Regulation of Food Contact Chemicals

Our client counsel includes the following:

• U.S. Regulatory Requirements –
• Determine possible pathways to market outside the FCN process
• E.g., where proposed use does not meet definition of FCS or is exempted
• E.g., where product is Generally Recognized As Safe (GRAS) or is exempted
• U.S. Center for Food Safety and Applied Nutrition (CFSAN) Submissions (Where FCN Submission Is Necessary) –
• Arrange and participate in pre-submission conferences intended to refine and limit data requirements
• Help determine needed testing
• Review draft notifications for sufficiency, and assist with CFSAN responses
• EU Regulatory Requirements –
• Determine compliance requirements with any EU national legislation depending on Member State
• Help determine needed migration limit testing
• Assist with compliance with Good Manufacturing Practice (Regulation 2023/2006)
• Prepare strategies for supply chain responsibilities

• Acta has assisted manufacturers in making decisions regarding whether possible FCSs can be regarded as GRAS and possibly exempt from pre-clearance.
• Acta professionals have reviewed possible food contact materials to determine if they are covered by regulations in the Code of Federal Regulations (C.F.R.) or possibly precluded by notifications previously declared effective.
• Acta professionals have advised manufacturers regarding the toxicology and chemistry needed to support a submission and have aided in the preparation of the administrative sections of FCNs.
• Our professionals routinely assist clients navigate regulatory issues under Framework Regulation (EC) No. 1935/2004, which address materials and articles intended to come into contact with food.
• Acta regularly counsels on issues arising under Good Manufacturing Practices (GMP) and compliance with Commission Regulation (EC) No. 2023/2006 addressing GMP for materials and articles