The ECHA had previously stated that BASF, a specialty chemicals player, was required to conduct a prenatal developmental toxicity study using rats or rabbits on one of its ingedients, a fatty acid derivative for cosmetic use.
It has now reversed this decision.
REACH and Cosmetics Regulation: how they interact
The European Ombudsman reportedly advised that animal-testing data generated for the purpose of REACH, the EU’s wider chemicals regulation programme, cannot necessarily be relied upon for the safety assessment report required under the Cosmetics Regulation.
Consequently, by barring the substance from the EU market, it was deemed that requested test would ultimately serve no real purpose in protecting humans.
BASF responds
“BASF welcomes the ECHA Board of Appeal decision (case A-013-2016) as a significant step towards alternative solutions,” the company said in a statement to Cosmetics Design.
“BASF applies alternative test methods including replacement methods (no animal testing involved) for screening tests in product development and for regulatory tests as soon as a method has been approved for this purpose.”
BASF notes that it works with national and international institutions and companies to establish and validate new alternative methods and is a world leader in this field.
To promote the development of alternative methods, the company set up its own dedicated laboratory in 2004 for the development of alternative methods.
Non-animal approaches
The reversal of position from the ECHA comes following an intervention by animal rights group PETA.
“Going forward, registrants would be well advised to use only non-animal approaches to the hazard assessment of cosmetics ingredients, and where ECHA has serious hazard concerns, these should be raised with the relevant member states in accordance with the law,” says Dr Julia Baines, a science policy advisor for the PETA International Science Consortium.
“REACH applies without prejudice to the animal testing bans laid out in the Cosmetics Regulation.
“The [ECHA] Board has agreed with the [PETA] Science Consortium, correctly recognising that ECHA has a duty to take into account the implications of the Cosmetics Regulation in its administration of REACH.”