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How is the risk envelope used in the assessments?

The risk envelope approach means that the assessment of a particular ‘most critical use’ also applies to other situations in which the GAP is equally critical or less critical. The assessment of the most critical GAP is then considered to be representative of all other less critical or similar GAPs. The text below concerns standing Ctgb policy and aims to explain how the risk envelope is used in assessments.

For the various parts of the dossier the use of the riske envelope is explained:

The overall assessment looks at parameters that determine the outcome of the risk assessment. These parameters may differ for the various parts of the dossier (human toxicology, residues, ecotoxicology and fate & behaviour). If these parameters for the requested uses in the new application are comparable to the parameters in the existing authorisation, then the outcome of the risk assessment will not change and the requested uses in the new application will fall within the risk envelope of the existing authorisation. To determine the risk envelope, the “Guidance document on the preparation and submission of dossiers for plant protection products according to the risk envelope approach” is used (SANCO/11244/2011 rev. 5, 14 March 2011).

For ecotoxicology and fate & behaviour, it is necessary to know which assessment framework has been used in the dossier before it can be determined whether the requested uses fall within the risk envelope of the existing authorisation.

The starting point for the assessment differs for each type of application.

  • For national applications for minor uses (NLKUG), the assessment framework of the original authorisation/last renewal is usually the starting point. In other words, if an extended authorisation does not fall under the risk envelope and must therefore be assessed, that assessment will be done in accordance with the assessment framework used for the original authorisation/last renewal. If the original assessment was completed before the first version of the evaluation manual came into effect, the assessment will be done in accordance with HTB 0.2. In exceptional cases, if a major unacceptable risk can be expected, it is possible to deviate from the previous assessment framework and use the current assessment framework.
  • For zonal applications to amend the current authorisation (ZWTG) and for national applications to amend the current authorisation (NLW(T)G), the assessment framework of the date the application was received will be used. In other words, if an extended authorisation does not fall under the risk envelope and must therefore be assessed, that assessment will be done in accordance with the assessment framework of the date the application is received.

A separate explanation of the use of the risk envelope is provided for various components of the dossier:

  1. Human toxicology
  2. Residues
  3. Fate & behaviour
  4. Ecotoxicology