Certification requirements vary significantly by target market and product application. This section provides foundational knowledge on the major certification frameworks, their purposes, and typical compliance pathways.
FDA Food Contact Substance (FCS) Requirements (United States): The U.S. Food and Drug Administration regulates materials that come into contact with food through its Food Contact Substance notification program. Any substance intended for use in food packaging requires pre-market authorization unless it is Generally Recognized As Safe (GRAS) or already listed in the 21 CFR inventory [6]. For plastic packaging exporters, this means:
• FCN Notification: New food contact substances require submission of a Food Contact Notification with safety data, migration testing, and intended use conditions
• 21 CFR Compliance: Existing approved substances are listed in Title 21 of the Code of Federal Regulations—merchants should verify their materials appear on this inventory
• Supplier Documentation: B2B buyers increasingly request copies of FDA compliance letters or GRAS determinations before placing bulk orders
• Recycled Plastic Guidelines: FDA maintains specific guidance for using recycled plastics in food contact applications, requiring demonstration that recycling processes remove potential contaminants
The FDA requires pre-market authorization for food additives used in packaging. Manufacturers must submit a Food Contact Notification (FCN) with safety data, or demonstrate that the substance is already approved under 21 CFR regulations. GRAS (Generally Recognized As Safe) determinations provide an alternative pathway for well-established materials [6].
BPI Compostable Certification (North America): The Biodegradable Products Institute administers compostability certification programs aligned with ASTM D6400 (industrial composting) and ASTM D6868 (coated paper) standards. Critically, 13+ U.S. states now mandate third-party certification for products labeled as compostable under AB 1201 and similar legislation [2]. Key requirements include:
• ASTM D6400 Testing: Materials must demonstrate biodegradation, disintegration, and eco-toxicity compliance in industrial composting facilities
• Third-Party Verification: Self-declared compostability claims are insufficient—certification must come from BPI-accredited laboratories
• Labeling Restrictions: Several states (California, Washington, Colorado) now require compostable products to have green, brown, or beige tint to distinguish from conventional plastics
• Certificate Specificity: Certifications are tied to exact product formulations and manufacturing facilities—changing suppliers typically requires new testing [4]
EN13432 & OK Compost (European Union): EN13432 is the European standard for industrially compostable packaging, often verified through TÜV Austria's OK Compost certification program. This certification serves as a de facto passport for compostable packaging entering EU markets. Requirements parallel ASTM D6400 but include additional disintegration timelines and heavy metal thresholds. For Southeast Asian exporters, EU OK Compost certification is increasingly mandatory for European buyers, particularly in food service and retail sectors [3].
CE Marking Considerations: While CE marking is commonly associated with electrical and mechanical products, certain plastic packaging applications may require CE compliance if they fall under specific EU directives (such as packaging that incorporates electronic components for freshness monitoring). However, for standard plastic bags and flexible packaging, CE marking is typically not applicable—merchants should verify whether their specific product category requires it before claiming CE certification.
