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 26 April 2024. Database contains 1080 unique substances/entries.
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641-029-4
156065-00-8
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
-
-
540
63940
yes
no
0.24 mg/kg
Only to be used as dispersant for plastics dispersions.
Details
617-129-9
8062-15-5
540
63940
yes
no
0.24 mg/kg
Only to be used as dispersant for plastics dispersions.
Details
-
-
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
-
-
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
-
-
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
222-020-0
3319-31-1
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
-
1010121-89-7
804
80510
yes
no
Only to be used as polymer production aid in polyethylene (PE), polypropylene (PP) and polystyrene (PS).
Details
211-492-3
652-67-5
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
-
-
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
204-211-0
117-81-7
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.
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
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
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
201-557-4
84-74-2
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
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
show/hide
Di-''isononyl'' phthalate EC / List no: 249-079-5 | CAS no: 28553-12-0
Bis(3,5,5-trimethylhexyl) phthalate EC / List no: 237-954-4 | CAS no: 14103-61-8
Bis(8-methylnonyl) phthalate EC / List no: 201-884-2 | CAS no: 89-16-7
Bis(2-methyloctyl) phthalate EC / List no: 274-944-9 | CAS no: 70857-56-6
Bis(4-methyloctyl) phthalate EC / List no: 286-804-4 | CAS no: 85391-50-0
Bis(2-propyloctyl) phthalate EC / List no: 288-645-6 | CAS no: 85851-85-0
2,5-dimethylheptyl 6-methyloctyl phthalate EC / List no: 288-636-7 | CAS no: 85851-77-0
3-ethylheptyl 2,5-dimethylheptyl phthalate EC / List no: 307-707-6 | CAS no: 97692-55-2
Isononyl isoundecyl phthalate EC / List no: 285-920-2 | CAS no: 85168-79-2
Bis(3-ethylheptyl) phthalate EC / List no: 286-806-5 | CAS no: 85391-51-1
Isodecyl isoundecyl phthalate EC / List no: 305-701-8 | CAS no: 94979-22-3
Bis(2-ethyloctyl) phthalate EC / List no: 288-640-9 | CAS no: 85851-81-6
Bis(2-methyldecyl) phthalate EC / List no: 288-643-5 | CAS no: 85851-83-8
Bis(2,5-dimethylheptyl) phthalate EC / List no: 286-802-3 | CAS no: 85391-48-6
3-ethylheptyl 4-methyloctyl phthalate EC / List no: 288-638-8 | CAS no: 85851-79-2
Bis(2-ethylnonyl) phthalate EC / List no: 288-641-4 | CAS no: 85851-82-7
Isodecyl isononyl phthalate EC / List no: 285-916-0 | CAS no: 85168-75-8
Bis(2-propylheptyl) phthalate EC / List no: 258-469-4 | CAS no: 53306-54-0
Bis(6-methyloctyl) phthalate EC / List no: 286-803-9 | CAS no: 85391-49-7
2,5-dimethylheptyl 4-methyloctyl phthalate EC / List no: 288-635-1 | CAS no: 85851-76-9
Bis(2-propylhexyl) phthalate EC / List no: 288-644-0 | CAS no: 85851-84-9
3-ethylheptyl 6-methyloctyl phthalate EC / List no: 288-639-3 | CAS no: 85851-80-5
Bis(2-ethylheptyl) phthalate EC / List no: 274-344-7 | CAS no: 70152-36-2
4-methyloctyl 6-methyloctyl phthalate EC / List no: 288-637-2 | CAS no: 85851-78-1
Di-''isodecyl'' phthalate EC / List no: 247-977-1 | CAS no: 26761-40-0
Diisoundecyl phthalate EC / List no: 306-165-8 | CAS no: 96507-86-7
-
-
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
show/hide
Bis(4-methyloctyl) phthalate EC / List no: 286-804-4 | CAS no: 85391-50-0
Diisoundecyl phthalate EC / List no: 306-165-8 | CAS no: 96507-86-7
Di-''isononyl'' phthalate EC / List no: 249-079-5 | CAS no: 28553-12-0
Isodecyl isoundecyl phthalate EC / List no: 305-701-8 | CAS no: 94979-22-3
Isodecyl isononyl phthalate EC / List no: 285-916-0 | CAS no: 85168-75-8
2,5-dimethylheptyl 6-methyloctyl phthalate EC / List no: 288-636-7 | CAS no: 85851-77-0
Bis(2,5-dimethylheptyl) phthalate EC / List no: 286-802-3 | CAS no: 85391-48-6
Di-''isodecyl'' phthalate EC / List no: 247-977-1 | CAS no: 26761-40-0
Isononyl isoundecyl phthalate EC / List no: 285-920-2 | CAS no: 85168-79-2
Bis(2-methyldecyl) phthalate EC / List no: 288-643-5 | CAS no: 85851-83-8
Bis(6-methyloctyl) phthalate EC / List no: 286-803-9 | CAS no: 85391-49-7
Bis(2-methyloctyl) phthalate EC / List no: 274-944-9 | CAS no: 70857-56-6
3-ethylheptyl 2,5-dimethylheptyl phthalate EC / List no: 307-707-6 | CAS no: 97692-55-2
Bis(3,5,5-trimethylhexyl) phthalate EC / List no: 237-954-4 | CAS no: 14103-61-8
Bis(2-propylhexyl) phthalate EC / List no: 288-644-0 | CAS no: 85851-84-9
3-ethylheptyl 6-methyloctyl phthalate EC / List no: 288-639-3 | CAS no: 85851-80-5
2,5-dimethylheptyl 4-methyloctyl phthalate EC / List no: 288-635-1 | CAS no: 85851-76-9
Bis(2-ethylheptyl) phthalate EC / List no: 274-344-7 | CAS no: 70152-36-2
Bis(2-ethyloctyl) phthalate EC / List no: 288-640-9 | CAS no: 85851-81-6
Bis(3-ethylheptyl) phthalate EC / List no: 286-806-5 | CAS no: 85391-51-1
Bis(2-propyloctyl) phthalate EC / List no: 288-645-6 | CAS no: 85851-85-0
Bis(2-ethylnonyl) phthalate EC / List no: 288-641-4 | CAS no: 85851-82-7
3-ethylheptyl 4-methyloctyl phthalate EC / List no: 288-638-8 | CAS no: 85851-79-2
Bis(8-methylnonyl) phthalate EC / List no: 201-884-2 | CAS no: 89-16-7
Bis(2-propylheptyl) phthalate EC / List no: 258-469-4 | CAS no: 53306-54-0
4-methyloctyl 6-methyloctyl phthalate EC / List no: 288-637-2 | CAS no: 85851-78-1
-
-
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
271-090-9
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;(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
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;(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
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;(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
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;(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
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;(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
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
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;(c)technical support agent in concentrations up to 0,1 % in the final product.
Details
show/hide
2-ethylhexyl octyl phthalate EC / List no: 701-508-1 | CAS no: 3461-26-5
Isodecyl isooctyl phthalate EC / List no: 255-760-8 | CAS no: 42343-35-1
3-ethylheptyl 2,5-dimethylheptyl phthalate EC / List no: 307-707-6 | CAS no: 97692-55-2
4-methyloctyl 6-methyloctyl phthalate EC / List no: 288-637-2 | CAS no: 85851-78-1
1,2-Benzenedicarboxylic acid, bis-(1-ethylhexyl) ester EC / List no: - | CAS no: 15495-94-0
Bis(2-propylheptyl) phthalate EC / List no: 258-469-4 | CAS no: 53306-54-0
Isononyl isooctyl phthalate EC / List no: 306-190-4 | CAS no: 96532-79-5
1,2-Benzenedicarboxylic acid, bis(2-propylpentyl) ester EC / List no: - | CAS no: 70910-37-1
2,5-dimethylheptyl 4-methyloctyl phthalate EC / List no: 288-635-1 | CAS no: 85851-76-9
3-ethylheptyl 6-methyloctyl phthalate EC / List no: 288-639-3 | CAS no: 85851-80-5
Bis(3-ethylheptyl) phthalate EC / List no: 286-806-5 | CAS no: 85391-51-1
2-ethylhexyl isononyl phthalate EC / List no: 288-652-4 | CAS no: 85851-92-9
Di-''isononyl'' phthalate EC / List no: 249-079-5 | CAS no: 28553-12-0
6-methylheptyl 8-methylnonyl phthalate EC / List no: 204-293-8 | CAS no: 119-05-1
Bis(2-methyloctyl) phthalate EC / List no: 274-944-9 | CAS no: 70857-56-6
2-ethylhexyl nonyl phthalate EC / List no: 288-646-1 | CAS no: 85851-86-1
1,2-Benzenedicarboxylic acid, bis(2,5-dimethylhexyl) ester EC / List no: - | CAS no: 104719-70-2
Bis(6-methyloctyl) phthalate EC / List no: 286-803-9 | CAS no: 85391-49-7
Bis(2-ethylheptyl) phthalate EC / List no: 274-344-7 | CAS no: 70152-36-2
Bis(2-ethylhexyl) phthalate EC / List no: 204-211-0 | CAS no: 117-81-7
Bis(2-propylhexyl) phthalate EC / List no: 288-644-0 | CAS no: 85851-84-9
Diisooctyl phthalate EC / List no: 248-523-5 | CAS no: 27554-26-3
Bis(2-ethyloctyl) phthalate EC / List no: 288-640-9 | CAS no: 85851-81-6
2-ethylhexyl 8-methylnonyl phthalate EC / List no: 201-883-7 | CAS no: 89-13-4
Bis(2,5-dimethylheptyl) phthalate EC / List no: 286-802-3 | CAS no: 85391-48-6
2,5-dimethylheptyl 6-methyloctyl phthalate EC / List no: 288-636-7 | CAS no: 85851-77-0
Bis(3,5,5-trimethylhexyl) phthalate EC / List no: 237-954-4 | CAS no: 14103-61-8
3-ethylheptyl 4-methyloctyl phthalate EC / List no: 288-638-8 | CAS no: 85851-79-2
Di-''isodecyl'' phthalate EC / List no: 247-977-1 | CAS no: 26761-40-0
Bis(1-methylheptyl) phthalate EC / List no: 205-014-2 | CAS no: 131-15-7
Bis(8-methylnonyl) phthalate EC / List no: 201-884-2 | CAS no: 89-16-7
Isodecyl isononyl phthalate EC / List no: 285-916-0 | CAS no: 85168-75-8
2-ethylhexyl isodecyl phthalate EC / List no: 258-455-8 | CAS no: 53272-22-3
Bis(4-methyloctyl) phthalate EC / List no: 286-804-4 | CAS no: 85391-50-0
-
-
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;(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
show/hide
Bis(2,5-dimethylheptyl) phthalate EC / List no: 286-802-3 | CAS no: 85391-48-6
2,5-dimethylheptyl 4-methyloctyl phthalate EC / List no: 288-635-1 | CAS no: 85851-76-9
Di-''isononyl'' phthalate EC / List no: 249-079-5 | CAS no: 28553-12-0
Di-''isodecyl'' phthalate EC / List no: 247-977-1 | CAS no: 26761-40-0
1,2-Benzenedicarboxylic acid, bis-(1-ethylhexyl) ester EC / List no: - | CAS no: 15495-94-0
Bis(3,5,5-trimethylhexyl) phthalate EC / List no: 237-954-4 | CAS no: 14103-61-8
Bis(6-methyloctyl) phthalate EC / List no: 286-803-9 | CAS no: 85391-49-7
1,2-Benzenedicarboxylic acid, bis(2-propylpentyl) ester EC / List no: - | CAS no: 70910-37-1
2-ethylhexyl 8-methylnonyl phthalate EC / List no: 201-883-7 | CAS no: 89-13-4
1,2-Benzenedicarboxylic acid, bis(2,5-dimethylhexyl) ester EC / List no: - | CAS no: 104719-70-2
Isodecyl isononyl phthalate EC / List no: 285-916-0 | CAS no: 85168-75-8
4-methyloctyl 6-methyloctyl phthalate EC / List no: 288-637-2 | CAS no: 85851-78-1
Bis(2-methyloctyl) phthalate EC / List no: 274-944-9 | CAS no: 70857-56-6
2,5-dimethylheptyl 6-methyloctyl phthalate EC / List no: 288-636-7 | CAS no: 85851-77-0
Bis(2-propylheptyl) phthalate EC / List no: 258-469-4 | CAS no: 53306-54-0
Bis(2-propylhexyl) phthalate EC / List no: 288-644-0 | CAS no: 85851-84-9
Bis(2-ethylheptyl) phthalate EC / List no: 274-344-7 | CAS no: 70152-36-2
Bis(1-methylheptyl) phthalate EC / List no: 205-014-2 | CAS no: 131-15-7
2-ethylhexyl isodecyl phthalate EC / List no: 258-455-8 | CAS no: 53272-22-3
Bis(2-ethylhexyl) phthalate EC / List no: 204-211-0 | CAS no: 117-81-7
Bis(8-methylnonyl) phthalate EC / List no: 201-884-2 | CAS no: 89-16-7
Bis(4-methyloctyl) phthalate EC / List no: 286-804-4 | CAS no: 85391-50-0
Isodecyl isooctyl phthalate EC / List no: 255-760-8 | CAS no: 42343-35-1
Isononyl isooctyl phthalate EC / List no: 306-190-4 | CAS no: 96532-79-5
3-ethylheptyl 2,5-dimethylheptyl phthalate EC / List no: 307-707-6 | CAS no: 97692-55-2
6-methylheptyl 8-methylnonyl phthalate EC / List no: 204-293-8 | CAS no: 119-05-1
Bis(2-ethyloctyl) phthalate EC / List no: 288-640-9 | CAS no: 85851-81-6
2-ethylhexyl nonyl phthalate EC / List no: 288-646-1 | CAS no: 85851-86-1
3-ethylheptyl 4-methyloctyl phthalate EC / List no: 288-638-8 | CAS no: 85851-79-2
2-ethylhexyl octyl phthalate EC / List no: 701-508-1 | CAS no: 3461-26-5
Bis(3-ethylheptyl) phthalate EC / List no: 286-806-5 | CAS no: 85391-51-1
Diisooctyl phthalate EC / List no: 248-523-5 | CAS no: 27554-26-3
2-ethylhexyl isononyl phthalate EC / List no: 288-652-4 | CAS no: 85851-92-9
3-ethylheptyl 6-methyloctyl phthalate EC / List no: 288-639-3 | CAS no: 85851-80-5
-
-
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
-
-
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
258-053-2
52628-03-2
1082
no
no
0.05 mg/kg
Only to be used at up to 0,35 % (w/w) to manufacture polymethylmethacrylate.
Details
-
-
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
-
-
1077
yes
no
Only to be used at up to 25.0 % w/w, including in the nanoform.
Details
219-348-1
2421-28-5
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
214-068-6
1076-97-7
806
14876
no
no
5 mg/kg
Only to be used for manufacture of polyesters.
Details
-
-
806
14876
no
no
5 mg/kg
Only to be used for manufacture of polyesters.
Details
-
-
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
201-180-5
79-14-1
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
-
-
1062
no
no
Only to be used for the production of recycled PET and at up to 0,12 % (w/w).
Details
235-798-1
12751-22-3
607
62245
yes
no
Only to be used in PET polymers and copolymers
Details
220-239-6
2682-20-4
451
66755
yes
no
0.5 mg/kg
Only to be used in aqueous polymer dispersions and emulsions.
Details
682-234-9
329238-24-6
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
224-709-1
4457-71-0
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
630-556-5
124578-12-7
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
-
263244-54-8
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
229-962-1
6864-37-5
498
16210
no
no
0.05 mg/kg
Only to be used in polyamides.
Details
THPE; TRIS(P-HYDROXYPHENYL)ETHANE; TRIS(PARA-HYDROXYPHENYL)ETHANE
405-800-7
27955-94-8
662
25927
no
no
0.005 mg/kg
Only to be used in polycarbonates.
Details
-
-
662
25927
no
no
0.005 mg/kg
Only to be used in polycarbonates.
Details
-
-
979
79987
yes
no
Only to be used in polyethylene terephthalate (PET) at a maximum level of 5 % w/w.
Details
213-245-5
931-88-4
381
15030
no
no
0.05 mg/kg
Only to be used in polymers contacting foods for which simulant A is laid down.
Details
-
287916-86-3
871
yes
no
Only to be used in polyolefins at levels of up to 20 weight %. These polyolefins shall only be used in contact with foods for which Table 2 of Annex III assigns food simulant E, at ambient temperature or below, and when migration of the total oligomeric fraction of less than 1 000 Da does not exceed 50 µg/kg food.
Details
ANOX 1315; ANOX BF; DURAD AX 38
413-750-2
171090-93-0
895
47060
yes
no
0.05 mg/kg
Only to be used in polyolefins in contact with foods other than fatty/ high-alcoholic and dairy products.
Details
209-249-1
563-45-1
351
21730
no
no
0.01 mg/kg
Only to be used in polypropylene.
Details
223-320-4
3825-26-1
468
71960
yes
no
Only to be used in repeated use articles, sintered at high temperatures.
Details
480-340-8
156157-97-0
1080
yes
no
Only to be used in rigid poly (vinyl chloride) in contact with foods included in the food category with reference number 01.01.A in table 2 of Annex III.
Details
480-340-8
156157-97-0
1080
yes
no
Only to be used in rigid poly (vinyl chloride) in contact with foods included in the food category with reference number 01.01.A in table 2 of Annex III.
Details
-
-
855
40560
yes
no
Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 12 % at room temperature or below.
Details
-
37953-21-2
857
66765
yes
no
Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 2 % at room temperature or below.
Details
-
40471-03-2
867
40815
yes
no
Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 2 %.
Details
608-050-0
27136-15-8
869
66763
yes
no
Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 3 %.
Details
-
-
866
40620
yes
no
Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 7 %.
Details
200-254-4
56-06-4
864
46330
yes
no
5 mg/kg
Only to be used in rigid poly(vinyl chloride) (PVC) in contact with non-acidic and non-alcoholic aqueous food.
Details
229-934-9
6846-50-0
497
95020
yes
no
5 mg/kg
Only to be used in single-use gloves.
Details
288-287-0
85711-28-0
1065
yes
no
5 mg/kg
Only to be used in the manufacture of articles made of polyolefins, and which do not come into contact with foods for which food simulant D2 is assigned in Table 2 of Annex III.
Details
-
-
861
71990
yes
no
Only 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.
Details
236-236-8
13252-13-6
861
71990
yes
no
Only 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.
Details
680-272-0
51798-33-5
860
71980
yes
no
Only 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.
Details
700-323-3
908020-52-0
926
71955
yes
no
Only to be used in the polymerisation of fluoropolymers that are processed at temperatures higher than 300 °C for at least 10 minutes.
Details
-
958445-44-8
896
71958
yes
no
Only to be used in the polymerisation of fluoropolymers when: (1.) processed at temperatures higher than 280 °C for at least 10 minutes, (2.) processed at temperatures higher than 190 °C up to 30 % w/w for use in blends with polyoxymethylene polymers and intended for repeated use articles.
Details
215-222-5
1314-13-2
1050
yes
no
Only to be used in unplasticised polymers.
Details
215-222-5
1314-13-2
1046
yes
no
Only to be used in unplasticised polymers.
The restrictions and specifications specified for FCM substance No 788 shall be respected.
Details
607-698-1
25322-99-0
865
40619
yes
no
Only to be used in: (a) rigid poly(vinyl chloride) (PVC) at a maximum level of 1 % w/w. (b) polylactic acid (PLA) at a maximum level of 5 % w/w.
Details
618-459-6
9010-88-2
868
53245
yes
no
Only to be used in: (a) rigid poly(vinyl chloride) (PVC) at a maximum level of 2 % w/w. (b) polylactic acid (PLA) at a maximum level of 5 % w/w. (c) polyethylene terephthalate (PET) at a maximum level of 5 % w/w.
Details
214-703-7
1187-93-5
391
22932
no
no
0.05 mg/kg
Only to be used in: anti-stick coatings; fluoro- and perfluoropolymers intended for repeated use applications where the contact ratio is 1 dm2 surface in contact with at least 150 kg food.
Details
843-371-1
25101-28-4
856
40563
yes
no
Only to be used in: rigid poly(vinyl chloride) (PVC) at a maximum level of 12 % at room temperature or below; or at up to 40 % w/w in blends of styrene acrylonitrile copolymer (SAN)/poly(methyl methacrylate) (PMMA) repeatuse articles at room temperature or below, and when either in contact only with aqueous, acidic and/or low alcoholic (< 20 %) foodstuffs for less than 1 day, or when in contact only with dry foodstuffs for any duration of time.
Details
-
1547-26-8
1063
no
no
Only to be used together with tetrafluoroethylene and/or ethylene co-monomers to manufacture fluorocopolymers for application as polymer processing aid at up to 0,2 % w/w of the food contact material, and when the low-molecular mass fraction below 1 500 Da in the fluorocopolymer does not exceed 30 mg/kg.
Details
213-551-9
976-56-7
1007
no
no
Only to be used up to 0,2 % w/w based on the final polymer weight in the polymerisation process to manufacture poly(ethylene terephthalate) (PET) and poly(ethylene 2,5-furandicarboxylate) (PEF)
Details
-
-
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.
Details
-
-
1016
yes
no
Only to be used up to: (a) 10 % w/w in non-plasticised PVC; (b) 15 % w/w in non-plasticised PLA.
The final material shall be used at room temperature or below.
Details
210-826-5
624-03-3
1048
yes
no
Only to be used when produced from a fatty acid precursor that is obtained from edible fats or oils.
Details
-
-
1053
yes
no
Only to be used when produced from a fatty acid precursor that is obtained from edible fats or oils.
Details
210-478-4
616-38-6
1067
no
no
Only to be used: a) with 1,6-hexanediol in the manufacture of polycarbonate pre-polymers that are used at up to 30 % to manufacture thermoplastic polyurethanes with 4,4'-methylenediphenyldiisocyanate and diols, such as polypropylene glycol and 1,4-butanediol. The resulting material shall only be applied in repeated use articles intended to come into short-term contact (≤ 30 min at room temperature) with food for which simulants A and/or B are assigned in Table 2 of Annex III; or b) for the production of other polycarbonates and/or under other conditions provided that the migration of dimethyl carbonate does not exceed 0,05 mg/kg food and that the migration of all polycarbonate oligomers with a molecular weight below 1 000 Da together does not exceed 0,05 mg/kg food.
Details
A clay that is essentially kaolinite, a hydrated aluminum silicate. It has a high fusion point and is the most refractory of all clays.
310-194-1
1332-58-7
410
62720
yes
no
Particles can be thinner than 100 nm only if incorporated at a quantity of less than 12 % w/w in an ethylene vinyl alcohol copolymer (EVOH) inner layer of a multi- layer structure, in which the layer in direct contact with the food provides a functional barrier preventing migration of particles into the food.
Details
-
-
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
215-609-9
1333-86-4
411
42080
yes
no
Primary particles of 10 - 300 nm which are aggregated to a size of 100 - 1200 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.
Details
-
132459-54-2
764
13317
no
no
0.05 mg/kg
Purity > 98,1 % (w/w).
Only to be used as co-monomer (max 4 %) for polyesters (PET, PBT).
Details
-
-
873
93460
yes
no
Reaction product of titanium dioxide with up to 2 % w/w surface treatment substance octyltriethoxysilane, processed at high temperatures.
Details
219-371-7
2425-79-8
442
13780
no
no
0.01 mg/kg
Residual content = 1 mg/kg in final product expressed as epoxygroup.
Molecular weight is 43 Da.
Details
213-048-4
919-30-2
377
12786
no
no
0.05 mg/kg
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.
Details
614-610-5
68554-70-1
730
66930
yes
no
Residual monomer in methylsilsesquioxane: < 1 mg methyltrimethoxysilane/kg of methylsilsesquioxane.
Details
224-594-8
4422-95-1
481
13060
no
no
0.05 mg/kg
SML expressed as 1,3,5-benzenetricarboxylic acid.
Details
204-179-8
117-21-5
786
14627
no
no
0.05 mg/kg
SML expressed as 3-chlorophthalic acid.
Details
204-251-9
118-45-6
787
14628
no
no
0.05 mg/kg
SML expressed as 4-chlorophthalic acid.
Details
681-637-7
25134-51-4
636
31500
yes
no
0.05 mg/kg
SML expressed as acrylic acid, 2-ethylhexyl ester.
Details
202-510-0
96-49-1
177
16955
no
no
30 mg/kg
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.
Details
Substance identity is confidential or pending assessment. If possible, following assessment the proper substance identifiers will be displayed.
-
-
685
85950
yes
no
0.15 mg/kg
SML expressed as fluoride.
Only to be used in layers of multi-layer materials not coming into direct contact with food.
Details
279-459-6
80410-33-9
745
68145
yes
yes
5 mg/kg
SML expressed as sum of phosphite and phosphate.
Details
ADK STAB PEP-36
410-290-4
80693-00-1
746
38810
yes
yes
5 mg/kg
SML expressed as sum of phosphite and phosphate.
Details

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