Procedure completed
Role | Committee | Rapporteur | Shadows |
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Lead | ENVI | ROTH-BEHRENDT Dagmar (PSE) |
Legal Basis RoP 132
Activites
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1997/04/28
Final act published in Official Journal
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1997/04/08
Decision by Parliament, 1st reading/single reading
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T4-0139/1997
summary
In adopting the report by Mrs. Dagmar Roth-Behrendt (PES, D) on alternatives methods to animal experiments, Parliament deplores the fact that the Commission is considering postponing the date of implementation of the ban on the marketing of cosmetic products which have been tested on animals which was due to take effect on 1 January 1998 under Directive 93/0035/EEC. It criticises the Commission's delay in publishing its report despite the urgent need to assess developments in this area and regrets that, more than three years after the directive was adopted, the Commission is still unable to provide detailed statistics on animal experiments and that so little progress has been made in developing alternative methods. Noting that the Commission now acknowledges that the expression "combination of ingredients" does include the final product, the report calls on the Commission to: - support the ban on the marketing of cosmetic products where the product or ingredients have been tested on animals after 1 January 1998. Parliament believes that this is the only approach which will give industry and the Member States a real incentive to develop non-animal alternative tests; - ensure that any postponement of the ban is restricted to two years with clear deadlines being set; - take measures to develop and validate alternatives with research commitments to other areas including general toxicity, carcinogenicity and teratogenicity, and measures to compel industry to make a greater commitment (eg. by requiring companies conducting animal tests to pay a levy or duty); - avoid further delays in adopting valid non-animal alternatives under the pretext that they require international acceptance (this is not stipulated in Directive 93/35/EEC); - take immediate measures to enforce the requirement that Member States to collect the statistical information stipulated in Directive 93/35/EEC and produce data on the number and type of experiments carried out on animals in each Member State; - design a strategy to stimulate the development, validation and legal acceptance of alternative methods; - include R & D activities aimed at devising alternative testing methods relating to acute and chronic toxicity, carcinogenicity, teratogenicity and toxicity in reproduction in the area of cosmetics in the Fifth Research Development Framework Programme. �
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T4-0139/1997
summary
- 1997/04/07 Debate in Parliament
- 1997/01/22 Vote in committee, 1st reading/single reading
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1996/12/13
Committee referral announced in Parliament, 1st reading/single reading
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1996/07/24
Non-legislative basic document published
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COM(1996)0365
summary
OBJECTIVE: This, the Commission's second annual report (for 1995) sets out the progress achieved by the Community in the development, validation and legal acceptance of alternative methods to those involving experiments on animals in the field of cosmetic products. SUBSTANCE: The report begins with a reminder that the 1994 report (COS0235) noted limited results in this field which did not permit animal models to be replaced but could contribute to reducing the number of animals used. However, the outlook was reasonably optimistic as regards the validation of alternative methods for eye irritation, percutaneous absorption, photo toxicity/photo irritancy and basic mutagenicity tests. The results in these different areas for 1995 were as follows:- photo toxicity/photo irritancy (skin reaction after epicutaneous application of a chemical substance in the presence of UV radiation): the results of in-vitro tests have allowed considerable progress to be made and validation should be possible in the near future; - percutaneous absorption: a new guideline on in-vitro tests could be approved by the Member States and the OECD in the near future; - skin irritation: it is proposed to evaluate skin irritation on human volunteers provided prior studies on the toxic risk supply adequate guarantees; - skin sensitisation: in-vitro evaluation of skin sensation requires more in-depth research before a validation study can be considered; - eye irritation: the results were disappointing and none of the tests met the studies' objective. A more flexible approach to experimentation could be encouraged by accepting a combination of scientifically validated methods and evaluating the toxicity of the substances under consideration by comparison with appropriate benchmark substances; - photo mutagenicity (all modifications of the information content of the genetic material arising in the presence of UV radiation): recommendations have been proposed for the criteria to be adopted with a view to defining the in-vitro test protocols; - skin corrosivity: corrosive ingredients are not used in cosmetic products. However, the ECVAM (European Centre for the Validation of Alternative Methods) validation study of in-vitro tests on skin corrosivity could be used at the screening phase and provide essential information, before considering studies on human volunteers; - mutagenicity: in-vitro tests to evaluate the mutagenic potential of cosmetic ingredients are in current use. In-vivo tests are carried out only when the in-vitro test results are unsatisfactory. It will probably be impossible to replace all in-vivo tests to evaluate the systemic risks, such as tests of acute toxicity sub-chronic toxicity, carcinogenicity and toxicity of reproduction and development, in the foreseeable future. However, by refining the methods used it has already been possible to reduce substantially the number of animals used; finished cosmetic products: eye tolerance and skin tolerance of finished cosmetic products can normally be evaluated invitro provided the data relating to the ingredients' toxicity and their physio-chemical properties are known and provide the necessary guarantees. Skin compatibility (absence of skin irritation) of finished cosmetic products can be evaluated in man provided this is done in the context of strictly controlled clinical studies. It is important to emphasize that the use of human volunteers to replace animal tests must be considered with the greatest caution. Such studies should only be authorized after invitro and in-vivo tests have demonstrated that there is no risk of serious consequences; - in summary: the validation of alternative methods of evaluating percutaneous absorption and photo irritancy in the case of ingredients, and for evaluating eye tolerance and skin tolerance in the case of finished products, can be envisaged in the near future. Progress with alternative methods for evaluating eye irritation, skin irritation and skin sensitisation in relation to ingredients requires that additional studies first be carried out. The development of invitro methods in the domains involving a systemic risk is not likely in the foreseeable future, even if it might be possible to reduce the number of animals used. �
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COM(1996)0365
summary
Documents
- Non-legislative basic document published: COM(1996)0365
- Committee report tabled for plenary, single reading: A4-0017/1997
- Debate in Parliament: Debate in Parliament
- Decision by Parliament, 1st reading/single reading: T4-0139/1997
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