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| Ecopa Working Groups position on the EU White Paper Strategy for a Future EU Chemicals Policy and The 6th Framework Programme of the European Community for Research, Technological Development and Demonstration |
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| 1. |
The White Paper proposes a policy aimed at hazard identification via prescriptive testing requirements. In order to promote better science and to eliminate unnecessary animal tests, ecopa strongly encourages the philosophy of targeted risk assessments for all chemicals, taking full account of alternative methods. Clear guidance is needed from the Commission to facilitate the estimation of exposure data for the purposes of risk assessment. This will allow for reduction in animal testing, and more targeted testing when compared to hazard identification.
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| 2. |
The Commission and Member States should make every effort to make publicly accessible all information available on existing chemicals, also by providing adequate resources.
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| 3. |
The provisions of 86/609/EEC should be fully considered by the regulator when requiring animal testing. Therefore, the regulator and legislator should exhaust all other options, according to the 3Rs principle, prior to stating a requirement for animal testing.
Guidelines should be developed on how existing data can be collated, presented and interpreted to ensure regulatory acceptance in place of hazard assessment data.
The regulator must provide clear guidance on how these non-validated historical data will be accepted. Examples include human experience, occupational exposure, environmental monitoring etc. All existing information should be incorporated into the risk assessment.
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| 4. |
Scope should be given for the use and regulatory acceptance of non-validated, but scientifically sound and standardized alternative methods to animal testing. Not only methodology such as QSARs or computer modelling, might provide data relevant to risk assessment but also 3R-methodology shown to be valid and relevant for e.g. a group of compounds or a substance class.
Guidance should be given on how such data could be considered in the risk assessment strategy in order to target risk assessment and reduce the need for prescriptive animal tests.
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| 5. |
ECVAM is in the process of publishing a detailed report on the current status and future prospects of alternative methods in the context of the White Paper. However, the ecopa Working Group on Chemicals and the ecopa Working Group on the 6th Framework Programme do not believe that within the next five years, alternative methods will be available for most if not all endpoints. More basic research is needed at all levels to develop alternative methods. Because of the numerous animal experiments requested by the proposals in the White Paper, it is of outmost importance that greater consideration should be given for substantial funding of research on alternative methods within the 6th Framework Programme e.g. by providing at least 20 million euro, as claimed by ecopa already before.
Also clear schemes and transparent, expedited processes should be developed for the regulatory acceptance of validated alternative methods, as such currently envisaged by the OECD. Ambitious timings have been proposed in the White Paper, for the use of alternative methods which do not currently exist. It is therefore the obligation and duty of the Commission to fund the research required to develop these methods.
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| 6. |
To arrive at a new approach to generate relevant data for these risk assessments, full account should be taken of recent technological advances in the fields of genomics, toxicogenomics etc. New models to predict toxicity in humans should be developed rather than the continued use of surrogate animal systems. |
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