Withdrawal or amendment of an authorisation

Date: 22 May 2020

An existing authorisation of a plant protection product may be withdrawn or amended based on two possible procedures:

1.)    On request of a Member State, according to Article 44 of Regulation (EC) No 1107/2009)

Whenever a Member State has an indication that the requirements for a product authorisation are not or no longer satisfied, a review of the authorisation is possible.

Explicitly stated as one possible reason is, that a review shall be done where the objectives of the framework for Community action in the field of water policy in regards to surface water, groundwater and drinking water may not be achieved (Directive 2000/60/EC, Article 4(1)(a)(iv) and (b)(i) and Article 7(2) and (3)).

Possible reasons for withdrawal or amendment of an authorisation after review are:

• • • The requirements for product authorisation (Article 29) are not or no longer satisfied
    • The granted authorisation was based on false or misleading information
    • A condition included in the authorisation has not been met
    • The manner of use and amounts used can be modified based on developments in scientific and technical knowledge.
  In addition, the Regulation specifies without further defining that a withdrawal or amendment is possible, where the authorisation holder fails to comply with the obligations resulting from Regulation (EC) No 1107/2009.
  When withdrawal or amendment of an authorisation is intended, the Member State shall inform the authorisation holder and give the opportunity to comment or to table further information.
  Once an authorisation is withdrawn or amended by a Member State, respective information has to be sent immediately to the authorisation holder, other Member States, the Commission and EFSA. Other Member States of the same political Zone shall also withdraw or amend the authorisation accordingly, whenever the reasons for withdrawal/ amendment are not based on national conditions or risk mitigation measures of the initial Member State only.
  2.)   On request of the authorisation holder, according to Article 45 of Regulation (EC) No 1107/2009
  A request for withdrawal or amendment of an authorisation may be raised by the authorisation holder. The request has to be justified.
  Prerequisite for an amendment of an existing authorisation is the maintenance of compliance with the requirements for a product authorisation (specified in Article 29).

   

  For both cases it is stated in Article 46, that a grace period for the sale and distribution (max. 6 months), and for disposal, storage and use of existing stocks (additional max. 1 year) may be granted, provided that the reasons for withdrawal/amendment are not related to the protection of human and animal health or the environment.

  Jasmin Philippi

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