Charles River Laboratories International Inc.
10/17/2024 | News release | Distributed by Public on 10/17/2024 06:54
Is Your Biocide Registration Data Complete
ECHA's Biocidal Product Committee (BPC) has expressed renewed concerns over missing data in dossiers relating to endocrine disrupting properties. Preliminary information was included in a recent news update from ECHA which could impact compounds currently under evaluation and new substances going through development, potentially leading to non-approval or non-authorization.
New Deadline for Biocidal Registration Endocrine Disruptor Data
The Biocidal Products Regulation (No 528/2012 - BPR), which has been in effect since 2018, bans substances with endocrine-disrupting properties based on hazard potential.
To drive completion ECHA has issued a new deadline of December 31, 2026 by which applicants must have submitted their missing endocrine disruptor data. ECHA has also issued clear notice of the possible consequences of failing to comply with this new deadline:
The evaluating Member States recommend non-approvals and non-authorisations if companies fail to provide the required data, such as information on efficacy or endocrine disruption, within the process deadlines. Consequently, the opinion of the Biocidal Products Committee will not be favourable."
Ensure Your Biocidal Registration Dossier is Complete
The Biocidal Product Committee (BPC) clarifies that the onus to ensure all required data is included lies with the applicant and not with them:
It is not the responsibility of the evaluating competent authority to ensure that the dossier is complete, but the responsibility of the applicant. So, make sure your dossier is complete before you submit it."
In addition to clarifying deadlines and where the responsibility lies, the BPC also confirms that incomplete applications may be considered withdrawn or terminated and that submission of "step by step" data, in iterations, will not be accepted.
With the 2026 deadline quickly approaching, our team is ready to answer your questions and provide guidance. We've been planning and executing endocrine disruptor testing programs since 2010 and have internal regulatory affairs experts who will partner with you to guide you through the path to regulatory success. Offering comprehensive programs from endocrine disruptor screening through in vitro and in vivo endocrine disruptor testing, and dossier preparation, we can support all your needs for biocide registration.