This draft Commission Implementing Regulation provides that the approval of the active substance ipconazole is withdrawn in accordance with Regulation (EC) No 1107/2009.
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.
Commission Delegated Regulation (EU) 2020/1182 amended Annex VI to Regulation (EC) No 1272/2008 and classified ipconazole as toxic for reproduction category 1B.
Negligible exposure to ipconazole for humans could not be concluded due to limitations with the available data.
Furthermore, a high long-term risk to birds from the representative uses of ipconazole was concluded by the European Food Safety Authority.
This means that ipconazole no longer fulfils the approval criteria as outlined in Regulation (EC) No 1107/2009 and the approval should therefore be withdrawn.
Existing authorizations will need to be withdrawn; EU member States must withdraw existing plant protection products containing ipconazole at the latest by three months from the date of entry into force.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 six months from the entry into force.
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 in which case a separate notification will be made in accordance with SPS procedures.
This draft Commission Implementing Regulation was also notified under the TBT Agreement in notice G/TBT/N/EU/944.