Cosmetic colourants are specifically regulated under the European Cosmetic Products Regulation (EC) No 1223/2009, which means that only those colours listed in an annex (Annex IV) to the Regulation are allowed for use in cosmetic products.
Cosmetic colourants are defined in the Regulation as substances which are exclusively or mainly intended to colour the product or the body where the product is applied by absorption or reflection of coloured light.
“In other words, if you can generate colour by another means, that substance would not be subject to the need to be on Annex IV, though of course it must be safe,” CTPA Director-General Chris Flower tells CosmeticsDesign-Europe.com.
“In addition, precursors of oxidative hair colorants are also considered to be colours even if they do not actually impart colour as they are.”
The team at the CTPA, which also includes Dr Emma Meredith, Director of Science, and Debbie Hunter, Director of Commercial Affairs, also say that in some cases there are specific purity criteria which apply to specific colours listed in Annex IV. In other cases, they say some colours may not be used for some product types.
An example of this is that some colours are not allowed for leave-on use or for use where ingestion is a possibility, such as in a lipstick – and these restrictions are clearly laid out for each colour where they exist, says the CTPA.
Teething problems
It means that any colourant that is not listed in Annex IV to the Regulation may not be used in cosmetic products placed on the European market, although Flower explains a number of discrepancies crept in when the Cosmetic Products Directive changed to the Regulation.
“A number of drafting errors crept in to the colours annex and these have led to real problems for the colour manufacturers and suppliers,” he says.
“However, Cosmetics Europe has made the European Commission aware of these errors but it will take some time before they are all corrected.”
The CTPA also says that adding new colours to the permitted list is problematic, as in order to be approved, a file of safety information on the colour has to be submitted and assessed by the European Commission’s expert scientific committee, and according to the requirements of that committee, some data can only be obtained via animal testing at the present time.
As we know, the same Regulation has prohibitions on animal testing and bans the sale of cosmetics that contain ingredients tested on animals in order to comply with the requirements of the Cosmetic Products Regulation.
“In effect, it means that the list of approved colours is closed for the time being as we could find ourselves in a Catch 22 position: no data = no approval, yet generate data = banned from use,” says Flower.