Cosmetics safety assessment in baby care: Safe design


Instituto Harris, São Paulo SP, Brazil


Children are developing organisms and are subject to toxic effects that can impact their whole lives. Due to the fragility of the skin barrier, cosmetic safety assessment of infantile products has to be extremely judicious when considering long-term effects such as allergy, cancer, and development impairment. From the analysis based on pre-existing animal data to predictive in silico and in vitro evaluations, potentially harmful molecules are identified. Selecting safe ingredients, baby care cosmetics need to be focused on the improvement of skin barrier, avoiding irritant agents and permeation enhancers, and as skin barrier is easily measured, clinical evaluations can be performed in two steps: first in adults and, if the product proves its benefits, the final in use test in children.


The objectives of the safety assessment are to identify hazards and events that could challenge consumer´s safety. Although it is, in fact, the front of the development of a safe product, in many situations it is seen only as a bureaucratic task resulting in the Cosmetic Safety Assessment (CSA) and the product information file (PIF), at the licensing stage, to comply with the regulatory requirements. 

However, to develop a good and safe cosmetic, it is essential that, from the very first briefing, the formulation be planned securely. This concept, known as SAFE DESIGN, is already applied by those cosmetic industries, which could realize the great savings and security that this procedure brings.

Formulating is not an easy task. 

Besides creating different sensorial properties and new effects, the innovation team, from the bigger to the smaller company, needs to assure a minimum risk. This is especially important in baby products (1) because: