# Commission Directive 2013/44/EUShow full title

Commission Directive 2013/44/EU of 30 July 2013 amending Directive 98/8/EC of the European Parliament and of the Council to            include powdered corn cob as an active substance in Annexes I and IA thereto (Text with EEA relevance)         

        - Previous
        - Next

U.K.

# Commission Directive 2013/44/EU                     

# of 30 July 2013

# amending Directive 98/8/EC of the European Parliament and of the Council to include powdered corn cob as an active substance                        in Annexes I and IA 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 powdered corn cob.

(2)Pursuant to Regulation (EC) No 1451/2007, powdered corn cob has been evaluated in accordance with Article 11(2) of Directive                              98/8/EC for use in product-type 14, rodenticides, as defined in Annex V to that Directive.

(3)Greece was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation,                              to the Commission on 22 October 2009 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.

(4)The competent authority report was reviewed by the Member States and the Commission with the involvement of the applicant.                              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)The assessment report concludes that biocidal products used as rodenticides and containing powdered corn cob may be expected                              to satisfy the requirements laid down in Article 5 of Directive 98/8/EC, and therefore recommends the inclusion of powdered                              corn cob for use in product type 14 in Annex I to that Directive. It is appropriate to follow that recommendation.

(6)The assessment report also concludes that biocidal products used as rodenticides and containing powdered corn cob may be expected                              to present only low risk to humans, non-target animals and the environment, in particular with regard to the use which was                              examined and detailed in the assessment report, that is, when used in the form of pellets in dry locations. The report therefore                              recommends the inclusion of powdered corn cob for that use in Annex IA to Directive 98/8/EC. It is appropriate to follow that                              recommendation.

(7)In accordance with current practice, and in compliance with Article 10(1) of Directive 98/8/EC, it is appropriate to limit                              the duration of the inclusion to 10 years.

(8)Not all potential uses and exposure scenarios have been evaluated at Union level. 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.

(9)The provisions adopted pursuant to 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 14 containing the active substance powdered corn                              cob and also to facilitate the proper operation of the biocidal products market in general.

(10)A reasonable period should be allowed to elapse before an active substance is included in Annex I and Annex IA 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.

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

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

(13)In accordance with the Joint Political Declaration of 28 September 2011 of Member States and the Commission on explanatory                              documents(3), 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.

(14)The Committee established by Article 28(1) of Directive 98/8/EC has not delivered an opinion on the measures provided for                              in this Directive, and the Commission therefore submitted to the Council a proposal relating to the measures and forwarded                              it to the European Parliament. The Council did not act within the two-month period provided for by Article 5a of Council Decision                              1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(4), and the Commission therefore submitted the proposal to the European Parliament without delay. The European Parliament did                              not oppose the measure within four months from the abovementioned forwarding,

HAS ADOPTED THIS DIRECTIVE:

# Article 1U.K.

Annexes I and IA to Directive 98/8/EC are 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 forthwith communicate to the Commission the text of those provisions.                  

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, 30 July 2013.

*For the Commission*                            

*The President*                            

José Manuel Barroso                            

## ANNEXU.K.

### (1)In Annex I to Directive 98/8/EC, the following entry is added:U.K.

### (2)In Annex IA to Directive 98/8/EC, the following entry is added:U.K.

1

OJ L 123, 24.4.1998, p. 1.                           

2

OJ L 325, 11.12.2007, p. 3.                           

3

OJ C 369, 17.12.2011, p. 14.                           

4

OJ L 184, 17.7.1999, p. 23.