Reassessment of MRL's for Isopyrazam for EU

This assessment is carried out on behalf of the Norwegian Food Safety Authority (NFSA) and will be executed in collaboration with the European Food Safety Authority, EFSA.

Isopyrazam

Pesticide residues in food may pose a danger to public health. For this reason, the EU has been established a comprehensive legislation on pesticide residues in food. Norway was assigned the role of “Rapporteur” Member State (RMS) for the reassessment of MRLs for isopyrazam in December 2018.

Isopyrazam is a fungicide that works against fungal leaf spot as well as fungal growth on wheat leaves. It is applied on grains and some other crops like banana.

Isopyrazam was introduced to the EU for use as an active substance in plant protection products in 2013. The existing approval will expire 31.03.2023, and a reassessment of its temporary MRLs has been initiated, in accordance with existing regulations.

Presently, Isopyrazam is not approved for use in plant protection products in Norway.

The approval process for plant protection products

Norway is affiliated with the European Union's approval scheme for the use of plant protection products through the EEA agreement, and adopted EUs regulations on pesticides in a new regulation in the summer of 2015.

In the EU, active substances are evaluated through a phased approach:

• The applicant submits an application for approval of the active substance to a designated RMS, together with a dossier.
• A designated RMS carries out an initial risk assessment and prepares a draft assessment report (DAR) for a new substance or a renewal assessment report (RAR) for an already approved active substance.

• EFSA reviews the DAR/RAR in cooperation with all Member States.
• EFSA drafts a conclusion on the active substance.
• The European Commission takes a legislative decision whether or not to include the substance in the Union’s list of approved active substances.

Active substances are generally approved for a period of 10 years. It is possible for an applicant to apply for renewal upon expiration.

The project group

Hubert Dirven – member of the VKM Panel on plant protection products (chair)

Dagrun Engeset - member of the VKM Panel on plant protection products

Ole Martin Eklo - member of the VKM Panel on plant protection products

Nana Yaa Boahene – Project manager, VKM-secretariat

The Panel on plant protection products is responsible for the assessment. The report is expected to be published in the autumn of 2020.