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Commission Directive 2010/8/EU (repealed)Show full title
Commission Directive 2010/8/EU of 9 February 2010 amending Directive 98/8/EC of the European Parliament and of the Council to include warfarin sodium as an active substance in Annex I thereto (Text with EEA relevance) (repealed)
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ANNEX
The following entry for the substance warfarin sodium is added in Annex I to Directive 98/8/EC:
| a For the implementation of the common principles of Annex VI, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm | ||||||||
| No | Common Name | IUPAC NameIdentification Numbers | Minimum purity of the active substance in the biocidal product as placed on the market | Date of inclusion | Deadline for compliance with Article 16(3)(except for products containing more than one active substance, for which the deadline to comply with Article 16(3) shall be the one set out in the last of the inclusion decisions relating to its active substances) | Expiry date of inclusion | Product type | Specific provisionsa |
|---|---|---|---|---|---|---|---|---|
| ‘33 | Warfarin sodium | Sodium 2-oxo-3-(3-oxo-1-phenylbutyl)chromen-4-olate EC No: 204-929-4 CAS No: 129-06-6 | 910 g/kg | 1 February 2012 | 31 January 2014 | 31 January 2017 | 14 | The active substance shall be subject to a comparative risk assessment in accordance with the second subparagraph of Article 10(5)(i) of Directive 98/8/EC before its inclusion in this Annex is renewed. Member States shall ensure that authorisations are subject to the following conditions: 1. the nominal concentration of the active substance shall not exceed 790 mg/kg and only ready-for-use products shall be authorised; 2. products shall contain an aversive agent and, where appropriate, a dye; 3. primary and secondary exposure of humans, non-target animals and the environment are minimised, by considering and applying all appropriate and available risk mitigation measures. These include, amongst others, the possibility of restriction to professional use only, setting an upper limit to the package size and laying down obligations to use tamper resistant and secured bait boxes.’ |
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