Safety is a key issue for Regulation (EC) No 1223/2009 on cosmetics in the EU. Cosmetic products must demonstrate compliance with Article 3 of the Regulation regarding safety by undergoing Safety Assessment. According to Annex I, Cosmetic Product Safety Report (CPSR) should be composed for this purpose. CPSR is the core of PIF (Product Information File).
Part A of the Cosmetic Product Safety Report intends to collect and evaluate information necessary to the cosmetic product’s safety. Part B involves the Safety Assessment conclusion. QACS Safety assessment services are in line with Regulation (EC) No 1223/2009, Annex I. All tests required for safety assessment can be performed by QACS Lab.
- Quantitative and qualitative cosmetic product formula
- Physicochemical characteristics and stability of the cosmetic product
- Microbiological quality
- Impurities, traces, information about the packaging material
- Normal and reasonably foreseeable use
- Exposure to the cosmetic product
- Toxicological profile of the substances
- Undesirable effects and serious undesirable effects
- Other information on the cosmetic product (e.g. studies on human volunteers)
- Assessment conclusion
- Labelled warnings and instructions of use
- Reasoning leading to the assessment conclusion
- Assessor’s credentials and approval of Part B