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Commission Regulation (EU) No 10/2011Show full title

Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food (Text with EEA relevance)

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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.

Table 1

(1)(2)(3)(4)(5)(6)(7)(8)(9)(10)(11)
FCM substance NoRef. NoCAS NoSubstance nameUse 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 specificationsNotes on verification of compliance
1123100266309-43-7albuminnoyesno
212340albumin, coagulated by formaldehydenoyesno
312375alcohols, aliphatic, monohydric, saturated, linear, primary (C4-C22)noyesno
422332mixture of (40 % w/w) 2,2,4-trimethylhexane-1,6-diisocyanate and (60 % w/w) 2,4,4-trimethylhexane-1,6-diisocyanatenoyesno(17)1 mg/kg in final product expressed as isocyanate moiety.(10)
525360trialkyl(C5-C15)acetic acid, 2,3-epoxypropyl esternoyesnoND

1 mg/kg in final product expressed as epoxygroup.

Molecular weight is 43 Da.

625380trialkyl acetic acid (C7-C17), vinyl estersnoyesno0,05(1)
730370acetylacetic acid, saltsyesnono
830401acetylated mono- and diglycerides of fatty acidsyesnono(32)
930610acids, 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)yesnono
1030612acids, C2-C24, aliphatic, linear, monocarboxylic, synthetic and their mono-, di- and triglycerol estersyesnono
1130960acids, aliphatic, monocarboxylic (C6-C22), esters with polyglycerolyesnono
1231328acids, fatty, from animal or vegetable food fats and oilsyesnono
1333120alcohols, aliphatic, monohydric, saturated, linear, primary (C4-C24)yesnono
1433801n-alkyl(C10-C13)benzenesulphonic acidyesnono30
1534130alkyl, linear with even number of carbon atoms (C12-C20) dimethylaminesyesnoyes30
1634230alkyl(C8-C22)sulphonic acidsyesnono6
1734281alkyl(C8-C22)sulphuric acids, linear, primary with an even number of carbon atomsyesnono
1834475aluminium calcium hydroxide phosphite, hydrateyesnono
1939090N,N-bis(2-hydroxyethyl)alkyl(C8-C18)amineyesnono(7)
2039120N,N-bis(2-hydroxyethyl)alkyl(C8-C18)amine hydrochloridesyesnono(7)SML(T) expressed excluding HCl
2142500carbonic acid, saltsyesnono
2243200castor oil, mono- and diglyceridesyesnono
2343515chlorides of choline esters of coconut oil fatty acidsyesnono0,9(1)
2445280cotton fibersyesnono
2545440cresols, butylated, styrenatedyesnono12
26467005,7-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)yesnono5
27489609,10-dihydroxy stearic acid and its oligomersyesnono5
2850160di-n-octyltin bis(n-alkyl(C10-C16) mercaptoacetate)yesnono(10)
2950360di-n-octyltin bis(ethyl maleate)yesnono(10)
3050560di-n-octyltin 1,4-butanediol bis(mercaptoacetate)yesnono(10)
3150800di-n-octyltin dimaleate, esterifiedyesnono(10)
3250880di-n-octyltin dimaleate, polymers (n = 2-4)yesnono(10)
3351120di-n-octyltin thiobenzoate 2-ethylhexyl mercaptoacetateyesnono(10)
3454270ethylhydroxymethylcelluloseyesnono
3554280ethylhydroxypropylcelluloseyesnono
3654450fats and oils, from animal or vegetable food sourcesyesnono
3754480fats and oils, hydrogenated, from animal or vegetable food sourcesyesnono
3855520glass fibersyesnono
3955600glass microballsyesnono
4056360glycerol, esters with acetic acidyesnono
4156486glycerol, 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)yesnono
4256487glycerol, esters with butyric acidyesnono
4356490glycerol, esters with erucic acidyesnono
4456495glycerol, esters with 12-hydroxystearic acidyesnono
4556500glycerol, esters with lauric acidyesnono
4656510glycerol, esters with linoleic acidyesnono
4756520glycerol, esters with myristic acidyesnono
4856535glycerol, esters with nonanoic acidyesnono
4956540glycerol, esters with oleic acidyesnono
5056550glycerol, esters with palmitic acidyesnono
5156570glycerol, esters with propionic acidyesnono
5256580glycerol, esters with ricinoleic acidyesnono
5356585glycerol, esters with stearic acidyesnono
5457040glycerol monooleate, ester with ascorbic acidyesnono
5557120glycerol monooleate, ester with citric acidyesnono
5657200glycerol monopalmitate, ester with ascorbic acidyesnono
5757280glycerol monopalmitate, ester with citric acidyesnono
5857600glycerol monostearate, ester with ascorbic acidyesnono
5957680glycerol monostearate, ester with citric acidyesnono
6058300glycine, saltsyesnono
6264500lysine, saltsyesnono
6365440manganese pyrophosphiteyesnono
6466695methylhydroxymethylcelluloseyesnono
6567155mixture of 4-(2-benzoxazolyl)-4′-(5-methyl-2-benzoxazolyl)stilbene, 4,4′-bis(2-benzoxazolyl) stilbene and 4,4′-bis(5-methyl-2-benzoxazolyl)stilbeneyesnono

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 %).

6667600mono-n-octyltin tris(alkyl(C10-C16) mercaptoacetate)yesnono(11)
6767840montanic acids and/or their esters with ethyleneglycol and/or with 1,3-butanediol and/or with glycerolyesnono
6873160phosphoric acid, mono- and di-n-alkyl (C16 and C18) estersyesnoyes0,05
6974400phosphorous acid, tris(nonyl-and/or dinonylphenyl) esteryesnoyes30
7076463polyacrylic acid, saltsyesnono(22)
7176730polydimethylsiloxane, γ-hydroxypropylatedyesnono6
7276815polyester of adipic acid with glycerol or pentaerythritol, esters with even numbered, unbranched C12-C22 fatty acidsyesnono(32)The fraction with molecular weight below 1 000 Da should not exceed 5 % (w/w)
7376866polyesters 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-decanolyesnoyes

(31)

(32)

7477440polyethyleneglycol diricinoleateyesnoyes42
7577702polyethyleneglycol esters of aliph. monocarb. acids (C6-C22) and their ammonium and sodium sulphatesyesnono
7677732polyethylene glycol (EO = 1-30, typically 5) ether of butyl 2-cyano 3-(4-hydroxy-3-methoxyphenyl) acrylateyesnono0,05Only for use in PET
7777733polyethyleneglycol (EO = 1-30, typically 5) ether of butyl-2-cyano-3-(4-hydroxyphenyl) acrylateyesnono0,05Only for use in PET
7877897polyethyleneglycol (EO = 1-50) monoalkylether (linear and branched, C8-C20) sulphate, saltsyesnono5
7980640polyoxyalkyl (C2-C4) dimethylpolysiloxaneyesnono
8081760powders, flakes and fibres of brass, bronze, copper, stainless steel, tin, iron and alloys of copper, tin and ironyesnono
8183320propylhydroxyethylcelluloseyesnono
8283325propylhydroxymethylcelluloseyesnono
8383330propylhydroxypropylcelluloseyesnono
8485601silicates, natural (with the exception of asbestos)yesnono
8585610silicates, natural, silanated (with the exception of asbestos)yesnono
8686000silicic acid, silylatedyesnono
8786285silicon dioxide, silanatedyesnono
8886880sodium monoalkyl dialkylphenoxybenzenedisulphonateyesnono9
8989440stearic acid, esters with ethyleneglycolyesnono(2)
9092195taurine, saltsyesnono
9192320tetradecyl-polyethyleneglycol(EO = 3-8) ether of glycolic acidyesnoyes15
9293970tricyclodecanedimethanol bis(hexahydrophthalate)yesnono0,05
9395858waxes, paraffinic, refined, derived from petroleum based or synthetic hydrocarbon feedstocks, low viscosityyesnono0,05

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).

9495859waxes, refined, derived from petroleum based or synthetic hydrocarbon feedstocks, high viscosityyesnono

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).

9595883white mineral oils, paraffinic, derived from petroleum based hydrocarbon feedstocksyesnono

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).

9695920wood flour and fibers, untreatedyesnono
9772081/10petroleum hydrocarbon resins (hydrogenated)yesnono

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:

  • Viscosity at 120 °C: > 3 Pa.s,

  • Softening point: > 95 °C as determined by ASTM Method E 28-67,

  • Bromine number: < 40 (ASTM D1159),

  • The colour of a 50 % solution in toluene < 11 on the Gardner scale,

  • Residual aromatic monomer ≤ 50 ppm,

98172600000050-00-0formaldehydeyesyesno(15)
54880
99194600000050-21-5lactic acidyesyesno
62960
100244900000050-70-4sorbitolyesyesno
88320
101360000000050-81-7ascorbic acidyesnono
102175300000050-99-7glucosenoyesno
103181000000056-81-5glycerolyesyesno
55920
104589600000057-09-0hexadecyltrimethylammonium bromideyesnono6
105227800000057-10-3palmitic acidyesyesno
70400
106245500000057-11-4stearic acidyesyesno
89040
107259600000057-13-6ureanoyesno
108248800000057-50-1sucrosenoyesno
109237400000057-55-61,2-propanediolyesyesno
81840
11093520

0000059-02-9

0010191-41-0

α-tocopherolyesnono
111536000000060-00-4ethylenediaminetetraacetic acidyesnono
112640150000060-33-3linoleic acidyesnono
113167800000064-17-5ethanolyesyesno
52800
114550400000064-18-6formic acidyesnono
115100900000064-19-7acetic acidyesyesno
30000
116130900000065-85-0benzoic acidyesyesno
37600
117215500000067-56-1methanolnoyesno
118238300000067-63-02-propanolyesyesno
81882
119302950000067-64-1acetoneyesnono
120495400000067-68-5dimethyl sulphoxideyesnono
121242700000069-72-7salicylic acidyesyesno
84640
122238000000071-23-81-propanolnoyesno
123138400000071-36-31-butanolnoyesno
124228700000071-41-01-pentanolnoyesno
125169500000074-85-1ethylenenoyesno
126102100000074-86-2acetylenenoyesno
127260500000075-01-4vinyl chloridenoyesnoND1 mg/kg in final product
128100600000075-07-0acetaldehydenoyesno(1)
129170200000075-21-8ethylene oxidenoyesnoND1 mg/kg in final product(10)
130261100000075-35-4vinylidene chloridenoyesnoND(1)
131484600000075-37-61,1-difluoroethaneyesnono
132261400000075-38-7vinylidene fluoridenoyesno5
133143800000075-44-5carbonyl chloridenoyesnoND1 mg/kg in final product(10)
23155
134436800000075-45-6chlorodifluoromethaneyesnono6Content of chlorofluoromethane less than 1 mg/kg of the substance
135240100000075-56-9propylene oxidenoyesnoND1 mg/kg in final product
136416800000076-22-2camphoryesnono(3)
137665800000077-62-32,2′-methylenebis(4-methyl-6-(1-methylcyclohexyl)phenol)yesnoyes(5)
138937600000077-90-7tri-n-butyl acetyl citrateyesnono(32)
139146800000077-92-9citric acidyesyesno
44160
140446400000077-93-0citric acid, triethyl esteryesnono(32)
141133800000077-99-61,1,1-trimethylolpropaneyesyesno6
25600
94960
142263050000078-08-0vinyltriethoxysilanenoyesno0,05Only to be used as a surface treatment agent(1)
143624500000078-78-4isopentaneyesnono
144192430000078-79-52-methyl-1,3-butadienenoyesnoND1 mg/kg in final product
21640
145106300000079-06-1acrylamidenoyesnoND
146238900000079-09-4propionic acidyesyesno
82000
147106900000079-10-7acrylic acidnoyesno(22)
148146500000079-38-9chlorotrifluoroethylenenoyesnoND(1)
149199900000079-39-0methacrylamidenoyesnoND
150200200000079-41-4methacrylic acidnoyesno(23)
151134800000080-05-72,2-bis(4-hydroxyphenyl)propanenoyesno0,6
13607
152156100000080-07-94,4′-dichlorodiphenyl sulphonenoyesno0,05
153152670000080-08-04,4′-diaminodiphenyl sulphonenoyesno5
154136170000080-09-14,4′-dihydroxydiphenyl sulphonenoyesno0,05
16090
155234700000080-56-8α-pinenenoyesno
156211300000080-62-6methacrylic acid, methyl esternoyesno(23)
157748800000084-74-2phthalic acid, dibutyl esteryesnono0,3(32)

Only to be used as:

(a)

plasticiser in repeated use materials and articles contacting non-fatty foods;

(b)

technical support agent in polyolefins in concentrations up to 0,05 % in the final product.

(7)
158233800000085-44-9phthalic anhydrideyesyesno
76320
159745600000085-68-7phthalic acid, benzyl butyl esteryesnono30(32)

Only to be used as:

(a)

plasticiser in repeated use materials and articles;

(b)

plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae as defined by Directive 2006/141/EC or processed cereal-based foods and baby foods for infants and young children as defined by Directive 2006/125/EC;

(c)

technical support agent in concentrations up to 0,1 % in the final product.

(7)
160848000000087-18-3salicylic acid, 4-tert-butylphenyl esteryesnoyes12
161921600000087-69-4tartaric acidyesnono
162655200000087-78-5mannitolyesnono
163664000000088-24-42,2′-methylene bis(4-ethyl-6-tert-butylphenol)yesnoyes(13)
164348950000088-68-62-aminobenzamideyesnono0,05Only for use in PET for water and beverages
165232000000088-99-3 o-phthalic acidyesyesno
74480
166240570000089-32-7pyromellitic anhydridenoyesno0,05
167252400000091-08-72,6-toluene diisocyanatenoyesno(17)1 mg/kg in final product expressed as isocyanate moiety(10)
168130750000091-76-92,4-diamino-6-phenyl-1,3,5-triazinenoyesno5(1)
15310
169162400000091-97-43,3′-dimethyl-4,4′-diisocyanatobiphenylnoyesno(17)1 mg/kg in final product expressed as isocyanate moiety(10)
170160000000092-88-64,4′-dihydroxybiphenylnoyesno6
171380800000093-58-3benzoic acid, methyl esteryesnono
172378400000093-89-0benzoic acid, ethyl esteryesnono
173602400000094-13-34-hydroxybenzoic acid, propyl esteryesnono
174147400000095-48-7 o-cresolnoyesno
175200500000096-05-9methacrylic acid, allyl esternoyesno0,05
176117100000096-33-3acrylic acid, methyl esternoyesno(22)
177169550000096-49-1ethylene carbonatenoyesno30

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.

178928000000096-69-54,4′-thiobis(6-tert-butyl-3-methylphenol)yesnoyes0,48
179488000000097-23-42,2′-dihydroxy-–5,5′-dichlorodiphenylmethaneyesnoyes12
180171600000097-53-0eugenolnoyesnoND
181208900000097-63-2methacrylic acid, ethyl esternoyesno(23)
182192700000097-65-4itaconic acidnoyesno
183210100000097-86-9methacrylic acid, isobutyl esternoyesno(23)
184201100000097-88-1methacrylic acid, butyl esternoyesno(23)
185204400000097-90-5methacrylic acid, diester with ethyleneglycolnoyesno0,05
186140200000098-54-44-tert-butylphenolnoyesno0,05
187222100000098-83-9α-methylstyrenenoyesno0,05
188191800000099-63-8isophthalic acid dichloridenoyesno(27)
189602000000099-76-34-hydroxybenzoic acid, methyl esteryesnono
190188800000099-96-7 p-hydroxybenzoic acidnoyesno
191249400000100-20-9terephthalic acid dichloridenoyesno(28)
19223187phthalic acidnoyesno(28)
193246100000100-42-5styrenenoyesno
194131500000100-51-6benzyl alcoholnoyesno
195373600000100-52-7benzaldehydeyesnono(3)
196186700000100-97-0hexamethylenetetramineyesyesno(15)
59280
197202600000101-43-9methacrylic acid, cyclohexyl esternoyesno0,05
198166300000101-68-8diphenylmethane-4,4′-diisocyanatenoyesno(17)1 mg/kg in final product expressed as isocyanate moiety(10)
199240730000101-90-6resorcinol diglycidyl ethernoyesnoND

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)
200516800000102-08-9N,N′-diphenylthioureayesnoyes3
201165400000102-09-0diphenyl carbonatenoyesno0,05
202230700000102-39-6(1,3-phenylenedioxy)diacetic acidnoyesno0,05(1)
203133230000102-40-91,3-bis(2-hydroxyethoxy)benzenenoyesno0,05
204251800000102-60-3N,N,N′,N′-tetrakis(2-hydroxypropyl)ethylenediamineyesyesno
92640
205253850000102-70-5triallylaminenoyesno

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.

206115000000103-11-7acrylic acid, 2-ethylhexyl esternoyesno0,05
207319200000103-23-1adipic acid, bis(2-ethylhexyl) esteryesnoyes18(32)(2)
208188980000103-90-2N-(4-hydroxyphenyl) acetamidenoyesno0,05
209170500000104-76-72-ethyl-1-hexanolnoyesno30
210133900000105-08-81,4-bis(hydroxymethyl)cyclohexanenoyesno
14880
211239200000105-38-4propionic acid, vinyl esternoyesno(1)
212142000000105-60-2caprolactamyesyesno(4)
41840
213824000000105-62-41,2-propyleneglycol dioleateyesnono
214618400000106-14-912-hydroxystearic acidyesnono
215141700000106-31-0butyric anhydridenoyesno
216147700000106-44-5 p-cresolnoyesno
217155650000106-46-71,4-dichlorobenzenenoyesno12
218115900000106-63-8acrylic acid, isobutyl esternoyesno(22)
219145700000106-89-8epichlorohydrinnoyesnoND1 mg/kg in final product(10)
16750
220205900000106-91-2methacrylic acid, 2,3-epoxypropyl esternoyesno0,02(10)
221405700000106-97-8butaneyesnono
222138700000106-98-91-butenenoyesno
223136300000106-99-0butadienenoyesnoND1 mg/kg in final product
224139000000107-01-72-butenenoyesno
225121000000107-13-1acrylonitrilenoyesnoND
226152720000107-15-3ethylenediaminenoyesno12
16960
227169900000107-21-1ethyleneglycolyesyesno(2)
53650
228136900000107-88-01,3-butanediolnoyesno
229141400000107-92-6butyric acidnoyesno
230161500000108-01-0dimethylaminoethanolnoyesno18
231101200000108-05-4acetic acid, vinyl esternoyesno12
232101500000108-24-7acetic anhydrideyesyesno
30280
233248500000108-30-5succinic anhydridenoyesno
234199600000108-31-6maleic anhydridenoyesno(3)
235147100000108-39-4 m-cresolnoyesno
236230500000108-45-21,3-phenylenediaminenoyesnoND
237159100000108-46-31,3-dihydroxybenzenenoyesno2,4
24072
238180700000108-55-4glutaric anhydridenoyesno
239199750000108-78-12,4,6-triamino-1,3,5-triazineyesyesno30
25420
93720
240457600000108-91-8cyclohexylamineyesnono
241229600000108-95-2phenolnoyesno
242853600000109-43-3sebacic acid, dibutyl esteryesnono(32)
243190600000109-53-5isobutyl vinyl ethernoyesno0,05(10)
244717200000109-66-0pentaneyesnono
245229000000109-67-11-pentenenoyesno5
246251500000109-99-9tetrahydrofurannoyesno0,6
247248200000110-15-6succinic acidyesyesno
90960
248195400000110-16-7maleic acidyesyesno(3)
64800
249172900000110-17-8fumaric acidyesyesno
55120
250535200000110-30-5N,N′-ethylenebisstearamideyesnono
251533600000110-31-6N,N′-ethylenebisoleamideyesnono
252872000000110-44-1sorbic acidyesnono
253152500000110-60-11,4-diaminobutanenoyesno
254137200000110-63-41,4-butanediolyesyesno(30)
40580
255259000000110-88-3trioxanenoyesno5
256180100000110-94-1glutaric acidyesyesno
55680
257135500000110-98-5dipropyleneglycolyesyesno
16660
51760
258704800000111-06-8palmitic acid, butyl esteryesnono
259587200000111-14-8heptanoic acidyesnono
260242800000111-20-6sebacic acidnoyesno
261157900000111-40-0diethylenetriaminenoyesno5
262352840000111-41-1N-(2-aminoethyl)ethanolamineyesnono0,05

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.

263133260000111-46-6diethyleneglycolyesyesno(2)
15760
47680
264226600000111-66-01-octenenoyesno15
265226000000111-87-51-octanolnoyesno
266255100000112-27-6triethyleneglycolyesyesno
94320
267151000000112-30-11-decanolnoyesno
268167040000112-41-41-dodecenenoyesno0,05
269250900000112-60-7tetraethyleneglycolyesyesno
92350
270227630000112-80-1oleic acidyesyesno
69040
271527200000112-84-5erucamideyesnono
272370400000112-85-6behenic acidyesnono
273527300000112-86-7erucic acidyesnono
274225700000112-96-9octadecyl isocyanatenoyesno(17)1 mg/kg in final product expressed as isocyanate moiety(10)
275239800000115-07-1propylenenoyesno
276190000000115-11-7isobutenenoyesno
277182800000115-27-5hexachloroendomethylenetetrahydrophthalic anhydridenoyesnoND
278182500000115-28-6hexachloroendomethylenetetrahydrophthalic acidnoyesnoND
279228400000115-77-5pentaerythritolyesyesno
71600
280737200000115-96-8phosphoric acid, trichloroethyl esteryesnonoND
281251200000116-14-3tetrafluoroethylenenoyesno0,05
282184300000116-15-4hexafluoropropylenenoyesnoND
283746400000117-81-7phthalic acid, bis(2-ethylhexyl) esteryesnono1,5(32)

Only to be used as:

(a)

plasticiser in repeated use materials and articles contacting non-fatty foods;

(b)

technical support agent in concentrations up to 0,1 % in the final product.

(7)
284848800000119-36-8salicylic acid, methyl esteryesnono30
285664800000119-47-12,2′-methylene bis(4-methyl-6-tert-butylphenol)yesnoyes(13)
286382400000119-61-9benzophenoneyesnoyes0,6
287601600000120-47-84-hydroxybenzoic acid, ethyl esteryesnono
288249700000120-61-6terephthalic acid, dimethyl esternoyesno
289158800000120-80-91,2-dihydroxybenzenenoyesno6
24051
290553600000121-79-9gallic acid, propyl esteryesnono(20)
291191500000121-91-5isophthalic acidnoyesno(27)
292945600000122-20-3triisopropanolamineyesnono5
293231750000122-52-1phosphorous acid, triethyl esternoyesnoND1 mg/kg in final product(1)
294931200000123-28-4thiodipropionic acid, didodecyl esteryesnoyes(14)
295159400000123-31-91,4-dihydroxybenzeneyesyesno0,6
18867
48620
296238600000123-38-6propionaldehydenoyesno
297239500000123-62-6propionic anhydridenoyesno
298141100000123-72-8butyraldehydenoyesno
299638400000123-76-2levulinic acidyesnono
300300450000123-86-4acetic acid, butyl esteryesnono
301891200000123-95-5stearic acid, butyl esteryesnono
302128200000123-99-9azelaic acidnoyesno
303121300000124-04-9adipic acidyesyesno
31730
304143200000124-07-2caprylic acidyesyesno
41960
305152740000124-09-4hexamethylenediaminenoyesno2,4
18460
306889600000124-26-5stearamideyesnono
307421600000124-38-9carbon dioxideyesnono
308912000000126-13-6sucrose acetate isobutyrateyesnono
309913600000126-14-7sucrose octaacetateyesnono
310163900000126-30-72,2-dimethyl-1,3-propanediolnoyesno0,05
22437
311164800000126-58-9dipentaerythritolyesyesno
51200
312214900000126-98-7methacrylonitrilenoyesnoND
313166500000127-63-9diphenyl sulphoneyesyesno3
51570
314235000000127-91-3β-pinenenoyesno
315466400000128-37-02,6-di-tert-butyl-p-cresolyesnono3
316232300000131-17-9phthalic acid, diallyl esternoyesnoND
317488800000131-53-32,2′-dihydroxy-4-methoxybenzophenoneyesnoyes(8)
318486400000131-56-62,4-dihydroxybenzophenoneyesnono(8)
319613600000131-57-72-hydroxy-4-methoxybenzophenoneyesnoyes(8)
320376800000136-60-7benzoic acid, butyl esteryesnono
321360800000137-66-6ascorbyl palmitateyesnono
322630400000138-22-7lactic acid, butyl esteryesnono
323114700000140-88-5acrylic acid, ethyl esternoyesno(22)
324837000000141-22-0ricinoleic acidyesnoyes42
325107800000141-32-2acrylic acid, n-butyl esternoyesno(22)
326127630000141-43-52-aminoethanolyesyesno0,05

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
327301400000141-78-6acetic acid, ethyl esteryesnono
328650400000141-82-2malonic acidyesnono
329593600000142-62-1hexanoic acidyesnono
330194700000143-07-7lauric acidyesyesno
63280
331224800000143-08-81-nonanolnoyesno
332697600000143-28-2oleyl alcoholyesnono
333227750000144-62-7oxalic acidyesyesno6
69920
334170050000151-56-4ethyleneiminenoyesnoND
335689600000301-02-0oleamideyesnono
336150950000334-48-5n-decanoic acidyesyesno
45940
337158200000345-92-64,4′-difluorobenzophenonenoyesno0,05
338710200000373-49-9palmitoleic acidyesnono
339861600000409-21-2silicon carbideyesnono
340474400000461-58-5dicyanodiamideyesnono
341131800000498-66-8bicyclo[2.2.1]hept-2-enenoyesno0,05
22550
342142600000502-44-3caprolactonenoyesno(29)
343237700000504-63-21,3-propanediolnoyesno0,05
344138100000505-65-71,4-butanediol formalnoyesnoND(10)
21821
345358400000506-30-9arachidic acidyesnono
346100300000514-10-3abietic acidnoyesno
347130500000528-44-9trimellitic acidnoyesno(21)
25540
348223500000544-63-8myristic acidyesyesno
67891
349255500000552-30-7trimellitic anhydridenoyesno(21)
350639200000557-59-5lignoceric acidyesnono
351217300000563-45-13-methyl-1-butenenoyesnoNDOnly to be used in polypropylene(1)
352163600000576-26-12,6-dimethylphenolnoyesno0,05
353424800000584-09-8carbonic acid, rubidium saltyesnono12
354252100000584-84-92,4-toluene diisocyanatenoyesno(17)1 mg/kg in final product expressed as isocyanate moiety(10)
355201700000585-07-9methacrylic acid, tert-butyl esternoyesno(23)
356188200000592-41-61-hexenenoyesno3
357139320000598-32-33-buten-2-olnoyesnoNDOnly to be used as a co-monomer for the preparation of polymeric additive(1)
358148410000599-64-44-cumylphenolnoyesno0,05
359159700000611-99-44,4′-dihydroxybenzophenoneyesyesno(8)
48720
360579200000620-67-7glycerol triheptanoateyesnono
361187000000629-11-81,6-hexanediolnoyesno0,05
362143500000630-08-0carbon monoxidenoyesno
363164500000646-06-01,3-dioxolanenoyesno5
364154040000652-67-51,4:3,6-dianhydrosorbitolnoyesno5Only to be used as a co-monomer in poly(ethylene-co-isosorbide terephthalate)
365116800000689-12-3acrylic acid, isopropyl esternoyesno(22)
366221500000691-37-24-methyl-1-pentenenoyesno0,05
367166970000693-23-2n-dodecanedioic acidnoyesno
368932800000693-36-7thiodipropionic acid, dioctadecyl esteryesnoyes(14)
369127610000693-57-212-aminododecanoic acidnoyesno0,05
370214600000760-93-0methacrylic anhydridenoyesno(23)
371115100000818-61-1acrylic acid, monoester with ethyleneglycolnoyesno(22)
11830
372186400000822-06-0hexamethylene diisocyanatenoyesno(17)1 mg/kg in final product expressed as isocyanate moiety(10)
373223900000840-65-32,6-naphthalenedicarboxylic acid, dimethyl esternoyesno0,05
374211900000868-77-9methacrylic acid, monoester with ethyleneglycolnoyesno(23)
375151300000872-05-91-decenenoyesno0,05
376669050000872-50-4N-methylpyrrolidoneyesnono
377127860000919-30-23-aminopropyltriethoxysilanenoyesno0,05

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.

378219700000923-02-4N-methylolmethacrylamidenoyesno0,05
379219400000924-42-5N-methylolacrylamidenoyesnoND
380119800000925-60-0acrylic acid, propyl esternoyesno(22)
381150300000931-88-4cyclooctenenoyesno0,05Only to be used in polymers contacting foods for which simulant A is laid down
382194900000947-04-6laurolactamnoyesno5
383721600000948-65-22-phenylindoleyesnoyes15
384400000000991-84-42,4-bis(octylmercapto)-6-(4-hydroxy-3,5-di-tert-butylanilino)-1,3,5-triazineyesnoyes30
385115300000999-61-1acrylic acid, 2-hydroxypropyl esternoyesno0,05

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)
386552800001034-01-1gallic acid, octyl esteryesnono(20)
387261550001072-63-51-vinylimidazolenoyesno0,05(1)
388250800001120-36-11-tetradecenenoyesno0,05
389223600001141-38-42,6-naphthalenedicarboxylic acidnoyesno5
390552000001166-52-5gallic acid, dodecyl esteryesnono(20)
391229320001187-93-5perfluoromethyl perfluorovinyl ethernoyesno0,05Only to be used in anti-stick coatings
392728000001241-94-7phosphoric acid, diphenyl 2-ethylhexyl esteryesnoyes2,4
393372800001302-78-9bentoniteyesnono
394412800001305-62-0calcium hydroxideyesnono
395415200001305-78-8calcium oxideyesnono
396646400001309-42-8magnesium hydroxideyesnono
397647200001309-48-4magnesium oxideyesnono
398357600001309-64-4antimony trioxideyesnono0,04SML expressed as antimony(6)
399816000001310-58-3potassium hydroxideyesnono
400867200001310-73-2sodium hydroxideyesnono
401244750001313-82-2sodium sulphidenoyesno
402962400001314-13-2zinc oxideyesnono
403963200001314-98-3zinc sulphideyesnono
404672000001317-33-5molybdenum disulphideyesnono
405166900001321-74-0divinylbenzenenoyesnoND

SML expressed as the sum of divinylbenzene and ethylvinylbenzene.

It may contain up to 45 % (m/m) of ethylvinylbenzene.

(1)
406833000001323-39-31,2-propyleneglycol monostearateyesnono
407870400001330-43-4sodium tetraborateyesnono(16)
408829600001330-80-91,2-propyleneglycol monooleateyesnono
409622400001332-37-2iron oxideyesnono
410627200001332-58-7kaolinyesnono
411420800001333-86-4carbon blackyesnono

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.

412452000001335-23-5copper iodideyesnono(6)
413356000001336-21-6ammonium hydroxideyesnono
414876000001338-39-2sorbitan monolaurateyesnono
415878400001338-41-6sorbitan monostearateyesnono
416876800001338-43-8sorbitan monooleateyesnono
417856800001343-98-2silicic acidyesnono
418347200001344-28-1aluminium oxideyesnono
419921500001401-55-4tannic acidsyesnonoAccording to the JECFA specifications
420192100001459-93-4isophthalic acid, dimethyl esternoyesno0,05
421130000001477-55-01,3-benzenedimethanaminenoyesno0,05
422385150001533-45-54,4′-bis(2-benzoxazolyl)stilbeneyesnoyes0,05(2)
423229370001623-05-8perfluoropropylperfluorovinyl ethernoyesno0,05
424150700001647-16-11,9-decadienenoyesno0,05
425108400001663-39-4acrylic acid, tert-butyl esternoyesno(22)
426135100001675-54-32,2-bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ethernoyesnoIn compliance with Commission Regulation (EC) No 1895/2005a
13610
427188960001679-51-24-(hydroxymethyl)-1-cyclohexenenoyesno0,05
428952000001709-70-21,3,5-trimethyl-2,4,6-tris(3,5-di-tert-butyl-4-hydroxybenzyl)benzeneyesnono
429132100001761-71-3bis(4-aminocyclohexyl)methanenoyesno0,05
430956000001843-03-41,1,3-tris(2-methyl-4-hydroxy-5-tert-butylphenyl) butaneyesnoyes5
431616000001843-05-62-hydroxy-4-n-octyloxybenzophenoneyesnoyes(8)
432122800002035-75-8adipic anhydridenoyesno
433683200002082-79-3octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionateyesnoyes6
434204100002082-81-7methacrylic acid, diester with 1,4-butanediolnoyesno0,05
435142300002123-24-2caprolactam, sodium saltnoyesno(4)
436194800002146-71-6lauric acid, vinyl esternoyesno
437112450002156-97-0acrylic acid, dodecyl esternoyesno0,05(2)
438388750002162-74-5bis(2,6-diisopropylphenyl) carbodiimideyesnono0,05For indirect food contact only, behind a PET layer
439212800002177-70-0methacrylic acid, phenyl esternoyesno(23)
440213400002210-28-8methacrylic acid, propyl esternoyesno(23)
441381600002315-68-6benzoic acid, propyl esteryesnono
442137800002425-79-81,4-butanediol bis(2,3-epoxypropyl)ethernoyesnoND

Residual content = 1 mg/kg in final product expressed as epoxygroup.

Molecular weight is 43 Da.

(10)
443127880002432-99-711-aminoundecanoic acidnoyesno5
444614400002440-22-42-(2′-hydroxy-5′-methylphenyl)benzotriazoleyesnono(12)
445834400002466-09-3pyrophosphoric acidyesnono
446107500002495-35-4acrylic acid, benzyl esternoyesno(22)
447200800002495-37-6methacrylic acid, benzyl esternoyesno(23)
448118900002499-59-4acrylic acid, n-octyl esternoyesno(22)
449498400002500-88-1dioctadecyl disulphideyesnoyes3
450244300002561-88-8sebacic anhydridenoyesno
451667550002682-20-42-methyl-4-isothiazolin-3-oneyesnono0,5Only to be used in aqueous polymer dispersions and emulsions
452388850002725-22-62,4-bis(2,4-dimethylphenyl)-6-(2-hydroxy-4-n-octyloxyphenyl)-1,3,5-triazineyesnono0,05Only to be used in aqueous foods
453263200002768-02-7vinyltrimethoxysilanenoyesno0,05(10)
454126700002855-13-21-amino-3-aminomethyl-3,5,5-trimethylcyclohexanenoyesno6
455205300002867-47-2methacrylic acid, 2-(dimethylamino)-ethyl esternoyesnoND
456108100002998-08-5acrylic acid, sec-butyl esternoyesno(22)
457201400002998-18-7methacrylic acid, sec-butyl esternoyesno(23)
458369600003061-75-4behenamideyesnono
459468700003135-18-03,5-di-tert-butyl-4-hydroxybenzylphosphonic acid, dioctadecyl esteryesnono
460149500003173-53-3cyclohexyl isocyanatenoyesno(17)1 mg/kg in final product expressed as isocyanate moiety(10)
461224200003173-72-61,5-naphthalene diisocyanatenoyesno(17)1 mg/kg in final product expressed as isocyanate moiety(10)
462261700003195-78-6N-vinyl-N-methylacetamidenoyesno0,02(1)
463258400003290-92-41,1,1-trimethylolpropane trimethacrylatenoyesno0,05
464612800003293-97-82-hydroxy-4-n-hexyloxybenzophenoneyesnoyes(8)
465680400003333-62-87-[2H-naphtho-(1,2-D)triazol-2-yl]-3-phenylcoumarinyesnono
466506400003648-18-8di-n-octyltin dilaurateyesnono(10)
467148000003724-65-0crotonic acidyesyesno0,05(1)
45600
468719600003825-26-1perfluorooctanoic acid, ammonium saltyesnonoOnly to be used in repeated use articles, sintered at high temperatures
469604800003864-99-12-(2′-hydroxy-3,5′-di-tert-butylphenyl)-5-chlorobenzotriazoleyesnoyes(12)
470604000003896-11-52-(2′-hydroxy-3′-tert-butyl-5′-methylphenyl)-5-chlorobenzotriazoleyesnoyes(12)
471248880003965-55-75-sulphoisophthalic acid, monosodium salt, dimethyl esternoyesno0,05
472665600004066-02-82,2′-methylenebis(4-methyl-6-cyclohexylphenol)yesnoyes(5)
473122650004074-90-2adipic acid, divinyl esternoyesnoND

5 mg/kg in final product.

Only to be used as co-monomer.

(1)
474436000004080-31-31-(3-chloroallyl)-3,5,7-triaza-1-azoniaadamantane chlorideyesnono0,3
475191100004098-71-91-isocyanato-3-isocyanatomethyl-3,5,5-trimethylcyclohexanenoyesno(17)1 mg/kg in final product expressed as isocyanate moiety(10)
476165700004128-73-8diphenylether-4,4′-diisocyanatenoyesno(17)1 mg/kg in final product expressed as isocyanate moiety(10)
477467200004130-42-12,6-di-tert-butyl-4-ethylphenolyesnoyes4,8(1)
478601800004191-73-54-hydroxybenzoic acid, isopropyl esteryesnono
479129700004196-95-6azelaic anhydridenoyesno
480467900004221-80-13,5-di-tert-butyl-4-hydroxybenzoic acid, 2,4-di-tert-butylphenyl esteryesnono
481130600004422-95-11,3,5-benzenetricarboxylic acid trichloridenoyesno0,05SML expressed as 1,3,5-benzenetricarboxylic acid(1)
482211000004655-34-9methacrylic acid, isopropyl esternoyesno(23)
483688600004724-48-5n-octylphosphonic acidyesnono0,05
484133950004767-03-72,2-bis(hydroxymethyl)propionic acidnoyesno0,05(1)
485135600005124-30-1dicyclohexylmethane-4,4′-diisocyanatenoyesno(17)1 mg/kg in final product expressed as isocyanate moiety(10)
15700
486540050005136-44-7ethylene-N-palmitamide-N′-stearamideyesnono
487456400005232-99-52-cyano-3,3-diphenylacrylic acid, ethyl esteryesnono0,05
488534400005518-18-3N,N′-ethylenebispalmitamideyesnono
489410400005743-36-2calcium butyrateyesnono
490166000005873-54-1diphenylmethane-2,4′-diisocyanatenoyesno(17)1 mg/kg in final product expressed as isocyanate moiety(10)
491827200006182-11-21,2-propyleneglycol distearateyesnono
492456500006197-30-42-cyano-3,3-diphenylacrylic acid, 2-ethylhexyl esteryesnono0,05
493392000006200-40-4bis(2-hydroxyethyl)-2-hydroxypropyl-3-(dodecyloxy)methylammonium chlorideyesnono1,8
494621400006303-21-5hypophosphorous acidyesnono
495351600006642-31-56-amino-1,3-dimethyluracilyesnono5
496716800006683-19-8pentaerythritol tetrakis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)-propionate]yesnono
497950200006846-50-02,2,4-trimethyl-1,3-pentanediol diisobutyrateyesnono5Only to be used in single-use gloves
498162100006864-37-53,3′-dimethyl-4,4′-diaminodicyclohexylmethanenoyesno0,05Only to be used in polyamides(5)
499199650006915-15-7malic acidyesyesnoIn 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
500385600007128-64-52,5-bis(5-tert-butyl-2-benzoxazolyl)thiopheneyesnoyes0,6
50134480aluminium fibers, flakes and powdersyesnono
502227780007456-68-04,4′-oxybis(benzenesulphonyl azide)noyesno0,05(1)
503460800007585-39-9β-dextrinyesnono
504862400007631-86-9silicon dioxideyesnonoFor 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.
505864800007631-90-5sodium bisulphiteyesnono(19)
506869200007632-00-0sodium nitriteyesnono0,6
507599900007647-01-0hydrochloric acidyesnono
508865600007647-15-6sodium bromideyesnono
509231700007664-38-2phosphoric acidyesyesno
72640
510127890007664-41-7ammoniayesyesno
35320
511919200007664-93-9sulphuric acidyesnono
512816800007681-11-0potassium iodideyesnono(6)
513868000007681-82-5sodium iodideyesnono(6)
514918400007704-34-9sulphuryesnono
515263600007732-18-5wateryesyesnoIn compliance with Directive 98/83/ECb
95855
516869600007757-83-7sodium sulphiteyesnono(19)
517815200007758-02-3potassium bromideyesnono
518358450007771-44-0arachidonic acidyesnono
519871200007772-98-7sodium thiosulphateyesnono(19)
520651200007773-01-5manganese chlorideyesnono
521583200007782-42-5graphiteyesnono
522145300007782-50-5chlorinenoyesno
523451950007787-70-4copper bromideyesnono
524245200008001-22-7soybean oilnoyesno
525626400008001-39-6japan waxyesnono
526434400008001-75-0ceresinyesnono
527144110008001-79-4castor oilyesyesno
42880
528637600008002-43-5lecithinyesnono
529678500008002-53-7montan waxyesnono
530417600008006-44-8candelilla waxyesnono
531368800008012-89-3beeswaxyesnono
532886400008013-07-8soybean oil, epoxidisedyesnono

60

30(*)

(32)
(*)In the case of PVC gaskets used to seal glass jars containing infant formulae and follow-on formulae as defined by Directive 2006/141/EC or processed cereal-based foods and baby foods for infants and young children as defined by Directive 2006/125/EC, the SML is lowered to 30 mg/kg.

Oxirane < 8 %, iodine number < 6.

533427200008015-86-9carnauba waxyesnono
534807200008017-16-1polyphosphoric acidsyesnono
535241000008050-09-7rosinyesyesno
24130
24190
83840
536843200008050-15-5rosin, hydrogenated, ester with methanolyesnono
537840800008050-26-8rosin, ester with pentaerythritolyesnono
538840000008050-31-5rosin, ester with glycerolyesnono
539241600008052-10-6rosin tall oilnoyesno
540639400008062-15-5lignosulphonic acidyesnono0,24Only to be used as dispersant for plastics dispersions
541584800009000-01-5gum arabicyesnono
542426400009000-11-7carboxymethylcelluloseyesnono
543459200009000-16-2dammaryesnono
544584000009000-30-0guar gumyesnono
545936800009000-65-1tragacanth gumyesnono
546714400009000-69-5pectinyesnono
547554400009000-70-8gelatinyesnono
548428000009000-71-9caseinyesnono
549800000009002-88-4polyethylene waxyesnono
550810600009003-07-0polypropylene waxyesnono
55179920

0009003-11-6

0106392-12-5

poly(ethylene propylene) glycolyesnono
552815000009003-39-8polyvinylpyrrolidoneyesnonoThe substance shall meet the purity criteria as laid down in Commission Directive 2008/84/ECc
553145000009004-34-6celluloseyesyesno
43280
554433000009004-36-8cellulose acetate butyrateyesnono
555532800009004-57-3ethylcelluloseyesnono
556542600009004-58-4ethylhydroxyethylcelluloseyesnono
557666400009004-59-5methylethylcelluloseyesnono
558605600009004-62-0hydroxyethylcelluloseyesnono
559616800009004-64-2hydroxypropylcelluloseyesnono
560667000009004-65-3methylhydroxypropylcelluloseyesnono
561662400009004-67-5methylcelluloseyesnono
562224500009004-70-0nitrocellulosenoyesno
563783200009004-97-1polyethyleneglycol monoricinoleateyesnoyes42
564245400009005-25-8starch, edibleyesyesno
88800
565611200009005-27-0hydroxyethyl starchyesnono
566333500009005-32-7alginic acidyesnono
567820800009005-37-21,2-propyleneglycol alginateyesnono
568790400009005-64-5polyethyleneglycol sorbitan monolaurateyesnono
569791200009005-65-6polyethyleneglycol sorbitan monooleateyesnono
570792000009005-66-7polyethyleneglycol sorbitan monopalmitateyesnono
571792800009005-67-8polyethyleneglycol sorbitan monostearateyesnono
572793600009005-70-3polyethyleneglycol sorbitan trioleateyesnono
573794400009005-71-4polyethyleneglycol sorbitan tristearateyesnono
574242500009006-04-6rubber, naturalyesyesno
84560
575767210063148-62-9polydimethylsiloxane (Mw > 6 800 Da)yesnonoViscosity at 25 °C not less than 100 cSt (100 × 10-6 m2/s)
576608800009032-42-2hydroxyethylmethylcelluloseyesnono
577622800009044-17-1isobutylene-butene copolymeryesnono
578796000009046-01-9polyethyleneglycol tridecyl ether phosphateyesnono5

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.

579618000009049-76-7hydroxypropyl starchyesnono
580460700010016-20-3α-dextrinyesnono
581368000010022-31-8barium nitrateyesnono
582502400010039-33-5di-n-octyltin bis(2-ethylhexyl maleate)yesnono(10)
583404000010043-11-5boron nitrideyesnono(16)
584136200010043-35-3boric acidyesyesno(16)
40320
585411200010043-52-4calcium chlorideyesnono
586652800010043-84-2manganese hypophosphiteyesnono
587684000010094-45-8octadecylerucamideyesnoyes5
588643200010377-51-2lithium iodideyesnono(6)
589526450010436-08-5cis-11-eicosenamideyesnono
590213700010595-80-9methacrylic acid, 2-sulphoethyl esternoyesnoND(1)
591361600010605-09-1ascorbyl stearateyesnono
592346900011097-59-9aluminium magnesium carbonate hydroxideyesnono
593449600011104-61-3cobalt oxideyesnono
594653600011129-60-5manganese oxideyesnono
595195100011132-73-3lignocellulosenoyesno
596959350011138-66-2xanthan gumyesnono
597671200012001-26-2micayesnono
59841600

0012004-14-7

0037293-22-4

calcium sulphoaluminateyesnono
599368400012007-55-5barium tetraborateyesnono(16)
600600300012072-90-1hydromagnesiteyesnono
601354400012124-97-9ammonium bromideyesnono
602702400012198-93-5ozokeriteyesnono
603834600012269-78-2pyrophylliteyesnono
604600800012304-65-3hydrotalciteyesnono
605110050012542-30-2acrylic acid, dicyclopentenyl esternoyesno0,05(1)
606652000012626-88-9manganese hydroxideyesnono
607622450012751-22-3iron phosphideyesnonoOnly to be used in PET polymers and copolymers
608408000013003-12-84,4′-butylidene-bis(6-tert-butyl-3-methylphenyl-ditridecyl phosphite)yesnoyes6
609834550013445-56-2pyrophosphorous acidyesnono
610934400013463-67-7titanium dioxideyesnono
611351200013560-49-13-aminocrotonic acid, diester with thiobis (2-hydroxyethyl) etheryesnono
612166940013811-50-2N,N′-divinyl-2-imidazolidinonenoyesno0,05(10)
613959050013983-17-0wollastoniteyesnono
614455600014464-46-1cristobaliteyesnono
615920800014807-96-6talcyesnono
616834700014808-60-7quartzyesnono
617106600015214-89-82-acrylamido-2-methylpropanesulphonic acidnoyesno0,05
618510400015535-79-2di-n-octyltin mercaptoacetateyesnono(10)
619503200015571-58-1di-n-octyltin bis(2-ethylhexyl mercaptoacetate)yesnono(10)
620507200015571-60-5di-n-octyltin dimaleateyesnono(10)
621171100016219-75-35-ethylidenebicyclo[2,2,1]hept-2-enenoyesno0,05(9)
622698400016260-09-6oleylpalmitamideyesnoyes5
623526400016389-88-1dolomiteyesnono
624188970016712-64-46-hydroxy-2-naphthalenecarboxylic acidnoyesno0,05
625367200017194-00-2barium hydroxideyesnono
626578000018641-57-1glycerol tribehenateyesnono
627597600019569-21-2huntiteyesnono
628961900020427-58-1zinc hydroxideyesnono
629345600021645-51-2aluminium hydroxideyesnono
630822400022788-19-81,2-propyleneglycol dilaurateyesnono
631591200023128-74-71,6-hexamethylene-bis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionamide)yesnoyes45
632528800023676-09-74-ethoxybenzoic acid, ethyl esteryesnono3,6
633532000023949-66-82-ethoxy-2′-ethyloxanilideyesnoyes30
634259100024800-44-0tripropyleneglycolnoyesno
635407200025013-16-5tert-butyl-4-hydroxyanisoleyesnono30
636315000025134-51-4acrylic acid, acrylic acid, 2-ethylhexyl ester, copolymeryesnono0,05(22)SML expressed as acrylic acid, 2-ethylhexyl ester
637716350025151-96-6pentaerythritol dioleateyesnono0,05Not to be used for articles in contact with fatty foods for which simulant D is laid down
638235900025322-68-3polyethyleneglycolyesyesno
76960
639236510025322-69-4polypropyleneglycolyesyesno
80800
640549300025359-91-5formaldehyde-1-naphthol, copolymeryesnono0,05
641223310025513-64-8mixture of (35-45 % w/w) 1,6-diamino-2,2,4-trimethylhexane and (55-65 % w/w)1,6-diamino-2,4,4-trimethylhexanenoyesno0,05(10)
642649900025736-61-2maleic anhydride-styrene, copolymer, sodium saltyesnonoThe fraction with molecular weight below 1 000 Da should not exceed 0,05 % (w/w)
643877600026266-57-9sorbitan monopalmitateyesnono
644880800026266-58-0sorbitan trioleateyesnono
645677600026401-86-5mono-n-octyltin tris(isooctyl mercaptoacetate)yesnono(11)
646504800026401-97-8di-n-octyltin bis(isooctyl mercaptoacetate)yesnono(10)
647567200026402-23-3glycerol monohexanoateyesnono
648568800026402-26-6glycerol monooctanoateyesnono
649472100026427-07-6dibutylthiostannoic acid polymeryesnonoMolecular unit = (C8H18S3Sn2)n (n = 1,5-2)
650496000026636-01-1dimethyltin bis(isooctyl mercaptoacetate)yesnono(9)
651882400026658-19-5sorbitan tristearateyesnono
652388200026741-53-7bis(2,4-di-tert-butylphenyl) pentaerythritol diphosphiteyesnoyes0,6
653252700026747-90-02,4-toluene diisocyanate dimernoyesno(17)1 mg/kg in final product expressed as isocyanate moiety(10)
654886000026836-47-5sorbitol monostearateyesnono
655254500026896-48-0tricyclodecanedimethanolnoyesno0,05
656247600026914-43-2styrenesuphonic acidnoyesno0,05
657676800027107-89-7mono-n-octyltin tris(2-ethylhexyl mercaptoacetate)yesnono(11)
658520000027176-87-0dodecylbenzenesulphonic acidyesnono30
659828000027194-74-71,2-propyleneglycol monolaurateyesnono
660475400027458-90-8di-tert-dodecyl disulphideyesnoyes0,05
661953600027676-62-61,3,5-tris(3,5-di-tert-butyl-4-hydroxybenzyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trioneyesnoyes5
662259270027955-94-81,1,1-tris(4-hydroxyphenol)ethanenoyesno0,005Only to be used in polycarbonates(1)
663641500028290-79-1linolenic acidyesnono
664950000028931-67-1trimethylolpropane trimethacrylate-methyl methacrylate copolymeryesnono
665831200029013-28-31,2-propyleneglycol monopalmitateyesnono
666872800029116-98-1sorbitan dioleateyesnono
667551900029204-02-2gadoleic acidyesnono
668802400029894-35-7polyglycerol ricinoleateyesnono
669566100030233-64-8glycerol monobehenateyesnono
670568000030899-62-8glycerol monolaurate diacetateyesnono(32)
671742400031570-04-4phosphorous acid, tris(2,4-di-tert-butylphenyl)esteryesnono
672768450031831-53-5polyester of 1,4-butanediol with caprolactoneyesnono

(29)

(30)

The fraction with molecular weight below 1 000 Da should not exceed 0,5 % (w/w)
673536700032509-66-3ethylene glycol bis[3,3-bis(3-tert-butyl-4-hydroxyphenyl)butyrate]yesnoyes6
674464800032647-67-9dibenzylidene sorbitolyesnono
675388000032687-78-8N,N′-bis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionyl)hydrazideyesnoyes15
676504000033568-99-9di-n-octyltin bis(isooctyl maleate)yesnono(10)
677825600033587-20-11,2-propyleneglycol dipalmitateyesnono
678592000035074-77-21,6-hexamethylene-bis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate)yesnoyes6
679390600035958-30-61,1-bis(2-hydroxy-3,5-di-tert-butylphenyl)ethaneyesnoyes5
680944000036443-68-2triethyleneglycol bis[3-(3-tert-butyl-4-hydroxy-5-methylphenyl) propionate]yesnono9
681183100036653-82-41-hexadecanolnoyesno
682532700037205-99-5ethylcarboxymethylcelluloseyesnono
683662000037206-01-2methylcarboxymethylcelluloseyesnono
684681250037244-96-5nepheline syeniteyesnono
685859500037296-97-2silicic acid, magnesium-sodium-fluoride saltyesnono0,15

SML expressed as fluoride.

Only to be used in layers of multi-layer materials not coming into direct contact with food.

686613900037353-59-6hydroxymethylcelluloseyesnono
687135300038103-06-92,2-bis(4-hydroxyphenyl)propane bis(phthalic anhydride)noyesno0,05
13614
688925600038613-77-3tetrakis(2,4-di-tert-butyl-phenyl)-4,4′-biphenylylene diphosphoniteyesnoyes18
689952800040601-76-11,3,5-tris(4-tert-butyl-3-hydroxy-2,6-dimethylbenzyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trioneyesnoyes6
690928800041484-35-9thiodiethanol bis(3-(3,5-di-tert-butyl-4-hydroxy phenyl) propionate)yesnoyes2,4
691136000047465-97-43,3-bis(3-methyl-4-hydroxyphenyl)2-indolinonenoyesno1,8
692523200052047-59-32-(4-dodecylphenyl)indoleyesnoyes0,06
693881600054140-20-4sorbitan tripalmitateyesnono
694214000054276-35-6methacrylic acid, sulphopropyl esternoyesno0,05(1)
695675200054849-38-6monomethyltin tris(isooctyl mercaptoacetate)yesnono(9)
696922050057569-40-1terephthalic acid, diester with 2,2′-methylenebis(4-methyl-6-tert-butylphenol)yesnono
697675150057583-34-3monomethyltin tris(ethylhexyl mercaptoacetate)yesnono(9)
698495950057583-35-4dimethyltin bis(ethylhexyl mercaptoacetate)yesnono(9)
699907200058446-52-9stearoylbenzoylmethaneyesnono
700315200061167-58-6acrylic acid, 2-tert-butyl-6-(3-tert-butyl-2-hydroxy-5-methylbenzyl)-4-methylphenyl esteryesnoyes6
701401600061269-61-2N,N′-bis(2,2,6,6-tetramethyl-4-piperidyl)hexamethylenediamine-1,2-dibromoethane, copolymeryesnono2,4
702879200061752-68-9sorbitan tetrastearateyesnono
703171700061788-47-4fatty acids, coconoyesno
704776000061788-85-0polyethyleneglycol ester of hydrogenated castor oilyesnono
70510599/90A0061788-89-4acids, fatty, unsaturated (C18), dimers, non hydrogenated, distilled and non-distillednoyesno(18)(1)
10599/91
706172300061790-12-3fatty acids, tall oilnoyesno
707463750061790-53-2diatomaceous earthyesnono
708775200061791-12-6polyethyleneglycol ester of castor oilyesnono42
709875200062568-11-0sorbitan monobehenateyesnono
710387000063397-60-4bis(2-carbobutoxyethyl)tin-bis(isooctyl mercaptoacetate)yesnoyes18
711420000063438-80-2(2-carbobutoxyethyl)tin-tris(isooctyl mercaptoacetate)yesnoyes30
712429600064147-40-6castor oil, dehydratedyesnono
713434800064365-11-3charcoal, activatedyesnono

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 Directive 95/45/ECd with exception of ash content which can be up to 10 % (w/w).

714844000064365-17-9rosin, hydrogenated, ester with pentaerythritolyesnono
715468800065140-91-23,5-di-tert-butyl-4-hydroxybenzylphosphonic acid, monoethyl ester, calcium saltyesnono6
716608000065447-77-01-(2-hydroxyethyl)-4-hydroxy-2,2,6,6-tetramethyl piperidine-succinic acid, dimethyl ester, copolymeryesnono30
717842100065997-06-0rosin, hydrogenatedyesnono
718842400065997-13-9rosin, hydrogenated, ester with glycerolyesnono
719659200066822-60-4N-methacryloyloxyethyl-N,N-dimethyl-N-carboxymethylammonium chloride, sodium salt -octadecyl methacrylate-ethyl methacrylate-cyclohexyl methacrylate-N-vinyl-2-pyrrolidone, copolymersyesnono
720673600067649-65-4mono-n-dodecyltin tris(isooctyl mercaptoacetate)yesnono(25)
721468000067845-93-63,5-di-tert-butyl-4-hydroxybenzoic acid, hexadecyl esteryesnono
722172000068308-53-2fatty acids, soyanoyesno
723888800068412-29-3starch, hydrolysedyesnono
724249030068425-17-2syrups, hydrolysed starch, hydrogenatednoyesnoIn compliance with the purity criteria for maltitol syrup E 965(ii) as laid down in Commission Directive 2008/60/ECe
725778950068439-49-6polyethyleneglycol (EO = 2-6) monoalkyl (C16-C18) etheryesnono0,05

The composition of this mixture is as follows:

  • polyethyleneglycol (EO = 2-6)monoalkyl (C16-C18) ether (approximately 28 %),

  • fatty alcohols (C16-C18) (approximately 48 %),

  • ethyleneglycol monoalkyl (C16-C18) ether (approximately 24 %),

726835990068442-12-6reaction products of oleic acid, 2-mercaptoethyl ester, with dichlorodimethyltin, sodium sulphide and trichloromethyltinyesnoyes(9)
727433600068442-85-3cellulose, regeneratedyesnono
72875100

0068515-48-0

0028553-12-0

phthalic acid, diesters with primary, saturated C8-C10 branched alcohols, more than 60 % C9yesnono

(26)

(32)

Only to be used as:

(a)

plasticiser in repeated use materials and articles;

(b)

plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae as defined by Directive 2006/141/EC or processed cereal-based foods and baby foods for infants and young children as defined by Directive 2006/125/EC;

(c)

technical support agent in concentrations up to 0,1 % in the final product.

(7)
72975105

0068515-49-1

0026761-40-0

phthalic acid, diesters with primary, saturated C9-C11 alcohols more than 90 % C10yesnono

(26)

(32)

Only to be used as:

(a)

plasticiser in repeated use materials and articles;

(b)

plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae as defined by Directive 2006/141/EC or processed cereal-based foods and baby foods for infants and young children as defined by Directive 2006/125/EC;

(c)

technical support agent in concentrations up to 0,1 % in the final product.

(7)
730669300068554-70-1methylsilsesquioxaneyesnonoResidual monomer in methylsilsesquioxane: < 1 mg methyltrimethoxysilane/kg of methylsilsesquioxane
731182200068564-88-5N-heptylaminoundecanoic acidnoyesno0,05(2)
732454500068610-51-5 p-cresol-dicyclopentadiene-isobutylene, copolymeryesnoyes5
73310599/92A0068783-41-5acids, fatty, unsaturated (C18), dimers, hydrogenated, distilled and non-distillednoyesno(18)(1)
10599/93
734463800068855-54-9diatomaceous earth, soda ash flux-calcinedyesnono
735401200068951-50-8bis(polyethyleneglycol)hydroxymethylphosphonateyesnono0,6
736509600069226-44-4di-n-octyltin ethyleneglycol bis(mercaptoacetate)yesnono(10)
737773700070142-34-6polyethyleneglycol-30 dipolyhydroxystearateyesnono
738603200070321-86-72-[2-hydroxy-3,5-bis(1,1-dimethylbenzyl)phenyl]benzotriazoleyesnoyes1,5
739700000070331-94-12,2′-oxamidobis[ethyl-3-(3,5-di-tert-butyl-4-hydroxyphenyl)-propionate]yesnono
740812000071878-19-8poly[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]yesnoyes3
741240700073138-82-6resin acids and rosin acidsyesyesno
83610
742927000078301-43-62,2,4,4-tetramethyl-20-(2,3-epoxypropyl)-7-oxa-3,20-diazadispiro-[5.1.11.2]-heneicosan-21-one, polymeryesnoyes5
743389500079072-96-1bis(4-ethylbenzylidene)sorbitolyesnono
744188880080181-31-33-hydroxybutanoic acid-3-hydroxypentanoic acid, copolymernoyesnoThe substance is used as product obtained by bacterial fermentation. In compliance with the specifications mentioned in the Table 4 of Annex I
745681450080410-33-92,2′,2′-nitrilo(triethyl tris(3,3′,5,5′-tetra-tert-butyl-1,1′-bi-phenyl-2,2′-diyl)phosphite)yesnoyes5SML expressed as sum of phosphite and phosphate
746388100080693-00-1bis(2,6-di-tert-butyl-4-methylphenyl)pentaerythritol diphosphiteyesnoyes5SML expressed as sum of phosphite and phosphate
747476000084030-61-5di-n-dodecyltin bis(isooctyl mercaptoacetate)yesnoyes(25)
748127650084434-12-8N-(2-aminoethyl)-β-alanine, sodium saltnoyesno0,05
749663600085209-91-22,2′-methylene bis(4,6-di-tert-butylphenyl) sodium phosphateyesnoyes5
750663500085209-93-42,2′-methylenebis(4,6-di-tert-butylphenyl) lithium phosphateyesnono5
751815150087189-25-1poly(zinc glycerolate)yesnono
752398900087826-41 – 30069158-41 – 40054686-97 – 40081541-12-0bis(methylbenzylidene)sorbitolyesnono
753628000092704-41-1kaolin, calcinedyesnono
754560200099880-64-5glycerol dibehenateyesnono
755217650106246-33-74,4′-methylenebis(3-chloro-2,6-diethylaniline)noyesno0,05(1)
756400200110553-27-02,4-bis(octylthiomethyl)-6-methylphenolyesnoyes(24)
757957250110638-71-6vermiculite, reaction product with citric acid, lithium saltyesnono
758389400110675-26-82,4-bis(dodecylthiomethyl)-6-methylphenolyesnoyes(24)
759543000118337-09-02,2′-ethylidenebis(4,6-di-tert-butylphenyl) fluorophosphoniteyesnoyes6
760835950119345-01-6reaction 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 biphenylyesnono18

Composition:

  • 4,4′-biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS No 0038613-77-3) (36-46 % w/w (*)),

  • 4,3′-biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS No 0118421-00-4) (17-23 % w/w (*)),

  • 3,3′-biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS No 0118421-01-5) (1-5 % w/w (*)),

  • 4-biphenylene-0,0-bis(2,4-di-tert-butylphenyl)phosphonite (CAS No 0091362-37-7) (11-19 % w/w (*)),

  • tris(2,4-di-tert-butylphenyl)phosphite (CAS No 0031570-04-4) (9-18 % w/w (*)),

  • 4,4′-biphenylene-0,0-bis(2,4-di-tert-butylphenyl)phosphonate-0,0-bis(2,4-di-tert-butylphenyl)phosphonite (CAS No 0112949-97-0) (< 5 % w/w (*))

(*)Quantity of substance used/quantity of formulation

Other specifications:

  • Phosphor content of min. 5,4 % to max. 5,9 %,

  • Acid value of max. 10 mg KOH per gram,

  • Melt range of 85– 110 °C,

761929300120218-34-0thiodiethanolbis(5-methoxycarbonyl-2,6-dimethyl-1,4-dihydropyridine-3-carboxylate)yesnono6
762315300123968-25-2acrylic acid, 2,4-di-tert-pentyl-6-(1-(3,5-di-tert-pentyl-2-hydroxyphenyl)ethyl)phenyl esteryesnoyes5
763399250129228-21-33,3-bis(methoxymethyl)-2,5-dimethylhexaneyesnoyes0,05
764133170132459-54-2N,N′-bis[4-(ethoxycarbonyl)phenyl]-1,4,5,8-naphthalenetetracarboxydiimidenoyesno0,05

Purity > 98,1 % (w/w).

Only to be used as co-monomer (max 4 %) for polyesters (PET, PBT).

765494850134701-20-52,4-dimethyl-6-(1-methylpentadecyl)phenolyesnoyes1
766388790135861-56-2bis(3,4-dimethylbenzylidene)sorbitolyesnono
767385100136504-96-61,2-bis(3-aminopropyl)ethylenediamine, polymer with N-butyl-2,2,6,6-tetramethyl-4-piperidinamine and 2,4,6-trichloro-1,3,5-triazineyesnono5
768348500143925-92-2amines, bis(hydrogenated tallow alkyl) oxidisedyesnono

Not to be used for articles in contact with fatty foods for which simulant D is laid down.

Only to be used in:

(a)

polyolefins at 0,1 % (w/w) concentration and in

(b)

PET at 0,25 % (w/w) concentration.

(1)
769740100145650-60-8phosphorous acid, bis(2,4-di-tert-butyl-6-methylphenyl) ethyl esteryesnoyes5SML expressed as sum of phosphite and phosphate
770517000147315-50-22-(4,6-diphenyl-1,3,5-triazin-2-yl)-5-(hexyloxy)phenolyesnono0,05
771346500151841-65-5aluminium hydroxybis [2,2′-methylenebis (4,6-di-tert-butylphenyl) phosphate]yesnono5
772475000153250-52-3N,N′-dicyclohexyl-2,6-naphthalene dicarboxamideyesnono5
773388400154862-43-8bis(2,4-dicumylphenyl)pentaerythritol-diphosphiteyesnoyes5SML expressed as sum of the substance itself, its oxidised form bis(2,4-dicumylphenyl)pentaerythritol-phosphate and its hydrolysis product (2,4-dicumylphenol)
774952700161717-32-42,4,6-tris(tert-butyl)phenyl-2-butyl-2-ethyl-1,3-propanediol phosphiteyesnoyes2SML expressed as sum of phosphite, phosphate and the hydrolysis product = TTBP
775457050166412-78-81,2-cyclohexanedicarboxylic acid, diisononyl esteryesnono(32)
776767230167883-16-1polydimethylsiloxane, 3-aminopropyl terminated, polymer with dicyclohexylmethane-4,4′-diisocyanateyesnonoThe fraction with molecular weight below 1 000 Da should not exceed 1,5 % (w/w)
777315420174254-23-0acrylic acid, methyl ester, telomer with 1-dodecanethiol, C16-C18 alkyl estersyesnono0,5 % in final product(1)
778716700178671-58-4pentaerythritol tetrakis (2-cyano-3,3-diphenylacrylate)yesnoyes0,05
779398150182121-12-69,9-bis(methoxymethyl)fluoreneyesnoyes0,05(1)
780812200192268-64-7poly-[[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]yesnono5
781952650227099-60-71,3,5-tris(4-benzoylphenyl) benzeneyesnono0,05
782767250661476-41-1polydimethylsiloxane, 3-aminopropyl terminated, polymer with 1-isocyanato-3-isocyanatomethyl-3,5,5-trimethylcyclohexaneyesnonoThe fraction with molecular weight below 1 000 Da should not exceed 1 % (w/w)
783559100736150-63-3glycerides, castor-oil mono-, hydrogenated, acetatesyesnono(32)
784954200745070-61-51,3,5-tris (2,2-dimethylpropanamido)benzeneyesnono0,05
785249100000100-21-0terephthalic acidnoyesno(28)
786146270000117-21-53-chlorophthalic anhydridenoyesno0,05SML expressed as 3-chlorophthalic acid
787146280000118-45-64-chlorophthalic anhydridenoyesno0,05SML expressed as 4-chlorophthalic acid
788214980002530-85-0[3-(methacryloxy)propyl]trimethoxysilanenoyesno0,05Only to be used as a surface treatment agent of inorganic fillers

(1)

(11)

78960027hydrogenated 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)yesnono

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)
79080480

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)]yesnono5

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)
791924700106990-43-6N,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-diamineyesnono0,05
792924750203255-81-63,3′,5,5′-tetrakis(tert-butyl)-2,2′-dihydroxybiphenyl, cyclic ester with [3-(3-tert-butyl-4-hydroxy-5-methylphenyl)propyl]oxyphosphonous acidyesnoyes5SML expressed as the sum of phosphite and phosphate form of the substance and the hydrolysis products
793940000000102-71-6triethanolamineyesnono0,05SML expressed as the sum of triethanolamine and the hydrochloride adduct expressed as triethanolamine
794181170000079-14-1glycolic acidnoyesnoFor indirect food contact only, behind a PET layer
795401550124172-53-8N,N′-bis(2,2,6,6-tetramethyl-4-piperidyl)-N,N′-diformylhexamethylenediamineyesnono0,05

(2)

(12)

796721410018600-59-42,2′-(1,4-phenylene)bis[4H-3,1-benzoxazin-4-one]yesnoyes0,05SML including the sum of its hydrolysis products
797768070007328-26-5polyester of adipic acid with 1,3-butanediol, 1,2-propanediol and 2-ethyl-1-hexanolyesnoyes

(31)

(32)

798922000006422-86-2terephthalic acid, bis(2-ethylhexyl)esteryesnono60(32)
79977708polyethyleneglycol (EO = 1-50) ethers of linear and branched primary (C8-C22) alcoholsyesnono1,8In compliance with the purity criteria for ethylene oxide as laid down in Directive 2008/84/EC laying down specific purity criteria on food additives other than colours and sweeteners (OJ L 253, 20.9.2008, p. 1)
800944250000867-13-0triethyl phosphonoacetateyesnonoOnly for use in PET
80130607acids, C2-C24, aliphatic, linear, monocarboxylic, from natural oils and fats, lithium saltyesnono
802331050146340-15-0alcohols, C12-C14 secondary, β-(2-hydroxyethoxy), ethoxylatedyesnono5(12)
803335350152261-33-1α-alkenes(C20-C24) copolymer with maleic anhydride, reaction product with 4-amino-2,2,6,6-tetramethylpiperidineyesnono

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)
804805101010121-89-7poly(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 acidyesnonoOnly to be used as polymer production aid in polyethylene (PE), polypropylene (PP) and polystyrene (PS)
80593450titanium dioxide, coated with a copolymer of n-octyltrichlorosilane and [aminotris(methylenephosphonic acid), penta sodium salt]yesnonoThe content of the surface treatment copolymer of the coated titanium dioxide is less than 1 % w/w
806148760001076-97-71,4-cyclohexanedicarboxylic acidnoyesno5Only to be used for manufacture of polyesters
80793485titanium nitride, nanoparticlesyesnono

No migration of titanium nitride nanoparticles.

Only to be used in PET bottles 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.

808385500882073-43-0bis(4-propylbenzylidene)propylsorbitolyesnono5SML including the sum of its hydrolysis products
809490800852282-89-4N-(2,6-diisopropylphenyl)-6-[4-(1,1,3,3-tetramethylbutyl)phenoxy]-1H-benzo[de]isoquinolin-1,3(2H)-dioneyesnoyes0,05Only for use in PET

(6)

(14)

(15)

81068119neopentyl glycol, diesters and monoesters with benzoic acid and 2-ethylhexanoic acidyesnono5(32)Not to be used for articles in contact with fatty foods for which simulant D is laid down.
811800770068441-17-8polyethylene waxes, oxidisedyesnono60
812803500124578-12-7poly(12-hydroxystearic acid)-polyethyleneimine copolymeryesnono

Only to be used in polyethylene terephthalate (PET), polystyrene (PS), high impact polystyrene (HIPS) and polyamide (PA) up to 0,1 % w/w.

Prepared by the reaction of poly(12-hydroxystearic acid) with polyethyleneimine.

81391530sulphosuccinic acid alkyl (C4-C20) or cyclohexyl diesters, saltsyesnono5
81491815sulphosuccinic acid monoalkyl (C10-C16) polyethyleneglycol esters, saltsyesnono2
81594985trimethylolpropane, mixed triesters and diesters with benzoic acid and 2-ethylhexanoic acidyesnono5(32)Not to be used for articles in contact with fatty foods for which simulant D is laid down
81645704cis-1,2-cyclohexanedicarboxylic acid, saltsyesnono5
81738507cis-endo-bicyclo[2.2.1]heptane-2,3-dicarboxylic acid, saltsyesnono5

Not to be used with polyethylene in contact with acidic foods.

Purity ≥ 96 %.

81821530methallylsulphonic acid, saltsnoyesno5
81968110neodecanoic acid, saltsyesnono0,05

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.

82076420pimelic acid, saltsyesnono
82190810stearoyl-2-lactylic acid, saltsyesnono
82271938perchloric acid, saltsyesnono0,05(4)
823248895-Sulphoisophthalic acid, saltsnoyesno5
854719430329238-24-6perfluoro acetic acid, α-substituted with the copolymer of perfluoro-1,2-propylene glycol and perfluoro-1,1-ethylene glycol, terminated with chlorohexafluoropropyloxy groupsyesnonoOnly 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
860719800051798-33-5perfluoro[2-(poly(n-propoxy))propanoic acid]yesnonoOnly 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
861719900013252-13-6perfluoro[2-(n-propoxy)propanoic acid]yesnonoOnly 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
862151800018085-02-43,4-diacetoxy-1-butenenoyesno0,05

SML including the hydrolysis product 3,4-dihydroxy-1-butene.

Only for use as a co-monomer for ethyl vinyl alcohol copolymers.

864463300000056-06-42,4-diamino-6-hydroxypyrimidineyesnono5Only to be used in rigid poly(vinyl chloride) (PVC) in contact with non-acidic and non-alcoholic aqueous food
865406190025322-99-0(butyl acrylate, methyl methacrylate, butyl methacrylate) copolymeryesnonoOnly to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 1 %
86640620(butyl acrylate, methyl methacrylate) copolymer, cross-linked with allyl methacrylateyesnonoOnly to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 7 %
867408150040471-03-2(butyl methacrylate, ethyl acrylate, methyl methacrylate) copolymeryesnonoOnly to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 2 %
868532450009010-88-2(ethyl acrylate, methyl methacrylate) copolymeryesnonoOnly to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 2 %
869667630027136-15-8(butyl acrylate, methyl methacrylate, styrene) copolymeryesnonoOnly to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 3 %
870955000160535-46-6N,N′,N″-tris(2-methylcyclohexyl)-1,2,3-propane-tricarboxamideyesnono5
875803450058128-22-6poly(12-hydroxystearic acid) stearateyesnoyes5
87831335acids, fatty (C8-C22) from animal or vegetable fats and oils, esters with branched alcohols, aliphatic, monohydric, saturated, primary (C3-C22)yesnono
87931336acids, fatty (C8-C22) from animal or vegetable fats and oils, esters with alcohols, linear, aliphatic, monohydric, saturated, primary (C1-C22)yesnono
880313480085116-93-4acids, fatty (C8-C22), esters with pentaerythritolyesnono
881251870003010-96-62,2,4,4-tetramethylcyclobutane-1,3-diolnoyesno5Only for repeated use articles for long term storage at room temperature or below and hotfill
882258720002416-94-62,3,6-trimethylphenolnoyesno0,05
883220740004457-71-03-methyl-1,5-pentanediolnoyesno0,05Only to be used in materials in contact with food at a surface to mass ratio up to 0,5 dm2/kg
884342400091082-17-6alkyl(C10-C21)sulphonic acid, esters with phenolyesnono0,05Not to be used for articles in contact with fatty foods for which simulant D is laid down.
885456760263244-54-8cyclic oligomers of (butylene terephthalate)yesnonoOnly 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.

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.

Table 2

(1)(2)(3)(4)
Group Restriction NoFCM substance NoSML (T)[mg/kg]Group restriction specification
1

128

211

6expressed as acetaldehyde
2

89

227

263

30expressed as ethyleneglycol
3

234

248

30expressed as maleic acid
4

212

435

15expressed as caprolactam
5

137

472

3expressed as the sum of the substances
6

412

512

513

588

1expressed as iodine
7

19

20

1,2expressed as tertiary amine
8

317

318

319

359

431

464

6expressed as the sum of the substances
9

650

695

697

698

726

0,18expressed as tin
10

28

29

30

31

32

33

466

582

618

619

620

646

676

736

0,006expressed as tin
11

66

645

657

1,2expressed as tin
12

444

469

470

30expressed as the sum of the substances
13

163

285

1,5expressed as the sum of the substances
14

294

368

5expressed as the sum of the substances
15

98

196

15expressed 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

NDexpressed as isocyanate moiety
18

705

733

0,05expressed as the sum of the substances
19

505

516

519

10expressed as SO2
20

290

386

390

30expressed as the sum of the substances
21

347

349

5expressed as trimellitic acid
22

70

147

176

218

323

325

365

371

380

425

446

448

456

636

6expressed as acrylic acid
23

150

156

181

183

184

355

370

374

439

440

447

457

482

6expressed as methacrylic acid
24

756

758

5expressed as the sum of the substances
25

720

747

0,05sum 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

9expressed as the sum of the substances
27

188

291

5expressed as isophthalic acid
28

191

192

785

7,5expressed as terephthalic acid
29

342

672

0,05expressed as the sum of 6-hydroxyhexanoic acid and caprolactone
30

254

672

5expressed as 1,4-butanediol
31

73

797

30expressed 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

60expressed as the sum of the substances

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.

Table 3

(1)(2)
Note NoNotes 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.
(4)Compliance testing when there is a fat contact should be performed using saturated fatty food simulants as simulant D.
(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

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.

Table 4

(1)(2)
FCM substance NoDetailed specification on the substance
744DefinitionThe 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 namePoly(3-D-hydroxybutanoate-co-3-D-hydroxypentanoate)
CAS number0080181-31-3
Structural formula

where n/(m + n) greater than 0 and less or equal to 0,25

Average molecular weightNot less than 150 000 Daltons (measured by gel permeation chromatography)
AssayNot 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
DescriptionWhite to off-white powder after isolation
Characteristics
Identification tests:
SolubilitySoluble in chlorinated hydrocarbons such as chloroform or dichloromethane but practically insoluble in ethanol, aliphatic alkanes and water
RestrictionQMA for crotonic acid is 0,05 mg/6 dm2
PurityPrior to granulation the raw material copolymer powder must contain:
  • nitrogen,

Not more than 2 500 mg/kg of plastic
  • zinc,

Not more than 100 mg/kg of plastic
  • copper,

Not more than 5 mg/kg of plastic
  • lead,

Not more than 2 mg/kg of plastic
  • arsenic,

Not more than 1 mg/kg of plastic
  • chromium,

Not more than 1 mg/kg of plastic

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