European Union | Draft Commission Implementing Regulation withdrawing the approval of the active substance isopyrazam
Title of document Draft Commission Implementing Regulation withdrawing the approval of the active substance Isopryrazam in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, amending Commission Implementing Regulation (EU) No 540/2011 and repealing Implementing Regulation (EU) No 1037/2012 (4 page(s), in English)
Description This draft Commission Implementing Regulation provides that the approval of the active substance isopyrazam is withdrawn in accordance with Regulation (EC) No 1107/2009. EU Member States shall withdraw authorisations for plant protection products containing isopyrazam as an active substance. This decision only concerns the placing on the market of this substance and plant protection products containing it. Following withdrawal of approval and the expiry of all grace periods for stocks of products containing this substance, separate action may be taken on MRLs and a separate notification will be made in accordance with SPS procedures.
Notifying member: European Union
Objective tag Protection of human health or safety; Protection of animal or plant life or health; Protection of the environment
Objective In order for an active substance to be approved in accordance with Regulation (EC) No 1107/2009 (concerning the placing of plant protection products on the market), it must be demonstrated that the substance is not harmful to human health, animal health or the environment. Criteria are listed in Article 4 of the Regulation (and also detailed in Annex II thereto) which must be met to enable approval. Active substances may be reviewed at any time where in the light of new scientific and technical knowledge there are indications that the substance no longer satisfies the approval criteria laid down in Article 4 of Regulation (EC) No 1107/2009.Substances that are or have to be classified as toxic for reproduction category 1B (R1B) according to Regulation (EC) No 1272/2008 cannot be approved unless exposure to humans is demonstrated to be negligible under realistic conditions of use. In December 2020, the ECHA Committee for Risk Assessment concluded that isopyrazam meets the criteria to be classified as R1B. Negligible exposure is not demonstrated since residues are expected in crops (therefore there is no negligible exposure demonstrated for consumers). This means that isopyrazam no longer fulfils the approval criteria as outlined in Regulation (EC) No 1107/2009 and the approval should therefore be withdrawn. Existing authorisations will need to be withdrawn; EU Member States must withdraw existing plant protection products containing isopyrazam at the latest by 3 months from the date of entry into force. A period of grace in line with Article 46 of Regulation 1107/2009 is allowed for and shall expire at the latest 6 months from the entry into force.
Agency responsibleEuropean Commission
- Submission: 25/11/2021
- Reception: 26/11/2021
- Distribution: 26/11/2021
- Final date for comments: 25/01/2022
- Proposed date of adoption: N/A