Nowadays market requires the Food and Drug Administration (FDA) to approve materials for food contact. In the United States, materials and articles intended for food contact are regulated by the FDA: they are included in the Indirect Food Additives. Therefore, even packaging is a food additive and it is regulated by Title 21 of the U.S. Code of Federal Regulations (21 CFR), which includes adhesives, coatings, paper and paperboard, polymers and adjuvants to the production process.
Indirect food additives are authorized through a notification program, or even through 21 CFR 170.39 (Threshold of regulation for substances used in food-contact articles).
Mérieux NutriSciences carries out compliance analyses of single materials and/or polymers according to the paragraphs of 21 CFR.
Mérieux NutriSciences also developed innovative screening tests through customized analytical protocols (volatile, semi-volatile, non-volatile substances and quantification of the residue content) taking the Protocol on the migration test included in the “Guidance for Industry: Preparation of premarket submission for food contact substances: chemistry recommendations” as a reference. The document lists the recommendations of the FDA which can be used when the compliance process is submitted -like the Food Contact Notification (FCN) or the Food Additive Petition (FAP) for food contact substances.
Mérieux NutriSciences also performs:
- verification of the requirements of adhesives for multilayer materials according to 175.105 Adhesives (21 CFR);
- SEM analysis to assess any detectable imperfections in the packaging edges.
Mérieux NutriSciences also benefits from the consulting activity of technical experts who evaluate packaging supporting documentation and propose appropriate analytical protocols to verify the compliance with US market.