cGMP-Compliant Food Packaging: GMP Requirements & FDA Rules

cGMP for Food Packaging at a Glance

• 174.5The 21 CFR section that defines good manufacturing practice for indirect food additiveseCFR
• 5Routes FDA recognizes for a substance in a food-contact material, from regulations to FCNsFDA
• 120 daysFDA's review window before a Food Contact Notification can become effective21 CFR 170.104
• 35PFAS grease-proofing FCNs FDA declared no longer effective as of January 6, 2025FDA

Updated October 6, 2026. Checked against the eCFR (21 CFR parts 1, 7, 117, 170, 174 and 181), FDA's food contact substance pages and guidance, and the SQF Food Safety Code: Manufacture of Food Packaging. This article is general information, not legal advice. Confirm current requirements with FDA and your customers before you rely on them.

What Does cGMP Mean for Food Packaging?

Primary food packaging, the layer that touches the food, is a food-contact article, so its components can move into the food. U.S. law treats that as a food safety issue. A food is adulterated if its container is made, in whole or in part, of any poisonous or deleterious substance that may make the contents injurious to health.^[1] Even a substance FDA has cleared for packaging can still make a food unfit; FDA's own example is a packaging material that gives a food an off odor or taste.^[2]

Good manufacturing practice (GMP) for packaging is the set of controls that keeps a food-contact material the way it was designed and authorized: the right substances in the right amounts, made and stored so nothing else gets into it. The "c" for "current" means the practices have to keep up with what's expected today. In the U.S. food industry, FDA's cGMP requirements for human food are in 21 CFR part 117 subpart B, written around plants that make, pack or hold food; for packaging, FDA's GMP requirement sits in its food additive rules instead.^[3][2] For the general difference between the two terms, see our cGMP vs GMP comparison.

Is There an FDA cGMP Regulation for Food Packaging?

Not as a plant-operations code. FDA has no regulation titled "cGMP for food packaging." What it has is a definition in its food additive rules: when an FDA regulation lists a substance for use in food-contact articles, that use is predicated on good manufacturing practice, and 21 CFR 174.5 spells out the restrictions.^[2]

• Use only what the job needs. The amount that ends up in food can't exceed what results from using no more of the substance than reasonably required for its intended physical or technical effect in the packaging. It must also stay within any limits FDA set, and it can't be meant to have a technical effect in the food itself, unless a regulation permits that.
• Use material of suitable purity. Any substance used as a component of a food-contact article must be of a purity suitable for its intended use.

Section 174.5 also makes clear that a listing in FDA's food-contact regulations doesn't excuse a packaging use from the rest of the Federal Food, Drug, and Cosmetic Act, and that a substance listed for packaging isn't thereby cleared to be added to food directly.^[2] One narrow rule does reach the plant itself: new equipment for manufacturing food-packaging materials must not contain or use PCBs.^[4]

Part 190 covers dietary supplements, not packaging, so "parts 174 to 190" overstates the range.^[5][2]

FDA's current good manufacturing practice rule for food, 21 CFR part 117 subpart B, mentions food-packaging materials about 20 times, mostly as something food plants must protect from contamination, and it requires quality control operations so packaging materials are safe and suitable.^[3][6]

How Does a Packaging Material Get FDA Authorization?

FDA says the regulatory status of a food-contact material comes from the status of each substance in it. Every substance reasonably expected to migrate into food has to be covered by one of five routes.^[7]

Sources for the five routes.^{[7][8][9][10][11][12]}

FDA's guidance says the substance's manufacturer is responsible for making sure food-contact materials meet every applicable authorization, and suggests checking each one in three parts: the identity of the substance, its specifications (purity or physical properties) and the limits on how it can be used.^[7]

Do Packaging Makers Have to Register With FDA or Follow FSMA?

Usually not. FDA's registration guidance reads the registration definition of "food" as excluding food contact substances and answers the question directly: a facility that makes, packs or holds food contact substances, including food packaging, isn't required to register.^[14][15] FDA's compliance guide for part 117 adds that a facility handling only a food contact substance isn't required to comply with the preventive controls rule for human food.^[16][17]

Registration and preventive controls duties fall on your customers, not you, but you still answer for your materials under 21 CFR 174.5 and the FD&C Act, and customers pass their own duties down to you. Under its CGMPs, a food plant must use quality control operations to make sure the food-packaging materials it uses are safe and suitable, and a facility covered by the preventive controls rule must evaluate how its packaging activities affect the safety of the finished food.^[6][19] Its CGMPs also require it to protect food-packaging materials from people, pests, water, chemicals and condensation in its own plant.^[3]

FDA's guidance says food contact substances aren't subject to the supply-chain program requirements of the preventive controls rule, and that FDA intends not to enforce its Foreign Supplier Verification Program rule against importers of food contact substances.^[20][21] That's one reason food companies rely on specifications, questionnaires and supplier audits instead.

What GMP Requirements Apply Inside a Packaging Plant?

With no FDA plant-operations code for packaging, a GFSI scheme's GMP module is a practical guide. In practice, packaging GMP looks a lot like food plant GMP, applied to materials instead of food. The SQF Food Safety Code: Manufacture of Food Packaging is a useful map, because its module 13 is written specifically for good manufacturing practice in packaging plants. Edition 9 is the edition audited today; SQFI says Edition 10 audits won't begin before January 2, 2027.^[22][23]

The same code also expects every raw material to be suitable for its intended use, food-contact compliant where applicable, and compliant with the law in the country of manufacture and, if known, the country of destination. It also requires you to make your raw material suppliers tell you about composition changes that could affect the finished product, its design, processing or food safety.^[22]

Each scheme words these requirements its own way. Kiwa ASI's own standard is summarized on its cGMP food packaging certification page.

What Paperwork Do Customers Ask Packaging Suppliers For?

Food companies need evidence that the packaging they buy is safe and suitable, so the requests land on you. FDA itself points buyers to the supplier: it suggests asking the manufacturer for a letter of guaranty that a product is acceptable for its intended food-contact use.^[7][24]

A guaranty is only as good as what's behind it. Build it on your formulation records, your suppliers' statements and your own controls, and keep it current when a formula, supplier or use changes.

What If Your Packaging Is Sold in the EU or Canada?

If your packaging, or the food packed in it, is sold in the EU, the EU's food contact rules apply, and they name GMP outright. The framework regulation says materials must be manufactured in compliance with good manufacturing practice, and a separate regulation spells out what that GMP system looks like.^[27][28]

Two details trip up exporters. EU law requires a written declaration of compliance only for materials covered by a specific EU measure, such as plastics and, under the BPA regulation, coatings, inks, adhesives, rubbers and silicones, though some EU countries require one for other materials.^[27][29][30] And for printing inks on the non-food side, the GMP regulation says inks must be formulated and applied so substances don't transfer through the substrate or by set-off in the stack or reel at levels that would breach the framework regulation's safety rule, and printed surfaces must not touch food directly.^[28]

Canada puts the duty on the seller of the food: no one may sell food in a package that may yield a substance injurious to health.^[31] Health Canada offers a voluntary premarket review that can end in a letter of no objection, which it says isn't a legal approval and doesn't relieve food sellers of their responsibilities.^[32]

What's Changing in Food Packaging Rules?

PFAS grease-proofers are no longer sold or authorized for U.S. food packaging. On February 28, 2024, FDA announced that grease-proofing substances containing PFAS were no longer being sold by manufacturers for food-contact use in the U.S. market, fulfilling voluntary phase-out commitments manufacturers made to FDA in 2020.^[33] FDA then found 35 Food Contact Notifications for these substances no longer effective as of January 6, 2025, with a compliance date of June 30, 2025 for certain paper packaging made, supplied or used before January 6, 2025.^[34] Other authorized food-contact uses of PFAS, such as nonstick coatings, sealing gaskets and manufacturing aids, remain; FDA says current data indicate only the paper and paperboard grease-proofing uses could lead to dietary exposure that may be a safety concern.^[35]

The EU has banned BPA in food contact materials. Regulation (EU) 2024/3190 prohibits bisphenol A in making seven groups of food contact materials (plastics, varnishes and coatings, printing inks, adhesives, rubbers, silicones and ion-exchange resins), with two narrow exceptions. Final articles made with BPA under the old rules could be first placed on the market until July 20, 2026; some, such as packaging for preserving fruit, vegetables and fishery products, until January 20, 2028.^[30]

The EU now limits PFAS in food-contact packaging. Since August 12, 2026, food-contact packaging can't be placed on the EU market if it contains PFAS at or above 25 ppb for any single PFAS, 250 ppb for the sum of targeted PFAS, or 50 ppm for total PFAS including polymeric PFAS.^[36]

Check every change against your formulas and your suppliers' statements, and update the guaranties and declarations you give customers when something moves.

What If a Customer Wants Third-Party Proof?

Customers often go beyond paperwork and ask for a third-party audit. FDA doesn't require packaging makers to be certified; some customers do.^[37] The usual options are:

• A non-GFSI GMP audit. Several exist. Kiwa ASI's cGMP Food Packaging standard is its own audit standard for food-contact and non-contact packaging makers. It isn't GFSI-benchmarked or accredited.^[37]
• A GFSI-recognized packaging program, when a customer asks for GFSI. GFSI's list for food packaging production includes the SQF Food Safety Code: Manufacture of Food Packaging (Edition 9), FSSC 22000 (version 6, food chain category I), BRCGS Packaging Materials (Issue 6) and IFS PACsecure (version 2). Newer editions are still in GFSI benchmarking: SQF Edition 10 and FSSC 22000 version 7, which aren't audited yet, and BRCGS Issue 7 and IFS PACsecure version 3, which are already being audited; confirm current status with the program owner.^{[38][39][40][23]}

ASI Food Safety, LLC (Kiwa ASI) offers SQF certification as an SQFI-licensed certification body accredited by ANAB for the SQF Food Safety Code: Manufacture of Food Packaging, Edition 9, and FSSC 22000 certification certificates are issued by Kiwa VERIN B.V., a Kiwa group certification body licensed by Foundation FSSC.^[41][42] For what Kiwa ASI's packaging audit covers, how it's scored and what drives its cost, see cGMP food packaging certification.

As a certification body, ASI Food Safety, LLC doesn't consult for the sites it certifies. Training, such as cGMP V2.0 training, comes from ASI Training and Consulting, LLC, which operates separately from the certification body and has no effect on audit outcomes.^[43]

Frequently Asked Questions