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EC planned Amendment of Food Contact Materials Regulation approves Use of 4 Nanoscale Substances

The European Commission (EC) has informed the World Trade Organization (WTO) of its intention to modify Commission Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food. According to the notification, ‘it amends the authorisation for nine substances, [and] includes six new substances with a favourable assessment by the European Food Safety Authority (EFSA)’; four of these materials are on the nanoscale.

One of the amendments is to kaolin, ‘to include particles in the nanoform with a thickness less than 100nm’. The EC states that ‘the use of the substance to the new specification does not endanger human health, and the authorisation [… for the substance] should be amended to include a specification and restriction on particle size’. Meanwhile three of the six additions are for substances in the nanoform, and are:

  • (butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer cross-linked with divinylbenzene
  • (butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer not cross-linked
  • (butadiene, ethyl acrylate, methyl methacrylate, styrene) cross-linked with 1,3-butanediol dimethacrylate

These 3 substances can be used ‘individually or in combination as an additive [… to] non-plasticised PVC’. Like the nanoform of kaolin, the EC states ‘the use of these three substances does not endanger human health if used according to these specifications’. An opinion on this was adopted by EFSA on 27 March 2014 following a request by the UK Food Standards Agency.

In general the proposed regulation is set to modify the Union list of approved substances. It is to be adopted in November 2014, and comments on it are due by 27 June 2014.


Follow this link to read the proposed Commission Regulation, and this to read the EC notice to the WTO. Furthermore follow this link to read EFSA's opinion on three of the four nanomaterials.

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