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 19 April 2024. Database contains 1080 unique substances/entries.
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230-022-8
6915-15-7
499
19965
65020
yes
no
In case of use as a monomer only to be used as a co-monomer in aliphatic polyesters up to maximum level of 1 % on a molar basis.
Details
216-823-5
1675-54-3
426
13610
13510
no
no
In compliance with Commission Regulation (EC) No 1895/2005 [OJ L 302, 19.11.2005, p. 28].
Details
231-791-2
7732-18-5
515
95855
26360
yes
no
In compliance with Directive 98/83/EC [OJ L 330, 5.12.1998, p. 32.].
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
270-337-8
68425-17-2
724
24903
no
no
In compliance with the purity criteria for maltitol syrup E 965(ii) as laid down in Commission Directive 2008/60/EC [OJ L 158, 18.6.2008, p. 17.].
Details
232-391-0
8013-07-8
532
88640
yes
no
30 mg/kg
In the case of PVC gaskets used to seal glass jars containing 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, the SML is lowered to 30 mg/kg.Oxirane < 8 %, iodine number < 6.
Details
-
26427-07-6
649
47210
yes
no
Molecular unit = (C8H18S3Sn2)n (n = 1,5-2).
Details
247-117-5
25583-20-4
807
93485
yes
no
No migration of titanium nitride nanoparticles.
Only to be used in polyethelyne terephthalate (PET) bottles up to 20 mg/kg.
In the PET, the agglomerates have a diameter of 100 - 500 nm consisting of primary titanium nitride nanoparticles; primary particles have a diameter of approximately 20 nm.
Details
234-354-4
11116-16-8
807
93485
yes
no
No migration of titanium nitride nanoparticles.
Only to be used in polyethelyne terephthalate (PET) bottles up to 20 mg/kg.
In the PET, the agglomerates have a diameter of 100 - 500 nm consisting of primary titanium nitride nanoparticles; primary particles have a diameter of approximately 20 nm.
Details
-
-
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 %)
Details

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