The EU's upcoming ban on products tested on animals could affect the availability of some novel cosmetic ingredients, though it is unlikely to have a jarring impact on large U.S. personal-care marketers.

During a June 4 interview with "The Rose Sheet," Personal Care Products Council Chief Scientist John Bailey, Ph.D., said that due to a lack of validated alternative methods, many firms have developed their own non-animal tests to satisfy requirements of a ban under the Seventh Amendment to the Cosmetics Directive, effective next year.

Companies are employing "very complicated approaches" involving "sophisticated computer modeling and batteries or different combinations of alternative tests" to verify product safety while observing restrictions of the imminent ban, Bailey said.

Additionally, "there is a huge amount of data available for similar compounds and they sort of rely on ... data from one study to support the safety of an ingredient that is related," he explained.

Under the ban, the sale of cosmetic products containing ingredients tested on animals will be prohibited in the EU starting in 2009. Products tested on animals to evaluate repeated dose toxicity, reproductive toxicity and toxicokinetics will have until 2013 to comply.

Alternative methods exist for most - but not all - animal assays subject to the 2009 ban, according to Bailey.

"For us as a trade organization, we're looking at this from a science perspective, and it tells us that for certain endpoints affected in 2009 there will not be alternative methods available to replace these endpoints," he said.

"So I think the 2009 ban can have an effect on the availability of ingredients, especially if those are novel ingredients where you don't have an exact body of data to rely on."

Companies will have to innovate strategies on their own to bridge those gaps, Bailey noted.

Regarding the second stage of the ban in 2013, Bailey said that currently there are no suitable methods to substitute for animal tests currently used to address the three endpoints, which are "very complex."

However, the needed technology may reasonably become available between now and 2013, he said.

The European Center for the Validation of Alternative Methods recently endorsed a number of alternative methods, including assays that test for severe eye irritants and skin allergy potential.

ECVAM's U.S. counterpart, the Interagency Coordinating Committee on the Validation of Alternative Methods, has been criticized by animal welfare groups for not moving quickly enough to approve tests validated across the Atlantic (¹ Also see "Federal Commitment To Reducing Animal Testing Called Into Question" - HBW Insight, 18 June, 2007., p. 3).

During ICCVAM's February anniversary symposium in which it outlined its five-year plan for advancing alternatives, Bailey suggested that regulatory acceptance of validated tests is the biggest challenge for the working group (² Also see "ICCVAM Successes, Challenges Addressed At Anniversary Symposium" - HBW Insight, 11 February, 2008., p. 3).

FDA has taken steps recently to move the process along, striking an agreement with the European Commission last November to work more closely in peer reviewing validation studies (³ Also see "FDA and EC Agree To Collaborate On Validation Of Animal Testing Alternatives" - HBW Insight, 19 November, 2007., p. 9).

Cosmetic Marketers Expect Business As Usual

Procter & Gamble and Estee Lauder claim to be prepared for the upcoming ban, saying it will have no effect on the marketing of their products in Europe.

In May 30 correspondence with "The Rose Sheet," P&G Beauty's Harald Schlatter, Ph.D., who handles global regulatory & technical relations for the firm, said the company has been applying animal alternative tests to cosmetics for over a decade.

P&G markets a wide range of beauty brands including Cover Girl and Max Factor cosmetics, Clairol hair color, Olay skin care, and prestige fragrances including Anna Sui .

"We have been working on alternatives for over two decades knowing full well that this was going to be challenging," Schlatter said, noting the firm has spent $225 million on the effort to date.

"However, we also know it is the right thing to do and the right investment."

P&G has adopted methods for all acute toxicological endpoints relevant to its business and covered by the 2009 deadline, he said.

"Some of these are industry and regulatory standards and others are now entering the formal validation process but can and have been used to address the safety needs," he explained.

The company's primary focus now is working across the industry and with ECVAM to gain formal validation and acceptance of the approaches.

Going forward, the firm will "continue to invest both money and resources worldwide to progress the development of alternatives, working in collaboration with other industries and representative trade associations," Schlatter said.

P&G's investment in the initiative so far is necessary not only to satisfy the ban, but also to "meet our eventual goal to eliminate all research with animals for evaluating safety of consumer products," according to Schlatter.

Estee Lauder also claims to have been using animal alternative tests for two decades, and says it continues to be an active party in collaborative efforts to find more alternatives.

In addition to serving on the European Cosmetic, Toiletry and Perfumery Association task force assigned to finding alternatives, Lauder is also a founding member of the European Partnership for Alternative Approaches To Animal Testing, a collaborative industry effort established in 2005.

During a May 30 interview with "The Rose Sheet," Lauder VP-R&D Ken Marenus echoed that most large U.S. cosmetic companies have already implemented alternatives to animal tests and will not be greatly affected by the ban.

"When I started at Lauder in 1986, in general people did [animal testing] without thinking about it," he said. "Then by the early '90s people realized they didn't need to do it."

Marenus noted that companies have invested heavily in the movement and have worked both individually and together to find acceptable replacement methods.

With many of those alternatives already identified, "what you will see in the future is a focus on more harmonized and standardized methods for alternative methods, and that will come from Europe," Marenus said.

While they maintain that the ban will whip up no significant waves for large U.S. firms, both P&G and Lauder acknowledge there could be some unforeseen issues - for example, if an authority for the EU's upcoming chemicals law requires animal testing for a particular testing endpoint.

The chemicals law, called the Registration, Evaluation, Authorization and Restriction of Chemicals, requires manufacturers and importers of chemicals in volumes greater than one metric ton a year to register with the European Chemicals Agency. As part of that process, companies will be required to share hazard studies on substances.

Though the registration deadline for REACH is in 2010, pre-registration is starting now (⁴ Also see "REACH Pre-Registration Opens In June; Firms Advised To Begin Amassing Data" - HBW Insight, 21 April, 2008., p. 3).

Animal Advocacy Weighs In

In a June 2 interview with "The Rose Sheet," the Humane Society of the United States' VP of Animal Issues Martin Stephens, Ph.D., was surprised by the marketers' claims that they are fully prepared for the ban.

Stephens acknowledges that companies have come a long way since the 1980s when animal testing was the norm for cosmetic ingredients, but he sees a significant amount of work yet to be done, especially in terms of validating and harmonizing methods between the U.S. and EU.

The exec applauds the upcoming ban as the force behind the progress. "It may have caused some short-term pain for the cosmetics industry, but it has served as a tremendous driver of alternative methods," Stephens said.

- Eileen Francis (e.francis@elsevier.com)

Major U.S. Cosmetic Firms Say They Are Ready For Animal Test Ban In EU

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