Development and Validation of Non-animal Tests and Testing Strategies: The Identification of a Coordinated Response to the Challenge and the Opportunity Presented by the Sixth Amendment to the Cosmetics Directive <i>(76/768/EEC)</i>

This paper presents a personal perspective on efforts during the past 15 years to replace animal testing for assessing the safety of chemicals and products. It is based on an invited lecture -the FRAME Annual Lecture -given in October 2005, with the theme of "making progress by working together" (government-industry-academia-NGOs). Where we have achieved some successes, these have clearly been due to effective cooperation and collaboration between the relevant stakeholders. In recent times, there has not been this same level of active commitment and coordination. This needs to change, since, if we are to make good progress in the years to come in responding to the new challenges of the EU policy to replace animal testing, this will undoubtedly require us to work together, hopefully facilitated by effective leadership and coordination from the EU policy-makers themselves.

Section: Stage 2: 1995-1999mentioning

confidence: 99%

Working Together to Respond to the Challenges of EU Policy to Replace Animal Testing

Fentem

2006

“…The European Centre for the Validation of Alternative Methods (ECVAM) chose the replacement of animal testing for cosmetics as one of its priority areas for action. In 1995, ECVAM organised an initial workshop on the development and validation of non-animal tests and testing strategies for the identification of a coordinated response to the challenge and the opportunities presented by the Sixth Amendment to the Cosmetics Directive (6). As a follow-up to this workshop, several other workshops (e.g.…”

Section: The Impact Of the Announced Marketing Ban On The Developmentmentioning

confidence: 99%

“…Another example is the outcome of previous validation studies for eye irritation testing. One of the main reasons that they failed is that the results gained from the Draize eye irritation test on rabbits are of such poor quality (6,15,20,21). These examples clearly demonstrate that major problems that arise during the validation of alternative methods are caused by defaults of animal experiments.…”

Section: The Impact Of the Announced Marketing Ban On The Developmentmentioning

confidence: 99%

EU Sales Ban on New Cosmetics Tested on Animals: Impact on Alternative Methods, WTO Implications and Animal Welfare Aspects

I¹

2004

In 1993, the European Union (EU) adopted Directive 93/35/EEC, calling for a sales ban on new cosmetic products containing ingredients tested on animals after 1 January, 1998, provided that alternative methods had been developed by then. In May 2000, for the second time, the European Commission postponed that ban. The Commission justified the repeated postponement of the sales ban by saying that no animal-free methods were available, although three in vitro methods were scientifically approved in 1997. With three years delay, these methods have been published and therefore “made available” in the EU. OECD acceptance is still awaited. Another reason for the postponement was the fear of possible World Trade Organisation (WTO) conflicts. However, according to WTO rules, the protection of public morality or animal health could justify a restriction of the free trade principle. From the animal welfare point of view, an unqualified EU sales ban, combined with an animal testing ban, would provide the incentive to further promote the development and acceptance of alternative methods and to prove that ethical standards are legitimate concerns under WTO rules.

“…However, the evolving strategy did not completely ignore the minefield of ocular toxicology. Appropriate resources, both monetary and intellectual, were channelled in that direction by ECVAM, and they resulted in extremely helpful contributions (15)(16)(17).…”

Section: Ecvam's Influence On the Search For Ocular Safety Testing Almentioning

confidence: 99%

“…We see many companies making an extraordinary effort to use in vitro methods within their ocular safety or product development programmes. Recently, several of these efforts have been presented to the toxicology community through poster presentations at annual meetings (9)(10)(11)(12)(13)(14)(15)(16)(17)(18)(19)(20)(21). I estimate that thousands of new products and materials are tested worldwide each year in in vitro eye irritation studies, with only a tiny fraction of the results being reported.…”

Section: Are In Vitro Ocular Irritation Tests Actually Being Used?mentioning

confidence: 99%

Ocular Safety: A Silent (In Vitro) Success Story

Curren

Harbell

2002

Ocular irritation testing has been one of the animal test methods most criticised by animal welfare advocates. Additional criticism has arisen from within the scientific community, based on the variability of the animal test results and the questionable relevance of the extremely high dose levels employed. As a result, the Draize eye irritation test has been one of the main targets for in vitro replacement. Despite extensive efforts, however, there is still no in vitro method that is fully validated as a regulatory replacement. In spite of this, many individual companies are using diverse in vitro ocular irritation tests to gain important safety and efficacy information about their products and raw materials, eliminating the need for animal testing in the process. This is done in a safe fashion by applying intelligent testing paradigms. ECVAM has played a major role in this success, through its many programmes that have emphasised the importance of understanding the true toxicological need, and then using in vitro tests to provide that information. Thus, even in the absence of a successfully validated regulatory assay, the desired result of reducing animal testing is being met.