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Assessment framework

To conduct the assessment, the Ctgb uses an assessment framework. This is the collective name for laws and regulations, national and international policies and guidance documents with scientific content.

Manuals

The assessment of plant protection products is based on the European Regulation 1107/2009 for plant protection, and national rules. The regulation divides Europe into three zones: north, middle and south, on the basis of similarities in f.e. climate and land use. The zonal assessment avoids duplication, encourages cooperation and worksharing between admission authorities. The country where the product is applied (know as Rapporteur Member State) is responsible for conducting the assessments and preparing a comprehensive assessment report, which is then given to the other concerned member states (cMS) for comment.
Within the EU it is possible to authorise a product in one country by means of mutual recognition of authorisations from other Member States. This enables applicants in an EU Member State to obtain an authorisation for their product in a relatively short time.

The rules differ for active substances and products. Active substances should be authorized at EU level first, before an application for a product based on this active substance may be admitted. Depending on their classification, active substances are re-evaluated after 7, 10 or 15 years.

Also, maximum residue limits are set at European level. They can be obtained from the admission authority in a Member State.

For crops that are grown on a small scale - called minor uses - national rules apply. The criteria for minor used differ between EU member states.

For products containing an active substance placed on the list Candidates for Substitution a comparative assessment will be carried out to search for possible and suitable low-risk alternatives.

The various regulations, the possibilities and conditions in the Member States causes many different types of applications. Hence the Ctgb developed two manual which cover both the zonal (European) and national authorisation requirements for plant protection products:

  • Registration Manual: The registration manual informs you about the application processes (including application and assessment process).See 'How to apply?'
  • Evaluation Manual: technical instruction and information on assessment standards, assessment framework, and calculation models that are used by Ctgbg to conduct the assessments.
    The Evaluation Manual is also intended to provide applicants with insight into the assessment framework. This means that in cases where guidance is lacking, still under development, unclear or a specific issue is not included and a consensus agreement has not yet been made the Ctgb will use, case by case, scientific expert judgement in order to perform up-to-date and appropriate risk assessments.
    See also the explanation of the working method of the Evaluation Manual.

Special Evaluation Manual Biopesticides

Especially for biopesticides like f.e. botanicals and semiochemicals Ctgb developed an Evaluation Manual. This manual describes in detail the data requirements and risk assessment for biopesticides.