BIT – one step closer to approval for PT6 and PT13

The Biocidal Products Committee of the European Union discussed in its September meeting (BPC meeting 52) Tier 2 efficacy data for BIT in PTs 6 and 13.

The BPC members concluded that the data requirements have been fulfilled and that efficacy has been proven. The BPC members adopted this opinion by consensus.

Assuming that subsequent deadlines will be met, the BPC process for BIT in PT6 and PT13 will be finalised by 21 January 2025. After that it is up to the European Commission to review the opinion and come to a decision on approval with the Member States representatives in the Standing Committee on Biocidal Products. Experience learns that this may take another 6 months.

Once an agreement is reached on formal approval, the Biocidal Product Regulation has to be amended (via an Implementing Regulation), which may take another 18-24 months. 

Although many applicants have started already, these timelines should give all applicants sufficient time to prepare their BIT-based product (family) dossiers for submission in 2027.

Until BIT has been formally approved under EU BPR for PTs 6 and 13, biocidal products containing this active substance that have already been notified/authorised under the transitional period (i.e. from BPD to BPR) in the various EU Member States can continued to be placed on the EU market.

After the formal EU BPR approval data for BIT for PTs 6 and 13, only the products that have been included in the EU BPR product (family) authorisation dossier are legally compliant. Once (and if) authorised under EU BPR, these products will benefit from a 10-year authorisation in the EU Member States where authorisation was sought (or from a 10-year period of EU wide authorisation in case Union Authorisation was sought).

The BIT active substance suppliers will most probably focus their efforts on the approval of the other PTs listed under Article 95: PTs 2, 9, 11 and 12.

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