Monday, December 14, 2009They are the cosmetics

Catherine Desmares : evaluation of cosmetics at the Afssaps

Catherine Desmares se félicite de l?adoption du nouveau Règlement européen, qui va renforcer la sécurité du consommateur et faciliter la surveillance du marché.

She's brown, dynamic, direct. She is Director of the evaluation of advertising, cosmetic products and biocides at Afssaps, the French Health Products Safety Agency. A very long title… for a list of responsibilities that is no less so! "Tell us about yourself," we asked Catherine Desmares. "I'm going to talk about the Afssaps" she answered us..;

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" Talk about me? What's the point? It is what the Afssaps does that is important! ", Catherine Desmares' entrance announcement. We agree, of course, but nevertheless, it is she, at least in part, and her teams, who participate in the Agency's action. However, she will only say a few things about herself, a few dates from her CV, a few stages in her career. Pharmacist by training, Inspector General of Public Health, she worked at the Ministry of Health for 10 years, participated in the creation of the Medicines Agency in 93, then that of the Afssaps in 99, until taking charge of a new directorate created in 2004, for which she still assumes responsibility today… On the Afssaps, on the other hand, it is inexhaustible! And can be done on this exhaustive, precise and most didactic chapter. Because it is the Agency that it wants to put forward, its role, its weight, its action in the cosmetic field, its influence at European level: in a word, its importance… often unknown. Message received. So let's talk about the Afssaps, actor if it is of the cosmetic world. In some questions to which Catherine Desmares brought us her answers. The Cosmetics Observatory : What is the Afssaps? Catherine Desmares : L’ Agence française de sécurité sanitaire des produits de santé is a national public institution of an administrative nature, under the supervision of the Ministry of Health. It is the single health safety authority for the protection of public health in the field of health products. Its mission is to ensure the safety of these products, to evaluate the benefits and risks associated with their use, in order to guarantee their safety, quality and proper use. The Afssaps is thus a delegated health authority exercising on behalf of the State health police missions

The products under the competence of the Afssaps include on the one hand health products (medicines and their raw materials, biological products of human origin such as cellular therapy products or labile blood products, medical devices and in vitro diagnostic medical devices…), and on the other hand cosmetics and tattooing products. My Directorate is also involved in the evaluation of certain biocidal products, i.e. products intended to destroy, repel or render harmless harmful organisms (such as bacteria or mosquitoes) by chemical or biological action. Our activity also includes the control of drug advertising and products or objects presented as beneficial to health… among other missions!

THE ODC : What is the Afssaps for? CD : The Afssaps has several professions: evaluation, control, inspection… and it is the complementarity of these professions which enables it to ensure its mission. For all health products, the Agency conducts regular market surveillance to detect, analyze, prevent and manage potential risks associated with their use. It is within this framework that the Afssaps collects and analyses quality defects or adverse events thanks to vigilance systems. France, via the Afssaps, was thus the first European country to set up a system of Cosmetovigilance . The Agency also ensures compliance with regulations by carrying out product controls in its own laboratories or inspection missions to production sites or other industrial operators. Finally, it has an information role vis-à-vis the public and health professionals, through the dissemination of messages, recommendations and other publications. THE ODC : What are the powers of the Afssaps? CD : The Agency, which takes 80 000 decisions a year, has very important prerogatives. In particular, it is empowered to take animal health decisions, which may consist of restrictions, suspensions or prohibitions on a product or category of products, possibly accompanied by measures for withdrawal from the market, destruction of lots or even withdrawal of authorisation to operate or other administrative and animal health measures, in the event of danger, suspected danger or serious breaches of the regulations in force.

THE ODC : How does the Afssaps decide to act on this or that theme? CD : The Afssaps can act on ministerial referral (as is currently the case for endocrine disruptors or nanomaterials…), within the framework of its participation in European work, or take action when a subject seems to it to deserve its attention. THE ODC : How does the Afssaps"manage" cosmetics? CD : Cosmetics occupy a very specific place within health products. Unlike medicinal products, which are highly supervised and"a priori" supervised and cannot be placed on the market without prior authorisation granted after a thorough evaluation, unlike medical devices subject to CE marking (which can only be affixed if the product complies with essential health and safety requirements set out in European standards), cosmetics are not subject to any evaluation procedure by the health authorities before being placed on the market. No MA, no CE marking, few harmonised standards… but the cosmetics manufacturer is obliged to meet the requirements defined by the regulation, in this case the"Cosmetics Directive". This includes, for example, the obligation to comply with the rules on the composition of cosmetic products, the need to carry out a human safety assessment for any cosmetic product before it is placed on the market, compliance with labelling rules…. It is only then, a posteriori, once the product is on sale and already used by consumers, that Afssaps market controls can intervene. In this regard, I welcome the adoption of the new This will enhance consumer safety and facilitate market surveillance. Indeed, new obligations are imposed in particular in terms of the identification of a single responsible person (the manufacturer, the importer or their authorised representative, or the distributor, etc.), Cosmetovigilance, the content of the cosmetic dossier and good manufacturing practices. Greater clarity of the obligations of the person responsible, more precise definitions and a framework for market surveillance activities should help to harmonise monitoring of the European market in cosmetic products and facilitate compliance with the expected requirements.

THE ODC : How does the Afssaps ensure consumer safety in the cosmetic field? CD : Its market surveillance and monitoring role, exercised in close collaboration with the DGCCRF (Directorate General for Competition, Consumer Affairs and Fraud Control), such as the recent"preservative-free" cosmetics survey, is crucial. In addition to occasional exchanges, annual joint market surveillance programmes are defined between the two institutions in the light of current health or regulatory developments. But the Afssaps' activity in the cosmetics sector does not stop there. The Agency also monitors new toxicological data involving ingredients used in cosmetics in order to assess them. Coupled with the system of Cosmetovigilance This monitoring makes it possible to target"risky" ingredients and assess their safety in the context of cosmetic use, which may lead to decisions to restrict or even ban products containing these ingredients. These measures, taken at national level, must be taken up at Community level. It is thus on the basis of the work of the Afssaps that Europe, in its turn, has changed the regulations by prohibiting the vitamin K1 or the diethylene glycol in cosmetics. This is not the only proof of the European influence of the French Agency: thus the Cosmetovigilance system will be extended to the whole of Europe by the next Regulation and the exchange of information concerning serious adverse effects linked to the use of cosmetics will be generalised between the Member States. THE ODC : The Afssaps' methods of intervention a posteriori for placing on the market and linked to the regulatory framework could give the impression that Afssaps agents only have the power to impose sanctions. Is the Afssaps only repressive? CD : I do not deny the importance of this aspect of my mission, but I highlight another, what I call a"proactive" approach. The aim is to define methodological tools for manufacturers to promote margins for progress in the evaluation of cosmetic ingredients and products, or to develop recommendations for the formulation or manufacture of products. Here are some of the recommendations developed by the Agency to solar products which were adopted at European level in 2006 and have become the common rule.

THE ODC : The criticism is underlying and reappears at regular intervals. Some criticize the Agency for too often or too sparingly for cosmetic companies, or for not being firm enough in its recommendations on certain ingredients suspected of toxicity… Does Afssaps not sometimes show itself a little"cautious"? CD : We work and we move on. We must be careful not to be naïve but also to avoid any systematic demonisation of the industry. We work to objectify security as objectively as possible, while remaining pragmatic. In my opinion, this approach is a guarantee of confidence for consumers and manufacturers in cosmetic products. Concerning the allergic risk, for example linked to an ingredient that cannot be immediately substituted, work is being developed on prevention, through better consumer information, for example through labelling, while encouraging manufacturers to reduce concentrations and look for substitutes. This is the case for work carried out at community level in which we participate for hair dyes. When we have sufficient elements supporting a significant risk, for example via the Cosmetovigilance system, we take the appropriate measures to prevent this risk. Concerning toxicity risks, the questions are obviously more complex, particularly for long-term toxicity risks. They require new approaches taking into account the notions of global exposure and multi-exposures (as in the case of endocrine disruptors), or even new toxicological evaluation methods. A relevant evaluation in this case requires specific tools, sometimes transversal between health institutions. These are heavy projects, particularly in the case of new technological innovations such as nanomaterials… In all cases, we try to optimise the means at our disposal and our methods of action in a limited context, it must be said, by the imperatives of the public budgetary economy.

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