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 23 April 2024. Database contains 1080 unique substances/entries.
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77 |
77733 |
yes |
no |
0.05 mg/kg |
Only for use in PET. |
Details | |
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76 |
77732 |
yes |
no |
0.05 mg/kg |
Only for use in PET. |
Details | |
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73 |
76866 |
yes |
yes |
Details | |||
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73 |
76866 |
yes |
yes |
Details | |||
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72 |
76815 |
yes |
no |
The fraction with molecular weight below 1000 Da shall not exceed 5 % (w/w). |
Details | ||
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71 |
76730 |
yes |
no |
6 mg/kg |
Details | ||
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70 |
76463 |
yes |
no |
Details | |||
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820 |
76420 |
yes |
no |
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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. |
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. |
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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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69 |
74400 |
yes |
yes |
30 mg/kg |
Details | ||
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68 |
73160 |
yes |
yes |
0.05 mg/kg |
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97 |
72081/10 |
yes |
no |
Petroleum hydrocarbon resins, hydrogenated are produced by the catalytic or thermalpolymerisation of dienes and olefins of the aliphatic, alicyclic and/or monobenzenoidarylalkene types from distillates of cracked petroleum stocks with a boiling range not greater than 220 °C, as well as the pure monomers found in these distillation streams, subsequently followed by distillation, hydrogenation and additional processing. Properties: 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. |
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822 |
71938 |
yes |
no |
Details | |||
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810 |
68119 |
yes |
no |
5 mg/kg |
Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down. |
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810 |
68119 |
yes |
no |
Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down. |
Details | ||
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14 |
33801 |
yes |
no |
30 mg/kg |
Details | ||
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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. |
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20 |
39120 |
yes |
no |
SML(T) expressed excluding HCl. |
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19 |
39090 |
yes |
no |
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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. |
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1030 |
yes |
no |
0.05 mg/kg |
Only to be used up to 12 % (w/w) in polyolefins in contact with dry foods to which simulant E is assigned in table 2 of Annex III at room temperature or below. The sum of the specific migration of 1-chlorohexadecane and 1-chlorooctadecane shall not exceed 0,05 mg/kg food. Can contain platelets in the nanoform that are only in one dimension thinner than 100 nm. Such platelets shall be oriented parallel to the polymer surface and shall be fully embedded in the polymer. |
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67 |
67840 |
yes |
no |
Details | |||
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66 |
67600 |
yes |
no |
Details | |||
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65 |
67155 |
yes |
no |
Not more than 0,05 % (w/w) (quantity of substance used/quantity of the formulation). Mixture obtained from the manufacturing process in the typical ratio of (58-62 %):(23-27 %):(13-17 %) |
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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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64 |
66695 |
yes |
no |
Details | |||
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818 |
21530 |
no |
no |
5 mg/kg |
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63 |
65440 |
yes |
no |
Details | |||
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62 |
64500 |
yes |
no |
Details | |||
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789 |
60027 |
yes |
no |
Average molecular weight not less than 440 Da. Viscosity at 100 °C not less than 3,8 cSt (3,8 × 10-6 m2/s). |
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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. |
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60 |
58300 |
yes |
no |
Details | |||
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51 |
56570 |
yes |
no |
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48 |
56535 |
yes |
no |
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46 |
56510 |
yes |
no |
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45 |
56500 |
yes |
no |
Details | |||
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43 |
56490 |
yes |
no |
Details | |||
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42 |
56487 |
yes |
no |
Details | |||
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41 |
56486 |
yes |
no |
Details | |||
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44 |
56495 |
yes |
no |
Details | |||
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59 |
57680 |
yes |
no |
Details | |||
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58 |
57600 |
yes |
no |
Details | |||
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57 |
57280 |
yes |
no |
Details | |||
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56 |
57200 |
yes |
no |
Details | |||
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55 |
57120 |
yes |
no |
Details | |||
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54 |
57040 |
yes |
no |
Details | |||
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38 |
55520 |
yes |
no |
Details | |||