Unmatched Food Contact Scientific Expertise
Any new material that is to be marketed for an application that has direct or indirect contact with food in the US requires a pre-marketing approval from the FDA. This includes new packaging materials, new baking or cooking materials, coatings for beverage cans and other drinkable liquid containers, and inks and adhesives that come into contact with plastic packages.
Avomeen’s food contact notification team is led by Ph.D. scientists with decades of industry experience and regulatory expertise. Avomeen’s industry-leading expert scientists are well-prepared to take on the most complex challenges, including method development and migration screening to establish methods for measuring the FCS as well as all impurities in the food simulant.
Regulatory Experts Provide a Complete Food Contact Pre-Marketing Approval Solution
Avomeen is the trusted partner of a number of leading organizations for the analysis of packaging and other materials which have direct or indirect food contact to obtain pre-marketing approval from the FDA for their products.
Our comprehensive programs include method validation per guidance which includes fortification and recovery experiments using three (3) sets of triplicate samples of the test simulants with each set fortified at a separate level.
Rigorous Regulatory Compliance
Avomeen’s depth and breadth of expertise extends far beyond analytical support. Leverage our comprehensive understanding of FDA Food Contact regulations and requirements, as our expert scientists act as an extension of your team. Our regulatory experts will:
- Recommend a submission strategy
- Perform the necessary analytical testing per the FDA Guidance to Preparation of Premarket Submissions for Food Contact Substances: Chemistry Recommendations
- Prepare the FCN
- Hold prenotification consultations with the FDA
- Respond to any deficiencies in the dossier
Avomeen’s Ph.D.-led teams of scientists have decades of experience preparing FCN dossiers on behalf of our clients. After the dossier is submitted, the reviewer at the FDA will conduct a phase 1 review typically within a month. Questions will be asked and the submitter will be required to respond, and a final decision must be made on the application within 120 days.
Our teams provide support throughout the entire process, and will respond to any deficiencies in the dossier. The 120 days starts from the original submission date and if the FDA does not provide a specific objection, the notification will become effective on day 120 regardless of any actual affirmation.
Ensure Compliance in the U.S. and Beyond
Avomeen’s Ph.D.-backed teams also perform testing for materials which are prior sanctioned under 21CFR 177. This routine end-use testing is required for all prior sanctioned polymers which contact food in the US.
Avomeen’s food contact materials testing laboratory can test packaging, cutlery, glassware, and more to ensure that your products meet safety and regulatory standards in a variety of countries and regions including the United States, Europe, China, Germany, Japan, France, and Korea. We have extensive experience handling food packaging and contact materials testing for clients who sell to a global audience, and our experienced chemists can ensure that your food contact materials are in compliance with all FDA and global food contact regulations.
Our Ph.D.-backed teams are experts in the study of food contact notification and can test a variety of materials, including:
- Polymers, Plastics and Rubbers
- Silicone, Adhesives and Sealants
- Non-Stick Coating
- Ceramics and Glass
- Paper and Paperboard
- Metals and Metallic Articles
- Wood Products
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Why Partner with Avomeen
Our wide-reaching capabilities incorporate industry-leading knowledge and expertise in analytical research, testing, and regulatory requirements. Bring your greatest challenges to us; we’ll bring you unprecedented scientific expertise and profound insights with our forward-thinking approach to chemical analysis.
Ph.D. –Backed Projects
Every Avomeen project is backed by Ph.D. scientists with decades of industry and lab experience. When you put your project in the hands of our specialists, you can trust your results reflect the unparalleled knowledge of our industry-leading scientific minds.
When routine testing laboratories don’t have the experience or qualified experts to take on a project, they pass it on to the next laboratory. When those projects come to Avomeen, they get done. Our unique blend of scientific, legal, and regulatory knowledge allows us to problem-solve from unusual angles. If it’s the right scope, we say yes when others say no.
The Avomeen Experience
We excel in building partnerships with our clients to ensure success at every stage of the product life-cycle. Our dedication to our clients is apparent in everything we do. We work with you to tailor our processes to your needs while maintaining scientific integrity.