It is in the name of"non-compliance and significant breaches" that the ANSM has just sent Nature & Découvertes an injunction to bring its Toussus-le-Noble establishment into compliance. The cause: several product safety and GMP compliance discrepancies.
This injunction, dated 5 January 2017, follows an inspection by the ANSM carried out on the company's premises on 20 and 21 September 2016.
The facts complained of
(a) The absence of safety reports in accordance with Annex 1 of Regulation 1223/2009 for certain products placed on the market. b) The marketing of cosmetic products suggesting on the packaging that they may be mixed with any other cosmetic product by consumers without the safety of the products obtained after mixing having been demonstrated, in accordance with recital 4 and Articles 3 and 10 of Regulation 1223/2009. (c) Safety reports on massage oils based on a toxicological evaluation of substances not in accordance with the requirements of Annex 1 of Regulation No. 1223/2009. d) Insufficient control of subcontracting in accordance with Chapter 12 of the harmonised standard NF EN ISO 22716 of January 2008 on good manufacturing practices for cosmetic products.
The injunction
1) Have safety reports and product information files that comply with the requirements of Regulation 1223/2009 for all products marketed under the Nature & Découvertes brand, including products suggesting that they may be mixed with other products, within 6 months. 2) Review the presentation, information and claims on products that may be mixed with any other product so that the company can control the safety of the suggested product mixtures within 6 months. 3) Have contracts with subcontractors and initiate an audit process to ensure that subcontracted operations are under control within 6 months.
To go further
- See the
Injunction n° 16COS090-INJ concerning the establishment of the company"Nature & Découvertes", located in Toussus-le-Noble (Les Yvelines)
on the ANSM website.
