We know that Scientific Consulting Company (SCC) is one of Europe’s largest privately owned and independent regulatory consulting companies on agrochemicals and biorationals, including biostimulants and fertilisers, etc. Recently, Dr Lars Huber,Head of Biostimulants, Fertiliser, IPM of SCC, received AgroPages’ interview to share his opinion on the biopesticide and fertilizer regulation in Europe.
In spite of the fact that low risk substances were introduced in EU 10y ago only 16 low risk substances are currently approved. What are the reasons?
First, most of currently registered low risk substances are new actives and due to the given timeframe for approvals it takes several years to get a new active approved. Second, the renewal process for many already approved substances which would qualify as low risk is currently ongoing or starting soon, but their low risk status will only be affirmed after completion of the renewal process, for which also lengthy timelines are fixed.
But regardless of new active or renewal, the biggest problem and the biggest waste of time and money is that the existing regulatory definitions and data requirements for an active substance approval were designed for conventional chemical actives and do not match with the characteristics of biologicals. The scientific and technical knowledge on the characteristics and use of biologicals is not the problem but the implementation of all this knowledge and progress gained in the regulatory registration process. Take, for example, the only currently applicable low risk criterion for microorganisms. To have included, after more than 30 y of research on the use and regulatory requirements for microorganisms, only one low risk criterion, namely the multiple resistance to anti-microbials, shows how far the regulatory process is away from scientific reality. These discrepancies, highlighted again and again not only by scientists and industry as well as a few experts from regulatory authorities but also by various recent resolutions of the European Parliament, are the main problem.
Of course, also the comparatively low demand for low risk products from end users is a problem, as a higher demand would increase the pressure on stakeholders to establish suitable and harmonised rules. But this is another issue, closely related to the lack of implementation of IPM. However, in the end it’s the same story, lack of implementation and lack of suitable regulations and guidelines.
But new data requirements were published in 2013 and low risk criteria in 2017. Why are there still problems then?
As already indicated for microorganisms, the current data requirements are newly published but this does not mean that they are sufficient or suitable. The criterion of multiple resistance to anti-microbials for microorganisms mentioned above considers the low risk status. If this would be the only criterion identifying a low risk microorganism this would be beneficial for producers but of course would not be sufficient to guarantee safety for humans and the environment. But to stay with the example of microorganisms, the general data requirements of 2013 in Regulations 283/2013 and 284/2013 were newly published but are more or less a copy and paste of the data requirements of 2001, which were never designed for microorganisms and themselves are a copy and paste of the data requirements for chemical actives. Have a look for example at the use of the regulatory terms “metabolite”, “relevant metabolite” or “secondary metabolite”: Useful for chemicals but having nothing to do with the biology of a living microorganism. Similar for other biologicals - the non-microorganism data requirements applying to chemicals as well as biological - the specific character of e.g. botanicals is not or not fully accounted for.
But there are also several guidance documents available.
True, but in these cases the situation is similar to the one already mentioned above. Insufficient and/or outdated or not covering all types of biological/low risk substances and characteristics, especially naturally occurring substances with natural background levels. In addition, availability of guidance, guidelines etc. is not the same as their implementation, at least not a harmonised one. Commenting tables of ongoing approval procedures imply that between evaluators from different member states but even within the same country different interpretations are used and box-ticking of unsuitable data requirements can still often be seen although scientifically sound counter argumentation was provided.
What is your advice for companies which want to register biologicals in EU?
I think the most important issue is to choose a different approach to study programmes and dossier preparation compared to chemical a.s., meaning not a regulatory but a scientific approach using scientific sound argumentation, public literature, if applicable natural background values and exposure scenarios, etc. Why? Because adapting the characteristics of biologicals to unsuitable regulatory requirements does not work, this was attempted again and again. Therefore, the regulatory requirements have to be adapted to the characteristics of the respective biological. This is only possible by a scientific approach. And this registration strategy should be started as early in the registration process as possible, at best already at the R&D stage. If academia are involved in R&D of a new active and results are to be published for example, already the publications should consider EFSA requirements for literature data to avoid problems or rejection of the publication later on.
How do you see the impact of the new European fertilizer regulation to the industry?
This is difficult to answer as the new Regulation will apply only from 2022 onwards and many critical issues will only be worked at in the coming years until applicability of the regulation. For many Product Function Categories (PFCs), at least the simple ones, I think overall market entry will be much easier and straightforward. For PFCs like biostimulants it is quite similar to the problems as for registration of biopesticides as discussed above. At least at first it will most likely be getting complicated and the current Regulation does not really clarify many important questions for industry, such as the real data requirements for product registration or if and how new component materials can be added to a respective Component Material Category (CMC). How beneficial this new Regulation will be will mainly depend on how good and how transparent the implementation of the Regulation will take place until 2022, especially in regards to the bias between plant protection active substances and biostimulants. Most problems most likely will arise in this area but it is too early to make a sound guess. Based on the decade-long experience with the national procedures of certain EU Member States with the registration of biostimulants and biostimulant-like products I would advise all manufacturers of such products to monitor the future developments very closely and develop suitable strategies for their actives and products.
Considering all these new regulatory developments in EU, are there any benefits for registration of biorationals on a global scale?
Yes, absolutely, whereat the common EU bane, the regulatory approach, in this case is the boon. Many countries worldwide are currently looking for and trying to develop a regulatory procedure for biostimulants, some of them being a long way off from a final framework. EU is the first to have finished this process at least in regards to definitions and distinction between biostimulants and related products and plant protection. Regardless if one agrees to the differentiation established now, it is better to have definitions available than having no concept on hand to work with. In this, EU has a pioneering role. Many countries are already indicating that their regulation will bear upon the EU approach. Thus, as with active substance approvals and certain national fertiliser registrations at present it may be the case that non-EU-countries will quite easily accept EU registrations in a mutual recognition-like way. This would ease global registrations for certain products such as biostimulants, a huge benefit for industry.
Please share the advantages of SCC to help clients to register biopesticide in EU?
As indicated above, I think the world of chemical pesticide registration is completely different to the world of biorationals. The lack of suitable guidelines and guidance as well as harmonised approaches and concepts making it necessary to be very flexible in regards to the development of suitable registration strategies. Being an independent company, SCC can react to this by using its available global network of co-operation partners, especially including universities and R&D research institutes. Combined with 30y of experience in regulatory matters for different substances and products in plant protection, biocides, food and feed etc. SCC is well prepared to cope with the challenges of the registration of biorationals.
This article was initially published in AgroPages '2019 Biologicals Special ' magazine. Download the PDF version of the magazine to read more articles.