EU Baby Care Compliance: PIF/CPSR + CPNP Checklist (Reg. 1223/2009)

European Union Regulation (EC) No. 1223/2009 is the backbone of cosmetics compliance in the EU — and baby care products such as lotions, wipes, and cleansing creams are no exception. This guide helps brand owners and sourcing managers navigate PIF (Product Information File), CPSR (Cosmetic Product Safety Report), and CPNP (Cosmetic Products Notification Portal) obligations before entering the EU market.

Understanding EU Compliance for Baby Care Products

Baby care formulas are treated as cosmetics under EU law if they are applied on skin, scalp, or hair for cleansing or protecting purposes. However, the sensitive user group (infants and toddlers) demands tighter substantiation, safety margins, and documentation rigor.

• PIF (Product Information File): A complete technical dossier containing formulas, safety assessment, GMP proofs, stability data, and product claims support.
• CPSR (Cosmetic Product Safety Report): Mandatory safety assessment consisting of Part A (data) and Part B (expert conclusion).
• CPNP (EU Portal Notification): Digital product registration done before the product is placed on the EU market.

Key Buyer Actions Before Manufacturing

• Lock your formulation and INCI list early — any changes restart safety evaluation.
• Confirm microbiological and stability testing meet use conditions (temperature, pH, packaging interaction).
• Request evidence of ISO 22716 GMP certification from the factory.
• Verify ingredients comply with Annexes II–VI restrictions (prohibited, restricted, preservatives, UV filters, colorants).
• Collect label artwork for compliance review (function, ingredients, warnings, batch, nominal content, Responsible Person).

PIF + CPSR Document Checklist

Below are the minimum components your manufacturer or compliance consultant should prepare.

Testing and Evidence Expectations

• Safety margins for infants usually include an extra dilution factor of 2–3× versus adult cosmetics.
• Patch testing (dermatological testing on sensitive skin) recommended to substantiate “baby-skin-safe” claims.
• Stability testing under accelerated and real-time conditions to confirm 30–36 months shelf life.
• Preservative efficacy (Challenge Test) required even for “preservative-free” formulas using alternative systems.

How to Avoid Delays

To keep your project compliant and efficient, align documents before mass production:

1. Gather all raw material SDS and COA during formula approval.
2. Book stability and compatibility tests concurrently with pilot batch.
3. Send draft labels for regulatory review before design lock.
4. Include technical files in your master PIF folder (digital + backup).

FAQ: EU Baby Care Compliance

1. Are baby products treated differently under EU law?

They follow the same Regulation (EC) No. 1223/2009 as adult cosmetics, but risk assessment and toxicological margins must account for infant sensitivity.

2. Who must hold the PIF?

The “Responsible Person” based in the EU must keep the PIF accessible to authorities for 10 years after the last batch is marketed.

3. Do baby wipes count as cosmetics?

Yes, if intended for skin cleansing and containing cosmetic ingredients. If combined with disinfectant or biocidal claims, separate Biocidal Product Regulation (BPR) review applies.

4. How long does the CPSR approval take?

Typically 10–20 working days after receiving all raw material data, stability, and safety tests.

5. Can I use “Hypoallergenic” on baby products?

Only if supported by documented testing showing negligible sensitization potential and reviewed under Reg. (EU) 655/2013 claim substantiation principles.

Next step: Ensure all compliance documents are built into your sourcing process before scaling production. Request a Quote from LAEYO Labs to start your EU-compliant baby care manufacturing project.

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.