Non-harmonised food contact materials in the EU : regulatory and market situation, baseline study : final report

The aim of this work is to support DG Health and Food Safety with a baseline study on non-harmonised food contact materials (FCMs). The study aimed to analyse the existing regulatory frameworks at national or sectorial level to demonstrate compliance with the general safety requirements for materials not harmonised at EU level. It also examined the perceived barrier to trade and the burden of the current measures in place. Overall the entire sector of FCM suffers to a certain extent from the current situation, which exhibits a lack of harmonisation of materials listed under the framework regulation and is the object of issues in mutual recognition. There are multiple forms of legislation across Member States, but they are disparate for the different sectors. Measures are not always sufficiently detailed, in particular for requirements and quality assurance towards declaration of compliance and supporting documents, certification where applicable, basis for enforcement and sanctions. In the absence of agreed incentives and requirements, Member States can face hurdles in demonstrating the lack of safety and practical difficulties for enforcement and removal of products in their own markets. With regard to good manufacturing practices (GMP), generic guidance from Member States are also seldom very detailed from an implementation standpoint and rarely material specific. The HSFAA and BTSF actions clearly indicated that GMP was an endemic issue in the FCMs sector, although from the industry side, GMP is tackled by professional associations in the form of guidelines. It is however not clear whether these guidelines are used in practice by the members at national and local level all the way down to small and medium-sized enterprises. Further indicators not existing at this stage would be needed. In terms of material-specific aspects, the main hurdles are access to relevant legislation and disparities in both the nature of substances considered, the types of restrictions and the numerical values imposed. These factors constitute an impediment to mutual recognition. Practical implementation and enforcement is impeded by the lack of access to or availability of testing methods to test compliance with legislative limits. The study found a gap in quantitative indicators to evaluate efficiency (including burden and barriers to trade) and food safety in more depth, particularly in regard to effectiveness. This investigation was initiated to support DG Health and Food Safety in conducting an (ex post) evaluation and exploring options. The JRC extended the scope of the baseline to make it a base reference for anyone seeking information on requirements and tools on FCMs.