CosmeticOBS - L'Observatoire des cosmétiques
May 15, 2010All about babies

Safety of cosmetics for babies: Rcommendations of the French Afssaps Add to my portfolio
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This is the second part of the answer given by the French Agency for sanitary safety of health products (Afssaps; also responsible for the control and the safety of cosmetics) to the topic initiated in 2008 by the Committee for a sustainable development of health products (C2DS, as per its French acronym): babies’ products harmlessness. The Agency gives now a full report on the evaluation of the safety of the cosmetics designed for use on children under three, along recommendations.

Reading time : ~ 4 minutes

Autumn 2008: the C2DS, a group of M.D.s, chemists, oncologists, managers of health facilities and maternity wards, fingered out the briefcases given new mothers that could contain a "toxic cocktail" of products of dubious harmlessness.

Following this controversy, the Afssaps began with a thorough check of the products then available on the market and went to the conclusion, on 27 Oct 2009, that the assessment was "overall acceptable".

In the meantime, the Agency had set up a workgroup responsible for writing recommendations so that the manufacturers may produce harmless products. After a public enquiry that lasted several months, these recommendations have been approved by the Cosmetology Commission on 11 March 2010 and are now published in their final form.

First, the document states the major points to consider to guarantee the harmlessness of cosmetic products designed for children under three, linked to:
• the peculiarities of children between 0 and 3, whose the surface/body mass ratio is far more important than adults’, and whose the functional immaturity of the metabolic systems may last up to 2,
• some specific conditions of exposure, especially that of the babies’ bottoms, which may be overexposed,
• some categories of products, especially the “leave-on” products likely to be applied several times a day for long periods.

The public enquiry helped to make clear some recommendations about rinse-off products. The retention factor after rinsing (the quantity of the product left on the skin) has been set at 10% for the calculus of the safety margin, when there were no data from the manufacturer on the efficiency of the rinsing.

The other points deal with the designing of the formula and the evaluation of the finished products.

When designing the formula, Afssaps recommends:
• for a given finished product, use the least of available different ingredients and pick up those for which a lot of data about their toxicities are known and for which we have hindsight enough to assure of the safety,
• to evaluate the toxicological data in relation with the known risk factors (area of application[bottom] and/or the category [rinse-off or leave-on products]) to have all the toxicological data necessary and sufficient to give proof of handling the risks.

When dealing with the finished products, Afssaps recommends:
• to pay a specific attention to the safety of the bottles, pots, cans and to their opening/locking systems, as well as to the microbiological and physic-chemical quality.
• to perform clinical tests on adults to confirm the tolerance and the cutaneous acceptance of the finished product, and to extrapolate the results for children under three.

As a final point, a specific attention is paid to premature babies (babies born before a 37-week amenorrhea). Considering the cutaneous permeability and the metabolic immaturity of these children, the Agency recommends not using any cosmetic product while the premature baby is in a neonatology ward.
These recommendations will then be completed with the help of the health professionals in neonatology wards by a careful consideration of the hygiene body cares given premature babies (6 to 7% of births) to delineate the quality and safety criteria needed for the products  used on these particularly vulnerable babies.

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