# Commission Directive 2013/6/EUShow full title

Commission Directive 2013/6/EU of 20 February 2013 amending Directive 98/8/EC of the European Parliament and of the Council            to include diflubenzuron as an active substance in Annex I thereto (Text with EEA relevance)         

        - Previous
        - Next

U.K.

# Commission Directive 2013/6/EU                     

# of 20 February 2013

# amending Directive 98/8/EC of the European Parliament and of the Council to include diflubenzuron as an active substance in                        Annex I thereto                     

# (Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing                           of biocidal products on the market(1), and in particular the second subparagraph of Article 16(2) thereof,                        

Whereas:

(1)Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in                              Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products                              on the market(2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive                              98/8/EC. That list includes N-[[(4-chlorophenyl)amino]carbonyl]-2,6-difluorobenzamide, which is a synonym for diflubenzuron.

(2)Pursuant to Regulation (EC) No 1451/2007, diflubenzuron has been evaluated in accordance with Article 11(2) of Directive 98/8/EC                              for use in product-type 18, insecticides, acaricides and products to control other arthropods, as defined in Annex V to that                              Directive.

(3)Sweden was designated as rapporteur Member State and submitted the competent authority report, together with a recommendation,                              to the Commission on 19 November 2007 in accordance with Article 10(5) and (7) of Commission Regulation (EC) No 2032/2003                              of 4 November 2003 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of                              the European Parliament and of the Council concerning the placing of biocidal products on the market, and amending Regulation                              (EC) No 1896/2000(3).

(4)The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation                              (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 21                              September 2012, in an assessment report.

(5)It appears from the evaluations that biocidal products used as insecticides, acaricides and products to control other arthropods                              and containing diflubenzuron may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is                              therefore appropriate to include diflubenzuron for use in product-type 18 in Annex I to that Directive.

(6)Not all potential uses and exposure scenarios have been evaluated at Union level. For example, outdoor use, use by non-professionals,                              and exposure of livestock were not assessed. It is therefore appropriate to require that Member States assess 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 and, when granting product authorisations, ensure that appropriate measures are                              taken or specific conditions imposed in order to reduce the identified risks to acceptable levels.

(7)In the light of the findings in the assessment report that there is a possible indirect human exposure via consumption of                              food as a result of those uses represented in the assessment, it is appropriate to require, where relevant, verification of                              the need to set new or to amend existing maximum residue levels in accordance with Regulation (EC) No 470/2009 of the European                              Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically                              active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC                              of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council(4) or with Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue                              levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC(5). Special consideration should be given to the *in vivo* genotoxic metabolite PCA. Measures should be adopted ensuring that the applicable maximum residue levels are not exceeded.

(8)In view of the assumptions made during the risk assessment, it is appropriate to require that professional users of products                              containing diflubenzuron wear appropriate personal protective equipment, unless it can be demonstrated in the application                              for product authorisation that risks to workers and operators can be reduced to an acceptable level.

(9)In view of the risks identified for the environment, it is appropriate to require, unless it can be demonstrated in the application                              for product authorisation that risks to the aquatic and terrestrial ecosystems can be reduced to an acceptable level, that                              products are not authorised in water systems, and that products authorised for use on manure are only used on dry manure,                              which has to undergo complete aerobic composting prior to application of the manure on arable land.

(10)The provisions of this Directive should be applied simultaneously in all Member States in order to ensure equal treatment                              on the Union market of biocidal products of product-type 18 containing the active substance diflubenzuron and also to facilitate                              the proper operation of the biocidal products market in general.

(11)A reasonable period should be allowed to elapse before an active substance is included in Annex I to Directive 98/8/EC, in                              order to permit Member States and interested parties to prepare themselves to meet the new requirements entailed and to ensure                              that applicants who have prepared dossiers can benefit fully from the 10-year period of data protection, which, in accordance                              with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from the date of inclusion.

(12)After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC.

(13)Directive 98/8/EC should therefore be amended accordingly.

(14)In accordance with the Joint Political Declaration of 28 September 2011 of Member States and the Commission on explanatory                              documents(6), Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one                              or more documents explaining the relationship between the components of a directive and the corresponding parts of national                              transposition instruments.

(15)The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS DIRECTIVE:

# Article 1U.K.

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

# Article 2U.K.

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 3U.K.

This Directive shall enter into force on the twentieth day following that of its publication in the *Official Journal of the European Union*.                  

# Article 4U.K.

This Directive is addressed to the Member States.

Done at Brussels, 20 February 2013.

*For the Commission*                            

*The President*                            

José Manuel Barroso                            

## ANNEXU.K.

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

1

OJ L 123, 24.4.1998, p. 1.                           

2

OJ L 325, 11.12.2007, p. 3.                           

3

OJ L 307, 24.11.2003, p. 1.                           

4

OJ L 152, 16.6.2009, p. 11.                           

5

OJ L 70, 16.3.2005, p. 1.                           

6

OJ C 369, 17.12.2011, p. 14.