Along with the campaigns of inspections and controls conducted in 2009 on products for children under three years of age, the French Agency for the Safety of Health Products (AFSSAPS) has established a multidisciplinary working group regarding the safety evaluation of these products and the characteristics that need to be taken into account in assessing the safety for this age population.
The recommendations of the working group have just been published and are about to be forwarded to the European authority for a better harmonization of regulatory requirements within the EU.
According to AFSSAPS, the safety assessment of cosmetic products intended for children under 3 years of age must take into account:
– the fact that, proportionally to their mass, the body surface of children of 0-3 years is more important than that of adults and that functional maturity of the metabolic systems may not be stabilized before 2 years of age,
– certain specific conditions of exposure, especially at the level of the seat area, which is highly exposed,
– the different types of products, especially not-rinsed products that can be applied several times a day with no limit.
For rinsed off products, a retention factor of 10% was also adopted for the calculation of safety margins, where the manufacturer did not measure the actual effectiveness of flushing.
Regarding the formulation of cosmetic products for children under 3 years of age, theFrench health agency recommends:
– using the lowest number of ingredients and choosing those for which the toxicity profile is well known and with a history use sufficient to ensure safety;
– distributing required toxicological data according to identified risk factors (area of application and / or product categories [rinsed off / non rinsed]).
As far as the safety assessment of finished products, is concerned, the AFSSAPS recommends:
– paying attention to the safety of primary packaging and to the opening and closing systems, as well as the physico-chemical and microbiological characteristics of the products,
– performing clinical trials on adults in order to assess skin tolerance and acceptability of the finished product, with the aim to extrapolate results to children under 3 years of age.
Eventually, the Agency recommends not using cosmetics on premature babies as long as they are in a neonatology service.
For more information, read the Agency’s reports on the assessment and safety of baby products (in French):
