A resin rated for food contact becomes non-compliant if molded on a machine that processed an incompatible material last week. Food-grade isn’t just about material selection. It’s a system that spans material sourcing, processing conditions, facility practices, and documentation. Any breakdown in that system can compromise compliance.
Understanding what “food-grade” actually means legally and practically prevents both compliance failures and unnecessary restrictions. The requirements are manageable but specific, and meeting them requires deliberate attention throughout the manufacturing process.
Regulatory Framework
Food contact compliance isn’t a single specification. It’s a patchwork of regulations that vary by jurisdiction and application.
FDA regulations in the United States are codified primarily in 21 CFR (Code of Federal Regulations). Parts 174 through 186 address indirect food additives, including plastics that contact food. The FDA maintains a list of substances that may be used in food contact applications, specifying permitted uses and limitations.
Direct contact versus indirect contact matters for regulatory requirements. Direct contact applications (food storage containers, utensils) face stricter requirements than indirect contact applications (outer packaging, equipment housings). The specific end use determines which regulations apply.
EU regulations under EC 10/2011 establish a positive list of approved monomers and additives for plastic food contact materials. EU requirements include overall migration limits and specific migration limits for certain substances. Products sold in Europe must meet these requirements regardless of where they’re manufactured.
Other jurisdictions have their own requirements. China, Japan, Canada, and other markets each regulate food contact materials. Products intended for global distribution must meet the requirements of each target market, which may differ significantly.
“Food-safe” legal meaning is narrower than common usage. A material is food-safe for a specific application under specific conditions. Temperature limits, contact duration, food type, and intended use all affect whether compliance exists. Generic claims of “food-grade” without specifying the application are imprecise at best and misleading at worst.
Material Requirements
The foundation of food-grade compliance is appropriate material selection.
FDA-compliant resin grades are specifically formulated for food contact. Material suppliers certify compliance and specify permitted applications. Standard industrial grades of the same polymer family may not be food-contact compliant, even if chemically similar. Always verify food-contact certification for the specific grade, not just the general material type.
Additive restrictions limit what can be included in food-contact formulations. Plasticizers, stabilizers, colorants, and processing aids must individually meet food-contact requirements. A compliant base resin combined with a non-compliant colorant produces a non-compliant compound.
Colorant limitations are particularly important. Not all pigments and dyes are approved for food contact. Some are approved only for specific applications (no red colorants for certain applications, temperature limitations on others). Color matching for food-contact applications must use approved colorants, which may limit achievable colors.
Filler and reinforcement restrictions apply to compounds. Glass fiber, minerals, and other reinforcements must be evaluated for food-contact suitability. Some fillers are approved; others are not. Reinforced grades for food-contact require specific certification.
How to verify material compliance: Request FDA compliance letters from material suppliers. These letters specify the applicable regulations, permitted uses, and any limitations. Generic claims of “food-grade” without supporting documentation are insufficient.
| Material Type | Common Food-Contact Grades | Notes |
|---|---|---|
| PP | Homopolymer, random copolymer | Wide temperature range |
| HDPE | Most grades compliant | Good chemical resistance |
| PET | Bottle and thermoform grades | Extensively used for food |
| PC | Specific food-contact grades | Temperature/BPA considerations |
| Nylon | Limited food-contact grades | Higher cost, specific applications |
Processing Requirements
Food-grade compliance can be lost during processing even with compliant materials.
Equipment dedication provides the most reliable compliance. Machines used exclusively for food-contact production eliminate cross-contamination risk. Dedication isn’t always practical, but it’s the safest approach for critical applications.
Purging protocols enable non-dedicated equipment to produce food-contact parts. Complete purging removes residual material from previous production. Purging procedures should be documented and validated. The amount of purge material and verification method depend on the previous material and the sensitivity of the food-contact application.
Mold release restrictions prohibit most conventional release agents on food-contact molds. Many mold releases contain substances not approved for food contact. Either eliminate mold release (through proper mold design and processing) or use FDA-approved release agents specifically formulated for food contact.
Lubricant restrictions apply to any lubricant that might contact the product. Machine lubricants, ejector pin lubricants, and slide lubricants must be food-grade or prevented from contacting the product. Incidental food-contact lubricants (NSF H1 rated) are designed for this purpose.
Colorant carrier restrictions matter when adding color concentrates. The carrier resin and any processing aids in the concentrate must be food-contact compliant. Not all colorant concentrate carriers are food-grade.
Documentation requirements support compliance verification. Material lot traceability, purge records, and process documentation demonstrate that compliant materials were processed under controlled conditions. Documentation should be retained according to customer and regulatory requirements.
Facility Requirements
The manufacturing environment affects food-contact compliance.
Clean manufacturing environments prevent contamination from facility sources. While ISO cleanrooms aren’t typically required for most food-contact molding, the manufacturing area should be clean, organized, and free from contamination sources.
Pest control is essential. Insects, rodents, and birds in manufacturing areas contaminate food-contact products regardless of material compliance. Professional pest control programs should be in place with documentation.
Personnel hygiene practices prevent human contamination of products. Handwashing requirements, restrictions on eating and drinking in production areas, and appropriate attire protect product integrity. Training ensures employees understand and follow hygiene requirements.
Storage and handling protocols maintain material and product integrity. Materials should be stored off the floor, protected from contamination, and used within recommended shelf life. Finished products should be handled and packaged to prevent contamination after production.
Segregation from non-food production prevents cross-contamination. If the facility produces both food-contact and non-food products, separation through physical barriers, scheduling, or dedicated equipment should prevent mixing.
Testing and Certification
Compliance claims should be supported by appropriate testing.
Migration testing measures substances that transfer from plastic to food or food simulants. Overall migration testing measures total extractable substances. Specific migration testing measures individual substances of concern. Testing protocols specify food simulants (representing fatty, acidic, aqueous foods), temperature, and contact duration based on intended use.
Organoleptic testing evaluates whether the plastic imparts taste or odor to food. Even compliant materials can affect food taste under some conditions. Organoleptic testing uses trained panels to detect any sensory impact.
When testing is required: New formulations, new applications, or new suppliers may require testing. Customer requirements may specify testing. Private label retailers often require certification testing. Testing may be required for regulatory submissions.
Third-party certification provides independent verification. Organizations like NSF International certify products and processes for food-contact compliance. Certification involves audit of manufacturing systems and testing of products. Certification simplifies customer qualification and provides credible compliance evidence.
Common Compliance Failures
Understanding how failures occur helps prevent them.
Cross-contamination from non-compliant materials is the most common failure mode. Inadequate purging, material mix-ups, or contamination from auxiliary equipment can introduce non-compliant substances. Rigorous material handling and process control prevent cross-contamination.
Documentation gaps leave compliance unverifiable. Without material certifications, lot traceability, and process records, compliance cannot be demonstrated even if actual practice is compliant. Documentation systems should be established before production begins.
Informal material substitutions happen when specified materials are unavailable. A “similar” grade substituted without verification may not be food-contact compliant. Substitution protocols should require explicit verification of food-contact compliance.
Unauthorized additives include release agents, lubricants, or processing aids that seem harmless but may not be food-contact approved. Anything that contacts the product must be verified compliant.
Scope creep occurs when products qualified for one application get used for another. A product qualified for room-temperature contact may not be suitable for hot-fill applications. Compliance applies to specific conditions; exceeding those conditions may exceed compliance.
Working with Food-Grade Molders
Selecting and managing capable suppliers protects compliance.
Qualification questions:
Do you have documented food-contact procedures?
What purging protocols do you follow?
What release agents and lubricants are used in production?
Can you provide material traceability for each lot?
What certifications do you hold (NSF, SQF, GFSI)?
Audit focus areas: Material control and traceability, purging procedures and records, release agent and lubricant practices, facility cleanliness and pest control, personnel hygiene practices, documentation and record retention.
Certification verification: Request and verify current certifications. Certifications expire and should be current. Certificates should match the scope of work: NSF certification for one product doesn’t cover other products.
Food-grade compliance is a system, not a specification. Every element from resin selection to shipping must maintain compliance. The requirements are manageable with deliberate attention, but casual approaches create compliance risk that affects both regulatory standing and customer trust.
Sources
- FDA. “Food Contact Substances.” 21 CFR Parts 174-186. https://www.fda.gov/
- European Commission. “EC 10/2011 on Plastic Materials and Articles Intended to Come into Contact with Food.”
- NSF International. “Food Equipment Standards and Certification.” https://www.nsf.org/
- Plastics Industry Association. “Food-Contact Plastics Compliance Guide.”
- MAPP (Manufacturers Association for Plastics Processors). “Food-Grade Manufacturing.” https://www.mappinc.com/