BRUSSELS, BELGIUM - Food Contact Materials (FCMs) play a crucial role in ensuring the safety and integrity of food products. However, regulatory requirements for FCMs vary significantly across different regions, posing challenges for global compliance and risk assessment. A new ILSI Europe paper addresses the areas for global harmonisation of risk assessment protocols for FCMs.
Companies producing and distributing Food Contact Materials (like plastic, metal, paper, inks, etc in food packaging or food processing machinery) must navigate a complex landscape of rules and limits. And these rules differ depending on the region in which they operate. A recent review examines these regulatory differences. It compares key aspects of FCM risk assessment across multiple jurisdictions, including the US, the EU, MERCOSUR, India, China, Japan, and Thailand. The paper highlights divergences in testing requirements, protocols, and assessment criteria. The fundamental goal remains the same: ensuring that materials in contact with food pose no threat to human health. But these differences can lead to inconsistencies in how risks are managed.
Given that both the substances released by FCMs and routes of human exposure are consistent worldwide, the review emphasises the need for greater harmonisation in risk assessment requirements. Aligning regulatory approaches could improve efficiency, enhance consumer protection, and facilitate global trade. The paper identifies key areas where harmonisation is most feasible, such as analytical procedures, foodstuff classifications, simulants, or bioassay testing, and offers insights into how a more unified regulatory framework could be achieved.
A workshop organised by ILSI Europe in April 2024 had revealed that while global harmonisation of FCM regulations remains a long-term goal, achieving global acceptance of the underlying principles of safety assessments is a more immediate and achievable objective. ILSI Europe’s Packaging Materials Task Force convened an expert group of academics and industry leaders quickly after that to review existing approaches.
Their report, now published in Trends in Food Science & Technology, highlights the criteria for risk assessment across regions (US, EU, MERCOSUR, India, China, Japan and Thailand) and material categories, and discusses hazard identification and characterisation, exposure assessment and risk characterisation. It also describes the experimental data required for risk assessment (migration testing, simulants, toxicity criteria, ...). With a gradual, step-by-step approach, the authors are confident that harmonization of risk assessment methods is achievable.
Authors’ comments
Cristina Nerin (University of Zaragoza, Spain): “Harmonization of risk assessment criteria of different regulatory regimes about the safety of food contact materials is essential in a global market, where processed and packaged food as well as the food contact materials travel around the world. But such harmonization is not easy, as it involves several areas. Some of them are already closer to harmonization, others will require further discussion and agreements. Deep collaboration between the different players in the subject is required. A clear overview of the real situation is the starting point, and this is what this manuscript emphasizes. From now on, harmonization of different areas, step by step, can be achieved.”
Peter Oldring (Sherwin Williams, United Kingdom): “This paper aims to point out similarities between different regulatory systems, but in doing so, it also reveals important differences. While the basic principles are often the same, the way they are applied varies from region to region. Since hazards are the same everywhere, risk assessments should be similar. However, risk management can differ due to local requirements. Cooperation between regulators, politicians and industry will be required align these approaches. If this is achieved, there will be a reduction in animal testing and resources required to enforce trade of packaged food across borders.”
Reference
Cristina Nerin, Alan R. Boobis, Kanungo Debarata, Sarah Dubail, Thomas Gude, Christian Kirchnawy, Bastian Knaup, Konrad J. Korzeniowski, Charlene Lacourt, Olivier Vitrac, Si Wang, Peter K.T. Oldring; Review of potential areas for global harmonization of risk assessment protocols for Food Contact Materials (FCMs), Trends in Food Science & Technology, Volume 159, 2025, 104987, ISSN 0924-2244. https://doi.org/10.1016/j.tifs.2025.104987
About the authors
The experts who contributed to this work –Nerin Cristina, Boobis Alan R., Debarata Kanungo, Dubail Sarah, Gude Thomas, Kirchnawy Christian, Knaup Bastian, Korzeniowski Konrad J., Lacourt Charlene, Vitrac Olivier, Wang Si, Oldring Peter K. T– are among leading scientists in food safety and toxicology from industry, academia and public institutions. This representation across multiple sectors ensures objective and reliable content.
For more information about the Packaging Materials Task Force, visit https://ilsi.eu/scientific-activities/food-safety/packaging-materials/
Contact
Dr. Konrad Korzeniowski, Scientific Project Manager: kkorzeniowski@ilsieurope.be
About ILSI Europe
ILSI Europe is the European branch of the International Life Sciences Institute (ILSI), a global, non-profit federation with 10 entities around the world. Our mission is to develop, communicate and disseminate science-based guidance to tackle food, public health, and sustainability challenges. We facilitate collaboration and consensus-building between academic, industry and public service experts. Learn more at ilsi.eu.