On April 28, 2014 the European Commission’s (EC) Directorate General for Health and Consumers (DG SANCO) convened stakeholders from Member State authorities and industry to discuss the 5th amendment to regulation EC 10/2011, the draft regulation for biocides used in food contact materials (FCMs) and a modified working plan for 2014 taking into consideration that the Head of Sector of the EC’s Food Contact Materials Group, Annette Schäfer, is leaving.

With regards to the substances to be added to Annex I of regulation EC 10/2011 on plastics food contact materials, DG SANCO specified that only the natural occurring L-form of tartaric acid is authorized for food contact as the D-form has not been evaluated for safety. Further, DG SANCO clarified that activated carbon (CAS 64365-11-3) is to be synonymous with activated charcoal. The listing of a PVC cross-linked copolymeric additive, which is composed of the monomers butadiene, ethylacrylate, methyl-methacrylate, and styrene, and cross-linked with 1,3-butanediol dimethacrylate, will include the specification “in nanoform”. The 5th amendment of EC 10/2011 will not include the polyethyleneglycolether specified by CAS 68439-49-6 as there remain open questions with respect to compliance testing. Thermoplastic elastomers are to be addressed in the 6th amendment to regulation EC 10/2011, which is expected for 2015. Gudrun Gallhoff, Deputy Head of Unit, was announced to take over interim-responsibility for the drafting of a regulation setting limits for biocides in FCM. The measure aims to resolve the regulatory overlap between the biocidal products regulation (BPR) EU 528/2012, the FCM framework regulation EC 1935/2004 and the food additive regulation EC 1333/2008. DG SANCO proposes a rule by which substances authorized under the BPR 528/2012 will not require additional evaluation by the European Food Safety Authority (EFSA) if they fulfill these specific criteria:

  • neither carcinogenic, mutagenic or toxic to reproduction (CMR), endocrine disrupting chemicals (EDCs) nor nanomaterials
  • do not migrate into food from FCM at levels >10ug/kg food
  • are not present as residues at levels >1mg total constituent/kg packaging material

Substances that do not meet these criteria will require evaluation by the European Food Safety Authority (EFSA), if no such assessment of the biocide has been carried out already. 

With Annette Schäfer leaving the Food Contact Sector Group on May 1, 2014, DG SANCO will proceed with the working plan for 2014 at reduced capacity. Until the appointment of a new Head of Group, , Bastiaan Schupp will carry out the main technical work, Agnes Joubert will lead the secretariat, and Gudrun Gallhoff will support the team. While the 5th substance amendment to EC 10/2011 is considered complete and will be presented to the Standing Committee on July 1, 2014, the text amendment is to be discussed again at the next meeting. DG SANCO stressed that the recycling and biocide regulations remain a priority, whereas the new migration guidelines and the ceramic regulation will be delayed. For further regulation of bisphenol A (BPA), DG SANCO will await the publication of the pending EFSA opinion which is to be expected by the end of 2014.