What Agency Approves Food Packaging

Introduction

What agency approves food packaging in the United States? The U.S. Food and Drug Administration (FDA) is the principal federal agency that regulates food packaging, but it is far from the only gatekeeper. Importers, private-label brands, and foodservice distributors routinely hear the phrase “FDA approved” from overseas suppliers — yet almost no one uses that phrase correctly. The FDA does not “approve” finished packaging the way it approves drugs. It regulates the materials that touch food, the substances that migrate from them, and the labels that ride on top. This guide walks through which agencies actually have authority over food packaging, how to obtain the underlying clearances, what information must appear on labels by law, and where barcodes fit into the picture — particularly for products destined for the European Union.

If you are sourcing disposable plastic food containers — clamshells, sushi trays, bento boxes, cake containers — from an overseas manufacturer, the regulatory questions in this article are the questions your supplier should already be able to answer in writing. Understanding them yourself is the only way to verify those answers.

The FDA: What Agency Approves Food Packaging in the US

The FDA regulates food packaging under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations in Title 21 of the Code of Federal Regulations (21 CFR). The relevant parts of 21 CFR for packaging are clustered in Parts 170–199, which cover food additives — and food contact materials are, legally speaking, a category of indirect food additives.

The FDA does not issue a single “food packaging license.” What it offers are several distinct pathways:

• Food Contact Substance (FCS) Notification — a manufacturer submits an FCS Notification (FCN) to the FDA when it intends to use a new food contact substance not already authorized. The FDA has 120 days to object. If it does not, the substance becomes effective for the notifier. As of 2024, more than 2,000 effective FCNs are on file in the FDA’s database.
• Threshold of Regulation (TOR) — substances with very low dietary exposure can be exempted from the FCN requirement via a TOR submission.
• 21 CFR clearances — many food contact substances are already authorized through regulations listed directly in 21 CFR (for example, 21 CFR 177.1520 for olefin polymers, which covers PP and PE; 21 CFR 177.1630 for PET; 21 CFR 177.1640 for PS; 21 CFR 174.5 for general indirect food contact). A material that conforms to an existing regulation does not need a new FCN — it is already “cleared.”
• Generally Recognized as Safe (GRAS) — applicable to some substances, though less common in packaging contexts than in food ingredients.

For a typical disposable food container made of polypropylene (PP), polystyrene (PS), PET, or HIPS, no separate FDA approval is required if the resin and additives comply with the applicable 21 CFR sections. What the FDA regulates is the finished article’s food-contact suitability through its resin and additive framework, not the article itself.

A common misconception: FDA registration is not the same as FDA approval. Many Chinese and other overseas manufacturers register their facilities with the FDA under the Food Facility Registration rule (21 CFR Part 1, Subpart H). That registration is for the facility, not for the products. It is required for the facility that manufactures, processes, packs, or holds food for consumption in the United States. Registration alone does not certify that any specific packaging product is safe or legal. Foreign facilities must also designate a U.S. Agent — a domestic contact point for FDA communications — as a practical prerequisite to maintaining active registration.

Other US Agencies That Approve Food Packaging

The FDA is the lead agency, but several other federal bodies have overlapping or adjacent authority. Understanding who does what prevents expensive compliance gaps.

USDA — For Meat, Poultry, and Egg Products

O U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) regulates the labeling and packaging of meat, poultry, and egg products under the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Egg Products Inspection Act. If your packaging will touch raw meat, poultry, or processed egg products, FSIS must approve the labeling and inspect the establishment producing the product. The packaging itself, however, falls under FDA jurisdiction — the two agencies coordinate through memoranda of understanding.

EPA — Environmental and Chemical Regulations

O Environmental Protection Agency regulates chemicals through the Toxic Substances Control Act (TSCA) and certain pesticide-related packaging claims. If your packaging is treated with antimicrobial pesticides (for example, silver-ion coatings marketed as “antibacterial”), those substances must be registered with the EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The EPA also regulates the recycling and end-of-life of packaging under the Resource Conservation and Recovery Act (RCRA), which becomes increasingly important as states adopt Extended Producer Responsibility (EPR) laws. In January 2025, the FDA went further and withdrew 35 PFAS-related food contact notifications in the Federal Register, accelerating the U.S. phase-out of grease-proofing substances containing PFAS in food packaging.

CPSC — Consumer Product Safety

O Consumer Product Safety Commission oversees packaging that may pose a physical hazard to consumers — for example, child-resistant closures, choking hazards from small component parts, or sharp edges. CPSC does not regulate food-contact safety, but it does regulate packaging-related physical safety under the Consumer Product Safety Act.

State-Level Authorities

Many US states — notably California (Proposition 65), New York, and Washington — impose additional labeling requirements. California’s Proposition 65 requires warnings for products containing chemicals known to cause cancer or reproductive toxicity, including certain phthalates and bisphenols. As of 2023, California expanded its restrictions on PFAS (per- and polyfluoroalkyl substances) in food packaging under AB 1817, prohibiting intentionally added PFAS at any detectable level. New York’s S.4630A and Washington’s HB 1623 follow similar templates. Buyers shipping into multiple states must stack these requirements, not treat them as optional.

How to Get a Food Packaging License or Approval — Step by Step

“How to get food packaging license” is one of the most searched phrases from overseas manufacturers and importers. The answer depends on whether you are a brand owner sourcing finished packaging or a manufacturer producing it. The general workflow applies to both. There is no single document labeled “food packaging license” in the U.S. — what exists is a chain of compliance evidence.

Step 1 — Determine the Material Category

Identify the resin, additives, and any coatings. For each, locate the applicable 21 CFR section or existing FCN. For PP, see 21 CFR 177.1520; for PET, 21 CFR 177.1630; for PS, 21 CFR 177.1640; for PLA, review FDA’s inventory of effective FCS notifications, because PLA is not universally cleared for all food-contact uses. Recycled-content materials trigger additional evaluation under FDA’s recycled plastics guidance.

Step 2 — Conduct Migration Testing

Migration testing determines how much of the packaging material transfers into food under simulated conditions. The FDA accepts migration testing against food-simulating solvents (distilled water, 10% ethanol, 50% ethanol, and food oil or synthetic triglyceride) under standardized time and temperature conditions. Test reports should come from an ISO 17025-accredited third-party laboratory. US buyers typically request test reports referencing 21 CFR 175.300 (resinous and polymeric coatings) or the relevant resin regulation.

Step 3 — File an FCN or Rely on Existing Clearance

If the resin and additives are already authorized in 21 CFR, document the chain of compliance: resin grade, supplier, certificate of analysis, and finished-product migration test. If you are introducing a new substance, file an FCN through the FDA’s CFSAN portal. Expect a 120-day review window. If the FDA does not object, your substance becomes effective for your use only — FCNs are not transferable across notifiers without an acknowledgment letter from the new notifier.

Step 4 — Maintain Documentation

For every shipment, retain:

• A Certificate of Compliance (CoC) from the manufacturer stating which 21 CFR sections apply
• A Certificate of Analysis (CoA) for the resin lot
• A migration test report dated within the last 12 months
• BPA-free, REACH, and Prop 65 statements when required by the buyer

For a manufacturer with FDA + EU food-contact + Japan MHLW certifications, this documentation is typically consolidated into a single regulatory dossier provided to the buyer with the first sample shipment. From a factory perspective, maintaining an up-to-date dossier — refreshed each calendar quarter and tied to the resin lot used in that production run — is cheaper than scrambling for documents after a customs hold. The same dossier template, when re-purposed for an EU shipment, also covers the Declaration of Conformity required by Regulation 1935/2004, which is why multi-jurisdiction compliance footprints pay off in practice.

What Is Required on Food Packaging by Law

“What needs to be on food packaging by law” overlaps with “what is required on food packaging” — the two questions cover the same legal territory from different angles. In the United States, the FDA’s Food Labeling regulations (21 CFR Part 101) govern most packaged food products, and the packaging labels must include the following mandatory elements:

For bilingual labeling in the US market, Canada, or Mexico, additional requirements apply. Canada requires bilingual English/French labeling under the Consumer Packaging and Labelling Act. Mexico follows NOM-051 labeling rules, with octagonal front-of-package warning labels for products exceeding thresholds of sugar, fat, sodium, or calories.

What About the Packaging Itself (Not the Food Label)?

When buyers ask “what are the requirements for food packaging,” they often mean the shipping case and primary container, not the consumer-facing label. For shipping cases, the FDA does not impose detailed content requirements, but retailers do — typically a UPC/EAN barcode, GTIN, supplier number, country of origin, lot/batch code, and case dimensions. The same is true for the EU, where the Food Information to Consumers regulation (EU 1169/2011) sets the consumer-facing label but leaves the case-level barcoding to retailer logistics.

Is Barcode Mandatory on Food Packaging Under EU Law?

This is one of the most common regulatory questions for US-based distributors expanding into Europe. The short answer: there is no EU regulation that makes a barcode legally mandatory on consumer-facing food packaging. However, the practical reality is that almost no retailer will accept a product without one.

The relevant facts:

• GS1 barcode (EAN/UPC) on consumer units — not legally required by EU food law, but mandatory for retail listings in every major EU market. Retailers require GS1-compliant barcodes because they tie into their point-of-sale and inventory systems.
• GTIN allocation — you need a GS1 Company Prefix from a national GS1 organization (GS1 Germany, GS1 France, GS1 UK, etc.). GS1 memberships typically cost €300–€1,500 per year depending on turnover band and country.
• EU Regulation 1169/2011 (Food Information to Consumers, FIC) — requires specific label elements but does not mention barcodes.
• EU Regulation 1935/2004 (Food Contact Materials) — covers the safety of packaging materials but does not mandate barcodes.
• EU PPWR — Packaging and Packaging Waste Regulation 2025/40 — applies from 12 August 2026, replacing the older Directive 94/62/EC. PPWR introduces mandatory recyclability performance grades, mandatory minimum recycled-content targets for plastic packaging (from 2030), mandatory deposit-return schemes for plastic beverage bottles and certain single-use formats, and substance-of-concern reporting. Barcode requirements are not the focus of PPWR; recyclability and traceability are. The regulation does push digital product passport concepts, which will rely on 2D barcodes such as GS1 DataMatrix — but that is a forward-looking requirement, not a current one for most food packaging categories.

So the precise answer to “is barcode mandatory on food packaging eu law” is: not legally, but practically unavoidable for any product that wants to reach an EU retailer. The cost of non-compliance is not a fine — it is a refused delivery.

Other Mandatory Information for EU-Labeled Food Packaging

For US-based B2B buyers evaluating whether to extend their product line to the EU, the mandatory food information per Regulation 1169/2011 includes:

• Name of the food
• List of ingredients (with allergens emphasized)
• Allergen information per Annex II
• Quantity of certain ingredients or categories of ingredients (QUID)
• Net quantity
• Date of minimum durability (“best before”) or use-by date
• Storage conditions and conditions of use
• Name and address of the food business operator
• Country of origin or place of provenance (for certain meats per Regulation 1337/2013)
• Nutrition declaration (energy + fat, saturates, carbohydrate, sugars, protein, salt)
• Lot/batch identifier for traceability
• Instructions for use where needed

In addition, Regulation 1935/2004 Article 15 requires that food contact materials be accompanied by a Declaration of Conformity (DoC) when placed on the EU market. The DoC must confirm compliance with 1935/2004 and identify the substances used. This is the EU equivalent of an FDA CoC — and it is one of the documents that ManLuen and other FDA-certified factories supply routinely as part of EU shipments, bundled into the same regulatory dossier that covers the U.S. side.

Common Mistakes B2B Buyers Make When Sourcing Compliant Packaging

From the factory side, three errors account for most compliance failures:

1. Conflating FDA registration with FDA approval. A facility registration number does not mean any specific product has been reviewed or cleared. Buyers should ask for the specific 21 CFR sections, FCN numbers, or migration test reports that apply to the products they are purchasing.
2. Skipping migration testing for new SKUs. A new color, new additive, or new supplier can change the regulatory status of an otherwise compliant part. Each change should trigger a new test cycle, especially for products that will touch high-fat or high-alcohol foods, where migration thresholds tighten.
3. Accepting supplier documents at face value without verifying dates, signatures, and laboratory accreditation. Migration tests dated more than 24 months ago, or reports from laboratories that are not ISO 17025-accredited, are common red flags. A “BPA-free” claim without the underlying test method is a marketing line, not a regulatory fact.

A factory with 17+ years in food-grade plastics will have a templated dossier for FDA, EU, and other jurisdictions. The presence of that dossier — and the speed with which it is supplied on the first sample shipment — is a more reliable signal of compliance maturity than any marketing claim.

Perguntas Frequentes

What agency approves food packaging in the United States?

O FDA is the primary agency. It regulates food packaging under the Federal Food, Drug, and Cosmetic Act e 21 CFR Parts 170–199. The FDA approves food contact substances (through FCNs) and clears resins used in food packaging, but does not “approve” the finished packaging article itself. USDA/FSIS regulates packaging for meat, poultry, and egg products, EPA regulates antimicrobial and chemical aspects, and CPSC addresses physical safety. State agencies such as California’s Proposition 65 enforcement add additional rules, including AB 1817’s PFAS prohibition.

How to get a food packaging license or approval?

There is no single “food packaging license” in the US. The practical workflow is: (1) confirm the resin and additives are authorized under 21 CFR 175–177, (2) commission migration testing at an ISO 17025 lab against food-simulating solvents, (3) if a new substance is involved, file a Food Contact Substance Notification (FCN) with a 120-day FDA review window, and (4) maintain a regulatory dossier (CoC, CoA, migration test, BPA-free statement) for every shipment. For the EU, the equivalent documentation is a Declaration of Conformity under Regulation 1935/2004, supported by Regulation 1169/2011 label compliance for consumer-facing packs.

What are the requirements for food packaging labels?

US food packaging labels must include the statement of identity, net quantity, ingredient declaration, allergen declaration, manufacturer/distributor name and address, country of origin, nutrition facts, and date marking where applicable, per 21 CFR Part 101. EU food labels must comply with Regulation 1169/2011, which adds allergen emphasis (Annex II), QUID, lot identifiers, and country-of-origin rules for certain meats. Both regimes treat the consumer label and the shipping case as separate compliance tracks.

Is barcode mandatory on food packaging under EU law?

No — there is no EU food law that mandates a barcode. Retailers, however, will not accept a product without a GS1-compliant EAN/UPC barcode. GS1 prefixes are obtained from a national GS1 organization and cost approximately €300–€1,500 per year. From 12 August 2026, the new EU PPWR (2025/40) adds recyclability, recycled-content, and traceability requirements but does not change the barcode picture for most product categories today — though digital product passport pilots point to 2D barcodes (GS1 DataMatrix) becoming more relevant in the next compliance cycle.

What needs to be on food packaging by law in the US?

At minimum: statement of identity, net quantity (dual units), ingredient list, allergen declaration, name and address of the responsible party, country of origin, and nutrition facts. Date marking is required where applicable. For products containing or derived from major allergens — including sesame since the FASTER Act of 2023 — an additional “Contains” statement is recommended. California Proposition 65 warnings are required if the packaging contains any of the listed chemicals at concentrations above the safe harbor levels, and California’s AB 1817 prohibits intentionally added PFAS at any detectable level.

How long does FDA Food Contact Substance Notification take?

The FDA has a statutory 120-day review period for FCNs. In practice, the review window can be extended if the FDA requests additional information. For substances that already comply with an existing 21 CFR regulation (e.g., 21 CFR 177.1520 for PP, 21 CFR 177.1630 for PET, 21 CFR 177.1640 for PS), no FCN is needed and approval is effectively immediate — the regulatory pathway is documentation rather than review. That is why the 21 CFR inventory, not FCN, is the first place a factory should look when qualifying a new resin grade.

Conclusão

“What agency approves food packaging” looks like a simple question but unravels into a multi-agency, multi-jurisdiction set of requirements that catches many B2B buyers off guard. The FDA is the lead authority in the United States, but it shares responsibility with USDA, EPA, CPSC, and state agencies. For European distribution, the answer shifts to the European Food Safety Authority, the European Commission, and individual Member States — with the new PPWR (2025/40) adding another layer of compliance from 12 August 2026, especially around recyclability, recycled content, and traceability.

For B2B buyers sourcing disposable food packaging from overseas, the actionable summary is straightforward. Demand the underlying documentation: a 21 CFR section or FCN number that covers the resin, a migration test from an ISO 17025 lab dated within 12 months, and a Declaration of Conformity for EU-bound shipments. A manufacturer with a multi-jurisdiction compliance footprint — FDA + EU + Japan MHLW + Saudi SASO — and a templated regulatory dossier refreshed each quarter can deliver that documentation on the first sample shipment. If the supplier cannot, the regulatory risk is the buyer’s, not the supplier’s. Understanding what agency approves food packaging — and what evidence that agency expects — is the difference between a clean customs entry and a six-week cargo hold

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References

U.S. Food and Drug Administration (FDA). Food Packaging & Other Substances That Come in Contact with Food—Information for Consumers.
Used for defining food-contact substances, explaining the Food Contact Notification process, and introducing how FDA evaluates migration and recycled plastics in food packaging.
U.S. Food and Drug Administration

U.S. Food and Drug Administration (FDA). Packaging & Food Contact Substances.
Used for explaining the FCN submission process and providing access to FDA inventories, conditions-of-use tables, the CEDI database, Threshold of Regulation exemptions, and recycled-plastic resources.
U.S. Food and Drug Administration

U.S. Food and Drug Administration (FDA). Producing a Food Product That Is Regulated by FDA.
Used for explaining the regulatory boundary between FDA and the U.S. Department of Agriculture for meat, poultry, certain processed egg products, catfish, and other food categories.
U.S. Food and Drug Administration

U.S. Food and Drug Administration (FDA). Is It Really “FDA Approved”?
Used for explaining the limits of the term “FDA approved” and why food packaging compliance cannot be established through a general approval claim alone.
U.S. Food and Drug Administration

U.S. Food and Drug Administration (FDA). Phthalates in Food Packaging and Food Contact Applications.
Used for the May 27, 2026 scientific evaluation of authorized phthalates and the proposed grouping of DEHP, DCHP, DIOP, and DINP for a future cumulative risk assessment.
U.S. Food and Drug Administration

U.S. Food and Drug Administration (FDA). Market Phase-Out of Grease-Proofing Substances Containing PFAS.
Used for the detailed PFAS regulatory timeline, including long-chain PFAS actions, the 2020 voluntary phase-out commitments, the 2024 market withdrawal, and the 2025 determination that 35 Food Contact Notifications were no longer effective.
U.S. Food and Drug Administration

U.S. Food and Drug Administration (FDA). FDA Announces PFAS Used in Grease-Proofing Agents for Food Packaging Are No Longer Being Sold in the U.S.
Used for confirming the February 28, 2024 completion of the voluntary market phase-out of PFAS-containing grease-proofing substances used in U.S. paper and paperboard food packaging.
U.S. Food and Drug Administration

U.S. Food and Drug Administration (FDA). Food Ingredient & Packaging Inventories.
Used as the central reference point for the FCN Inventory, 21 CFR food-contact listings, GRAS notices, food-additive status lists, color-additive resources, and related FDA databases.
U.S. Food and Drug Administration

Owusu-Apenten, R., and Vieira, E. Food Regulatory Agencies.
Used for the academic overview of food-regulatory institutions and the roles of different government agencies in food-safety governance.
Springer

Heckman, J. H. Food Packaging Regulation in the United States and the European Union.
Used for comparing the historical development, regulatory structures, and underlying approaches of U.S. and European Union food-packaging law.
ScienceDirect

REACH24H. U.S. Food Contact Materials Compliance.
Used for summarizing the practical U.S. food-contact compliance pathways, including 21 CFR listings, Food Contact Notifications, GRAS status, prior sanctions, and Threshold of Regulation exemptions.
REACH24H

Intertek. Food Contact Materials Testing & Food Packaging Analysis.
Used for explaining third-party migration testing, chemical analysis, packaging evaluation, and market-specific food-contact compliance services.
Intertek

ECA Academy. What Is an FDA-Approved Product?
Used as a supporting industry reference for explaining which products require FDA premarket approval and why “FDA approved” should not be treated as a universal regulatory claim.
ECA Academy

Acme Corrugated Box. Why Food Processors Trust Acme Corrugated Box for Their Packaging Solutions.
Used for illustrating how B2B packaging suppliers address food-processor requirements involving product protection, customization, production reliability, warehousing, and supply-chain support.
Acme Corrugated Box

Sohu. 美国FDA加强食品包装监管，含PFAS材料再受关注.
Used as a Chinese-language secondary reference for cross-checking PFAS terminology and the FDA regulatory timeline. Primary regulatory claims should be verified against the corresponding FDA sources above.
Sohu

ManLuenpack

ManLuen Plastic Packaging Company, especializada na produção de Embalagens de Alimentos de Plástico há mais de 20 anos. Os nossos produtos são feitos de PP virgem e livre de BPA, em conformidade com os padrões da FDA e Europeus.

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