Biocides are chemical or biological products designed to control harmful organisms, such as bacteria, viruses, fungi, insects, or rodents. They are commonly used in a variety of applications, including disinfectants, insect repellents, preservatives, and pest control products. Biocides are essential for ensuring hygiene, protecting materials, and maintaining public health in diverse environments.
Active substances, on the other hand, are the specific components within biocides that are responsible for their biocidal action. These substances are what make biocides effective against the targeted harmful organisms. For example, in a disinfectant, the active substance could be a chemical compound that kills bacteria or viruses.
Approved active substances are chemical or biological agents that have been evaluated and authorized for specific uses in various industries, including pharmaceuticals, agriculture, and biocides. These substances must meet stringent regulatory requirements to ensure safety, efficacy, and environmental compatibility.
The Biocidal Products Regulation (BPR) requires all biocidal products to be authorised before they can be placed on the EU market and used, and their active substances must be approved at EU level.
The production and use of biocides and their active substances are strictly regulated to ensure safety for both humans and the environment. This involves thorough testing and evaluation to minimize risks while maximizing their effectiveness. (REGULATION (EU) No 528/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22 May 2012 concerning the making available on the market and use of biocidal products). These evaluations aim to clarify potential risks associated with these substances and may lead to EU-wide risk management measures if necessary.
In the European Union, active substances used in biocidal products undergo a rigorous approval process to ensure they meet safety and efficacy standards. The European Chemicals Agency (ECHA) maintains a comprehensive list of these approved substances
Recent approvals for 2024 and 2025 include:
Approvals for 2026 include:
| Active substance | CAS number | EC number | Product type | Approval start date | Evaluation competent authority | Approval/Assessment status |
| 2-methyl-4-oxo-3-(prop-2-ynyl)cyclopent-2-en-1-yl 2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate (Prallethrin) | 23031-36-9 | 245-387-9 | PT18 | 1.3.2026 | Greece | approved |
| reaction products of boric acid with didecylamine and ethylene oxide (polymeric betaine) | 214710-34-6 | 695-923-4 | PT8 | 1.6.2026 | Greece | approved |
| Silver zinc zeolite | 130328-20-0 | 603-404-0 | PT2 | 1.3.2026 | Sweden | approved |
| Silver zinc zeolite | 130328-20-0 | 603-404-0 | PT7 | 1.3.2026 | Sweden | approved |
| Silver zinc zeolite | 130328-20-0 | 603-404-0 | PT9 | 1.3.2026 | Sweden | approved |
Detailed list of all approved active substances are found in ECHA webpage: https://www.echa.europa.eu/web/guest/regulations/biocidal-products-regulation/approval-of-active-substances/list-of-approved-active-substances?utm_source=chatgpt.com
Active Substances with Extended Approval Periods
The European Union has extended the approval periods for several active substances to allow sufficient time for comprehensive renewal assessments. Notable extensions include:
- Sulphur: Approval extended until April 15, 2025.
- Clomazone, Fludioxonil, Flufenacet: Approval extended until June 15, 2025.
- Tritosulfuron: Approval extended until July 15, 2025.
- Amidosulfuron, Lenacil, Fenoxaprop-P, Paraffin oil (CAS No. 8042-47-5): Approval extended until August 15, 2025.
- Daminozide: Approval extended until September 15, 2025.
- Diflufenican: Approval extended until January 15, 2026.
- Difenoconazole: Approval extended until March 15, 2026.
- Eugenol, Geraniol, Thymol: Approval extended until April 30, 2026.
- Flumetralin: Approval extended until May 11, 2026.
- Esfenvalerate, Fenpyrazamine, Fluazifop P, 1-naphthylacetamide, 1-naphthylacetic acid, Prohexadione, Spiroxamine: Approval extended until May 31, 2026.
- Bensulfuron, Chlorotoluron, Deltamethrin, MCPA, MCPB: Approval extended until August 15, 2026.
It is highly beneficial to stay informed about which active substances will be approved this year and in the coming year, in order to allow clients to prepare for the biocidal product authorization process. Authorization is a lengthy and complex procedure that demands thorough analysis, meticulous control, and comprehensive preparation of documentation.
In such cases, having the support of an experienced professional is invaluable. Their expertise can guide clients through the various steps of the process, ensuring compliance with regulatory requirements and improving the chances of a successful authorization. Staying proactive and well-prepared is key to navigating this intricate process effectively.
Our consulting firm is at your disposal to provide expert support in the authorization process for biocides. We are committed to finding optimal solutions in compliance with current regulations and tailored to the specific needs of your business.
- Ekotox Centers are providing consultancy services and customers support in the area of EU chemicals legislation – REACH Registration, Only Representative, REACH Authorisation, REACH/CLP Screening, Safety Data Sheets, Legal Compliance Services
- – just call us +421 2 45943712, send an e-mail on ekotox(at)ekotox.eu or skype ekotox.bratislava