Safety Assessment

When assessing the safety of a cosmetic product, we always start from the definition of the cosmetic product.

A "cosmetic product" shall mean any substance or mixture intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition.

The term cosmetic product does not include substances or mixtures intended for ingestion, inhalation, injection or implantation in the human body."

Safety Assessment   or the Cosmetic Product Safety Report (CPSR) is a part of the Product Information File (PIF). According to the EU Cosmetic Regulation (Cosmetic Regulation 1223/2009), this document consists of two parts:

Part A: Cosmetic product safety information

Part B: Assessment of the safety of the cosmetic product - the assessment is given by an expert (Safety Assessor).

Cosmetic products placed on the market must be safe for human health, if applied under normal or reasonably foreseeable conditions. This is the main principle of the Regulation on cosmetic products and the EU Regulation. Accordingly, the safety assessment of each cosmetic product is carried out. The Cosmetic Product Safety Assessment Report (CPSR) contains all essential information about the product itself and is an integral part of the Product Information File (PIF).

The Cosmetic Product Safety Assessment Report (CPSR) contains:

Part A. Cosmetic Product Safety Information:

1. Quantitative and qualitative composition of the cosmetic product (including chemical identity of substances, CAS numbers)
2. Physical and chemical characteristics and stability of the cosmetic product
3. Microbiological tests
4. Impurities, traces of impurities, information about the packaging material (in the case of traces of prohibited substances - proof of their technical inevitability)
5. Normal and reasonably foreseeable use
6. Exposure to a cosmetic product
7. Exposure to substances
8. Toxicological profile of substances
9. Side effects and serious side effects