|Written by DPR Biocides - Anses|
|Friday, 09 April 2010 16:05|
- Regulatory reference texts:
- The name of the product,
- The research and development authorisation number,
- The name, address and telephone number of the authorisation holder,
- The labelling in accordance with the Ministerial Order of 20 April 1994,
- Any other precautions of use or contraindications, if relevant, appearing on the authorisation decision,
- The claimed product type,
- The specific statement "product for experimental use only".
4 months with the possibility of a suspension of the evaluation if additional information is necessary
- Validity of the authorisation:
2 years renewable, for limited quantities.
- Fees payable to ANSES:
- Composition of the dossier:
- Manufacturing site.
- Contact details of the user(s).
- Quantities required for production research and development operations and justification of these quantities.
- The research and development programme. If relevant, surface of the area to be treated.
- Undertaking that the biocidal substance or product will only be handled by personnel of the users and will not be available to the public.
- Spectral and analytical data.
- Available information on the physico-chemical, toxicological and ecotoxicological properties.
- Proposal for classification and labelling with, if necessary, the notice "Caution: substance not yet fully tested".
If no physico-chemical, toxicological or ecotoxicological data is available in the dossier from the applicant, the Minister shall determine, on a case-by-case basis, the information to be provided taking into account the following points:
|Last Updated on Friday, 25 March 2011 16:12|