Food Packaging Regulations: FDA, EU and China GB Standards Guide

Food packaging that migrates harmful substances into food is a serious liability — regulatory, legal and reputational. Every market where you sell food has mandatory requirements for the materials that may contact food, the substances that may migrate from those materials, and the testing required to demonstrate compliance. This guide covers the three most important regulatory frameworks for exporters and importers.

US FDA Food Contact Requirements

In the US, food contact materials are regulated by the FDA under 21 CFR (Code of Federal Regulations). Materials must be either GRAS (Generally Recognized As Safe) or approved under specific 21 CFR sections. Key sections for packaging:

• 21 CFR 176 (Paper and paperboard): Permitted additives and coatings for paper food packaging
• 21 CFR 177 (Polymers): Permitted polymer materials including PE, PP, PET, EVOH
• 21 CFR 178 (Adjuvants, production aids, sanitizers): Permitted additives in plastic manufacture

Suppliers must provide a compliance letter (also called a Certificate of Compliance) confirming that materials meet the applicable 21 CFR sections for the intended food type and processing conditions.

EU Regulation 10/2011 (Plastics)

EU Regulation 10/2011 on plastic materials and articles intended to contact food establishes the positive list of permitted monomers and additives, overall migration limits (OML: 10 mg/dm² or 60 mg/kg food), and specific migration limits (SML) for individual substances. Migration testing must simulate the intended food contact conditions (contact time, temperature, food type). EU compliance documentation requires a Declaration of Compliance (DoC) from the packaging manufacturer stating which Regulation applies, the food types and conditions covered, and the identity of substances with their SML values.

China GB 9685 Standard

China's primary food packaging standard is GB 9685 (Standard for Use of Additives in Food Contact Materials and Articles). It defines the permitted additives in food contact plastics, coatings, rubber and paper. For products sold or manufactured in China, packaging materials must come from suppliers with GB 9685-compliant formulations. Chinese customs may inspect certificates for imported packaging materials.

Key Compliance Documents to Request

• Certificate of Compliance (US FDA 21 CFR) from film or board manufacturer
• Declaration of Compliance (EU Reg 10/2011) from film or board manufacturer
• Material Safety Data Sheet (MSDS/SDS) for all inks, coatings and adhesives
• Migration test reports (overall migration, specific migration for heavy metals and restricted substances)
• Food contact suitability statement specifying food types, contact temperature and duration

Printing Inks and Adhesives

The outer layers of flexible laminates are printed, then laminated. Ink set-off or ink migration through the laminate to the food contact inner surface is a known risk. All printing inks used for food-contact flexible packaging should comply with Swiss Ordinance (SR 817.023.21) or EuPIA GMP guideline — the most widely referenced standards for printing ink food safety. Solvent-based inks used in rotogravure printing must have residual solvent levels below 5 mg/m² to minimise migration risk.

What to Include in Your Packaging Brief

• Food type: dry, aqueous, fatty, acidic — migration risk varies significantly
• Contact temperature: ambient, refrigerated, hot-fill (above 70°C), retort (121°C)
• Contact duration: seconds (portion pack), hours (catering supply), years (long shelf life)
• Target market(s): US, EU, UK, China, Australia — each has different standards
• Request compliance documentation for all material layers from your supplier