Sunday, March 18, 2018ANSM

Injunction of the ANSM to the company Pharmexence

Injonction ANSM

The ANSM has just sent Pharmexence an injunction to bring its Lacoste plant into compliance in the name of"major non-conformities and shortcomings". In question: several discrepancies relating to compliance with the requirements of Cosmetics Regulation 1223/2009 and ISO standard 22716 on GMP.

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This injunction, dated February 27, 2018, follows an inspection by the ANSM carried out on the premises of this company on May 18 and 19, 2017.

The facts complained of

- Pharmaceutical and therapeutic indications and advice for skin treatment on Oleassence brand websites as well as the use of claims for certain products (finished products, essential oils, vegetable oils) which do not have a cosmetic purpose, which may lead to consumer confusion with a product intended for pharmaceutical use in accordance with the provisions of Article L.5111-1 of the CSP.
- The provision of products based on karanja oil indicating sun protection activity when it is not an authorised filter provided for by Regulation (EC) No 1223/2009.
- Reports on the safety of products drawn up by a service provider which do not comply with the expectations of Annex I to Regulation (EC) No 1223/2009, including a safety assessment which concludes that restrictions concerning the product have not been taken into account or are justified.
- The absence of a safety report drawn up in accordance with Annex I to Regulation (EC) No 1223/2009 for certain finished products and for vegetable oils to be personalised with essential oils according to the indications recommended in accordance with Articles 3 and 10 of Regulation (EC) No 1223/2009.
- Placing on the market of essential oils whose labelling is not specific to the recommended function, which does not ensure compliance with the applicable regulations (Regulation (EC) No 1907/2006 on REACH and Regulation (EC) No 1272/2008 on CLP).
- The marketing of certain products (essential oils, vegetable oils, vegetable butters and hydrolats) which may meet the definition of cosmetic products with regard to presentation, labelling and instructions concerning their use without holding safety reports and PIDs in accordance with Articles 2 and 3 of Regulation (EC) No 1223/2009.
- The control of insufficient subcontracting in accordance with Article 8 of Regulation (EC) No 1223/2009 and Chapter 12 of the harmonised standard NF EN ISO 22716 of January 2008 on good manufacturing practices for cosmetic products.

The injunction

The ANSM enjoins Pharmexence to:
1/ review the Oleassence brand websites containing therapeutic and pharmaceutical advice and claims with a view to removing the claims within 1 month;
2/ review the commercial documentation of products that may indicate sun protection for substances that are not authorized filters, within 1 month;
3/ implement corrective actions to ensure the safety of products whose safety assessments may indicate restrictions based on the formula, within 1 month;
4/ to have safety reports for all products meeting the definition of cosmetic products, drawn up in accordance with the requirements of the Regulation, within 6 months;
5/ to have the formulas, safety reports and information dossiers to frame personalised products with other components such as essential oils or vegetable oils in order to ensure that the finished products used by consumers are evaluated on the basis of appropriate information and that they are safe for human health as provided for in Regulation (EC) No 1223/2009 on cosmetic products, within 6 months;
6/ review the qualification, labelling and commercial documentation of products, including on websites, with regard to their claims and their use so that these products comply with the regulations applicable to them, within a period of 6 months;
7/ have contracts with subcontractors and initiate audit planning to ensure that subcontracted operations are under control within 6 months.

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