Safety Assessment (PIF)

Cosmetic Product Safety Assessment (PIF)

For your cosmetic products, we offer safety assessment in line with Regulation (EC) No 1223/2009, Annex I, Part A and Part B. Safety is a key issue in the regulation of cosmetics in the EU. Part A of the Cosmetic Product Safety Report is intended to gather the information necessary to prove that a cosmetic product is safe. Part B refers to the cosmetic product safety assessment.

What documents are necessary

As stipulated in Annex I of Regulation (EC) No 1223/2009, the following documentation is necessary to perform a safety assessment and compile the Product Information File (PIF) for your cosmetic products:

  • Producer’s and distributor’s address.
  • Good manufacturing practice (GMP) certification from the producer.
  • Formulas and International Nomenclature of Cosmetic Ingredients (INCI) names for all ingredients. Details must include preservatives, filters, perfumes or ingredients under limitation of use.
  • Specifications of raw materials.
  • Specifications of packaging materials.
  • Material Safety Data Sheet (MSDS) of raw materials. Especially for perfumes, section 2 of the MSDS Certificate of Allergens must include all allergens.
  • Production method (descriptive, not detailed).
  • Specifications of final product.
  • Claim substantiation studies.
  • Product labels.

The following 3 necessary documents can be obtained from our lab:

  • Stability data of final product.
  • Preservation efficacy test / challenge test.
  • Dermatological test / patch test.

If products are 100% different to each other, every product is considered a main formula. Same formulations with minor changes, such as colour or perfume, will generate variants.

How much does cosmetic safety assessment cost?

Fill in our contact form to request our price list and find out how our QACS Laboratory team can help you.