It is in the name of'major non-conformities and shortcomings' that the ANSM has just sent Centiflor (which owns the brands Huiles & Sens and MaCosmetoPerso) an injunction to bring its Entrechaux plant into conformity. The cause: several discrepancies relating to compliance with the requirements of Cosmetics Regulation 1223/2009 and ISO standard 22716 on Good Manufacturing Practices.
This injunction, dated 16 February 2018, follows an inspection by the ANSM carried out on the company's premises on 16 and 17 May 2017.
The facts complained of
- The absence of verification of the microbiological quality of raw materials, the absence of microbiological controls and release of finished products on the basis of the batch dossier in accordance with chapters 6.5, 8.2, 9.2 and 9.3 of the harmonised standard NF EN ISO 22716 of January 2008 on Good Manufacturing Practices for cosmetic products, Article 12 of the Cosmetics Regulation and the ISO standards in force for the microbiological control of cosmetic products. - The use of claims on documentation associated with products (essential oils and vegetable oils) of the brand Oils & Sens which may cause confusion for consumers with a product intended for pharmaceutical use or a biocidal product in accordance with Article L.5111-1 of the PSC and Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products. - Placing essential oils on the market as ingredients in cosmetic products that do not meet the obligations of the regulations in force (Regulation (EC) No 1907/2006 on REACH and Regulation (EC) No 1272/2008 on CLP). - The qualification of certain products, in particular vegetable oils, pure hydrolats and vegetable butters, as raw materials even though they may meet the definition of cosmetic products with regard to presentation, labelling and instructions concerning their use, in accordance with the requirements of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 concerning cosmetic products. - The absence of formulae and safety reports for products to be personalised with essential oils according to the instructions provided in accordance with Annex I of Regulation (EC) No 1223/2009 for certain products placed on the market. - Product safety reports prepared by a provider, based on a toxicological evaluation of substances that do not comply with Regulation (EC) No 1223/2009 (NOAEL and toxicological profiles to be completed).
LANSM enjoins the company Laboratoire Centiflor de : - set up appropriate controls to verify the microbiological quality of raw materials and finished products, in particular hydrolats, according to defined methods, and set up the release of finished products by the personnel in charge of quality on the basis of the batch file, within 1 month ; - review the claims and/or the qualification of certain products under the Oils & Sens brand that have a purpose other than cosmetic, within a period of 3 months; - review the qualification, labelling and commercial documentation of essential oils so that they comply with the regulations applicable to them, within 3 months; - have the safety reports and information files for all products meeting the definition of cosmetic products under the Oils & Sens brand, drawn up in accordance with the requirements of the Regulation, within 6 months; - have the formulae, safety reports and information dossiers to frame personalised products with other components such as essential oils or vegetable oils, in order to ensure that finished products used by consumers are evaluated on the basis of appropriate information and are safe for human health as provided for in Regulation (EC) No 1223/2009 on cosmetic products, within 6 months; - review safety reports to ensure that toxicological assessments of substances are completed as required by the Regulations within 6 months.
To go further
- See the Injunction n° 17COS027-INJ concerning the establishment of Laboratoire Centiflor located in Entrechaux (Vaucluse), on the ANSM website.