plastic-material-food-contact

FCM and Articles Regulation, Annex I - Authorised Substances

EU. Union List of Authorised Substances: Annex I, Plastics Food Contact Regulation 10/2011/EU, as amended by Regulation 2020/1245/EU, 3 September 2020

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 27 February 2021. Database contains 1072 unique substances/entries.
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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.
Details
418-280-1
18600-59-4
796
72141
yes
yes
0.05 mg/kg
SML including the sum of its hydrolysis products.
Details
213-436-3
948-65-2
383
72160
yes
yes
15 mg/kg
Details
-
-
509
72640
23170
yes
no
Details
214-987-2
1241-94-7
392
72800
yes
yes
2.4 mg/kg
Details
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-
68
73160
yes
yes
0.05 mg/kg
Details
204-118-5
115-96-8
280
73720
yes
no
0.01 mg/kg
Details
416-140-4
145650-60-8
769
74010
yes
yes
5 mg/kg
SML expressed as sum of phosphite and phosphate.
Details
700-485-5
939402-02-5
974
74050
yes
yes
10 mg/kg
SML expressed as the sum of the phosphite and phosphate forms of the substance, 4-tert-amylphenol and 2,4-di-tert-amylphenol.
Details
700-485-5
939402-02-5
974
74050
yes
yes
1 mg/kg
The migration of 2,4-di-tert-amylphenol shall not exceed 1 mg/kg food.
Details
250-709-6
31570-04-4
671
74240
yes
no
Details
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-
69
74400
yes
yes
30 mg/kg
Details
201-873-2
88-99-3
165
74480
23200
yes
no
Details
201-622-7
85-68-7
159
74560
yes
no
30 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 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
201-622-7
85-68-7
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 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
204-211-0
117-81-7
283
74640
yes
no
1.5 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.
Details
204-211-0
117-81-7
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
201-557-4
84-74-2
157
74880
yes
no
0.3 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
201-557-4
84-74-2
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
271-090-9
68515-48-0
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 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
271-090-9
68515-48-0
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 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
249-079-5
28553-12-0
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 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
249-079-5
28553-12-0
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 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
-
-
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 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
-
-
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 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
271-091-4
68515-49-1
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
271-091-4
68515-49-1
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
247-977-1
26761-40-0
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
247-977-1
26761-40-0
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
-
-
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
-
-
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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-
820
76420
yes
no
Details
-
-
70
76463
yes
no
Details
613-156-5
63148-62-9
575
76721
yes
no
Viscosity at 25 °C not less than 100 cSt (100 × 10-6 m2/s).
Details
-
167883-16-1
776
76723
yes
no
The fraction with molecular weight below 1000 Da shall not exceed 1,5 % (w/w).
Details
-
661476-41-1
782
76725
yes
no
The fraction with molecular weight below 1000 Da shall not exceed 1 % (w/w).
Details
-
-
71
76730
yes
no
6 mg/kg
Details
-
73018-26-5
797
76807
yes
yes
Details
-
73018-26-5
797
76807
yes
yes
Details
-
-
72
76815
yes
no
The fraction with molecular weight below 1000 Da shall not exceed 5 % (w/w).
Details
608-670-1
31831-53-5
672
76845
yes
no
The fraction with molecular weight below 1000 Da shall not exceed 0,5 % (w/w).
Details
608-670-1
31831-53-5
672
76845
yes
no
The fraction with molecular weight below 1000 Da shall not exceed 0,5 % (w/w).
Details
-
-
73
76866
yes
yes
Details
-
-
73
76866
yes
yes
Details
680-598-3
70142-34-6
737
77370
yes
no
Details
-
-
74
77440
yes
yes
42 mg/kg
Details
1 - 6.5 moles ethoxylated
500-151-7
61791-12-6
708
77520
yes
no
42 mg/kg
Details
1 - 6.5 moles ethoxylated
500-147-5
61788-85-0
704
77600
yes
no
Details
-
-
75
77702
yes
no
Details
-
-
799
77708
yes
no
1.8 mg/kg
In compliance with the maximum ethylene oxide content as laid down in the purity criteria for food additives in Commission Regulation (EU) No 231/2012.
Details

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