EUROPEAN MARKET OF BIOLOGICAL CONTROL ….docx

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1、EUROPEAN MARKET OF BIOLOGICAL OONTTOL AgTS :ACTUAL SITUATION AND PERSPECTIVESLE MARCHE DES ACNTS DE LLTTE BIOLOGIQUE EN EUROPE : SITUATION ACRJELLE ET PERSPECTIVES.M. Haissam JijakliProf, a IVniversite de Liege, Gembloux Agro-Bio Tech, Unite de Phytopathologie,Passage des Deportes, 2, 5030 Gembloux,

2、 Belgique, MH. Jijakliulg. ac. beEt consultant pour la societe Lallemand, 233 chaussee de Waterloo, 1060 Bruxelles,Belgique, hjijaklilallemand. comRESUMESince thirty years, public institutes and privates companies work for the development of biocontrol agents and their associated markets. However, t

3、he size of the market is still very small in comparison with global plant protection world market. Europe is the largest market in the world for beneficial insects and the second largest market for microbial biopesticides. Biopesticides have been developed for agriculture, forestry, amenities and pu

4、blic health. However, the largest current market for biopesticides is low surface, high value crops, such as vegetable, fruits, nuts and ornamentals. In comparison with Europe, the US market offers the largest range of biopesticides based on more than 60 different biological control agents currently

5、 approved by the EPA. That situation is partially due to the European registration procedures. Many requirements must be met before introducing a new substance on the European market and the procedure remains slow and complicated. However, a novel regulation (Regulation No 1107/2009 of the European

6、Parliament and of the Council) is now coming into force, giving hope that it will go towards a lightening of the procedure. Until now, the growth of the biopesticides market has been constrained by a number of internal and external factors. However, based on good perspective to solve these problems,

7、 a recent study predicts that the market will grow around 7 % a year over the next 10 years.INTRODUCTIONNowadays, the majority of the agricultural systems in our industrialized countries are characterized by an intensive use of soils, a genetic homogeneity of the cultures, a specialization on a larg

8、e scale as well as an important mechanization. These cultivation methods worsen the impact and the frequency of the diseases requiring a frequent utilisation of plant protection products which support the development of resistant pathogenic populations to these products. In that context, new strateg

9、ies of production are in development aiming at ensuring profitability for agriculture and a less damage for the environment. Among these strategies, the biological control aims at controlling the pathogenic agents by means of biological control agents i.e. fungi, bacteria, viruses and products deriv

10、ed from these micro-organisms. The biopesticides constitute the products marketed and derived from these biological control agents.Since thirty years, public institute and private companies are interested in the development of biological pesticides or biopesticides. However, compared to the number o

11、f synthetic molecules approved in Europe, the number of agents of biological control currently approved for the control of the diseases remains unimportant Despite some commercial successes, the market of biological control agents remains to be developed in order to obtain an effective system of con

12、trol, answering adequately to the biological, technical and economic constraints imposed by the requirements of the different stakeholders (industrial companies, users, retailers, consumers and the registration authorities of the plant protection products).1 STEPS REQUIRED FOR A SUCCESSFUL DEVELOPME

13、NT OF BCASBefore becoming an economically feasible alternative to chemical control, BCAs have to satisfy different requirements related to biological, technological and toxicological properties (see figure 1). We will review the requirements that an ideal antagonist must meet. An ideal antagonisf sh

14、ould have the following characteristics: effective at low concentrations in several post-harvest host pathogen combinations; able to survive under adverse environmental conditions such as low temperatures and controlled atmospheres adopted prevailing in storage facilities ; amenable to inexpensive p

15、roduction and formulation with a long shelf life; easy to dispense; compatible with commercial handling practices; genetically stable ; non pathogenic for the consumer and for the host commodity.Figure 1 - Steps leading to the practical use of BCA!sMARKET DEFINITION AND MARKET SIZE1.1 World marketAn

16、 accurate figure for the size of the global biopesticides market is currently unavailable, mainly because an in depth survey of the global market has yet to be undertaken.Even if the number of available biocontrol products is increasing, the total sales turnover of the biopesticides (including micro

17、-organisms and arthropods for herbicides, nematicides, fungicides, bactericides, insecticides) was 200 millions dollars in 1995 (102 millions dollars for Europe) and 250 millions dollars in 2004. The plant protection world market exceeding the 30 billion dollars in 1995 and 27 billion dollars in 200

18、4, the biopesticides thus account for 0.7% of this market in 1995 and 0.9 % in 2004.In 2004, the biopesticides represented 80 % of the total sales turnover, while arthropods 20 %. The pheromones market represented 60 millions for that year.It is generally acknowledged that the largest regional marke

19、t for biopesticides are US and Europe. An estimation can be obtained based on figures released by International Biocontrol Manufacturers Association (IBMA) which states that 40 % are based in US, 35 % in Europe and 25 % in the rest of the world.In 1995, 90% of these biopesticides are insecticides an

20、d 92% of the bioinsecticide market being occupied by Bacillus thuringiensis. In 2004, Bacillus thuringiensis products still dominate the global biopesticides market, accounting for 80 to 90% of the microbial market. This dominance is also reflected in the number of different 8卜based products that ar

21、e commercially available. In US for example, there are almost 130 registered Bt- based products. The second most popular microbial biopesticides are those based on entomopathogenic nematodes, with those based on fungi, viruses and protozoa bringing up the rear. Some other biopesticides have also est

22、ablished a strong hold on certain niche markets.1.2 Europe: one of the leader of regional marketThe US is the largest single market for biopesticides products. But Europe is the largest market in the world for beneficial insects and the second largest market for microbial biopesticides. In 2000, the

23、 market was around 97 millions dollars (including pheromones), with beneficial organisms accounting for 55 %, microbial biopesticides for 26%. In 2004, the European market was estimated to reach 110 millions dollars.Other major developed world markets for biopesticides include Japan, Canada, Austral

24、ia and New Zealand with many companies based in these countries and developing products specifically targeted at controlling the major local agricultural pests.Use of biopesticides is also growing in the developing world. This is especially the case in India and in China, where the governments are a

25、ctively encouraging the development and use of biopesticides.In China, there were over 200 biopesticides manufacturers and 77 registered biopesticides in 2004 (the majority are Bacillus thuringiensi-base6 products or antibiotics). Around 30 millions hectares of crops in China were treated with biope

26、sticides that year and the market seems to grow at around 5% a year. In India, biopesticides represent 2% of the pesticide market. Products are based on a variety of biopesticide agents, including Bacillus thuringiensi (insecticide), Trichoderma viride (fungicide) and Beauveria bassiana (insecticide

27、).1.3 Crops targeted by biocontrol methodsBiopesticide products have been developed for a range of different markets including agriculture, forestry, amenities and public health. However, the largest current market for biopesticides, whether based on bacteria, fungi, nematodes or viruses, is low sur

28、face, high value crops, such as vegetable, fruits, nuts and ornamentals. This is because growers of theses corps are most likely for value advantages of biopesticides such as their low toxicity, high pest specificity while not being put off by their disadvantages, such as their relatively high cost

29、and slow mode of action (lower efficacy than chemicals).Low surface, high value crops are often specifically marketed as not having exposed to chemical pesticides (particularly for organic crops). Growers can often charge more for their produce (recouping the extra expense of using a biopesticide).

30、Bf-based products are the exception, being used on both low surface, high value crops but also major field crops (maize, cotton, soybeans). Certain fungi-based biofungicide products have also been developed for the major crops. These products include Bioworks T-22 Planter Box, which contains the fun

31、gus Trichoderma harzianum, and Prohytas Contans, which contains the fungus Coniothyrium minitans. Nevertheless, the uptake of biopesticides has been greatest by growers of low surface, high value crops.2 COMPARISON OF BCAS PRODUCTS IN EUROPE AND IN USIn 2005, the US market offers the largest range o

32、f biopesticides with over 240 products based on 60 different biological control agents currently approved by the EPA. These products are based from 60 different biological control agents (30 insecticides, 22 fungicides/bactericides, 2 nematicides, 2 herbicides 4 others). Bacteria (39 %) and fungi (4

33、1 %) account for the majority of registered agents, followed by viruses (17 %) and protozoa (3 %).27 biological control agents have been approved at EU level in 2005. Only 6 biofungicides were registered at a European level. They are registered in the annex 1 of the Directive 91/414/EEC.There are al

34、so 18 old micro-organisms (11 bioinsecticides and 7 fungicides) which are now reviewed in the last tier of the review programme for all pesticide active ingredients that were on the market in 1993. Among the 27 micro-organisms, bacteria (34 %) and fungi (54 %) account for the majority of registered

35、agents, followed by viruses (12 %).Fifteen other biological control agents (giving 50 biopesticides products) have been approved by national regulatory authorities and are being sold in those countries.3 REGISTRATION IN EUROPEThe concerns relating to the registration must be taken into account as so

36、on as possible in the stages of isolation and selection because this procedure is expensive, takes time and must guarantee the effectiveness for the users and an absolute harmlessness of the micro-organisms for both environment and human.In Europe, Great Britain was a pioneer in registration by form

37、ulating in the late 80s a list of the requirements which the BCAs must meet. Although a questionnaire is also required, the Netherlands decided to treat on a case-by-case basis the registration of the biopesticides immediately after the Great Britain. Since that period, OECD published a booklet of r

38、ecommendations concerning the salting out of micro-organisms in the environment. Majority of the countries, of which those of the European Union incorporated the conclusions of this report (OECD, 1995) in their national legislation.In this respect, no directive as regards plant protection registrati

39、on appeared before July 1993 at the European level, which hardly encouraged the recording of the biopesticides. Indeed, this legislative lack of harmonization contributes to restrict the market at a national scale usually not very profitable for the marketing of a BCA. Since this date and until rece

40、ntly, directive CEE/91/414 was valid and regarded the biopesticides as plant protection products. Many requirements must be met before introducing a new substance on the market.The technical registration dossier of a BCA provides information necessary concerning the foreseeable risks that this subst

41、ance can create for human health and environment. The requirements relate mainly to the identity of the organism, its biological properties, the description of the analytical methods for its identification, its toxicological impact (pathogenicity, infectivity) and its ecotoxicological properties. Si

42、nce the directive CEE/91/414 was amended by the directive CE/2001/36 (specifically dealing with BCAs), more special attention was given to environmental fate of the BCA in comparison to chemical products. Furthermore, if some metabolites are produced by the BCA, specific data on the toxicological an

43、d ecotoxicological impact for each metabolite must be provided, except if sufficient data were already available in literature. The cost of the procedure depends on the micro-organism, knowledges already generated on that micro-organism, the results of the first toxicological tests, the presence of

44、metabolites.The implementation of the procedure implies as a preliminary the choice by the industrialist of a country reporter member state (RMS). This last will evaluate the admissibility of the file first of all and will submit its conclusions to the European Committee.After acceptance, the RMS ev

45、aluates the content of the file and will propose a toxicological and ecotoxicological classification. Again, the European committee will rule on these proposals and will ask the petitioner to take into account the complements of study and requested remarks. At the end of this procedure, the active m

46、atter, in fact the strain of micro-organism is registered on a positive lisC. Each Member State comes to a conclusion thereafter only about the use of the formulated products. At least 3 years are necessary before the first authorisation of sales in one of the European countries (an average of more

47、than 50 months was recently recorded).Until now, the European procedures of registration thus remain slow and complicated and leave little space for individually, the heaviness of this procedure can discourage the development of biopesticides considering the restricted size of the market and also th

48、e size of the companies (often SMEs). However, a novel regulation (Regulation (EC) No 1107/2009 of the European Parliament and of the Council) is now coming into force. One can hope that it will go towards a lightening of the procedure.In opposite, the United States has since 1980 a single legislati

49、on for the commercialisation and the use of biopesticides. The Agency of Environmental Protection (EPA) encourages the development and the use of these biopesticides. The EPA considers a priori that the use of those involves less risks than that of the conventional pesticides. Thus, in general, the

50、data required for the registration are fewer and the procedure takes a minimum of one year and a half (an average of less than 24 months was recently recorded) whereas it is an average of more than three years for the recording of conventional pesticides. It is not astonishing to note that the numbe

51、r of products marketed in the United States is more important than in Europe (cf. section 3). Sometimes, the US requirements for health and environment safety are not considered sufficient by the EU legislator. Furthermore, EU registration requires efficacy tests. Both phenomenas could explain that

52、most US products are not registered in EU.4 FUTURE MARKET POTENTIALUntil now, the growth of the market has been constrained by a number of factors inherent to the products (less efficacy than chemical products, low storability, high pest specificity, high cost, formulation problems) and by some exte

53、rnal factors (niche markets, time and cost regulation).Nevertheless, as some of these problems start to be solved, growers begin to appreciate the advantages of biopesticides, the future of the market looks positive. Indeed the problems caused by lack of funding, costly regulations and some negative

54、 perceptions, most representatives of biopesticide companies were positive about the growth prospects for the market over the next ten years. The general growth of niche markets, the continued withdrawal of chemical pesticides from the market and the restrictions on the use of others, and the increa

55、sed adoption of IPM by growers should all act to stimulate the growth of the market.The growth may be higher in certain sections of the market. Disease control is one area where growth could be fairly rapid, and a relatively large number of protective products based on bacteria and fungi are either

56、commercially available or in the final stages of development as confirmed by numerous recent demands of patents.Technology advances could provide the greatest impetus to the growth of the biopesticide market by overcoming many of the shortcomings of current biocontrol products.A recent study predicts that the market as a whole will grow around 7 % a year over the next 10 years.