On 9 February 2017, the ANSM published a Notice to manufacturers on sunscreen products containing karanja oil. A warning to remind that it is not an authorised sun filter and that its use to obtain a protection factor is not compliant.
ANSM issues an Opinion to manufacturers
The French National Agency for Medicines and Health Products Safety (ANSM) wishes to remind manufacturers that cosmetic products cannot contain any UV filter other than those listed in Annex VI of Cosmetics Regulation 1223/2009.
ANSM was informed of a RAPEX alert issued by another Member State of the European Union on the non-compliance of a cosmetic product presented as a sunscreen product with naturally protective karanja oil and a Sun Protection Factor (SPF) of 30.
It is reminded that UV filters are defined as substances which are exclusively or mainly intended to protect the skin against certain UV radiation by absorbing, reflecting, or scattering UV radiation (Article 2 of the Cosmetics Regulation). These filters are assessed before being authorized in cosmetic products and added to Annex VI to Cosmetics Regulation.
Under Article 14 of the European Regulation, cosmetic products cannot contain any UV filter other than those listed in Annex VI of the Regulation. As a matter of fact, karanja oil is not in Annex VI.
Since karanja oil is not an authorized UV filter, its use in a sunscreen product to provide it with a Sun Protection Factor is not compliant with the …
