Barabara Novak is an agronomic engineer and consultant who participated in the European Biostimulant Industry Council (EBIC) that interfaced with the European Commission (EC) with the aim to promote the development of suitable regulatory frameworks for biostimulants and specialty fertilizers. Novak presented a paper at the FERTASA Biofertilizer Workshop held in November 2017 on the European perspective of the development of the biostimulant / biofertilizer concept and definition and its implications for product placement in EU regulatory frameworks.
The use of biological products in agriculture and crop chemistry has gained considerable attention in the last ten years, and is now no longer considered as a “fad” of “fly by night” product segment and has evolved into a structural component of the crop chemicals market. They are considered as one of the most attractive investment segments in the crop chemicals industry with forecasted double digit growth for the next ten years.
Novak explained that the group of biological plant nutrition products that are referred to as biofertilizers in South Africa are referred to as biostimulants, metabolic enhancers, phytostimulators, plant elicitors, biogenic stimulators amongst other terms in other countries. The term biofertilizers used in South Africa refers to a specific group of products that are termed as biostimulants in Europe – biofertilizers are referred to as biostimulants for the remainder of this article.
The wide range of terminology and definitions used to describe these products is considered as one of the key barriers for growth of this segment of the industry and has created confusion in the market with negative implications for market development such as a lack of market information and product registries which influences industry validation which in turn is influences end-user acceptance and creates mistrust. Novak stressed that possibly the most important outcome is that a science based and industry accepted definition is a prerequisite for the development of a regulatory framework that can distinguish these products from existing legislative product categories.
The Development of the European Biostimulant Definition
Currently these is no regulatory or legally-accepted definition of biostimulants anywhere in the world including the European Union (EU). Literature reviews indicate that the term was first used in 1997 in a web journal for turf professionals where biostimulants were defined as “materials that in minute quantities promote plant growth”. The use of the words “minute quantities” distinguish biostimulants from fertilizers which also promote plant growth but in much larger quantities. In 2007 the term was first defined in scientific literature as “materials other than fertilizers, that promote plant growth”. The addition of the phrase “other than fertilizer” is significant as an early attempt to explicitly distinguish this class of compounds from traditional fertilizer products. In subsequent years the term has been used to define an even wider range of compounds and has been used as a versatile descriptor of virtually any substance beneficial to plants without being a fertilizer, Plant Protection Product (PPP) or soil improver. Clearly there was a necessity clarify the status of biostimulant products not just in the scientific community but also in the industry as well.
As a first attempt to rationalize and define biostimulants initial studies undertook a component-focused approach to identify, list and categorize all substances that were covered by the concept. Although there is no legal recognition, in general seven main biostimulant categories have been recognized based on source and content which includes both substances and micro-organisms:
- Humic acids/ fulvic acids
- Protein hydrolysates and N-containing compounds
- Seaweed extracts and botanicals
- Chitosans and other biopolymers
- Inorganic compounds
- Beneficial fungi
- Beneficial bacteria
Novak explained that products that carry the fungal or bacterial inoculum are defined as biofertilizers in the European context and are considered a niche segment of the biostimulant product category. It is evident that a very wide range of components that can be used to describe biostimulants which is useful to describe certain elements of this product category however it wasn’t very useful in providing a definition.
As a second approach there was a shift in focus from product component to product outcomes where complementary reviews collected, described and categorized the positive effects of biostimulant applications. Cellular, physiological, agronomic, environmental and economic outcomes were described which when considering the effects of applications on measureable crop performance only they could be categorized into a discrete set of agronomic outcomes such as growth promotion, modification of development, improved quality traits and enhanced tolerance to stress. From these studies common features and shared characteristics of biostimulants were identified laying down a science-based foundation from which a useful definition could emerge. These common features could be described as the following:
- that the nature of stimulants are diverse that they can consist of substances or micro-organisms of single or groups of compound,
- that their physiological functions when applied to plants are diverse, and
- the scientifically demonstrated effects converge into at least one or several of the discrete set of agronomic outcomes
The identification of these common features lead to the development of the official European industry definition which was proposed by EBIC:
“plant biostimulants contain substance(s) and or micro organisms whose function when applied to plants or the rhizosphere is to stimulate natural processes to enhance / benefit nutrient uptake, nutrient efficiency, tolerance to abiotic stress, and crop quality”.
Novak explained that there are three significant points in the definition, the first is that this definition focuses on agronomic outcomes which is significant because it is not practical to define products by their components or modes of action; its the agronomic outcomes that are really the crux of the definition as it is these outcomes that distinguish these products from other legislative product categories:
- Nutrient efficiency – nutrient mobilization, nutrient uptake from the soil, root development, N fixation, transport, storage and assimilation…
- Abiotic stress – enhanced tolerance to physical or chemical stressor of non-biological origin such as drought, salinity, cold…
- Quality traits – can include a diverse range of outcomes such as enhanced nutritional value, grain protein content, shelf life, coloration, ripening uniformity…
It is important to note that some biostimulants could elicit a plant protection response or enhanced tolerance to biotic stress, however there was a general consensus from the biostimulants industry to separate PPP’s and biostimulants from a regulatory point of view and so “biotic stress” has not been included in the scope of this definition.
The second significant point is that the components that form biostimulant products are not restricted by the use of the word substance which may be single or groups of compounds with variable or of unknown chemical composition. This is congruent with the use of the word “substance” in other EU regulations such as REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) (EC No 1907/2006), REACH recognizes and authorize the use of these substances. In this definition the word substance should be understood in a similar way and should leverage on the REACH framework.
The third point of significance is that the definition refers to biostimulants as a final finished product which acknowledges the multi-component nature of the product as well as the importance of the formulate in the commercial context for things such as application, efficacy and storage. This consideration also enforces confidentiality, protection of intellectual property and industry innovation.
This definition proposed by EBIC has not yet been accepted on the European level yet and as it stands today there is no distinct place for biostimulants in current EU frameworks which has created a complicated regulatory situation. Nonetheless biostimulants can be placed on the EU market by either the National fertilizer laws of each member state or the European law for PPP’s (EC No 1107/2009).
The EU regulation for PPP’s combines both national and supranational provisions for introducing PPP’s on the market which can be applied to all categories of biostimulants due to the very broad definition of PPP’s. However PPP registration is a very lengthy and costly process so most companies choose to register biostimulants via the fertilizer route which is problematic due to the large differences that exist in national fertilizer laws between member states.
The EU fertilizer law has a strict definition that recognizes fertilizer as a material with the main function to provide the primary nutrients (N, P & K), secondary nutrients (Ca, Mg, Na & S) and micronutrients (B, Co, Cu, Fe, Mn, Mo, & Zn) to plants. It is so restrictive that many plant nutrition products such organic fertilizers, soil improvers, growing media and liming agents can’t be included in the definition and as such biostimulants also cannot be included in the definition. Over 50% of the fertilizer products in the EU aren’t covered by this regulation and there is a need to create EU laws that make provisions for all fertilizer categories including biostimulants for an affective internal market.
The Need for Revision of EU Fertilizer Laws
In 2010 the European Commission (EC) along with the fertilizer working group initiated ambitious revisions to the EU fertilizer laws with the aim of creating and effective internal market ensuring the free circulation of all categories of fertilizer. In 2015 legislative revisions were fast tracked and prioritized as fertilizers were included in the “circular economy” plan. Draft regulations were released in 2016 in the form of a completely New Legislative Framework (NLF) whereby product registration is simultaneously considered according to two categories, a Component Material Category and a Product Function Category. Products that meet the requirements are eligible to receive the “CE” mark and can be circulate freely with the member states of EU.
This initiative has generally been well received by the industry and for biostimulants there have been some positive outcomes and significant achievements:
- biostimulants can now be included in the fertilizer regulation because of a new definition of fertilizers in the legislation.
- biostimulants have a distinct place in the framework under the product function category.
- this requires that biostimulants must have a legally accepted definition, by and large the EC has accepted the definition proposed by the industry with very few modifications.
- Another significant breakthrough is the amendment of the PPP regulations which specifically exclude biostimulants from PPP law, this keeps biostimulants within fertilizer regulation and outside the regulations for PPP’s.
The NLF is considered to be technically appropriate and valid because the EC have been open to receive feedback and input from stakeholders within the fertilizer and chemicals industry as well as supply chain and adjacent industries as well. There are however still some concerns with the NLF and uncertainties concerning efficacy trials and the range of outcomes and certification bodies, issues regarding product claims, uncertainties on micro-organisms and their will be regulation within the framework as well as with dual use products and how to distinguish the nature of products that have two functions. Discussions are continuing on the EC draft proposal for the NLF and a final version is may possibly be released in 2018.
There are many learnings from the European experience for the South African biostimulants industry that is navigating the regulatory framework of Group 3 fertilizer registrations. Two points of significance highlighted by Novak are that the right definitions are the foundation for everything and are the bedrock of any regulation and define the products and terms of their use. The second point is that transparency and multi stakeholder engagement with the regulating authority along with strong industry associations, common voice objectives and coordinated action, need a high level of involvement from producers, consumers, retail chains, chemical manufacturers are required. These two points are critical to get the right footing and promote the industry and create trust and credibility for the Southern African industry.