Biopesticides and Biostimulants in Europe:
What Should We Do?

 

 

Certis USA: Overall we see significant expansion in the market in Europe for bio pesticides.  With the European retail market under pressure to reduce pesticides in produce with  initiatives such as residue-free specialty crops (zero detectable residues in fresh produce), and the withdrawal of a number of conventional pesticides, we believe that the strong growth the European biopesticide market has experienced over the last several years will continue. The key challenge to the industry is to develop environmentally sustainable systems for controlling pests while maintaining crop quality, productivity and profitability.  Integrated Crop Management (ICM) strategies are gaining momentum in Europe, where we see microbial and botanical products from Certis USA and other suppliers used successfully in programs with chemical pesticides and classical biological control agents (beneficial insects) in the overall farm/ crop plan.  The need for improvement of the regulatory system in Europe is another challenge to this growth.  This entails: 1) successful implementation or revision of the EU Directive 91/414 regulation,  2) a simplified registration process for biopesticides, especially those naturally-occurring materials such as neem extracts that fall under Plant Protection Products (PPP) legislation but are treated the same as synthetic chemical pesticides by the authorities, and 3) simplifying the mutual recognition arrangement between the EU countries. 

 

Crop IQ Technology: Globally, Europe is the second-largest market for biopesticides consumption, and we expect a tremendous expansion and growth of effective alternatives of conventional chemicals/ pesticides, specially after the recent ban on the use of some strategic convectional chemicals/pesticides is expected to dramatically enhance the growth of any potential effective alternatives. This will definitely lead to create better conditions for developing new eco-friendly products to fill the market gap. 

 

Unfortunately we are facing some obstacles in the EU market, as the EU regulatory process is complex and cumbersome; the registration timescales of biopesticides are at least twice as long and double the cost of registration in many other regions. Simply this situation is discouraging product developers from applying for registration in Europe or even investing on related R&D projects. 

 

On contrary US still leads the way in biopesticides, the US Environmental Protection Agency (EPA) has established itself as the world leader in biopesticide regulation. It has pioneered the simplification of the registration process for biopesticide products through the development of modified test methodologies with reduced data requirements that have significantly lowered registration costs and timescales. The success of this approach is reflected in the fact that today US farmers today are having many effective and economical tools to replace chemicals with biopesticides, which pushed the US to its leading position in this field.

 

China and India as well are considered as the driving forces in the growth of biopesticides. I believe both countries will be the global source of economic biopesticides not only to Asia pacific region, but also to the whole world. 

 

Bioline AgroSciences: The European biopesticide market is growing and will continue to grow for row crops and specialty crops, due to the following opportunities and challenges : 

- increasing consumers’ demand for zero residue products 

- increasing demand for organic products 

- increasing resistances of pests with no solutions available  

- demand from users (farmers and growers) for less harmful products for the applicator 

- regulatory issues and harder legislation towards conventional products 

 

Biolchim: The importance of biostimulants is increasing very fast both at the global level and in Europe with forecasted double-digit market growth for the next 5 years according to market reports. 

 

In Europe, the increasing focus on more efficient use of agricultural inputs, the necessity to cope with environmental stresses, and the enhancement of produce quality required by consumers are major factors driving growth in the market. In that sense biostimulants are seen as innovative solutions that address the actual needs of the farmers. 

 

One of the biggest challenges comes from the regulatory situation which is very complex today. Europe is still lacking a harmonized framework for biostimulants, which makes the market fragmented and forces manufacturers to deal with different sets of national rules. The new fertilizing product regulation that is currently being discussed in Europe will provide one set of rules for all countries that will underlie a single biostimulants market. 

 

In the future, the establishment of the new regulation, further R&D studies, increasing awareness of the agronomical benefits for farmers, will play an important role for the growth of the biostimulant market.

 

Tradecorp: The biostimulant segment opens a very interesting door for agriculture and brings great opportunities for all the players in the value chain. Europe, the world leader in biostimulants, is a very dynamic market, with a very high growth rate. This has attracted many players not only from around Europe, but also from many other countries that, attracted by the opportunities, decide to invest and increase their presence in Europe. 

 

Undoubtedly, this has brought an increased competitiveness as well as a change in the structure of this industry. The European biostimulant market used to be a scenario dominated by small and medium-sized companies, especially regional. Now, large companies with a strong M&A strategy, either specialized in biostimulation, or in the nutrition or protection businesses, have stepped in, as we have recently seen in the new companies that joined EBIC. 

 

Despite this change in the scenario, great challenges and opportunities continue to emerge within the biostimulant industry. For example, achieving greater productivity and profitability is no longer the only concern for farmers. In addition, today, they must face the consequences of climate change, while simultaneously meeting the final consumer’s growing demand for healthy eating and the minimization of the environmental impact.

 

Feem O Feed: We see, as well as others an increasing demand for these products.  Because this has been happening, a lot of different producers has been trying to get a piece market. We have seen that the quality was not everywhere as good as they claimed. Therefore, a lot of first hour users did not receive the results they expected. This resulted in a misconception of the effect a good product good give. The challenge in the market is to get these users to realize that a good quality product could be of great help to the plants fertility.

 

 

Certis USA: We see the commercialization of biopesticide in Europe affected strongly by the regulatory environment in Europe. Overall, the European regulatory process is much more complicated and demanding compared to the USA.   For some biopesticides, the regulatory authorities demand the same information required for registration of synthetic chemical pesticides.  In some cases we have seen that the regulatory agencies in Europe are overly risk-averse, especially when it comes to EFSA recommendations.  Given that biopesticides can make an important contribution to the development of environmentally sustainable systems for controlling pests we believe that improvement of the European regulatory system will lead to more products reaching the market. 

 

Crop IQ Technology: Frankly speaking and as mentioned before, the EU regulatory process remains complex.To be more specific biopesticides based on microbial, biochemical and semiochemical are registered under the same regulatory framework as chemical pesticides although some special provisions have been developed. Imagine the legislation provides for measures that favour the registration of products defined as ‘low risk’ but the process has not worked well in practice. 

 

Additionally, there are significant inconsistencies between the rules for products destined for organic and conventional agricultural production. 

 

Bioline AgroSciences: The biopesticide registration regulations in Europe is often made of 2 steps: the first one is a submission to Registration on a European level followed by a 2nd level with a national authorization. 

 

Homogenization of European rules among the countries will probably remain a difficult case, but we could expect easier processes of regulations for biopesticides in the following years, as the market need urgent solutions to face pests new resistances and lack of solutions to solve these problems, and it also faces increasing demand in more friendly environmental products and solutions. 

 

These challenges will weigh on the European regulations evolutions in the next years. 

 

Biolchim: Currently, there is no harmonized regulation at the EU level, but biostimulants are included in the new fertilizing product regulation that is under discussion. This framework will provide a common definition of biostimulants, and rules for placing products on the European market, which will facilitate trading and increase trust between consumers and industry. 

 

Tradecorp: To date, no global legislation at the European level exists to regulate biostimulants. Therefore, the regulatory evaluation is performed country by country, by complying with the requirements demanded by each one of them. These requirements vary and can range from a self-verification of conformity to registration processes that can last up to 2 to 3 years and include efficacy, toxicological, ecotoxicological tests... Within the EU there is the option of mutual recognition from one state to another, however, in practice, this is not always effective. 

 

In this scenario, it is great news to hear that the European Commission has made a legislative proposal to create a harmonized regulatory framework for fertilizer products, including biostimulants, applicable for the whole EU. This framework would not only have a positive impact at the administrative level (a single "registry" would give access to 28 markets); but also on the recognition of these products and as a means to guarantee their quality. In addition, the approach of the new regulation, based not only on content control, but also on the demonstration of claims, will guarantee the quality and effectiveness of biostimulation products in the market. Another aspect to highlight is safety: the new regulation does not only set limits for contaminants and pathogens, it also follows other European regulations that control chemical safety (I.e. REACH), taking care of food safety from the beginning of the chain, from the production of food and the protection of the environment.

 

 

Certis USA: Certis USA recognized from an early stage that our strength is in shepherding new products through the development, manufacturing scale-up, registration, and commercial launch stages, rather than early stage discovery R&D.  We have a team that is very experienced in turning discoveries into products, whether those discoveries come from public research institutions,  small start-up labs, or from industry discovery programs by way of our Mitsui connections.  This was exemplified by our launch in 2017 of LifeGard™ WG biological plant activator, based on a university-discovered Bacillus strain, which received awards from both Agrow and the International Biocontrol Manufacturers Association (IBMA) in recognition of its novelty and potential market impact.  We follow a traditional 2- or 3-step distribution strategy in most of our markets, selling our products through a country-specific mix of multinational, national, and regional distributors (including Mitsui & Co. in some areas).  In the USA we maintain our own field sales and technical team who are quite active generating pull-through at the grower and retailer level in the agriculture markets.  In other markets such as professional ornamental horticulture and consumer home & garden, we work through channel partners who offer Certis USA-manufactured products under their own brand as subregistrants.  Whether pertaining to the product development process or market presence, we have learned through experience that it is important to recognize our strengths as an organization and focus our own efforts in those areas, and form strong partnerships rather than overextend into areas outside our expertise.  

 

Crop IQ Technology: We believe that developing a novel biopesticide needs less than USD 5 million and from three to four years for the same process. As a less expensive and quicker development process compared to developing conventional chemicals, which will translate that biopesticide R&D can be more attractive for start-ups and small companies with limited research budgets. 

 

While all involved companies should set promising budget to educate the growers and enhance their awareness and knowledge about importance of the biopesticides, in addition to promoting use of biopesticides should be under the Integrated Pest Management approach, which employs cultural, mechanical & biological methods of pest control along with need based judicious use of chemical pesticides. 

 

Bioline AgroSciences: As experience from Bioline Agrosciences in developing biocontrol and biopesticides, we think there are 3 main things to do to succeed with these technologies: 

 

- demonstrate the efficiency of biosolutions & biopesticides to distributors, farmers and growers: that’s what we do since more than 30 years around the world on many crops and ways of producing – distributors, farmers and growers need to be sure of the efficiency of the products when using a biopesticide or a biostimulant 

 

- training for distributors, farmers & growers to biosolutions & biopesticides products: today most of the people think that biopesticides are less efficient and more costly than chemical products – the major thing we have to do today is to train the users and distributors bringing them the right information, which mainlyl lack on an advisor or user level 

 

- demonstrate the facility to use biosolution and biopesticide products: people often think that these products are more difficult to use than a classical product, which is a false idea 

 

Biolchim: R&D is crucial to driving innovation and that is why we invest a significant amount of our turnover on R&D every year. Key to success are the team and the product development strategy. Our R&D department is composed of scientists, agronomists, chemists and engineers, constantly committed to the development of innovative products that can concretely improve crop quality and yield creating value to growers.

 

Through the WIN network (Worldwide Innovation Network) we collaborate with leading Universities and Research Centers as well as commercial partners in all phases of product development, from ideation to marketing, to facilitate technology transfer and reduce the time-to-market of the products. 

 

We focus on testing our products in different regions and agronomic contexts. As you know, each country has its own traditional agronomic practices, climate and soil. Our team of agronomists assists with developing application guidelines in each specific region, taking local features into consideration. Locally, we make field trials, product demonstrations and participate in exhibitions. The team also takes care of collecting and analyzing field data that altogether constitute a wealth of information vital to promote a better understanding and an appropriate use of the products. 

 

Tradecorp: Biostimulation is one of Tradecorp's core businesses. Therefore, many of our efforts and investments are focused on research and development within this segment. Just to give an idea of what this market means for Tradecorp I will present you a figure: almost 40% of the products that Tradecorp launched in 2017 were biostimulants, including the launch of a range of products made of amino acids of vegetal origin. 

 

In addition, we have important projects underway with universities and research centers, which allow us to gain a better understanding of the physiological effects biostimulants have in plants. 

 

Biostimulants are very complex products; some of which have multi-component and active ingredients with different physiological effects. The physiological interaction between them has a huge impact on the performance of the product. Therefore, understanding a substance’s mode of action or its individual components and their interactions is fundamental, in order to develop a high performance biostimulant product. 

 

We are investing in several projects to delve into mechanisms at all levels (phenotypic, molecular and genetic expression), in order to develop products and solutions based on a deeper understanding of plant physiology. At Tradecorp, we believe that genetic expression research is the next fundamental step in biostimulation and, as a result, a great deal of our investments and efforts are focused towards this direction of research. 

 

Feem O Feed: We are just in the verge of launching this ourselves and we see some reservations in the more traditional markets. Trails we have been doing and user experiences make people more willing to assess the products themselves.  If the people cannot affiliate with a colleague-grower, or with other user experiences you see is harder to get people enthusiastic. It is our job to create the awareness and to create the added value it gives the users.

 

 

Certis USA: Compared to many other market regions, the impact of the extended European regulatory process on product launch timelines cannot be underestimated.   From start to finish, the first end use registration can take up to 4-5 years. Companies must take this into account when forecasting the business lifecycle of a new biopesticide product. 

 

Crop IQ Technology: First, companies need to pay close attention to compliance with regulatory and the EU laws. Second, they need to focus on educating the growers to ideally apply and evaluate the biopesticdes. 

 

Bioline AgroSciences: If a company wants to enter the European market, this company needs to pay attention to the following points: 

 

- regulatory issues (which are sometimes different between countries in UE) 

 

- answer to the market drivers on a product point of view 

 

- answer to the distribution network and bring the information on the right place 

 

Biolchim: There has been a boom of investments in plant biostimulants in Europe and the interest in this sector has increased enormously resulting in an intense competition. Also, there are challenges facing the market such as uncertain regulatory environment, market fragmentation and saturation in some countries. To succeed in such a competitive scenario, there is the need to propose innovative products, of very high and constant quality, and to offer growers qualified technical support to help them achieve their agronomic goals. All this has to come with a good degree of adaptation to the changing regulatory requirements. 

 

Tradecorp: The key to entering the European biostimulant market is to align with the challenges and opportunities of this sector, starting with the challenge of producing more, with a higher quality and with less environmental impact. However, even if aligning with the objectives of farmers is fundamental, it is not the only criteria to be taken into account. 

 

Feem O Feed: That Europe is a market with a huge potential, but it also has a huge amount of offers from third parties. Therefor good service, good advice and guidance, and a good and stable product. Are the most important to establish yourself in the EU market. On the outside it might look as a simple market to penetrate, but because we have many smaller end-users in comparison to the US, it is challenging to maintain your position.