ANSM has just published a decision to suspend the distribution and placing on the market of Bioaromes cosmetic products. To the French National Agency for Medicines and Health Products Safety, they are not compliant with regulations, both in terms of composition (they contain a preservative that is not in the list of authorized substances) and labelling.
The decision, dated 11 July 2017, was made public in the evening of July 18. It ‘provides for the suspension of the manufacturing and conditioning of the cosmetic products sold on the Lamblore website by the Bioaromes company,' as well as for ‘the suspension of the distribution and placing on the market, free of charge or against payment, of the cosmetic products made by the Bioaromes company.'
ANSM made these decisions after finding several failures to comply with the regulations in force on cosmetic products.
First, the company does not fully comply with Good Manufacturing Practices, so that, according to the Agency, there are ‘risks of errors throughout the production process […], as well as a risk of product contamination and deterioration likely to harm quality.'
ANSM also highlights non-conformities with European Regulation 1223/2009 on cosmetic products, like:
• Incomplete product safety reports, in particular as regards the qualitative and quantitative product formulas, as well as the toxicological profile of the substances used
• Presence of a preservative not in the list of preservative agents authorized in cosmetic products
• Labels that do not mention the list of the ingredients actually contained in the products, the batch number, the date of minimum durability, the conditions for use, and the warnings, as provided for in the Cosmetics Regulation
The Agency adds that the decision will remain valid for these products ‘until they are compliant with the legislative and regulatory provisions applicable.'
• Read the decision of health authority ANSM – download it below