Chemical name: Isopyrazam Final regulatory action has been taken for the category: Pesticide Final regulatory action: The chemical is Banned Use or uses prohibited by the final regulatory action: All applications as plant protection product. Not relevant Use or uses that remain allowed: Not relevant Pesticide use or uses that remain allowed: Not relevant The final regulatory action was based on a risk or hazard evaluation: Yes Summary of the final regulatory action: It is prohibited to place on the market or use plant protection products containing isopyrazam because isopyrazam is not approved as an active substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market. EU Member States had to withdraw all authorisations for plant protection products containing isopyrazam as active substance by 8 September 2022 at the latest. Disposal, storage, placing on the market and use of existing stocks of plant protection products containing isopyrazam is prohibited as of 8 December 2022. The reasons for the final regulatory action were relevant to: Human health Summary of known hazards and risks to human health: It was concluded that no plant protection product containing the active substance isopyrazam is expected to satisfy in general the requirements laid down in Article 29(1) of Regulation (EC) No 1107/2009 and the uniform principles laid down in Commission Regulation (EU) 546/2011. Specifically, under point 3.6.4 of Annex II to Regulation (EC) No 1107/2009 an active substance can only 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 of 0,01 mg/kg within the meaning of Article 18(1), point (b), of Regulation (EC) No 396/2005 of the European Parliament and of the Council, therefore the condition of negligible exposure with respect to dietary exposure is not met. Consequently, isopyrazam no longer fulfils the criterion for approval laid down in point 3.6.4 of Annex II to Regulation (EC) No 1107/2009. Data from field studies on residue levels on raw agricultural commodities and feeding stuffs for the representative uses of isopyrazam are available in EFSA (2012, 2021). Information in relation to residues of isopyrazam in crops and food is available in the peer review of the pesticide risk assessment of the active substance isopyrazam (EFSA, 2012) and on the EFSA opinions on the setting of maximum residue levels (EFSA, 2010, 2011, 2013a,b, 2015, 2020). References: EFSA (European Food Safety Authority), 2010. Setting of new MRLs for isopyrazam in several cereals and food commodities of animal origin. EFSA Journal 2010;8(9):1785, 34 pp. https://doi.org/10.2903/j.efsa.2010.1785 EFSA (European Food Safety Authority), 2011. Reasoned opinion on the setting of MRL for isopyrazam in bananas prepared by EFSA Pesticide Risk Assessment Peer Review (PRAPeR) Unit. EFSA Journal 2011;9(4):2134, 29 pp. https://doi.org/10.2903/j.efsa.2011.2134 EFSA (2012). Conclusion on the peer review of the pesticide risk assessment of the active substance isopyrazam. https://doi.org/10.2903/j.efsa.2012.2600 EFSA (European Food Safety Authority), 2013a. Reasoned opinion on the modification of the existing MRLs for isopyrazam in various vegetables prepared by EFSA Pesticide Risk Assessment Peer Review (PRAPeR) Unit. EFSA Journal 2013;11(9):3385, 38 pp. https://doi.org/10.2903/j.efsa.2013.3385 EFSA (European Food Safety Authority), 2013b. Reasoned opinion on the modification of the existing MRLs for isopyrazam in pome fruits, various stone fruits and oilseeds prepared by EFSA Pesticide Risk Assessment Peer Review (PRAPeR) Unit. EFSA Journal 2013;11(4):3165, 34 pp. https://doi.org/10.2903/j.efsa.2013.3165 EFSA (European Food Safety Authority), 2015. Reasoned opinion on the modification of the existing MRLs for isopyrazam in various crops. EFSA Journal 2015;13(1):3994, 25 pp. https://doi.org/10.2903/j.efsa.2015.3994 EFSA (2021). Review of the existing maximum residue levels for isopyrazam according to Article 12 of Regulation (EC) No 396/2005. https://doi.org/10.2903/j.efsa.2021.6684 Expected effect of the final regulatory action in relation to human health: Reduction of risk for human health from the use of plant protection products containing isopyrazam. Summary of known hazards and risks to the environment: Not relevant Expected effect of the final regulatory action in relation to the environment: Not relevant Date of entry into force of the final regulatory action: 08/06/2022 |