EU Commission outlines derogation to cosmetics animal testing ban

SCCS would judge claims that animal test data was only way to prove ingredient safety

05-Jan-2012

The European Commission is seeking stakeholders' views on its most recent proposal for “balancing the interests at stake” regarding the 2013 ban on the marketing in the EU of cosmetics containing ingredients that were tested on animals.

The Commission is required to analyse whether for technical reasons alternative test methods for three toxicological endpoints - repeated-dose toxicity, reproductive toxicity and toxicokinetics - will not be developed and validated before March 2013. Its most recent annual report to the European Parliament and Council of Ministers on alternative tests for cosmetics, published in September (CW 14 September 2011(http://chemicalwatch.com/8406) ), said they will not be available for the three endpoints by the deadline.

Colipa, the European cosmetics industry association, says allowing the ban to apply would damage its ability to innovate and do little to reduce the number of animal tests globally, while animal rights groups say current alternative test methods and existing ingredients are sufficient to ensure the safety of cosmetics.

In order to decide whether or not a legislative proposal should be made, the Commission is working on an impact assessment. Until recently, this was looking at four options: maintaining the 2013 ban; postponing the 2013 deadline to a later specified date; postponing the deadline for certain endpoints only; and postponing it without setting another date.

But in a recent working document seen by Chemical Watch the Commission sets out the main elements of an additional fifth option – how a derogation to the marketing ban could operate in practice if it was chosen as the preferred solution.

The new option would allow cosmetics containing ingredients which had been subject to animal testing for one or more of the endpoints to be placed on the EU market after 2013 if such animal data was the only data available to prove an ingredient's safety. Such testing would have to be carried out outside the EU. The conditions of such a derogation, says the Commission, could be that:

● it would be requested by a cosmetic or ingredient manufacturer, or a trade association, rather than a member state, as is the case for testing ban derogations;

● the manufacturer or association would need to demonstrate to the Commission's Scientific Committee for Consumer Safety (SCCS) that toxicological data needed for the safety assessment is not available and can not be obtained using alternative methods in a “reasonable time”;

● it would need to demonstrate to the Commission that the ingredient would bring “considerable technical progress and a significant added-value to the health and/or well-being of consumers/society or to the environment”. The cases to which it applies “should represent the exception, not the rule”. If the Commission accepted the arguments the derogation would be issued as a Commission Decision;

● the request would need to provide details of where the testing had been conducted, the protocol followed, the number of animals involved and the animal welfare standards applied. Manufacturers would also need to demonstrate “their commitment in relation to investments in research for alternative methods”; and

● respective animal data would have to be made available to all manufacturers that want to use the substance, possibly after a certain time in the case of a proprietary substances.

Although the derogation option is not the Commission's final position it is probably its preferred way forward, said Dr Nick Palmer, head of policy at the British Union for the Abolition of Vivisection. If it is adopted, he said, it would “drive a coach and horses” through the ban because industry is arguing that a huge number of ingredients should qualify – in particular by saying so-called “cosmaceuticals” can improve mental health and sense of well being. But he said the derogation option could run into opposition from the European Parliament.