It is in the name of"nonconformities and significant breaches" that the ANSM has just sent Propos Nature a compliance injunction concerning its establishment at La Roque d'Anthéron. 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 24 October 2017, follows an ANSM inspection carried out at the company's premises from 14 to 16 February 2017.
The facts complained of
- The provision of sun protection cosmetic products under the Propos Nature brand, based on karanja oil, claiming sun protection activity even though this ingredient is not an authorised filter provided for by Regulation (EC) No 1223/2009 on cosmetic products. Its use in a sunscreen product, in order to provide a sun protection factor, does not comply with the regulations in force for cosmetic products (Article 14 and Annex VI). - The availability of products of the Propos Nature brand (in particular nasal sprays) with a purpose other than cosmetic by 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 on cosmetic products, and which are therefore marketed without complying with the regulations applicable to them. - Claims used for certain products (composed exclusively or mainly of essential oils and vegetable oils) 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. - The absence of control and release of raw materials and packaging items before their implementation for the manufacture of cosmetic products in accordance with chapters 6.2 and 6.5 of the harmonised standard NF EN Iso 22716 of January 2008 on good manufacturing practices for cosmetic products. - The re-evaluation of raw materials not appropriately managed in accordance with chapter 6.7 of the harmonised standard NF EN Iso 22716 of January 2008 relating to good manufacturing practices for cosmetic products. - The marketing of sets of products (joli'box, joli'recipes) including ingredients, equipment and instructions intended to manufacture cosmetic products by consumers, which corresponds to the definition of a cosmetic kit according to European recommendations on products borderline, while the company has not carried out the safety and PID reports in accordance with the requirements of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on the scope of application of the Cosmetics Regulation (EC) No 1223/2009 (Art.2(1)(a)) (Version 2.2, February 2016). - The absence of formulas and safety reports for customised finished products (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. - Safety reports on certain products drawn up by a service provider, based on an incomplete toxicological assessment of substances (NOAEL and incomplete toxicological profiles) which does not meet all the expectations of Annex 1 of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products.
The ANSM enjoins the company Propos Nature : 1. to implement corrective actions allowing to market sun protection products in conformity, within 1 month; 2. review the claims and/or the qualification of products which have a purpose other than cosmetic, within a period of 3 months; 3. to review the qualification, labelling and commercial documentation of products (composed exclusively or mainly of essential oils and vegetable oils) with a view to their claims and use so that these products comply with the regulations applicable to them, within a period of 3 months; 4. to carry out controls on receipt according to defined methods for all raw materials and packaging items and to release raw materials and packaging items by persons responsible for quality within 6 months; 5. put in place the necessary controls for the re-evaluation of raw materials that have reached their expiry date and store them properly within 6 months; 6. have formulas, safety reports and information dossiers for all cosmetic products, in particular for products made to measure from neutral bases and for kits (such as pretty'box and pretty'recipes), 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 9 months; 7. to review the safety reports taking into account the set of expectations in Annex I of Regulation (EC) No 1223/2009, in order to ensure that toxicological evaluations of substances comply with the requirements of the Regulation within 9 months.
To go further
- See the Injunction n° 17COS011-INJ concerning the establishment of the company Propos Nature, located in La Roque d'Anthéron (Bouches-du-Rhône) on the ANSM website.