Decision

You will receive a response from us by regular mail. This will be in the form of a decision. The decisions of the Ctgb are written in Dutch. The evaluations/ registration reports are in English. This  facilitates the exchange of evaluations between the EU Member States.

The authorisations (and changes) will be published in De Staatscourant (government gazette) and in our Pesticides database (in the latter together with the registration report). From the moment of publication it is allowed to practice the content of the decision (e.g. use the authorised product (following an application for authorisation) or conduct the trial (application for permit for trial purposes)). The time between the signing of the decision and publishing of it in the government gazette is about 10 days.

In certain cases the Ctgb grants an authorization with the condition that after the authorisation additional data have to be provided for confirmatory purposes. These data mainly concern shelf life studies for authorisations where the shelf life claim is based on the extrapolation of an accelerated shelf life study. To confirm the extrapolation, the complete shelf life study, including the summary, must be provided after the authorisation of the product. These “post-registration data” will be assessed and the conclusion will be included in the risk assessment.

Version management of the Legal Instructions for Use (WG) for plant protection products – W-codering – W-code.

At the first authorization of a plant protection product, the Legal Instructions for Use (in Dutch 'Wettelijk Gebruiksvoorschrift' or 'WG' for short) is determined. This WG is based on:

• the authorized GAP,
• the national conditions, and
• restrictions for the authorization resulting from the GAP and the assessment.

This first WG is considered “version 0”  and is not labelled explicitly as such (W.0 does not exist).
Upon every decision that changes the WG, the so-called W-code (version number) will be increased with 1; starting with W.1 at the first change of WG. This W-code needs to be explicitly mentioned on the label of the product produced after the decision enters into force.
Products with an authorization for professional as well as for non-professional use do have separate WGs for professional and non-professional use with their own independent version management.

Reasons to increase the W-code of the WG

• Any broadening or restriction in the Legal Instructions for Use (WG) as stated under ‘Toepassingsvoorwaarden’ (Conditions for use) and ‘Overige Toepassingsvoorwaarden’ (Other conditions for use); e.g.:
  • Change in use (crop)
  • Change in claim
  • Change in application method(s)
  • Change in dose, frequency, interval or crop stage; including addition of an LDS or split application
  • Change in PHI
  • Change in restriction sentences
  • Any other change affecting the use of the product
  • Any combination of the above mentioned changes
• Change of the format of the WG.

Use of the new WG version and grace periods for the old WG version

The new version of the WG applies to new batches of product packed after the signature date of the Board decision.  A Board decision on an existing authorization that establishes a new version of the WG, also states whether grace periods apply for sales, distribution, storage, use and removal of product labelled with the old WG version. Products may be relabelled with the new WG in case grace periods are not sufficient.

In what cases there are no reasons to increase the W-code of the WG?

• Changes in the ‘Aanbevelingen’ (Recommendations) that are not mentioned in the WG as published with the Ctgb decision or on the Ctgb website.
• Changes in the CLP classification.
• Changes in any other aspect of the authorization that are not mentioned on the WG, as composition, production location, address of notifier, etc.    

Such label changes not affecting the WG – ‘Toepassingsvoorwaarden’ and ‘Overige toepassingsvoorwaarden’ are not subject to grace periods and consequently can be sold and used without time limit.