UK Declares Non-Approval for 63 Active Substances in Biocidal Products Regulations
Manufacturers, suppliers, and users are urged to review the list and prepare for the upcoming changes to ensure compliance.
In a significant legislative update, the UK Government has unveiled The Biocidal Products (Health and Safety) (Amendment and Transitional Provision etc.) Regulations 2024. Scheduled to be enacted on 6 April 2024, these amendments are designed to bring the UK's regulatory framework in line with the latest scientific and technological developments in the biocidal products sector, ensuring a superior level of protection for human health and the environment.
Legislative Background
The regulations, detailed in UK Statutory Instruments 2024 No. 352, were officially made on 11 March 2024 and presented to Parliament on 13 March 2024. They emerge from the Secretary of State's powers under Article 85(1) and Article 83A(2) of Regulation (EU) No 528/2012 regarding the marketing and usage of biocidal products. With the approval of both Scottish and Welsh Ministers, these adjustments reflect the UK's dedication to maintaining and enhancing health and safety standards following its exit from the European Union.
Key Amendments and Their Implications
The principal modifications in these regulations update Annex 2 and Annex 3 of Regulation (EU) No 528/2012, which detail the information requirements for applications concerning active substances and biocidal products, respectively. These amendments introduce modern testing methodologies, stress the reduction of vertebrate testing, and mandate pre-submission consultations with competent authorities. This approach aims to streamline the regulatory review process, fostering innovation while ensuring the highest levels of safety and efficacy for biocidal products.
Transitional Arrangements
A transitional period is outlined, during which, from 6 April 2024 to 5 October 2025, applicants can opt to comply with either the new requirements or those that were in place prior to the enactment of these regulations. After 6 October 2025, only the amended requirements will apply to submissions made to the competent authority. This grace period is intended to give manufacturers and other stakeholders adequate time to adapt to the new standards.
Impact Assessment and Availability
An impact assessment, detailing the anticipated effects of these regulations on business expenses, is obtainable from the Health and Safety Executive. This assessment, alongside the regulations, is accessible on the UK legislation website, underscoring the government's commitment to transparency and accountability.
Source:
legislation.gov.uk
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