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.
RELEVANT LEGISLATION
| FCM No |
159
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|
| Ref No. |
74560
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|
| Additive or PPA |
yes
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|
| Use as monomer/macromolecule |
no
|
|
| FRF applicable |
no
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|
| SML(T) Group Restriction No |
G32 Group Restriction No. 32 corresponds to FCM substance No. 8,72,73,138,140,157,159,207,242,283,532,670,728,729,775,783,797,798,810,815,1078,1085. Group restriction specification is expressed as the sum of the substances (plasticisers).
|
|
| SML(T) Group FCM substances |
8,72,73,138,140,157,159,207,242,283,532,670,728,729,775,783,797,798,810,815,1078,1085
|
|
| SML(T) (mg/kg) |
60 mg/kg
|
|
| Restriction(s) |
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.
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| Notes on verification |
V7 If testing in food is performed, Annex V 1.4 shall be taken into account.
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| Notes |
eupn3 Diisobutyl phthalate, FCM No 1085, with synonyms 1,2-bis(2-methylpropyl) benzene-1,2-dicarboxylate or ‘DIBP’ and CAS number 84-69-5 is not listed as an authorised substance in Table 1. However, it may co-occur with other phthalates as a consequence of its use as an aid to polymerisation and is included in group restrictions with the assignment FCM No 1085
eupn4 Infant, infant formula and follow-on formula as defined in Article 2(2) of Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, p. 35).
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| Expressed As |
As the sum of the substances
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