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Consultation: Hair Dyes: Maximum Authorized Concentration for PPD & PTD
13 August 2008
P-PHENYLENEDIAMINE (PPD) and related compounds are used in permanent hair dyes, and more than two thirds of hair dyes currently used contain PPD. PPD is a well-known and extremely potent skin sensitizer. Scientific reporting and clinical diagnosis in patients with dermatitis from hair dyes have focused on PPD as the main skin sensitizer.
PPD is currently regulated by the Cosmetics Directive Annex III, Part 1 under entry 8 on the "List of substances which cosmetic products must not contain except subject to restrictions and conditions laid down". The present restriction is 6% of PPD calculated as free base in the finished cosmetic products.
In the updated safety file submitted in the framework of the re-assessment strategy the cosmetics industry defends the use of PPD in oxidative hair dye products at a maximum concentration of 2.0% in the formulation applied to hair.
TOLUENE-2,5-DIAMINE (PTD)
Apparently, aside from PPD, it is mostly the use of PTD that causes skin allergies by hair dyes in the population. It is almost as potent as PPD and it occurs in up to 70-90% of oxidising hair dye products on the EU market.
PTD is currently regulated by the Cosmetics Directive, Annex III, Part 1 under entry 9. The present restriction is 10% of PTD calculated as free base in the finished cosmetic products. In the updated safety file submitted in the framework of the re-assessment strategy the cosmetics industry defends the use of PTD and its sulfate salt in oxidative hair dye products at a concentration of 4.0% in the formulation applied to hair.
MEASURES ENVISAGED CONCERNING THE REGULATION OF PPD AND PTD
Taking into consideration that the risk assessment of additional data on PPD and PTD and final opinions made might still require a considerable amount of time, the Commission intends, as a precautionary measure of reducing the risk of allergies to hair dye products among consumers, to decrease the maximum authorized concentrations of PPD and PTD to the levels which are defended by the cosmetics industry in their submitted safety files.
