It is in the name of"nonconformities and important failures" that the ANSM has just sent to the company Universkin an injunction to bring its Nice establishment into conformity. In question: several discrepancies relating to compliance with the requirements of Cosmetics Regulation 1223/2009.
This injunction, dated 25 May 2018, follows an ANSM inspection carried out on the company's premises on 30 and 31 August 2017. As a result of this inspection and the responses provided by the establishment, non-compliances and deficiencies were identified and were not satisfactorily resolved.
The facts complained of
- The presentation of certain assets does not comply with the defined qualification.
- Updated product safety reports drawn up by a service provider, based on a toxicological evaluation of substances, do not meet all the requirements of Annex 1 of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 concerning cosmetic products.
The injunction
The ANSM enjoins the company Universkin to:
- review the labelling and documentation of assets to ensure that they comply with applicable regulations within 3 months;
- update the safety reports drawn up by a provider, taking into account all the expectations of Annex 1 of Regulation (EC) No 1223/2009, in order to ensure that toxicological evaluations of substances comply with the requirements of that Regulation, within a period of 6 months.
