Regulations for food contact materials in packaging.

United States: how the FDA regulates food packaging

Under the Federal Food, Drug, and Cosmetic Act, a substance in packaging that can reasonably be expected to migrate into food is regulated as a food additive unless it is exempt. In practice, a packaging material is legal for a food use when every substance in it is covered for that use in one of these ways:

• A listing in 21 CFR Parts 174 to 186, the “indirect food additive” regulations, with their conditions of use.
• An effective food contact notification (FCN). An FCN is effective only for the manufacturer or supplier named in it and for the uses it describes. FDA keeps a public inventory of effective FCNs.
• A threshold of regulation exemption under 21 CFR 170.39, for substances whose dietary exposure is negligible.
• GRAS status or a prior sanction (Parts 181, 182, 184 and 186).

Conditions of use matter as much as the substance. Many listings depend on the type of food (aqueous, acidic, fatty, alcoholic or dry) and the temperature of use, from frozen storage to hot fill. A film that is fine for dry snacks may not be covered for hot, fatty foods.

Good manufacturing practice. 21 CFR 174.5 requires food contact substances to be used in amounts no greater than needed for their intended effect, and to be of a purity suitable for that use.

European Union: the framework and the plastics rules

• Regulation (EC) No 1935/2004 applies to all food contact materials. Article 3 requires that they do not endanger human health, bring an unacceptable change in the food’s composition, or spoil its taste and smell. It also sets labelling (“for food contact” or the glass and fork symbol, Article 15), declarations of compliance where specific measures require them (Article 16) and traceability (Article 17).
• Regulation (EC) No 2023/2006 sets good manufacturing practice for food contact materials.
• Regulation (EU) No 10/2011 covers plastic materials. Only substances on its Union list may be used to make the plastic layers; the overall migration limit is 10 mg per dm² of food contact surface; many substances also have specific migration limits; and a written declaration of compliance must accompany the material through the supply chain.
• Paper and board have no harmonised EU-wide measure, so national rules apply alongside Regulation 1935/2004.

PFAS: the federal position and state laws

PFAS were used as grease-proofing agents on paper and paperboard food packaging. In February 2024 the FDA announced that grease-proofing substances containing PFAS are no longer being sold by manufacturers into the US market for food contact use, and in January 2025 it announced that the 35 food contact notifications for those uses are no longer effective.

Several states go further and ban food packaging with intentionally added PFAS. Examples:

• California: AB 1200 (Health and Safety Code section 109000 and following) prohibits plant fiber-based food packaging that contains intentionally added PFAS, or total organic fluorine of 100 ppm or more, from January 1, 2023.
• New York: Environmental Conservation Law section 37-0209 prohibits food packaging containing intentionally added PFAS, from December 31, 2022.
• Minnesota: Statutes section 325F.075 prohibits selling food packages that contain intentionally added PFAS, from January 1, 2024.
• Washington: RCW chapter 70A.222 restricts PFAS in specific food packaging types once the Department of Ecology identifies safer alternatives.

Other states have passed similar laws, and dates and scope differ. If you sell nationally, the simplest rule is to specify no intentionally added PFAS in every food-contact layer.

What this means for your packaging

1. Decide whether the pack touches the food. If the food is sealed in an inner bag, the outer box does not touch it. Direct contact changes the specification.
2. Describe the food and the temperature: dry, fatty, moist or acidic; frozen, ambient or hot. Compliance depends on it.
3. Ask your supplier for a written statement naming the regulations each food-contact layer complies with, for your food and conditions of use. For the EU, ask for the declaration of compliance for plastic layers.
4. Specify no intentionally added PFAS for every food-contact layer if you sell in states with PFAS laws.
5. Watch recycled board in direct contact. Recycled fiber can carry mineral oil residues that migrate into fatty foods, so direct contact usually calls for virgin-fiber or barrier-coated board.
6. Keep records of specs, statements and batch information so you can trace a material if you ever need to.

For direct-contact bakery boxes, tell us the product touches the board and we quote grease-resistant board with mineral-oil-free laminates; see our custom bakery packaging page. For shelf-stable foods sealed in a pouch, our custom pouches store lists the full layer structure of every film.

Primary sources

• 21 CFR Parts 170 to 199 (eCFR, Subchapter B)
• 21 CFR 174.5, general provisions for indirect food additives (GMP)
• 21 CFR 176.170, paper and paperboard in contact with aqueous and fatty foods
• 21 CFR 170.39, threshold of regulation
• FDA, Packaging and Food Contact Substances
• FDA, Inventory of Effective Food Contact Substance Notifications
• FDA, Authorized Uses of PFAS in Food Contact Applications
• Regulation (EC) No 1935/2004
• Regulation (EU) No 10/2011
• Regulation (EC) No 2023/2006 (good manufacturing practice)
• California AB 1200 (2021), Health and Safety Code section 109000 and following
• New York Environmental Conservation Law section 37-0209
• Minnesota Statutes section 325F.075
• Washington RCW chapter 70A.222

Frequently asked questions

Who regulates food packaging in the US?

The FDA, under the Federal Food, Drug, and Cosmetic Act. Packaging substances that may migrate into food must be covered by a regulation in 21 CFR Parts 174 to 186, an effective food contact notification, a threshold of regulation exemption, GRAS status or a prior sanction.

What is a food contact notification?

A notification to the FDA for a specific food contact substance and use. Once effective, it covers only the manufacturer or supplier named in it and the uses it describes.

Is PFAS banned in food packaging?

There is no single federal ban, but the FDA announced in February 2024 that PFAS grease-proofers are no longer sold into the US market for food contact use, and several states, including California, New York and Minnesota, ban food packaging with intentionally added PFAS.

What is the EU overall migration limit for plastic packaging?

10 mg per dm² of food contact surface, under Regulation (EU) No 10/2011. Many substances also have their own specific migration limits.