(Utkast) Kommisjonens gjennomføringsbeslutning om etablering av et arbeidsprogram for vurdering av søknader om forlengelse av godkjenningene til aktive stoffer med utløpsdato i 2022, 2023 og 2024 i henhold til europaparlaments- og rådsforordning (EF) nr. 1107/2009
(Draft) Commission Implementing Decision on the establishment of a work programme for the assessment of applications for the renewal of approvals of active substances expiring in 2022, 2023 and 2024 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council
Utkast til kommisjonsbeslutning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 16.6.2018
BAKGRUNN (fra kommisjonsbeslutningen, engelsk utgave)
(1) A large number of active substances approved under Regulation (EC) No 1107/2009 and listed in Parts B and E of the Annex to Commission Implementing Regulation (EC) No 540/2011 have an expiry date set between 1 January 2022 and 31 December 2024. Part C of the Annex to Commission Implementing Regulation (EU) No 686/2012 lists those active substances and allocates to the Member States the evaluation of those active substances, naming for each active substance a rapporteur and a co-rapporteur Member State for the purposes of the renewal procedure.
(2) In view of the time and resources necessary for completing the assessment of applications for the renewal of approvals of the active substances concerned by the Member States and by the European Food Safety Authority (the Authority), it is necessary to establish a work programme grouping together similar active substances and setting priorities on the basis of safety concerns for human and animal health or the environment as provided for in Article 18 of Regulation (EC) No 1107/2009.
(3) It is appropriate to provide for the identification of substances, for which, given their properties, it is expected that they may fail to satisfy the approval criteria set out in points 3.6.2 to 3.6.5 and point 3.7 of Annex II to Regulation (EC) No 1107/2009 and to prioritise their assessment.
(4) Among the active substances listed in Part C of the Annex to Implementing Regulation (EU) No 686/2012 it is appropriate to identify those substances that are listed in Part E of the Annex to Regulation (EC) No 540/2011 as candidates for substitution, for which, given their properties, the approval periods do not exceed seven years. It is also appropriate to identify substances that are listed in the Annex to Commission Implementing Regulation 2015/408 as candidates for substitution. The programme should prioritise their assessment.
(5) Active substances fluxapyroxad, bixafen, sedaxane, penflufen and penthiopyrad share similar properties. Active substances disodium phosphonates and potassium phosphonates share similar properties. The active substances eugenol, geraniol and thymol share similar properties. The active substances Trichoderma atroviride (strain I 1237) and Trichoderma asperellum (strain T34) share similar properties. The active substances benzovindiflupyr and isopyrazam also share similar properties. As it is appropriate to align the timing of the assessment and the peer-review process carried out by the Authority of substances with similar properties, the dossiers for these substances should be submitted to their respective rapporteur Member States within the same time frame.
(6) Given the available resources of the authorities conducting the assessment of applications for the renewal of approvals, it cannot be excluded that as a result of the prioritisation of the assessment of substances provided for by this Decision the approval of some other active substances may expire before a decision has been taken on the renewal of the approval of such substances. In such cases, the approval period of such active substances should be extended in due time in accordance with Article 17 of Regulation (EC) No 1107/2009.
(7) In addition to providing for the grouping together of similar active substances based on priorities for their assessment, Article 18 of Regulation (EC) No 1107/2009 also provides that the work programme is to include specific elements. Commission Implementing Regulations (EU) No 844/2012 and (EU) No 686/2012 are, respectively, implementing points (a) to (e) and point (f) of the second paragraph of Article 18 of Regulation (EC) No 1107/2009.
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