Review of potential areas for global harmonization of risk assessment protocols for Food Contact Materials (FCMs)

Food Contact Materials (FCMs) are produced and marketed worldwide global value in excess of 400.20 billion dollars. All FCMs have to be safe and guarantee the safety and security of food in contact with them. Specific regulations, which establish the rules for all materials, exist in different regions, which implies that the same material has to comply with different limits depending on the region in which it is distributed and marketed. This paper reviews differences and similarities between the FDA, EU, MERCOSUR, India, China, Japan and Thailand. Various areas essential for a risk assessment are compared. Requirements for testing substances or materials is an area where there are divergencies or commonalities. Harmonization of regulations and procedures is needed, as humans are the same, independently of where they live, and the substances released by the FCMs are the same. The same protocols and procedures are not applied worldwide, but the results are essential for the risk assessment of FCMs. Examining the approaches of different regions showed that there is room for harmonization in many areas, to obtain a more harmonized risk assessment and facilitate subsequent risk management. This review establishes the main areas of risk assessment of FCMs, compares the main regulations in different regions and discusses the essential areas that influence their global risk assessment and provides a guide to help to the development of the relevant research field and industry. Some examples and proposals for the main areas for harmonising risk assessment globally, are given. • Criteria for risk assessment in FDA, EU, Mercosur, India, China, Japan and Thailand are reviewed. • Hazard identification and characterization are discussed. • Exposure assessment and risk characterization are discussed. • Experimental data required for risk assessment are described. • Areas closer to risk assessment harmonization are highlighted.