Monday, October 26, 2009All about babies

Cosmetics for Babies: The Response of Afssaps to the C2DS

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The ‘anti-kit’ campaign, started by the C2DS (Committee for Sustainable Development in Health) in autumn 2008, made a lot of noise and alerted the public. This group of doctors, chemists, oncologists, directors of health care institutes and maternity clinics, then claimed that the kits offered at birth to young mothers represented a veritable ‘toxic cocktail’ which contained products of doubtful harmlessness.  Ever since, we have awaited the position of Afssaps (French agency for health safety of  of health products) on cosmetics for babies. It has just been made public.

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Following the polemic and anxiety arising from the alert from the C2DS, Afssaps (health authority in charge of surveillance and safety of health products, and therefore of cosmetics) implemented several actions.

Initially it acted to draw up an inventory, based on programmed inspections and checking of manufacturers of cosmetics intended for children under 3 years, conducted in collaboration with the DGCCRF (Head office for competition, consumption and the repression of fraud).

In addition, a working group set up for the occasion was charged with development of recommendations intended for industrialists to ensure the harmlessness of their products.

Assessment of Inspections: ‘Broadly Satisfactory’

Recalling the preamble in which regulations do not envisage prior approval of marketing for a cosmetic (even if it is intended for young children), Afssaps wants reassuring however, following the implementation of its role in overseeing the market.

Of the 35 inspections that were conducted and covered a total of 79 products (washing gels, lotions, shampoos, creams for changing, perfumed water, wipes, cleansing cloths, etc.). With samples and analyses being key, only a few were deemed unsatisfactory. The majority, according to the summary presented on 27 October (French document), met the regulatory requirements in force regarding the composition, microbiological quality, labeling and content of the legal file .

This report specifies that the examined products did not contain any prohibited substance.

Admittedly, some of them contained preservatives in large number (and among them the Parabens and Phenoxyethanol denounced by the C2DS) but the Agency specifies that the analyses carried out showed that the restrictions of use concerning preservative agents are respected.

The analyses also showed a good microbiological quality of the products.

The few shortcomings ate to regulation: 8 nonconformities in the list of the ingredients , failure in declaration of allergens , some mislabelling … And Afssaps concluded that the compliance rate of the analyzed samples is high if we compare it with the results usually observed for cosmetic products intended for adults.

Everything is okay then? Yes, if we believe the Agency and if we deem that the guarantees brought by the regulations are sufficient.

In a companion document, Afssaps even takes the trouble to recall:
• that the only authorized phthalate was the subject of several evaluations at the European level which all have concluded its harmlessness for cosmetic use …
• that studies of general toxicity (acute, subacute or chronic) carried out on various animal species made it possible to show the absence of toxic, genotoxic, cancerogenic, or teratogenic effects of Parabens
• that it was following the intervention of the Agency, that glycol ethers were made the object of an evolution of Community legislation …
• and for good measure, that data relating to innocuity of cosmetic products which contain aluminium "seem satisfactory" …
Even if the evaluation of the scientific data on parabens is not finished at the European level, and even if the only glycol ether which was not affected by the  changing regulations is precisely Phenoxyethanol

Safety Assessment: Progress to Be Made

The blackmark of these inspections, however, concerns assessment of safety for the human health of cosmetic products intended for young children. For the 47 products tested, no assessment was noted for 3 products and 44 assessments (or 93%!) were judged "perfectible" …

It is within this framework that a draft recommendation (document in French) adopted by the Commission of Cosmetology October 12 was conceived and which currently is the object of public consultation.

This text first points out the characteristics of the skin of very young children, the functional immaturity of their metabolic systems, their high ratio of skin surface to body mass which makes systemic toxicity  more serious than for the adult, as well as conditions of specific exposures (sucking or friction which change risk factors).

Afssaps therefore recommends that specific assessments planned for children under 3 years of age be strengthened for the category of rinse-off products, for ingredients and finished products. It also underlines, considering cutaneous permeability and metabolic immaturity of premature infants, that cosmetic products not be intended for them.

It recommends assessment in various phases:

 1- Safety assessment of the ingredients: based on bibliographical data and the opinions of the committees of experts, their toxicological profile, their analytical and microbiological compositions, and also the decline of use: it is recommended to use preferentially those ingredients for which a history of marketing in end products is available.

 2- The formula: the Agency recommends the reduction of the number of ingredients used, to the strict minimum, making sure to obtain good tolerance of the product and providing a safety margin adapted to young children and taking into account the potential interaction of the different ingredients.

 3- Safety assessment of the end product, which must take into account many factors, such as the conditions of application (rinsing or not, massage, etc), quantity of product used in each application, frequency application, contact surface and its duration.

The Question of Tests

There do not exist, to date, opposable reference frames specifying the precise tests to realize for safety assessment of a cosmetic product . And the question often arises of knowing whether (or not) if they should be tested on babies, and where (the question is not trivial: more and more often we hear talk about  tests, in this moment about tests on Polish or Indian babies …).

Afssaps recommends first to take into account the data of in vitro tests, obtained thanks to the alternative methods to tests on animals which we now have and which already have been validated.

In addition, and taking into account, says the Agency, vulnerability of the target population and frequency of use of certain products in this population, it is recommended to perform, prior to marketing a cosmetic product , clinical trials in humans to confirm the tolerance and acceptability of the skin and possibly of the ocular and/or mucous membrane of the end product. For ethical reasons, Afssaps recommends conducting clinical trials of safety, and in particular the tests of use, by adult volunteers, with the responsibility of the safety assessor to specify whether the data obtained from the adults can be extrapolated for the target population of children under three years.

However, tests on the young children are not excluded since the text continues as follows: "Once these pre-requirements are established for adults, the safety assessor will deliver an opinion in order to perform, if necessary, tests of use, under medical supervision, on children under 3 years."

But we can be assured, above all we can be assured, that Afssaps won’t forget to specify that taking into account the importance in medical terms of the population of children under three years, it will maintain a special vigilance concerning cosmetic products intended for this age bracket within the framework of its inspections. Therefore can we continue to butter our tranquil toddler?

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