On March 3, 2014 the European Commission’s (EC) Directorate General for Consumer Health (DG SANCO) invited stakeholders to participate in its regular meeting on food contact materials (FCMs). Topics included (i) the new Regulation for biocidal products (EC No. 528/2012) and how it affects FCMs, (ii) amendments to the Plastics Regulation EC 10/2011 concerning thermoplastic elastomers (TPEs) and the Declaration of Compliance requirements, and (iii) the new draft guidelines for migration testing of plastic FCMs.
(i) Biocides Regulation
The relevance of the new Biocidal Products Regulation (EC 528/2012) for FCMs was discussed in a presentation by DG Environment. Biocidal products in FCMs require authorization, if they have an intended biocidal effect in the FCM. Such biocides are considered surface biocides. The use of process biocides, namely biocidal products applied during the manufacture of FCMs and not intended to be present in the final FCM article, will likely also require special authorization for FCM use. However, this is still subject to clarification. Substances that are already used in FCMs as biocides but are not yet under review as such will require separate authorization. Applications must be submitted before September 1, 2016. Notably, the new Biocides Regulation applies to all FCMs, also if they are not subject to harmonized regulations (i.e. the non-plastics FCMs).
(ii) Amendments to the Plastics Regulation EC 10/2011
New amendments to the Plastics Regulation EC 10/2011 are planned for 2014, aiming at clarifying its scope with respect to Thermoplastic Polymers (TPEs) and the Declaration of Compliance requirements. Whether TPEs fall under the scope of the Plastics Regulation has been debated; DG SANCO clarified that TPEs are defined as polymers to which additives are added, and therefore the Plastic Regulation does apply. Several additives used in the manufacture of TPEs are currently not authorized on the regulation’s positive list. The Commission proposes a transitory period for including these substances on the list. In addition, Thermoplastic Vulcanizates (TPVs) which are used as additives in polymers to convey elastic properties, also fall under the scope of the Plastics Regulation and will need special authorization as additives, similar to glass fiber additives.
Amendments to Articles 15 and 16 of the regulation (EC 10/2011), concerning the Declaration of Compliance (DoC) and Supporting Documentation, were presented and discussed. The purpose of these amendments is to clarify objectives and responsibilities of the various stakeholders throughout the FCM supply chain. Notably, all importers of FCM articles, even those already in contact with foods (i.e. packaged foodstuffs), must issue DoCs and provide them to their customers. For foods manufactured and packaged in Europe this provision does not apply. The final amendments are expected to be published in autumn 2014.
(iii) Guidelines for migration testing
The EC’s Joint Research Centre (JRC) has prepared a draft guideline on migration testing, together with experts from Member States and industry. At the meeting, this draft was made available and comments were solicited. Additional comments may be provided to DG SANCO by March 20, 2014. The final guidelines will be subject to discussions during the next stakeholder meeting at the end of April.