EU Responsible Person & PIF Basics for Sunscreen Brands (Practical Guide)

Sourcing and launching sunscreen products for the EU market requires brand owners to understand two core compliance pillars: appointing an EU Responsible Person (RP) and maintaining a compliant Product Information File (PIF). This guide focuses on the practical steps procurement teams can take to secure these foundations early in the project, reduce delays, and keep product registrations audit-ready.

Understanding the EU Responsible Person (RP)

The RP acts as the regulatory contact within the EU for your sunscreen brand. They are legally responsible for ensuring the product meets all requirements under the EU Cosmetic Regulation (EC) No 1223/2009.

Key Duties of an RP

• Ensure safety assessment is complete and signed by a qualified assessor.
• Verify that all ingredients, including UV filters, comply with Annex restrictions.
• Maintain and update the PIF for each SKU.
• Submit product notification via the Cosmetic Products Notification Portal (CPNP).
• Serve as contact point for competent authorities regarding safety or compliance inquiries.

When to Appoint the RP

Appoint the RP before final formula lock. This allows for early review of ingredient compliance, labeling, and test plans, reducing the risk of last-minute rework.

Product Information File (PIF) Essentials

The PIF contains all technical details and evidence proving your product is safe, compliant, and appropriately marketed. It must be kept for 10 years after the last batch is placed on the market.

Core Components of a Sunscreen PIF

• Product description: Formulation and function overview.
• Safety report: Cosmetic Product Safety Report (CPSR) signed by a qualified safety assessor.
• Manufacturing method: GMP evidence and batch records.
• Proof of claims: SPF/UVA test reports, water resistance substantiation.
• Labeling artwork: Ingredient list (INCI), warnings, and usage instructions.
• Stability and microbiological test reports: Minimum shelf life proof under intended storage conditions.

Procurement Actions to Secure Compliance Early

• Request PIF template from the manufacturer at RFQ stage.
• Confirm who will act as EU Responsible Person (internal team, distributor, or contracted service).
• Lock formula and packaging specs before initiating SPF/UVA testing to avoid repeating tests.
• Ensure stability studies cover intended packaging and shelf life claim.
• Cross-check INCI list against Annexes of the Regulation.

Evidence Request Table

FAQ

1. Can a non-EU company act as the Responsible Person?

No. The RP must be established within the EU (including EEA countries).

2. How long must the PIF be retained?

Ten years after the last batch is placed on the EU market.

3. Do SPF tests need to be conducted within the EU?

Not necessarily, but the lab must follow recognized ISO methods and be accepted by EU authorities.

4. Is the CPNP notification handled by the RP?

Yes, the RP is responsible for submitting product details to the CPNP before market launch.

5. What triggers re-testing of SPF/UVA?

Changes to formula, manufacturing site, or packaging that could affect performance.

Request a Quote to discuss EU-compliant sunscreen manufacturing, including RP appointment and complete PIF preparation.

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.