L_2013044EN.01000601.xml
| 15.2.2013 | EN | Official Journal of the European Union | L 44/6 |
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. |
| (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, |
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