# Commission Directive 2013/3/EUShow full title

Commission Directive 2013/3/EU of 14 February 2013 amending Directive 98/8/EC of the European Parliament and of the Council            to extend the inclusion in Annex I thereto of the active substance thiamethoxam to product-type 18 (Text with EEA relevance)         

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U.K.

# Commission Directive 2013/3/EU                     

# of 14 February 2013

# amending Directive 98/8/EC of the European Parliament and of the Council to extend the inclusion in Annex I thereto of the                        active substance thiamethoxam to product-type 18                     

# (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 thiamethoxam.

(2)Commission Directive 2008/77/EC of 25 July 2008 amending Directive 98/8/EC of the European Parliament and of the Council to                              include thiamethoxam as an active substance in Annex I thereto(3) included thiamethoxam as an active substance in Annex I to Directive 98/8/EC for use in product-type 8, wood preservatives,                              as defined in Annex V to Directive 98/8/EC.

(3)Pursuant to Regulation (EC) No 1451/2007, thiamethoxam has now 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.

(4)Spain was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation,                              to the Commission on 2 March 2009 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.

(5)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.

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

(7)Not all potential uses have been evaluated at Union level. For example, neither outdoor use, nor use by non-professional users                              were assessed. It is therefore appropriate 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.

(8)In the light of the unacceptable risks identified for professional users in the brushing application scenario, it is appropriate                              to require that products are not authorised for such uses, unless data are submitted demonstrating that the product will meet                              the requirements of both Article 5 of and Annex VI to Directive 98/8/EC, if necessary by the application of appropriate risk                              mitigation measures.

(9)In the light of the risks identified for the aquatic and terrestrial ecosystems when products were emitted via a sewage treatment                              plant or directly to surface water, it is appropriate to require that products are not authorised for such uses, unless data                              are submitted demonstrating that the product will meet the requirements of both Article 5 of and Annex VI to Directive 98/8/EC,                              if necessary by the application of appropriate risk mitigation measures.

(10)In the light of the risks identified in several scenarios of use without personal protective equipment, it is appropriate                              to require that products authorised for professional use be used with such equipment, unless it can be demonstrated in the                              application for product authorisation that risks to professional users can be reduced to an acceptable level by other means.

(11)In the light of the possible indirect human exposure via consumption of food as a result of those uses presented in the assessment                              report, 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). Measures should be adopted ensuring that the applicable maximum residue levels are not exceeded.

(12)In view of the risks identified for the environment, it is appropriate to require that product authorisations are subject                              to appropriate risk mitigation measures for the protection of honey bees.

(13)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 containing the active substance thiamethoxam and also to facilitate the proper operation                              of the biocidal products market in general.

(14)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.

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

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

(17)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.

(18)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, 14 February 2013.

*For the Commission*                            

*The President*                            

José Manuel Barroso                            

## ANNEXU.K.

In Annex I to Directive 98/8/EC, the following is added to entry No 14:

1

OJ L 123, 24.4.1998, p. 1.                           

2

OJ L 325, 11.12.2007, p. 3.                           

3

OJ L 198, 26.7.2008, p. 41.                           

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.