Application of the principle of mutual recognition on authorisations of plant protection products

In the following answer to a Member of the EU Parliament, the EU Commission did a useful recap of the applicable regime in the sector, quoting an ever useful guidance from 2014 about zonal evaluation and mutual recognition under of plant protection products under Regulation (EC) No 1107/2009.

Question for written answer to the Commission -12th February 2020

Regulation (EC) No 1107/2009 recognises the principle of mutual recognition and provides that a Member State must accept authorisations granted by another Member State if agricultural, plant-health and environmental conditions are comparable. However, in some Member States, the competent authorities for the evaluation and authorisation of plant protection products do not accept applications for mutual recognition for the following reasons: (i) guidance documents are followed which were not available at the time of submission of the application, without allowing the applicant to adapt, modify or improve the documentation; (ii) a re-evaluation in accordance with national requirements is launched; (iii) risk mitigation and refining measures, which were accepted in applications for zonal evaluation, are not accepted; or (iv) the final report has not been not registered and published by the Member State on CIRCA BC.

All of these factors call into question the assessment made by other countries and the harmonisation aimed for by the Regulation with this principle.

Is there any provision or guidance by the Commission which could facilitate the application of mutual recognition in the Member States?

Are any concrete improvements in the application of mutual recognition in the Member States foreseen under REFIT?

Answer given by Ms Kyriakides on behalf of the European Commission – 22nd April 2020

The principle of mutual recognition is enshrined in Regulation (EC) No 1107/2009 and is built on the assumption that the assessment done by one Member State shall not be repeated by other Member States when recognising an authorisation.

However, Member States may refuse to authorise a plant protection product in their territory, where justified as a result of specific environmental or agricultural circumstances or where the high level of protection of both human and animal health and the environment required by this regulation cannot be achieved.

Article 77 of Regulation (EC) No 1107/2009 provides that the Commission may, in accordance with the advisory procedure referred to in Article 79(2), adopt or amend technical and other guidance documents for the implementation of the regulation. The Commission has used this provision to adopt a guidance document on zonal evaluation and mutual recognition, which explains how the provisions on mutual recognition should be applied by Member States.

The guidance document addresses, among others, timelines, common procedures after the zonal assessment, as well as reporting and exchange of information on authorisations.

The REFIT evaluation of the pesticides legislation, which is expected to be published in spring 2020, will, among others, examine the functioning of the zonal system for product authorisation and mutual recognition of authorisation

(Soruce: EU Parliament)

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