Substance Approval and Product Authorisation Renewals of the Anticoagulant Rodenticides

CA-Feb13-Doc.5.2.b - Final

SUBSTANCE APPROVAL AND PRODUCT AUTHORISATION RENEWALS OF THE ANTICOAGULANT RODENTICIDES

At the 47th, 48thand 49thCA meetings, discussions took place concerninga proposal to streamline the renewal of substance approvals and product authorisations of anticoagulant rodenticides. Even though some concerns were expressed regarding the expected workload, the Commission noted a large support for the proposal.

Following the 49th CA meeting, only a few comments were received. Having considered them, the Commission proposes to maintain the approach already proposed, as described thereafter.

It is also important to recall that the Commission services have commissioned a state-of-the-art and independent report on risk mitigation measures that may be applied to anticoagulant rodenticideswhich purpose is to compare the properties and risks of the different anticoagulant rodenticides and to propose a series of risk mitigation measures for all anticoagulant rodenticides. The conclusions of this work should be available in June 2014.

The purpose of this proposal is therefore to also make sure that the conclusions of this report can be taken into consideration at the time of renewing substance approvals and product authorisations of anticoagulant rodenticides.

Concerning the application for renewal of the active substances

(1)Inclusion Directives of anticoagulant rodenticides state that a "comparative assessment" shall be done in accordance with the second subparagraph of Article 10(5)(i) of Directive 98/8/EC[1] before Annex inclusions can be renewed. This "comparative assessment" is different that the one established in article 23 of the BPR which concerns only the comparative assessments of biocidal products. Nevertheless, the intention of this specific provision in the inclusion directives of anticoagulant rodenticides was to compare these substances, and one of the objectives of the proposal is indeed to be able to make this comparison, taking into account the conclusions of the report on risk mitigation measures that may be applied to anticoagulant rodenticides, in order to decide if the approval of each active substance should be renewed, and with additional specific provisions where appropriate.

(2)Applications for active substance approval renewal should therefore be processed in parallel. The first applications received would as a consequence have to be put on hold until the last ones are submitted in July 2015. Member states should therefore suspend the assessment of these first applications on the basis of Article 14(2) of the BPR.

(3)At the time of the submission, applicants should submit elements requested under article 13(2) of the BPR. Nonetheless, until the results of thestudy on risk mitigation measures that may be applied to anticoagulant rodenticides are available, ECHA and evaluating MSs should be flexible concerning the acceptance and the validation of these applications with regards to their content.

(4)According to BPR, applicants shall submit their application for renewal of approval of their substance at the latest 550 days before the expiry date of inclusion.

(5)For difethialone, if the BPR was already into application, applicants would have to submit their application before 29/04/2013. It is therefore proposed that the applicants submit their applicationas soon as possible after 1st September 2013.

(6)During the suspension of the assessment andonce the conclusions of the reporton risk mitigation measures that may be applied to anticoagulant rodenticideswill be available, applicants for difethialone and difenacoum approval renewal should be given the opportunity to amend their application for renewal to address the conclusions of this report.

(7)With regards to fees, the application fee payable to ECHA should be paid when applications are submitted in accordance with Article 13(3) of the BPR. As applications will be afterwards be put on hold by Member States, Member States may consider asking applicants to pay the evaluation fee only when they will really start to evaluate the application.

(8)The Commission services would also ensure that the expiry dates of the different substances approval would be postponed for a period sufficient to complete the exercise, in accordance with the provisions of Article 14(5) of the BPR.

(9)In addition, ECHA will play an important role in the renewal of these substances, firstly by coordinatingthe assessment to be carried out by the different evaluating Competent Authorities and ensuring that the conclusions of the report on risk mitigation measures that may be applied to anticoagulant rodenticidesare duly taken into consideration during that exercise; secondly by collecting information on possible available substitutesin accordance with Article 5(2) 2nd paragraph and Article 10(3) of the BPR, to be taken into account by the BPC in its opinion.

Concerning the applications for renewal of product authorisations

(1)According to Article 23 of the BPRa comparative assessment shall be carried out for products containing substances, that are candidates for substitution, before such products can be authorised or their authorisations renewed. This is likely to be the case of all anticoagulant rodenticides. Another objective of the proposal is to be able to make one single comparative assessment of the different products used as anticoagulant rodenticides (either at Member State level or at EU level, see below), based on the conclusions of the report on risk mitigation measures that may be applied to anticoagulant rodenticides.

(2)The current practice under the BPD is to set the expiry date of authorisation on the exact expiry date of the Annex I inclusion of the active substance contained in the product (or earliest expiry date when the product contains several active substances). The deadline for submission of the applications for renewal of a product authorisation is therefore triggered by its active substance(s), and is the same as the deadline for submission of application for renewal of approval of the active substance.

(3)Applicants shall thus submit their application for renewal of product authorisation at the latest 550 days before the expiry date of their authorisation, and as a consequence for authorisations given so far under the BPD, 550 days before the expiry date of inclusion of the active substance.

(4)For difethialone-containingproduct, if the BPR was already into application, applicants would have to submit their applications before 29/04/2013. It is therefore proposed that the applicants submit their applicationsas soon as possible after 1st September 2013.

(5)As the last applications for product authorisation renewal would be submitted in July 2015, the assessment of applications received before would have to be put on hold until the last ones are received, so that they can then all be processed in parallel. In accordance with the provisions of Articles 30(2) and 31(7) of the BPR, Member States could put on hold the assessment of the applications received for the renewal of the product authorisations and grant a renewal for the period necessary to complete the evaluation. Derogations obtained in accordance with Article 4(4) of BPD would remain valid during that period.

(6)At the time of the submission, applicants should submit elements requested under article 31(3) of the BPR. Nonetheless, until the results of thestudy on risk mitigation measures that may be applied to anticoagulant rodenticides are available, ECHA and evaluating MSs should be flexible concerning the acceptance and the validation of these applications with regards to their content.

(7)During the suspension of the assessment and once the conclusions of the report on risk mitigation measures that may be applied to anticoagulant rodenticideswill be available, applicants for difethialone- and difenacoum-containingproduct authorisationrenewal should be given the opportunity to amend their application for renewal to address the conclusions of this report.

(8)With regards to fees, as applications are expected to be put on hold by Member States until the outcome of the substance approval renewal is known, Member States may consider asking applicants to pay the fee only when they will really start to evaluate the application.

(9)Lastly, regarding the comparative assessment to be performed at the renewal of product authorisations, as this comparative assessment would involve questions, which, by reason of their scale, could be better addressed at the Union level, Member States should refer the matter to the Commission in accordance with Article 23(5), rather than to conduct 27 times the same exercise in parallel.

Appendix – List of anti-coagulant rodenticides

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[1] Article 10(5)(i) of Directive 98/8/EC ; "[…] an assessment of an alternative active substance or substances shall take place to demonstrate that it can be used with similar effect on the target organism without significant economic and practical disadvantages for the user and without an increased risk for health or for the environment"