EU Cosmetics Animal Testing Ban To Be Executed Three Years After Approval

A European Union comprehensive ban on animal testing for cosmetics ingredients is slated to go into effect three years after implementation by the member states, the European Commission announced April 5.

Implementation of the ingredient testing ban could be postponed by one two-year extension "if there has been insufficient progress in developing satisfactory methods to replace animal testing," according to a memorandum accompanying the rule language.

The EU also proposes an immediate ban on the testing of finished cosmetics products within the member states, the memo reads. Ingredients for which an alternative method has been validated also will be immediately banned from animal testing.

Commonly known as the Seventh Amendment to the Commission's Cosmetic Directive, the testing ban is meant to replace the Sixth Amendment, which prohibits the marketing of any cosmetic "ingredient or combination of ingredients" tested on animals. The marketing ban is due to go into effect July 1.

The Seventh Amendment animal testing ban would apply only to activities within EU member states, thus rectifying what is being perceived as a potential World Trade Organization conflict with the marketing ban. As written, the Sixth Amendment could affect EU imports, including those from the U.S.

The proposal thus aims to make the current legislative provisions "WTO-compliant, legally and practically enforceable." The testing ban language (The Seventh Amendment), however, needs to be approved by the European Parliament before June 30 the marketing ban when (Sixth Amendment) goes into effect.

Draft language of the Seventh Amendment was outlined by then-EC Directorate General III-Pharmaceuticals and Cosmetics Unit Administrator Lee Bansil at the Cosmetic, Toiletry and Fragrance Association's 1998 scientific conference (¹ (Also see "EU Animal Testing Ban Would Apply Only To Member States - Draft Proposal" - HBW Insight, 9 Nov, 1998.)).

Speaking at the Cosmetic, Toiletry and Perfumery Association's Mutual Understanding meeting in St. Julians, Malta April 10-13, Colipa Secretary General Robert Vanhove expressed concern the new language will not be approved before the Sixth Amendment deadline.

"If the Commission does not succeed in postponing the Sixth Amendment, we will take for the first of July an interdiction for products coming from the U.S., Japan and other countries to market the products tested on animals," Vanhove said.

U.S. Trade Representative senior EU liaison Nancy Adams noted the U.S. has been closely monitoring the development of the Cosmetics Directive and its potential impact on trade between the U.S. and EU.

"We are very concerned, and I know in the industry you are as well, about this development," she told the Colipa audience. "We are pleased to see the Commission's efforts to try to get this one right," but we "are also concerned about the next steps."

Adams recommended the U.S. work with the Commission to avoid a formal WTO initiative and ensure the proper steps are taken to prevent a trade dispute.

The main objective as outlined in the memorandum is to protect public health. Thus, "it is vital to carry out tests to assure the safety for human health of chemicals used in cosmetic formulations," the Commission states.

The proposed amendment aims to "make mandatory use of validated alternative methods for the testing of chemicals used in cosmetic products, as soon as such methods become available." Three alternative methods have been validated to date.

The Commission plans to obtain the "rapid acceptance by the Organization for Economic Cooperation and Development of alternative methods validated at community level." After the two-year extension, however, the effective date would not be delayed again even if no alternatives exist.

The Commission urges an acceleration in the study of alternatives for skin and eye tests, which have proven to be a thorny issue for the scientific community.

"Taking into account the progress made...to date, it can be reasonably expected that within five to seven years, a battery of in vitro tests could well be available for testing the possible short-term toxic effects of a cosmetic."

Guidelines on appropriate marketing claims for products not tested on animals will be developed to "ensure that common criteria" are used for an "aligned understanding" of claims, the proposal states.