Consumer Products (including Cosmetics)
Our work
It is imperative that products used on a day-to-day basis by the general population are safe. Unlike in industrial settings, where users are trained and have access to the necessary protective equipment, consumers at home have to trust that the products they buy are safe. We are experienced in the assessment of cosmetics and other consumer products, and can assist with their evaluation before they go to market – for example through screening out undesirable chemicals – and if specific concerns are raised during their lifetime.
Even if they aren’t covered by a sector-specific regulation, companies are still required by the General Product Safety Regulation to ensure that their products are safe for use. This includes an understanding of the risks posed by the product as a whole, but also any potential residual substances that may be present in trace amounts from the manufacturing process. We can assist with the understanding of the health hazards and risks associated with a wide range of consumer products.
Cosmetics
Cosmetic products are often mixtures – and even mixtures of mixtures. This makes carrying out a defensible toxicological assessment very challenging. The ban on testing cosmetic ingredients on vertebrate animals adds a further complication. Through collaboration with our clients, our skills in searching the toxicological literature and carrying out read-across and (Q)SAR assessments, we are able to provide robust evaluations of safety, including for Cosmetic Product Safety Reports (CPSRs) as required in the EU under Regulation (EC) 1223/2009.
Helpful information
The General Product Safety Regulations
Some of our case studies in this area
NAMs for NGRAs
Blog articles
Traditionally, toxicological risk assessment has involved identifying a point of departure (PoD) such as a NOAEL or LOAEL in a study of small creatures, adjusting it to be relevant to humans (to derive, for example, a TI or DNEL), and then calculating the margin of safety to a measured or estimated external exposure. As part of this process, toxicologists have to account for the uncertainties that arise in moving from the species, route and duration of the laboratory animal study to the real human world.
FDA memoranda: genotoxicity and carcinogenicity assessments of ENDS
Blog articles
As discussed in a previous blog post, the U.S. Food and Drug Administration (FDA) Center for Tobacco Products (CTP) has issued several “scientific policy memoranda” that provide some great insights into the Agency’s evaluation process. In June 2024, the FDA made two new memos available that relate to the genotoxicity and carcinogenicity assessment of chemical constituents of Electronic Nicotine Delivery Systems (ENDS).
FDA memoranda: shedding light on health risk assessment of ENDS in PMTA submissions
Blog articles
In 2016, the United States (US) Food and Drug Administration (FDA) ruled that Electronic Nicotine Delivery Systems (ENDS) were to be regulated just like more traditional tobacco products, meaning that ENDS (e-cigarettes and e-liquids) are subject to premarket review requirements, despite containing no tobacco. ENDS manufacturers must therefore submit a Premarket Tobacco Product Application (PMTA) to the FDA Center for Tobacco Products (CTP) in order to have any chance of legally marketing their products in the US.
