
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 31 January 2014 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.They shall apply those provisions from 1 February 2015.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, 20 February 2013.
For the Commission
The President
José Manuel BARROSO
ANNEX

In Annex I to Directive 98/8/EC, the following entry is added:

No Common Name IUPAC NameIdentification Numbers Minimum degree of purity of the active substance Date of inclusion Deadline for compliance with Article 16(3), unless one of the exceptions indicated in the footnote to this heading applies Expiry date of inclusion Product type Specific provisions
‘63 diflubenzuron 1-(4-chlorophenyl)-3-(2,6-difluorobenzoyl)ureaEC No: 252-529-3CAS No: 35367-38-5 960 g/kg 1 February 2015 31 January 2017 31 January 2025 18 The Union level risk assessment did not address all potential uses and exposure scenarios; certain uses and exposure scenarios, such as outdoor use, use by non-professionals, and exposure of livestock were excluded. 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.For products containing diflubenzuron that may lead to residues in food or feed, Member States shall verify the need to set new or to amend existing maximum residue levels (MRLs) in accordance with Regulation (EC) No 470/2009 or Regulation (EC) No 396/2005, with special consideration to the in vivo genotoxic metabolite PCA, and take any appropriate risk mitigation measures ensuring that the applicable MRLs are not exceeded.Member States shall ensure that authorisations are subject to the following conditions unless it can be demonstrated in the application for product authorisation that the risks can be reduced to an acceptable level:
((1)) Professional users shall wear appropriate personal protective equipment.
((2)) Product information shall include the requirement that products shall only be used on dry manure, and that the manure must undergo complete aerobic composting by professionals prior to application on arable land.
((3)) Products shall not be used in water systems.’



