Competent authority strategy to speed up Biocides review programme
- 1. Resources in Member States
Member States must allocate sufficient resources to complete the work.
2. Governance in the assessment of applications for approval
i. Taking-over mechanism: the provisions for taking over the role of participant will be removed for the Review Regulation.
ii. Backlog active substance reports: CA must conclude on their backlog reports (i.e. those submitted to ECHA before 1 September 2013) so that all the corresponding BPC opinions can be available by 31 December 2025 at the latest. Backlog dossiers continue to be assessed based on the BPD principles.
iii. Respect of rules and procedures: Better compliance with the procedures and rules is required by applicants and Member States. For instance:
a. when no data is submitted by a set deadline, the application must be considered withdrawn.
b. New uses or change of uses within a PT shall not be allowed by the eCAs.
iv. No new technical guidance or updated version of existing technical guidance, agreed after 1 January 2024, is applied for dossiers in the review programme. Applicable guidance documents are those available 6 months before the submission of the draft assessment report to ECHA.
Exception: the assessment cannot be completed due to absence of existing guidance. This exception allows great space to authorities to decide on what guidance to apply.
v. No more suspension of the progress of dossiers pending a RAC opinion of the substance, when the harmonised classification concerns an exclusion criteria, or mutagen category 2.
vi. Examination of the ED criteria: the following proposals will be further investigated:
ECHA shall produce an overview of the situation of each active substance still in the review programme regarding ED assessment (human health, non-target organisms). Each Member States must provide to ECHA:
a. Information on whether they concluded the ED assessment (yes/no);
b. In case the assessment is not yet concluded, if data has been already requested by the eCA (yes/no);
c. If data has already been requested: when was the data requested, what were the requested data (list of data), and what is the deadline set for the submission of the data.
This overview is restricted only to Commission and Member States.
Common final deadline for data on ED:
a. Member States shall send their request for the missing ED data to the applicant by 30 June 2024 at the latest.
b. Member States may give until 31 December 2026 at the latest to applicants to submit the missing ED data.
Member States shall not ask again for ED data. If the applicants failed to comply with their duties, the application should be considered withdrawn.
2 additional points needs to be discussed and will be reported once approved by CA.
Other actions
Renewal of approval of active substances:
a. Member States are encouraged to make a limited evaluation, to limit the workload.
b. the Commission will continue to extend the duration of approval, where requested by Member States.
c. The evaluation of review programme applications are prioritized over the renewal applications, except when the renewal concern active substances meeting exclusion criteria.
d. Member States can volunteer to take over the role of eCA for active substances subject to future renewals for certain PTs, except when the same active substance is still under assessment in the review programme for other PTs.
When requesting data from applicants, Member States must apply strictly the requirements and timelines set in the BPR. Failure from applicants to comply, leads to non-renewal of approval.
Practices/management of applications: the following proposals were made:
a. Perform a qualitative assessments with sound justifications when quantitative guidance does not meet reality. Identify and discuss technical guidances which do not allow the performance of a sound quantitative assessment, but do not block the progress of a qualitative assessment of a specific active substance dossier.
b. Decisions in the BPC must be based on majority when consensus cannot be found quickly;
c. Regular discussion in the BPC to monitor progress on applications, and discuss on specific applications to help the eCA progress.
