Packaging compliance for export is one of the most under-resourced areas in international product launches. Brands invest heavily in formulation, branding, and logistics — then discover at the border, or worse, in a retailer audit, that the packaging fails a regulation they didn’t know existed.

The cost of getting it right is a documentation exercise. The cost of getting it wrong is a market withdrawal.

2025 has been a decisive year for global packaging and pharmaceutical packaging regulations. The EU’s Packaging and Packaging Waste Regulation (PPWR) entered into force in February 2025 and applies from August 2026. The UK confirmed its EPR fee modulation framework. The FDA finalized MoCRA registration guidance for foreign cosmetic establishments. 

Each of these changes affects which packaging formats you can sell, where you can sell them, and what documentation is required.

Why Packaging Compliance for Export Is Now a Supply Chain Issue

Regulatory compliance used to sit with legal and regulatory affairs teams. It now sits in procurement — because packaging suppliers are the primary source of compliance documentation.

For tubes specifically, the compliance burden falls on material declarations, recycled content certification, migration testing data, and labeling capability that a manufacturer can provide. A supplier who cannot supply this documentation is not export-ready, regardless of pricing.

Market-by-Market Requirements

Based on each market, here’s how the requirements vary.

European Union: EU PPWR (Regulation (EU) 2025/40)

Adopted in December 2024, the PPWR entered into force on 11 February 2025 and applies from 12 August 2026.

Key obligations:

• All packaging on the EU market must be designed for recyclability — mandatory from 2030
• Minimum recycled content targets for plastic packaging apply from 2030
• Packaging manufacturers must prepare an EU Declaration of Conformity
• EPR obligations apply to all companies placing packaging on the EU market, regardless of the country of origin
• Pharmaceutical packaging is not fully exempt — recyclability requirements broadly apply

Request from your supplier: EU Declaration of Conformity template, material composition documentation, and recyclability assessment per applicable EU standards.

United Kingdom: Plastic Packaging Tax + EPR

Two mechanisms affect packaging sourcing:

• UK Plastic Packaging Tax: Applies to packaging containing less than 30% recycled content. It will rise to £228.82 per tonne in April 2026.
• UK Packaging EPR: From 2026, the RAM will modulate fees based on recyclability. Lighter, more recyclable packaging will attract lower fees.

Tubes entering the UK market must contain at least 30% recycled content to avoid the plastic packaging tax. Ensure that you receive documentation regarding recycled content in the materials. Sustainability alone is insufficient for exemption from the plastic tax.

United States: FDA and DSCSA

Cosmetic tubes:

• Under the MoCRA (Modernization of Cosmetics Regulation Act 2022), cosmetic product manufacturers must register with the FDA. Manufacturing establishments must register with the FDA, and foreign establishments must appoint a US-based agent.
• Compliance with cosmetic labeling requirements according to 21 CFR Part 701.

Pharmaceutical tubes:

• Pharmaceutical tubes must comply with 21 CFR Part 211 GMP standards and demonstrate compatibility through E&L testing.
• Under DSCSA, all prescription drug products must carry a serialized product identifier with a barcode. Interoperable electronic tracing of all prescription drugs starts from 2025.
• OTC drug tubes require tamper-evident packaging per 21 CFR 211.132.

Request from your supplier: E&L test reports, GMP compliance documentation, and tamper-evident closure capability with documented seal strength data.

Middle East / GCC Countries

GCC cosmetics regulations align closely with the EU Cosmetics Regulation 1223/2009. Products should comply with GSO 1943/2016 (cosmetic product safety) and GSO 2528/2016 (cosmetic product claims).

Product packaging must include Arabic labeling alongside the language of origin. Halal certification is becoming increasingly common in major retail outlets across Saudi Arabia, the UAE, Kuwait, Bahrain, Qatar, and Oman.

Pharmaceutical products must meet local health authority registration requirements in each country, including stability testing data and approved packaging specifications for product dossiers.

Australia: APCO and TGA

Cosmetics and personal care packaging fall under the Australian Packaging Covenant Organisation (APCO).

For pharmaceutical packaging, goods must comply with TGA requirements and related pharmaceutical packaging regulations covering labeling, tamper evidence, and child-resistant closures for applicable product categories.

Compliance Documentation Checklist

Document	Cosmetics	Pharma	Market
Material composition declaration	✓	✓	All markets
Recycled content certification	✓	✓	EU, UK
EU Declaration of Conformity	✓	✓	EU
Extractables & leachables report	—	✓	USA, EU pharma
Migration testing data	✓	✓	EU, food-contact
GMP certification (ISO 15378)	—	✓	Pharma supply chains
DSCSA serialization confirmation	—	✓	USA prescription drugs
Tamper-evidence specification	—	✓	USA OTC drugs
Arabic labeling capability	✓	✓	GCC markets
APCO recyclability assessment	✓	—	Australia

Build Compliance Into Supplier Selection

The most common compliance failure is treating regulatory requirements as a final-stage labeling issue. By the time artwork is in development, tube material, construction, and closure are already locked in — changing them means restarting sampling, stability testing, and supplier qualification.

For effective packaging compliance for export, compliance requirements for each target market should be defined before a packaging brief reaches a supplier. Recyclability, recycled content, E&L testing capability, and certification availability are supplier qualification criteria — not afterthoughts.

Wrapping Up: Compliance Is a Pre-Sourcing Activity

Successful packaging compliance for export doesn’t start at customs. It starts when a material is specified, and a supplier is qualified.

EU PPWR, UK PPT, FDA pharma requirements, GCC labeling mandates, and Australia APCO targets all require supplier-level documentation decisions made before artwork, not after.

Frequently Asked Questions

Can one tube specification simultaneously meet EU PPWR, UK Plastic Packaging Tax, and US FDA requirements without separate packaging versions?

In some instances, yes. Mono-material PE co-extruded tubes with recycled content documentation and migration test data can help meet overlapping regulatory requirements, resulting in reduced SKUs and qualifying suppliers.

What would happen if a packaging company’s compliance documentation were discovered to be false once a commercial order had been made?

The importer of record takes on the regulatory responsibility in virtually every market. False compliance documents can lead to product detention, product recalls, and regulatory fines. Always ask for independent verifications of any certificate provided by the manufacturer.

What is the difference between migration testing and extractables and leachables testing, and when would each be necessary?

Migration testing measures the transfer of substances from packaging into the product under defined conditions. Migration testing is required for food contact products and cosmetics. Extractables and leachables (E&L) testing is a pharmaceutical-grade assessment that evaluates substances that could migrate from packaging into the product throughout its shelf life.

How frequently do global packaging regulations change, and what systems should sourcing teams have in place to stay current?

Regulatory frameworks update frequently. The EU PPWR alone has staggered deadlines through 2040. Sourcing teams should maintain relationships with regulatory consultants in key markets, subscribe to official regulatory authority updates, and build compliance review cycles into annual supplier qualification processes.