By Martijn van Velthoven, ERT

In the latest ECHA Biocidal Products Committee (BPC) meeting four opinions on active substances were adopted and concerns were raised on the number of non-supporting opinions due to incomplete data is on the rise.

Last May, one opinion supporting the renewal of dinotefuran (PT18) and another supporting the first approval (finally!) of polymeric betaine (PT8) announced.

Great news of course but not all news from Helsinki was positive…

The renewal of medetomidine (PT21) was advised against as well as for the first approval of the innovative CIT (PT6) active substance.

Renewal Medetomidine (PT21)

Let’s focus on the renewal dossier for medetomidine, a racemic mixture used in marine antifouling that is considered a Candidate for Substitution due to its classification. In such a case an Assessment of Alternatives is required. Usually it takes already a lot of time to identify what the the potential alternatives would be (but not if your company uses the Rules4Biocides tool of course!), let alone to find all the relevant technical and socio-economic data required for such an AoA.

Would Rules4Biocides have led to a different ECHA BPC opinion for medetomidine? Maybe yes: more time, resources and budget might have been available to strengthen the ingredient defense advocacy strategy as a whole but I guess we will never know for sure because Rules4Biocides was not live until after the BPC published its opinion…

Warning all BPR Applicants!

Finally, let me echo the warning of ECHA’s BPC Chairperson (voicing the opinion of the evaluating Member States) that if companies fail to provide the required data (although some crystal ball gazing might be necessary to fulfill these MSCA data requirements) within the process deadlines, the opinion of the Biocidal Products Committee will not be favourable….

So contact Rules4Regulatory if you need any help on either determining what data is (or will be) ‘required’ or in further ingredient defense for those Candidates for substitution!