Regulation of Food Contact Chemicals

Overview:

When a consumer opens a can of soda or bag of potato chips, they have little knowledge of the scientific and legal resources invested in that can, bag, beverage, or chip. Food packaging, for instance, incorporates a variety of strategic decisions for producers:  how well does the packaging preserve the product, how easy is it to distribute, how appealing is it to consumer tastes? Layered atop these decisions is a host of regulatory issues, including packaging safety and labeling accuracy.

While the U.S. Food and Drug Administration (FDA) has simplified the approval process for food packaging and food additives in the U.S., the process remains detailed and requires significant strategic decision-making. Complicating matters for companies marketing products in Europe are regulatory developments brought about by the European Food Safety Authority (EFSA). EFSA has attempted to both simplify the European Union (EU) Framework Regulation as well as synthesize the relevant laws of the EU Member States. This has led to an amending process that has kept the EU regulatory framework in persistent flux. In China, the State Council is undertaking a “crackdown” on food safety measures, which may lead to more onerous requirements for packaging in that country.

The Acta Group’s (Acta^®) professionals, who include in-house polymer chemists and other scientists, provide clients the legal and scientific know-how to navigate these regulatory challenges while keeping an eye on the end-goal of consumer appeal.

Our Experience:

Acta professionals offer clients a combination of regulatory, strategic, and scientific expertise. That combination is key to assisting clients in bringing their products to market, staying on top of regulatory issues, and responding effectively to matters that may arise over the course of a product’s life.

Karin Baron, M.S.P.H., has an extensive track record of chemical regulatory work. Prior to joining Acta she served as manager of FDA compliance for a major specialty chemical company, among other roles, and her 15 years of industry experience are a tremendous asset to clients in matters regarding food contact notifications (FCN).

Dr. Jane Vergnes, DABT^®, a toxicologist with a Ph.D. in Human Genetics and 25 years of experience with global chemical companies, advises clients on the science and strategy needed to demonstrate that materials are safe for the intended FDA-regulated use. Dr. Vergnes offers considerable expertise in designing and monitoring toxicology studies for diverse materials, including food packaging, lubricants for food processing machinery, preservatives, personal care ingredients, pharmaceutical excipients, and tablet coatings.

Jayne Bultena has over 20 years of experience in food and drug regulatory matters. She has counseled Fortune 100 companies, start-ups, and venture capital investors across issues, including FDA inspections, responding to deficiencies, and coordinating press and media relations. Ms. Bultena has worked with companies to assess the regulatory options for bringing food contact and packaging materials into the U.S. market. She has represented clients before FDA, the U.S. Consumer Product Safety Commission (CPSC), and the U.S. Federal Trade Commission (FTC).

Dr. David Peveler, holding a Ph.D. in organic chemistry, is expert in product regulatory compliance, FDA food contact and packaging matters, and Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) product registration and labeling matters. Dr. Peveler previously served as a consultant to Evonik Degussa Corporation and as Senior Regulatory Scientist with Chemtura Corporation. His portfolio includes directing research in a variety of areas involving polymer additives, including PVC heat stabilizers and polymeric plasticizers, and antioxidants for polyolefins.

Scott J. Burya, Ph.D., a Regulatory Chemist with a Ph.D. in analytical chemistry, managed compliance and notification activities for a multinational coating manufacturer and has obtained FCNs, Letters of No Objection (LONO), and other approvals needed to commercialize new products. Dr. Burya specializes in the review of food contact substances (FCS) per FDA and EU regulations, dietary exposure calculations, compliance testing requirements, and notifications to global regulatory agencies, including FDA, the European Food Safety Authority (EFSA), and Health Canada. 

What We Do:

Acta professionals have extensive experience assisting clients in obtaining appropriate authority to market FCSs in Europe, Asia, and the Americas. 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

Representative Engagements:

• 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