Serious danger to plant health

Date: 5 May 2020

The Article 4 (7) of REGULATION (EC) No 1107/2009 provides information about a special case for approval of active substances. It states: “Where on the basis of documented evidence […] an active substance is necessary to control a serious danger to plant health which cannot be contained by other available means including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding five years even if it does not satisfy the criteria set out in points 3.6.3, 3.6.4, 3.6.5 or 3.8.2 of Annex II [meaning: classifications as carcinogenic and/or toxic for reproduction, or the presence of endocrine disrupting properties in regards to mammalian toxicity or ecotoxicity].”

Such an approval is only possible under the premise that risk mitigation measures are taken for the use of the active substance to minimise exposure of humans and the environment. Moreover, maximum residue levels have to be set. Furthermore this exemptional approval may only be applied where the active substance is not classified as carcinogenic category 1A or carcinogenic category 1B without a threshold, or as toxic for reproduction category 1A.

Plant protection products containing an active substance approved on basis of the above may only be authorised on Member State level, when there is a necessity to control a serious danger to plant health in the respective country. The Member State is obliged to develop a plan to control the respective serious danger for plant health by any other means (including non-chemical methods) for phasing out the product, which must be communicated to the EU Commission.

Thus, with respect to the above mentioned conditions the evidence for control of a serious danger to plant health may provide a (time-limited) possibility for a “second life” of an active substance falling under the cut-off criteria (separate article in our online academy).

Jasmin Philippi