Regulating Biostimulant Products
Posted 20th August 2018 by Jane Williams
Degrading soil quality and increased interest in sustainable farming have caused the biostimulant market to go from strength-to-strength and it is expected to reach $4.14 billion by 2025.  Despite this, companies have expressed concerns that the regulation of biostimulants will hinder industry growth and the longevity of small companies and start-ups.
We spoke to Nick Moon, Global Regulatory Manager, Plant Impact, to discuss the regulation of biostimulants and its impact on industry.
Can you tell us a little bit more about Plant Impact?
Plant Impact formulates products in the soy and wheat areas, but we also have a speciality crop division, operating in North America, Brazil, Argentina, and Europe.
In April, Plant Impact was acquired by Croda, which is a huge UK chemical company. They also have a plant health division, so that’s quite exciting. We will retain our Plant Impact brand and our name, but we will have increased support from a bigger organisation, which is great.
What does a typical day look like for you as Global Regulatory Manager?
It varies according to what projects we’re working on and how many deadlines I have to reach with regards to regulation, but usually I will need to keep myself updated on the situation in Europe.
We’re members of the Biostimulant Industry Council and they are very active in that area with their individual task forces, who work in various areas. Keeping abreast of what’s going on in Europe, while remaining proactive, is crucial because there are certain aspects of the regulation that we will disagree with or we would like to be changed, but we will discuss these thoroughly. We would like to make sure that we are fully involved in all areas there.
Globally, we’re preparing to get all of our compounds together to do studies in Brazil. My involvement at the moment includes looking at the kinds of compounds that we want to evaluate, analysing them from a regulatory perspective, and deciding how we need to get those compounds shipped across for further evaluation.
How are biostimulants currently being regulated?
It’s quite exciting. This will be the first time that biostimulants will be defined in the regulation. The first line of regulation involved creating the term ‘biostimulants’ and the specific definition. Then the next steps involved going through various processes with the council and the parliament and get to work to move forward from there. Basically, this is the first time that we’re going to have a proper definition of a plant biostimulant in the regulation and this will give access to single market biostimulants for the first time.
In fact, in the USA, there will be a biostimulant coalition. Their definition of a biostimulant has just recently been drafted and in it there’s a farm bill, so that’s exciting too. However, they are behind, as they have to go through all the legislative processes, but in Europe, we’re marching further forward.
What will it mean for industry and will the new regulation present any challenges?
There’s no doubt about that. As I said, the access to single markets will be provided for the first time. With regards to positive uptake, I don’t think it produces a level playing field. There are lots of products on the market that we hear about all the time: you get these promises claiming to do wonders and often they don’t have any backup studies in the field standing behind them and there are no organisations that regulate that.
We need to pull everything together and make the industry aligned with the biostimulant aspect of the regulation. There will be challenges, but Biostimulants are incredible. It can be a substance or a microorganism, so it has the potential to change the possibility of a lot of compounds and these different microorganisms.
Companies will be influenced. For instance, more than half a dozen companies have suddenly looked at the challenges of heavy metal in the formulation. Cadmium is being regulated, but reaching those regulatory levels is often very difficult. But you need to embrace those requirements and face those challenges.
There are individual challenges for each company, depending on their biostimulant formulation, and one of the general challenges as the regulation moves forward is that there is the probability of stricter requirement. This is still in the discussion phase and anything can happen.
When do you expect the regulation to come into place?
Well, at the moment, it’s going through the so-called ‘trial’ phase, so the three institutions are engaging in discussions to try to reach a compromise on the final text. There’s a deadline of the 10th of April 2019, because we feel an agreement has to be made before the European election because the text might be abandoned.
We expect the regulation to be fully operational a couple of years after publication because there are various elements that still need to be finalised. For example, assessment bodies still need to be set up and there are numerous standards that need to be drafted. We think that the regulation should be fully operational should be fully operational in 2022 at the latest.
What kind of support can the European Biostimulants Industry Council offer?
The European Biostimulants Industry Council is the voice of the industry. We’re made up of about fifty-four companies. We are split into different task forces: the national task force, such as the UK task force, the German task force, and the Spanish task force. Then there are individual task forces within that structure, such as ‘inorganic’ and ‘organic microrganisms’.
It’s all focused on getting what we want out of legislation and getting heavily involved with all of the institutions, whether it’s the domestic part of the council, the commission or the other institutions to support and advise and move the regulation in the direction that we want it to move. They are supporting industry in a big way and bringing it altogether to try to achieve the same goal.
Regulation was clearly a key theme at the Partnerships in Biocontrol, Biostimulants, & Microbiome event, which illustrates how much of a concern it is for companies in the industry.
Especially with regards to biostimulants: all the fertiliser regulations will involve biostimulants, so the REACH (Registration, Evaluation, Authorisation and Restrictions of Chemicals) aspect is a particular challenge for smaller organisations. Because, at the moment, with how the draft stands, the problem is that if small organisations have to start thinking about putting a dossier together for some of these biostimulants components, then we’re talking about a €80,000 to €100,000 price tag, which is not exactly what a small organisation, who’s moving forward and trying to increase their revenue stream, wants to hear. That’s just one particular challenge, but it is one that we would like to be sorted out as the discussions move forward.
Do you have any advice for any biostimulant or biologicals companies that are trying to get their products out there?
You’ve really got to know what’s happening with the regulation. You’ve got to keep up with it and not just sit back and let it suddenly swamp you. You’ve got to move forward and be prepared to be active in these forums and try to gain information from other experts in the area.
You really can’t afford to ignore the fact that biostimulants will be regulated. It’s not a question of if; it’s a question of when. You’ve got to stop and look at what kind of implications that has for your company and the kind of research you’re looking at and not just sit back and suddenly find out that you’re not compliant when you’re ready to bring your products to market. That’s obviously not what any organisation wants to have happen to them.
You need to embrace what’s going on and keep track of it and follow it and get involved if you can, which is then through such organisations such as EBIC, which is the kind of forum where they have proven experts in particular different areas that you can also tap into and gain knowledge from.
We’re all in it together. It’s not a question of viewing each other as competitors. We all know that we’re out there, trying to put products on the market that have value, and obviously have the function of a biostimulant and help improve crop quality and efficacy and so forth. We’re all doing the research element and at the end of the day, we’re all involved in the same goal.
When you go to forums, such as Partnerships in Biocontrol, Biostimulants, & Microbiome, you don’t see each other as competitors. It’s a really nice environment to work in and nurture. You can get a lot of information and also get a lot of expertise at a minimal cost.
Nick Moon joined Plant Impact in 2015 as Global Regulatory Manager. He has previously worked for other large companies in the biocides regulatory sphere, including the Dow Chemical organisation and Microban Europe.
To find out more about the regulation of biostimulants, join us in San Diego for the Partnerships in Biocontrol, Biostimulants, & Microbiome: USA. Find out more here.
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