Food contact materials (FCM) include packaging, utensils, appliances, and processing equipment that touch food. Regulatory requirements are strict because chemical migration can contaminate food and harm consumers. This guide covers the three major FCM regulatory frameworks.
EU Regulation 10/2011
The EU's Plastics Regulation specifies:
Authorized substances list (positive list approach)
Overall migration limit: 10 mg/dm2 or 60 mg/kg
Specific migration limits for individual substances
Testing protocols using food simulants (water, acetic acid, ethanol, olive oil)
Compliance requires testing by an EU-accredited laboratory. Testing costs: $300-800 per material type.
FDA 21 CFR (USA)
US food contact regulations are substance-specific:
21 CFR 175: Adhesives and coatings
21 CFR 176: Paper and paperboard
21 CFR 177: Polymers (plastics)
21 CFR 178: Adjuvants and production aids
Unlike EU's positive list, FDA uses a "safe for intended use" approach. However, specific substances still have migration limits.
German LFGB (Food and Feed Code)
LFGB is stricter than EU 10/2011 in some areas:
Sensory testing (no odor or taste transfer)
Additional heavy metal limits
Formaldehyde restrictions for melamine
German market entry often requires LFGB testing even if EU 10/2011 compliance is established.