plastic-material-food-contact
plastic-material-food-contact
FCM and Articles Regulation, Annex I - Authorised Substances
EU. Union List of Authorized Substances: Annex I, Plastics Food Contact Regulation 10/2011/EU, as amended by Regulation (EU) 2023/1627, OJ L 201, 11 August 2023
This list contains the Union list of authorised monomers, other starting substances, macromolecules obtained from microbial fermentation, additives and polymer production aids. It is taken from Annex I of the Commission Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food.
Last updated 18 April 2024. Database contains 1080 unique substances/entries.
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75100 |
yes |
no |
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;(c)technical support agent in concentrations up to 0,1 % in the final product. Not to be used in combination with FCM substances 157, 159, 283, or 1085. |
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201-622-7
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85-68-7
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159 |
74560 |
yes |
no |
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;(c)technical support agent in concentrations up to 0,1 % in the final product. |
Details | ||
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201-622-7
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85-68-7
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159 |
74560 |
yes |
no |
6 mg/kg |
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;(c)technical support agent in concentrations up to 0,1 % in the final product. |
Details | |
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201-622-7
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85-68-7
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159 |
74560 |
yes |
no |
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;(c)technical support agent in concentrations up to 0,1 % in the final product. |
Details | ||
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249-079-5
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28553-12-0
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728 |
75100 |
yes |
no |
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;(c)technical support agent in concentrations up to 0,1 % in the final product. Not to be used in combination with FCM substances 157, 159, 283, or 1085. |
Details | ||
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249-079-5
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28553-12-0
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728 |
75100 |
yes |
no |
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;(c)technical support agent in concentrations up to 0,1 % in the final product. Not to be used in combination with FCM substances 157, 159, 283, or 1085. |
Details | ||
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271-090-9
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68515-48-0
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728 |
75100 |
yes |
no |
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;(c)technical support agent in concentrations up to 0,1 % in the final product. Not to be used in combination with FCM substances 157, 159, 283, or 1085. |
Details | ||
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271-090-9
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68515-48-0
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728 |
75100 |
yes |
no |
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;(c)technical support agent in concentrations up to 0,1 % in the final product. Not to be used in combination with FCM substances 157, 159, 283, or 1085. |
Details | ||
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729 |
75105 |
yes |
no |
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. |
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729 |
75105 |
yes |
no |
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. |
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247-977-1
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26761-40-0
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729 |
75105 |
yes |
no |
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. |
Details | ||
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247-977-1
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26761-40-0
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729 |
75105 |
yes |
no |
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. |
Details | ||
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271-091-4
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68515-49-1
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729 |
75105 |
yes |
no |
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. |
Details | ||
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271-091-4
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68515-49-1
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729 |
75105 |
yes |
no |
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. |
Details | ||
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201-557-4
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84-74-2
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157 |
74880 |
yes |
no |
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. |
Details | ||
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201-557-4
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84-74-2
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157 |
74880 |
yes |
no |
0.12 mg/kg |
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. |
Details | |
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201-557-4
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84-74-2
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157 |
74880 |
yes |
no |
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. |
Details | ||
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204-211-0
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117-81-7
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283 |
74640 |
yes |
no |
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. |
Details | ||
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204-211-0
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117-81-7
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283 |
74640 |
yes |
no |
0.6 mg/kg |
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. |
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204-211-0
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117-81-7
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283 |
74640 |
yes |
no |
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. |
Details | ||
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364 |
15404 |
no |
no |
5 mg/kg |
Only to be used as: (a) a co-monomer in poly (ethylene-co-isosorbide terephthalate); (b) a co-monomer at levels of up to 40 mole % of the diol component in combination with ethylene glycol and/or 1,4-bis(hydroxymethyl)cyclohexane, for the production of polyesters. Polyesters made using dianhydrosorbitol together with 1,4-bis(hydroxymethyl)cyclohexane shall not be used in contact with foods containing more than 15 % alcohol. |
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211-492-3
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652-67-5
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364 |
15404 |
no |
no |
5 mg/kg |
Only to be used as: (a) a co-monomer in poly (ethylene-co-isosorbide terephthalate); (b) a co-monomer at levels of up to 40 mole % of the diol component in combination with ethylene glycol and/or 1,4-bis(hydroxymethyl)cyclohexane, for the production of polyesters. Polyesters made using dianhydrosorbitol together with 1,4-bis(hydroxymethyl)cyclohexane shall not be used in contact with foods containing more than 15 % alcohol. |
Details | |
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1010121-89-7
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804 |
80510 |
yes |
no |
Only to be used as polymer production aid in polyethylene (PE), polypropylene (PP) and polystyrene (PS). |
Details | ||
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222-020-0
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3319-31-1
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1078 |
yes |
no |
1 mg/kg |
Only to be used as plasticiser to manufacture soft poly(vinyl chloride). Not to be used in contact with foods intended for infants. |
Details | ||
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-
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998 |
yes |
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. |
Details | |||
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-
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859 |
yes |
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. |
Details | |||
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-
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1043 |
yes |
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. |
Details | |||
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617-129-9
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8062-15-5
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540 |
63940 |
yes |
no |
0.24 mg/kg |
Only to be used as dispersant for plastics dispersions. |
Details | |
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-
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540 |
63940 |
yes |
no |
0.24 mg/kg |
Only to be used as dispersant for plastics dispersions. |
Details | |
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641-029-4
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156065-00-8
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874 |
16265 |
no |
no |
0.05 mg/kg |
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). |
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641-029-4
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156065-00-8
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874 |
16265 |
no |
no |
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). |
Details | ||
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231-710-0
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7695-91-2
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1055 |
yes |
no |
Only to be used as antioxidant in polyolefins. |
Details | |||
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200-405-4
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58-95-7
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1055 |
yes |
no |
Only to be used as antioxidant in polyolefins. |
Details | |||
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283-829-2
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84731-70-4
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1079 |
yes |
no |
0.05 mg/kg |
Only to be used as an additive in poly(vinyl chloride) (PVC) at up to 25 % w/w in contact at room temperature or below with foods for which food simulants A or B are assigned in Table 2 of Annex III. |
Details | ||
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-
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1075 |
yes |
no |
Only to be used as additive at up to 4.0 % w/w in polylactic acid plastics intended for long-term storage of water at ambient temperature or below. Can form platelets in the nanoform that are in one or two dimensions thinner than 100 nm. Such platelets shall be oriented parallel to the polymer surface and shall be fully embedded in the polymer. |
Details | |||
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201-081-7
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78-08-0
|
142 |
26305 |
no |
no |
0.05 mg/kg |
Only to be used as a surface treatment agent. |
Details | |
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219-785-8
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2530-85-0
|
788 |
21498 |
no |
no |
0.05 mg/kg |
Only to be used as a surface treatment agent of inorganic fillers. |
Details | |
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429-840-1
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24937-78-8
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969 |
yes |
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. |
Details | |||
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37486-69-4
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903 |
yes |
no |
Only to be used as a polymer production aid in the polymerisation of fluoropolymers intended for: (a) repeated and single use materials and articles when sintered or processed (non-sintered) at temperatures at or above 360 °C for at least 10 minutes or at higher temperatures for equivalent shorter times; (b) repeated use materials and articles when processed (non-sintered) at temperatures from 300 °C and up to 360 °C for at least 10 minutes. |
Details | |||
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682-238-0
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1190931-27-1
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1045 |
yes |
no |
Only to be used as a polymer production aid during the manufacture of fluoropolymers under high temperature conditions of at least 370 °C. |
Details | |||
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221-800-8
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3238-40-2
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1031 |
no |
no |
5 mg/kg |
Only to be used as a monomer in the production of polyethylene furanoate. The migration of the oligomeric fraction of less than 1 000 Da shall not exceed 50 µg/kg food (expressed as furan-2,5-dicarboxylic acid). |
Details | ||
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-
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1031 |
no |
no |
5 mg/kg |
Only to be used as a monomer in the production of polyethylene furanoate. The migration of the oligomeric fraction of less than 1 000 Da shall not exceed 50 µg/kg food (expressed as furan-2,5-dicarboxylic acid). |
Details | ||
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604-479-2
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1455-42-1
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1052 |
no |
no |
5 mg/kg |
Only to be used as a monomer in the production of polyesters. The migration of oligomers of less than 1 000 Da shall not exceed 50 µg/kg food (expressed as SPG). |
Details | ||
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223-054-9
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3710-30-3
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1034 |
no |
no |
0.05 mg/kg |
Only to be used as a crosslinking co-monomer in the manufacture of polyolefins for contact with any type of foods for long term storage at room temperature, including when packaged under hot-fill conditions. |
Details | ||
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219-784-2
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2530-83-8
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1068 |
no |
no |
Only to be used as a component of a sizing agent to treat glass fibres to be embedded in glass-fibre-reinforced low diffusivity plastics (polyethylene terephthalate (PET), polycarbonate (PC), polybutylene terephthalate (PBT), thermoset polyesters and epoxy bisphenol vinylester) in contact with all foodstuffs. In treated glass fibres, residues of the substance must not be detectable at 0,01 mg/kg for the substance and 0,06 mg/kg for each of the reaction products (hydrolysed monomers and epoxy-containing cyclic dimer, trimer and tetramer). |
Details | |||
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813-638-7
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80512-44-3
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1061 |
no |
no |
Only to be used as a comonomer in the manufacture of polyether ether ketone plastics up to 0,3 % w/w of the final material. |
Details | |||
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219-547-3
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2459-10-1
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971 |
25885 |
no |
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. |
Details | ||
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243-053-7
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19430-93-4
|
973 |
22931 |
no |
no |
Only to be used as a co-monomer up to 0,1 % w/w in the polymerisation of fluoropolymers, sintered at high temperatures. |
Details | ||
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-
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23985-75-3
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1066 |
no |
no |
0.05 mg/kg |
Only to be used as a co-monomer in the manufacture of a polyester non-food contact layer in a plastic multilayer material, which is to be used only in contact with foods for which food simulants A, B, C and/or D1 are assigned in Table 2 of Annex III. The specific migration limit in column 8 refers to the sum of the substance and of its dimers (cyclic and open chain). |
Details | ||
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-
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-
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357 |
13932 |
no |
no |
0.01 mg/kg |
Only to be used as a co-monomer for the preparation of polymeric additive. |
Details | |