How can consortia navigate Commodity Substances?
Koen Van Maldegem and Britt Gerritsen of Fieldfisher Belgium explain why biocides consortia need reinventing for Commodity Substances
The consortium for biocides was built on three assumptions: one substance, one dossier and one regulatory destination. With Commodity Substances, all three are challenged. The product or substance sells in markets that go far beyond biocides alone as the decisions taken in a biocides dossier follow it into related markets and the members paying for the dossier no longer want the same outcome.
Thus, a vehicle designed to share the cost of one submission then goes on to do something else: it concentrates risk. Here we explain why.
What consortia were designed for
Historically, the Biocidal Products Directive( BPD) encouraged joint dossiers and the creation of consortia for active substances in the review programme. As it was a directive, it still depended on the implementing legislation of each Member State.
The review programme has been extended to 31 December 2030; so many consortia formed under the BPD are still in place, governed by agreements drafted for a different landscape. Participants seeking review of the same active substance for the same product types have to make all reasonable efforts to submit a collective dossier, while respecting competition rules, and explain any failure to cooperate.
The incentive was practical too. Where a consortium submits several dossiers, the evaluating competent authority( eCA) prepares only one assessment report.
The Biocidal Products Regulation( BPR) repeats that logic for biocidal product consortia through the biocidal product family( BPF), which allows products to be grouped where they share uses and active substances, have similar composition within set variations and present similar levels of risk and efficacy.
Both models assume the participants are heading to the same place. Commodity Substances break that assumption in three ways: the molecule is regulated under several regimes at once, the members want different outcomes from the same classification and the rules they are building towards keep moving.
One molecule, many regimes
Commodity Substances are made at scale for many markets: ethanol, hydrogen peroxide, sodium hypochlorite, formaldehyde and iodine. The defining challenge is not the biocides dossier itself but the interaction between the various regulatory regimes.
A substance manufactured only for biocidal use is treated as registered for that use, but every other use remains fully subject to REACH. The BPR is often the trigger for harmonised classification, since biocidal actives are normally subject to it. Classification rests on intrinsic properties, which sits awkwardly with BPR exposure scenarios, ethanol being the clearest illustration.
The consequence for consortium design is direct. A conclusion reached for biocidal purposes does not stay in the biocides file: it follows the molecule into REACH registrations, downstream uses, restrictions and safety data sheets. A consortium whose mandate ends with the assessment report is governing only part of what it has set in motion. This is a dangerous game.
24 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981