EU Science Hub

Mapping the industry and regulatory frameworks for food contact materials to support better regulation

Jan 18 2017

The EC-JRC released a EU wide review at national and sectorial level on food contact materials (FCMs) for which there are no specific measures at EU level. The study reveals a number of shortcomings for these sectors with variations in for example national risk assessment approaches, their risk management and their controls. This baseline study provides insight in the possible safety and trade impact of the current regulatory scheme and indicates where improvements are needed, thus serving as a reference for potential policy options.

Materials and articles intended to come in contact with food (food contact materials or FCMs) fall under a framework regulation that establishes principles of safety assessment and management regarding the risk of transfer of chemicals from such materials to the foods.  

The market for FCMs in Europe represents around EUR 100 billion annual turnover. Plastic together with paper and board represent more than half, followed by glass, metal and machinery. Sectors of adhesives, inks, resins, waxes, ceramics, cork, wood, rubbers, silicone and coatings are smaller. Many sectors have a significant portion of small and medium enterprises even if their contribution to the turnover is limited.

While some materials are covered by EU wide specific measures, 13 out of 17 sectors are remain overseen by national rules and depend on mutual recognition, raising concerns that inconsistencies can impact safety and trade.

The EC-JRC study reviewed the frameworks for food safety compliance and burden of having only national legislation. It found four principal shortcomings to the current situation:

(1) There is a lack of common guidelines and transparency in undertaking risk assessment (RA) work across Member States. Schemes and requirements for the authorisation of substances are not the same in all MSs and often differ from that of EFSA. The potential of RA tools developed in the EU is not fully exploited.
(2) National measures can be difficult to access and are not always consistently structured or sufficiently detailed. Standards on common food safety requirements to all FCMs and Good Manufacturing Practice (GMP) are needed. In particular, the Declaration of Compliance (DoC) and supporting documents need quality criteria potentially linked to sanctions for the adequate quality and traceability of information transfer along the chain.
(3) Measures are based on lists of authorised substances (with a total of close to 8 000), but show disparities among MSs in the nature of substances considered, the type of restrictions imposed and their numerical values. This leads to multiple testing requirements and further complicates mutual recognition.
(4) Testing methods are lacking for enforcement and compliance, making it more difficult to demonstrate that food safety is consistently ensured.
The study also found a gap in quantitative indicators on efficiency and effectiveness.

This baseline study mapped the industry supply chain and national frameworks in place for these materials. This information will allow the European Commission to assess the efficiency and effectiveness of the current situation, including the benefits as well as the administrative burdens on businesses. It will support a Commission's evaluation to consider what, if any, possible steps need to be taken in the future concerning the regulation of FCMs in the EU.

To read more: Non-harmonised food contact materials in the EU: Regulatory and market situation (Baseline study - Final report) - C. Simoneau et al, 2016, EUR 28357 EN; doi:10.2788/234276