Home / Our Focus / International & Export / Europe & UK

Export to the EU & UK: ISO 22716 OEM Manufacturing from Malaysia

OEM & private label manufacturer for European brands: ISO 22716 cosmetics GMP — the EU’s own GMP standard — plus CPNP and UK SCPN notification support, Responsible Person coordination and the supply-chain audit evidence European retailers require.

Direct answer

Yes — cosmetics manufactured in Malaysia can be sold across the EU and the UK, provided they meet Regulation (EC) No 1223/2009 (EU) and the UK Cosmetics Regulation. The key manufacturing requirement is Good Manufacturing Practice to the ISO 22716 standard — and ORIZI Group’s cosmetics company, Dr Orizi (M) Sdn. Bhd., is ISO 22716-certified, the exact standard the EU regulation recognises. Your EU Responsible Person notifies each product on the CPNP portal (SCPN for Great Britain), and ORIZI prepares the Product Information File inputs, safety data and compliant formulations the notification depends on.

Who this page is for

A European brand or distributor sourcing an Asian manufacturer that already meets EU GMP expectations
A buyer comparing Southeast Asian manufacturing against a China-only supply chain
A UK brand navigating post-Brexit SCPN notification alongside EU CPNP

What does the EU require from a non-EU cosmetics manufacturer?

The EU regulates cosmetics under Regulation (EC) No 1223/2009. In plain language, four things must be true before your product goes on an EU shelf:

GMP manufacturing. The product must be manufactured under Good Manufacturing Practice. The harmonised standard the regulation points to is ISO 22716 — so an ISO 22716 certificate from your manufacturer is the direct, recognised answer to the EU’s GMP requirement, not an approximation of it.
A Responsible Person (RP) in the EU. Every product needs a legal or natural person established in the EU who holds the compliance file and answers to authorities. For a non-EU manufacturer’s product, this is typically your importer or a third-party RP service.
A Product Information File (PIF) with a safety assessment. The RP keeps a PIF including the Cosmetic Product Safety Report (CPSR) signed by a qualified safety assessor — built from the manufacturer’s formula disclosure, specifications, stability and challenge test data.
CPNP notification. Before launch, the RP notifies the product on the European Commission’s Cosmetic Products Notification Portal (CPNP). There is no product “approval” step — compliance responsibility sits with the RP and the file.

The division of labour is clean: your RP files and holds the paperwork; the manufacturer determines whether the paperwork is even possible. A formula that ignores the EU’s annexes of restricted ingredients, or a factory that cannot produce stability and safety data to CPSR standard, stalls the whole chain. ORIZI builds EU-bound formulas against Regulation 1223/2009’s ingredient annexes from day one and supplies the full PIF input pack.

How is the UK different after Brexit?

Great Britain now runs a parallel system under the UK Cosmetics Regulation: a UK-based Responsible Person, a UK PIF, and notification on the SCPN service (Submit Cosmetic Product Notifications) operated by the Office for Product Safety and Standards instead of CPNP. Northern Ireland continues to follow the EU system. In practice, a brand selling in both markets appoints an EU RP and a UK RP and files two notifications from the same technical file — which is why we build one master dossier per product, structured so both filings draw from it without rework.

Which ORIZI credentials matter for Europe?

ISO 22716 cosmetics GMP — held by Dr Orizi (M) Sdn. Bhd.; this is the GMP standard the EU cosmetics regulation recognises, and the certificate’s status can be checked with the certification body. It sits alongside Dr Orizi’s listing on Malaysia’s NPRA GMP-compliant cosmetic manufacturer list.
Food-safety systems — for functional food and beverage, the group’s food companies operate under ISO 22000, HACCP and GMP certifications, supporting EU food-import documentation.
Ethical and supply-chain audit evidence — see the next section; EU retail increasingly asks for it as standard.
Halal certification — JAKIM Halal across four group companies: relevant both for Europe’s Muslim consumers and for brands that sell the same product line into the Middle East. See Halal OEM manufacturing.

Each credential is presented with its holding entity on our certifications page.

Supply-chain due diligence: what European procurement asks for

European retailers and brand groups now run supplier due diligence shaped by the EU’s corporate sustainability reporting and due-diligence agenda — which means a serious European buyer will ask an Asian factory for ethical-audit evidence, not just product quality documents. ORIZI Group’s answers, stated precisely:

SA8000:2014 social accountability — Dr Orizi (M) Sdn. Bhd. is certified to SA8000, the international standard for labour practices, health and safety, and social management systems.
Sedex membership & SMETA audit — Dr Orizi is a Sedex member with a SMETA audit on the platform; European customers linked on Sedex can review it directly. Sedex is a membership platform and SMETA an audit methodology — not certifications, and we never present them as such.
Disney FAMA-authorised facility — Dr Orizi has passed The Walt Disney Company’s International Labor Standards audit, an independent signal of sustained social-compliance practice.
Packaging and materials — printed packaging can be sourced through an FSC Chain-of-Custody-certified packaging partner, and formulations can be developed with EcoCert/COSMOS-certified and RSPO-certified raw materials on request (the material certifications belong to the suppliers; we state that honestly).
Energy — the Dr Orizi plant runs rooftop solar as part of its operations.

Why choose Malaysia over China for an EU-bound supply chain?

European buyers rarely frame it as either/or; they frame it as risk-adjusted sourcing. Malaysia’s case is practical: English-language technical documentation that goes straight into a PIF without translation risk; a manufacturing base already certified to the exact GMP standard the EU names (ISO 22716) rather than a local equivalent; ethical-audit evidence (SA8000, SMETA) already in place because Malaysian export manufacturers have been serving Western audit regimes for decades; and a stable, diversified alternative for brands reducing single-country dependence. Add JAKIM Halal and the same product can serve European and Middle Eastern distribution from one factory — something few Chinese OEMs can offer with government-issued Halal credentials.

The trade practicalities line up the same way. Port Klang and Penang Port sit directly on the Strait of Malacca — the Asia–Europe mainline — with regular services to Rotterdam, Hamburg and the UK gateways. Malaysia’s business environment is natively multilingual, with English first and Malay and Chinese spoken in-house, so briefs and audits run without interpreters. And export invoicing can be settled in US dollars, euros or other agreed major currencies, letting your finance team pay in the currency it already manages.

What this means for your brand

Plan the EU/UK project in this order: lock the formula against Regulation 1223/2009’s ingredient annexes, commission the stability and safety data during development (not after), appoint your EU RP and UK RP, then notify on CPNP and SCPN from one master dossier. Done in sequence, notification is an administrative step rather than a bottleneck — and your manufacturer’s file quality decides that. For the broader export checklist, see the complete cosmetic export guide and cosmetic export documents explained.

Questions about exporting to the EU & UK

Is ISO 22716 mandatory for selling cosmetics in the EU?

The EU cosmetics regulation requires manufacturing under Good Manufacturing Practice, and ISO 22716 is the harmonised standard that demonstrates it. A manufacturer certified to ISO 22716 — as Dr Orizi (M) Sdn. Bhd. is — answers the EU’s GMP requirement with the exact standard the regulation recognises.

Can ORIZI act as my EU Responsible Person?

No — the Responsible Person must be established in the EU (or the UK for SCPN), so it is typically your importer or a specialist RP service. ORIZI works alongside your RP, supplying the formula disclosures, specifications, stability data and safety documentation the Product Information File requires.

Do I need separate notifications for the EU and the UK?

Yes. Since Brexit, Great Britain requires its own SCPN notification with a UK-based Responsible Person, while the EU uses CPNP; Northern Ireland follows the EU system. Both filings can be built from one master technical dossier, which is how ORIZI structures the documentation.

Is CPNP notification an EU approval of the product?

No. CPNP is a notification portal, not an approval scheme — no EU authority “approves” a cosmetic before sale. Compliance responsibility sits with the Responsible Person and the Product Information File behind the product.

What ethical-audit evidence can ORIZI show an EU retailer?

SA8000:2014 certification (Dr Orizi), Sedex membership with a SMETA audit reviewable on the platform, and a Disney FAMA authorisation earned through The Walt Disney Company’s International Labor Standards audit. Each is stated with its holding entity on the ORIZI certifications page.

Building an EU or UK launch from Asia?

Tell us your product, target markets and Responsible Person arrangements — we will review the formula against EU ingredient rules and assemble the PIF input pack alongside development.

Discuss your EU/UK project