EU Seventh Amendment Compromise To Reduce Animal Tests Over 70%

The European Union expects to reduce the number of animals used in cosmetic testing from 30,000 to between 7,000 and 8,000, or more than 70%, under an animal testing ban compromise approved by the Council of Ministers.

The office of the Belgian Presidency announced the council had reached a compromise on the proposed animal testing and marketing ban included in the Seventh Amendment to the Cosmetics Directive on Nov. 21.

The compromise text requires that "animal experiments be replaced by alternative methods, when such methods exist and are scientifically satisfactory." The legislation marks a significant change from that which passed through committee and Parliament earlier this year, which would have implemented an animal testing and marketing ban after Dec. 31, 2004.

The new text carries no deadline "because there is as yet no way of knowing when alternatives to current tests will become available," according to the presidency.

Under the new compromise, manufacturers will be banned from using animal tests if a validated alternative has been approved by the European Centre for the Validation of Alternative Methods or the Organization for Economic Cooperation and Development. ECVAM has approved three alternatives and is currently reviewing a skin absorption test.

The compromise text also mandates the ban apply when scientists can agree on an acceptable alternative to animal testing that provides safety guarantees "in the area of application of the cosmetic product in question," according to the text. When no validated alternative exists, it will be mandatory to turn to the test that causes the least possible animal suffering.

"It continues to be indispensable to carry out certain toxicological tests to evaluate the safety of cosmetic products," the revised text reads.

The EU Belgian Presidency defended the council's decision to do away with an outright ban, noting "this debate has been dragging on for many years and actually started at a time when the general consensus was that valid alternatives to animal experiments could be found in the relatively short term."

"Every day, cosmetic products are used to care for babies as well as sick people and the elderly," the EU adds. "It is this precise fact that they are in general use and are in contact with more than just the surface of the body...that makes consumer protection such an important issue."

The compromise text applies foremost to finished products, but also will be extended to include individual ingredients or combinations of ingredients, according to the presidency. To dissuade companies from moving outside the EU to conduct animal testing, the text also includes a measure banning the sale of products formulated with ingredients tested on animals where worldwide validated alternatives exist.

Although the Council of Ministers has reached a compromise, the proposal will return to Parliament for a second reading and will return again to the council before being finalized. The council is hoping to reach a final decision on the text before the Belgian Presidency expires at the end of the year.

The European Cosmetic, Toiletry and Fragrance Association called the new approach an improvement over the previous proposal. The text is more realistic and likely will reduce the possibility of legal conflicts with the World Trade Organization, Colipa said.

Originally developed strictly as an animal testing prohibition to avoid conflict with the WTO, the Seventh Amendment was changed to include a marketing ban while in the Environmental Committee. The legislation passed committee in March and Parliament in April ¹('The Rose Sheet' March 26, pp. 3-5 and "²The Rose Sheet' April 9, p. 12).

In addition to the animal testing ban, the compromise text recommends that labeling guidelines be developed to address animal testing claims. The text will also require minimum durability expiration dating on cosmetic products.

With regard to fragrance allergens, which the Seventh Amendment also addresses, the council proposal is similar to Parliament's in that it would require listing of ingredients known to cause allergic reactions, but no fragrance warning labels.

In addition to the cosmetics proposal, the Council of Ministers also supported an upcoming revision to the European directive governing animal experiments in the chemical industry, marking an "important step forward," as cosmetics only account for .3% of animal tests in Europe (30,000 of nearly 10 mil.).