In October 2017, the European Commission’s (EC) Directorate-General for Health and Food Safety (DG SANTE) published three presentations of the latest meeting of its Technical Expert Group for Food Contact Materials (FCMs). The meeting took place on September 14, 2017.
The EC’s Joint Research Centre (JRC) gave a detailed presentation on the baseline study on non-harmonized FCMs in the EU that was published in January 2017 (FPF reported). The presentation outlines how the non-harmonized sectors are less effectively and less efficiently regulated as compared to the material types for which EU-wide regulations exist. The safety of non-harmonized FCMs is less guaranteed because of e.g. different risk assessment and authorization processes in different countries and inconsistent enforcement. Non-harmonized FCMs are also a burden to industry because of e.g. multiple and diverging national legislation and issues with mutual recognition.
The EC informed about the planned EU measure on printed FCMs (FPF reported). The EC is considering two options for regulating printed FCMs: 1) A traditional structure similar to the plastic FCM Regulation (EU) No 10/2011, and 2) a new approach based on designated bodies. The first option requires the setting of a scope, definitions, as well as rules on composition (e.g. positive list and limit values), documentation (e.g. declaration of compliance) and verification of compliance. This option is currently deemed problematic because it would result in several decades of work. The second option shifts the responsibilities to designated bodies (e.g. accredited commercial laboratories or consultants) and relies on a rule base directing the work, a central database, and a governance committee. This option is currently “selected for further development.” Official EC planning is scheduled for the fourth quarter of 2017 and the measure is expected to be ready by the end of 2018.
The draft of the 10th amendment to the plastic FCM Regulation (EU) No 10/2011 was presented. The draft foresees to update the entry for the substance phosphorous acid, mixed 2,4-bis(1,1-dimethylpropyl)phenyl and 4-(1,1-dimethylpropyl)phenyl triesters (CAS 939402-02-5) in the Union List so as to increase its specific migration limit from 5 to 10 mg/kg food (FPF reported). Two new food contact substances are to be added to the Union List: 1,2,3,4-Tetrahydronaphthalene-2,6-dicarboxylic acid, dimethyl ester (TDCM, CAS 23985-75-3) (FPF reported) and dimethyl carbonate (CAS 616-38-6) (FPF reported).
The meeting agenda and summary have not been published yet.
JRC (September 14-15, 2017). “FCM baseline study.” (pdf)
EC (September 14, 2017). “p-FCM.” (pdf)