Upcoming Changes to the BPR Review Programme: EU Commission to Accelerate Active Substance Assessment
The EU Commission recently commissioned a public consultation concerning an extension to the Biocidal Active Substance Review Programme (RP). Under the RP, any substance placed on the EU market as an active substance in biocidal products before 14th May 2000 must undergo an evaluation by a Member State (MS) Competent Authority (CA) and be approved under the EU BPR. There have been various changes to the RP since its first introduction in the Review Programme Regulation (Regulation (EU) No 1062/2014), including two previous extensions.
The most recent proposed extension sets a final deadline of December 31, 2030, for the evaluation of all substances. To make this deadline achievable, the EU Commission, te Biocidal Products Committee (BPC), the MS CAs and ECHA have identified various actions intended to accelerate the progress of the RP. These proposed actions will significantly impact ongoing evaluations and introduce further regulatory deadlines that the Biocides industry must now meet.
Actions to accelerate the RP
The first (and most important) change prevents further “movement of the goalposts”. This is accomplished by making new guidance not applicable to active substances in the RP as of 1st January 2024. It is thought that this will prevent future delays similar to those imposed by introducing the Endocrine Disruptor guidance document and its regulatory obligations. This guidance saw a significant reduction in the number of approval or non-approval decisions published for substances for many years following its publication in 2017.
In considering the implications of the Endocrine Disruptor (ED) guidance document, the EU Commission is also considering changing the regulatory requirements for ED. First, they intend to allow active substances to be approved where conclusive data shows no ED concern for Human Health, even if the Environmental ED assessment is inconclusive. In this case, the additional environmental ED data must be provided in the active substance renewal, although this point is still under discussion between the CA and EU Commission. During the December CA meeting, it was agreed that the CA must submit all requests for additional ED data to the applicant before 30th June 2024. Additionally, all ED data must be submitted to the relevant regulatory authority before 31st December 2026. Due to its effect on the availability of contract labs that can perform the required testing, it is advised that these tests be scheduled as soon as possible to avoid missing the deadline. Some representatives for the Biocides industry and some CAs raised concerns about these deadlines but they were finalised at the last CA meeting.
The next change proposed by the EU Commission is that the BPC will have the power to conclude on the substance classification. Under the current process, the BPC evaluates the active substance, but the harmonised classification under CLP is determined by the Risk Assessment Committee (RAC). The BPC can request that the RAC evaluate a specific substance; however, this process still incurs delays as the BPC cannot conclude their opinion and submit this to the EU Commission for implementation until the RAC opinion on the harmonised classification is published. Under the new proposal, the BPC will not have to wait for the RAC opinion and can finalise their BPC opinion without having a harmonised classification in advance. It raises significant potential risk as the BPC and RAC may derive different classifications, causing a conflict with no information available as to what could happen in this circumstance.
In addition, ECHA and the EU Commission have agreed to extend approvals to postpone the need for renewal submissions. However, the exact details of which substances will be affected are unknown. In addition, if a regulatory deadline is missed for any application, it will be withdrawn and a non-approval decision will be produced, which will include the new ED data submission deadline. When industrial support is withdrawn for a substance, there will no longer be any option for a new applicant to take over the submission which could lead to the loss of certain chemistries where it is considered that continuing the evaluation is not viable for the current applicant.
The final change proposed by the EU Commission is to bring forward the publication of any public consultation. Under the current system, the public consultation is only published after the Competent Authority Report is finalised. If an active substance meets both the exclusion and substitution criteria, two different consultations are required under the regulations. The EU Commission intends to reduce the regulatory burden of these substances by combining the two consultations into a single document and enacting this as soon as the potential for meeting the exclusion and/or substitution criteria is identified under the evaluation. This will reduce delays caused by ongoing public consultations to approval/non-approval decisions.
How can Yordas help
Yordas offers expert assistance in all regulatory aspects of the BPR, from the development of an approval strategy to product authorisations. We also provide expert study monitoring services for all required test data, including the development of ED test data to address the new regulatory deadline. If you would like to learn more about how you will be affected by any of these changes or how Yordas can support you to address any new obligations, please contact our team. You can also visit our website for more insight into our BPR-related services. To stay informed about future regulatory changes and obligations, subscribe to our newsletter.