At the symposium “NAMs and NGRA for the predictive assessment of systemic toxicity (TOX26)”, organised by the Adebiotech association on 1 and 2 October 2026, Corinne Benoliel, founder of Institut Scientis, chaired the session on the regulatory framework for the assessment of systemic risk in cosmetics. She summarises the session here.
Overview of the regulatory framework
In Europe, a cosmetic product is defined as “any substance or mixture intended to be placed in contact with the 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, protecting them, keeping them in good condition or correcting body odours.”
Under Regulation No.1223/2009 on cosmetic products and Implementing Decision 2013/674 on guidelines for the application of Annex I to Regulation No.1223/2009, cosmetic products must be safe for human health under normal and reasonably foreseeable conditions of use.
Before a cosmetic product is placed on the market, a safety assessment must be carried out and signed off by a qualified person: the safety assessor, commonly known as a “toxicologist”.
To assess the safety of a cosmetic product, every substance contained in each raw material of the finished cosmetic formulation must be evaluated. This involves examining, on the one hand, the ingredients – the substances intentionally included in the product – and, on the other hand, traces – unintentional substances derived from …
