CosmeticOBS - L'Observatoire des cosmétiques
March 31, 2010ANSM

Cosmetovigilance 2009 report: the FEBEA reading Add to my portfolio
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We spoke to you about it on 27 March in this same section: the Afssaps (French Health Products Safety Agency) has just published the Cosmetovigilance balance sheet for 2009. A report which was also studied by the FEBEA (Federation of the companies of the beauty), one of the representatives of the cosmetic companies, which transmitted us its analysis in the form of additional information, which we publish here in full.

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March 31, 2010 What adverse reactions were reported to AFSSAPS in 2009? (FEBEA text)

First of all, it should be noted that in Cosmetovigilance 2009 results , l’ Afssaps announced the development of various documents: the accountability method, recommendations for the proper use of cosmetic products intended for consumers, the consumer warning campaign concerning skin whitening products and voluntary depigmentation, and the draft recommendations for the proper use of permanent hair dyes. It should also be noted that the information is more detailed since the 2007 balance sheet (published in 2008).

Number of adverse reactions received

In 2009, 232 adverse reactions were reported to the AFSSAPS compared to 193 in 2008. This represents an increase of 20%. Between 2007 and 2008, this increase was 53% (126 versus 193). Over two years, the number of adverse reactions received has thus doubled.

Notifiers shall

Two new types of tax filers were identified this year: nurses and the DGCCRF (total 4%). The other declarants, already mentioned last year, are found in the same proportions EXCEPT industrialists who in 2008 and 2007 represented 1% of declarants and now represent 16% this could explain the increase in reported cases?

Gravity

The number of serious adverse reactions remained stable or even slightly decreased (34 cases in 2007, 32 cases in 2008, 28 cases in 2009). The number of adverse reactions"considered serious" is more variable: 50 cases in 2007, 97 cases in 2008, 81 cases in 2009. In contrast, the number of non-serious adverse reactions reported increased from 38 cases in 2007 to 65 cases in 2008 and 116 cases in 2009. This shows that the increase in reported adverse reactions is mainly related to non-serious cases.

The nature of adverse reactions

There was a decrease in adverse events other than allergic or irritative (from 26 cases in 2007 (20%) and 37 cases in 2008 (19%) to 7% (16 cases) in 2009).

The population

Information concerning the age and sex of users is new and was not provided in previous assessments: there is a high percentage of children (16 per cent or 37 cases).

The categories of cosmetic products involved

This section is much more detailed than before. New product categories are emerging: perfumes and eaux de toilette, deodorants, nail care products, cosmetic wipes and skin whitening products. Hair care is no longer mentioned. For the categories of products associated with allergic skin reactions, these are the same as those cited in 2009 for 2008 reports. The categories cited as associated with allergic skin reactions in 2007 (hair dyes, ephemeral black tattoos, facial care products) are also found in the 2009 reports.

Significant Cases

Permanent hair dyes While it is true that since 2004 reports of adverse reactions secondary to the production of these dyes have increased, it is now necessary to note (which is not indicated in the AFSSAPS report) a stagnation or even a slight decrease in these cases: 28 cases in 2008 and 25 cases in 2009. In addition, in 2009, the number of cases followed by allergological testing was lower (10 patients were tested in 2009 while 23 patients were epicutaneously tested in 2008). Skin whitening products Obviously, these are all illegal products. Sun protection products Most of these products contain octocrylene. Cases of misuse  10 in 2009 versus 9 in 2008, but not all of them are described in this new 2009 balance sheet, which is regrettable because it makes it possible to identify them in relation to ARs linked to a reasonably foreseeable use. Finally, more generally, and as in previous reviews, it is unfortunate that there is no information on the degree of imputability to the product, that examples of adverse reactions"considered serious" are not detailed in order to understand their definition, and that the overall figures amalgamate ARs due to misuse and others, regardless of the degree of imputability since the latter parameter is unknown.

To go further see the complete review of the Cosmetovigilance 2009 on the Afssaps website.


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