EU Sunscreen Compliance: Regulation 1223/2009 + Buyer Document Checklist

EU market entry for sunscreen products requires precise alignment with Regulation (EC) No 1223/2009, ensuring both safety and claim compliance. Brand owners and sourcing managers must coordinate formulation specifications, testing, and documentation early in procurement to avoid costly delays or rejections. This guide distills the essential steps and evidence to request from your manufacturer before locking your supply chain.

Core Compliance Requirements Under 1223/2009

• Safety Report (CPSR) – Cosmetic Product Safety Report compiled by a qualified safety assessor.
• Notification via CPNP – Centralised Cosmetic Product Notification Portal submission prior to placing on the market.
• Labeling in EU languages – Ingredients (INCI), warnings, and SPF/UVA claims meet format rules.
• Responsible Person (RP) – An EU-based entity legally responsible for product compliance.
• Testing Verification – SPF/UVA laboratory test reports from an ISO/GLP-compliant lab.

Buyer Document Checklist

• Finalised formulation with INCI names and percentages
• Batch-specific Certificates of Analysis (COA)
• Microbiological safety test reports
• Stability and compatibility test data
• PIF (Product Information File) including CPSR
• CPNP notification confirmation
• Packaging material specifications & conformity declarations
• Full label artwork with claims substantiation references

Minimum Evidence to Request from Manufacturer

Procurement Actions for Sunscreen Formulations

1. Confirm active UV filters are on the EU approved list and within max concentrations.
2. Specify primary SPF level and whether UVA claim will be made (requires ISO 24443 testing).
3. Lock packaging materials compatible with the emulsion and resistant to UV degradation.
4. Agree on timelines for lab testing (SPF/UVA, micro, stability).
5. Ensure RP is appointed and documentation flow is planned.

FAQ

Do I need to retest SPF if the formula changes slightly?

Yes. Even minor changes in emulsifiers, UV filter percentages, or packaging can alter SPF results. Request updated lab reports whenever formulation changes before a new batch is released.

Can my manufacturer act as the Responsible Person?

Only if they have an EU legal entity and agree to assume RP duties. Many contract manufacturers do not; you may need a third-party compliance service.

How long does CPNP notification take?

Once the PIF and CPSR are complete, submission can be done within days. However, gathering the required documentation can take weeks – plan accordingly.

Are natural UV filters allowed?

Only if they are approved in Annex VI of 1223/2009. “Natural” status doesn’t bypass regulatory requirements.

What languages should my label be in?

All official languages of the Member State(s) where the product is marketed, covering mandatory information and warnings.

Request a Quote with your target market, SKU specs, formulation notes, and desired timeline for faster procurement support.

Hi, I'm Alex Zong, hope you like this blog post.

With more than 20 years of experience in OEM/ODM/Private Label Cosmetics, I'd love to share valuable knowledge related to cosmetics & skincare products from a top-tier Chinese supplier's perspective.