Scope:

Evaluation of Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food.

The evaluation covered the functioning of the food contact material Regulation in its entirety and the rules and tools provided for by this legislation applicable in the European Union. This included the relevant aspects of specific implementing measures. It also examined the situation concerning materials for which there are no EU specific measures and which are subject to national measures.

Evaluation findings:

The evaluation concluded that overall, the FCM Regulation functions, to a certain extent, as expected and partly fulfils its objectives, in particular for plastic FCMs for which specific EU rules apply. The main deficiencies relate to lack of specific rules for FCMs besides plastic, the inability to demonstrate compliance, unavailability of information in the supply chain, challenges in enforcement and lack of prioritisation of the most hazardous substances. The current system in general provides inadequate support to SMEs. Finally, the current legislation and approaches are also largely incompatible with current trends in the switch from materials synthesised from traditional chemistry such as polymers to more novel or natural, sustainable alternatives

More specifically, the evaluation showed that EU rules for plastic FCMs are technically complex and resource intensive: for the Commission to manage, for EFSA to provide scientific risk assessment, for EU Member States to implement and enforce and for industry, in particular SMEs, to ensure compliance. In contrast to the specific complexities of the plastics Regulation, the FCM Regulation does not define the level of safety or quality expected for FCMs. Further, it does not state how safety should be achieved nor how it can be demonstrated. Many Member States have therefore introduced national measures for non-plastic FCMs. However, those measures often differ, which has created confusion over required levels of safety and legal uncertainty for businesses, particularly SMEs, who may be faced, for example, with multiple testing regimes, increased costs and reduced access to the EU market.