Export Compliance for Cosmetic Packaging: FDA, EU 10/2011 and Beyond

When you import cosmetic bottles into the US or EU, the paperwork often arrives before the product — and it is the paperwork that decides whether your shipment clears customs or sits in a bonded warehouse accruing demurrage.

This guide breaks down the compliance documents that matter for cosmetic packaging, what each market expects, and the specific files a responsible manufacturer like ShiJin should be able to provide. It is written for brand owners and sourcing managers, not regulators.

Why Compliance Documents Matter

Cosmetic packaging is treated as a food-contact-adjacent article in most markets. Even though the bottle never touches food, regulators care about what could migrate from plastic into a product that ends up on skin or (accidentally) in mouths. Two risks drive the paperwork:

• Customs holds and rejection. Missing or inadequate documentation can stall a shipment at the border.
• Brand liability. If a non-compliant bottle causes a safety issue, the brand — not just the factory — carries the recall and reputational cost.

Good compliance is not a certificate you file away; it is a chain of documents that traces every bottle back to a tested, authorized resin.

US Market — The FDA Framework

In the United States, the Food and Drug Administration regulates both cosmetics and the materials that contact them. Importantly, the FDA does not issue pre-market approval for cosmetic packaging. Instead, bottles fall under food-contact material rules defined in the Code of Federal Regulations (21 CFR) — for example, PET under 21 CFR 177.1630 and HDPE under 21 CFR 177.1520.

What this means in practice:

• The resin and any additives must be authorized for food contact and used within defined limits.
• The supplier should provide a written FDA compliance / food-contact statement confirming the article meets the relevant 21 CFR provisions.
• Cosmetics themselves are covered by the Modernization of Cosmetics Regulation Act (MoCRA, 2022), which raised record-keeping and adverse-event obligations for brands — making clean supplier documentation more valuable than ever.

You do not need an FDA "stamp" on the bottle. You need a credible, written statement from a manufacturer who can trace the resin. ShiJin's PET and HDPE bottles are supplied with material and compliance statements on request.

EU Market — EU 10/2011

The European Union regulates plastic food-contact materials through Regulation (EC) No 1935/2004 (the general framework) and Regulation (EU) 10/2011 (the specific rules for plastics). Key points brand owners should know:

• Overall Migration Limit (OML): no more than 10 mg of substances may migrate per dm² of food-contact surface.
• Positive list: only substances on the authorized list may be used, within defined limits.
• Declaration of Compliance (DoC): the supplier must provide a written declaration confirming the article complies, including the OML and the substances used. It must be traceable to the specific production batch.
• Supporting tests: for higher-risk or sensitive applications, specific migration and heavy-metal testing reports back up the DoC.

A DoC is not optional in the EU — it is the document your importer and QA team will ask for. Treat it as part of the product, not an afterthought.

Other Key Markets

If you sell beyond the US and EU, keep these in view:

• China (GB 4806 series): national food-contact standards with their own positive lists and migration limits.
• Japan: the JHOSPA positive-list framework for synthetic resins.
• Gulf (GCC): GSO standards aligned loosely with international practice.
• UK: post-Brexit, the UK retains a framework similar to EU 10/2011; confirm current UK-specific requirements.

Documents Your Supplier Should Provide

Here is the document set we recommend requesting before you place a production order:

How ShiJin Supports Compliance

ShiJin operates a documented quality system and holds 8 recognized certifications covering management, food-contact safety and third-party verification. We provide a compliance package — material statements, FDA food-contact statements and EU 10/2011 Declarations of Compliance — matched to your target market.

Our 15,000㎡ facility with 30+ blow-molding lines and in-house QC means documentation is generated against real, traceable production batches — not generic templates.

Common Pitfalls

• Accepting verbal "it's compliant" assurances. If it is not on paper, it does not exist at the border.
• Mixing up food vs. cosmetic standards. Bottles are evaluated under food-contact rules even for cosmetics — know which applies.
• Ignoring regulatory updates. MoCRA and EU revisions change obligations; stale documents create risk.
• Assuming one DoC covers all resins. PET, HDPE and PETG each need their own documentation.

Frequently Asked Questions