The EU Regulation 2019/1381, the now well-known Regulation introducing amendments to the General Food Law with the aim of enhancing transparency guarantees in the area of food safety, has also led to some changes in Regulation (EC) No. 1107/2009, which governs the placing on the market of plant protection products.
Timelines
The draft Regulation is available on the European Commission website and can be commented on until 1 October 2020.
It will apply from 27 March 2021 (although renewal procedures for active substances expiring by 27 March 2024 will still follow EU Regulation 844/2012).
What changes for companies?
- A company intending to renew an active substance will need to submit a pre-submission notification, which will allow EFSA to provide a preliminary opinion on the matter and ensure transparency through a public consultation.
- In line with increased transparency, the company will be required to publish the data and studies that EFSA has deemed admissible for the renewal project. These will be open for public comment for 60 days.
- The submission must be made through the IUCLID platform.
What happens after the submission?
- The evaluating Member State will be required to submit to ECHA – prior to or at the same time as the dossier submission – a classification proposal under the CLP Regulation (Article 37), in order to receive an opinion regarding the classification of the substance for certain hazard classes (mutagenicity, carcinogenicity, reproductive toxicity, aquatic environmental toxicity).