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(EU)No.10/2011-New EU Regulation on Plastic Materials and Articles that Come into Contact with Food Published

New EU Regulation (EU) No.10/2011 on plastic materials and articles that come into contact with food was published on 15 January 2011 by the European Commission.
This new EU regulation repeals several existing directives, including EU Directive No. 2002/72/EC, 80/766/EEC and 81/432/EEC, which are repealed with effect from 1 May 2011.
A number of new provisions have been made in the new regulation,which will take effect on 1 May 2011.
New Commission Regulation (EU) No.10/2011 on Plastic Materials and Articles that Come into Contact with Food-Key Changes and Highlights
Expanded Scope - The scope for plastic materials in Regulation No.10/2011 has been
expanded to encompass the plastic layers in multi-material multi-layer materials and articles.
Union List of Authorised Substances - The list of authorised substances (a union list that
contains 885 substances) published in Annex I is a substitute for the exhaustive list of
monomers and additives in the former directives.
Migration Limits on Heavy Metals - Limitations on the migration limits of heavy metals in
plastic food contact materials are newly specified in Annex II.
New List of Simulants - The rules for verification of the compliance of materials and objects
have been modified. A new list of simulants and certain conditions is now included in Annex III.
The list of food simulants is as follows.

List of food simulants
Ethanol 10 % (v/v)
Food simulant A
Acetic acid 3 % (w/v)
Food simulant B
Ethanol 20 % (v/v)
Food simulant C
Ethanol 50 % (v/v)
Food simulant D1
Vegetable oil
Food simulant D2
poly(2,6-diphenyl-p-phenylene oxide), particle size 60-80 mesh, pore size 200 nm
Food simulant E

New Requirements for Dry Foods - Migration of substances from dry foods is now subject
to specific migration tests performed with food simulant E according to Annex III.
Date of Enforcement - The new regulation will come into force on 1 May 2011. A transitional
period from 31 December 2012 to 31 December 2015 has been set for implementation of the
new provisions.
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