Change in practice regarding derogations according to Article 53 in the Plant Protection Product Regulation

The EU Commission has issued a new guidance document regarding Article 53. The guidance document can be found on the EU Commission website (link).

In connection to this, the Danish EPA will change the administrative practice for granting derogations according to Article 53 in order to meet the requirements of the EU guidance document.

The current practice has put special emphasis on an increased environmental load when assessing alternatives. When assessing alternatives, focus has also been on the risk of development of resistance for accepted alternatives. Previously, Danish EPA has not put special emphasis on repeated derogations for a non-approved active substance, as safe use for health and the environment must be shown for all derogations.

The change in practice means that:

  • For the assessment of alternatives, emphasis will be on observed beginning development of resistance.

  • For the assessment of alternatives, the combined environmental load of alternatives can only be used as a secondary argument.

  • For derogations for non-approved active substances, special emphasis will be put on repeated derogations and the applicant must document the following:

    • The applicant must demonstrate that no other viable options exist, and that the socio-agronomic system could not be changed within the time-period since the first derogation was granted, and that temporary continuation of the use of the non-approved active substance is necessary to avoid unacceptable damages to plant production or ecosystems.
    • The applicant must state how the use can be limited as much as possible (e.g. dose and number of treatments) and how the combined use of other existing partially effective actions can be promoted in the best possible way.
    • The applicant must initiate and document current and future activities aimed at finding long-term solutions to eliminate the need for repeated applications of derogations in the future.
    • The applicant must consider research projects that searches for alternative acceptable solutions including holistic approaches. Available reports must be submitted including further information on the objectives, a specific time schedule and information on planned and completed efforts.

As previously, safe use must be shown for health and the environment.

The change in practice applies to applications received by the Danish EPA after 1. March 2021.