The EU Commission’s responsible office for food contact materials (FCMs) at the Directorate General for Health and Consumers (DG SANCO) held a stakeholder meeting on FCMs last Friday, February 22, 2013. Topics discussed at the meeting included guidance on the Declaration of Compliance for plastic FCMs, new ceramics legislation and amendments to the Plastics Regulation EC/10/2011. Meeting attendants included representatives from EU Member States, industry trade associations, and the Food Packaging Forum.

The Commission is preparing a guidance document for the Declaration of Compliance (DoC) for plastic FCMs (EC/10/2011, Articles 16 and 17). The DoC is intended as documentation on legal compliance for the scope of intended use. For example it may inform a food company whether a packaging material is suitable for containing fatty foods. At the same time, the DoC aims to maintain private and business-relevant information confidential. Practical issues related to the DoC were discussed, such as responsibility for compliance of non-intentionally added substances (NIAS) that may be formed throughout the supply chain. Final agreement on the guidance is expected later in 2013. Further, the necessity for an amendment of the underlying legal text in order to remove current ambiguity has been discussed.

Two new substances will be proposed in amendment to the Plastics Regulation for use in plastic FCMs based on favorable EFSA scientific opinions. The substance 2-phenyl-3,3-bis(4-hydroxyphenyl)phthalimidine (CAS # 6607-41-6), also known as N-Phenyl Phenolphthalein, is proposed for authorization as co-monomer in polycarbonate copolymers with a specific migration limit of  50 ppb (EFSA scientific opinion 2012). Another proposal covers the manufacture of middle layer coatings using 1,3-bis(isocyanatomethyl)benzene (CAS # 3634-83-1) as co-monomer. Together with the monomer’s breakdown substance 1,3-benzenedimethanamine (CAS # 1477-55-0), migration may not exceed 50 ppb (EFSA scientific opinion 2012). The inclusion of the perfluorinated polymerization aid for fluoropolymers (Freon E5, CAS #37486-69-4) had been postponed due to ongoing discussions about risk management. EFSA has already given its OK for this substance’s use in FCMs (EFSA scientific opinion 2012).

Planned discussions for new legislation on ceramics have been postponed until autumn 2013, due to several practical issues concerning testing methods requiring further clarification. The EU Commission’s Joint Research Centre (JRC) is tasked with a dedicated project that will be ongoing during the next 12 months.


EFSA opinion on 2-phenyl-3,3-bis(4-hydroxyphenyl)phthalimidine 2012

EFSA opinion on 1,3-bis(isocyanatomethyl)benzene 2012

EFSA opinion on 2H-perfluoro-[(5,8,11,14-tetramethyl)-tetraethyleneglycol ethyl propyl ether] 2012