
Article 1 
Annex I to Directive 98/8/EC is amended in accordance with the Annex to this Directive.
Article 2 

1. Member States shall adopt and publish, by 30 June 2010 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.They shall apply those provisions from 1 July 2011.When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Article 3 
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
Article 4 
This Directive is addressed to the Member States.
Done at Brussels, 31 July 2009.
For the Commission
Stavros DIMAS
Member of the Commission
ANNEX

The following entry ‘No 15’ 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 provisions
‘15 alphachloralose (R)-1,2-O-(2.2,2-Trichloroethylidene)-α-D-glucofuranoseEC No: 240-016-7CAS No: 15879-93-3 825 g/kg 1 July 2011 30 June 2013 30 June 2021 14 When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, when relevant for the particular product, the populations that may be exposed to the product and the use or exposure scenarios that have not been representatively addressed at the Community level risk assessment.When granting product authorisation, Member States shall assess the risks and subsequently ensure that appropriate measures are taken or specific conditions imposed in order to mitigate the identified risks.Product authorisation can only be granted where the application demonstrates that risks can be reduced to acceptable levels.In particular, products cannot be authorised for outdoor use unless data is submitted to demonstrate that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures.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 40 g/kg.
2.. Products shall contain an aversive agent and a dye.
3.. Only products for use in tamper resistant and securely closed bait boxes shall be authorised.’

