Tuesday, February 19, 2013Focus

Annex I.A.9 - Undesirable effects and serious undesirable effects

© CosmeticOBS-L'Observatoire des Cosmétiques

Section 9 of Annex I to the Regulation is a direct result of the establishment of a harmonised cosmetovigilance system at European level. In practice, it essentially requires good organisation and the implementation of internal procedures for data collection and processing.

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Annex I requires that the Cosmetic Product Safety Report (CPSR) contains “all available data on the undesirable effects and serious undesirable effects to the cosmetic product or, where relevant, other cosmetic products. This includes statistical data.”

Required data

They are related to the undesirable effects (UE) and the serious undesirable effects (SUE), whatever the level of imputability (Very likely, Likely, Non-clearly likely, Non-likely), unless when completely excluded.

Note that, obviously, on the very first placing of a product on the market, all these data are not available. In such a case, and if it is relevant, it is advisable to supply the data available for similar products, with a close formula, already on the market.
As a key-example: a new lipstick, added to an already existing range, the only difference being a new colourant…

Data to be collected

For every case of undesirable effect, a dossier shall be prepared, which comprises the following data:
• The notification date of the undesirable effect
• The country of reporting
• The identity of the registrant
• The identification of the involved product (name of the product, presentation, batch number…)
• The description of the undesirable effect (outbreak, itching, redness, eczema…)
• Its …

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