
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 September 2013 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.They shall apply those provisions from 1 October 2014.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 twentieth day following that of its publication in the Official Journal of the European Union.
Article 4 
This Directive is addressed to the Member States.
Done at Brussels, 26 November 2012.
For the Commission
The President
José Manuel BARROSO
ANNEX

The following is added to entry ‘No 41’ 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
    ‘1 October 2014 30 September 2016 30 September 2024 2 When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, where relevant for the particular product, those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment.Member States shall ensure that authorisations of products for non-professional use are subject to the packaging being designed to minimise user exposure, unless it can be demonstrated in the application for product authorisation that risks for human health can be reduced to acceptable levels by other means.’

