Many biocidal actives no longer available
In 2013, when the EU BPR entered into effect, there were just under 1000 active substance/Product Type-combinations, based on just over 400 unique active substances. Currently, over one-third of the a.s./PT-combinations and 40% (!) of the unique active substance are no longer available in the EU.
Surprisingly, only 20% of the reduction seems to be due to authority non-approval decisions.
Based on ECHA data (i.e. the number of cancelled, expired or no longer supported a.s./PT combinations) this amounts to roughly 80% that seems to be based on lacking a positive business case for biocides industry to continue to support these a.s./PT-combinations.
The significant decrease in available biocidal actives warrant concerns as it is crucial to have access to sufficient a.s./PT combinations that are at least as safe and effective as the options no longer available.
Hurdle for innovation
Another data element seems to point out that very little innovation takes place in the biocides industry. Only 15% of the unique active substances is considered a new active substance under EU BPR. We would like to note that this number also includes a.s. that are considered ‘new’ because of a redefinition of existing actives based on the current EU chemical management schemes (e.g. REACH, CLP) and their substance definitions.
Having said that, when we compare the regulatory ‘rating’ of new actives with those of the existing actives under BPR, we see that the approval percentage is similar (around one-third). However, the new a.s./PT combinations do not make up for the ‘existing a.s.’/PT-combinations that are no longer available (either based on authority or industry decisions) – namely one-fifth versus one-third respectively.
There seems to be a significantly lower risk of non-approval for ‘new’ actives versus ‘existing’ actives (based on the number of authority decisions to either approve or not approve). We will further the investigate the reasons why.
We tentatively conclude that, despite this lower risk of non-approval for ‘new’ actives, it is still more interesting for companies to continue the investment in existing actives compared to ‘new’ active substances. The additional time-to-market for ‘new’ actives (at least 3-5 years) compared to that for ‘existing’ actives (3-18 months, depending on BPR approval status), seems to be such a significant hurdle that innovation related to new biocidal actives is seriously hampered.
Once approved, always approved?
In the Food & Feed Omnibus the European Commission entertains the thought to no longer use renewal applications for all a.s./PT combinations under certain circumstances (e.g. no new data that would affect the safety risk assessment under BPR). As we are not there yet, it makes sense to also take a look at the renewals that are currently taking place.
At this point in time, a quarter of the new a.s./PT combinations is under evaluation for renewal and roughly 40% of the approved existing a.s./PT combinations.
Taking a closer look at the year 2026, it is clear that not for all a.s./PT-combinations renewal has been sought (or progressed): 9 approved a.s./PT-combinations are likely to expire this year. For 2027 this number is 20 (vs. 27 renewals in progress) and for 2028 even 47 (vs. 32 renewals in progress).
Although there is still some time to submit a notification for renewal of approved a.s./PT-combinations that have an approval deadline ending in 2028, for 2027 the number of 20 a.s./PT-combinations where no renewal notification has been submitted yet might imply another few percentages of available biocidal actives might be lost in the next couple of years.
Conclusions
Since the introduction of the EU BPR, the number of biocidal actives and a.s./PT-combinations has been and is still steadily decreasing. This is already affecting (and will increasingly have an effect on) how we contain microbiological spoilage of materials avoiding waste, maintain proper disinfection level to protect human and animal health, manage populations of harmful insect and rodent species, protect critical infrastructure and avoid additional fuel costs due to marine fouling on ship hulls.
A sufficient number of alternative a.s./PT-combinations remains necessary to avoid that we throw away ‘the baby with the bath water’ and these alternatives need to be at least as safe and as effective as the a.s./PT-combinations that are no longer available.
Based on the above information, it seems that there is no clear incentive for biocidal industry to invest in new biocidal actives, despite the lower chance of non-approval. The reasons for this go beyond this analysis but let us know if you are interested to know more about this and we might cover this in a next post.
And keep an eye out for the updates on this website. In a next blog post we will take a deep dive into the reasons why these no longer available actives have been withdrawn from the EU market.
If you are interested to learn more on how Rules4Biocides can support your organisation with these challenges, or if you are interested in some more detailed numbers that form the foundation of this analysis, feel free to reach out to our founders, Annemarie Haasnoot or Martijn van Velthoven or contact us via the details on the website.
