Considerations on COM(2013)46 - Amendment of Directive 98/8/EC to include powdered corn cob as an active substance in Annexes I and IA thereto - Main contents
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| dossier | COM(2013)46 - Amendment of Directive 98/8/EC to include powdered corn cob as an active substance in Annexes I and IA thereto. |
|---|---|
| document | COM(2013)46  |
| date | February 5, 2013 |
(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 ten 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 Member States and the Commission of 28 September 2011on explanatory documents[4], 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.