonia | yes | yes | no | ||||
35320 | ||||||||||
511 | 91920 | 0007664-93-9 | sulphuric acid | yes | no | no | ||||
512 | 81680 | 0007681-11-0 | potassium iodide | yes | no | no | (6) | |||
513 | 86800 | 0007681-82-5 | sodium iodide | yes | no | no | (6) | |||
514 | 91840 | 0007704-34-9 | sulphur | yes | no | no | ||||
515 | 26360 | 0007732-18-5 | water | yes | yes | no | In compliance with Directive 98/83/EC20 | |||
95855 | ||||||||||
516 | 86960 | 0007757-83-7 | sodium sulphite | yes | no | no | (19) | |||
517 | 81520 | 0007758-02-3 | potassium bromide | yes | no | no | ||||
518 | 35845 | 0007771-44-0 | arachidonic acid | yes | no | no | ||||
519 | 87120 | 0007772-98-7 | sodium thiosulphate | yes | no | no | (19) | |||
520 | 65120 | 0007773-01-5 | manganese chloride | yes | no | no | ||||
521 | 58320 | 0007782-42-5 | graphite | yes | no | no | ||||
522 | 14530 | 0007782-50-5 | chlorine | no | yes | no | ||||
523 | 45195 | 0007787-70-4 | copper bromide | yes | no | no | ||||
524 | 24520 | 0008001-22-7 | soybean oil | no | yes | no | ||||
525 | 62640 | 0008001-39-6 | japan wax | yes | no | no | ||||
526 | 43440 | 0008001-75-0 | ceresin | yes | no | no | ||||
527 | 14411 | 0008001-79-4 | castor oil | yes | yes | no | ||||
42880 | ||||||||||
528 | 63760 | 0008002-43-5 | lecithin | yes | no | no | ||||
529 | 67850 | 0008002-53-7 | montan wax | yes | no | no | ||||
530 | 41760 | 0008006-44-8 | candelilla wax | yes | no | no | ||||
531 | 36880 | 0008012-89-3 | beeswax | yes | no | no | ||||
532 | 88640 | 0008013-07-8 | soybean oil, epoxidised | yes | no | no | 60 30(*) | (32) |
| |
533 | 42720 | 0008015-86-9 | carnauba wax | yes | no | no | ||||
534 | 80720 | 0008017-16-1 | polyphosphoric acids | yes | no | no | ||||
535 | 24100 | 0008050-09-7 | rosin | yes | yes | no | ||||
24130 | ||||||||||
24190 | ||||||||||
83840 | ||||||||||
536 | 84320 | 0008050-15-5 | rosin, hydrogenated, ester with methanol | yes | no | no | ||||
537 | 84080 | 0008050-26-8 | rosin, ester with pentaerythritol | yes | no | no | ||||
538 | 84000 | 0008050-31-5 | rosin, ester with glycerol | yes | no | no | ||||
539 | 24160 | 0008052-10-6 | rosin tall oil | no | yes | no | ||||
540 | 63940 | 0008062-15-5 | lignosulphonic acid | yes | no | no | 0,24 | Only to be used as dispersant for plastics dispersions | ||
541 | 58480 | 0009000-01-5 | gum arabic | yes | no | no | ||||
542 | 42640 | 0009000-11-7 | carboxymethylcellulose | yes | no | no | ||||
543 | 45920 | 0009000-16-2 | dammar | yes | no | no | ||||
544 | 58400 | 0009000-30-0 | guar gum | yes | no | no | ||||
545 | 93680 | 0009000-65-1 | tragacanth gum | yes | no | no | ||||
546 | 71440 | 0009000-69-5 | pectin | yes | no | no | ||||
547 | 55440 | 0009000-70-8 | gelatin | yes | no | no | ||||
548 | 42800 | 0009000-71-9 | casein | yes | no | no | ||||
549 | 80000 | 0009002-88-4 | polyethylene wax | yes | no | no | ||||
550 | 81060 | 0009003-07-0 | polypropylene wax | yes | no | no | ||||
551 | 79920 | 0009003-11-6 0106392-12-5 | poly(ethylene propylene) glycol | yes | no | no | ||||
552 | 81500 | 0009003-39-8 | polyvinylpyrrolidone | yes | no | no | The substance shall meet the purity criteria as laid down in Commission Directive 2008/84/EC21 | |||
553 | 14500 | 0009004-34-6 | cellulose | yes | yes | no | ||||
43280 | ||||||||||
554 | 43300 | 0009004-36-8 | cellulose acetate butyrate | yes | no | no | ||||
555 | 53280 | 0009004-57-3 | ethylcellulose | yes | no | no | ||||
556 | 54260 | 0009004-58-4 | ethylhydroxyethylcellulose | yes | no | no | ||||
557 | 66640 | 0009004-59-5 | methylethylcellulose | yes | no | no | ||||
558 | 60560 | 0009004-62-0 | hydroxyethylcellulose | yes | no | no | ||||
559 | 61680 | 0009004-64-2 | hydroxypropylcellulose | yes | no | no | ||||
560 | 66700 | 0009004-65-3 | methylhydroxypropylcellulose | yes | no | no | ||||
561 | 66240 | 0009004-67-5 | methylcellulose | yes | no | no | ||||
562 | 22450 | 0009004-70-0 | nitrocellulose | no | yes | no | ||||
563 | 78320 | 0009004-97-1 | polyethyleneglycol monoricinoleate | yes | no | yes | 42 | |||
564 | 24540 | 0009005-25-8 | starch, edible | yes | yes | no | ||||
88800 | ||||||||||
565 | 61120 | 0009005-27-0 | hydroxyethyl starch | yes | no | no | ||||
566 | 33350 | 0009005-32-7 | alginic acid | yes | no | no | ||||
567 | 82080 | 0009005-37-2 | 1,2-propyleneglycol alginate | yes | no | no | ||||
568 | 79040 | 0009005-64-5 | polyethyleneglycol sorbitan monolaurate | yes | no | no | ||||
569 | 79120 | 0009005-65-6 | polyethyleneglycol sorbitan monooleate | yes | no | no | ||||
570 | 79200 | 0009005-66-7 | polyethyleneglycol sorbitan monopalmitate | yes | no | no | ||||
571 | 79280 | 0009005-67-8 | polyethyleneglycol sorbitan monostearate | yes | no | no | ||||
572 | 79360 | 0009005-70-3 | polyethyleneglycol sorbitan trioleate | yes | no | no | ||||
573 | 79440 | 0009005-71-4 | polyethyleneglycol sorbitan tristearate | yes | no | no | ||||
574 | 24250 | 0009006-04-6 | rubber, natural | yes | yes | no | ||||
84560 | ||||||||||
575 | 76721 | 0063148-62-9 | polydimethylsiloxane (Mw > 6 800 Da) | yes | no | no | Viscosity at 25 °C not less than 100 cSt (100 × 10-6 m2/s) | |||
576 | 60880 | 0009032-42-2 | hydroxyethylmethylcellulose | yes | no | no | ||||
577 | 62280 | 0009044-17-1 | isobutylene-butene copolymer | yes | no | no | ||||
578 | 79600 | 0009046-01-9 | polyethyleneglycol tridecyl ether phosphate | yes | no | no | 5 | For materials and articles intended for contact with aqueous foods only. Polyethyleneglycol (EO ≤ 11) tridecyl ether phosphate (mono-and dialkyl ester) with a maximum 10 % content of polyethyleneglycol (EO ≤ 11) tridecylether. | ||
579 | 61800 | 0009049-76-7 | hydroxypropyl starch | yes | no | no | ||||
580 | 46070 | 0010016-20-3 | α-dextrin | yes | no | no | ||||
581 | 36800 | 0010022-31-8 | barium nitrate | yes | no | no | ||||
582 | 50240 | 0010039-33-5 | di-n-octyltin bis(2-ethylhexyl maleate) | yes | no | no | (10) | |||
583 | 40400 | 0010043-11-5 | boron nitride | yes | no | no | (16) | |||
584 | 13620 | 0010043-35-3 | boric acid | yes | yes | no | (16) | |||
40320 | ||||||||||
585 | 41120 | 0010043-52-4 | calcium chloride | yes | no | no | ||||
586 | 65280 | 0010043-84-2 | manganese hypophosphite | yes | no | no | ||||
587 | 68400 | 0010094-45-8 | octadecylerucamide | yes | no | yes | 5 | |||
588 | 64320 | 0010377-51-2 | lithium iodide | yes | no | no | (6) | |||
589 | 52645 | 0010436-08-5 | cis-11-eicosenamide | yes | no | no | ||||
590 | 21370 | 0010595-80-9 | methacrylic acid, 2-sulphoethyl ester | no | yes | no | ND | (1) | ||
591 | 36160 | 0010605-09-1 | ascorbyl stearate | yes | no | no | ||||
592 | 34690 | 0011097-59-9 | aluminium magnesium carbonate hydroxide | yes | no | no | ||||
593 | 44960 | 0011104-61-3 | cobalt oxide | yes | no | no | ||||
594 | 65360 | 0011129-60-5 | manganese oxide | yes | no | no | ||||
595 | 19510 | 0011132-73-3 | lignocellulose | no | yes | no | ||||
596 | 95935 | 0011138-66-2 | xanthan gum | yes | no | no | ||||
597 | 67120 | 0012001-26-2 | mica | yes | no | no | ||||
598 | 41600 | 0012004-14-7 0037293-22-4 | calcium sulphoaluminate | yes | no | no | ||||
599 | 36840 | 0012007-55-5 | barium tetraborate | yes | no | no | (16) | |||
600 | 60030 | 0012072-90-1 | hydromagnesite | yes | no | no | ||||
601 | 35440 | 0012124-97-9 | ammonium bromide | yes | no | no | ||||
602 | 70240 | 0012198-93-5 | ozokerite | yes | no | no | ||||
603 | 83460 | 0012269-78-2 | pyrophyllite | yes | no | no | ||||
604 | 60080 | 0012304-65-3 | hydrotalcite | yes | no | no | ||||
605 | 11005 | 0012542-30-2 | acrylic acid, dicyclopentenyl ester | no | yes | no | 0,05 | (1) | ||
606 | 65200 | 0012626-88-9 | manganese hydroxide | yes | no | no | ||||
607 | 62245 | 0012751-22-3 | iron phosphide | yes | no | no | Only to be used in PET polymers and copolymers | |||
608 | 40800 | 0013003-12-8 | 4,4′-butylidene-bis(6-tert-butyl-3-methylphenyl-ditridecyl phosphite) | yes | no | yes | 6 | |||
609 | 83455 | 0013445-56-2 | pyrophosphorous acid | yes | no | no | ||||
610 | 93440 | 0013463-67-7 | titanium dioxide | yes | no | no | ||||
611 | 35120 | 0013560-49-1 | 3-aminocrotonic acid, diester with thiobis (2-hydroxyethyl) ether | yes | no | no | ||||
612 | 16694 | 0013811-50-2 | N,N′-divinyl-2-imidazolidinone | no | yes | no | 0,05 | (10) | ||
613 | 95905 | 0013983-17-0 | wollastonite | yes | no | no | ||||
614 | 45560 | 0014464-46-1 | cristobalite | yes | no | no | ||||
615 | 92080 | 0014807-96-6 | talc | yes | no | no | ||||
616 | 83470 | 0014808-60-7 | quartz | yes | no | no | ||||
617 | 10660 | 0015214-89-8 | 2-acrylamido-2-methylpropanesulphonic acid | no | yes | no | 0,05 | |||
618 | 51040 | 0015535-79-2 | di-n-octyltin mercaptoacetate | yes | no | no | (10) | |||
619 | 50320 | 0015571-58-1 | di-n-octyltin bis(2-ethylhexyl mercaptoacetate) | yes | no | no | (10) | |||
620 | 50720 | 0015571-60-5 | di-n-octyltin dimaleate | yes | no | no | (10) | |||
621 | 17110 | 0016219-75-3 | 5-ethylidenebicyclo[2,2,1]hept-2-ene | no | yes | no | 0,05 | (9) | ||
622 | 69840 | 0016260-09-6 | oleylpalmitamide | yes | no | yes | 5 | |||
623 | 52640 | 0016389-88-1 | dolomite | yes | no | no | ||||
624 | 18897 | 0016712-64-4 | 6-hydroxy-2-naphthalenecarboxylic acid | no | yes | no | 0,05 | |||
625 | 36720 | 0017194-00-2 | barium hydroxide | yes | no | no | ||||
626 | 57800 | 0018641-57-1 | glycerol tribehenate | yes | no | no | ||||
627 | 59760 | 0019569-21-2 | huntite | yes | no | no | ||||
628 | 96190 | 0020427-58-1 | zinc hydroxide | yes | no | no | ||||
629 | 34560 | 0021645-51-2 | aluminium hydroxide | yes | no | no | ||||
630 | 82240 | 0022788-19-8 | 1,2-propyleneglycol dilaurate | yes | no | no | ||||
631 | 59120 | 0023128-74-7 | 1,6-hexamethylene-bis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionamide) | yes | no | yes | 45 | |||
632 | 52880 | 0023676-09-7 | 4-ethoxybenzoic acid, ethyl ester | yes | no | no | 3,6 | |||
633 | 53200 | 0023949-66-8 | 2-ethoxy-2′-ethyloxanilide | yes | no | yes | 30 | |||
634 | 25910 | 0024800-44-0 | tripropyleneglycol | no | yes | no | ||||
635 | 40720 | 0025013-16-5 | tert-butyl-4-hydroxyanisole | yes | no | no | 30 | |||
636 | 31500 | 0025134-51-4 | acrylic acid, acrylic acid, 2-ethylhexyl ester, copolymer | yes | no | no | 0,05 | (22) | SML expressed as acrylic acid, 2-ethylhexyl ester | |
637 | 71635 | 0025151-96-6 | pentaerythritol dioleate | yes | no | no | 0,05 | Not to be used for articles in contact with fatty foods for which simulant D is laid down | ||
638 | 23590 | 0025322-68-3 | polyethyleneglycol | yes | yes | no | ||||
76960 | ||||||||||
639 | 23651 | 0025322-69-4 | polypropyleneglycol | yes | yes | no | ||||
80800 | ||||||||||
640 | 54930 | 0025359-91-5 | formaldehyde-1-naphthol, copolymer | yes | no | no | 0,05 | |||
641 | 22331 | 0025513-64-8 | 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 | no | yes | no | 0,05 | (10) | ||
642 | 64990 | 0025736-61-2 | maleic anhydride-styrene, copolymer, sodium salt | yes | no | no | The fraction with molecular weight below 1 000 Da should not exceed 0,05 % (w/w) | |||
643 | 87760 | 0026266-57-9 | sorbitan monopalmitate | yes | no | no | ||||
644 | 88080 | 0026266-58-0 | sorbitan trioleate | yes | no | no | ||||
645 | 67760 | 0026401-86-5 | mono-n-octyltin tris(isooctyl mercaptoacetate) | yes | no | no | (11) | |||
646 | 50480 | 0026401-97-8 | di-n-octyltin bis(isooctyl mercaptoacetate) | yes | no | no | (10) | |||
647 | 56720 | 0026402-23-3 | glycerol monohexanoate | yes | no | no | ||||
648 | 56880 | 0026402-26-6 | glycerol monooctanoate | yes | no | no | ||||
649 | 47210 | 0026427-07-6 | dibutylthiostannoic acid polymer | yes | no | no | Molecular unit = (C8H18S3Sn2)n (n = 1,5-2) | |||
650 | 49600 | 0026636-01-1 | dimethyltin bis(isooctyl mercaptoacetate) | yes | no | no | (9) | |||
651 | 88240 | 0026658-19-5 | sorbitan tristearate | yes | no | no | ||||
652 | 38820 | 0026741-53-7 | bis(2,4-di-tert-butylphenyl) pentaerythritol diphosphite | yes | no | yes | 0,6 | |||
653 | 25270 | 0026747-90-0 | 2,4-toluene diisocyanate dimer | no | yes | no | (17) | 1 mg/kg in final product expressed as isocyanate moiety | (10) | |
654 | 88600 | 0026836-47-5 | sorbitol monostearate | yes | no | no | ||||
655 | 25450 | 0026896-48-0 | tricyclodecanedimethanol | no | yes | no | 0,05 | |||
656 | 24760 | 0026914-43-2 | styrenesuphonic acid | no | yes | no | 0,05 | |||
657 | 67680 | 0027107-89-7 | mono-n-octyltin tris(2-ethylhexyl mercaptoacetate) | yes | no | no | (11) | |||
658 | 52000 | 0027176-87-0 | dodecylbenzenesulphonic acid | yes | no | no | 30 | |||
659 | 82800 | 0027194-74-7 | 1,2-propyleneglycol monolaurate | yes | no | no | ||||
660 | 47540 | 0027458-90-8 | di-tert-dodecyl disulphide | yes | no | yes | 0,05 | |||
661 | 95360 | 0027676-62-6 | 1,3,5-tris(3,5-di-tert-butyl-4-hydroxybenzyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione | yes | no | yes | 5 | |||
662 | 25927 | 0027955-94-8 | 1,1,1-tris(4-hydroxyphenol)ethane | no | yes | no | 0,005 | Only to be used in polycarbonates | (1) | |
663 | 64150 | 0028290-79-1 | linolenic acid | yes | no | no | ||||
664 | 95000 | 0028931-67-1 | trimethylolpropane trimethacrylate-methyl methacrylate copolymer | yes | no | no | ||||
665 | 83120 | 0029013-28-3 | 1,2-propyleneglycol monopalmitate | yes | no | no | ||||
666 | 87280 | 0029116-98-1 | sorbitan dioleate | yes | no | no | ||||
667 | 55190 | 0029204-02-2 | gadoleic acid | yes | no | no | ||||
668 | 80240 | 0029894-35-7 | polyglycerol ricinoleate | yes | no | no | ||||
669 | 56610 | 0030233-64-8 | glycerol monobehenate | yes | no | no | ||||
670 | 56800 | 0030899-62-8 | glycerol monolaurate diacetate | yes | no | no | (32) | |||
671 | 74240 | 0031570-04-4 | phosphorous acid, tris(2,4-di-tert-butylphenyl)ester | yes | no | no | ||||
672 | 76845 | 0031831-53-5 | polyester of 1,4-butanediol with caprolactone | yes | no | no | (29) (30) | The fraction with molecular weight below 1 000 Da should not exceed 0,5 % (w/w) | ||
673 | 53670 | 0032509-66-3 | ethylene glycol bis[3,3-bis(3-tert-butyl-4-hydroxyphenyl)butyrate] | yes | no | yes | 6 | |||
674 | 46480 | 0032647-67-9 | dibenzylidene sorbitol | yes | no | no | ||||
675 | 38800 | 0032687-78-8 | N,N′-bis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionyl)hydrazide | yes | no | yes | 15 | |||
676 | 50400 | 0033568-99-9 | di-n-octyltin bis(isooctyl maleate) | yes | no | no | (10) | |||
677 | 82560 | 0033587-20-1 | 1,2-propyleneglycol dipalmitate | yes | no | no | ||||
678 | 59200 | 0035074-77-2 | 1,6-hexamethylene-bis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) | yes | no | yes | 6 | |||
679 | 39060 | 0035958-30-6 | 1,1-bis(2-hydroxy-3,5-di-tert-butylphenyl)ethane | yes | no | yes | 5 | |||
680 | 94400 | 0036443-68-2 | triethyleneglycol bis[3-(3-tert-butyl-4-hydroxy-5-methylphenyl) propionate] | yes | no | no | 9 | |||
681 | 18310 | 0036653-82-4 | 1-hexadecanol | no | yes | no | ||||
682 | 53270 | 0037205-99-5 | ethylcarboxymethylcellulose | yes | no | no | ||||
683 | 66200 | 0037206-01-2 | methylcarboxymethylcellulose | yes | no | no | ||||
684 | 68125 | 0037244-96-5 | nepheline syenite | yes | no | no | ||||
685 | 85950 | 0037296-97-2 | silicic acid, magnesium-sodium-fluoride salt | yes | no | no | 0,15 | SML expressed as fluoride. Only to be used in layers of multi-layer materials not coming into direct contact with food. | ||
686 | 61390 | 0037353-59-6 | hydroxymethylcellulose | yes | no | no | ||||
687 | 13530 | 0038103-06-9 | 2,2-bis(4-hydroxyphenyl)propane bis(phthalic anhydride) | no | yes | no | 0,05 | |||
13614 | ||||||||||
688 | 92560 | 0038613-77-3 | tetrakis(2,4-di-tert-butyl-phenyl)-4,4′-biphenylylene diphosphonite | yes | no | yes | 18 | |||
689 | 95280 | 0040601-76-1 | 1,3,5-tris(4-tert-butyl-3-hydroxy-2,6-dimethylbenzyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione | yes | no | yes | 6 | |||
690 | 92880 | 0041484-35-9 | thiodiethanol bis(3-(3,5-di-tert-butyl-4-hydroxy phenyl) propionate) | yes | no | yes | 2,4 | |||
691 | 13600 | 0047465-97-4 | 3,3-bis(3-methyl-4-hydroxyphenyl)2-indolinone | no | yes | no | 1,8 | |||
692 | 52320 | 0052047-59-3 | 2-(4-dodecylphenyl)indole | yes | no | yes | 0,06 | |||
693 | 88160 | 0054140-20-4 | sorbitan tripalmitate | yes | no | no | ||||
694 | 21400 | 0054276-35-6 | methacrylic acid, sulphopropyl ester | no | yes | no | 0,05 | (1) | ||
695 | 67520 | 0054849-38-6 | monomethyltin tris(isooctyl mercaptoacetate) | yes | no | no | (9) | |||
696 | 92205 | 0057569-40-1 | terephthalic acid, diester with 2,2′-methylenebis(4-methyl-6-tert-butylphenol) | yes | no | no | ||||
697 | 67515 | 0057583-34-3 | monomethyltin tris(ethylhexyl mercaptoacetate) | yes | no | no | (9) | |||
698 | 49595 | 0057583-35-4 | dimethyltin bis(ethylhexyl mercaptoacetate) | yes | no | no | (9) | |||
699 | 90720 | 0058446-52-9 | stearoylbenzoylmethane | yes | no | no | ||||
700 | 31520 | 0061167-58-6 | acrylic acid, 2-tert-butyl-6-(3-tert-butyl-2-hydroxy-5-methylbenzyl)-4-methylphenyl ester | yes | no | yes | 6 | |||
701 | 40160 | 0061269-61-2 | N,N′-bis(2,2,6,6-tetramethyl-4-piperidyl)hexamethylenediamine-1,2-dibromoethane, copolymer | yes | no | no | 2,4 | |||
702 | 87920 | 0061752-68-9 | sorbitan tetrastearate | yes | no | no | ||||
703 | 17170 | 0061788-47-4 | fatty acids, coco | no | yes | no | ||||
704 | 77600 | 0061788-85-0 | polyethyleneglycol ester of hydrogenated castor oil | yes | no | no | ||||
705 | 10599/90A | 0061788-89-4 | acids, fatty, unsaturated (C18), dimers, non hydrogenated, distilled and non-distilled | no | yes | no | (18) | (1) | ||
10599/91 | ||||||||||
706 | 17230 | 0061790-12-3 | fatty acids, tall oil | no | yes | no | ||||
707 | 46375 | 0061790-53-2 | diatomaceous earth | yes | no | no | ||||
708 | 77520 | 0061791-12-6 | polyethyleneglycol ester of castor oil | yes | no | no | 42 | |||
709 | 87520 | 0062568-11-0 | sorbitan monobehenate | yes | no | no | ||||
710 | 38700 | 0063397-60-4 | bis(2-carbobutoxyethyl)tin-bis(isooctyl mercaptoacetate) | yes | no | yes | 18 | |||
711 | 42000 | 0063438-80-2 | (2-carbobutoxyethyl)tin-tris(isooctyl mercaptoacetate) | yes | no | yes | 30 | |||
712 | 42960 | 0064147-40-6 | castor oil, dehydrated | yes | no | no | ||||
F4713 | 43480 | 0064365-11-3 | charcoal, activated | yes | no | no | Only for use in PET at maximum 10 mg/kg of polymer. Same purity requirements as for Vegetable Carbon (E 153) set out by Commission Regulation (EU) No 231/201222 with exception of ash content which can be up to 10 % (w/w). | |||
0007440-44-0 | ||||||||||
714 | 84400 | 0064365-17-9 | rosin, hydrogenated, ester with pentaerythritol | yes | no | no | ||||
715 | 46880 | 0065140-91-2 | 3,5-di-tert-butyl-4-hydroxybenzylphosphonic acid, monoethyl ester, calcium salt | yes | no | no | 6 | |||
716 | 60800 | 0065447-77-0 | 1-(2-hydroxyethyl)-4-hydroxy-2,2,6,6-tetramethyl piperidine-succinic acid, dimethyl ester, copolymer | yes | no | no | 30 | |||
717 | 84210 | 0065997-06-0 | rosin, hydrogenated | yes | no | no | ||||
718 | 84240 | 0065997-13-9 | rosin, hydrogenated, ester with glycerol | yes | no | no | ||||
719 | 65920 | 0066822-60-4 | N-methacryloyloxyethyl-N,N-dimethyl-N-carboxymethylammonium chloride, sodium salt -octadecyl methacrylate-ethyl methacrylate-cyclohexyl methacrylate-N-vinyl-2-pyrrolidone, copolymers | yes | no | no | ||||
720 | 67360 | 0067649-65-4 | mono-n-dodecyltin tris(isooctyl mercaptoacetate) | yes | no | no | (25) | |||
721 | 46800 | 0067845-93-6 | 3,5-di-tert-butyl-4-hydroxybenzoic acid, hexadecyl ester | yes | no | no | ||||
722 | 17200 | 0068308-53-2 | fatty acids, soya | no | yes | no | ||||
723 | 88880 | 0068412-29-3 | starch, hydrolysed | yes | no | no | ||||
724 | 24903 | 0068425-17-2 | syrups, hydrolysed starch, hydrogenated | no | yes | no | In compliance with the purity criteria for maltitol syrup E 965(ii) as laid down in Commission Directive 2008/60/EC23 | |||
726 | 83599 | 0068442-12-6 | reaction products of oleic acid, 2-mercaptoethyl ester, with dichlorodimethyltin, sodium sulphide and trichloromethyltin | yes | no | yes | (9) | |||
727 | 43360 | 0068442-85-3 | cellulose, regenerated | yes | no | no | ||||
728 | 75100 | 0068515-48-0 0028553-12-0 | phthalic acid, diesters with primary, saturated C8-C10 branched alcohols, more than 60 % C9 | yes | no | no | (26) (32) | Only to be used as:
| (7) | |
729 | 75105 | 0068515-49-1 0026761-40-0 | phthalic acid, diesters with primary, saturated C9-C11 alcohols more than 90 % C10 | yes | no | no | (26) (32) | Only to be used as:
| (7) | |
730 | 66930 | 0068554-70-1 | methylsilsesquioxane | yes | no | no | Residual monomer in methylsilsesquioxane: < 1 mg methyltrimethoxysilane/kg of methylsilsesquioxane | |||
731 | 18220 | 0068564-88-5 | N-heptylaminoundecanoic acid | no | yes | no | 0,05 | (2) | ||
732 | 45450 | 0068610-51-5 | p-cresol-dicyclopentadiene-isobutylene, copolymer | yes | no | yes | 5 | |||
733 | 10599/92A | 0068783-41-5 | acids, fatty, unsaturated (C18), dimers, hydrogenated, distilled and non-distilled | no | yes | no | (18) | (1) | ||
10599/93 | ||||||||||
734 | 46380 | 0068855-54-9 | diatomaceous earth, soda ash flux-calcined | yes | no | no | ||||
735 | 40120 | 0068951-50-8 | bis(polyethyleneglycol)hydroxymethylphosphonate | yes | no | no | 0,6 | |||
736 | 50960 | 0069226-44-4 | di-n-octyltin ethyleneglycol bis(mercaptoacetate) | yes | no | no | (10) | |||
737 | 77370 | 0070142-34-6 | polyethyleneglycol-30 dipolyhydroxystearate | yes | no | no | ||||
738 | 60320 | 0070321-86-7 | 2-[2-hydroxy-3,5-bis(1,1-dimethylbenzyl)phenyl]benzotriazole | yes | no | yes | 1,5 | |||
739 | 70000 | 0070331-94-1 | 2,2′-oxamidobis[ethyl-3-(3,5-di-tert-butyl-4-hydroxyphenyl)-propionate] | yes | no | no | ||||
740 | 81200 | 0071878-19-8 | 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] | yes | no | yes | 3 | |||
741 | 24070 | 0073138-82-6 | resin acids and rosin acids | yes | yes | no | ||||
83610 | ||||||||||
742 | 92700 | 0078301-43-6 | 2,2,4,4-tetramethyl-20-(2,3-epoxypropyl)-7-oxa-3,20-diazadispiro-[5.1.11.2]-heneicosan-21-one, polymer | yes | no | yes | 5 | |||
743 | 38950 | 0079072-96-1 | bis(4-ethylbenzylidene)sorbitol | yes | no | no | ||||
744 | 18888 | 0080181-31-3 | 3-hydroxybutanoic acid-3-hydroxypentanoic acid, copolymer | no | yes | no | The substance is used as product obtained by bacterial fermentation. In compliance with the specifications mentioned in the Table 4 of Annex I | |||
745 | 68145 | 0080410-33-9 | 2,2′,2′-nitrilo(triethyl tris(3,3′,5,5′-tetra-tert-butyl-1,1′-bi-phenyl-2,2′-diyl)phosphite) | yes | no | yes | 5 | SML expressed as sum of phosphite and phosphate | ||
746 | 38810 | 0080693-00-1 | bis(2,6-di-tert-butyl-4-methylphenyl)pentaerythritol diphosphite | yes | no | yes | 5 | SML expressed as sum of phosphite and phosphate | ||
747 | 47600 | 0084030-61-5 | di-n-dodecyltin bis(isooctyl mercaptoacetate) | yes | no | yes | (25) | |||
748 | 12765 | 0084434-12-8 | N-(2-aminoethyl)-β-alanine, sodium salt | no | yes | no | 0,05 | |||
749 | 66360 | 0085209-91-2 | 2,2′-methylene bis(4,6-di-tert-butylphenyl) sodium phosphate | yes | no | yes | 5 | |||
750 | 66350 | 0085209-93-4 | 2,2′-methylenebis(4,6-di-tert-butylphenyl) lithium phosphate | yes | no | no | 5 | |||
751 | 81515 | 0087189-25-1 | poly(zinc glycerolate) | yes | no | no | ||||
752 | 39890 | 0087826-41 – 30069158-41 – 40054686-97 – 40081541-12-0 | bis(methylbenzylidene)sorbitol | yes | no | no | ||||
753 | 62800 | 0092704-41-1 | kaolin, calcined | yes | no | no | ||||
754 | 56020 | 0099880-64-5 | glycerol dibehenate | yes | no | no | ||||
755 | 21765 | 0106246-33-7 | 4,4′-methylenebis(3-chloro-2,6-diethylaniline) | no | yes | no | 0,05 | (1) | ||
756 | 40020 | 0110553-27-0 | 2,4-bis(octylthiomethyl)-6-methylphenol | yes | no | yes | (24) | |||
757 | 95725 | 0110638-71-6 | vermiculite, reaction product with citric acid, lithium salt | yes | no | no | ||||
758 | 38940 | 0110675-26-8 | 2,4-bis(dodecylthiomethyl)-6-methylphenol | yes | no | yes | (24) | |||
759 | 54300 | 0118337-09-0 | 2,2′-ethylidenebis(4,6-di-tert-butylphenyl) fluorophosphonite | yes | no | yes | 6 | |||
760 | 83595 | 0119345-01-6 | reaction product of di-tert-butylphosphonite with biphenyl, obtained by condensation of 2,4-di-tert-butylphenol with Friedel Craft reaction product of phosphorous trichloride and biphenyl | yes | no | no | 18 |
| ||
761 | 92930 | 0120218-34-0 | thiodiethanolbis(5-methoxycarbonyl-2,6-dimethyl-1,4-dihydropyridine-3-carboxylate) | yes | no | no | 6 | |||
762 | 31530 | 0123968-25-2 | acrylic acid, 2,4-di-tert-pentyl-6-(1-(3,5-di-tert-pentyl-2-hydroxyphenyl)ethyl)phenyl ester | yes | no | yes | 5 | |||
763 | 39925 | 0129228-21-3 | 3,3-bis(methoxymethyl)-2,5-dimethylhexane | yes | no | yes | 0,05 | |||
764 | 13317 | 0132459-54-2 | N,N′-bis[4-(ethoxycarbonyl)phenyl]-1,4,5,8-naphthalenetetracarboxydiimide | no | yes | no | 0,05 | Purity > 98,1 % (w/w). Only to be used as co-monomer (max 4 %) for polyesters (PET, PBT). | ||
765 | 49485 | 0134701-20-5 | 2,4-dimethyl-6-(1-methylpentadecyl)phenol | yes | no | yes | 1 | |||
766 | 38879 | 0135861-56-2 | bis(3,4-dimethylbenzylidene)sorbitol | yes | no | no | ||||
767 | 38510 | 0136504-96-6 | 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 | yes | no | no | 5 | |||
768 | 34850 | 0143925-92-2 | amines, bis(hydrogenated tallow alkyl) oxidised | yes | no | no | Not to be used for articles in contact with fatty foods for which simulant D is laid down. Only to be used in:
| (1) | ||
769 | 74010 | 0145650-60-8 | phosphorous acid, bis(2,4-di-tert-butyl-6-methylphenyl) ethyl ester | yes | no | yes | 5 | SML expressed as sum of phosphite and phosphate | ||
770 | 51700 | 0147315-50-2 | 2-(4,6-diphenyl-1,3,5-triazin-2-yl)-5-(hexyloxy)phenol | yes | no | no | 0,05 | |||
771 | 34650 | 0151841-65-5 | aluminium hydroxybis [2,2′-methylenebis (4,6-di-tert-butylphenyl) phosphate] | yes | no | no | 5 | |||
772 | 47500 | 0153250-52-3 | N,N′-dicyclohexyl-2,6-naphthalene dicarboxamide | yes | no | no | 5 | |||
773 | 38840 | 0154862-43-8 | bis(2,4-dicumylphenyl)pentaerythritol-diphosphite | yes | no | yes | 5 | SML expressed as sum of the substance itself, its oxidised form bis(2,4-dicumylphenyl)pentaerythritol-phosphate and its hydrolysis product (2,4-dicumylphenol) | ||
774 | 95270 | 0161717-32-4 | 2,4,6-tris(tert-butyl)phenyl-2-butyl-2-ethyl-1,3-propanediol phosphite | yes | no | yes | 2 | SML expressed as sum of phosphite, phosphate and the hydrolysis product = TTBP | ||
775 | 45705 | 0166412-78-8 | 1,2-cyclohexanedicarboxylic acid, diisononyl ester | yes | no | no | (32) | |||
776 | 76723 | 0167883-16-1 | polydimethylsiloxane, 3-aminopropyl terminated, polymer with dicyclohexylmethane-4,4′-diisocyanate | yes | no | no | The fraction with molecular weight below 1 000 Da should not exceed 1,5 % (w/w) | |||
777 | 31542 | 0174254-23-0 | acrylic acid, methyl ester, telomer with 1-dodecanethiol, C16-C18 alkyl esters | yes | no | no | 0,5 % in final product | (1) | ||
778 | 71670 | 0178671-58-4 | pentaerythritol tetrakis (2-cyano-3,3-diphenylacrylate) | yes | no | yes | 0,05 | |||
779 | 39815 | 0182121-12-6 | 9,9-bis(methoxymethyl)fluorene | yes | no | yes | 0,05 | (1) | ||
780 | 81220 | 0192268-64-7 | 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-hexanediyl[(2,2,6,6-tetramethyl-4-piperidinyl)imino]]-α-[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]-ω-N,N,N′,N′-tetrabutyl-1,3,5-triazine-2,4-diamine] | yes | no | no | 5 | |||
781 | 95265 | 0227099-60-7 | 1,3,5-tris(4-benzoylphenyl) benzene | yes | no | no | 0,05 | |||
782 | 76725 | 0661476-41-1 | polydimethylsiloxane, 3-aminopropyl terminated, polymer with 1-isocyanato-3-isocyanatomethyl-3,5,5-trimethylcyclohexane | yes | no | no | The fraction with molecular weight below 1 000 Da should not exceed 1 % (w/w) | |||
783 | 55910 | 0736150-63-3 | glycerides, castor-oil mono-, hydrogenated, acetates | yes | no | no | (32) | |||
F4784 | 95420 | 0745070-61-5 | 1,3,5-tris (2,2-di-methylpropanamido) benzene | yes | no | no | 5 | |||
785 | 24910 | 0000100-21-0 | terephthalic acid | no | yes | no | (28) | |||
786 | 14627 | 0000117-21-5 | 3-chlorophthalic anhydride | no | yes | no | 0,05 | SML expressed as 3-chlorophthalic acid | ||
787 | 14628 | 0000118-45-6 | 4-chlorophthalic anhydride | no | yes | no | 0,05 | SML expressed as 4-chlorophthalic acid | ||
788 | 21498 | 0002530-85-0 | [3-(methacryloxy)propyl]trimethoxysilane | no | yes | no | 0,05 | Only to be used as a surface treatment agent of inorganic fillers | (1) (11) | |
789 | 60027 | — | hydrogenated homopolymers and/or copolymers made of 1-hexene and/or 1-octene and/or 1-decene and/or 1-dodecene and/or 1-tetradecene (Mw: 440–12 000) | yes | no | no | Average molecular weight not less than 440 Da. Viscosity at 100 °C not less than 3,8 cSt (3,8 × 10-6 m2/s). | (2) | ||
790 | 80480 | 0090751-07-8 0082451-48-7 | poly(6-morpholino-1,3,5-triazine-2,4-diyl)-[(2,2,6,6-tetramethyl-4-piperidyl)imino)] hexa-methylene-[(2,2,6,6-tetramethyl-4-piperidyl)imino)] | yes | no | no | 5 | Average molecular weight not less than 2 400 Da. Residual content of morpholine ≤ 30 mg/kg, of N,N′-bis(2,2,6,6-tetramethylpiperidin-4-yl)hexane-1,6-diamine < 15 000 mg/kg, and of 2,4-dichloro-6-morpholino-1,3,5-triazine ≤ 20 mg/kg. | (16) | |
791 | 92470 | 0106990-43-6 | N,N′,N″,N″-tetrakis(4,6-bis(N-butyl-(N-methyl-2,2,6,6-tetramethylpiperidin-4-yl)amino)triazin-2-yl)-4,7-diazadecane-1,10-diamine | yes | no | no | 0,05 | |||
792 | 92475 | 0203255-81-6 | 3,3′,5,5′-tetrakis(tert-butyl)-2,2′-dihydroxybiphenyl, cyclic ester with [3-(3-tert-butyl-4-hydroxy-5-methylphenyl)propyl]oxyphosphonous acid | yes | no | yes | 5 | SML expressed as the sum of phosphite and phosphate form of the substance and the hydrolysis products | ||
793 | 94000 | 0000102-71-6 | triethanolamine | yes | no | no | 0,05 | SML expressed as the sum of triethanolamine and the hydrochloride adduct expressed as triethanolamine | ||
F6794 | 18117 | 0000079-14-1 | glycolic acid | no | yes | no | Only to be used for manufacture of polyglycolic acid (PGA) for (i) indirect food contact behind polyesters such as polyethylene terephthalate (PET) or polylactic acid (PLA); and (ii) direct food contact of a blend of PGA up to 3 % w/w in PET or PLA. | |||
795 | 40155 | 0124172-53-8 | N,N′-bis(2,2,6,6-tetramethyl-4-piperidyl)-N,N′-diformylhexamethylenediamine | yes | no | no | 0,05 | (2) (12) | ||
796 | 72141 | 0018600-59-4 | 2,2′-(1,4-phenylene)bis[4H-3,1-benzoxazin-4-one] | yes | no | yes | 0,05 | SML including the sum of its hydrolysis products | ||
F6797 | 76807 | 0073018-26-5 | polyester of adipic acid with 1,3-butanediol, 1,2-propanediol and 2-ethyl-1-hexanol | yes | no | yes | (31) (32) | |||
798 | 92200 | 0006422-86-2 | terephthalic acid, bis(2-ethylhexyl)ester | yes | no | no | 60 | (32) | ||
F4799 | 77708 | polyethyleneglycol (EO = 1-50) ethers of linear and branched primary (C8-C22) alcohols | yes | no | no | 1,8 | In compliance with the maximum ethylene oxide content as laid down in the purity criteria for food additives in Commission Regulation (EU) No 231/2012. | |||
800 | 94425 | 0000867-13-0 | triethyl phosphonoacetate | yes | no | no | Only for use in PET | |||
801 | 30607 | — | acids, C2-C24, aliphatic, linear, monocarboxylic, from natural oils and fats, lithium salt | yes | no | no | ||||
802 | 33105 | 0146340-15-0 | alcohols, C12-C14 secondary, β-(2-hydroxyethoxy), ethoxylated | yes | no | no | 5 | (12) | ||
803 | 33535 | 0152261-33-1 | α-alkenes(C20-C24) copolymer with maleic anhydride, reaction product with 4-amino-2,2,6,6-tetramethylpiperidine | yes | no | no | Not to be used for articles in contact with fatty foods for which simulant D is laid down. Not to be used in contact with alcoholic foods. | (13) | ||
804 | 80510 | 1010121-89-7 | poly(3-nonyl-1,1-dioxo-1-thiopropane-1,3-diyl)-block-poly(x-oleyl-7-hydroxy-1,5-diiminooctane-1,8-diyl), process mixture with x = 1 and/or 5, neutralised with dodecylbenzenesulfonic acid | yes | no | no | Only to be used as polymer production aid in polyethylene (PE), polypropylene (PP) and polystyrene (PS) | |||
805 | 93450 | — | titanium dioxide, coated with a copolymer of n-octyltrichlorosilane and [aminotris(methylenephosphonic acid), penta sodium salt] | yes | no | no | The content of the surface treatment copolymer of the coated titanium dioxide is less than 1 % w/w | |||
806 | 14876 | 0001076-97-7 | 1,4-cyclohexanedicarboxylic acid | no | yes | no | 5 | Only to be used for manufacture of polyesters | ||
F5807 | 93485 | — | titanium nitride, nanoparticles | yes | no | no | No migration of titanium nitride nanoparticles. Only to be used in polyethylene terephthalate (PET) up to 20 mg/kg. In the PET, the agglomerates have a diameter of 100-500 nm consisting of primary titanium nitride nanoparticles; primary particles have a diameter of approximately 20 nm. | |||
808 | 38550 | 0882073-43-0 | bis(4-propylbenzylidene)propylsorbitol | yes | no | no | 5 | SML including the sum of its hydrolysis products | ||
809 | 49080 | 0852282-89-4 | N-(2,6-diisopropylphenyl)-6-[4-(1,1,3,3-tetramethylbutyl)phenoxy]-1H-benzo[de]isoquinolin-1,3(2H)-dione | yes | no | yes | 0,05 | Only for use in PET | (6) (14) (15) | |
810 | 68119 | neopentyl glycol, diesters and monoesters with benzoic acid and 2-ethylhexanoic acid | yes | no | no | 5 | (32) | Not to be used for articles in contact with fatty foods for which simulant D is laid down. | ||
811 | 80077 | 0068441-17-8 | polyethylene waxes, oxidised | yes | no | no | 60 | |||
F6812 | 80350 | 0124578-12-7 | poly(12-hydroxystearic acid)-polyethyleneimine copolymer | yes | no | no | Only to be used in plastics up to 0,1 % w/w. Prepared by the reaction of poly(12-hydroxystearic acid) with polyethyleneimine. | |||
813 | 91530 | — | sulphosuccinic acid alkyl (C4-C20) or cyclohexyl diesters, salts | yes | no | no | 5 | |||
814 | 91815 | — | sulphosuccinic acid monoalkyl (C10-C16) polyethyleneglycol esters, salts | yes | no | no | 2 | |||
815 | 94985 | — | trimethylolpropane, mixed triesters and diesters with benzoic acid and 2-ethylhexanoic acid | yes | no | no | 5 | (32) | Not to be used for articles in contact with fatty foods for which simulant D is laid down | |
816 | 45704 | — | cis-1,2-cyclohexanedicarboxylic acid, salts | yes | no | no | 5 | |||
817 | 38507 | — | cis-endo-bicyclo[2.2.1]heptane-2,3-dicarboxylic acid, salts | yes | no | no | 5 | Not to be used with polyethylene in contact with acidic foods. Purity ≥ 96 %. | ||
818 | 21530 | — | methallylsulphonic acid, salts | no | yes | no | 5 | |||
819 | 68110 | — | neodecanoic acid, salts | yes | no | no | 0,05 | Not to be used in polymers contacting fatty foods. Not to be used for articles in contact with fatty foods for which simulant D is laid down. SML expressed as neodecanoic acid. | ||
820 | 76420 | — | pimelic acid, salts | yes | no | no | ||||
821 | 90810 | — | stearoyl-2-lactylic acid, salts | yes | no | no | ||||
822 | 71938 | — | perchloric acid, salts | yes | no | no | 0,05 | (4) | ||
823 | 24889 | — | 5-Sulphoisophthalic acid, salts | no | yes | no | 5 | |||
854 | 71943 | 0329238-24-6 | perfluoro acetic acid, α-substituted with the copolymer of perfluoro-1,2-propylene glycol and perfluoro-1,1-ethylene glycol, terminated with chlorohexafluoropropyloxy groups | yes | no | no | Only to be used in concentrations up to 0,5 % w/w in the polymerisation of fluoropolymers that are processed at temperatures at or above 340 °C and are intended for use in repeated use articles | |||
F9855 | 40560 | (butadiene, styrene, methyl methacrylate) copolymer cross-linked with 1,3-butanediol dimethacrylate | yes | no | no | Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 12 % at room temperature or below. | ||||
856 | 40563 | (butadiene, styrene, methyl methacrylate, butyl acrylate) copolymer cross-linked with divinylbenzene or 1,3-butanediol dimethacrylate | yes | no | no | Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 12 % at room temperature or below. | ||||
857 | 66765 | 0037953-21-2 | (methyl methacrylate, butyl acrylate, styrene, glycidyl methacrylate) copolymer | yes | no | no | Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 2 % at room temperature or below. | |||
38565 | 0090498-90-1 | 3,9-bis[2-(3-(3-tert-butyl-4-hydroxy-5-methylphenyl)propionyloxy)-1,1-dimethylethyl]-2,4,8,10-tetraoxaspiro[5,5]undecane | yes | no | yes | 0,05 | SML expressed as the sum of the substance and its oxidation product 3-[(3-(3-tert-butyl-4-hydroxy-5-methylphenyl)prop-2-enoyloxy)-1,1-dimethylethyl]-9-[(3-(3-tert-butyl-4-hydroxy-5-methylphenyl)propionyloxy)-1,1-dimethylethyl]-2,4,8,10-tetraoxaspiro[5,5]-undecane in equilibrium with its para quinone methid tautomer. | (2) | ||
F1859 | (butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer crosslinked with divinylbenzene, in nanoform | yes | no | no | Only to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long-term storage. When used together with the substance with FCM No 998 and/or the substance with FCM No 1043, the restriction of 10 % w/w applies to the sum of those substances. The diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm. | |||||
860 | 71980 | 0051798-33-5 | perfluoro[2-(poly(n-propoxy))propanoic acid] | yes | no | no | Only to be used in the polymerisation of fluoropolymers that are processed at temperatures at or above 265 °C and are intended for use in repeated use articles | |||
861 | 71990 | 0013252-13-6 | perfluoro[2-(n-propoxy)propanoic acid] | yes | no | no | Only to be used in the polymerisation of fluoropolymers that are processed at temperatures at or above 265 °C and are intended for use in repeated use articles | |||
F6862 | 15180 | 0018085-02-4 | 3,4-diacetoxy-1-butene | no | yes | no | 0,05 | SML including the hydrolysis product 3,4-dihydroxy-1-butene Only to be used as a co-monomer for ethylvinylalcohol (EVOH) and polyvinylalcohol (PVOH) copolymers. | (17) (19) | |
F9863 | 15260 | 0000646-25-3 | 1,10-decanediamine | no | yes | no | 0,05 | Only to be used as a co-monomer for manufacturing polyamide articles for repeated use in contact with aqueous, acidic and dairy foodstuffs at room temperature or for short term contact up to 150 °C. | ||
864 | 46330 | 0000056-06-4 | 2,4-diamino-6-hydroxypyrimidine | yes | no | no | 5 | Only to be used in rigid poly(vinyl chloride) (PVC) in contact with non-acidic and non-alcoholic aqueous food | ||
F5865 | 40619 | 0025322-99-0 | (butyl acrylate, methyl methacrylate, butyl methacrylate) copolymer | yes | no | no | Only to be used in:
| |||
866 | 40620 | — | (butyl acrylate, methyl methacrylate) copolymer, cross-linked with allyl methacrylate | yes | no | no | Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 7 % | |||
867 | 40815 | 0040471-03-2 | (butyl methacrylate, ethyl acrylate, methyl methacrylate) copolymer | yes | no | no | Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 2 % | |||
F5868 | 53245 | 0009010-88-2 | (ethyl acrylate, methyl methacrylate) copolymer | yes | no | no | Only to be used in:
| |||
869 | 66763 | 0027136-15-8 | (butyl acrylate, methyl methacrylate, styrene) copolymer | yes | no | no | Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 3 % | |||
870 | 95500 | 0160535-46-6 | N,N′,N″-tris(2-methylcyclohexyl)-1,2,3-propane-tricarboxamide | yes | no | no | 5 | |||
F10872 | 0006607-41-6 | 2-phenyl-3,3-bis(4-hydroxyphenyl)phthalimidine | no | yes | no | 0,05 | To be used only as a co-monomer in polycarbonate copolymers | (20) | ||
F9873 | 93460 | titanium dioxide reacted with octyltriethoxysilane | yes | no | no | Reaction product of titanium dioxide with up to 2 % w/w surface treatment substance octyltriethoxysilane, processed at high temperatures. | ||||
F3874 | 16265 | 0156065-00-8 | α-dimethyl-3-(4’-hydroxy-3’-methoxyphenyl)propylsilyloxy, ω-3-dimethyl-3-(4’-hydroxy-3’-methoxyphenyl)propylsilyl polydimethylsiloxane | no | yes | no | 0,05 | (33) | Only to be used as comonomer in siloxane modified polycarbonate. The oligomeric mixture shall be characterised by the formula C24H38Si2O5(SiOC2H6)n (50 > n ≥ 26). | |
875 | 80345 | 0058128-22-6 | poly(12-hydroxystearic acid) stearate | yes | no | yes | 5 | |||
878 | 31335 | — | acids, fatty (C8-C22) from animal or vegetable fats and oils, esters with branched alcohols, aliphatic, monohydric, saturated, primary (C3-C22) | yes | no | no | ||||
879 | 31336 | — | acids, fatty (C8-C22) from animal or vegetable fats and oils, esters with alcohols, linear, aliphatic, monohydric, saturated, primary (C1-C22) | yes | no | no | ||||
F4880 | 31348 | acids, fatty (C8-C22), esters with pentaerythritol' | yes | no | no | |||||
881 | 25187 | 0003010-96-6 | 2,2,4,4-tetramethylcyclobutane-1,3-diol | no | yes | no | 5 | Only for:
| ||
882 | 25872 | 0002416-94-6 | 2,3,6-trimethylphenol | no | yes | no | 0,05 | |||
883 | 22074 | 0004457-71-0 | 3-methyl-1,5-pentanediol | no | yes | no | 0,05 | Only to be used in materials in contact with food at a surface to mass ratio up to 0,5 dm2/kg | ||
884 | 34240 | 0091082-17-6 | alkyl(C10-C21)sulphonic acid, esters with phenol | yes | no | no | 0,05 | Not to be used for articles in contact with fatty foods for which simulant D is laid down. | ||
885 | 45676 | 0263244-54-8 | cyclic oligomers of (butylene terephthalate) | yes | no | no | Only to be used in poly(ethylene terephthalate) (PET), poly(butylene terephthalate) (PBT), polycarbonate (PC), polystyrene (PS) and rigid poly(vinyl chloride) (PVC) plastics in concentrations up to 1 % w/w, in contact with aqueous, acidic and alcoholic foods, for long term storage at room temperature. | |||
F9894 | 93360 | 0016545-54-3 | thiodipropionic acid, ditetradecyl ester | yes | no | no | (14) | |||
895 | 47060 | 0171090-93-0 | 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoic acid, esters with C13-C15 branched and linear alcohols | yes | no | no | 0,05 | Only to be used in polyolefins in contact with foods other than fatty/high-alcoholic and dairy products. | ||
896 | 71958 | 0958445-44-8 | 3H-perfluoro-3-[(3-methoxy-propoxy)propanoic acid], ammonium salt | yes | no | no | Only to be used in the polymerisation of fluoropolymers when:
| |||
F3902 | 0000128-44-9 | 1,2-benzisothiazol-3(2H)-one 1,1-dioxide, sodium salt | yes | no | no | The substance shall comply with the specific purity criteria as set out in Commission Regulation (EU) No 231/201226. | ||||
F1903 | 37486-69-4 | 2H-perfluoro-[(5,8,11,14-tetramethyl)-tetraethyleneglycol ethyl propyl ether] | yes | no | no | Only to be used as a polymer production aid in the polymerisation of fluoropolymers intended for:
| ||||
923 | 39150 | 0000120-40-1 | N,N-bis(2-hydroxyethyl)dodecanamide | yes | no | no | 5 | The residual amount of diethanolamine in plastics, as an impurity and decomposition product of the substance, should not result in a migration of diethanolamine higher than 0,3 mg/kg food. | (18) | |
924 | 94987 | trimethylolpropane, mixed triesters and diesters with n-octanoic and n-decanoic acids | yes | no | no | 0,05 | Only for use in PET in contact with all types of foods other than fatty, high-alcoholic and dairy products. | |||
926 | 71955 | 0908020-52-0 | perfluoro[(2-ethyloxy-ethoxy)acetic acid], ammonium salt | yes | no | no | Only to be used in the polymerisation of fluoropolymers that are processed at temperatures higher than 300 °C for at least 10 minutes. | |||
F1969 | 24937-78-8 | ethylene-vinyl acetate copolymer wax | yes | no | no | Only to be used as a polymeric additive up to 2 % w/w in polyolefins. The migration of low molecular weight oligomeric fraction below 1 000 Da shall not exceed 5 mg/kg food. | ||||
971 | 25885 | 0002459-10-1 | trimethyl trimellitate | no | yes | no | Only to be used as a co-monomer up to 0,35 % w/w to produce modified polyesters intended to be used in contact with aqueous and dry foodstuffs containing no free fat at the surface. | (17) | ||
972 | 45197 | 0012158-74-6 | copper hydroxide phosphate | yes | no | no | ||||
973 | 22931 | 0019430-93-4 | (perfluorobutyl)ethylene | no | yes | no | Only to be used as a co-monomer up to 0,1 % w/w in the polymerisation of fluoropolymers, sintered at high temperatures. | |||
974 | 74050 | 939402-02-5 | phosphorous acid, mixed 2,4-bis(1,1-dimethylpropyl)phenyl and 4-(1,1-dimethylpropyl)phenyl triesters | yes | no | yes | 5 | SML expressed as the sum of phosphite and phosphate form of the substance and the hydrolysis product 4-t-amylphenol. The migration of the hydrolysis product 2,4-di-t-amylphenol should not exceed 0,05 mg/kg. | ||
F3979 | 79987 | — | (polyethylene terephthalate, hydroxylated polybutadiene, pyromellitic anhydride) copolymer | yes | no | no | Only to be used in polyethylene terephthalate (PET) at a maximum level of 5 % w/w. | |||
F10988 | 3634-83-1 | 1,3-bis(isocyanatomethyl)benzene | no | yes | no | (34) | SML(T) applies to the migration of its hydrolysis product, 1,3-benzenedimethanamine To be used only as co-monomer in the manufacture of a middle layer coating on a poly(ethylene terephthalate) polymer film in a multilayer film | |||
F1998 | (butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer not cross-linked, in nanoform | yes | no | no | Only to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long-term storage. When used together with the substance with FCM No 859 and/or the substance with FCM No 1043, the restriction of 10 % w/w applies to the sum of those substances. The diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm. | |||||
1017 | 25618-55-7 | polyglycerol | yes | no | no | To be processed under conditions preventing the decomposition of the substance and up to a maximum temperature of 275 °C. | ||||
1043 | (butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer crosslinked with 1,3-butanediol dimethacrylate, in nanoform | yes | no | no | Only to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long-term storage. When used together with the substance with FCM No 859 and/or the substance with FCM No 998, the restriction of 10 % w/w applies to the sum of those substances. The diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm. | |||||
Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications of food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (OJ L 83, 22.3.2012, p. 1). | ||||||||||
Infant as defined in Article 2 of Directive 2006/141/EC. | ||||||||||
This restriction is applicable from 1 May 2011 as regards the manufacture and from 1 June 2011 as regards the placing on the market and importation into the Union. | ||||||||||
2.Group restriction of substances
Table 2 on Group restrictions contains the following information:
Column 1 (Group restriction No): contains the identification number of the group of substances for which the group restriction applies. It is the number referred to in Column 9 in Table 1 of this Annex.
Column 2 (FCM substance No): contains the unique identification numbers of the substances for which the group restriction applies. It is the number referred to in Column 1 in Table 1 of this Annex.
Column 3 (SML (T) [mg/kg]): contains the total specific migration limit for the sum of substances applicable to this group. It is expressed in mg substance per kg food. It is indicated ND if the substance shall not migrate in detectable quantities.
Column 4 (Group restriction specification): contains an indication of the substance whose molecular weight forms the basis for expression of the result.
(1) | (2) | (3) | (4) |
Group Restriction No | FCM substance No | SML (T)[mg/kg] | Group restriction specification |
---|---|---|---|
1 | 128 211 | 6 | expressed as acetaldehyde |
2 | 89 227 263 | 30 | expressed as ethyleneglycol |
3 | 234 248 | 30 | expressed as maleic acid |
4 | 212 435 | 15 | expressed as caprolactam |
5 | 137 472 | 3 | expressed as the sum of the substances |
6 | 412 512 513 588 | 1 | expressed as iodine |
7 | 19 20 | 1,2 | expressed as tertiary amine |
8 | 317 318 319 359 431 464 | 6 | expressed as the sum of the substances |
9 | 650 695 697 698 726 | 0,18 | expressed as tin |
10 | 28 29 30 31 32 33 466 582 618 619 620 646 676 736 | 0,006 | expressed as tin |
11 | 66 645 657 | 1,2 | expressed as tin |
12 | 444 469 470 | 30 | expressed as the sum of the substances |
13 | 163 285 | 1,5 | expressed as the sum of the substances |
F614 | 294 | 5 | expressed as the sum of the substances and their oxidation products |
368 | |||
894 | |||
F415 | 98 196 344 | 15 | expressed as formaldehyde |
16 | 407 583 584 599 | 6 | expressed as boron Without prejudice to the provisions of Directive 98/83/EC |
17 | 4 167 169 198 274 354 372 460 461 475 476 485 490 653 | ND | expressed as isocyanate moiety |
18 | 705 733 | 0,05 | expressed as the sum of the substances |
19 | 505 516 519 | 10 | expressed as SO2 |
20 | 290 386 390 | 30 | expressed as the sum of the substances |
21 | 347 349 | 5 | expressed as trimellitic acid |
22 | 70 147 176 218 323 325 365 371 380 425 446 448 456 636 | 6 | expressed as acrylic acid |
23 | 150 156 181 183 184 355 370 374 439 440 447 457 482 | 6 | expressed as methacrylic acid |
24 | 756 758 | 5 | expressed as the sum of the substances |
25 | 720 747 | 0,05 | sum of mono-n-dodecyltin tris(isooctylmercaptoacetate), di-n-dodecyltin bis(isooctyl mercaptoacetate), mono-dodecyltin trichloride and di-dodecyltin dichloride) expressed as the sum of mono- and di-dodecyltin chloride |
26 | 728 729 | 9 | expressed as the sum of the substances |
27 | 188 291 | 5 | expressed as isophthalic acid |
28 | 191 192 785 | 7,5 | expressed as terephthalic acid |
29 | 342 672 | 0,05 | expressed as the sum of 6-hydroxyhexanoic acid and caprolactone |
F430 | 254 344 672 | 5 | expressed as 1,4-butanediol |
31 | 73 797 | 30 | expressed as the sum of the substances |
32 | 8 72 73 138 140 157 159 207 242 283 532 670 728 729 775 783 797 798 810 815 | 60 | expressed as the sum of the substances |
F333 | 180 874 | ND | expressed as eugenol |
F1034 | 421 988 | 0,05 | Expressed as 1,3-benzenedimethanamine |
3.Notes on verification of compliance
Table 3 on notes on verification of compliance contains the following information:
Column 1 (Note No): contains the identification number of the Note. It is the number referred to in Column 11 in Table 1 of this Annex.
Column 2 (Notes on verification of compliance): contains rules that shall be respected when testing for compliance of the substance with specific migration limits or other restrictions or it contains remarks on situations where there is a risk of non-compliance.
(1) | (2) |
Note No | Notes on verification of compliance |
---|---|
(1) | Verification of compliance by residual content per food contact surface area (QMA) pending the availability of an analytical method. |
(2) | There is a risk that the SML or OML could be exceeded in fatty food simulants. |
(3) | There is a risk that the migration of the substance deteriorates the organoleptic characteristics of the food in contact and then, that the final product does not comply with Article 3(1) c of the Framework Regulation (EC) No 1935/2004. |
F5(4) | Compliance testing when there is a fat contact should be performed using saturated fatty food simulants as simulant D2. |
(5) | Compliance testing when there is a fat contact should be performed using isooctane as substitute of simulant D2 (unstable). |
(6) | Migration limit might be exceeded at very high temperature. |
(7) | If testing in food is performed, Annex V 1.4 shall be taken into account. |
(8) | Verification of compliance by residual content per food contact surface area (QMA); QMA = 0,005 mg/6 dm2. |
(9) | Verification of compliance by residual content per food contact surface area (QMA) pending the availability of analytical method for migration testing. The ratio surface to quantity of food shall be lower than 2dm2/kg. |
(10) | Verification of compliance by residual content per food contact surface area (QMA) in case of reaction with food or simulant. |
(11) | Only a method of analysis for the determination of the residual monomer in the treated filler is available. |
(12) | There is a risk that the SML could be exceeded from polyolefins. |
(13) | Only a method for determination of the content in polymer and a method for determination of the starting substances in food simulants are available. |
(14) | There is a risk that the SML could be exceeded from plastics containing more than 0,5 % w/w of the substance. |
(15) | There is a risk that the SML could be exceeded in contact with foods with high alcoholic content. |
(16) | There is a risk that the SML could be exceeded from low-density polyethylene (LDPE) containing more than 0,3 % w/w of the substance when in contact with fatty foods |
(17) | Only a method for determination of the residual content of the substance in the polymer is available |
F9(18) | There is a risk that the SML could be exceeded from low-density polyethylene (LDPE) |
(19) | There is a risk that the OML could be exceeded in direct contact with aqueous foods from ethylvinylalcohol (EVOH) and polyvinylalcohol (PVOH) copolymers |
F10(20) | The substance contains aniline as an impurity; verification of compliance with the restriction set for primary aromatic amines in Annex II (2) is necessary |
F1(21) | In case of reaction with foods or simulants verification of compliance shall include verification that the migration limits of the hydrolysis products, formaldehyde and 1,4-butanediol, are not exceeded. |
4.Detailed specification on substances
Table 4 on detailed specifications on substances contains the following information
Column 1 (FCM substance No): contains the unique identification number of the substances referred to in Column 1 in Table 1 of Annex I to which the specification applies.
Column 2 (Detailed specification on the substance): contains the specification on the substance.
(1) | (2) | |
FCM substance No | Detailed specification on the substance | |
---|---|---|
744 | 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 wildtype 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 | 0080181-31-3 | |
Structural formula | where n/(m + n) greater than 0 and less or equal to 0,25 | |
Average molecular weight | Not less than 150 000 Daltons (measured by gel permeation chromatography) | |
Assay | Not less than 98 % poly(3-D-hydroxybutanoate-co-3-D-hydoxy-pentanoate) analysed after hydrolysis as a mixture of 3-D-hydro-xybutanoic and 3-D-hydroxypentanoic acids | |
Description | White to off-white powder after isolation | |
Characteristics | ||
Identification tests: | ||
Solubility | Soluble in chlorinated hydrocarbons such as chloroform or dichloromethane but practically insoluble in ethanol, aliphatic alkanes and water | |
Restriction | QMA for crotonic acid is 0,05 mg/6 dm2 | |
Purity | Prior to granulation the raw material copolymer powder must contain: | |
| Not more than 2 500 mg/kg of plastic | |
| Not more than 100 mg/kg of plastic | |
| Not more than 5 mg/kg of plastic | |
| Not more than 2 mg/kg of plastic | |
| Not more than 1 mg/kg of plastic | |
| Not more than 1 mg/kg of plastic |
ANNEX IIRestrictions on materials and articles
1.
Plastic materials and articles shall not release the following substances in quantities exceeding the specific migration limits below:
Barium = 1 mg/kg food or food simulant.
Cobalt = 0,05 mg/kg food or food simulant.
Copper = 5 mg/kg food or food simulant.
Iron = 48 mg/kg food or food simulant.
Lithium = 0,6 mg/kg food or food simulant.
Manganese = 0,6 mg/kg food or food simulant.
Zinc = 25 mg/kg food or food simulant.
2.
Plastic materials and articles shall not release primary aromatic amines, excluding those appearing in Table 1 of Annex I, in a detectable quantity into food or food simulant. The detection limit is 0,01 mg of substance per kg of food or food simulant. The detection limit applies to the sum of primary aromatic amines released.
ANNEX IIIFood simulants
1.Food simulants
For demonstration of compliance for plastic materials and articles not yet in contact with food the food simulants listed in Table 1 below are assigned.
Food simulant | Abbreviation | ||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Ethanol 10 % (v/v) | Food simulant A | ||||||||||||||||
Acetic acid 3 % (w/v) | Food simulant B | ||||||||||||||||
Ethanol 20 % (v/v) | Food simulant C | ||||||||||||||||
Ethanol 50 % (v/v) | Food simulant D1 | ||||||||||||||||
Vegetable oil27 | Food simulant D2 | ||||||||||||||||
poly(2,6-diphenyl-p-phenylene oxide), particle size 60-80 mesh, pore size 200 nm | Food simulant E | ||||||||||||||||
This may be any vegetable oil with a fatty acid distribution of
|
2.General assignment of food simulants to foods
Food simulants A, B and C are assigned for foods that have a hydrophilic character and are able to extract hydrophilic substances. Food simulant B shall be used for those foods which have a pH below 4.5. Food simulant C shall be used for alcoholic foods with an alcohol content of up to 20 % and those foods which contain a relevant amount of organic ingredients that render the food more lipophilic.
Food simulants D1 and D2 are assigned for foods that have a lipophilic character and are able to extract lipophilic substances. Food simulant D1 shall be used for alcoholic foods with an alcohol content of above 20 % and for oil in water emulsions. Food simulant D2 shall be used for foods which contain free fats at the surface.
Food simulant E is assigned for testing specific migration into dry foods.
3.Specific assignment of food simulants to foods for migration testing of materials and articles not yet in contact with food
For testing migration from materials and articles not yet in contact with food the food simulants that corresponds to a certain food category shall be chosen according Table 2 below.
For testing overall migration from materials and articles intended to come into contact with different food categories or a combination of food categories the food simulant assignment in point 4 is applicable.
Table 2 contains the following information:
Column 1 (Reference number): contains the reference number of the food category.
Column 2 (Description of food): contains a description of the foods covered by the food category
Column 3 (Food simulants): contains sub-columns for each of the food simulants
The food simulant for which a cross is contained in the respective sub-column of column 3 shall be used when testing migration of materials and articles not yet in contact with food.
For food categories where in sub-column D2 the cross is followed by an oblique stroke and a figure, the migration test result shall be divided by this figure before comparing the result with the migration limit. The figure is the correction factor referred to in point 4.2 of Annex V to this Regulation.
For food category 01.04 food simulant D2 shall be replaced by 95 % ethanol.
For food categories where in sub-column B the cross is followed by (*) the testing in food simulant B can be omitted if the food has a pH of more than 4.5.
For food categories where in sub-column D2 the cross is followed by (**) the testing in food simulant D2 can be omitted if it can be demonstrated by means of an appropriate test that there is no ‘fatty contact’ with the plastic food contact material.
(1) | (2) | (3) | |||||
---|---|---|---|---|---|---|---|
Reference number | Description of food | Food simulants | |||||
A | B | C | D1 | D2 | E | ||
01 | Beverages | ||||||
01.01 | Non-alcoholic beverages or alcoholic beverages of an alcoholic strength lower than or equal to 6 % vol.: | ||||||
| X(*) | X | |||||
| X(*) | X | |||||
01.02 | Alcoholic beverages of an alcoholic strength of between 6 %vol and 20 %. | X | |||||
01.03 | Alcoholic beverages of an alcoholic strength above 20 % and all cream liquors | X | |||||
01.04 | Miscellaneous: undenaturated ethyl alcohol | X(*) | Substitute 95 % ethanol | ||||
02 | Cereals, cereal products, pastry, biscuits, cakes and other bakers’ wares | ||||||
02.01 | Starches | X | |||||
02.02 | Cereals, unprocessed, puffed, in flakes (including popcorn, corn flakes and the like) | X | |||||
02.03 | Cereal flour and meal | X | |||||
02.04 | Dry pasta e.g. macaroni, spaghetti and similar products and fresh pasta | X | |||||
02.05 | Pastry, biscuits, cakes, bread, and other bakers’ wares, dry: | ||||||
| X/3 | ||||||
| X | ||||||
02.06 | Pastry, cakes, bread, dough and other bakers’ wares, fresh: | ||||||
| X/3 | ||||||
| X | ||||||
03 | Chocolate, sugar and products thereof Confectionery products | ||||||
03.01 | Chocolate, chocolate-coated products, substitutes and products coated with substitutes | X/3 | |||||
03.02 | Confectionery products: | ||||||
| |||||||
| X/3 | ||||||
| X | ||||||
| |||||||
| X/2 | ||||||
| X | ||||||
03.03 | Sugar and sugar products | ||||||
| X | ||||||
| X | ||||||
04 | Fruit, vegetables and products thereof | ||||||
04.01 | Whole fruit, fresh or chilled, unpeeled | ||||||
04.02 | Processed fruit: | ||||||
| X | ||||||
| X(*) | X | |||||
| |||||||
| X | ||||||
| X | ||||||
04.03 | Nuts (peanuts, chestnuts, almonds, hazelnuts, walnuts, pine kernels and others): | ||||||
| X | ||||||
| X | ||||||
| X | X | |||||
04.04 | Whole vegetables, fresh or chilled, unpeeled | ||||||
04.05 | Processed vegetables: | ||||||
| X | ||||||
| X | ||||||
| X(*) | X | |||||
| |||||||
| X | X | |||||
| X | ||||||
05 | Fats and oils | ||||||
05.01 | Animals and vegetable fats and oils, whether natural or treated (including cocoa butter, lard, resolidified butter) | X | |||||
05.02 | Margarine, butter and other fats and oils made from water emulsions in oil | X/2 | |||||
06 | Animal products and eggs | ||||||
06.01 | Fish: | ||||||
| X | X/3(**) | |||||
| |||||||
| X | X | |||||
| X(*) | X | |||||
06.02 | Crustaceans and molluscs (including oysters, mussels, snails) | ||||||
| |||||||
| |||||||
| X | X | |||||
| X(*) | X | |||||
06.03 | Meat of all zoological species (including poultry and game): | ||||||
| X | X/4(**) | |||||
| X | X/4(**) | |||||
| X | X | |||||
06.04 | Preserved meat: | ||||||
| X | X/3 | |||||
| X(*) | X | |||||
06.05 | Whole eggs, egg yolk, egg white | ||||||
| X | ||||||
| X | ||||||
07 | Milk products | ||||||
07.01 | Milk | ||||||
| X | ||||||
| X | ||||||
07.02 | Fermented milk such as yoghurt, buttermilk and similar products | X(*) | X | ||||
07.03 | Cream and sour cream | X(*) | X | ||||
07.04 | Cheeses: | ||||||
| X | ||||||
| X/3(**) | ||||||
| X(*) | X | |||||
| |||||||
| X | X | |||||
| X(*) | X | |||||
08 | Miscellaneous products | ||||||
08.01 | Vinegar | X | |||||
08.02 | Fried or roasted foods: | ||||||
| X | X/5 | |||||
| X | X/4 | |||||
08.03 | Preparations for soups, broths, sauces, in liquid, solid or powder form (extracts, concentrates); homogenised composite food preparations, prepared dishes including yeast and raising agents | ||||||
| |||||||
| X/5 | ||||||
| X | ||||||
| |||||||
| X | X(*) | X/3 | ||||
| X(*) | X | |||||
08.04 | Sauces: | ||||||
| X(*) | X | |||||
| X | X(*) | X | ||||
08.05 | Mustard (except powdered mustard under heading 08.14) | X | X(*) | X/3(**) | |||
08.06 | Sandwiches, toasted bread pizza and the like containing any kind of foodstuff | ||||||
| X | X/5 | |||||
| X | ||||||
08.07 | Ice-creams | X | |||||
08.08 | Dried foods: | ||||||
| X/5 | ||||||
| X | ||||||
08.09 | Frozen or deep-frozen foods | X | |||||
08.10 | Concentrated extracts of an alcoholic strength equal to or exceeding 6 % vol. | X(*) | X | ||||
08.11 | Cocoa: | ||||||
| X | ||||||
| X/3 | ||||||
08.12 | Coffee, whether or not roasted, decaffeinated or soluble, coffee substitutes, granulated or powdered | X | |||||
08.13 | Aromatic herbs and other herbs such as camomile, mallow, mint, tea, lime blossom and others | X | |||||
08.14 | Spices and seasonings in the natural state such as cinnamon, cloves, powdered mustard, pepper, vanilla, saffron, salt and other | X | |||||
08.15 | Spices and seasoning in oily medium such as pesto, curry paste | X |
4.Food simulant assignment for testing overall migration
To demonstrate compliance with the overall migration limit for all type of foods testing in distilled water or water of equivalent quality or food simulant A and food simulant B and simulant D2 shall be performed.
To demonstrate compliance with the overall migration limit for all types of food except for acidic foods testing in distilled water or water of equivalent quality or food simulant A and food simulant D2 shall be performed.
To demonstrate compliance with the overall migration limit for all aqueous and alcoholic foods and milk products testing in food simulant D1 shall be performed.
To demonstrate compliance with the overall migration limit for all aqueous, acidic and alcoholic foods and milk products testing in food simulant D1 and food simulant B shall be performed.
To demonstrate compliance with the overall migration limit for all aqueous foods and alcoholic foods up to an alcohol content of 20 % testing in food simulant C shall be performed.
To demonstrate compliance with the overall migration limit for all aqueous and acidic foods and alcoholic foods up to an alcohol content of 20 % testing in food simulant C and food simulant B shall be performed.
ANNEX IVDeclaration of compliance
The written declaration referred to in Article 15 shall contain the following information:
- (1)
the identity and address of the business operator issuing the declaration of compliance;
- (2)
the identity and address of the business operator which manufactures or imports the plastic materials or articles or products from intermediate stages of their manufacturing or the substances intended for the manufacturing of those materials and articles;
- (3)
the identity of the materials, the articles, products from intermediate stages of manufacture or the substances intended for the manufacturing of those materials and articles;
- (4)
the date of the declaration;
- (5)
confirmation that the plastic materials or articles, products from intermediate stages of manufacture or the substances meet relevant requirements laid down in this Regulation and Regulation (EC) No 1935/2004;
- (6)
adequate information relative to the substances used or products of degradation thereof for which restrictions and/or specifications are set out in Annexes I and II to this Regulation to allow the downstream business operators to ensure compliance with those restrictions;
- (7)
adequate information relative to the substances which are subject to a restriction in food, obtained by experimental data or theoretical calculation about the level of their specific migration and, where appropriate, purity criteria in accordance with Directives 2008/60/EC, 95/45/EC and 2008/84/EC to enable the user of these materials or articles to comply with the relevant EU provisions or, in their absence, with national provisions applicable to food;
- (8)
specifications on the use of the material or article, such as:
- (i)
type or types of food with which it is intended to be put in contact;
- (ii)
time and temperature of treatment and storage in contact with the food;
- (iii)
ratio of food contact surface area to volume used to establish the compliance of the material or article;
- (i)
- (9)
when a functional barrier is used in a multi-layer material or article, the confirmation that the material or article complies with the requirements of Article 13(2), (3) and (4) or Article 14(2) and (3) of this Regulation.
ANNEX VCOMPLIANCE TESTING
For testing compliance of migration from plastic food contact materials and articles the following general rules apply.
CHAPTER 1Testing for specific migration of materials and articles already in contact with food
1.1.Sample preparation
The material or article shall be stored as indicated on the packaging label or under conditions adequate for the packaged food if no instructions are given. The food shall be removed from contact with the material or article before its expiration date or any date by which the manufacturer has indicated the product should be used for reasons of quality or safety.
1.2.Conditions of testing
The food shall be treated in accordance with the cooking instructions on the package if the food is to be cooked in the package. Parts of the food which are not intended to be eaten shall be removed and discarded. The remainder shall be homogenised and analysed for migration. The analytical results shall always be expressed on the basis of the food mass that is intended to be eaten, in contact with the food contact material.
1.3.Analysis of migrated substances
The specific migration is analysed in the food using an analytical method in accordance with the requirements of Article 11 of Regulation (EC) No 882/2004.
1.4.Special cases
When contamination occurs from sources other than food contact materials this has to be taken into account when testing for compliance of the food contact materials, in particular for phthalates (FCM substance 157, 159, 283, 728, 729) referred to in Annex I.
CHAPTER 2Testing for specific migration of materials and articles not yet in contact with food
2.1.Verification method
Verification of compliance of migration into foods with the migration limits shall be carried out under the most extreme conditions of time and temperature foreseeable in actual use taking into account paragraphs 1.4, 2.1.1, 2.1.6 and 2.1.7.
Verification of compliance of migration into food simulants with the migration limits shall be carried out using conventional migration tests according to the rules set out in paragraphs 2.1.1 to 2.1.7.
2.1.1.Sample preparation
The material or article shall be treated as described by accompanying instructions or by provisions given in the declaration of compliance.
Migration is determined on the material or article or, if this is impractical, on a specimen taken from the material or article, or a specimen representative of this material or article. For each food simulant or food type, a new test specimen is used. Only those parts of the sample which are intended to come into contact with foods in actual use shall be placed in contact with the food simulant or the food.
2.1.2.Choice of food simulant
Materials and articles intended for contact with all types of food shall be tested with food simulant A, B and D2. However, if substances that may react with acidic food simulant or foods are not present testing in food simulant B can be omitted.
Materials and articles intended only for specific types of foods shall be tested with the food simulants indicated for the food types in Annex III.
2.1.3.Conditions of contact when using food simulants
The sample shall be placed in contact with the food simulant in a manner representing the worst of the foreseeable conditions of use as regard contact time in Table 1 and as regard contact temperature in Table 2.
If it is found that carrying out the tests under the combination of contact conditions specified in Tables 1 and 2 causes physical or other changes in the test specimen which do not occur under worst foreseeable conditions of use of the material or article under examination, the migration tests shall be carried out under the worst foreseeable conditions of use in which these physical or other changes do not take place.
Contact time in worst foreseeable use | Test time |
---|---|
t ≤ 5 min | 5 min |
5 min < t ≤ 0,5 hour | 0,5 hour |
0,5 hours < t ≤ 1 hour | 1 hour |
1 hour < t ≤ 2 hours | 2 hours |
2 hours < t ≤ 6 hours | 6 hours |
6 hours < t ≤ 24 hours | 24 hours |
1 day < t ≤ 3 days | 3 days |
3 days < t ≤ 30 days | 10 days |
Above 30 days | See specific conditions |
Conditions of contact in worst foreseeable use | Test conditions |
---|---|
Contact temperature | Test temperature |
T ≤ 5 °C | 5 °C |
5 °C < T ≤ 20 °C | 20 °C |
20 °C < T ≤ 40 °C | 40 °C |
40 °C < T ≤ 70 °C | 70 °C |
70 °C < T ≤ 100 °C | 100 °C or reflux temperature |
100 °C < T ≤ 121 °C | 121 °C28 |
121 °C < T ≤ 130 °C | 130 °C28 |
130 °C < T ≤ 150 °C | 150 °C28 |
150 °C < T < 175 °C | 175 °C28 |
T > 175 °C | Adjust the temperature to the real temperature at the interface with the food28 |
This temperature shall be used only for food simulants D2 and E. For applications heated under pressure migration testing under pressure at the relevant temperature may be performed. For food simulants A, B, C or D1 the test may be replaced by a test at 100 °C or at reflux temperature for duration of four times the time selected according to the conditions in Table 1. |
2.1.4.Specific conditions for contact times above 30 days at room temperature and below
For contact times above 30 days at room temperature and below the specimen shall be tested in an accelerated test at elevated temperature for a maximum of 10 days at 60 °C. Testing time and temperature conditions shall be based on the following formula.
t2 = t1 * Exp ((-Ea/R) * (1/T1-1/T2))
Ea is the worst case activation energy 80kJ/mol
R is a factor 8,31 J/Kelvin/mol
Exp -9627 * (1/T1-1/T2)
t1 is the contact time
t2 is the testing time
T1 is the contact temperature in Kelvin. For room temperature storage this is set at 298 K (25 °C). For refrigerated and frozen conditions it is set at 278 K (5 °C).
T2 is the testing temperature in Kelvin.
Testing for 10 days at 20 °C shall cover all storage times at frozen condition.
Testing for 10 days at 40 °C shall cover all storage times at refrigerated and frozen conditions including heating up to 70 °C for up to 2 hours, or heating up to 100 °C for up to 15 minutes.
Testing for 10 days at 50 °C shall cover all storage time at refrigerated and frozen conditions including heating up to 70 °C for up to 2 hours, or heating up to 100 °C for up to 15 minutes and storage times of up to 6 months at room temperature.
Testing for 10 days at 60 °C shall cover long term storage above 6 months at room temperature and below including heating up to 70 °C for up to 2 hours, or heating up to 100 °C for up to 15 minutes.
The maximum testing temperature is governed by the phase transition temperature of the polymer. At the test temperature the test specimen should not undergo any physical changes.
For storage at room temperature testing time can be reduced to 10 days at 40 °C if there is scientific evidence that migration of the respective substance in the polymer has reached equilibration under this test condition.
2.1.5.Specific conditions for combinations of contact times and temperature
If a material or article is intended for different applications covering different combinations of contact time and temperature the testing should be restricted to the test conditions which are recognised to be the most severe on the basis of scientific evidence.
If the material or article is intended for a food contact application where it is successively subject to a combination of two or more times and temperatures, the migration test shall be carried out subjecting the test specimen successively to all the applicable worst foreseeable conditions appropriate to the sample, using the same portion of food simulant.
2.1.6.Repeated use articles
If the material or article is intended to come into repeated contact with foods, the migration test(s) shall be carried out three times on a single sample using another portion of food simulant on each occasion. Its compliance shall be checked on the basis of the level of the migration found in the third test.
However, if there is conclusive proof that the level of the migration does not increase in the second and third tests and if the migration limits are not exceeded on the first test, no further test is necessary.
The material or article shall respect the specific migration limit already in the first test for substances for which in Annex I Table 1 column 8 or Table 2 column 3 the specific migration limit is set as non-detectable and for non-listed substances used behind a plastic functional barrier covered by the rules of point (b) of Articles 13(2) which should not migrate in detectable amounts.
2.1.7.Analysis of migrating substances
At the end of the prescribed contact time, the specific migration is analysed in the food or food simulant using an analytical method in accordance with the requirements of Article 11 of Regulation (EC) No 882/2004.
2.1.8.Verification of compliance by residual content per food contact surface area (QMA)
For substances which are unstable in food simulant or food or for which no adequate analytical method is available it is indicated in Annex I that verification of compliance shall be undertaken by verification of residual content per 6 dm2 of contact surface. For materials and articles between 500 ml and 10 l the real contact surface is applied. For materials and articles below 500 ml and above 10 l as well as for articles for which it is impractical to calculate the real contact surface the contact surface is assumed to be 6 dm2 per kg food.
2.2.Screening approaches
To screen if a material or article complies with the migration limits any of the following approaches can be applied which are considered more severe than the verification method described in section 2.1.
2.2.1.Replacing specific migration by overall migration
To screen for specific migration of non-volatile substances, determination of overall migration under test conditions at least as severe as for specific migration can be applied.
2.2.2.Residual content
To screen for specific migration the migration potential can be calculated based on the residual content of the substance in the material or article assuming complete migration.
2.2.3.Migration modelling
To screen for specific migration the migration potential can be calculated based on the residual content of the substance in the material or article applying generally recognised diffusion models based on scientific evidence that are constructed such as to overestimate real migration.
2.2.4.Food simulant substitutes
To screen for specific migration, food simulants can be replaced by substitute food simulants if it is based on scientific evidence that the substitute food simulants overestimate migration compared to the regulated food simulants.
CHAPTER 3Testing for overall migration
Overall migration testing shall be performed under the standardised testing conditions set out in this chapter.
3.1.Standardised testing conditions
The overall migration test for materials and articles intended for the food contact conditions described in column 3 of Table 3 shall be performed for the time specified and at the temperature specified in column 2. For test OM5 the test can be performed either for 2 hours at 100 °C (food simulant D2) or at reflux (food simulant A, B, C, D1) or for 1 hour at 121 °C. The food simulant shall be chosen in accordance with Annex III.
If it is found that carrying out the tests under the contact conditions specified in Table 3 causes physical or other changes in the test specimen which do not occur under worst foreseeable conditions of use of the material or article under examination, the migration tests shall be carried out under the worst foreseeable conditions of use in which these physical or other changes do not take place.
Column 1 | Column 2 | Column 3 |
---|---|---|
Test number | Contact time in days [d] or hours [h] at Contact temperature in [°C] | Intended food contact conditions |
OM1 | 10 d at 20 °C | Any food contact at frozen and refrigerated conditions. |
OM2 | 10 d at 40 °C | Any long term storage at room temperature or below, including heating up to 70 °C for up to 2 hours, or heating up to 100 °C for up to 15 minutes. |
OM3 | 2 h at 70 °C | Any contact conditions that include heating up to 70 °C for up to 2 hours, or up to 100 °C for up to 15 minutes, which are not followed by long term room or refrigerated temperature storage. |
OM4 | 1 h at 100 °C | High temperature applications for all food simulants at temperature up to 100 °C. |
OM5 | 2 h at 100 °C or at reflux or alternatively 1 h at 121 °C | High temperature applications up to 121 °C. |
OM6 | 4 h at 100 °C or at reflux | Any food contact conditions with food simulants A, B or C, at temperature exceeding 40 °C. |
OM7 | 2 h at 175 °C | High temperature applications with fatty foods exceeding the conditions of OM5. |
Test OM 7 covers also food contact conditions described for OM1, OM2, OM3, OM4, OM5. It represents the worst case conditions for fatty food simulants in contact with non-polyolefins. In case it is technically not feasible to perform OM 7 with food simulant D2 the test can be replaced as set out in paragraph 3.2.
Test OM 6 covers also food contact conditions described for OM1, OM2, OM3, OM4 and OM5. It represents worst case conditions for food simulants A, B and C in contact with non-polyolefins.
Test OM 5 covers also food contact conditions described for OM1, OM2, OM3, OM4. It represents the worst case conditions for all food simulants in contact with polyolefins.
Test OM 2 covers also food contact conditions described for OM1 and OM3.
3.2.Substitute test for OM7 with food simulant D2
In case it is technically NOT feasible to perform OM7 with food simulant D2 the test can be replaced by test OM 8 or OM9. Both test conditions described under the respective test shall be performed with a new test sample.
Test number | Test conditions | Intended food contact conditions | Covers the intended food contact conditions described in |
---|---|---|---|
OM 8 | Food simulant E for 2 hours at 175 °C and food simulant D2 for 2 hours at 100 °C | High temperature applications only | OM1, OM3, OM4, OM5, and OM6 |
OM 9 | Food simulant E for 2 hours at 175 °C and food simulant D2 for 10 days at 40 °C | High temperature applications including long term storage at room temperature | OM1, OM2, OM3, OM4, OM5 and OM6 |
3.3.Repeated use articles
Where a material or article is intended to come into repeated contact with foods, the migration test shall be carried out three times on a single sample using another sample of the food simulant on each occasion.
Its compliance shall be checked on the basis of the level of the migration found in the third test. However, if there is conclusive proof that the level of the migration does not increase in the second and third tests and if the overall migration limit is not exceeded on the first test, no further test is necessary.
3.4.Screening approaches
To screen if a material or article complies with the migration limits any of the following approaches can be applied which are considered more severe than the verification method described in sections 3.1. and 3.2.
3.4.1.Residual content
To screen for overall migration the migration potential can be calculated based on the residual content of migratable substances determined in a complete extraction of the material or article.
3.4.2.Food simulant substitutes
To screen for overall migration food simulants can be replaced if based on scientific evidence the substitute food simulants overestimate migration compared to the regulated food simulants.
CHAPTER 4Correction factors applied when comparing migration test results with migration limits
4.1.Correction of specific migration in foods containing more than 20 % fat by the Fat Reduction Factor (FRF)
For lipophilic substances for which in Annex I it is indicated in column 7 that the FRF is applicable the specific migration can be corrected by the FRF. The FRF is determined according to the formula FRF = (g fat in food/kg of food)/200 = (% fat × 5)/100.
The FRF shall be applied according to the following rules.
The migration test results shall be divided by the FRF before comparing with the migration limits.
The correction by the FRF is not applicable in the following cases:
- (a)
when the material or article is or is intended to be brought in contact with food intended for infants and young children as defined by Directives 2006/141/EC and 2006/125/EC;
- (b)
for materials and articles for which it is impracticable to estimate the relationship between the surface area and the quantity of food in contact therewith, for example due to their shape or use, and the migration is calculated using the conventional surface area/volume conversion factor of 6 dm2/kg.
The application of the FRF shall not lead to a specific migration exceeding the overall migration limit.
4.2.Correction of migration into food simulant D2
For the food categories where in sub-column D2 of column 3 of Table 2 of Annex III the cross is followed by a figure the migration test result into food simulant D2 shall be divided by this figure.
The migration test results shall be divided by the correction factor before comparing with the migration limits.
The correction is not applicable to the specific migration for substances in the Union list in Annex I for which the specific migration limit in column 8 is ‘not detectable’ and for non-listed substances used behind a plastic functional barrier covered by the rules of Article 13(2)(b) which should not migrate in detectable amounts.
4.3.Combination of correction factors 4.1 and 4.2.
The correction factors described in 4.1 and 4.2 can be combined for migration of substances for which the FRF is applicable when testing is performed in food simulant D2 by multiplying both factors. The applied maximum factor shall not exceed 5.
ANNEX VICorrelation tables
Directive 2002/72/EC | This Regulation |
---|---|
Article 1(1) | Article 1 |
Article 1(2), (3) and (4) | Article 2 |
Article 1a | Article 3 |
Article 3(1), Article 4(1) and Article 5 | Article 5 |
Article 4(2), Article 4a(1) and (4), Article 4d, Annex II (2) and (3) and Annex III (2) and (3) | Article 6 |
Article 4a(3) and (6) | Article 7 |
Annex II (4) and Annex III (4) | Article 8 |
Article 3(1) and Article 4(1) | Article 9 |
Article 6 | Article 10 |
Article 5a(1) and Annex I (8) | Article 11 |
Article 2 | Article 12 |
Article 7a | Article 13 |
Article 9(1) and (2) | Article 15 |
Article 9(3) | Article 16 |
Article 7 and Annex I (5a) | Article 17 |
Article 8 | Article 18 |
Annex II (3) and Annex III (3) | Article 19 |
Annex I, Annex II, Annex IV, Annex IVa, Annex V Part B, and Annex VI | Annex I |
Annex II (2), Annex III (2) and Annex V, Part A | Annex II |
Article 8(5) and Annex VIa | Annex IV |
Annex I | Annex V |
Directive 93/8/EEC | This Regulation |
---|---|
Article 1 | Article 11 |
Article 1 | Article 12 |
Article 1 | Article 18 |
Annex | Annex III |
Annex | Annex V |
Directive 97/48/EC | This Regulation |
---|---|
Annex | Annex III |
Annex | Annex V |