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Article 4(7) derogation and serious dangers to plant health

As a result of continued conservatism in decision making within the EU there is an increasing need to rely more heavily on derogations in order to maintain product authorisations. Use of Article 4(7) and the derogation on negligible exposure permitted in Annex II, 3.6.3 – 3.6.5 may provide a way forward in some cases.

The European Food Safety Authority (EFSA) has initiated procedures for the evaluation of data concerning the necessity of the application of herbicide, insecticide and fungicide active substances to control serious dangers to plant health which cannot be contained by other available means, including non-chemical methods within the context of Article 4(7) of Regulation (EC) No 1107/2009.

Protocols

Protocols are being developed by EFSA with the aim of helping to ensure consistent and transparent evaluation of submissions made by applicants in accordance with this derogation. All of the protocols take into account relevant international standards from the European and Mediterranean Plant Protection Organization (EPPO) and the proposed methodology has been commented on by Member States (MS).

EFSA will act as the coordinator of the process ensuring that the methodology is applied consistently and issuing a scientific report on the evaluation of each active substance reviewed.

Dossier

The dossier to support a request for this derogation under Article 4(7) should include the following:

  •  Information, data and evidence to demonstrate that the substance is necessary to control a serious danger to plant health that cannot be sufficiently contained by any other available means including non-chemical methods. JSC can prepare the case to demonstrate the need.
  • The dossier should be prepared in accordance with the methodology and harmonised template presented in the protocols. JSC can prepare the information that must be provided for each specific crop/pest combination separately, in a suitable form at national level, for which derogation is applied.

MS evaluation

  • The MS will verify the information provided by the applicant and will provide supplementary information, data and evidence from their respective countries and may include other uses that were not requested by the applicant e.g. Article 51 extensions of minor use.
  • The MS will evaluate the overall information based on the methodology applied to each specific crop/pest combination separately, at national level for which derogation is requested.

The evaluation process is done in a stepwise process tailored to the type of active substance under consideration; herbicide, insecticide or fungicide. The protocols for herbicides and insecticides respectively can be accessed via the following links:

http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2016.EN-1060/epdf

http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2017.EN-1201/epdf

The protocol for fungicides is due to be published later this year.

For advice on risk assessment and further information on the registration of plant protection products, biocides or general chemicals, or any other regulatory issues, please contact JSC on +44 (0)1423 520245, enquiries@jsci.co.uk

Published 21st July 2017
Categories Agrochemicals, News
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