Food-Contact Plastics: Compliance and PFAS Guide

A food-contact part is a regulatory product before it is an engineering one. The resin, the colorant, the mold release agent, the processing aids and even the regrind can all introduce substances that migrate into food, and the burden of proof sits with the manufacturer. Recent restrictions on PFAS and bisphenol A have moved this from a paperwork exercise to a design constraint that reshapes material selection.

Figure 1. FDA and EU 10/2011 compliance framework with restricted substances table.

This guide summarizes the compliance frameworks, the test evidence that satisfies them, and the current restrictions that designers need to plan around. It is an engineering overview, not legal advice; the final determination is made by the resin supplier's regulatory documents and the destination market's authority.

The two frameworks designers encounter most

United States — FDA. Food-contact materials are regulated under the Federal Food, Drug, and Cosmetic Act. A substance is either Generally Recognized As Safe (GRAS), a prior-sanctioned substance, or covered by a Food Contact Notification (FCN) or an effective Food Contact Substance Notification. In practice, the manufacturer relies on the resin supplier's food-contact compliance statement, which cites the applicable regulation or notification number for the specific grade.

European Union — Regulation (EU) No 10/2011. This is a positive-list regulation: only substances on the Union list may be used, each with a Specific Migration Limit (SML) and/or an Overall Migration Limit (OML). The regulation defines the food simulants (aqueous, acidic, alcoholic, fatty) and the test conditions (time and temperature) used to demonstrate compliance. A Declaration of Compliance (DoC) accompanies the material through the supply chain.

Other markets have their own schemes — China's GB 4806 series, Japan's Positive List, Mercosur resolutions — and a part intended for global sale has to satisfy the strictest applicable regime for each market it enters.

The evidence chain

Compliance is demonstrated by documentation and testing, in this order:

1. Resin and additive compliance. The supplier's DoC or FDA statement confirming the grade is listed for the intended food-contact use and conditions.
2. Migration testing. Overall migration (total mass transferred to the simulant) and specific migration (individual substances of concern). Test conditions mimic the real use: hot fill, microwave, long-term storage at room temperature, fatty contact.
3. Migration modeling. Where testing is impractical, migration modeling per the EU framework can estimate worst-case transfer.
4. Sensory testing. Odor and taste transfer (organoleptic testing) is a separate requirement and is not covered by chemical migration.
5. Process validation. Confirming that the actual molding process — including any release agents and regrind — does not introduce non-compliant substances.

The last point is the one designers forget. A compliant resin can be made non-compliant by a non-compliant mold release spray or by regrind contaminated with non-food-grade material.

The restrictions reshaping material selection

### PFAS

Per- and polyfluoroalkyl substances are a broad family of fluorinated chemicals used historically as processing aids, mold release agents and in some fluoropolymer applications. Regulatory activity has been rapid: the EU has moved toward broad restriction of PFAS, and several jurisdictions have banned PFAS in food-contact packaging specifically.

For designers, the practical implications are:

• Mold release agents. Avoid fluorinated release sprays on food-contact tooling; specify PFAS-free or silicone-free release systems, or eliminate release agents entirely through part design and polish.
• Processing aids. Some polyolefin grades use fluoropolymer processing aids. Confirm the grade is PFAS-free if the destination market restricts it.
• Fluoropolymers. PTFE and similar materials have legitimate food-contact uses, but the regulatory trend is toward requiring justification and, in some markets, phase-out.
• Documentation. Ask the supplier explicitly for a PFAS-free declaration; "food grade" alone does not answer the PFAS question.

### Bisphenol A (BPA)

BPA is a monomer used in polycarbonate and in some epoxy and can coatings. It is restricted in food-contact applications in the EU and in infant and child products in many jurisdictions, with SMLs tightened repeatedly. Polycarbonate remains compliant for many adult applications where the BPA migration limit is met, but for infant feeding products and where the market bans BPA outright, PC must be replaced.

Alternatives that avoid BPA include polypropylene, Tritan copolyester, PET, and specialty copolyesters. Each has its own migration profile, and each must be documented for the specific application.

### Other substances of concern

• Phthalate plasticizers, restricted in many markets, especially for fatty foods.
• Heavy-metal colorants (cadmium, lead, certain chromates), restricted for food contact.
• Primary aromatic amines from certain colorants and from polyamide, subject to their own migration limits.
• Mineral-oil hydrocarbons (MOSH/MOAH) from a wide range of sources, under review and increasingly restricted in packaging.

Designing for food contact

Compliance is easier when the design helps:

• Avoid raw-material colorants. Use pre-compounded, food-contact-approved masterbatch rather than shop-floor colorant added without documentation.
• Minimize regrind, or control it rigorously. Specify a maximum regrind percentage and confirm the regrind stream is food-grade.
• Design for cleanliness. Smooth, drainable surfaces with generous radii are easier to clean and less likely to trap food residue than sharp corners and deep pockets.
• Avoid in-mold decoration and adhesives unless the film, ink and adhesive are themselves food-contact compliant.
• Plan for cleaning and sterilization if the part will be washed or steam-cycled; repeated thermal and chemical exposure can change migration behavior.
• Document everything. Keep the DoC, the migration test reports and the PFAS declaration with the part number.

A material selection shortcut

Common compliance mistakes

• Assuming "food grade" answers every question. It does not cover PFAS, BPA or the specific market's positive list.
• Reusing regrind without documentation. The cheapest way to lose compliance.
• Ignoring mold release. Fluorinated sprays on the tool contaminate the part surface.
• Testing at the wrong conditions. A room-temperature migration test does not demonstrate compliance for a hot-fill application.
• Forgetting organoleptic testing. A chemically compliant part that smells of plastic is still a reject.
• Not updating the DoC when the formulation changes. Suppliers reformulate; the paperwork must follow.

Figure 2. Quick reference: the key checks and reference values from this guide.

Checklist

• Destination markets identified, and the strictest applicable regime selected
• Resin grade confirmed by supplier DoC or FDA statement for the intended use and conditions
• Colorant and additives are food-contact approved and documented
• Mold release agents eliminated or confirmed PFAS-free and food-contact compliant
• Regrind limited and kept within a documented food-grade stream
• Migration testing performed at conditions matching real use
• Organoleptic (odor and taste) testing planned
• PFAS and BPA declarations obtained explicitly from the supplier
• Design favors cleanliness: radii, drainage, no food traps
• Documentation retained with the part number and reviewed on reformulation

Food-contact compliance is not a box to tick at the end of a project. When the material, the colorant, the release system and the regrind policy are chosen with the destination market in mind from the start, the part passes the paperwork and the tests without redesign. When they are decided at the last minute, the project pays for it in requalification.