The European Commission has taken a significant step in biocidal product regulation by granting a Union authorisation for the biocidal product 'EuLA hydra-lime 23' under the Commission Implementing Regulation (EU) 2023/2701. This decision, made on 4 December 2023, marks a crucial development in the availability and use of biocidal products in the EU, aligning with the standards set by Regulation (EU) No 528/2012 of the European Parliament and the Council.
A Milestone for Biocidal Product Regulation
'EuLA hydra-lime 23' is a unique product containing calcium dihydroxide (hydrated lime), an approved active substance for product-types 2 and 3, as outlined in Annex V to Regulation (EU) No 528/2012. The product is designed for specific uses, including disinfection of sewage sludge, manure, and indoor floor surfaces of animal accommodations and transportation, showcasing its versatility in maintaining hygiene standards in various settings.
The European Lime Association aisbl's application for 'EuLA hydra-lime 23', submitted on March 29, 2018, underwent a comprehensive evaluation process. The European Chemicals Agency (ECHA) received the application and, following an in-depth assessment, submitted its opinion to the Commission in July 2022. This detailed examination ensures that only products meeting the highest safety and efficacy standards are approved for use in the EU.
Safety and Efficacy: Core Principles of authorisation
The Commission's decision to grant Union authorisation to 'EuLA hydra-lime 23' is based on the product's compliance with the stringent criteria set forth in Article 19(1) of Regulation (EU) No 528/2012. The authorisation underscores the product's capacity to effectively address biocidal needs while adhering to safety standards, thereby protecting public health and the environment.
The authorisation details extensive usage instructions, highlighting the product's application methods, safety precautions, and emergency measures. These guidelines are crucial for users, ensuring safe and effective use while minimising potential risks. The detailed instructions reflect the EU's commitment to upholding the highest standards of safety and environmental protection.
Looking Ahead: Implications and Expectations
The authorisation of 'EuLA hydra-lime 23' signifies a progressive step in the EU's approach to biocidal products. It sets a precedent for future authorisations, emphasising the importance of thorough evaluation, safety, and efficacy. As the product becomes available from 25 December 2023, to 30 November 2033, stakeholders are encouraged to familiarise themselves with its usage guidelines to ensure compliance and optimal benefits.
In conclusion, the authorisation of 'EuLA hydra-lime 23' marks a significant advancement in the EU's regulation of biocidal products. It exemplifies the Union's commitment to ensuring high standards of public health and environmental safety while addressing the evolving needs in the field of biocides. As this product becomes a part of the EU's biocidal landscape, it is essential for users and stakeholders to adhere to the set guidelines and embrace the opportunities it presents for improved hygiene and sanitation practices.
