Chemical Safety – EU strengthens Plastics Regulations

As part of the ongoing process to ensure the chemical safety of Food Contact Materials (FCMs) the EU has recently amended its ‘plastic materials and articles intended to come into contact with food’ Regulation. This amendment is being implemented in two phases starting on the 19th May 2017.

EU chemical safety regulation – a history

In October 2004 the EC published the framework regulation (EC) No 1935/2004[1] to provide a harmonised legal EU framework and to set out general principles of chemical safety and inertness for all FCMs. This was followed in January 2011 by Regulation (EU) 10/2011 [2] to regulate food contact plastics. This comprehensive piece of legislation established specific requirements for plastic materials and articles which are intended or could reasonably be expected to come into contact with food, or are already in contact with food.

Between 2011 and 2008 several amendments were made to Regulation (EU) 10/2011, in the main these added further chemicals to Annex 1 which contains the list of authorised substances.

In August 2016, regulation (EU) 10/2011 was substantially amended by Regulation (EU) 2016/1416[3]. This included, among other things, a new list of authorised substances, new restrictions, a newly defined set of simulants for ‘fresh or chilled fruit’ and ‘fresh or chilled vegetables’, and a new definition for ‘hot-fill’.

Latest Amendment

On April 29, 2017, the EU published Regulation (EU) 2017/752 [4] which further amends Regulation (EU) 10/2011. This amendment contains a number of important changes, including:

  • A completely new entry for the specific migration of nickel, restricting it to no more than 0.02 mg/kg (Item 8, Table 1) in point 1 to Annex II (Restrictions on materials and articles). Thus the increasing the number of heavy metals with specific migration level restrictions from 8 to 9
  • Adding 6 substances to the authorised list of substances
  • Editorial changes to Table 3 in point 4 to Annex III (Food simulant assignment for demonstrating compliance with the overall migration limit) by establishing the information in the form of a table for ease of reference
  • Replacing the residual content requirements of 10 substances with specific migration limits

Effective date and transitional period

There are two effective dates:

  1. May 19, 2017 for Regulation (EU) 2017/752 (except for the specific migration of nickel falling under point 1 to Annex II)
  2. May 19, 2019 for the specific migration of nickel falling under point 1 to Annex II

The amendment allows for a transitional period for plastic FCMs that are compliant with Regulation (EU) 10/2011 prior to the amendment Regulation (EU) 2017/752 coming into force. Such materials may be placed on the market until 19th May 2018 and may remain on the market until stocks are exhausted.


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