ANNEX
The following entry ‘No 4’ is inserted in Annex I to Directive 98/8/EC:
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 provisions3
‘4
Difethialone
3-[3-(4′-bromo[1,1′biphenyl]-4-yl)-1,2,3,4-tetrahydronaphth-1-yl]-4-hydroxy-2H-1-benzothiopyran-2-one
EC No: n/a
CAS No: 104653-34-1
976 g/kg
1 November 2009
31 October 2011
31 October 2014
14
In view of the fact that the active substance characteristics render it potentially persistent, liable to bioaccumulate and toxic, or very persistent and very liable to bioaccumulate, the active substance is to 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 in the products shall not exceed 0,0025 % w/w and only ready-for-use baits shall be authorised.
- (2)
Products shall contain an aversive agent and, where appropriate, a dye.
- (3)
Products shall not be used as tracking powder.
- (4)
Primary as well as 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 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