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 17 April 2024. Database contains 1080 unique substances/entries.
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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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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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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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show/hide
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-
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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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-
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-
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1060 |
yes |
no |
Only to be used at room temperature or below in contact with foods for which Table 2 of Annex III assigns food simulant E. The seed hulls shall be obtained from sunflower seeds that are fit for human consumption. The processing temperature of the plastic containing the additive shall not exceed 240 °C. |
Details | |||
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258-053-2
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52628-03-2
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1082 |
no |
no |
0.05 mg/kg |
Only to be used at up to 0,35 % (w/w) to manufacture polymethylmethacrylate. |
Details | ||
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-
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-
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1081 |
yes |
no |
Only to be used at up to 2 % (w/w) in plastic materials and articles intended for the packaging by food business operators of dry foods for which simulant E is assigned in table 2 of Annex III. |
Details | |||
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-
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-
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1077 |
yes |
no |
Only to be used at up to 25.0 % w/w, including in the nanoform. |
Details | |||
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219-348-1
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2421-28-5
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1083 |
no |
no |
0.05 mg/kg |
Only to be used at up to 43 % (w/w) as a co-monomer in the production of polyimides for use in contact with foods for which only simulants B and/or D2 are laid down in table 2 of Annex III at temperatures up to 250 °C. |
Details | ||
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214-068-6
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1076-97-7
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806 |
14876 |
no |
no |
5 mg/kg |
Only to be used for manufacture of polyesters. |
Details | |
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-
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-
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806 |
14876 |
no |
no |
5 mg/kg |
Only to be used for manufacture of polyesters. |
Details | |
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-
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-
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794 |
18117 |
no |
no |
Only to be used for manufacture of polyglycolic acid (PGA) for (i) indirect food contact behind polyesters such as polyethylene terephthalate (PET) or polylactic acid (PLA); and (ii) direct food contact of a blend of PGA up to 3 % w/w in PET or PLA. |
Details | ||
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201-180-5
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79-14-1
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794 |
18117 |
no |
no |
Only to be used for manufacture of polyglycolic acid (PGA) for (i) indirect food contact behind polyesters such as polyethylene terephthalate (PET) or polylactic acid (PLA); and (ii) direct food contact of a blend of PGA up to 3 % w/w in PET or PLA. |
Details | ||
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-
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-
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1062 |
no |
no |
Only to be used for the production of recycled PET and at up to 0,12 % (w/w). |
Details | |||
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235-798-1
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12751-22-3
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607 |
62245 |
yes |
no |
Only to be used in PET polymers and copolymers |
Details | ||
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220-239-6
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2682-20-4
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451 |
66755 |
yes |
no |
0.5 mg/kg |
Only to be used in aqueous polymer dispersions and emulsions. |
Details | |
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682-234-9
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329238-24-6
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854 |
71943 |
yes |
no |
Only to be used in concentrations up to 0,5 % w/w in the polymerisation of fluoropolymers that are processed at temperatures at or above 340 °C and are intended for use in repeated use articles. |
Details | ||
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224-709-1
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4457-71-0
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883 |
22074 |
no |
no |
0.05 mg/kg |
Only to be used in materials in contact with food at a surface to mass ratio up to 0,5 dm2/kg. |
Details | |
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630-556-5
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124578-12-7
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812 |
80350 |
yes |
no |
Only to be used in plastics up to 0,1 % w/w. Prepared by the reaction of poly(12-hydroxystearic acid) with polyethyleneimine. |
Details | ||
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-
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263244-54-8
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885 |
45676 |
yes |
no |
Only to be used in poly(ethylene terephthalate) (PET), poly(butylene terephthalate) (PBT), polycarbonate (PC), polystyrene (PS) and rigid poly(vinyl chloride) (PVC) plastics in concentrations up to 1 % w/w, in contact with aqueous, acidic and alcoholic foods, for long term storage at room temperature. |
Details | ||
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229-962-1
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6864-37-5
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498 |
16210 |
no |
no |
0.05 mg/kg |
Only to be used in polyamides. |
Details | |
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THPE; TRIS(P-HYDROXYPHENYL)ETHANE; TRIS(PARA-HYDROXYPHENYL)ETHANE
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405-800-7
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27955-94-8
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662 |
25927 |
no |
no |
0.005 mg/kg |
Only to be used in polycarbonates. |
Details |
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-
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-
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662 |
25927 |
no |
no |
0.005 mg/kg |
Only to be used in polycarbonates. |
Details | |