Food Packaging Regulations — A Buyer's Guide to FDA, EU 10/2011, LFGB & GB 4806

Why this guide exists

A pattern shows up in maybe 30% of the RFQs we receive: a new brand asks for “FDA-compliant packaging” without knowing what FDA compliance actually means. They’ve read the term on a competitor’s website, or a co-packer mentioned it, or a retailer listed it as a default-spec requirement. Then they get vendor quotes and don’t know how to evaluate the compliance answer.

A few years ago I’d just answer the question. Now I write this kind of guide because the buyer ecosystem keeps showing up uncalibrated and the cost of that miscalibration shows up in three places: failed retailer onboarding, customs problems, and (worst case) a product recall traced to a packaging-migration issue.

This is the version of the regulatory-overview document I wish more buyers had read before they started talking to suppliers.

The four regulatory regimes that matter

For ~80% of global food packaging sales, you’ll encounter at most four regulatory regimes:

FDA (United States) — 21 CFR Parts 174-186

The US food contact framework. The relevant CFR sections:

• 21 CFR 174 — general regulations for all indirect food additives
• 21 CFR 175 — adhesives and components of coatings (this is where the lacquer on your foil lives)
• 21 CFR 176 — paper and paperboard components
• 21 CFR 177 — polymers (BOPP, PET, PE, EVOH, nylon — each has its own subsection)
• 21 CFR 178 — adjuvants, production aids, sanitizers

FDA’s approach is positive-list: a material is allowed if it appears on an approved list with conditions of use. Anything not listed is not approved unless the FDA issues a letter of non-objection (LNO) for that specific application.

For a converter to claim FDA compliance, every component in the laminate — base film, ink, adhesive, lacquer, additives — must trace back to an authorized 21 CFR citation. That documentation is what you should demand.

EU 10/2011 (European Union) — Plastic Food Contact

The EU’s specific regulation for plastics in food contact. The key compliance metrics:

• OML (Overall Migration Limit): 10 mg/dm² across all substances migrating from packaging to food
• SML (Specific Migration Limits): per-substance caps for restricted chemicals (typically 50 mg/kg food but varies)
• Positive list (Annex I): only listed substances may be used in plastics for food contact

EU 10/2011 is more rigorous than FDA in one important way: it requires testing under simulated worst-case conditions matching the food you’re actually packing. If you’ll pack chocolate in a foil-laminate at room temperature for 12 months, the test simulates exactly that.

EU 10/2011 also requires a Declaration of Conformity (DoC) from the converter to the food brand — a formal document attesting that the packaging meets the regulation. This is the single most important document to ask for on EU-bound packaging.

LFGB §30/§31 (Germany)

Germany’s national food law, applied across the German market and required by many German retailers (REWE, Edeka, Lidl, Aldi). LFGB is broadly aligned with EU 10/2011 but adds:

• Sensory testing (taste / smell / appearance changes)
• Specific testing on print outer surfaces (ink can migrate inward through some substrates)
• Stricter limits on certain dye and pigment migration

For most projects, an EU 10/2011 compliant stack also passes LFGB. The exception is brightly colored printed packaging — German testing sometimes flags dye migration that EU testing doesn’t catch.

GB 4806 (China)

China’s national standard for food contact materials. Required for any product sold into the Chinese domestic market. The relevant subsections:

• GB 4806.6 — plastics resins for food contact
• GB 4806.7 — plastic films and sheets
• GB 4806.9 — metal and alloys (foil)
• GB 9685 — permitted additives in food contact materials

China’s approach is similar to EU’s — positive lists plus specific migration limits — but the approved-substance list differs in specific substances. A stack approved under EU 10/2011 is not automatically approved under GB 4806; specific re-testing per Chinese standards is often required.

The seven documents to demand from every supplier

This is the documentation a competent converter ships alongside every food packaging order. If your supplier can’t produce these, you have a vendor problem.

1. Material Safety Declaration (DoC for EU, similar for FDA)

A single PDF declaring conformity with each applicable regulation. Signed by the converter’s QA manager, dated within 12 months. Should reference specific regulatory citations per component.

2. Migration test report

Specific Migration Limits (SML) and Overall Migration Limit (OML) test panel from an accredited third-party lab (SGS, Intertek, Eurofins, TÜV). Tests should match the food simulant class your product actually uses. Report should be less than 12 months old or re-tested annually.

3. Material Certificate of Analysis (COA)

Per material lot from the upstream supplier. Lists thickness, dyne (surface energy), treatment value, regulatory citations. This is what proves the converter actually used the material they claim.

4. Heavy metals and SVOC test

Cadmium, lead, mercury, chromium VI, plus restricted SVOCs (semi-volatile organic compounds). Annually revalidated per ink supplier. Important for printed packaging especially.

5. Allergen control statement

Plant-wide declaration of allergen-control protocols. Critical for gluten-free, nut-free, soy-free SKUs that require segregated production lines.

6. BPA / phthalate / PFAS declaration

Specific declaration that the full stack (films + inks + adhesives + lacquers) is free of bisphenol-A, ortho-phthalates, and per/polyfluoroalkyl substances (PFAS). Increasingly a default requirement for US retail.

7. FSC chain-of-custody (for paper components)

Required by major retail chains (Whole Foods, Aldi, Lidl) for any paper packaging component. Documents the paper’s source forest and certification level (FSC Mixed, 100%, or Recycled).

For specific applications, add: BPI / TÜV OK Compost certification (compostable packaging), Halal / Kosher certification (religiously marketed product), retort-grade compliance testing (sterilized pouches), BRC Packaging certification (UK retail).

Food simulant testing — what to verify

Migration testing is run against food simulants, not your actual food. The simulant is matched to your food’s chemical profile:

The verification step: make sure the simulant tested matches your food’s actual profile.

A common compliance trap: a converter tests a coffee-pouch stack with a dry-food simulant (Tenax) because the coffee inside is dry. But if your coffee has high fat content (oily roasts release significant oils during steeping), the more conservative fatty-food simulant should be used. This shows up in audits.

For chocolate above 20% cocoa butter content, always test with a fatty-food simulant — Tenax doesn’t capture the actual migration risk.

The migration limits that matter

Two metrics drive pass/fail:

Overall Migration Limit (OML)

10 mg/dm² total — capped across all non-volatile substances migrating from packaging into food (or simulant) under test conditions.

A well-designed laminate hits 3-6 mg/dm² under standard test. Approaching 10 means you’re near the limit and small process drift could cause failures. Above 10 is automatic non-compliance.

Specific Migration Limit (SML)

Per-substance caps for restricted chemicals. The list of restricted substances is in EU 10/2011 Annex I; common substances include:

• Plasticizers (phthalates, adipates) — limits typically 50 mg/kg food
• Stabilizers (specific lead, cadmium compounds) — typically 0.05-1 mg/kg food
• Antioxidants (BHT, BHA, specific phenols) — typically 3-6 mg/kg food
• Photo-initiators (from UV-curable inks) — typically 0.01-1 mg/kg food
• Primary aromatic amines (from certain inks) — typically 10 µg/kg food

The pragmatic point: SML test results either pass or fail. If they pass, your packaging is compliant for that substance. If they fail, the stack needs to be re-engineered — either change the substance, reduce its concentration, or add a functional barrier.

The vendor-management problem (this is the real story)

After 16 years in the industry, my honest assessment: compliance is a vendor-management problem, not a regulatory problem.

The regulations are stable. The test methods are well-established. The labs are competent. What varies wildly is whether a given converter actually runs the testing, keeps the documentation, and ships it with the product.

The pattern of failed compliance I see is usually one of these:

The “trust me” supplier. Claims FDA compliance but can’t produce the specific 21 CFR citations per laminate component. The compliance is real (the materials are food-grade), but the documentation chain is incomplete. This shows up in retailer audits and customs inspections.

The “tested once” supplier. Ran migration testing on a generic version of the stack two years ago, hasn’t re-tested since changing adhesive suppliers. The original test isn’t valid for current production. This shows up in finished-product testing if a buyer does incoming QC.

The “we cover both” supplier. Tests against one food simulant (usually aqueous, the cheapest), declares compliance across all food categories. The compliance claim is overstated. This shows up in product recalls when packaging interacts unexpectedly with high-fat or high-acid foods.

The “we test the wrong stack” supplier. Customer requests a specific laminate; supplier substitutes a similar-but-not-identical stack and ships test results from the original. The compliance documentation doesn’t match the actual product.

The defense against all four is the same: demand documentation upfront, verify it covers your specific product and conditions, and retest at intervals.

What we actually do (the converter’s perspective)

For full transparency, here’s the compliance workflow we run on every new project:

1. Stack design with explicit regulatory scope. When a quote includes “FDA + EU 10/2011” we map every component (base film, ink, adhesive, lacquer) to specific regulatory citations. If anything in the stack falls outside the citation list, we flag and re-spec.

2. Pre-production qualification testing. First production run sent to an accredited third-party lab (SGS for US/EU work, Intertek for global, Eurofins for Europe-specific). Specific migration + OML + heavy metals tested. Report becomes part of the customer’s job folder.

3. Annual revalidation. Migration testing reruns every 12 months while the stack is in production, or whenever a material supplier changes. New report replaces old in the folder.

4. Per-shipment documentation bundle. Seven documents shipped with every PO using the qualified stack — the customer doesn’t request them, we send them by default.

5. Lot-traceable production. Every material roll lot is logged against customer orders. If a finished-product issue arises, we can trace back to the specific raw material lot within hours.

6. Retain samples held 24 months. One signed retain per SKU per batch. Any future quality dispute is reconciled against this reference.

This isn’t unique to us — it’s what a competent converter should be doing. The variance in the industry is who actually does it vs who claims to. The way to tell which kind you’re talking to: ask for sample documents from a recent shipment before signing the PO.

Common buyer mistakes

Patterns I see new brands make:

Skipping the EU declaration if they’re not selling in EU. Then later wanting to export, and finding the existing stack needs full re-testing before it can ship to EU. Spec EU compliance from day one — it’s cheap insurance.

Confusing “food-grade” with “compliant.” Food-grade materials are necessary but not sufficient. A food-grade adhesive used outside its approved application is non-compliant. The compliance is in the application, not just the material.

Trusting verbal supplier claims. “Yes we’re FDA compliant” without documents isn’t compliance. It’s a sales statement. Always require written documentation citing specific regulations.

Not specifying the food simulant. Letting the supplier choose. They’ll choose the cheapest (usually aqueous). Specify the simulant that matches your actual product — fatty for chocolate and oily snacks, alcoholic for alcohol-filled, acidic for fruit and acidic foods.

Believing one-time testing covers ongoing production. Supplier changes adhesive supplier; old test report is invalid; nobody re-tests; problems emerge months later. Demand annual re-testing or per-batch lot traceability with periodic verification.

Confusing migration limits with food safety. Migration limits are a calculated safety margin, not a contamination threshold. A package passing OML is broadly safe; a package failing OML may still be safe but is non-compliant. The regulatory frame is conservative on purpose.

When to involve a regulatory consultant

For most standard food packaging projects (mainstream materials, standard food categories, established retail channels), a competent converter handles compliance without external consulting. The consultant becomes valuable when:

• Launching a novel material structure (new biodegradable laminate, novel barrier coating)
• Entering a new geographic market with unfamiliar regulations
• Recovering from a compliance failure (recall, retailer rejection, customs hold)
• Pre-acquisition due diligence (verifying a supply chain claims)
• Major retailer onboarding with specific compliance audit requirements

Specialist firms include Keller and Heckman (US food contact law), Stewart McCallister Compliance (EU), Intertek’s regulatory consulting practice (global). Engagement costs run $5,000-$25,000 for typical project-scoped advisory work.

For routine compliance, talk to your converter first. We do this every day across hundreds of customer projects; we know which questions matter and which are theatre.

The summary checklist

Before signing a PO on food packaging:

1. ✅ Verify the supplier can name specific regulations covered (FDA 21 CFR sections, EU 10/2011, others)
2. ✅ Demand sample migration test report from a recent (under 12 months) production run of similar stack
3. ✅ Verify the food simulant tested matches your product’s category
4. ✅ Confirm SML + OML are both tested, not just one
5. ✅ Ask for the Declaration of Conformity (DoC) — should be PDF, signed, dated
6. ✅ Verify FSC certification for paper components (if applicable)
7. ✅ Verify BPA / phthalate / PFAS declaration covers full stack
8. ✅ Get written commitment to annual re-testing or per-batch traceability
9. ✅ For EU + multiple jurisdictions: confirm DoC covers all target markets
10. ✅ Hold a retain-sample mechanism in the supplier contract (24 months minimum)

If your supplier balks at any of these items, the time to find out is before you place the production order — not after the first finished-product test fails.

Where to go from here

For specific spec conversations on your project, talk to us directly — we’ll walk through your compliance scope as part of the quote, and the seven documents listed in this guide ship with every order using our standard workflow.

For deeper material-specific compliance information, see our material guides on aluminum foil, PET film, BOPP, and biodegradable laminates — each covers the food contact compliance angles specific to that material family.

For our full compliance workflow as applied to projects, see the food-safe packaging solution page.