BIOCIDES
Table 1- Elements of a flexible consortium structure
Element Data pool Sub-groups Ownership Submission options
Details
on what a classification costs them in disinfectants, cosmetics or industrial processing. A structure that can produce only one position funded by one budget and decided by one vote forces those members to choose between an outcome that damages them and an exit that costs them their data rights.
Product consortia, on the other hand, rely on a representative core BPF authorisation held by a consultant, with members covering their own products and uses through same biocidal products( SBPs). Revised guidance has narrowed families in practice to one representative product with many uses, or many products with the same use, changing how dossiers are built and defined. 3
SBPs must stay identical to the reference product apart from trade name, authorisation holder, authorisation number and manufacturers. Changes to the reference product must be made to linked products at the same time and cancelling the reference product cancels all of them. Article 22 of the BPR conditions may also require confirmatory data or a change application. Short authorisation periods force applicants to run authorisation and renewal in parallel.
Both types of consortia( i. e., product and substance) work against a patchwork of CA documents, coordination group agreements, guidance, technical agreements and practical guides. The fast-changing guidance affects both types and needs to be monitored closely.
References: 1: Commission Delegated Regulation( EU) 2017 / 2100 of 4 September 2017, OJ L 301, 17 November 2017, p. 1; Commission Delegated Regulation( EU) 2023 / 707 of 19 December 2022, OJ L 93, 31 March 2023, p. 7.
Centralised data set( testing, assessments) accessible to all members Optional, for specific formulations or use cases Joint data rights for data that members co-fund Union authorisation, national authorisation with mutual recognition or SBP
2: Regulation( EC) No 1272 / 2008, Article 37( 7), as inserted by Regulation( EU) 2024 / 2865 of 23 October 2024, OJ L, 20 November 2024.
For instance, cut-off rules vary if they concern a first authorisation or a renewal: two years before submission for first authorisation and mutual recognition, three and a half years before expiry for renewals. The exception matters most. Where superseded guidance would cause a level of concern triggering revision of existing authorisations, the eCA should require alignment with the newer guidance regardless, and work plans and budgets should assume that will happen.
Reinventing consortia
The three fault lines point to one conclusion: the shared asset is the data collected along the way, not the destination. Agreements must be flexible enough to absorb changed circumstances, changing guidance and legislation, and the vocabulary is shifting accordingly, towards data pool agreements, interest groups and memoranda of understanding( Table 1).
Members bring existing data into a sharing mechanism and then choose their route, individually or jointly within a sub-group. The pool can be closed or open to late joiners following a compatibility assessment by an independent consultant.
However, flexibility brings its own exposure. Aligning products and exchanging sensitive information on ingredients, compositions, uses and claims engages competition rules under Article 101 of the Treaty on the Functioning of the European Union( TFEU), particularly in product consortia, and common
3: CA-July19-Doc. 4.2-Final rev. 3, Implementing the Concept of Biocidal Product Family, as revised by CA-Feb20- Doc. 4.6 and CA-Jun21-Doc. 4.8.
applications for changes increase the volume of exchange.
The first mitigation is to agree upfront, based on objective criteria, a representative simple formulation that minimises disclosure of commercially sensitive data. The second is to fit into a safe harbour where possible: the De Minimis Notice, as well as the R & D Block Exemption and Specialisation Agreements Regulations. None is self-executing; each depends on restricting exchanges to what is objectively necessary and recording why.
The third is to build for duration. Renewal, confirmatory data and revised guidance can absorb as much cost as the first submission, and a structure funded only for that submission will not survive long term.
The case for cooperawtion is stronger than ever, but a singlepurpose consortium concentrates risk as efficiently as it shares cost. For Commodity Substances, the better model is a governed platform: common where interests align, modular where they diverge and disciplined with data and clean teams. ●
k J
Koen Van Maldegem
PARTNER, EU REGULATORY
Tel: + 32 2 742 70 62 koen. vanmaldegem @ fieldfisher. com www. fieldfisher. com
26 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981