With REACH laws implemented and a total ban for the testing of cosmetic ingredients on animals looming ever closer, industry players must adapt their business operations to comply with these the new regulations. Likewise industry will have to contribute significantly to ensure that such regulation can be implemented smoothly.

CosmeticsDesign-Europe spoke to Thomas Hartung, unit head responsible for the European Centre for the Validation of Alternative Methods (ECVAM). The body is part of the European Commission, directly providing scientific support to the Commission and Member States in making such regulation a reality. Most importantly this makes it independent of vested interests.

Animal testing ban

With REACH laws implemented at the beginning of June, the focus at ECVAM is turning towards developing alternative methods to animal testing on cosmetic ingredients.

However, as with all the research work the body undertakes, co-operation with industry is crucial - co-operation that Hartung feels has been lacking.

"Altogether the extent and pace of industry contribution has been below our expectations, given the urgency of the problem. Much more could be done," he said.

Hartung added that with more input from industry, the research ECVAM carries out could be better financed, and, likewise, information relating to animal testing and alternatives methods could be shared more freely.

Despite this, ECVAM is still clearly focused on finding alternatives to animal testing, with the aim of enforcing a complete ban on its use in animal ingredients by 2009.

The new regulations mean that if ECVAM has validated an alternative method and the animal experiment is carried out on the ingredient, then a marketing ban is enforced on any finished cosmetic product using such an ingredient.

In detail the 2009 ban will be reinforced by an instant marketing ban for acute and topical effects - backed up by a second deadline in 2013 for the more complex endpoints.

Expounding on this, Hartung says that the only areas presenting continued challenges for ECVAM are acute toxicity and mutagencity. Evidently more studies are on the way for acute toxicity and problems have been incurred for mutagencity testing because of high rates of false-positives.

However, with alternative testing pin-pointed for skin corrosion, skin penetration, and photoxicity, and the investigations of a number of alternatives for eye irritation, it seems that deadlines are well within reach.

"Altogether we are optimistic with regard to this deadline, if the respective programmes are pursued," added Hartung.

Indeed a strategic plan has been in place since 2003 that has so far achieved the objectives set out through a programme of support that heavily involves Colipa.

ECVAM's role in industry testing

When it comes to the personal care industry, the body's involvement lies in providing support in the areas of toxicity and sensitization, together with mutagenecity and cancer.

"Beside the respective ECVAM staff members, we have at least one taskforce for external experts, who help us to develop strategies and prioritise projects." he said.

These taskforces work closely with the European cosmetic association Colipa, which essentially provides the 'buffer' zone, between the cosmetics industry and the EU regulation authorities.

An example of the vast scope of ECVAM's work is the fact that Hartung estimates that approximately 70 per cent of the most promising methods for any type of testing procedure carried out by the body actually fail to be adopted.

This gives an indication of the drawn-out process of thorough scientific laboratory research that each test method has to undergo.

"This is a less visible part of our work, but prevents premature methods from going into regulatory use."

To be fit for regulatory use, alternative methods to animal testing must meet three main principles: based on scientifically plausible principles, reproducible, and deliver relevant results.

ECVAM works in conjunction with a number of other authorities on the regulation of cosmetics, including the European Chemical Bureau, the New European Chemicals Agency, OECD and the Scientific Committee for Consumer Products (SCCP), as well as its US and Japanese counterparts.

REACH

Although EU-wide enforcement for REACH came into being at the end of June, ECVAM still has its work cut out during the regulation's enforcement period, which will be further impacted by the new regulations on animal testing.

"For the last 18 months ECVAM has co-ordinated, on behalf of the European Commission, the development of testing strategies for REACH. This process has involved 200 experts from regulatory agencies, industry and other stakeholders, has developed a testing strategy based on existing data in silico, in vitro and in vivo methods."

Hartung pointed out that an analysis conducted by EVCAM shows that methods currently under validation and that should be ready by 2009 could cut animal testing relating to REACH by as much as half.

"REACH foresees a rapid inclusion of newly validated methods and the participation of ECVAM in the animal welfare panel, suggesting that intense collaboration will be instrumental."

With economic growth continuing apace in Europe and the EU eyeing further extensions to its geographic boundaries, one thing is for sure, the on-going process of updating and modernizing EU regulation is not going to go away.

For the cosmetics industry the process of updating existing regulations and adding new ones will be on-going. And without continued co-operation between industry and bodies such as ECVAM compliance with regulation will only get tougher.