top of page

Cosmetic Safety Assessment
A Challenge & An Opportunity

Benedict M Mascarenhas
For ISCC Newsletter March 2015

22 Mar 2015

Formulators as well as ingredient suppliers need to have much greater understanding of the regulatory climate in order to navigate smoothly through the maze of Cosmetic Regulations.

The cosmetic industry has grown significantly in recent years, both in size as well as in complexity. Associated with the recent developments in novel ingredients, product formats and claims are the rapid changes in cosmetic regulations within India as well as internationally, which need a high level of focus. Formulators as well as ingredient suppliers need to have much greater understanding of the regulatory climate in order to navigate smoothly through the maze of Cosmetic Regulations. One of the important aspects within cosmetic regulations is the area of Safety Assessment. With the EU, Israel and India imposing a ban on animal testing for cosmetics as well as import of cosmetics tested on animals,and some other countries contemplating the same; conventional safety assessment approach has been turned on its head and the cosmetic industry now needs to move even more rapidly towards incorporating newer alternatives in their safety assessment programme.

Skills associated with category-specific product safety assessment of formulations, raw materials, ingredients and additives as well as toxicological risk characterisation, exposure assessment and risk assessment are emerging requirements that are going to be mainstay and need special attention. Data mining and Data gap analysis – Read across, Group and Category approach by S.A.R., Q.S.A.R., T.T.C., AOP, Weight of Evidence (WoE), In-silico prediction of toxicity using OECD toolbox, EPA-Oncologic, Episuite, Toxtree, Japan and EU open source software as well as commercial software such as DEREK, TOPKAT, etc. coupled with validated alternate in-vitro techniques will see increased usage as preliminary methods to establish safety, prior to conducting human volunteer studies. While on one hand, safety in cosmetics and toiletries is of prime importance, as only safe products should be allowed to be used by consumers; on the other hand, any human testing must be scientifically justified, as unjustified and indiscriminate testing is unethical. This brings to the fore the role of the safety assessor in-charge of product safety evaluation, who needs to decide whether each new formula represents a minor adaptation without toxicological significance, a toxicologically important modification, or a new technological concept. Safety assessor’s decision will become an important aspect of the safetytesting programme that is adopted. Development of simple, cost effective and fully validated alternate methods covering each and every aspect of product safety is also an important area for consideration. With our honorable Prime Minister making a fervent appeal to ‘Make in India’ a reality, it is an opportunity for eminent toxicologists across India to play a major role in leading as well as being part of the global validation programmes currently underway.

Changes in the regulations pertaining to cosmetic safety testing have thus opened avenues for new skills to be developed as well as for new roles within organizations in order to ensure that safety of the end user is not compromised. Tracking the developments that are taking place globally will help organizations to be updated on the most recent advances in this area; which would go a long way towards implementing the best practices towards ensuring safe cosmetics.

The author Benedict M. Mascarenhas is CMD of EnvisBE Solutions Pvt. Ltd. and Honorary Secretary of The Indian Society of Cosmetic Chemists (ISCC). For further details, you can send your emails to

bottom of page