Revised EU Data Rules Set to Reshape Active Substance Approvals for Plant Protection Products
The EU is updating data requirements for active substances in plant protection products, raising safety standards and regulatory expectations.
The European Chemicals Agency (ECHA) has announced the commencement of a public consultation regarding the harmonised classification and labelling (CLH) of Clethodim, a chemical primarily used in plant protection products. This process, integral to the regulation of chemicals within the European Union, seeks input from concerned parties to ensure a comprehensive assessment of the substance’s potential hazards.
Overview of the Consultation
The consultation focuses on various hazard classes related to Clethodim, a substance whose current entry in Annex VI of CLP (Classification, Labelling and Packaging) Regulation includes classifications such as Acute Tox. 4 (H302), Skin Sens. 1 (H317), and Aquatic Chronic 3 (H412). The dossier submitter, Sweden, has proposed additional classifications including Self-react. G, STOT RE 2 (H373), and more severe classifications for aquatic toxicity.
Participation and Scope
Stakeholders, experts, and the public are invited to comment on the proposed classifications. The consultation allows for input on general issues such as substance identification, physicochemical properties, and the accuracy of data sources. Comments can also address specific hazard classes, providing insights into the classification itself, the information considered, and the justification of conclusions.
The CLH process is a cornerstone in the EU’s approach to chemical regulation, aiming to ensure a high level of protection for human health and the environment. It involves a thorough assessment of hazard classes by the dossier submitter, followed by an evaluation by ECHA’s Committee for Risk Assessment (RAC). The RAC may propose amendments to the classifications, including more or less severe categorizations based on the information presented.
Clethodim, with the chemical name (5RS)-2-{(1EZ)-1-[(2E)-3-chloroallyloxyimino]propyl}-5-[(2RS)-2-(ethylthio)propyl]-3-hydroxycyclohex-2-en-1-one, is under scrutiny for its potential health and environmental impacts. The consultation will play a pivotal role in determining how this substance is regulated, labelled, and used within the EU.
Key Dates and How to Participate
The consultation opened on 11 December 2023, and will close on 9 February 2024. Comments must be submitted before the deadline to be considered in the final assessment. Detailed information, including how to participate in the consultation, is available on the ECHA website.
This consultation offers a vital opportunity for stakeholders to contribute to the safe and responsible management of chemicals in the EU. Engagement in this process not only influences regulatory decisions but also reflects a commitment to public health and environmental stewardship.
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