Cosmetic Product Safety Report (CPSR)

Safety assessment of cosmetic products by a qualified safety assessor, as required by Article 10 and Annex I of Regulation (EC) 1223/2009.

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What it is

The Cosmetic Product Safety Report (CPSR) is the safety assessment that every cosmetic product needs before it is placed on the EU market. Part A sets out the safety information: composition, physical and chemical characteristics and stability, microbiological quality, impurities and packaging material, normal and reasonably foreseeable use, exposure, the toxicological profile of the substances and undesirable effects. Part B is the safety assessment itself: the conclusion, label warnings and instructions of use, the reasoning, and the assessor's credentials and approval. The CPSR is part of the Product Information File (PIF).

What we do

  • Review of the formula (INCI names and percentages) against the annexes of Regulation (EC) 1223/2009
  • Collection of the raw-material data the safety assessor needs
  • CPSR Part A (safety information) and Part B (safety assessment), signed by a qualified safety assessor
  • Warnings and conditions of use to put on the label
  • Ready to use in the Product Information File (PIF) and the CPNP notification

Who needs it

Every cosmetic product placed on the EU market needs a CPSR drawn up according to Annex I before it is sold, and the assessor must hold a qualification in pharmacy, toxicology, medicine or a similar discipline (Article 10). Brands from outside the EU often have test reports or a formula but no CPSR in the EU format, or a CPSR that no longer matches the current formula or label.

What you provide

  • Full quantitative formula (INCI names and percentages)
  • Raw-material specifications and safety data sheets (SDS)
  • Stability and compatibility data, and preservative efficacy (challenge) test where applicable
  • Microbiological test results
  • Label artwork and intended use (who uses it, where on the body, how often)

Common problems we help with

  • CPSR missing or not in the Annex I format
  • Formula changed after the CPSR was signed
  • Missing raw-material data delays the assessment
  • Claims or warnings on the label do not match the CPSR

How it works

  1. Send the formula, label and available test data
  2. We check completeness and list any missing data
  3. Assessment by the safety assessor; questions go through us
  4. You receive the signed CPSR (Parts A and B) and the label warnings
  5. If you also appoint us as Responsible Person, we use it directly for the PIF and the CPNP notification

Ready to sell in the EU with confidence?

Tell us your products, markets and sales channels. We reply with a tailored proposal.

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contact@ibertrust.info