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 provisions^a
‘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.’

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

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 provisions^a

‘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

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:

the nominal concentration of the active substance shall not exceed 790 mg/kg and only ready-for-use products shall be authorised;

products shall contain an aversive agent and, where appropriate, a dye;

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.’