Applicability of new data requirements to applications for authorisation of plant protection products
SCC has learnt that the legal services of the European Commission informed Member State authorities that the current understanding of the applicability of the new data requirements for product authorisations cannot be upheld.
The interpretation of article 4 of COMMISSION REGULATION (EU) No 284/2013 that Regulation (EU) No 545/2011 (i.e. the old data requirements) continued to apply only, where the respective application for product authorisation is submitted prior to 31 December 2015. The Commission stipulates now that this condition only holds for plant protection product applications, containing an active substance for which a dossier or supplementary dossier has been submitted prior to 31 December 2013, as is stated in the second part of article 4 (i.e. AIR 2 a.s.).
If the condition on active substance dossier submission is not fulfilled (i.e. for all AIR 3 a.s.), COMMISSION REGULATION (EU) No 284/2013 (i.e. the new data requirements) applies for all applications for product authorisations submitted as of 1 January 2014!
Summarising the above, the old data requirements continue to apply, only to applications for authorisation of plant products containing at least one AIR 2 a.s. (alone or in mixtures), if the application is submitted prior to 1 January 2016. In all other cases the new data requirements must be observed.
The legal services of the Member States are currently examining the view of the Commission.
Renewal of Authorisations according to Article 43 of Regulation (EC) No 1107/2009 (SANTE/2010/13170 rev. 13)
The application should include any new product data which are required due to new endpoints or criteria. The published Renewal Assessment Report is to be used to be aware of tests and studies. The EFSA conclusion shows where critical endpoints have been changed in the active substance renewal procedure.
Changes concerning authorised uses (e.g. amendment of the GAP) are only acceptable where it is necessary to comply with changes in the assessment of the active substance (e.g. new endpoints or restrictions). One exception is a non-significant formulation change according to SANCO/12638/2011.
Before the application, the so called “pre-notification-form” (as summarised in SANCO/12544/2014) is to be provided by the authorisation holder to the concerned Member State(s). A new outcome of this Guidance document is that the “pre-notification-form” should be submitted by the deadline for the submission of the supplementary dossier for the renewal of the active substance. An updated version should be submitted within 2 months following the publication of the EFSA-conclusion.
For the application to renew the authorisation, the EU PPP Application Management System is to be used. After every step in the procedure, it should be updated by the applicant or the concerned Member State.
NEW EU LIST OF CANDIDATES FOR SUBSTITUTION
PESTICIDES: EXPERTS ENDORSE NEW EU LIST OF CANDIDATES FOR SUBSTITUTION
A Commission proposal to establish an EU list of 77 candidates for substitution was endorsed on 27 January 2015 by EU Member State experts. Candidates for substitution (CfS) are pesticides for which national authorities need to carry out an assessment to establish whether more favorable alternatives to using the plant protection product exist, including non-chemical methods. The aim is to encourage more sustainable crop protection.
Please refer to http://europa.eu/rapid/press-release_MEMO-15-3743_en.htm for further information.