Food Contact Materials and Food Safety

Steptoe supports clients throughout the entire regulatory life cycle of their food and food contact products, including production and marketing of finished food (including dietary supplements), foods for specific groups (sportsmen, infants, weight loss, medicated foods), and other functional foods and food ingredients.  The team has substantial experience establishing legal and regulatory compliance of food contact substances and packaging materials worldwide, for both food contact material suppliers and food manufacturers.  Our team members have authored thousands of opinions on food contact compliance. 

Our practice is interdisciplinary: we have an integrated team of lawyers, scientists, technical advisers, and former decision makers from leading regulatory authorities who work in close coordination to serve clients in the US, the EU, China, Japan, and the MERCOSUR countries.  The team is consistently ranked by leading legal directories such as Legal 500 in the top tier for Food Contact and Food Regulation.

Over the past 20 years, our practitioners have gained a reputation for constructive engagement with the relevant industry bodies and regulators, such as the US Food and Drug Administration (FDA), US Department of Agriculture (USDA), Environmental Protection Agency (EPA), US Federal Trade Commission (FTC), the Directorate General for Health and Food Safety at the European Commission (EC), EU Member State authorities, European Food Safety Authority (EFSA), the European Chemicals Agency (ECHA), and China Food and Drug Administration.  

Steptoe’s Food Contact Materials and Food Safety practice covers:

Food Contact Materials

  • Establishing regulatory compliance of food contact substances, including self-determinations of FDA compliance based on the absence of significant migration to food or on Generally Recognized as Safe (GRAS) status
  • Preparing Food contact notifications (FCNs) and facilitating clearance by FDA
  • Assisting food packers in assessing compliance of the packaging materials with the legal requirements
  • Assisting food contact material manufacturers to assess the compliance of their products with the regulatory requirements of the EU and its individual Member States
  • Assisting new materials suppliers to achieve food contact compliance for their substances in the EU, the US, and China
  • Preparing dossiers for food contact material authorization by the European Food Safety Authority (EFSA)
  • Preparing dossiers for food contact material authorization in China (GB9685)
  • Reviewing the compliance of recycled materials for food contact applications
  • Reviewing the safety of nanomaterials when intended for food contact applications and support their compliance
  • Assisting trade associations in determining the regulatory requirements under specific EU and Member States regimes affecting their members 

Food and Feed Additives and GRAS Ingredients

  • Preparing dossiers for food additive clearance in the US, the EU, China, and other jurisdictions
  • Establishing regulatory compliance of food and feed ingredients, including self-determinations of FDA compliance based on GRAS status
  • Forming and chairing expert panels to make GRAS determinations
  • Preparing and facilitating FDA clearance of GRAS Notices
  • Preparing food additive and color additive petitions, and facilitating FDA clearance
  • Advising on compliance with the Bioterrorism Act and Food Safety Modernization Act (FSMA)

Dietary Supplements

  • Establishing US regulatory compliance of dietary supplement products including labeling, claims, and new dietary ingredients
  • Preparation of New Dietary Ingredient Notifications and Structure Function Claim Notifications to FDA
  • Establishing EU regulatory compliance for dietary supplements and Canadian regulatory compliance for Natural Health Products

Safety and Risk Assessment

  • Applying threshold principles to abbreviated risk assessments when quick risk management decisions are needed
  • Developing safety and risk assessments for food and dietary ingredients as well as food contact substances
  • Developing exposure assessments for food ingredients, food contact substances, food contaminants, and other dietary ingredients
  • Providing guidance on the toxicology testing, including computational toxicology and structure activity analysis of food and dietary ingredients, and food contact substances
  • Advising on the use of nanomaterials in food, food ingredient, dietary supplement, and food contact applications
  • Assisting in developing preventive controls to meet FSMA requirements

Food Labeling and Claims

  • Advising on food labeling (including allergen labeling), point-of-purchase materials, advertising claims, and promotional materials
  • Advising on permissible health and nutrition claims, and related authorization procedures 
  • Preparing submissions to FDA and EU authorities to request authorization of claims

Compliance Support

  • Assisting with post-market compliance issues concerning food, direct food additives, and food contact substances
  • Advising on traceability issues
  • Providing risk management advice to companies in the food supply chain (retailers, food producers, food additive and color additive suppliers, food contact substance suppliers)
  • Responding to regulatory inspections and enforcement actions, including mandatory and voluntary recalls
  • Advising on good manufacturing practice compliance
  • Assisting with food import and export issues, including pesticide residues
  • Advising on food related legislative and policy developments
  • Assisting with compliance issues regarding the FSMA