How to achieve food contact material approval
Food contact materials are materials that come into contact with food such as processing equipment, packaging, as well as containers used in transport. Because molecules can migrate from the food contact material to the food, many countries regulate FCMs to ensure consumer safety. Common food contact substances include coatings, plastics, paper, adhesives, colorants, printing inks, and antioxidants. Constituents of these materials can migrate from the packaging or containers into the food products and, as such, they are regulated in a number of countries worldwide. In the U.S., the FDA has established a Food Contact Notification (FCN) program, through which all FCMs must be approved. Similarly in Europe, all food contact materials are subject to general controls, while for certain types of FCMs, e.g., plastics, specific measures have been adopted at an EU level. In addition, national controls are in place in certain European countries for other types of FCMs. Similar controls are in effect in the U.K. and Switzerland, as well as a number of other countries worldwide.
Exponent's Chemical Regulation and Food Safety scientists assist FCM manufacturers with regulatory submissions in different countries, including to the U.S. FDA, EFSA, Member State national authorities as well as U.K., Switzerland, and other countries. Our staff is focused on delivering timely, high-quality, creative, and practical solutions to challenges that affect our clients' ability to conduct business globally. Our staff includes both technical and regulatory consultants who are experienced in dealing with regulatory submissions for FCMs. We draw upon expertise in a variety of backgrounds, including regulatory affairs, chemistry and toxicology, and where relevant, ecotoxicology, environmental sciences, and risk modeling, to best meet our clients' needs. We also assist food businesses in ensuring the FCMs they use, whether for packaging or processing of food, are fully regulatory compliant.
For 50+ years, we’ve thrived on solving unstructured problems that require bespoke solutions. Some of our services include:
• Customized strategy for FCM submissions in multiple jurisdictions
• Guidance and interpretation of current food contact regulations globally
• Liaison with U.S., EU, U.K., and national regulatory bodies
• Facilitation of chemical testing and analysis, including design of migration testing protocols, and migration study placement, monitoring, and technical troubleshooting
• Human health safety and FCM exposure assessment
• Review of toxicity studies and identification of publicly available literature
• Safety assessment of FCMs at proposed use levels
• Tailored strategy to meet safe dose benchmarks
• In the U.S., environmental impact assessment in accordance with FCN requirements
• Preparation and submission of the complete FCM package
• Follow-up with regulatory agencies as needed
Our Capabilities Are Unparalleled
With expertise in over 90 disciplines and hundreds of capabilities, tools, and methodologies — we get to the root of even the most complex challenges and give you the objective answers you need.
Food safety, nutrition, and dietary exposure assessments, and technical and regulatory support.
Biocides & Antimicrobials
Expertise in multifaceted regulatory requirements in biocide and antimicrobial product approval processes.
Agrochemicals & Pesticides
Navigate complex requirements for agrochemicals and pesticides in Europe and North America.
Consumer Products: Cosmetics & Personal Care
Personal care products consulting for registration, notification targets, and product development.
Regulatory support for chemicals, solvents, polymers, antimicrobials, biocides, and more.
Our global and comprehensive expertise across industries gives us a deep understanding of current challenges, best industry practices, and the implications of emerging technologies.