An alert for a serious undesirable effect in a female user of the”Royal Henna” trade mark hair dyess led the ANSM (National Agency for the Safety of Medicines  - previously known as the Afssaps) and the DGCCRF (French General Directorate for Competition Policy, Consumer Affairs and Fraud Control) to act and to perform analyses.

These analyses have detected the presence of para-phenylene-diamine (PPD) well above the allowed content rate, plus the presence of forbidden substances in the cosmetic products.

The products identified as non compliant and dangerous are:
• Royal Black Henna
• Royal Red Henna
• Royal Brown Henna

Further, none of these products displays a list of ingredients, the name and the address of the manufacturer or of the importer in the European Union; the label is not translated into French. All these points do not comply with the current regulation.

The DGCCRF has seized, in the distributor warehouse, all the non-compliant and dangerous products, and takes the right measures to be sure none of these product is yet available on the French territory.

The ANSM and the DGCCRF recommend consumers:
• To seek medical advice in case of any allergic reactions during or after the application  of one of these dyes;
• Not to buy "Royal Black Henna," "Royal Red Henna," "Royal Brown Henna" products, and not to use any they could have at home.

The authorities remind health professionals that they must declare any serious or unanticipated undesirable effect to the ANSM, using the pertaining document available on the ANSM website. Users can do the same, either through the same channel or through an association of consumers.

For further information:
• Read the ANSM press release on the agency’s website (in French)
• Get the means to declare to the ANSM an undesirable effect due to a cosmetic product (in French)