Industry dragged feet over animal testing alternatives, says expert

The March 2009 deadline is only weeks away but a number of objectives have not been, and will not be, fulfilled in time.

According to the Cosmetics Directive, animal testing cannot be used for skin irritancy, phototoxicity, corrosivity, percutaneous absorption, genotoxicity, ocular irritancy and acute toxicity, after March 2009.

Portfolio of validated alternatives is lacking

However, validated alternatives exist for only four of these seven tests, leaving companies with few options when it comes to genotoxicity, ocular irritancy and acute toxicity tests.

According to a spokesperson for SkinEthic (a provider of reconstructed human epidermis models that have been validated for skin irritancy and corrosivity), this is due, in part at least, to the industry dragging its feet.

“These changes to the regulation were made public 11 years ago, and now the industry finds it hasn’t got all of the right tools to comply” he said.

Some people may have expected the EU to postpone the deadline, he said, something that has not occurred.

In the last few years the cosmetics trade association Colipa has made significant progress on ocular irritancy and genotoxicity, but these will not be validated in time for March’s deadline.

This leaves suppliers in a regulatory pickle from March. The Cosmetics Directive states that no more animal tests for these outcomes can be performed however no validated alternatives exist.

There are a number of pre-validated methods that could be used but it is not clear how companies will react to the inherent contradiction between incoming regulation and current available methods.

A further deadline for another eight tests (carcinogenicity, photoallergy, cutaneous allergy, toxicokinetics, reprotoxicity, teratogenesis, toxicity – sub chronic and chronic, and photomutagenesis) is set for 2013