What is the cosmetics safety assessment, why do you need it and how is it performed?
Cosmetics Regulation 1223/2009 and UK Schedule 34 to the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 aim to ensure the safety of cosmetic product consumers. This means that each cosmetic product must be the subject of a safety assessment performed by a qualified person, before the product can be placed on the EU/UK market.
Safety assessment forms part B of the cosmetic product safety report (CPSR), and therefore is a vital part of the product information file. Cosmetic product safety assessment is conducted based on part A of the CPSR, which gives cosmetic product safety information and includes documents such as:
the cosmetic product formula (the qualitative and quantitative composition of the product)
raw material specifications and toxicological profiles of the substances used
physical and chemical specifications of the finished product
microbiological quality and the results of the preservation challenge test (if relevant)
stability of the cosmetic product and its compatibility with the packaging
information about the packaging material
information about the normal and reasonably foreseeable use of the product
exposure to the cosmetic product and the substances and
any other information on the cosmetic product that may be available to the product manufacturer
The safety assessor reviews these documents, checks whether the ingredients used in the product are restricted or banned in the EU/UK, checks that the other information about the cosmetic product is in order and checks that the tests were conducted properly. Based on the no observed adverse effects level (NOAEL), he or she then calculates the margins of safety (MoS) and prepares the cosmetics safety assessment report.
In order to demonstrate that a cosmetic product complies with Article 3, the responsible person shall, prior to placing a cosmetic product on the market, ensure that the cosmetic product has undergone a safety assessment on the basis of the relevant information and that a cosmetic product safety report is set up in accordance with Annex I. (EU Regulation 1223/2009, Article 10.1)
CE.way can deliver the CPSR in 3 working days.