Reporting new information on authorisation

Authorisation holders have a legal obligation to inform Ctgb immediately when they have new information about harmful or unacceptable effects concerning the specified plant protection product, the active substance or its metabolites, a safener, synergist or co-formulant.

Two types of notifications : immediate and annual notification

Authorised plant protection products are safe when used according to the legal instructions for use.

The authorisation holder has a legal obligation to notify Ctgb immediately when they have information that indicates that harmful or unacceptable effects occur which suggest that the plant protection product (or its components) no longer comply with the authorisation criteria.

The authorisation holder of a plant protection product has a legal obligation to notify the Ctgb annually about information that indicates that the efficacy of the product is below expectation, about development of resistance and about any unexpected effect on plants, plant products or the environment.

Assessment of submitted data

The zonal process applies for the assessment of the submitted data. The data will be evaluated by the member state which first granted an authorisation for the product. The evaluation will show whether a withdrawal or an amendment of the authorisation is necessary.

When the evaluation of the submitted data leads to withdrawal or amendment of the authorisation, the evaluating member state will inform the other member states in the zone.

The authorisation holder remains at all time responsible for the authorisation and for making sure that the authorisation continues to meet the criteria of article 29 of Reg. (EC) no 1107/2009. However, when a required change or withdrawal of the authorisation is not actively requested by the authorisation holder, the competent authority will have to step in to make sure that the authorisation meets the authorisation criteria, by either amending or withdrawing the authorisation, whichever is appliccable.

Amendment or withdrawal of authorisations

For the amendment or withdrawal of the authorisation by the competent authority an 'article 44' (Regation 1107/2009) procedure is followed. This means that:

  • a member state that intends to withdraw or amend an authorisation, informs the authorisation holder;
  • the authorisation holder is given the opportunity to provide further information and / or comments;
  • the authorisation will be amended or withdrawn where:
  1. the requirements referred to in Article 29 are not or are no longer satisfied;
  2. false or misleading information was supplied concerning the facts on the basis of which the authorisation was granted;
  3. a condition included in the authorisation has not been met;
  4. on the basis of developments in scientific and technical knowledge, the manner of use and amounts used can be modified; or
  5. the authorisation holder fails to comply with the obligations resulting from this Regulation.
    1. The evaluating Member state immediately informs the authorisation holder, the other Memeber States, the EU-commission and EFSA about the amendments or withdrawal;
    2. a grace period can be granted, where appropriate.

The evaluating Member State may also conclude that the criteria for the approval of the active substance, safener or synergist are no longer met. (Or: in case of a co-formulant: the evaluating Member State could consider the co-formulant to be no longer acceptable. If this is the case the evaluating Member state will propose to withdraw the approval or amend the authorisation.)

Any information available to the authorisation holder concerning lack of efficacy of the authorised product, the development of resistance to the authorised product and any other unexpected effects of the authorised products on plants / plant products or the environment, should be notified once anually by the authorisation holder to the competent authorities of the Member States.