Overview
According to the review programme of the European Chemicals Agency (ECHA), four active substances used for biocidal preservation—BIT (1,2-benzisothiazol-3(2H)-one), Formic acid, DBNPA (2,2-dibromo-2-cyanoacetamide), and MIT (2-methyl-2H-isothiazol-3-one)—are scheduled to receive formal approval between October 2026 and February 2027.
This marks the impending end of the assessment transitional period for these substances under the EU Biocidal Products Regulation (BPR, Regulation (EU) No 528/2012), and relevant companies should initiate compliance preparations as soon as possible.
Regulatory Background: Transitional Period and Approval Path of Four Substances under EU BPR
Under the BPR, active substances are categorized into "existing active substances" and "new active substances." The former refers to substances already placed on the EU market before May 14, 2000, which are permitted to be sold during the assessment period; the latter must obtain approval before being placed on the market. The four substances involved in this update are all "existing active substances" and are currently still within the assessment transitional period. Once formally approved, relevant products that have completed transitional period registration must complete the formal product authorization application within the specified deadlines—or face removal from the EU market.
Approval Schedule of Four Active Substances
According to the published approval plan, the estimated approval dates for the following four active substances are as follows:
Active Substance (Common Name/Abbreviation) | CAS No. | EC No. | Estimated Approval Date | Product Types (PT) |
BIT (1,2-benzisothiazol-3(2H)-one) | 2634-33-5 | 220-120-9 | October 1, 2026 | PT6, PT13 |
Formic acid | 64-18-6 | 200-579-1 | October 1, 2026 | PT6 |
DBNPA (2,2-dibromo-2-cyanoacetamide) | 10222-01-2 | 233-539-7 | November 1, 2026 | PT6 |
MIT (2-methyl-2H-isothiazol-3-one) | 2682-20-4 | 220-239-6 | February 1, 2027 | PT6 |
Note: PT6 refers to preservatives for products during storage; PT13 refers to working or cutting fluid preservatives
Next Steps for Companies
With the forthcoming approval of the four preservative active substances—BIT, Formic acid, DBNPA, and MIT, relevant companies should proactively plan and initiate the formal product authorization application process to ensure compliance continuity and avoid future interruptions in market.
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