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Nature News. 11 March 2009

The lowdown on animal testing for cosmetics. European Union continues phasing out animal experiments.
Alison Abbott

The European Union has outlawed the use of animals in seven toxicity tests for cosmetics ingredients.

An amendment to the European Union's Cosmetics Directive today phases out the use of animals in testing for any acute toxic effects of beauty products and toiletries — effects such as eye and skin irritation that might be seen shortly after exposure.

Nature News finds out what this entails.

What is the Cosmetics Directive and how is it changing? The Cosmetics Directive was introduced in 1976 to enforce high safety standards for cosmetics across the EU member states. It was amended in 1993 to phase out the use of animals in testing, but the amendment was never implemented because no alternative, animal-free tests had been approved. A stricter amendment was made in 2003. It forced a ban on the
use of animals in testing of finished cosmetics products within one year, and imposed two further deadlines to phase out animal testing on any ingredient in a cosmetic product - regardless of whether alternative tests are available. From today, the first of the two deadlines outlaws the use of animals in seven mandatory tests of toxicity following a single application. These are tests for skin irritancy, sensitivity to light, corrosivity, absorption through the skin, genetic toxicity, eye irritancy and acute toxicity.

The amendment also bans the import of cosmetics containing ingredients that have been animal tested in this way after the deadline.

The second deadline, 11 March 2013, would see a ban on eight tests designed to establish longer-term toxicity following multiple applications, for example their ability to cause cancer or birth defects. However, this deadline may be renegotiated.

Why didn't the Commission forbid the marketing of cosmetics tested on animals — even without available alternatives — given that they are vanity products?

Money and politics. Europe is a world leader in cosmetics, with global sales approaching €80 billion (US$102 billion). That is nearly half of the world market. There are around 2,000 cosmetics manufacturers in the European Union, including some of the world's largest, such as L'Oreal and Estée Lauder, and they sell five billion items every year. It would have been difficult to get a political agreement to restrict such a
profitable industry. And it's not just about mascara. Products like toothpaste, sunscreens and shampoos also fall under the Cosmetics Directive.

Have alternative tests become available for the 11 March 2009 deadline?

Alternatives to four of the seven tests banned today have been validated and approved by the European Union, and work on the other three is advanced. Experts say that solutions will be found within two years. During this time, the cosmetics industry will not be able to introduce new products that include chemicals not tested before the cut-off date. How did scientists get so many new tests validated so fast?
The European Union has been pumping €35 million into efforts to develop alternative methods every year since the Cosmetics Directive was amended. EU member states are estimated to put in a combined total of a further €25 million per year. The European Union has implemented a systematic pan-European research programme to find alternatives, coordinated with the smaller efforts that are going on elsewhere in the world.
The cosmetics industry itself has contributed €25 million for developing alternatives, which was matched by a further €25 million by the European Union.

How many animals does the European cosmetics industry use in testing?

Not that many. In 2005, they used fewer than 6,000, just 0.05% of the total number of animals used in regulatory testing. Nonetheless, around 400 new substances find their way into cosmetics each year. Some are natural ingredients that don't require testing. And others that already have safety approval are bought in from chemicals manufacturers. That will now be difficult since the directive bans cosmetic ingredients that
have been tested on animals anywhere in the world. What is the procedure for getting a new alternative test
approved? An alternative test has to prove itself as reliable as the animal test it is replacing. The EU Joint Research Centre in Ispra, Italy, is responsible for approving such tests that then have to be adopted by regulatory authorities. Then they go to the Organization for Economic Co-operation and Development, which oversees global acceptance of new animal-free tests.

How does the European Union compare with the rest of the world?

No country has yet introduced legislation outlawing animal tests on cosmetics and cosmetic ingredients. But nations such as the United States and Japan are attempting to align the tests their regulatory bodies accept to those within Europe. Is the cosmetics industry on track for the 2013 deadline? Unfortunately not, and these tests for toxicity following longer-term exposure account for most of the animals used by
the cosmetics industry. The tests are more difficult to reproduce in vitro because the biology involved is not so well understood. It may take a decade or more to develop and validate alternative tests that use no animals at all. But this deadline is negotiable.

Isn't the European Union dealing with other legislation on animal experiments at the moment?
Yes. The European Parliament's Agriculture Committee is due to debate a revised version of the wide-reaching directive on animal experiments on 31 March.

However, businesses and academic groups are concerned that the draft amendment would limit the reuse of the same animal in a series of experiments, and curb the use of specimens captured from the wild. The proposed amendment would also ban research on non-human primates unless it related to preserving the
species in question or to life-threatening or debilitating clinical conditions in humans.
The full European Parliament could vote on the revised directive as early as the end of April if it passes the
Agriculture Committee. But any disagreement at the committee stage could push the vote back. If members of the European Parliament cannot vote on the legislation before the European Parliament elections in June, the whole process may have to start again.

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