Health police decision from the Afssaps (French Health Products Safety Agency, also in charge of cosmetics): Sun cream IP 99 = SPF 40 Very high protection from the company Bio Arômes is now prohibited from manufacturing, packaging, distribution and marketing.
18 December 2008 It was following an inspection by the This decision was taken on 24 July at the premises of Bio Arômes. On the one hand, this company is accused of regulatory shortcomings in the design and distribution of this product, and in particular in the accuracy and availability of the product file provided for by the Code of Public Health:
- inaccurate qualitative and quantitative formula
- no safety assessment for human health taking into account the general toxicological profile of the ingredients, their chemical structure and their level of exposure, available
- proof of the claimed effect on labelling (Sun Protection Factor SPF 40) absent from the product dossier
- form not forwarded to Poison Control Centres, as provided for in the regulations, in the interest of prompt and appropriate medical treatment in the event of problems arising from the use of the product
In addition, the Agency's analysis of the cream found that it"was likely to present a danger to human health":
- contamination by mould was highlighted by the Afssaps Laboratories and Controls Department, on one of the lots taken during the inspection
- the sun protection factor measured on this same lot was 13, thus very much lower than the SPF 40 claimed on the label
The product is therefore prohibited from being marketed and Bio Arômes must withdraw it, wherever it is located.
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