EU withdraws the approval of SDHI fungicide isopyrazam

The European Commission (“EC”) has decided to withdraw the approval of fungicide isopyrazam, according to the Commission Implementing Regulation (EU) 2022/782 published on May 18, 2022. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

On 10 December 2020, the Committee for Risk Assessment of the European Chemicals Agency concluded that isopyrazam meets the criteria to be classified as toxic for reproduction category 1B and carcinogenic category 2. Commission Delegated Regulation (EU) 2022/692(6) consequently amended Annex VI to Regulation (EC) No 1272/2008 and classified isopyrazam as toxic for reproduction category 1B.

Under point 3.6.4 of Annex II to Regulation (EC) No 1107/2009 an active substance is only to be approved if it is not or has not to be classified in accordance with the provisions of Regulation (EC) No 1272/2008 as toxic for reproduction category 1B, unless the exposure of humans to that substance in a plant protection product under realistic proposed conditions of use is negligible.

For the representative uses of isopyrazam, residues of isopyrazam on food and feed exceed the default value within the meaning of Article 18(1), point (b), of Regulation (EC) No 396/2005 of the European Parliament and of the Council (7), therefore the condition of negligible exposure with respect to dietary exposure is not met.

According to the EC, Member States shall withdraw authorisations for plant protection products containing isopyrazam as active substance by 8 September 2022. Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) No 1107/2009 shall expire by 8 December 2022.

Isopyrazam is Syngenta’s first SDHI fungicide which was launched in the market. Isopyrazam is used the most in cereal crops. Europe is the largest market for isopyrazam, and Germany is the country where the product is used the most. Approval withdrawal in EU may have a significant impact on the global sales of isopyrazam.