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.

Which 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.

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.

All tests required for safety assessment can be contained from QACS Lab.

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