Study supporting the Evaluation of Food Contact Materials (FCM) legislation - (Regulation (EC) No 1935/2004)

The “Study supporting the Evaluation of Food Contact Materials (FCM) legislation - (Regulation (EC) No 1935/2004)” provides an analysis of the current EU legislative framework for FCM. The study assesses the effectiveness, efficiency, relevance, coherence, and the EU added value of the Regulation. The analysis is mainly based on case studies and on an extensive consultation strategy which encompassed interviews, focus groups, workshops, and surveys. The study finds that despite its overall positive impact, the overall performance of the legislative framework is not completely satisfactory due to insufficient availability of resources and important gaps in implementation and enforcement. Positive developments mainly relate to the coherent framework provided by the legislation, in which measures can be taken at EU and national levels. The Regulation provides a basis for securing a high level of protection of human health regarding individual materials, with benefits estimated to outweigh costs. The EU positive list approach is effective in contributing to the functioning of the internal market. Declarations of compliance, traceability, and labelling requirements also contribute positively to the functioning of the internal market.