On September 30, 2015 over 200 experts gathered in Luxembourg to discuss food contact materials (FCMs) risk assessment, regulation, enforcement and innovation. The meeting was organized by the Grand Duchy of Luxembourg in collaboration with the European Food Safety Authority (EFSA) on the occasion of the current Luxembourg EU presidency and was entitled “Food contact materials: Working together for safety and innovation in Europe.”
Several speakers from government institutions and industry associations shared their views on challenges related to innovation, risk assessment of chemicals present in FCMs, and enforcement of existing regulations. Michael Flüh of the European Commission’s (EC) Directorate-General for Health and Food Safety (DG SANTE) showed the relevance of FCMs for the European market, with around 100 billion € market value generated annually with food packaging in Europe. Most European FCM manufacturers are small and medium enterprises (SMEs). Further, he explained that strengthening the EU single market and removing trade barriers were top priorities for the current EU government; in the context of FCMs this is challenging since EU-wide, harmonized legislation currently does not exists for all materials. Therefore, the focus lies on the principle of mutual recognition, whereby a product lawfully marketed in one Member State is also legal in another. Further, Mr. Flüh also highlighted the need for more efficient ways to evaluate the large number of chemicals (>10,000) present in FCMs today.
The Council of Europe (CoE) was represented by Francois-Xavier Lery who explained CoE’s work on FCMs. As an intergovernmental organization, CoE collaborates with the EU and further non-EU countries, like Switzerland. Since 1989 CoE has published several resolutions and technical documents on FCMs that are as such not legally binding, but CoE members can chose to adopt them for their national legislation. For example, Switzerland has done this for FCM printing inks.
Speaking on behalf of EFSA, Jeffrey Moon explained that increased efforts were being made to coordinate scientific opinions and cooperate with EU Member States on issues of increased public interest. The goal of this effort is to avoid duplications and differing conclusions on scientific opinions between national authorities and EFSA, as occurred for example in the case of bisphenol A (BPA, CAS 80-05-7) where the French agency ANSES reached a different conclusion concerning the chemical’s safety than EFSA (FPF reported).
The afternoon was structured in three parallel sessions on risk analysis, official controls and innovation. In the session on risk analysis, Catherine Simoneau of the EU Reference Laboratory on FCMs (EURL-FCM) at the EC Joint Research Center (JRC) reported that currently over 930 substances were authorized in Europe for use in plastic FCMs (Simoneau 2015). For 33% of these regulated substances the EURL-FCM identified methods for chemical analysis, while only for 28 substances internationally agreed standardized methods are presently available. Applicants need to provide a chemical sample when seeking authorization for a new substance; nevertheless, for only around 40% of already authorized substances such chemical samples are available or can be purchased from chemical suppliers. This implies that the majority of presently authorized substances cannot be measured chemically, thus making regulatory enforcement impossible.
Francoise Gods of Plastics Europe presented her organization’s work on non-intentionally added substances (NIAS). The industry association has published an online tool that provides support with the risk assessment of NIAS, the Matrix Calculation Tool. She concluded that a standard method was needed for the detection of NIAS, and that the present situation without guidance was especially challenging for SMEs.
In conclusion, the present regulatory situation is complex and challenging especially for SMEs. Legislation can be a driver for innovation, but its absence in the area of non-harmonized FCMs (i.e. all FCMs other than plastics, regenerated cellulose, recycled plastics materials, ceramics, and active and intelligent materials) was seen as an obstacle for innovation. New approaches are needed in the area of chemical risk assessment for managing the large number of relevant chemicals, and practical solutions need to be found for enforcing the FCM Framework Regulation EU 1935/2004, Article 3.
Sécurité alimentaire (2015). “Conference – Food Contact Materials: Working together for safety and innovation in Europe.” The Grand Duchy of Luxembourg
EC – DG GROWTH. “Mutual recognition.”
Simoneau, C. (2015). “Annual report 2014 of the EURL-FCM on activities carried out for the implementation of Regulation (EC) no 882/2004.” Joint Research Center
Plastics Europe et al. (2015). “Matrix Calculation Tool.”