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Comparative assessment and substitution

Regulation (EC) No 1107/2009 introduced “comparative assessment and substitution” to the regulatory process for plant protection products as a tool for risk reduction. Comparative assessment became necessary from 01 August 2015 and applies to all new applications for authorisation, extension or renewal of a PPP containing an active substance that is a candidate for substitution (for a list of candidates for substitution see: http://ec.europa.eu/food/plant/pesticides/approval_active_substances/docs/draft_list_cfs_en.pdf).

The comparative assessment will be carried out by Member State Authorities which will compare the PPP containing the candidate for substitution with alternative chemical or non-chemical alternatives already available to farmers. If suitable alternatives which are significantly safer exist and they are not expected to present unacceptable consequences, then that use of the PPP will be substituted.

The conditions for substitution described in Regulation (EC) No 1107/2009 include

  • significantly lower risk to health or the environment, whilst ensuring similar effect of the alternative on target organism
  • sufficient methods or chemical diversity to minimize the occurrence of resistance
  • lack of significant economic and practical disadvantages
  • in addition the consequences of substitution on minor use authorisations must be taken into account

Guidance on the conduct of comparative assessment advocates a stepwise approach:

Step 1. Identification of candidate for substitution.  Does the product contain an active substance identified as a candidate for substitution?

Step 2. Assessment of the agronomic aspects of the uses of the product containing a candidate for substitution.  The comparative assessment is performed on all the specified uses of the candidate product, for which alternatives need to be identified.  Chemical as well as non-chemical control or prevention methods should be considered.  Comparative assessments of effectiveness, crop safety, the risks of resistance, practicality, economic disadvantages, alternative measures and effects on minor uses are considered.  If the conclusion of the assessment is that substitution is not appropriate in view of agronomic considerations, then no further assessment is needed. If it is concluded that substitution is possible the assessment continues to the next step.

Step 3. First assessment for health and the environment.  The first part of the comparison for health and the environment is intended to clarify whether the potential for substituting a candidate product actually exists and should be further explored.  An assessment focused on the specific criteria that resulted in the active substance being defined as a candidate for substitution should be made.  If substitution is still considered appropriate then a second assessment for health and the environment is carried out.

Step 4. The second part of the comparison for health and the environment requires the complete risk profiles of the candidate product and the potential alternative to be taken into account.  It may be that the alternative was not of concern in relation to the specific criterion used in the comparison at Step 3, but instead poses a risk for some other aspect of the assessment for human or animal health and the environment.  In such cases the conclusion may be that substitution would not be the best tool for achieving a reduction of risk.

If, on completion of the comparative assessment, it is concluded that substitution is appropriate then that use will be substituted.

JSC can assist in the preparation of the applicant conclusion on comparative assessment and substitution to be submitted in the draft Registration Report.  Contact Ben Bolton on 01423 520245, enquiries@jsci.co.uk.

Published 12th November 2015
Categories Agrochemicals, News
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European Commission publishes draft Guidance document on Comparative Assessment and Substitution of Plant Protection Products
The document provides guidance to Member States on how to conduct comparative assessment when evaluating applications for authorisation of plant protection products.
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