Leading organizations choose Element as their trusted partner to analyze food contact substances (FCS), including food packaging, food processing and commercial food equipment, consumer products, and other materials and articles that come into direct or indirect contact with foodstuffs, to obtain pre-marketing approval from the FDA and other global food contact regulatory bodies.
In the US, pre-marketing approval from the FDA is required for any new material that is to be marketed for an application that has direct or indirect contact with food. Examples include new packaging materials, baking or cooking materials, coatings for beverage cans and liquid containers, and inks and adhesives that have contact with plastic packaging. Food contact testing is critical to protect consumer health, as food contact materials (FCMs) should not change the quality, nature, or substance of foodstuffs. Additionally, unacceptable quantities of the constituents present in FCMs must not migrate into food in unacceptable quantities.
Element’s teams of food contact notification scientists have decades of industry experience and regulatory expertise. They are well-prepared to take on the most complex challenges, including complete method development and migration screening, including overall migration testing, specific migration testing, and non-intentionally added substances (NIAS) testing, to establish methods for measuring the FCS and all impurities in food simulants. Our comprehensive programs incorporate method validation in accordance with guidance, including fortification and recovery experiments using three (3) sets of triplicate samples of test simulants, with each set fortified at a separate level.
Food contact regulatory compliance support services
Our depth and breadth of expertise extends far beyond analytical support. Confidently and successfully navigate the food contact notification submission and approval process with the assistance of our consultative team and their comprehensive understanding of FDA Food Contact regulations and requirements. We have decades of experience preparing FCN dossiers on our clients’ behalf, and our regulatory experts provide extensive regulatory compliance support throughout the entire process.
- Food contact submission strategy recommendations
- Analytical testing per the FDA Guidance to Preparation of Premarket Submissions for Food Contact Substances: Chemistry Recommendations
- Food contact notification (FCN) preparation
- Holding prenotification consultations with the FDA
- Responding to any deficiencies in the dossier
Types of food contact materials tested
- Polymers, plastics, and rubbers
- Silicones, adhesives, and sealants
- Non-stick coatings
- Ceramics and glass
- Paper and paperboard
- Metals, alloys, and metallic articles
- Pigments and dyes
- Printing inks and lacquers
- Surface coatings
- Wood products
The Element advantage
Protect consumer health and ensure your products meet established safety and regulatory standards in a variety of countries and regions, including the United States, Europe, China, Germany, Japan, France, and Korea. From routine end-use testing of all prior sanctioned polymers that contact food in the U.S. under 21CFR 177 regulations, to preparing and shepherding FCN dossiers through the regulatory submission and approval process, our experienced scientists can ensure that your food contact materials comply with all FDA and global food contact regulations.
To learn more about our end-to-end food contact testing and regulatory support services, or to speak with one of our experts, contact us today.
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