On May 6, 2013 the EU Commission’s Directorate General for Consumer Health (DG SANCO) held a stakeholder meeting on food contact materials (FCMs). The new forthcoming EU guidance on plastic migration testing figured prominently amongst the topics discussed. The guidance will assist both enforcement labs and industry in performing migration testing for plastic FCMs, based on the legal requirements of the EU Plastics Regulation (EC 10/2011). Scientists from the EU’s Joint Research Centre (JRC), together with experts from DG SANCO, EU member state enforcement labs, industry and consulting are charged with drafting the comprehensive new guidance text that will be critical for ensuring FCM chemical safety. The new document will not lean on any previous guidance. It addresses questions the EU Commission has already received concerning migration testing according to the new Plastics Regulation. The new guidance is expected to be finalized and published by the end of 2013.
Other topics of discussion included the new EU Biocides Regulation (EC 528/2012) entering into force September 1, 2013 and covering all biocides, including those used in FCMs. For the latter, several transitional periods exist. Even so, any biocides applied in FCMs require dedicated evaluations, including for environmental impacts. The Commission distinguishes between surface biocides and process biocides. Surface biocides are applied to FCMs intending an effect in the final article. Process biocides are used as components during the manufacture of FCMs, but are without an intended function in the final product. Examples of surface biocides are compounds like triclosan, used in antibacterial chopping boards or fridge shelves. For process biocides a generic migration limit of 10 µg/kg food is planned, except for those biocides that already have a specific migration limit. Substances with biocidal properties migrating above 10 µg/kg food will require a separate application for authorization, even if they are not used as surface biocides.
Finally, the group discussed amendments to the text of the new Plastics Regulation (EC 10/2011). Amongst several of the points requiring clarification, the issue of oligomers stood out. These by-products of polymerization are not explicitly mentioned in the legal text, and from a legal perspective they are not considered to be non-intentionally added substances (NIAS). Therefore, their presence in FCM plastics implies uncertainty as to how legal safety requirements shall be met. The new amendment is expected by the end of 2013. Further amendments to the Plastics Regulation for authorization of new compounds will be published. This will, however, be realized in a separate document.