Staphyt Regulatory Affairs informs you
We share with you some latest regulatory news that may impact your products registration and development.
Update of the guidance on Biocidal Product Regulation – Volume II, Parts B+C Efficacy Assessment and Evaluation
The efficacy guidance has been updated. It now addresses the efficacy tests requirements and the acceptance criteria of preservatives for liquid-cooling and processing systems (product-type 11), and slimicides (product-type 12).
New period of extension of RP beyond 2024
During the 100th Competent Authority (CA) meeting, a document “CA-June23-Doc.5.2 – Extension of RP beyond 2024” discussing the new end date of the Review Programme for Biocidal active substances was issued.
The Commission would propose to extend the duration of the review programme until 31 December 2030.
This extension would be linked to some actions to speed up the procedure, among them the resources in Member States and the Governance in the assessment of applications for approval with several proposals concerning backlog dossiers, ED assessment, RAC opinion,…
Upcoming postponement of the review program deadline and its impact on biocides under national transitional procedures on the Belgian market
Following the proposal of the Commision to extend the RP beyond 2024, the Belgian Competent Authority (BE CA) wishes to inform all current authorisation/notification/registration holders for biocides under national transitional procedures on the Belgian market on the impact of the aforementioned deadline postponement. In addition, BE CA wishes to notify them on the actions that must be taken in order to avoid disruptions within the market, whilst at the same time continuing to ensure a high level of protection of human and animal health and the environment.
Next approval deadlines
| Substance name | EC /List no | CAS no | Product-type | Approval start date |
|---|---|---|---|---|
| Quaternary ammonium compounds, benzyl-C12-16-alkyldimethyl, chlorides (ADBAC/BKC) | 270-325-2 | 68424-85-1 | PT1 | 01/07/2024 |
| Ozone generated from oxygen | – | – | PT2, 4, 5, 11 | 01/07/2024 |
| Chrysanthemum cinerariaefolium extract from open and mature flowers of Tanacetum cinerariifolium obtained with supercritical carbondioxide and Chrysanthemum cinerariaefolium extract from open and mature flowers of Tanacetum cinerariifolium obtained with hydrocarbon solvents | 289-699-3 | 89997-63-7 | PT18 | 01/02/2025 |
| Formic acid | 200-579-1 | 64-18-6 | PT2, 3, 4, 5 | 31/10/2024 |
BPC opinions recently published
| Substance name | EC /List no | CAS no | Product-type | BPC Opinion Date |
|---|---|---|---|---|
| Quaternary ammonium compounds, benzyl-C12-16-alkyldimethyl, chlorides (ADBAC/BKC) | 270-325-2 | 68424-85-1 | PT2 | 07/06/2023 |
| Pentapotassium bis(peroxymonosulphate) bis(sulphate) | 274-778-7 | 70693-62-8 | PT2, 3, 4 | 06/06/2023 |
| Thermally treated garlic juice | – | – | PT19 | 05/06/2023 |
| Willaertia subsp. magna, C2c.Maky | – | – | PT11 | 05/06/2023 |
