1. EBIC‟s views on the options outlined in the pre-study of the revision of Reg (EC) 2003/2003
29 November 2011
The European Biostimulants Industry Consortium (EBIC) welcomes the inclusion of biostimulants in the review of Regulation (EC) 2003/2003. We offer the views of EBIC‟s members on the policy options being considered in the pre-study of the review and the implications of each option for the biostimulants sector.
After careful consideration of these options, as outlined below, Option 7 is most appropriate for our sector. Under this option, biostimulants would be included under an enlarged definition of fertilising materials, with common elements include in the framework regulation and biostimulant-specific provisions either in a separate chapter or a separate text that would already be cross-referenced in the framework regulation. EEBIC proposes a regulatory approach based on product claims, similar to the approach currently being elaborated for nutraceuticals/functional foods.
The innovative nature of the biostimulant sector requires a flexible regulatory approach. Flexible does not mean lower safety or efficacy requirements. In fact the EBIC proposal takes many best aspects of efficacy and safety from existing EU Regulations (REACH, PPP, 2003/2003) and incorporates these into a new proposal. Data protection would be foreseen through a manufacturer-based registration, thus nurturing innovation. The importance of a product from the agricultural point of view is its functional use, not necessarily what it contains. Thus, a claim-based approach linked to the functional use makes the most sense from a farmer/marketing perspective and allows regulators to focus on what matters most: giving farmers and other end users a choice of effective and safe products that allow them to grow crops and other plants ever more sustainably.
Because of the need for a framework that fosters innovation and is friendly to small and medium-sized companies, it is preferable for DG Enterprise to remain the lead directorate general on biostimulant regulation.
2. Biostimulants — a sector born from industry convergence and sustainability-driven innovation
The biostimulants sector is the result of industry convergence, the “blurring of boundaries between industries, induced by converging value propositions, technologies and markets [which appear] to be a pervasive phenomenon leading to the emergence of inter-industry segments.”1 In recent decades, agronomists‟ understanding of how plants grow has shifted significantly. Whereas earlier agricultural research focused on isolated functions (improved nutrition, fighting pests, etc.), researchers today increasingly look at how interconnected elements of the plant and its immediate ecosystem work together as a system. Instead of a simple input-output model (e.g. more nitrogen equals greater yield or better pesticides equal fewer pests), agronomists are increasingly studying and understanding the interdependencies and interactions within a plant and between a plant and its immediate environment, both the abiotic growing conditions to which it is exposed and the soil biodiversity with which it interacts. These synergies are the target of biostimulants products, and the sector has emerged at the same time that producers of plant nutrients are looking for ways to improve nutrient use efficiency and plant protection producers are looking for “softer” alternatives to traditional synthetic chemistry.
Although biostimulants were originally popularised in organic agriculture, they are increasingly moving into conventional agriculture. Biostimulants first moved into high-value agricultural and horticultural production and are increasingly used on other conventional crops2. This trend is likely to continue as application methods that can be scaled up are being developed.
Broadly speaking, there are several different types of companies operating in this sector: traditional input companies that are seeking to diversify their product ranges, green biotechnology companies elaborating products around a core set of technologies (not always limited to agricultural uses) and suppliers of “traditional” biostimulant substances such as seaweed extracts. Production processes are quite varied and may include mechanical extraction and mixing, chemical extraction and synthesis of “copies” of natural molecules, biological extraction and biological cultures. As a result, biostimulants include diverse formulations of compounds, substances and other products such as micro-organisms.
In this way, the emergence of the biostimulants sector is very similar to the emergence of the nutraceutical/functional foods sector, as this description reflects: “Although it is still in its infancy, and consequently riddled by irreconcilable definitions3 and typologies, this new market offering demonstrates significant growth potential that can be attributed both to changing societal attitudes towards health and to public policies”4. Unfortunately, the multiplicity of definitions makes it extremely challenging to compile meaningful quantitative data because definitions and classifications vary from one jurisdiction to another.
Innovation in the biostimulants sector can take several forms: formulations (ingredients, but also their combinations and synergies), production processes, and application/use. Because many of the basic ingredients in biostimulants are common in nature many products cannot be patented. Nonetheless, we have built an index of “innovation density” by comparing the number academic publications in a sector with the number of patents published the same year to give an indication of the level of innovation.5 According to this index, biostimulants and nutraceuticals both show a significant uptick in innovation since the turn of the century. It is not surprising that the consumer-facing nutraceuticals sector shows how a higher level of innovation, but the drop in nutraceuticals innovation since 2008 is notable and may be linked to uncertainties over the EU regulatory framework for these products dampening67.
We also looked at the amount of research being conducted as indicated by peer-reviewed scholarly articles. With the exception of two upward blips in 1996-7 and 2000, the trend has been steadily upwards since the early 1990s, with more than 150 research studies per year being published with the keyword biostimulant(s).8 In addition, there is a large amount of proprietary research being conducting by/for specific companies. EBIC members report investing between 3% and 30% of their annual turnover in research, with as much as 12% of their workforce dedicated to research.
3. A fragmented and contradictory regulatory patchwork currently exists
Because biostimulants sit in a grey zone between traditional concepts of plant nutrition and plant protection, attempting to classify them into existing regulatory frameworks has resulted in a fragmented and contradictory system in Europe. Amino acids are unregulated in some countries, categorised as fertilisers in others and at least some amino acids are assimilated to pesticides in other markets. In most countries, biostimulants are considered stand-alone products, and in France are only considered “additives”. Furthermore, in some countries products could potentially be sold under both regimes, and in other countries (like Germany) a product can either be a plant strengthener or a plant growth enhancer, but not both. There are also inconsistencies between the rules for products destined for organic and conventional agricultural production (see the example from Italy below).
To give a flavour of the current situation with regard to the fragmented regulatory landscape, EBIC members and stakeholders have provided summaries of relevant national regulations in selected EU member states:
France – Fertilisers, soil conditioners and growing media must have an authorisation to be placed on the market. Approval is based on agronomic trials, safety for humans, animals and the environment and quality assurance of the product composition. The cost of the dossier is 3,000-12,000 euros for the tax, around 40,000 euros for the dossier and 20,000-50,000 euros for the trials. The announced time to receive a response is 6 months, but it is usually 12-24 months. All of these products must respect agreed technical standards, and the French government does not apply Reg. 764/2008 to any of these materials. Biostimulants are currently not defined in a standard as a stand-alone product. For the past few months, it has been possible to include some “additives” like microbial preparations, humic substances and growth enhancers in growing media if authorisation has previously been obtained for the additive.
Germany – Regulations currently distinguish between plant growth enhancers, which are subject to fertiliser rules, and plant strengtheners, which are more or less assimilated as pesticides. A substance cannot simultaneously be a fertiliser and a plant protection product. Plant strengtheners include substances intended to increase plant resistance, to protect plants against non- parasitic impairments and for use on cut ornamental plants. The list of plant strengtheners is updated monthly and currently includes products containing some amino acids, seaweed-based products, plant extracts, sugar, phosphate and a variety of other substances.
Ireland – Products that make purely nutritional claims are unregulated and can be sold without proving nutritional claims through trials. If plant health claims are made, then the product must be registered in line with EU pesticide regulations. The department of agriculture advises companies (on request) of the need to register the product as a plant protection product.
Italy – In 2010, Italy updated its fertiliser law, which now includes a category for “Specific action products” acting on fertilisers, soil and plants”, and this corresponds to biostimulants among other products. This is based on a positive list. However, the Italian decree implementing provisions of the European regulations pertaining to organic agriculture (Reg (EC) 834/2007 et al.) also provides a list of products that can be marketed without prior authorisation, and this list includes “biodynamic preparations” (which are mentioned in article 12 of Reg (EC) 834/2007 without any further definition), propolis, stone dust, sodium bicarbonate, silica gel, edible vegetable oils, lecithin, vinegar, soap and quicklime. The decree specifies that these products can also be used in conventional agriculture. Provisos placed on this simplified process of putting products on the market: 1) They should not bear any plant protection claims. 2) Only generic names can be used on the label, which means that it is impossible to create and protect a brand/trade name.
Spain – Royal Decree 824/2005 includes a category of “Other fertilisers and special products” that includes amino acids and humic acids, among others. These products can be sold without prior registration but for any product containing organic matter, quality controls must include heavy metals and microbial contaminants. In addition, the national directive on biological control organisms (APA 1470/2007) has been extended to cover plant strengtheners, a category that includes seaweed-based products and some microorganisms. Products must be listed in a registry of approved products before they may be put on the market.
United Kingdom – There is no specific regulatory framework in the UK, and products do not have to be registered as long as they do not claim any direct effects on pests or diseases. Manufacturers of biostimulants usually check with the Chemical Regulation Directorate (CRD) in advance to make sure that their products and claims are considered outside the scope of pesticide regulation. However, in order to be able to make marketing claims with regard to secondary effects on plant health, some companies has voluntarily registered products that would otherwise be unregulated under the pesticide framework. The CRD has indicated that it is reviewing the situation, but no public announcements of policy change have yet to be made. Mixtures of biostimulants with nutrients can be sold under the Fertilisers Regulation, and only the nutrient content needs to be declared. It is not necessary to validate the claim of the biostimulant effect.
Bringing greater clarity and predictability to the European market
EBIC suggests the creation of a regulatory framework that would recognise the diverse nature of biostimulant substances and protect the innovation in the new generation of such products while ensuring a high level of protection for end users and consumers. Biostimulant effects are not just the result of isolated ingredients but also result from synergies among them and in the plant production systems to which they are applied. We therefore propose an approach that is focused on product claims, similar to the system currently being elaborated for nutraceuticals/functional foods. According to the European Commission9, “The Regulation on Health and Nutrition Claims aims to ensure that consumers are not misled by unsubstantiated, exaggerated or untruthful claims about foodstuffs. With the new legislation, consumers will be able to rely on clearer and more accurate information on food labels, enabling them to be properly informed on the food they choose. This ties in with the EU campaign for healthier lifestyle choices, as well as the Commission‟s consumer protection objectives. The Regulation also aims to provide food producers and manufacturers with clear, harmonised rules that would ensure fair competition and help protect innovation in the food industry, by ensuring that manufacturers making genuine health and nutrition claims are not competing with false or inaccurate claims.” A parallel approach for biostimulants would provide end users (farmers and gardeners) with clear and accurate information to allow them make informed decisions about options for more sustainable production while providing the biostimulants sector with the necessary framework for fair competition and robust innovation.
Under such an approach, claims relating to the enhancement of the plant‟s growth and quality (such as “improved tolerance to abiotic stresses”, “favours higher sugar content”, stimulates chlorophyll production…) would be allowed on any label so long as the producer can verify the link between the claim and the product (which includes demonstrating effectiveness in use either through compiling existing data or conducting new trials), and the product complies with the described physico-chemical product characteristics and basic safety requirements.
Briefly, a producer would submit a registration application for a specific formulation that claims specific effects and the conditions under which those claims are valid (crop, growing conditions, application instructions, etc.). The producer must defend the safety of the product on the basis of a number of usual criteria. The data for justifying the safety should, to the extent possible, be recycled from existing sources (REACH data, scientific literature, other jurisdictions, etc.); new studies and tests should only be required when the data cannot be produced in any other manner. Furthermore, appropriate waivers should be de rigueur, e.g. for substances that are approved as foodstuffs. The producer must also justify the claim by demonstrating the product‟s effectiveness under the conditions specified. Again, new trials should only be required if there is not enough existing data from other sources to justify the claim. In order to protect innovation, the exact formulation and study data would be confidential elements of the registration dossier, while a general description would be made available on the label so that end users are able to make informed decisions and to use the products appropriately.
4. Some things that distinguish biostimulants from other crop inputs
Biostimulants are one of the oldest agricultural inputs used by humanity, and yet the research & development phase of their history is only a decade or two old10. Knowledge about biostimulants substances and how to use them has been growing rapidly in recent years as researchers begin to understand the complex interactions within plants and between plants and the soil ecosystem in which they are rooted. Biostimulants are different from both plant nutrients and from plant protection products and are complementary to their use. Once reserved largely for organic production, biostimulants have an important role to play in helping to improve the efficiency of conventional agricultural.
• While some biostimulants may contain small amounts of nutrients, but their main function is not to provide nutrients for plants11.
• Biostimulants are produced through a variety of manufacturing processes, some of which may be unique to the producer company. This reduces the feasibility of positive lists of products or standardisation. Production processes may be patented.
• Biostimulant formulations can take many forms, but often include fairly common substances. Few biostimulant substances or products are patentable (in part because many substances are derived from nature or copied from nature and not synthetic molecules), yet effective biostimulants require a significant investment in research and development with regard to formulations, novel uses for well-known substances and developing appropriate application protocols.
• Biostimulants differ from crop protection products because they act only on the plant‟s general vigour and do not have any direct actions against pests or disease.
• Biostimulants are used in relatively small quantities of active ingredients, making parallels to high-volume, commodity- based products like fertilisers inappropriate.
• Biostimulant companies are often small or medium-sized enterprises. They are often located in rural areas, thus creating much needed knowledge-intensive jobs outside of traditional economic centres. 5. Why is it urgent to regulate biostimulants at the EU-level? Biostimulants currently face a fragmented regulatory landscape, a landscape that changes from one member state to another and sometimes from one day to another within a given national market. There is no single market for biostimulants. This raises the costs of doing business and puts a brake on the development of a highly innovative sector. The contributions of biostimulants have the potential to be wide-ranging:
• They are a powerful set of new tools to improve the efficiency and quality of farm production; among other beneficial effects, they reduce nutrient losses and increase nutrient use efficiency so that farmers receive a better return on their investment in fertilisers, and they support plant vigour so that plants require fewer treatments of plant protection products and respond better to their use. EBIC members report that their products raise yields, help increase fertilizer use efficiency (and thus reduce losses to the environment) and improve water use efficiency. Exact ranges depend on the basis of the crop, original state of the soil, how well managed crops already are and a number other factors. Minimum yield increases being reported are 5-10%. Fertilizer use efficiency is being documented to
increase by 5% at a minimum (and often much higher). If this conservative figure were generalised to the entire EU, it
would mean a savings of some 517,000 tonnes of nitrogen fertiliser in a single year.12
• The biostimulants sector is a driver of innovation and the creation of knowledge-intensive jobs.
• Biostimulant facilities are often located outside of traditional concentrations of economic activity, bringing high-quality jobs to rural economies. Our sector can make an important contribution to the “smart, sustainable and inclusive growth,” outlined in the Europe 2020 Strategy, but only if an appropriate regulatory framework exists. The current situation creates too much uncertainty and slows down innovation and the investment that feeds innovation. Although it is difficult to argue what would happen if the situation were to change, we can extrapolate from the nutraceutical sector. Although it is much closer to securing appropriate claims-based regulation at EU level, difficulties in finalising a list of approved food health claims is already slowing down innovation in the food sector by obliging manufacturers to fall back on more general (and less differentiating) claims1314. If the European Union truly wants to green the Common Agricultural Policy, then it needs to invest in the regulatory framework that will foster the necessary innovation. 6. EBIC‟s evaluation of the options outlined in the pre-study for the review of Reg. (EC) 2003/2003 Option 1 – baseline option with no policy change The current regulation 2003/2003 specifies that a “fertiliser means material, the main function of which is to provide nutrients for plants”. The regulation then goes on to list the nutrients in question. While nutrients may be among the ingredients in a biostimulant product, this is not always the case, and it is never their primary function to provide nutrients. Biostimulants would remain unregulated in various Member States as is the situation today. This would allow the commerce of unverified products. The lack of regulation for biostimulants would be inconsistent with their potential important role in the future of sustainable agriculture through more efficient nutrition and more tolerant plants. Furthermore, if the regulation were to remain at Member State level, recent experiences in mutual recognition show that it is at best difficult to make work, and constitutes a real practical barrier to intra-EU trade. Please see below for some concrete examples. It is critical that the market be regulated in a harmonised way, to ensure the same rules for everyone in all EU Member States. Some practical examples experienced from the lack of harmonisation and working of mutual recognition for biostimulants and classical fertilisers: 15
1. Present lack of Mutual Recognition leads to the following practical barrier to inter-Member State trade:
• Italy/Hungary: in Hungary, 2 years of experimental trials are required for registration of biostimulants containing organic matter (non-EC Fertilisers)
• Italy/France: problems with registration in France of biostimulants containing amino acids
• Italy/Spain: problems with registration in Spain of biostimulants containing algal extract.
2. In Italy seaweed extract of a certain profile is recognised as a fertiliser material under the national Italian fertiliser legislation. In Spain, since the listing of a seaweed extract in Annex I of 91/414, it has refused to recognise the registration of a seaweed-based product as a fertiliser, even through mutual recognition from Italy. Multiple companies have had this problem. One submitted a request to register a seaweed extract as “Fortificantes- otros medios de Defensa” according to the APA rules Orden 1470/2007 2 years ago, but no response has been received and this product has not yet been registered. This product is currently being sold only because the law allows the product to be sold if the company has not received any refusal from the authorities in a timely manner.
3. Although not a biostimulant, a recent experience of an Italian company trying to sell a micronutrient complexed with ligninsulphonate (LS): this product is legislated for in Italy in the fertiliser law (75/2010), and the company legally sells the product in Italy. The equivalent category in France does not exist, and the attempt to sell in France using mutual recognition resulted in a request to produce a dossier with an estimated cost of 20,000 euros for registration in France.
4. A further example of a fertiliser is Ca-EDTA. It is not an EC-Fertiliser. In Spain this product is recognised as a fertiliser product according to Spanish national legislation. In Italy it is not recognised as a fertiliser in national legislation. Therefore the situation exists that a Spanish company can sell a Ca-EDTA product imported from Spain using mutual recognition to Italian farmers, but the same product cannot be sold by an Italian company to its own farmers. This creates an uneven playing field. Similarly, a Belgian company active in Italy sells a product based on seaweeds with 4.5 potassium (K2O), a product based on calcium chelate (CaO 8.5%) with DTPA, a product made with magnesium (MgO 3.7% ) chelated by HEEDTA referring to the Regulation 764/2008 EC. But Italian companies are forbidden from selling the same kinds of products because they are not covered by the Italian law on fertilizers.
5. Therefore, biostimulant producers either have the choice to make plant protection claims about their products (which some of EBIC‟s members have done in the past in order to achieve an EC registration that afforded a sufficient level of protection for their innovation) or facing a fragmented regulatory landscape. There is no harmonisation or protection of innovation, and significant market uncertainty remains.
6. An Italian company would like to sell fertilisers (already legally sold in Italy) in Poland using mutual recognition. The Polish authorities have replied that they would allow the registration using mutual recognition only if the country of origin had the same standards of registration as they have in Poland. This would include, amongst others, efficacy testing in Hungary, which is not a requirement in Italy for product registration (it is a requirement to have the category inserted into law in the first place).
7. A practical problem of lack of harmonisation arises from changes in national legislations and methodology used in various countries. For those who produces multi-language labels, it can be a logistical and economic challenge to change labels when a single country changes their laws, requiring a part of the label to be up-dated.
8. A new biostimulant, based on an enzymatic hydrolysate of vegetal origin, was developed and tested by an Italian Company from 2006 to 2008. Following a year-long registration process, it was approved to be placed on the market in Germany as a plant strengthener. However, the product is still not completed in the home market of Italy, which has a totally different registration process. This is another demonstration that registration in a single EU Country is neither a guarantee of free and complete circulation nor of recognition of the product in any other EU country. The lack of definite and shared registration timing and procedures is often a cause of loss of market opportunities. This is particularly regrettable where the efficiency of these new products is already widely demonstrated.
9. The registration of amino acid-based fertilisers is a very simple procedure in Italy and Spain, where basically the compliance of the product with national regulation suffices. It is a very long and expensive affair in other EU States, like Poland for instance, where the procedure requires the following steps :
a. Fertilizer Institute opinion
b. Veterinary Institute opinion
c. Medicine Institute opinion
d. Environmental Institute opinion
e. Vegetable Institute opinion
f. Dossier evaluation and approval by the Ministry of Agriculture.
10. Each opinion implies the execution of field tests for each crop class, and of microbiological, chemical-physical, and toxicological analyses. Currently, it is therefore necessary to spent more than two years and 10,000 euros to register one fertiliser based on amino acids.
11. In Spain products containing extracts of algae cannot be recognized as a fertiliser, but are authorized in Italy.
12. A French company has problems in France to register a biostimulant product based on amino acids that in Italy is considered fertilizer with specific action (biostimolante).
At the moment, national regulations regarding biostimulant products are extremely varied, both with regard to definitions and processes as noted in section 3 above.
Option 2 – repeal of Reg (EC) 2003/2003
Since biostimulants do not current qualify as fertilisers under the definition given in Reg (EC) 2003/2003, a repeal would make no significant difference for biostimulant products from the current, unsatisfactory situation. The same market uncertainties would remain. However, for the broader fertilising materials industry, it would be chaos as the problems that are now endemic for non-EC fertilisers (see examples under Option1) would be generalised to all products.
Option 3 – Current regulatory framework is enhanced with a voluntary industry regulation
Under this option, a voluntary industry framework would complement the current regulatory framework. Since biostimulants are not currently covered by Reg (EC) 2003/2003, this would not significantly improve the situation. Given the difficulties that EBIC members are facing securing mutual recognition for products (see the text on Option 6 below), it is unlikely that voluntary industry regulation would result in uniform treatment of products from one member state to another. It is also difficult to see how enforcement might work, which would make it virtually impossible to sanction irresponsible companies and to distinguish them from responsible players in the market.
In addition, it would be difficult to see how to foster innovation. Innovation is protected when the investment is protected. Data protection in an unregulated market would be difficult to achieve, and therefore innovation would not be encouraged to its full extent.
Voluntary industry regulation, however, could play a role with regard to the initial development of guidelines on product claims, labelling, marketing, etc. where codes of conduct have more meaning than with regard to the content and quality of diverse products.
Option 4 – Extend Reg (EC) 2003/2003 to all fertilising materials with lists of designated products
Under this option, the definition of fertilisers would be extended to include all fertilising materials, and annexes listing approved products in each category would be added. Full harmonisation is a step in the right direction, eliminating the need to rely on differing national legislations and the problems of mutual recognition. The widening of the definition of fertilising materials, including biostimulants amongst others, would be beneficial and a recognition of the reality that products other than nutrients are also important for agricultural production.
However, the current structure of Reg 2003/2003 is based on definite substances with pre-defined characteristics (manufacturing characteristics, minimal nutrient content, etc.). A positive list is appropriate for sectors where the product offering is fairly stable. Had the biostimulants sector remained in its first generation of products (mono-component products whose biostimulant properties on plant physiological processes have been recognised in the marketplace for a long time, such as seaweed extracts, amino acids, humic acids…) or even the second generation consisting of combinations of these, this approach might have been feasible.
This pre-defined approach can restrict the pace of innovation. If a product is beneficial, but does not enter into a pre-defined category, why should the regulatory context stop it?
However, the current generation is comprised of innovative multi-component products based on plant extracts mixed with other biostimulant substances (see Annex III – An indicative list of some biostimulant products on the market today). These formulations are complex and may include hundreds of ingredients. Furthermore, these formulations are differentiated from one producer to another, and keeping the exact formulation confidential is is one of the few ways that producers are able to capitalise on their investment in innovation since few biostimulant products can be patented (although the related production processes may be). The detailed listing necessary in a positive list would therefore undermine innovation. Innovation is also encouraged when the innovation is protected. If the current structure of Reg 2003/2003 were maintained, a company would be less willing to invest in the insertion of a new category, if it were then available for everyone to use.
Option 5 – Extend Reg (EC) 2003/2003 to all fertilising materials with lists of ingredients and additives
Full harmonisation is a step in the right direction, eliminating the need to rely on differing national legislations and the problems of mutual recognition. The widening of the definition of fertilising materials, including biostimulants amongst others, would be beneficial and a recognition of the reality that products other than nutrients are also important for agricultural production.
The adoption of a positive list of ingredients would remove some of the rigidity of pre-defined categories in terms of minimal content, etc. Nonetheless, Option 5 entails many of the same difficulties for regulating biostimulants as Option 4. A positive list still pre-defines what is possible to use as a raw material. As innovation in the biostimulants sector continues apace (or even accelerates), static lists will have difficulty following. While biostimulants were composed of a limited palette of ingredients in the past, the diversity of components is increasing rapidly. Biostimulants may include hundreds of ingredients, including plants extracts that are classified by REACH as being of “Unknown or variable composition, complex reaction products or biological materials”.
It is also questionable whether companies would invest in having new ingredients added to the approved list if that would simply give ideas to the competition. Innovation is encouraged when it is protected. If a company invests money to insert a new raw material into the positive list, this would then be available for everyone to use without any data protection. This would be a disincentive to innovate.
Option 6 – Full harmonisation under the New Approach
Full harmonisation is a step in the right direction, eliminating the need to rely on differing national legislations and the problems of Mutual Recognition. The widening of the definition of fertilising materials, including biostimulants amongst others, would be beneficial and a recognition of the reality that products other than nutrients are also important for agricultural production.
Under this option, safety requirements, agronomic efficacy and minimal technical requirements would be outlined in an annex with all other specifications determined by technical standardisation bodies.
The New Approach, in the sense of ensuring basic characteristics in terms of safety and efficacy, without a pre-defined category or positive list is a further step in the right direction. This would allow products to be variable in their composition, but ensuring efficacy and safety. However, the traditional standardisation process is also ill-adapted to the diversity of biostimulant products and their production processes. Furthermore, the development of technical standards by working groups and their subsequent political approval is not necessarily rapid enough to accommodate the speed with which biostimulants are being developed and their uses are expanding. Slow standardisation procedures would inhibit innovation. The product composition may be so variable that it might be difficult to create standards flexible enough to cater for the market.
It is not clear how this option would ensure data protection, which is critical for fostering innovation.
One of EBIC‟s member representatives has chaired the French Standardisation Committee (AFNOR) about soil improvers and growing media since 2006 and can testify that it generally takes 3-5 years to modify a standard. Furthermore, standardisation only begins when there are at least 5-7 similar products on the market. While this critical mass might be reached for the first generation of biostimulants, it is unlikely to be the case for future generations of biostimulants as formulations are increasingly complex and differentiated. Additional reasons why standards are inappropriate for biostimulants follow:
1. No committee is in currently responsible for biostimulants, meaning that a new CEN committee would have to be constituted (or the mandate of an existing committee enlarged) before drafting could begin.
2. The delays for establishing standards are long and would not keep with innovation.
3. No biostimulant could be sold until its standard is finalized. First, we would have to write standards for the methods then after for the biostimulants description. This means that there would be no harmonisation for 5-6 years at a minimum.
4. The cost of CEN is payable by the participating experts. There is currently a problem with the CEN/TC 223 (soil improvers) because nobody wants to pay for it. As a result, this committee may be discontinued, which means that it would then become impossible to have a new standard or to revise an older standard.
5. For the methods, it would be necessary to conduct ring tests among relevant laboratories, and these are at the expense of the experts. Since many laboratories are necessary to approve the method, the cost rises quickly.
6. Standards don‟t protect the innovation, because they‟re public. So, if a company discovers a new product, it‟s impossible to sell it without giving all the information to competitors.
7. Standards cannot be formulated for claims-based definitions.
8. Standards aren‟t free and companies must pay to obtain a regulation. This creates unfair competition against small companies that cannot afford to pay for their products to be standardised.
9. Although all member states belong to each committee, they often do not have the resources to attend, which means that standards do not necessarily represent an agreed consensus of all member states.
With standardisation, the issue of mutual recognition remains. At the moment, national fertilisers are supposed to be recognised on the basis of mutual recognition; however, serious dysfunctions exist as outlined under Option 1 above.
Case in point: One of EBIC‟s members makes a Mycorrhizae product, which is authorised in Italy. They would like to sell it in France and therefore applied for mutual recognition under Reg (EC) 764/2008. The French authorities refused to recognise the product via mutual recognition and have required what amounts to a parallel registration, although somewhat simplified. One month after submitting the file, ANSES informed the company that the dossier was not complete, although it met all the requirements of the various legal texts (and the company replied along these lines). At the end of the decision period (3 months), ANSES replied that only the administrative portion of the dossier had been completed. At this point in time, the member company contacted SOLVIT and received a reply stating that ANSES often misses its own deadlines and has requested disproportional proofs of innocuousness. According to the response, the Ministry of Agriculture was going to ask ANSES to render an opinion within two weeks and had, in any case, decided to authorise the product.16 More than a month later, the company is still without the official paperwork confirming this authorisation. The cost so far has been the equivalent of 10 working days to prepare and follow the dossier, 1,000 euros for product analysis, 2,000 euros in taxes and months of delays and lost market opportunities. It is unlikely that mutual recognition would become simpler in future as innovative biostimulant products become increasingly complex and differentiated.
Option 7 – Different policy options are applied to different sub-categories of “fertilising materials”
Full harmonisation is a step in the right direction, eliminating the need to rely on differing national legislations and the problems of Mutual Recognition. The widening of the definition of fertilising materials, including biostimulants amongst others, would be beneficial and a recognition of the reality that products other than nutrients are also important for agricultural production.
Given the significant differences between biostimulants and other products the European Commission has grouped under the umbrella “fertilising materials” and given the wide diversity of biostimulant products, the most appropriate of the options outlined in the pre-study is Option 7. This would entail a framework text setting out the overarching goals, an enlarged definition of fertilising materials that is broader than just nutrient content, requirements with regard to describing products‟ physico-chemical properties, and basic safety requirements (and how to demonstrate compliance), etc. A specific text would then address the modalities for biostimulant product registration, including any additional safety questions related to the nature of the product in question, rules regarding which biostimulant claims are admissible and demonstrations that such claims can be justified.
As mentioned above, the innovative nature of the biostimulant sector requires a flexible regulatory approach. Flexibility does not mean lower safety or efficacy requirements. EBIC envisages a tailored approach that includes many best aspects of efficacy and safety from existing EU Regulations (REACH, PPP, 2003/2003). Data protection would be foreseen through a manufacturer-based registration, thus nurturing innovation. The importance of a product from the agricultural point of view is its functional use, not necessarily what it contains. Thus, the claim-based approach is linked to the functional use and to the benefit that farmers and, ultimately, consumers would gain from the use of biostimulants.
7. About the European Biostimulants Industry Consortium and its products
The European Biostimulants Industry Consortium (EBIC) was formed in June 2011 to foster the role of the biostimulants sector in helping agriculture to produce more with less. To do this, EBIC advocates an operating environment that creates a truly European market for biostimulants and recognises their contribution to sustainable agricultural production, green innovation, economic growth and other European Union (EU) policy objectives. Membership is open to biostimulant producers active in Europe that are interested in cooperating in areas of common interest.
Biostimulants include diverse formulations of compounds, substances and other products (including microbial products) that are applied to plants or soils to enhance the crop‟s physiological processes, thus making them more efficient. Biostimulants act on plant physiology through different pathways than nutrients to improve crop vigour, yields, and quality. Enhanced quality improves crop profitability and allows produce to better tolerate storage and handling. Biostimulants are complementary to plant nutrients and plant protection products. Biostimulants are increasingly used in conventional agriculture and can help address inefficiencies that remain in agriculture today despite improved production practices.
More information on biostimulant products can be found in Annex III. Learn more about EBIC and biostimulants at www.biostimulants.eu.
ANNEX I – A selection of research on biostimulants
In alphabetical order by author
Seaweed Extract Improves Growth, Yield and Quality of Different Watermelon Hybrids
Abdel-Mawgoud, A.S. Tantaway, Magda M. Hafez and Hoda A.M. Habib Research Journal of Agriculture and Biological Sciences, 6(2): 161-168, 2010 Effect of seaweed extract foliar application on three watermelon hybrids was investigated during the two successive cultivation seasons of 2008 and 2009….The effect of seaweed extract application was positive and correlated with the applied concentrations. Applying seaweed extract increased the response of different growth parameters and yield responses… Data are further discussed in relation to different possible mechanisms of growth enhancement.
The Effect of Seaweed Extract Sprays Derived from Ascophyllum nodosum on Lettuce and Cauliflower Crops
P. Abetz and CL. Young Botanica Marina. Volume 26, Issue 10, Pages 487–492
Effect of a seaweed concentrate on the growth and yield of three varieties of Capsicum annuum
Arthur G. D. ; Stirk W. A. ; Van Staden J. Abstract The effect of different modes of application of a seaweed concentrate on the growth and yield of three varieties of greenhouse cultivated peppers was investigated. In most instances, application of the concentrate improved the marketable fruit yield. A combined treatment of dipping the seedlings in 0.4% solution for 2h prior to transplanting followed by three applications of 0.4% solution as a foliar spray during the growth of the plants significantly increased the number and size of the marketable fruit. South African journal of botany ISSN 0254-6299, 2003, vol. 69, no2, pp. 207-211
Impact of Microbial Inoculant Application on Agrostis Stolonifera Var.’Penn A4’performance under Reduced Fertilisation, T Butler, II International Conference on Turfgrass Science 2007
Screening of Rhizobacteria for Their Plant Growth Promoting Activities
M. Chaiharn, S. Chunhaleuchanon, A. Kozo, and S. Lumyong KMITL Sci. Tech. J. Vol. 8 No. 1 Jan. – Jun. 2008 Rhizospheric bacteria are known to influence plant growth by direct and indirect mechanisms. A total of 220 phosphate solubilizing bacteria were isolated from different rhizosphere soil in Northern part of Thailand. These isolates were screened for their plant growth promoting factors like production of ammonia, siderophore and cell wall degrading enzyme activities; cellulase, chitinase and proteolytic enzyme. More than 64% of the isolates produced ammonia and 23% produced siderophore on chrome azurole S agar plates. Moreover, test isolates produced cell wall degrading enzyme; cellulose (6%), chitinase (6%) and proteolytic enzyme (5%) on agar plate method. The results show that rhizospheric phosphate utilizing bacteria could be a promising source for plant growth promoting agent in agriculture.
Mechanisms of Plant Growth Stimulation by Humic Substances: The Role of Organo-Iron Complexes
Y Chen, CE. Clapp & H Magen Soil Sci Plant Nutr, 50 (7), 1989-1095, 2004.
Effect of seaweed concentrate on the growth and mineral nutrition of nutrient-stressed lettuce
I. J. Crouch, R. P. Beckett and J. Staden
Journal of Applied Phycology, Volume 2, Number 3, 269-272, DOI: 10.1007/BF02179784
The effects of a seaweed concentrate on the growth and mineral nutrition of lettuce plants grown under conditions of varying nutrient supply were investigated. The concentrate significantly increased the yield and the concentration and amounts of Ca, K and Mg in the leaves of lettuce receiving an adequate supply of nutrients, but had little effect on nutrient stressed plants. Results are discussed in relation to the physiological mechanisms that have been proposed to explain the beneficial effects of seaweed concentrate on plants.
Effect of foliar application of N and humic acids on growth and yield of durum wheat
S. Delfine, R. Tognettia E. Desiderio, A. Alvino Agron. Sustain. Dev. 25 (2005) 183–191 The aim of this study was to monitor the effect of foliar application of humic acid on plant growth, photosynthetic metabolism and grain quality of durum wheat grown in a Mediterranean-type climate. We conclude that humic acid had limited promoting effects on plant growth, grain yield and quality, and photosynthetic metabolism of durum wheat crops grown in a typical Mediterranean-type agro-ecosystem of southern Italy, with respect to split soil N application.
Growth promotion and yield enhancement of peanut (Arachis hypogaea L.) by application of plant growth-promoting rhizobacteria R. Dey , , K.K. Pal, D.M. Bhatt, S.M.
Chauhan Microbiological Research Volume 159, Issue 4, 15 December 2004, Pages 371-394
Use of Bioinoculants in Ameliorative Effects on Radish Plants under Salinity Stress
Ertan Yildrima, Mesude Figen Donmezb & Metin Turanc, pages 2059-2074, Journal of Plant Nutrition Volume 31, Issue 12, 2008
The Effect of Plant Growth Promoting Rhizobacteria (PGPR) on Germination, Seedling Growth and Yield of Maize, A. Gholami, S. Shahsavani, and S. Nezarat, World Academy of Science, Engineering and Technology 49 2009
Physiologia Plantarum, Volume 111, Issue 2, pages 206–211, February 2001
The plant-growth-promoting rhizobacteria Bacillus pumilus and Bacillus licheniformis produce high amounts of physiologically active gibberellins Francisco Javier Gutiérrez-Mañero, Beatriz Ramos-Solano, Agustı ́n Probanza, Jalel Mehouachi, Francisco R. Tadeo, Manuel Talon
Seaweed extract as a biostimulant for legume crop, green gram
R. Kavipriya, P. K. Dhanalakshmi, S. Jayashree, N. Thangaraju Journal of Ecobiotechnology 2011, 3(8): 16-19 The aim of this research is to investigate the effect of seaweed extracts obtained from the marine green algae, Ulva lactuca Linnaeus, Caulerpa scalpelliformis (R.Brown ex Turner) C. Agardh, brown algae Sargassum plagiophyllum C. Agardh, Turbinaria conoides (J. Agardh) Kutzing, Padina tetrastromatica Hauck, Dictyota dichotama (Hudson) J. V. Lamouroux on the stimulate germination, growth parameters of the Vigna radiata. The present study reveals the seeds germination, fresh weight and dry weight of shoots and roots. These results suggested that seaweed extracts stronger induce seed germination and growth parameters.
Screening plant growth-promoting rhizobacteria for improving growth and yield of wheat, A. Khalid, M. Arshad, Z.A. Zahir Journal of Applied Microbiology Volume 96, Issue 3, pages 473–480, March 2004
Seaweed Extracts as Biostimulants of Plant Growth and Development
Khan W, Rayirath U, Prithiviraj B, et al. Seaweed Extracts as Biostimulants of Plant Growth and Development. Journal of Plant Growth Regulation[serial online]. December 1, 2009;28(4):386-399. Available from: E-Journals, Ipswich, MA. Accessed October 28, 2011.
Marine algal seaweed species are often regarded as an underutilized bioresource, many have been used as a source of food, industrial raw materials, and in therapeutic and botanical applications for centuries. Moreover, seaweed and seaweed-derived products have been widely used as amendments in crop production systems due to the presence of a number of plant growth- stimulating compounds. However, the biostimulatory potential of many of these products has not been fully exploited due to the lack of scientific data on growth factors present in seaweeds and their mode of action in affecting plant growth. This article provides a comprehensive review of the effect of various seaweed species and seaweed products on plant growth and development with an emphasis on the use of this renewable bioresource in sustainable agricultural systems.
Enhanced plant growth by siderophores produced by plant growth-promoting rhizobacteria
Nature 286, 885 – 886 (28 August 1980); doi:10.1038/286885a0 Joseph W. Kloepper*, John Leong†, Martin Teintze† & Milton N. Schroth* *Department of Plant Pathology, University of California, Berkeley, California 94720 †Department of Chemistry, University of California, San Diego, La Jolla, California 92093 Specific strains of the Pseudomonas fluorescens-putida group have recently been used as seed inoculants on crop plants to promote growth and increase yields. These pseudomonads, termed plant growth-promoting rhizobacteria (PGPR), rapidly colonize plant roots of potato, sugar beet and radish, and cause statistically significant yield increases up to 144% in field tests1–5. These results prompted us to investigate the mechanism by which plant growth was enhanced. A previous study indicated that PGPR increase plant growth by antagonism to potentially deleterious rhizoplane fungi and bacteria, but the nature of this antagonism was not determined6. We now present evidence that PGPR exert their plant growth-promoting activity by depriving native microflora of iron. PGPR produce extracellular siderophores (microbial iron transport agents)7 which efficiently complex environmental iron, making it less available to certain native microflora.
Effect of a biostimulant product on sweet cherry fruit quality
Laghezza L, Piccinini L, Fiori G, Noferini M, Donati I, Ravaglia D, Kusch K, Grandi M, Lugli S, Costa G. Department of Fruit Trees and Woody Plant Sciences, University of Bologna Presented at the Convegno nazionale del ciliegio, Vignola (Mo) Italy, 8-10 June 2011. Study of a commercial product based on botanical extracts, methionine, phenylalanine, and monosaccharides. The product is a biostimulant of fruit color development and sugar accumulation. In the present paper, the effect of product application on „Giorgia‟ sweet cherry fruit are reported. Trials were carried out in Emilia Romagna (Northern Italy) and Apulia (Southern Italy). In both areas, treated fruit showed increased soluble sugar content and improved skin color relative to controls.
Annual Review of Microbiology Vol. 63: 541-556 (Volume publication date October 2009) Ben Lugtenberg and Faina Kamilova Leiden University, Institute of Biology, Clusius Laboratory, 2333 AL Leiden, The Netherlands; email: firstname.lastname@example.org, email@example.com Several microbes promote plant growth, and many microbial products that stimulate plant growth have been marketed. In this review we restrict ourselves to bacteria that are derived from and exert this effect on the root. Such bacteria are generally designated as PGPR (plant-growth-promoting rhizobacteria). The beneficial effects of these rhizobacteria on plant growth can be direct or indirect. This review begins with describing the conditions under which bacteria live in the rhizosphere. To exert their beneficial effects, bacteria usually must colonize the root surface efficiently. Therefore, bacterial traits required for root colonization are subsequently described. Finally, several mechanisms by which microbes can act beneficially on plant growth are described. Examples of direct plant growth promotion that are discussed include (a) biofertilization, (b) stimulation of root growth, (c) rhizoremediation, and (d) plant stress control….
Application of Biostimulators in Nursery
Lajos Magyar, Z. Barancsi, A. Dickmann, Karoly Hrotko
Corvinus University of Budapest, Faculty of Horticultural Sciences
Bulletin UASVM, Horticulture 65(1)/2008, pISSN 1843-5254; eISSN 1843-5394
In agriculture some biostimulators are used to improve root growth and due to this increase the crop. By our experience the root growth capacity might be an important factor in this development. Biostimulators containing seaweed extract, as stimulators of root growth may positively influence both root quality and shoot growth. Our poster reports on nursery trial carried out on Sorbus aucuparia seedlings and one-year-old „Idared‟ apple trees using bioregulators.
Physiological effects of humic substances on higher plants, S. Nardi, D. Pizzeghello, A. Muscolo & A. Vianello Soil Biology & Biochemistry 34 (2002) 1527-1536
Plant Growth Promoting Rhizobacteria (PGPR): Prospects for New Inoculants, Louise M. Nelson, Vice President (Research), Okanagan University College, 3333 University Way, Kelowna BC V1V 1V7, Published 1 March 2004
Rhizobium leguminosarum as a plant growth-promoting rhizobacterium: direct growth promotion of canola and lettuce
T. C. Noel, C. Sheng, C. K. Yost, R. P. Pharis, M. F. Hynes Canadian Journal of Microbiology, 1996, 42:(3) 279-283
Controlling sweet cherry fruit cracking and quality: preliminary results
Published in Italian under the title “Indagini preliminari sulle possibilità di controllo chimico del “cracking” e della qualità dei frutti di ciliegio” Piccinini L, Savini A, Grandi M, Laghezza L, Ravaglia D, Bonora E, Fiori G, Noferini M, Correale R, Lugli S, Costa G. Frutticoltura, 2010, No. 5, 48-55
Department of Fruit Trees and Woody Plant Sciences, University of Bologna This study looks at a commercial product based on botanical extracts, methionine, phenylalanine, and monosaccharides. It is a biostimulant of fruit color development and sugar accumulation. In the present paper, the effects of applying the product on sweet cherry fruit are reported. Based on evaluations of skin color and sugar content conducted at harvest, the product improved soluble sugar content and skin color (brightness, intensity and uniformity) of both Ferrovia and Giorgia fruit relative to controls. In both cultivars, the improvement of fruit skin color was related to the increase in total phenol content of treated fruit relative to untreated ones; in particular, the product enhanced the accumulation of anthocyanins.
Plant growth promoting rhizobacteria for winter wheat
J. Renato de Freitas, James J. Germida Canadian Journal of Microbiology, 1990, 36:(4) 265-272, 10.1139/m90-046 The association of winter wheat (Triticum aestivum L. cv. Norstar) with root-colonizing bacteria (rhizobacteria) was studied in potted soil experiments in the growth chamber. Thirty-six known bacteria, some of which have been reported to stimulate plant growth, and 75 isolates obtained from the rhizosphere of winter wheat were tested for their effects on plant growth and development in two different soils. Two known bacteria and 12 isolates stimulated growth of winter wheat. Of these, the most effective were nine isolates that significantly (P < 0.01) increased plant height, root and shoot biomass, and number of tillers. The plant growth promoting effects of isolates were different in the two soils. Three of these strains were tentatively classified as Pseudomonas aeruginosa, and two each as Pseudomonas cepacia, Pseudomonas fluorescens, and Pseudomonas putida. Some isolates induced significant increases in seedling emergence rates and (or) demonstrated antagonism in vitro against Rhizoctonia solani and Leptosphaeria maculans. These results demonstrate the potential use of plant growth promoting rhizobacteria as inoculants for winter wheat. Effect of Some Biostimulant on Growth and fruiting of Anna Apple Trees in Newly Reclaimed Areas Mohamed F.M. Sahain, Elham Z. Abd El Motty, Mohamed H.El- Shiekh and Laila. F. Hagagg Research Journal of Agriculture and Biological Sciences, 2007 Plant Growth Promoting Rhizobacteria: A Critical Review BS Saharan*, V Nehra, Department of Microbiology, Kurukshetra University, Kurukshetra, Haryana 136 119, India.Life Sciences and Medicine Research, Volume 2011: LSMR-21 Plant growth-promoting rhizobacteria (PGPR) are naturally occurring soil bacteria that aggressively colonize plant roots and benefit plants by providing growth promotion. Inoculation of crop plants with certain strains of PGPR at an early stage of development improves biomass production through direct effects on root and shoots growth. Inoculation of ornamentals, forest trees, vegetables, and agricultural crops with PGPR may result in multiple effects on early-season plant growth, as seen in the enhancement of seedling germination, stand health, plant vigor, plant height, shoot weight, nutrient content of shoot tissues, early bloom, chlorophyll content, and increased nodulation in legumes. PGPR are reported to influence the growth, yield, and nutrient uptake by an array of mechanisms. They help in increasing nitrogen fixation in legumes, help in promoting free-living nitrogen-fixing bacteria, increase supply of other nutrients, such as phosphorus, sulphur, iron and copper,... There has been much research interest in PGPR and there is now an increasing number of PGPR being commercialized for various crops. Several reviews have discussed specific aspects of growth promotion by PGPR. In this review, we have discussed various bacteria which act as PGPR, mechanisms and the desirable properties exhibited by them. Root Regeneration of Dahlia Invariabilis Using Bioinoculants R. Singh, Sunita Suneja, Kamlesh Kukreja, Neeru Narula and K. Lakshminarayana Department of Microbiology, College of Basic Sciences and Humanities, CCS Haryana Agricultural University, Hisar - 125 004, India Root regeneration in stem cuttings of Dahtia invariabilis were tested by dipping them in microbial culture broths of 12 different strains and then transferred to Bryan agar tubes. All the strains performed better with respect to root regeneration and plant growth parameters over uninoculated control. A novel type of seaweed extract as a natural alternative to the use of iron chelates in strawberry production Spinelli F, Fiori G, Noferini M, Sprocatti M, Costa G. A novel type of seaweed extract as a natural alternative to th e use of iron chelates in strawberry production. Scientia Horticulturae [serial online]. June 28, 2010;125(3):263-269. Available from: E- Journals, Ipswich, MA. Accessed October 28, 2011. The new generation of seaweed extracts may represent a promising strategy to reduce the use of phytochemicals in agriculture. One such example is a metabolic enhancer derived by the algae Ascophillum nodosum, but differently from some older seaweed extracts, it has a constant and balanced formulation containing kahydrin, alginic acid and betaines which synergistically contribute to the efficacy of the product. It has been proposed to increase the mineral nutrient uptake and the abiotic stress tolerance. The aim of this work was to evaluate, under a multidisciplinary approach, the effect of the biostimulant on the vegetative and productive performances of strawberry plants grown on a lime inducing iron chlorosis substrate. This biostimulant increased the vegetative growth (10%), the leaf chlorophyll content (11%), the stomata density (6.5%), the photosynthetic rate and the fruit production (27%) and berry weight. The most significant result was the increase of the plant biomass: the shoot dry matter was increased up to 27% and root dry matter up to 76%. Finally, preliminary experiments showed that the product positively influenced also the root-associated microbial biocoenosis. These results are discussed in relation to the physiological and ecological mechanisms proposed to explain the beneficial effects of this seaweed extract. Finally, the effects of the product and sequestrene were significantly similar, thus showing that this biostimulant may represent an environmental-friendly substitute of the iron chelates. Use of biostimulants on soil restoration: Effects on soil biochemical properties and microbial community Tejada M, Benítez C, Gómez I, Parrado J. Use of biostimulants on soil restoration: Effects on soil biochemical properties and microbial community.Applied Soil Ecology [serial online]. September 1, 2011;49(7):11-17. Available from: E-Journals, Ipswich, MA. Accessed October 28, 2011. The application of biostimulants had a positive effect on soil biology. Soil biodiversity was highest in soil amended with biostimulants with higher percentage of peptides (<0.3kDa). The application of biostimulants favours the appearance of spontaneous vegetation. The application of biostimulants may be considered a good strategy for recovering semiarid areas. Influence of Humic Substances on Irrigation Frequency and Phosphate Absorption of Creeping Bentgrass Putting Greens A Van Dyke Plant Nutrition-PSB6430, Fall Semester 2005 Published online by the Utah State University Crop Physiology Laboratory at http://www.usu.edu/cpl/pdf/adamvandyke_humicacids.pdf. Other USU/CPL research on humic acids can be found at http://www.usu.edu/cpl/research_humic.htm. Effect of seaweed concentrate on the growth of the seedlings of three species of Eucalyptus Van Staden, J | Beckett, RP| Rijkenberg, MJ South African Journal of Botany [S. Afr. J. Bot./S.-Afr. Tydskr. Plantkd.]. Vol. 61, no. 4, pp. 169-172. 1995. The effect of a seaweed concentrate on the growth of seedlings of three species of Eucalyptus was investigated. A preliminary experiment showed that foliar sprays of the concentrate significantly increased the growth of seedlings of E. nitens and E. macarthurii. The main experiment was carried out on E. grandis, and studied the best method of applying the seaweed concentrate and the best time of application. Results showed that both foliar sprays and root flushes increased root and shoot growth. For both methods of application, a single dose early in the life of the seedling was optimal. There was little benefit in applying the concentrate after transplantation. Results clearly showed that seaweed concentrate can improve seedling growth in Eucalyptus species. Plant growth promoting rhizobacteria as biofertilizers, J. Kevin Vessey Plant and Soil Volume 255, Number 2, 571-586, DOI: 10.1023/A:1026037216893 (2003) Effect of Bio-stimulant [seaweed concentrate] on Potato Yield Xiao Yanbo(School of Chemistry and Biotechnology,Yunnan Nationalities University,Kunming,Yunnan 650031,China) Chinese Potato Journal, 2008-03 [The product] is a seaweed concentrate (SWC) prepared by a cell burst process from the brown alga Ecklonia maxima. In order to explore yield increasing effects of the on potato, field experiments were carried out to investigate two potato varieties' yield response. The results showed that yield of potato with the product was higher than that without, and yield increase was 22.5% and 19.2% in Luliang and Jinning respectively. Yield increase resulted from increase in tuber number and large tuber percentage affected by the product, tuber number per plant being 0.4 and 0.7 more than that without the product, and percentage point of large tuber increasing with the product being 3% and 4% in Luliang and Jinning respectively. Benefits analysis showed that more harvested potato generated more income at RMB 6256·ha-1 and RMB 6 993·ha-1 for the two sites mentioned respectively. These results suggest that spraying the product over seed tuber at planting plus one time foliar spray during 3-4 leaf stage is economically viable and could be extended. In 2006, a special issue (Vol. 1, no. 1) of the Fertilitas Agrorum, the official journal of the Italian Scientific Fertilizer Center, was dedicated to the proceedings of a conference held that July entitled “Biostimolanti in agricoltura : aspetti agronomici, analytici, normativi” (Biostimulants in agriculture: agronomic, analytical and regulatory questions”. Translations of the main paper titles are provided below, some of them provided by the authors themselves (abstracts are in English where the article is in Italian and vice versa): • €Issues related to inserting biostimulants in fertilizer legislation (C. Ciavatta & L Cavani) • €Biostimulants: A tool for improving quality and yield (P. Vernieri, A. Ferrante, E. Borghesi & S. Mugnai) • €Effects of biostimulants in horticulture: comparing several experiments (S. Tagliavini & C. Kubiskin) • €The experience of the first biostimulant, based on amino acids and peptides: a short retrospective review on the laboratory researches and the practical results (P. Maini) (Original English title) • €Methods to measure the biostimulant activity (S. Nardi, A. Ertani, G. Concheri, D. Pizzeghello) • €An in-depth investigation to provide scientific bases to the biostimulant activity (F. Apone, S. Arciello, G. Colucci, L. Filippini, D. Portoso) • €Plant growth promoting Rhizobacteria: a new opportunity for sustainable agriculture (A. Linzer, L. Cazzara & G. Barbieri) • €Assessment of the biostimulants effect from the Petri dish to the field (A. Altissimo, L. Peserico & A. Zuin) • €The relationships among mineral nutrition, biostimulation and plant defense mechanisms: an example in citrus plants (JM. Garcia-Mina) • €Characterization of biostimulating properties in fertilisers using bioassays (A. Benedetti & F. Barroccio) • €The activity of new Italian Commission in charge of editing and issuing official methods of fertilizer analysis: a new method of biostimulant check (G. Gagliano & RM. Maestro) ANNEX II – Some examples of the same substances existing in different legislation (both member state and EU) depending on the functional use The following non-exhaustive list shows that there are numerous substances that are classified and regulated under multiple regimes across Europe. Not all of these substances are biostimulants. The point of this table is simply to show that there are precedents for a single substance being successfully regulated differently on the basis of its use and claimed effect rather than on the basis of its nature. This indicative list of products provides an overview of the broad range of claims and the evolving profile of biostimulant products. It is in no way meant to be exhaustive or to provide a positive list defining all acceptable biostimulant products or ingredients. To help familiarize people outside the industry with the evolution of the sector, we have added a descriptor called “generation of innovation”. Again, this is just an approximate indication and does not imply that the later generations are preferable to the earlier generations. Even for first generation products, innovation continues around production methods. For all products, innovation extends to application methods and use, which means that new effects may be discovered for existing formulations. It also means that the current application method indicated in this table may be complemented by others in future. “Class” refers to a description of the product formulation in terms used for REACH17 classification. 17 REACH is the European Community Regulation on chemicals and their safe use (EC 1907/2006). It deals with the Registration, Evaluation, Authorisation and Restriction of Chemical substances 1 Bröring S, Martin Cloutier L, Leker J. The front end of innovation in an era of industry convergence: evidence from nutraceuticals and functional foods. R&D Management [serial online]. November 2006;36(5):487-498. 2 A search for research articles using keywords biostimulant(s) and wheat returns nearly 700 entries. 3 The difficulty of clarifying definitions has been increased by pre-existing regulatory and conceptual frameworks, which were established when there was a clear division between plant nutrition on one hand and plant protection on the other: plant nutrition nourished and nurtured, whereas pesticides were biocides. As new products emerged that did not fit easily into these categories, they were either assimilated to one category or another or left outside the regulatory framework altogether. 4 Siedlok F, Smart P, Gupta A. Convergence and reorientation via open innovation: the emergence of nutraceuticals. Technology Analysis & Strategic Management [serial online]. July 2010;22(5):571-592. 5 Methodology and caveats: Using Google Scholar, we searched for generic keywords for each sector (biostimulant/biostimulants, fertiliser/fertilizer/fertilisers/fertilisers, nutraceutical/nutraceuticals, pesticide/pesticides), so this is far from being an exhaustive catalog of research articles on each sector‟s products, but it provides a general idea. For each keyword, we noted the total number of research articles and the number of patents listed. There are probably a number of other factors that influence the results, including maturity of the industry. Younger industries have more “low-hanging fruit” leading to an initial burst of innovation. The number of research articles relative to patents is also likely to increase when side effects of products become apparent, which is more likely for older industries. Finally, since we used the word “pesticide” as the keyword, the flat line could also reflect a shift to research into other forms of plant protection (e.g. GMOs) where the word pesticide might not occur. Because many scientific articles are published in English, despite their origin, whereas Google Scholar only returns patent results for the USA, the exact index number may not be accurate, however all four sectors should be affected in the same way, and the general trends should therefore still be indicative. 6 Softer Health Claims in the Offing for 2011. Nutraceutical Business & Technology [serial online]. March 2011;7(2):5. Available from: Business Source Complete, Ipswich, MA. Accessed October 30, 2011. 7 Europe‟s Food Makers Opt for General Health Claims. Nutraceuticals World. December 2010. Rodman Publishing. Ramsey, NJ, USA. 8 This would not include any research that covers specific biostimulant effects without using the generic keyword searched in our exercise. See Annex I for some examples. 10 An analysis of articles in Google Scholar reveals a significant upswing in innovation since 2000 as measured by the percentage of patent applications with regard to the total number of peer-reviewed articles published. 11 Under regulation (EC) 2003/2003, “„Fertiliser‟ means material, the main function of which is to provide nutrients for plants”. 12 Calculated using online statistics from the International Fertilizer Industry Association (IFA) at http://www.fertilizer.org/ifa/ifadata/search. 13 Softer Health Claims in the Offing for 2011. Nutraceutical Business & Technology [serial online]. March 2011;7(2):5. Available from: Business Source Complete, Ipswich, MA. Accessed October 30, 2011. 14 Europe‟s Food Makers Opt for General Health Claims. Nutraceuticals World. December 2010. Rodman Publishing. Ramsey, NJ, USA. 15 Since this scenario would not provide an alternative to the current fertiliser regulation, we have included examples that include fertilisers and not just biostimulants. In any case, it is unlikely that Members States would be more open to allow biostimulants to enter their markets through mutual recognition than more familiar fertilisers. 16 « Deux éléments sont à souligner en particulier. D‟une part, les délais impartis à l‟ANSES pour rendre un avis dans ce type de dossier sont très régulièrement dépassés. D‟autre part, le manque d‟éléments suffisants pour apprécier l‟innocuité du produit examiné, argument le plus souvent avancé par l‟ANSES pour rendre un avis défavorable, ne correspond pas aux exigences de proportionnalité et de charge de la preuve prévues par le droit européen. Dans ce contexte, et afin de trouver rapidement une solution pragmatique dans votre dossier, le ministère de l‟Agriculture nous a informés qu‟il demanderait à l‟ANSES de rendre un avis sur votre demande dans un délai de quinze jours. Quel que soit l‟avis rendu par l‟ANSES, le ministère de l‟Agriculture s‟est engagé à prendre une décision favorable d‟homologation de l‟ensemble de produit XXX. »