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.
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