Tuesday, October 31, 2017ANSM

Injunction of the ANSM to the Hyteck company (Aroma-Zone)

© CosmeticOBS-L'Observatoire des Cosmétiques

The ANSM has just sent Hyteck an injunction to bring its Cabrières d'Avignon 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.

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This injunction, dated 24 October 2017, follows an ANSM inspection carried out on the company's premises from 31 January to 2 February 2017.

The facts complained of

- Placing on the market of products bearing the Aroma-Zone brand with a purpose other than cosmetic through their use, as defined in Article 2 of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 concerning cosmetic products; and which are therefore marketed without complying with the regulations applicable to them. - The use of claims on documentation associated with essential oils of the Aroma-Zone brand 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 and Regulation (EU) No 655/2013 setting common criteria for cosmetic product claims. - The marketing of essential oils under the Aroma-Zone brand as ingredients in cosmetic products that do not comply with the labelling requirements 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 under the Aroma-Zone brand, 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 for use, in accordance with Articles 2 and 3 of Regulation (EC) 1223/2009. - The marketing of certain products under the Aroma-Zone brand indicating that they may be mixed with any other cosmetic product by consumers, which is not considered to be a practice covered by the Regulation since the company has not demonstrated the safety of all the products obtained after mixing, in accordance with recital 4 and Articles 3 and 10 of Regulation (EC) 1223/2009. - The absence of formulas and safety reports for certain finished products tailor-made from neutral bases, in accordance with the requirements of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products. - Updates of product safety reports prepared by a provider, according to a toxicological evaluation of substances that do not meet all the expectations of Annex I of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products.

The injunction

ANSM enjoins Hyteck :  1. to review the claims and/or the qualification of certain products of the Aroma-Zone brand which have a purpose other than cosmetic, within a period of 3 months;  2. to review the qualification, labelling and commercial documentation of raw materials so that they comply with the regulations applicable to them, within a period of 3 months;  3. finalise the revision of claims associated with products that can be mixed with any other product and with products presented as cosmetic products, in order to comply with the regulations in force, within 6 months;  4. finalise, for all products, the approach initiated to regulate products made to measure from neutral bases, in order to ensure that 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 a period of 6 months;  5. to update the safety reports drawn up by a provider taking into account all the expectations of Annex I 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.

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