News Brief
The European Chemicals Agency (ECHA) has initiated public consultations regarding the approval and renewal of four biocidal active substances under the Biocidal Products Regulation (BPR). The consultations concern substances identified as Candidates for Substitution (CfS), with several also meeting the exclusion criteria which requires specific derogations for approval.
Regulatory Background
Under the BPR (Regulation (EU) No 528/2012), active substances are scrutinized to ensure a high level of protection for human health and the environment.
Candidates for Substitution (CfS): According to Article 10(1) of the BPR, if a substance meets specific hazard criteria (such as being a respiratory sensitizer or having persistent, bioaccumulative, and toxic (PBT) properties), it is flagged as a Candidate for Substitution. ECHA must then launch a consultation (Article 10(3)) to collect information on potential alternatives to this substance.
Exclusion Criteria: Substances classified as carcinogens, mutagens, reprotoxic (CMR) category 1A or 1B, endocrine disruptors, or PBT fall under Article 5(1). These are generally excluded from approval.
Derogation Conditions: Under Article 5(2), substances meeting exclusion criteria may only be approved if specific derogations apply. Stakeholders must prove that the risk is negligible, the substance is essential to prevent serious danger, or non-approval would cause disproportionate negative impacts on society.
Key Consultation Details
ECHA is currently seeking feedback on the availability of alternatives for the following substances. For those meeting exclusion criteria, stakeholders must also provide justifications on how the substance meets derogation conditions.
Active Substance | CAS No. | Product Type(s) (PT) | Scope | Consultation End Date |
Silver nitrate | 7761-88-8 | PT 1, 4, 5, 9 | CfS & Derogation | 23/01/2026 |
formaldehyde released from the reaction products of paraformaldehyde and benzyl alcohol ((benzyloxy)methanol) | - | PT 6 | CfS & Derogation | 26/01/2026 |
Imidacloprid | 138261-41-3 | PT 18 | CfS | 09/02/2026 |
1-(4-chlorophenyl)-4,4-dimethyl-3-(1,2,4-triazol-1-ylmethyl)pentan-3-ol [tebuconazole] | 107534-96-3 | PT 8 | CfS & Derogation | 13/02/2026 |
Regulatory Implications and Next Steps for CfS Substances
These consultations represent a critical juncture for companies manufacturing or formulating products containing these active substances. The identification of a substance as a Candidate for Substitution signals regulatory pressure to phase it out in favor of safer alternatives.
Implications for Stakeholders:
Market Access Risk: If suitable alternatives are identified during this process, the active substance may be denied approval or renewal.
Derogation Burden: For Silver nitrate, formaldehyde released from the reaction products of paraformaldehyde and benzyl alcohol ((benzyloxy)methanol), and Tebuconazole, the burden of proof is higher. Applicants must demonstrate that banning the substance would have severe societal consequences or that the substance is strictly essential for public health/safety.
The window to influence the regulatory trajectory is now open but finite. To mitigate market access risks, stakeholders must move with urgency. Failure to demonstrate the absence of suitable alternatives or the necessity of derogation could result in market removal. All comments must be submitted via the ECHA website by the respective deadlines.
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