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Latin America 2017news, features and interviews

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INCLUDING: Service Company Guide 2017

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Contents


02 South American agchem market continues to drag

09 Brazil drives GMO adoption in Latin America

14 Latin America confronts twin threats of high piracy and low registration

21 Deals and M&A activity in Latin America this year

22 New active ingredients registered or launched in 2017 in Latin America

23 Low-risk substances in the EU

25 SERVICE COMPANY GUIDE 2017

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Editor-in-Chief Sanjiv Rana (Europe/Asia) Email: [email protected]

Deputy Editor Andy Beer (North America/Australia) Email: [email protected]

Editorial Writer Robert Birkett (Latin America) Email: [email protected]

Editorial Writer J R Pegg (United States) Email: [email protected]

Contributor Dr Jackie Bird (EU Affairs) Email: [email protected]

Correspondent Dr Shuyou Han (China) Email: [email protected]

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The Latin American crop protection market suffered the largest fall of any region in 2016, according to figures from Agrow parent company Informa’s seed and agrochemical consultancy, Phillips McDougall. Falls in other regions were typically 1-2%, but in Latin America sales dropped by over 6%. However, the fall ebbed on the previous year. Weather impacts and low crop prices hit business, as well as a lack of access to credit or of access to expensive credit for growers.

The major falls came in Argentina and Brazil, while business in other national markets – where major crop commodity prices are less significant - fell less severely. Other markets depend more on crop exports that are driven by coffee, cocoa, flowers, bananas and other fruit and vegetables. Figures from Brazil indicated a fall of just 1% in sales to some $9.6 billion, a considerable momentum change following the over 20% fall the previous year.

Predictions for the current year in Brazil, which accounts for some 70% of the regional market, is for a drop of some 3%. Industry analysis sees similar trends to last year with a fall in use of older products, and

a rise in use of products focused on the harder-to-control diseases and pests, towards fungicide mixtures and newer herbicides. Reported sales are lagging those of last year with some speculation that growers are delaying purchases in the hope of better conditions later on.

However, credit availability conditions are reportedly improving, with significantly longer periods allowed for repayments.

One key indicator could be imports, which account for the majority of pesticides purchased in Brazil. They made up some 85% of the Brazilian agrochemical market last year. Imports were down some 13% in the first five months of this year. However, the month of May saw a near doubling (+90%) of pesticide imports in value terms compared with the previous month. Volume imports in May were up 49.6% on April at 25,660 tonnes. The volume of pesticides imported into Brazil rose by 5.7% to 414,975 tonnes in 2016.

RegistrationsThe Brazilian agrochemical registration system has been a thorny issue for the industry for several years. Process times are typically longer than in many other

By Robert Birkett

South American agchem market continues to drag


South American agchem market continues to drag

countries, including neighbouring nations. However, the country saw a four-fold increase in approvals in 2016. The Brazilian Ministry of Agriculture granted a record 277 pesticide registrations last year. The “historical average” is some 140, while the record of 2007 brought 203 new product approvals. Biological product approvals rose by some 65% to 38.

The Ministry’s pesticide co-ordinator general’s office rates the change in volumes and quality of products offered as a “great evolution”, citing the efforts of the regulatory agencies, the national health surveillance agency, the Anvisa, the environmental agency, the Ibama, and the Ministry.

However, a study claimed that the “deficit” in the registration of pesticides in Brazil is growing at a rate of 45% per year. That compares the amount of registrations with the number of new applications entering the process. Last year’s 277 approvals were outnumbered by some 400 products that entered the approval process. The study also noted that of the 277, only five were “novel products” that “brought some form of innovation in pest and disease control”.

Discussions over the past 2-3 years in government have considered amendments to speed up the approval process in Brazil. In July, a Ministry of Agriculture working group listed 12 measures to change the regulation of agrochemicals including of the registration process. The proposals included the creation of an electronic system to integrate the three bodies responsible for registering agrochemicals in the country: the Ministry of Agriculture, along with the Ibama, and the Anvisa.

Another recommendation is that the Ministry become the lead authority. The working group – including growers’ groups – wants amendments to legislation or deregulation. The goal is to slash approval process times.

Earlier in the year, The Ministry said that it would launch its integrated pesticide system along with the other registration bodies this year. “It is not only about

simplifying processes for the approval of pesticides, but developing co-ordinated actions so that the supply of agrochemicals is speeded up,” a Ministry official said.

The Ministry has also recently drafted proposals to loosen registration rules towards a risk-based approval system and away from hazard criteria. The major proposal is to amend existing legislation that prohibits the use of certain toxicity pesticides to permit registrations under risk mitigation measures. Meanwhile, the Anvisa held a public audience on proposals that included adopting risk-based cut off criteria.

Significant changes were made last year in the Dominican Republic’s and Costa Rica’s

agrochemical registration system. Fundamental reforms improved the efficiency and transparency of the Dominic system, industry association CropLife Latin America comments.

Costa Rica’s Regulation RTCR 484/2016 on synthetic pesticide formulations, active ingredients and other substances for agricultural use was published in the official gazette in January. It is due to enter into force this month.

Minister of Agriculture Luis Felipe Arauz Cavallini noted that international trade agreements informed the regulation. He lauded the system as able to facilitate farmers’ access “to new and more innovative formulations that are more environmentally friendly and lead to a reduction in applications and lower costs”. The Ministry’s plant health inspection service, the SFE, will administer the regime, with input from the Ministries of Health and the Environment.

CropLife notes that the reform is expected to end the almost ten years in which it was impossible to register new ais, leaving the country behind in the provision of technology.

Last year, the Argentine government committed itself to seeking ways to accelerate the approval processes for the imports of agricultural inputs including pesticides.

Argentina set quotas on agrochemical imports with various pesticides no longer obtaining “automatic licences”. Agrochemicals acquired outside of Argentina would have to be submitted to the animal and plant health inspection

“The Ministry has also recently drafted proposals to loosen registration rules towards a risk-based approval system and away from hazard criteria”

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service, the Senasa, for analysis with a 60-day deadline. The move reportedly followed national industry lobbying against the import of particularly Chinese formulated products, which accounted for 80% of imports. Among the restricted ais under Resolution 301 of the Ministry of Trade are the herbicides, glyphosate, paraquat and 2,4-D. Affected products would make up some 30% of the Argentine market.

Also last year, Colombia amended requirements for the registration and use extension of pesticides for use on ornamentals on the principle of “grouping” to facilitate more approvals.

Brazil Anvisa reassessmentsEarly this year, the Anvisa issued a public consultation call on its recommendations to alter its pesticide toxicology re-evaluation procedures. The agency’s board, the Dicol, approved the consultation programme at a meeting in February.

One of the most important points of the proposed regime is the definition of criteria for the selection of ais that should be submitted for re-evaluation. The regulation anticipates the publication of a list of the selected ais for re-evaluation, in advance, in order to provide greater predictability to the public, pesticide manufacturers and users, the Anvisa says. Users and manufactures would have more time to seek alternatives to those ais that may be restricted, it adds.

The updating of the regulations is focused on “guaranteeing greater objectivity, clarity, transparency and effectiveness of re-evaluation procedures”, the agency says. It says that the current RD No 48 Resolution of 2008 that has governed the reassessment of 14 pesticide ais, and which remains in force, “no longer addresses the inherent complexity of re-evaluations and presents limitations”. They include a lack of re-evaluation of ai priority criteria definitions and of more detailed action procedures.

The Anvisa has warned that procedures needed to change, including running re-evaluation programmes on fewer than the 14 above, which has a couple of ai assessments outstanding including that of glyphosate.

The agency had set a deadline for the end of 2016 to conclude its reassessment

programme of 14 ais. Six ais remained on the programme. They were: the herbicides, glyphosate, lactofen and paraquat; the fungicide, thiram; the insecticide, carbofuran; and the acaricide/insecticide, abamectin.

Early last year, the agency created a panel to expedite the reassessment of glyphosate. It also convened a panel to expedite a conclusion on the reassessment of paraquat, which it concluded should be banned pending public comments. The panel would consider those received comments that covered calls to widen the debate on its impact to the economy, health and agriculture. However, the re-evaluation of paraquat is reportedly

under threat of a two-year suspension. Although the re-evaluation is almost completed, there are calls for an extension with other international authorities also working on assessments.

The agency recommended a ban on carbofuran early last year, pending public comments. That followed the agency’s call for comments for its re-evaluation of thiram and lactofen. The Anvisa studies concluded that those registrations remain in place. It confirmed its decision to maintain the registration of all lactofen-based products in the second half of last year. Late in 2016, the agency decided to re-examine several toxicological aspects of thiram, following contributions received during the consolidation of the public consultation of January and international updates particularly from Canada and the EU. It has set a new deadline for thiram’s reassessment for this year. No updates have been published on abamectin.

The agency also opened for public comment early this year on its proposals

governing the evaluations and toxicological classification criteria for agrochemicals. The proposals seek to simplify procedures to toxicological evaluations for pesticide registrations or alterations to use approvals. The aim is to cut the bureaucratic process by establishing “traceability” among products that have the same qualitative and quantitative composition and have already been evaluated by the Anvisa. The agency seeks to expedite the conclusion of applications that fall within the simplified procedure. It is to hold a public debate this month on results of public consultations on the proposals.

SuspensionsThe Brazilian Ministry of Agriculture suspended the sale and use of 37 fungicide products for the control of Asian soybean rust (Phakopsora pachyrhizi) this year. That followed the suspension at the end of last year of 63 fungicide products used against the disease. The suspensions followed efficacy evaluations on single ai products last year and combinations in 2017. Registrants have had to exclude recommendation for that use for a period of 120 days from publication of the listed products.

The Uruguayan Ministry of Agriculture has withdrawn commercial registrations on four ais and placed restrictions on another two. The withdrawn ais are the insecticides, azinphos-methyl, methidathion and methomyl, and the herbicide, atrazine, while restrictions have been placed on “certain uses” of parathion-methyl and carbofuran insecticides.

Paraguayan regulators are seeking to eradicate the use of carbaryl insecticide on sesame.

EmergenciesParaguayan authorities have started implementation of emergency application of insecticides to control bird grasshoppers (Schistocerca cancellata). Aerial and ground applications have been approved following detections in localities within a 50 km radius of each other. Applications for control of the pest have been carried out since the start of the year in neighbouring Bolivia.

Several Brazilian states extended the emergency controls against earworms (Helicoverpa armigera) for 2017. Growers

“One of the most important points of the proposed regime is the definition of criteria for the selection of ais that should be submitted for re-evaluation”

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may continue to apply emamectin benzoate insecticide against the pest on affected crops. Emergency controls were adopted by a few states after the national government issued a decree allowing for emergency controls including the import and use of emamectin benzoate in 2013. Early this year, researchers in the country detected a new plant pathogen, Puccinia kuehnii, affecting the country’s sugar cane. The pathogen causes orange rust disease on the crop.

Asian soybean rust is developing resistance to succinate dehydrogenase inhibitor (SDHI) carboxamide fungicides in Brazil, the industry’s Fungicide Resistance Action Committee (FRAC) reported this year. It has identified a mutation following monitoring allowing increased resistance following monitoring work in a Brazilian region with high levels of rust pressure.

The FRAC notes that performance of such fungicides “remains in general good”, but that for the first time in 2015/16, and more so in 2016/17 in areas of intensive use of SDHIs and where rust pressure is great a fall in efficacy rates was noted.

The Brazilian Ministry has determined which pesticide products should get priority analysis in 2017 at a meeting this year of the competent authorities in the country.

The Ministry prioritised 53 products. The major pests, weeds and diseases for which products were granted priority included: whiteflies, white mould, sourgrass (Digitaria insularis), Asian soybean rust and earworms. With reference to the last pest, the second ranking product for registration was Syngenta’s Proclaim 50 (emamectin benzoate). That ai has no registration in Brazil, but is approved for import and use under emergency controls in place for three years.

The nine products in the highest category are all insecticides.

Booming contrabandSpecialists have given evidence to national Senators on the booming contraband market for pesticides in Brazil. Illegal trafficking of agrochemicals had risen from 7% of the national market in 2005 to some 20% at the time of the public meeting at the Senate’s agriculture commission at the end of last year. The contraband costs the country some $1 billion a year.

M&ABrazil and Mexico are among the major markets whose competition authorities have authorised the merger of Dow AgroSciences’ parent company Dow Chemical and DuPont.

Dow Chemical has agreed to sell a portion of Dow AgroSciences’ hybrid maize seed business in Brazil to the Chinese CITIC Agri Fund for $1,100 million. The planned divestiture includes seed processing plants and research centres, a copy of its Brazilian maize germplasm bank, the Morgan seed brand and a licence to use the Dow Sementes brand for a certain period of time. The assets to be divested generated revenues of some $287 million in 2016.

Brazil’s authority has called for a more in-depth impact assessment of the Bayer acquisition of Monsanto on the markets the two companies trade in. The moves follow the recent completed acquisition of Syngenta by ChemChina.

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Latin America again led growth in the planting of genetically modified crops last year. That was largely down to the increasing use of the technology in Brazil. The country led growth not only in the region but globally too.

Planting of the technology was up 11.1% in Brazil to 49.1 million ha, according to the International Service for the Acquisition of Agri-biotech Applications (ISAAA). That comprised some 32.7 million ha of soybeans, 15.7 million ha of maize and 800,000 ha of cotton. The total area of these crops in Brazil amounted to some 52.6 million ha, representing a GM crop adoption rate of 93.4% (90.7% in 2015).

Argentina remained the third-largest adopter of GM crops after the US and Brazil. The area fell by about 3% to 23.8 million ha. GM soybeans amounted to 18.7 million ha and the maize area set a record of over 4.7 million ha.

The other major users of GM crops in Latin America included: Paraguay, where planting acreage was largely unchanged at some 3.6 million ha; Uruguay with a 7% fall to 1.3

million ha; Bolivia with a 9% rise to 1.2 million ha; and Colombia and Mexico, which each maintained planting at some 100,000 ha.

The growth followed the previous year when Latin America bucked the trend of falling adoption of GM crops last year.

National surveys showed somewhat contradictory news. A maize growers’ association found that the adoption rate for GM maize was unchanged in 2016 compared with the previous year, while a wider national survey of GM crops from the consultancy, Celeres found strong growth in adoption of the technology.

The Celeres study revealed growth in GM maize and soybean planting with stacked traits dominating in Brazil. It revealed a near 4% rise in GM soybean area to 32.7 million ha, and a near 16% increase in the planting of GM maize to 15.7 million ha – over two planting seasons. The smaller GM cotton area dropped 3% to over 700,000 ha.

Stacked traits accounted for almost two-thirds (65.1%) of the areas for cotton, maize and soybeans at some 32 million ha.

By Robert Birkett

Brazil drives GMO adoption in Latin America


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Of the 96.5% adoption rate for GM soybeans that were planted, some 59.8 percentage points were of stacked events and 36.7 of herbicide-tolerant soybeans. Of the 88.4% adoption rate for GM maize, 63.9 percentage points were of stacked traits, 20.7 insect resistance and 3.8 for herbicide tolerance technology.

There were 31 stacked event products available on the market, accounting for 44% of GMO technologies. Of those, three were for soybeans, 22 for maize and six for cotton. A total of 69 GMOs had been approved in Brazil, of which four were for import and use in food and feed only.

Cuba is to start planting GM maize and soybeans commercially this year. GM crops will be introduced “on greater extensions of land” following successful trials. Among the products to be launched is a new GM herbicide-tolerant soybean line in trials at the company, Cubasoy.

Meanwhile, late last year, an industry association claimed that major seed suppliers were considering leaving the Uruguayan market due to the “uncertainty” over trade in GM seed. The majority of applications for approval of GM crops had only passed the “administrative” stage with a majority of applications running at over 40 months, and as long as 70 months at the time of the report.

Last year, academic researchers in Chile concluded that a lack of clear guidelines was responsible for the apparent contradiction that Chile had become a leading GM seed producer for trials and “off-season” markets, while Chilean farmers were not using GM seeds for domestic purposes. The Agriculture Ministry’s agriculture and cattle service, the Sag, has provisions to regulate the production of GM seeds for export, while for domestic production there are rules that grant powers to the Ministries of Health and the Environment. But a lack of political will exists to use them, the authors claimed.

ApprovalsThe Brazilian biosafety authority, the CTNBio, recommended the approvals of nine GM crops in 2016. They included five for soybeans, and four for maize. Since the turn of the year, it has provisionally approved another five and requested comments for a sixth.

Those five include two for GM maize: Dow AgroSciences’ MON89034xTC1507-xNK603xMIR162; and Syngenta’s Bt11xMIR162xMON89034xGA21; a first for a GM sugar cane, Centro de Tecnologia Canaviera’s (CTC – Piracicaba) insect-resistant Bt cane; and one each for a Monsanto GM soybean line (its insect-resistant MON87751), and a GM cotton line (its herbicide-tolerant MON88701). The sixth may be confirmed this month for Dow’s insect-resistant and herbicide-tolerant DAS44406xDAS81419 soybean.

The other major GM crop nation, neighbouring Argentina, approved seven GM crops in 2016. Four were for stacked events, and overall covered three maize and four soybean lines. That was an acceleration on the previous two years. Five came in the second half of last year, but the last came in November 2016.

Paraguay’s Ministry of Agriculture has this year approved the commercial use of a stacked GM insect-resistant and

herbicide-tolerant maize line: DuPont Pioneer’s TC1507xMON810xMIR162xNK603 technology. Several of the events had already been granted approval individually or in combination in the country.

LaunchDuPont seed subsidiary DuPont Pioneer is to launch GM glyphosate-tolerant and insect-resistant Intacta RR2 Pro (MON87701xMON89788) soybeans as part of its own offerings in Brazil this year. The company will debut the technology for the summer season. DuPont Pioneer and Monsanto agreed a licensing deal for the latter’s Intacta RR2 Pro soybeans in Brazil last year.

Brazilian growers became able to access news on Monsanto’s Intacta technology through an app called Intacta RR2 PRO available through various mobile platforms. It offers market and weather data and monitor the performance of the soybean technology across the country.

Late last year, the Paraguayan agricultural biotechnology institute, the Inbio, launched its second variety of GM disease-resistant soybeans. The Asian soybean rust (Phakopsora phachyrhizi)-resistant soybeans were co-developed with the public body, the Paraguayan agrarian technology institute, the IPTA. The Sojapar 24 line followed the first variety, rust-resistant and glyphosate-tolerant Sojapar R19, which debuted in 2015. Two further varieties are in late development for resistance to other major soybean diseases.

Around the same time, Syngenta debuted two hybrids of its GM insect-resistant and herbicide-tolerant Viptera 3 (Bt11xMIR162xGA21) maize in Uruguay. They are SYN 840 and SYN 860, which are adapted to early and late planting.

Early this year, Monsanto warned that a regulatory framework guaranteeing its royalty rights in Argentina would be required for the company to launch its stacked Intacta RR2 Pro soybeans. The company was in discussions with the national government over royalty rights for its technology. Private deals with growers for Monsanto technology have been made, but the company is seeking legislation.

Argentina approved the sale and use of Monsanto’s Intacta RR2 Pro soybeans last

“The Brazilian biosafety authority, the CTNBio, recommended the approvals of nine GM crops in 2016: five for soybeans; and four for maize”

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year. The government has since sent a Seed Law to Parliament that would allow the charging of royalties for use of saved seed for up to three years, while Monsanto has since been in discussions with growers over a longer term payment for the technology.

Monsanto suspended launches of new soybean technologies in the country last year over the issue of royalties. Meanwhile, the Ministry of Agriculture agreed a deal with Monsanto on inspecting for the reuse of its technology and charging for it. The company had been holding up cargoes at ports and making its own inspections. Future inspections would be carried out by official bodies.

National policy movesThe Argentine Ministry of Agroindustry has “institutionalised” the opening of public comments on biotechnology events through this year’s Resolution 4/2017. Comments can be made on GM events that have passed through the second phase evaluations of the Argentine agricultural biotechnology assessor commission, the Conabia. The commission would then produce a report from the process for the authorities.

The Ecuadorian Parliament has recently approved the import of GM seeds for use in research. The issue moved to Parliament following a presidential veto against an article in the country’s Agrobiodiversity Law that prevents the entry of GMOs. The move will allow research of such seeds at universities. The country declared itself GMO-free in 2008 but leaders have flirted with the idea of overturning the status.

Paraguayan authorities approved procedures for the issuing of certificates for GM organisms through the single export window, the Vue. Resolution No 285/17 establishes the Directorate of Agricultural Biosafety as responsible for issuing the GMO certificates (COGM in Spanish) on commercially approved GM events. The certificate is a new requirement that some countries demand for the entry of products into their markets. It contains all export operation data for seeds and stresses that such shipments may contain commercially approved events in Paraguay.

In the second half of last year, Peru’s President signed a decree to enact a surveillance and early detection of GMOs plan. Decree No 006/2016-Minam authorises the Ministries of Agriculture, the Environment and Production to enforce the ten-year moratorium on GM crop use that was initiated in 2014. A further decree has since listed commodities to be restricted under the moratorium including plants. However, no practical changes are expected from the decrees, which merely enact the moratorium and related legislation already in place.

An industry legal challenge to the suspension of approvals for GM crop trials in Mexico failed early this year. The class action included Syngenta, Dow, DuPont Pioneer and Monsanto. A court postponed the presentation of the action. The defendants say that the ruling effectively maintains the suspension of GM maize trials.

In 2013, a Mexican judge ordered the Ministries of Agriculture and of the Environment not to grant further authorisations for trials, pilot planting and commercialisation of GM maize. The suspension was justified on the precautionary principle due to the technology representing “an immediate threat to the environment”. Reports claimed that industry feared the ban on planting of GM maize in Mexico would likely to continue for years as “a slow-moving legal battle grinds on”.

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14 www.agrow.com

There has been a reported boom in illegal/contraband pesticide products in Brazil. The market share is estimated to have risen from 7% some ten years ago to 20% last year. Do you recognise those statistics? What is the picture in other Latin American countries?

Jose Perdomo: It is hard to confirm the accuracy of an estimate on an illegal market, because of the nature of such activity. But if the UNICRI [United Nations Interregional Crime and Justice Research Institute] report estimates 15% of the global pesticide market as illegal, it would not be surprising that illegal trade of pesticides in Brazil accounted for a double digit market share. In any case, our member companies have brought to our attention the growth in illegal sales of pesticides, so yes illegal trade most likely is on the up.

The issue is also on the rise on other countries in the region. The fact that more national associations have launched their own campaigns is indicative of such

rise. Traditionally, Paraguay has been a complex country as it borders three countries and access points to Brazil [Paraguay has often been cited as the source of much trafficking of counterfeit products in Brazil]. But Uruguay has become a hotspot of transit for illegal products too, while Chile and Guatemala have surfaced as countries with illegal trade problems.

In the case of Chile, the Iquique port has seemingly become a transit hub into other countries in the region. Import statistics in Bolivia do not match the country’s acreage, which could signal a transit problem there, too. Recently in Colombia, a manufacturing site of counterfeited products was raided by police. Meanwhile, Mexico has a longstanding problem of product theft from retailers and in transit, which feeds back into the supply channels and this issue seems to repeat itself in Brazil too.

What is driving the growth, and is the trend reversing?

President of industry association CropLife Latin America Jose Perdomo describes hurdles and trends in Latin America’s agrochemical sector and his association’s influence in an interview with Agrow’s Robert Birkett

Latin America confronts twin threats of high piracy and low registration

“It is easy to trade illegal pesticides. Non-deterring penalties when compared with other illicit activities, such as drug trafficking, is an incentive. Small fines can easily be offset by the profit margins”

Latin America 2017 | Agrow


JP: It is easy to trade illegal pesticides. Non-deterring penalties when compared with other illicit activities, such as drug trafficking, is an incentive. Small fines can easily be offset by the profit margins. Long-lasting criminal prosecution with few adjudications is another problem.

Most importantly, the time to market and cost for legitimate product registration creates a market for illegal products. The emamectin-benzoate insecticide story in Brazil is a clear example of the impact on the market of an [up to] ten-year registration backlog [in some countries]. Product solutions are not available when pest pressures materialise, and illegal traders find a way to capture the gap in the market. Our industry is held captive.

The trend is not reversing.

While not all counterfeit products are manufactured in China, most of them are. To the extent that China continues to have such a manufacturing capacity, these rising trends will be maintained in the region in the absence of effective customs controls and commitment from shipping companies through compliance policies.

What actions are being used to counter this?

JP: Our member companies deploy their intelligence and security teams in the region together with national and regional authorities and international agencies such as Interpol. CropLife Latin America and its network of national associations support those efforts through the training of authorities. There is increasing interest in having regulatory authorities demand the China ICAMA [Institute for the Control of Agrochemicals, Ministry of Agriculture] certificate for export

authorisation for suspected consignments. The paper trail approach would help raise probable cause for further inspection.

Of course, such documentation may be forged, thwarting any attempts to combat the trade. A lot of training is required, but we are seeing an increased commitment in certain countries for our associations to engage authorities and make them aware of how the illegal trade in pesticides impacts their agriculture.

CropLife Latin America and its association network leads an awareness campaign

about the risks of illegal trade on agricultural productivity and the environment. It is targeted at distributors, farmers, authorities and the general community.

Various national and regional product registration systems have recently undergone or are undergoing change in Latin America. Are there emerging common themes among the region’s new systems or those that are expected to be adopted?

JP: No, the Anvisa’s [Brazilian national health surveillance agency] aspiration of introducing hazard-based cut-off criteria in the evaluation process for products is unique in the region. We regret the attempts to introduce such criteria to restrict product registrations and we wonder whose protection goals are being advanced. The various unsuccessful attempts at issuing regulations following public consultations is testament to inconsistencies of a thorough regulatory system supporting the largest agricultural market in the world.

Other Latin American countries debate about how to adopt GHS [globally harmonised system], perhaps of an equivalence registration system. Certainly, hazard-based cut offs is a discussion unique to Brazil which threatens - in our view - the viability of large and small agricultural production alike.

Are there reasons that justify divergent systems? For example, does Brazil’s diverse climate justify its system of using different authorities for different aspects? [the Anvisa covers toxicology, the environmental agency, the Ibama, covers environmental aspects, and the Ministry of Agriculture agronomic aspects]

“Our member companies deploy their intelligence and security teams in the region together with national and regional authorities and international agencies such as Interpol”

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ADVERTORIAL

Chemspec Europe 2017 in Munich ends with thoroughly positive resultsThe 32nd International Exhibition for Fine and Speciality Chemicals, Chemspec Europe 2017, concluded after two successful exhibition days. From 31 May to 1 June 2017, international industry experts from the fine and speciality chemicals industry met at the Munich Trade Fair Centre for their major sourcing and networking event in Europe. Prior to the show, the organiser Mack Brooks Exhibitions had already announced a record net floor space of 6,200m2 and an increase in exhibitor numbers of around 2%. This positive forecast has now been affirmed by an increase of around 2% in visitor numbers.

The 32nd International Exhibition for Fine and Speciality Chemicals came to an end with thoroughly positive results: with a total of 401 exhibitors and 6,476 attendees from all over the world, the specialised industry event could further increase its overall attendance figure (exhibitors, visitors, press and conference delegates), compared to the previous show in Basel. This year’s Chemspec Europe attracted a total of 3,867 trade visitors which represents an increase in visitors of approximately 2%.

“We are delighted that our exhibitors were actually able to perceive the higher number of visitors at their stands. Aside from the visitors’ high calibre, the exhibitors also valued the fact that they were able to meet existing clients as well as a striking number of new faces”, said Liljana Goszdziewski, Exhibition Director at the organisers, Mack Brooks Exhibitions. “Throughout the two exhibition days, there was a bustling atmosphere in the halls. Chemspec Europe offered international industry experts an ideal platform to conduct successful business deals and exchange views on current trends which were mainly regarding “Continuous Flow Chemistry”, the approaching REACH deadline and the changing competition in worldwide markets.”

At Chemspec Europe 2017, a total of 401 exhibitors from 29 countries showcased a wide variety of fine and speciality chemicals for a large range of applications on a record net floor space of 6,200m2. Compared to the previous year’s

event, this represents a growth of 5% in net floor space and an increase of 2% in exhibitors. The major European exhibitor countries were Germany, the UK, France and Switzerland; Asian exhibitors mainly came from China and India. The USA was also well represented by exhibitors.

Visitors to Chemspec Europe 2017 came from a total of 75 countries; predominantly from Germany (43%), followed by the UK, Switzerland, France, India, Italy, China, the Netherlands, Spain, Japan and the USA.

The preliminary results of the exhibition survey show that the majority of visitors came from the following industries: pharmaceuticals, agrochemicals, petrochemicals, cosmetics,


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adhesives and sealants, paints and coatings, polymers, biotechnology, colourants and dyestuffs, industrial cleaning as well as water treatment. The majority of visitors were manufacturers, distributors or raw material suppliers and work in research and development or for consulting firms. The main responsibilities of the visitors within their companies were senior management, purchasing and procurement, research and development and marketing.

Visitors were mainly interested in the following products and services: chemical intermediates, general chemicals, pharmaceuticals, industrial chemicals, custom synthesis, agrochemicals, contract and toll manufacturing, catalysts, green chemicals and polymers.

New conferences well receivedChemspec Europe works with a large number of renowned partner organisations and offers its visitors a great selection of free conferences on various topics. Due to popular demand, this year’s conference programme was expanded and complemented by additional lectures and workshops.

For the first time, Dr Magid Abou-Gharbia not only moderated the Pharma Outsourcing Best Practices Panel, but also gave a lecture on the topic “Drug development in a changing environment: Current challenges and future opportunities”. BCNP Consultants were also represented for the first time with their conference “Innovative Start-ups: New Chemicals & Industrial Biotechnology” and in addition, the European Fine Chemicals Group (EFCG) returned with their “7th Crop Protection & Fine Chemicals Forum”.

The remaining conference programme consisted of the RSC Symposium, organised by the Royal Society of Chemistry, dedicated to the topic “Continuous Flow Chemistry for Industrial Processes: Across Speciality and Fine Chemical Market Sectors”, the Regulatory Services Conference, organised by REACHReady,

the Chemspec Agrochemical Outlook Conference, sponsored by Agrow Magazine, the Chemspec Careers Clinic, organised by Chemical Search International (CSI) as well as the Scientific Update Sessions by Dr Will Watson.

High re-booking rate among exhibitors for Chemspec Europe 2018An initial evaluation of the exhibition survey revealed that exhibitors, visitors and conference delegates were highly satisfied with the show. A large majority of exhibitors already secured their stands for Chemspec Europe 2018 whilst on-site. As a result, 72% of the total net floor space is already booked and reserved for the upcoming exhibition.

Chemspec Europe 2018 will take place from 20 to 21 June 2018 in hall 8 of the Koelnmesse in Cologne. The Rhineland is one of the leading chemical regions in Europe, where a large number of chemical parks and approximately 250 chemical companies with more than 80,000 employees are located.

“Chemspec Europe has grown into the central meeting point for industry experts from the fine and speciality chemicals industry from all over the world. Chemspec Europe is a must for everyone who wants to establish new contacts and do business at an international level. Together with the broad conference programme, which will certainly be expanded further, Chemspec Europe 2018 is an exhibition which should be a fixed date in everyone’s diary”, emphasised Liljana Goszdziewski.

Issued byElina Wolff, PR & Marketing Manager Chemspec Europe Press Office Mack Brooks Exhibitions Ltd Romeland House, Romeland Hill, St Albans, Herts AL3 4ET, United Kingdom Tel.: +44 (0)1727 814400, Fax: +44 (0)1727 814501, Email: [email protected]

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JP: There is no real reason for it but to have three different agencies evaluate pesticides is a global trend that has been slowly adopted in the region. You can point out ANLA’s [the Colombian environmental licences authority] recent involvement in pesticide clearances in Colombia. Chile has recently witnessed more involvement from health and environmental agencies. Perhaps Uruguay is the last country in the region where product approvals remain a full competence of the agricultural authorities.

We support such “expanded involvement”, if it is not politicised and newly involved agencies do not introduce biased criteria towards pesticides. We can understand that authorities need to adapt, increase their capacities and agree on their respective responsibilities, but serving anti-industry biased agendas is not acceptable.

Are registration numbers changing in some countries? If so which and what is driving that?

JP: Perhaps there is a slowdown in new product approvals. It is a natural consequence of regulatory overhaul, such as most recently in Chile. On the other hand, it is a concern that some newcomers to the market are gaining a huge amount of registrations in record time. It is hard to come up with evidence of illegal wrongdoing, but it is easy to identify who and where is profiting from this.

In Brazil, authorities have prioritised biological products in the approval system over the past few years. Is this happening elsewhere in the region? What are the advantages of this?

JP: Not really, over the years we have heard about various ways of prioritising

product evaluations, including the EU’s [agrochemical Regulation] 1107 type of priority for more benign products. However, the reality is that there is a ten-year backlog and that directly impacts all farmers. Novel technologies, resistance management, you name it, limiting access to more tools can only negatively impact agriculture.

How far is the prioritisation of biologicals having an impact on chemical registrations? How is the prioritisation helpful to growers? How far is this expanding IPM and availability of mixed chem/bio applications?

JP: The parallel regulatory approval systems are multifactorial. Establishing a direct correlation between biological and chemical policies does not explain the issue. We are pleased to see farmers having more options in their toolboxes, but would be more so, if the backlog on chemistry were significantly reduced, complementing the farmer’s abilities to manage pests soundly and in an integrated fashion.

How close is Brazil to a new approval system? What is the likely new regime? Just more co-ordination among Ministry of Agriculture, the Anvisa, and the Ibama, or a move towards a single body, or the Ministry as lead body?

JP: I would love to have an answer. We have debated deeply around the regulatory future of Brazil in the past month. While we thought that transitioning into an election period and the corruption scandals closely linked to the Presidency and the Ministry of Agriculture, a couple of weeks ago we were surprised with yet more public

consultations geared towards the introduction of cut-off criteria. The Ministry of Agriculture had drafted an encouraging provisional measure which would strike a balance in modern regulatory requirements but unfortunately it seems to be losing traction. The Ibama’s role is more technical, setting protection goals and regulatory requirements to meet them. Unfortunately, having three regulatory approval paths, plus state clearances is quite complex. I do not envisage that changing soon, unfortunately and to everyone’s regret especially the farmers that need the best technologies.

Informa figures show that agrochemical sales in the world’s regions fell 1-2% last year, but by 6.6% in Latin America. Why the divergence? What is impacting Latin America that is not elsewhere or at least less severely than in your region?

JP: Third-party sources report that Latin America as other regions has been impacted by weather changes and insect/disease pressures compared with previous years. High stocks and low commodities prices worldwide have been depressed, impacting farmers directly and if we add carry over inventories still in the supply chain plus currency impacts in many countries, we see some of the ingredients to account for these adjustments. The growing world needs food and Latin America is the one continent that already provides today 11-16% of the world’s food needs and IICA [ Inter-American Institute for Co-operation on Agriculture] expects this capacity to double in the very near future led by Brazil especially but together with the other 14 million small and medium-sized farms in this promising region.

http://www.yngf.com/


http://www.rainbowchem.com



JANUARYBASF and Brazil-based start-up facilitator ACE launched the second edition of its programme to aid start-up companies delivering agricultural products and services in Latin America.

US biological products provider Vegalab and El Salvadorean pesticide and fertiliser supplier Fertica Group agreed an exclusive distribution deal in Guatemala.

MARCHUS agrochemical and specialty chemical company Albaugh’s Brazilian operation, Albaugh Brasil, signed a distribution deal with fertiliser supplier P H Soluções to commence sales of its products in the north-east region of Brazil.

Bayer CropScience and Brazilian co-operative Cooperativo Coprossel set up a partnership for the installation of industrial seed treatment machines at the co-operative’s seed processing unit.

Bayer CropScience established a partnership with the Sao Paulo Federal

Institute of Education, Science and Technology, the IFSP, in Brazil to back education and develop technologies for agriculture.

Bayer CropScience and Brazilian seed multiplier Plantar formed a partnership to provide precision farming in the Brazilian Parana state.

Dutch bioproducts company Koppert Biological Systems, Brazilian pest management company ISCA Technologies and Dutch remote sensing firm TEC-IB joined forces on a project to control red palm weevils (Rhynchophorus ferrungineus) on date palms in the Middle East.

Brazilian agrochemical company Ourofino Agrociencia agreed a tie-up with start-up company Perfect Flight to supply pesticide application tools.

APRILGerman agrochemical company Jebagro agreed to acquire part of Israeli biopesticide company Stockton’s generic registrations

and distribution rights for various countries in Central and South America.

Brazilian agrochemical company Ourofino Agrociencia signed a partnership deal with the Brazilian Ministry of Science’s innovations funder agency, the Finep, to fund formulation improvements and an industrial facility for water-dispersible granule formulations.

MAYBrazilian fertiliser supplier Grupo Vittia acquired an 80% stake in Brazilian biopesticide company Biovalens.

The US biopesticide company, Marrone Bio Innovations, and US agrochemical and specialty chemical company Albaugh’s Mexican distributor, Agri-Star, agreed a distribution deal in Mexico.

JULYUS agrochemical company Gowan’s (Yuma, Arizona) affiliate, Gowan Crop Protection, has acquired the remaining stake in Chilean company Agrotechnology (Santiago) it did not already own.

Deals and M&A activity in Latin America this yearLatin American companies have been active on striking deals since January, as well as attracting suitors for their businesses. Agrow has tracked some of the noteworthy moves in the first half of this year.


Company & active ingredient Use Status

FUNGICIDESSyngentabenzovindiflupyr (trade-marked as) Cereals Launched by DuPont in Brazil as Vessarya Solatenol (with picoxystrobin)

pydiflumetofen (trade-marked as Adepidyn) Soybeans Launched in Argentina as Miravis Duo (with difenoconazole)

BIOPESTICIDES & OTHERSBayer CropScienceBacillus firmus [bionematicide] Cotton, maize & soybeans Approved in Brazil as Oleage

Novozymes BioAg

Simbiose AgroTrichoderma harzianum strain Cepa Launched in Brazil Simb-T5 [biofungicide]

Vitae Rural BiotecnologiaSpodoptera frugiperda multiple Maize Launched in Brazil as CartuchoVIT nucleopolyhedrovirus [bioinsecticide]

BrazilIsaria fumosorosea strain ESALQ 1296 Citrus fruits Use approval recommended by Anvisa

Orius insidiosus Citrus fruits Use approval recommended by Anvisa

New active ingredients registered or launched in 2017 in Latin AmericaNew active ingredients registered or launched this year in Latin America, with links to the original articles.


The comprehensive package of new legislation published from 2009 onwards, including the EU agro-chemical registration Regulation (1107/2009) and the EU sustainable use of pesticides Directive (2009/128) have set a completely new framework for crop protection, introducing low-risk substan-ces in the EU regulatory framework.

Low-risk substances are often incorrectly considered the equivalent of biopesticides, for which no official definition exists under EU legislative frameworks. According to the European Commission’s Health and Food Safety Directorate General’s (DG SANTE’s) criteria for low-risk pesticides (SANTE/11953/2015), low-risk substances are “in many cases botanical active substances, semio-chemicals, micro-organisms [biopesticides] or minerals. However, neither must the scope of low-risk active substances be limited to this non-exhaustive list of substance groups, nor can all substances belonging to these groups be considered as low-risk substances without further assessment”. Thus, chemical active ingredients can also attain low-risk status,

depending solely on the characteristics of the substance and not its origin.

Besides the regulatory framework, there are a lot of political and socio-economic developments and legislation supporting the introduction and use of non-conventional crop protection methods, based, for example, on the EU Common Agricultural Policy. Important steps are the “Motion for a European Parliament resolution on technological solutions for sustainable agriculture in the EU” (2015/2225(INI)) adopted in April 2016 and the European Parliament resolution of February 15th 2017 on low-risk pesticides of biological origin (2016/2903(RSP)). Considering economic, agricultural, ecological, food safety and political aspects, these resolutions not only demand “clear criteria for defining low-risk active substances for the development and use of low-risk pesticides” but also take the view that “non-chemical alternatives to plant protection products such as biological controls, should be given provisional approval for use and priority for evaluation”. They not only state that the “faster approvals process would increase the availability of low-risk

By Bernd Brielbeck

Low-risk substances in the EU

Bernd Brielbeck, Senior Manager Regulatory Affairs, Agrochemicals and Biopesticides at SCC Scientific Consulting Company

24 www.agrow.com

plant protection products on the market and reduce the risk of resistance to active substances and the effects on non-target species linked to commonly used plant protection products” but also “invite the member states to include the use of low-risk pesticides of biological origin in their national action plans on the protection of the environment and of human health”.

This clearly shows that the low availability of low-risk crop protection products is not due to the lack of political will at an EU level. Rather, the adaption of the regulatory process at EU and member state level is the obstacle. Some of the main challenges to applicants do not differ between traditional chemical and low-risk crop protection products, such as the lack of harmonisation or the very signifi-cant delays in ai and product evaluations. As low-risk ais are often manufactured and registered by small and medium-sized enterprises, the resulting lack of planning reliability and delays in entry onto the market have an even more negative impact on low-risk ais than on traditional chemicals. Some member states, such as France, try to remedy these problems and promote low-risk products by additional national efforts or, as in case of the Netherlands, also support industry by providing re-spective guidance documents (CTGB (2017): Evaluation manual for the authorisation of biopesticides according to regulation (ec) no 1107/2009 - microorganisms, botanicals, semiochemicals version 1.0; July 2017).

Guidance related to low-risk and handling of low-risk criteriaSANTE-2016-10616–rev 7 of May 2017 provides an overview of the possible low-risk status of already existing ais after the renewal of these substances expiring between January 1st 2019 and December 31st 2021, indicating that a huge number may be classified as low risk in the future. Paradoxically, point 3 of Article 47 of Regulation 1107/2009 stipulates that “the member state shall decide within 120 days whether to approve an application for authorisation of a low-risk plant protection product”. This, however, does not apply to the renewal of product authorisations regulated by Article 43 of Regulation 1107/2009, which states that “member states shall decide on the renewal of the authori-sation of a plant protection product at the latest 12 months after the renewal of the approval of the active substance…“.

One of the main challenges for low-risk substances, many of which belong to the very inhomogene-ous group of biopesticides comprising different types of micro-organisms and/or their metabolites, semiochemicals, botanicals and minerals is the lack, or sketchiness, of respective guidance and guide-lines. At present, this is especially true, for example, for the possible new definitions of the low-risk criteria for micro-organisms. Not showing multiple resistances to anti-microbials used in human or veterinary medicine is the only criterion given. Therefore, every micro-organism not showing such resistance in general qualifies for being low risk (draft SANTE/12376/2015 ANNEX 1). But, as the first evaluations and comments from national authorities imply, there may be a lot of exceptions and additional restrictions on a micro-organism-(strain)-specific basis. Thus, it is to be suspected that exceptions from the rule will become the rule. This, of course, will reduce the confidence of possible manufacturers and registrants in the EU low-risk/biopesticide regulatory system and restrict their willingness to take on the tedious and increasingly time consuming task of obtaining approvals and authorisations leaving the EU market as depleted of low-risk substances as it currently is.

Another major problem is that scientific argumentation and rationales are often not accepted to the full extent of their relevance or not at all and some authorities or the European Food Safety Authority use an exclusively regulatory approach similar to that for traditional chemical ais. But due to the huge variety of low-risk ais (botanicals, bacteria, fungi, viruses, semiochemicals etc) and their often very complex characteristics, a purely scientific approach is needed.

One promising step forward to facilitate the commercialisation of low-risk plant protection products is the upcoming guideline on “principles of efficacy

evaluation for low-risk plant protection products (PP 1/296),” which was approved by the responsible working party in May 2017. It still needs to be adopted by the Council (scheduled for September 2017) and published (scheduled for early October 2017). Adaption of the efficacy requirements to the low-risk characteristics of the respective ais will reduce the costs for authorisation of low-risk products significantly, and thus (hopefully) will lead to an increase in product authorisations.

Experience and way aheadConsidering current and future economic, eco-logic and socio-economic requirements, the need for low-risk ais and products is without question and is also acknowledged by most stakeholders. As de-scribed above, there are several hurdles to overcome; some of them specific for low-risk ais, others related to general problems of the EU product registra-tion process such as the lack of harmonisation and significant, intolerable delays.

To achieve a significant increase in low-risk ai approvals and product authorisations, a cost-effective registration process that provides sufficient planning reliability to manufacturers and distributors is mandatory. This requires a “coherent, efficient, predictable, risk-based and scientifically robust as-sessment and approvals system” (2015/2225(INI)).

While it is imperative to have a cost-effective registration process for low-risk ais and products, it is also vital to maintain risk assessment at a high level mainly to keep “snake oil products” out of the market and to verify the importance and reliability of low-risk products for IPM and precision farming.

(Dr Bernd Brielbeck is Senior Manager Regulatory Affairs, Agrochemicals and Biopesticides at SCC Scientific Consulting Company)

Latin America 2017 | Agrow

Agrow | Service Company Guide 2017 25www.agrow.com

Service Company Guide 2017


www.tsgeforum.com

WHEN30 November - 1 December 2017 (Thursday - Friday)

WHEREIQS - Ramon Llull University Barcelona, Spain

PRICE Early Bird Rate €300 + VAT(Full Rate €350 + VAT until 3 November Inclusive of Congress pass and Drinks Reception )

Should you wish to register, sponsor or advertise, contact us by:

+44 (0) 1423 863 522 [email protected]

The Development and Regulation of Crop Protection Technologies

in Southern Europe30 November - 1 December 2017 | Barcelona, Spain

Held in the beautiful city of Barcelona, presentations will be delivered by representatives from policy-making bodies and evaluating authorities at European and national level, from industry and leading academic and research institutions.

A conference on crop protection technologies in Southern Europe

This conference brings together professionals concerned with the health and protection of crops in Southern Europe. In particular, the programme will focus on the regulation of chemical, biological and agronomic technologies.

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AgrowAgrowAgribusiness intelligence |

WHY ATTEND

Connect with old and new colleagues in the industry and have the opportunity to network between different professions (particularly industry and regulatory officials) in a relaxed but professional atmosphere.

C3692 Barcelona Agrow Ad.indd 1 28/07/2017 11:04

27www.agrow.com Agrow | Service Company Guide 2017

Contents


28 Biopesticides

32 Consultancies & other advisory bodies

40 Contract research organisations

56 Custom manufacturers

57 Formulation companies & additives suppliers

59 Market research

61 Index

62 Who’s Who in CROs

66 Agrow biologicals review 2017

71 Biologicals-related mergers, acquisitions and deals in 2016

76 New active ingredients registered or launched in 2017

77 EU to set new approval criteria for low-risk pesticides

78 Four biopesticides cleared for EU approval

79 Moving towards a simpler EU biostimulant registration regime

Agribusiness Intelligence | Informa UK Ltd. | Christchurch Court | London EC1A 7AZ | UK Telephone: +44 20 7017 7500AgrowAgrow

Agribusiness intelligence

Marketing Enquiries Email: [email protected]

Agribusiness Intelligence Client Services Team EMEA: +44 20 7017 6242 (9am-5pm BST) APAC: +61 287 056 966 (9am-5pm AEST) NORTH AMERICA and LATAM: +1 21 26 52 53 22 (9am-5pm EDT) Email: [email protected]

www.agribusinessintelligence.com

Disclaimer: Within this issue some advertisements may contain references to active ingredients still under patent protection in certain countries. Where this occurs, such advertisements are deemed inapplicable to those countries.

© Informa UK Ltd 2017

Editor-in-Chief Sanjiv Rana (Europe/Asia) Email: [email protected]

Deputy Editor Andy Beer (North America/Australia) Email: [email protected]

Editorial Writer Robert Birkett (Latin America) Email: [email protected]

Editorial Writer J R Pegg (United States) Email: [email protected]

Contributor Dr Jackie Bird (EU Affairs) Email: [email protected]

Correspondent Dr Shuyou Han (China) Email: [email protected]

Advertising Sales Ben Watkins Tel: +44 20 3377 3911 Email: [email protected]

Advertising Sales (China) Lihong (Lily) Lai Email: [email protected]

28 www.agrow.comService Company Guide 2017 | Agrow

GAB CONSULTING GmbHOttenbecker Damm 10 21684 Stade, Germany Tel: +49 4141 80010 110Fax: +49 4141 90010 20 Email: [email protected] Contact: Dr. Wolfgang Häußler www.gabconsulting.de

Bio pesticides

Agri LifePlot No.154/A5, SVCIE, IDA Bollaram – 502325Sangareddy District, Telangana, India Tel: +91 98854 38365 Email: [email protected] Contact: Dr. Venkatesh Devanur www.agrilife.in

Agri Life, is a research based agri-biotech manufacturing enterprise based in Hyderabad, India. The Company is focused on bio solutions for crops and soils, Agri Life manufactures BioPesticides, BioFertilizers, BioStimulants and other Agri inputs. The enterprise is promoted by technocrats having experience in similar agri-biotech industry.

GAB Consulting is a leading consulting company offering comprehensive registration services for chemical industry in Europe, USA/Canada, Latin-America, Asia, Oceania and Africa.

We meet your needs by providing competent and flexible regulatory and scientific expertise to ensure your product gets registered. Our full range of services includes initial data gap analyses and dossier preparation, risk assessments, expert statements and dossier defence.

Our project managers and senior specialists are always available to help you and solve any issues with authorities’ requests or any general questions you may have. Our goal is that you can sell your product as soon as possible.


Clients working with LKC benefit from independent regulatory advice from an experienced international team for the cost effective registration of specialty chemical products.

Manufacturing companies can optimise their strategic development in the European market with LKC‘s established contacts with Regulating Authorities, technical skills for key studies; impact and risk assessments, dossier preparation, submission including CADDYxml, VNEES and IUCLID formats and technical support post submission.

With a diverse network of regulatory advisors and a focus on major regions of agronomic importance, clients receive scientific and practical solutions to resolve regulatory challenges.

LKC Switzerland LtdPostfach 167 4414 Füllinsdorf, SwitzerlandTel: +41 61 906 85 00 Fax: +41 61 906 8509 Email: [email protected] Contact: Dr. David Kane www.lkc-ltd.com/EU-services.html

Kerona Scientific LtdHeadquarters:30 Thomas Hand Street, Skerries, Co Dublin, K34 RX24, Ireland Tel: +353 1 849 5284Email: [email protected]

Kerona Scientific LtdPaseo de la Castellana, 179C.P. 28046, Madrid, EspañaTel: +34 912 865667www.kerona.ie

Kerona Scientific is an award winning regulatory consultancy headquartered in Ireland and with offices in Spain. Our experience spans all areas from plant protection products to plant biostimulants, fertilisers, and agronomic additives at European and Member State level, working equally with chemical, microbial and low risk active substances. Our services include:• Strategic advice on product development programmes• Comprehensive data gap analysis• Task force management• Study commissioning and monitoring• Preparation of full zonal dRR dossiers and national addenda including all necessary

risk assessments• Project Management of AIR renewal programmes• Preparation of biological assessment dossiers (BAD)• Data matching and technical equivalence applications• Literature searches• Classification and labelling advice

Our native English, German, Spanish, Lithuanian, Polish and Arabic speakers can assist with registrations across the Middle Eastern and all European regions.


Bio pesticides

STAPHYT provides reliable solutions and high level of expertise to agro-chemical, bioproducts manufacturers and plant breeding companies for the development, registration and promotion of their products.

The strength of our network combined within the expertise of our people guaranteed the success of the studies, in complete safety and within the time limits allowed.

These key points show our commitment to provide the best quality and to succeed in your trials, their management and registration issues:- 30 years experience- over 400 team members- Access to all crops all over Europe, Australasia (Peracto), in Americas through partners.- GEP, GLP certified and CIR Agreement

From screening to registration, Staphyt offers the most complete area of expertise:• GEP trials (efficacy & dose response, crop safety, practical value, rotational, drift studies, …)• GLP studies (residue, OPEX, soil dissipation and accumulation, DFR…)• Screening trials in field and glasshouse• Biologicals screening/testing and consulting (Bioteam)• Sales support and development trials• Seed variety testing on all crops, including silage & compositional analysis• Processing laboratory (+100 different processes available)• Ecotox field & tunnel studies for honey/ bumble bees• Research studies (rain fastness…)• Fungi resistance monitoring for pre and post registration purpose

Staphyt regulatory & consulting provides support for registration of chemicals, biologicals, fertilisers, growth media and adjuvants:• Consulting and strategy• Pan-European registration program• Active substance (CA) and preparation (CP) dossier’s (study management, write up of

dossier’s according to dRR format including Risk Assessments and BADs)• Mutual recognition, Bis application, Second trade name…• Direct contact with National Authorities in Europe• Trial permits

Staphyt23 Rue De Moeuvres 62860–Inchy En Artois, France Tel: 00 33 3 21 21 45 21 Fax: 00 33 3 21 21 45 19 Contact: Fanny Vanel (Marketing Manager) Email: [email protected] www.staphyt.com


TSGE Consulting Concordia House, St James Business Park, Grimbald Crag Court, Knaresborough, HG5 8QBTel: +44 (0) 1423 799 633 Fax: +44 (0) 1423 797 804 Email: [email protected] Contact: Steve Dobson, Tracy Roberts, Gareth Marshall, Hermann Wilhelmy www.tsgeconsulting.com

TSGE Consulting is a leading European consultancy providing scientific and regulatory services to the chemical industries.

With a wealth of expertise, gained from industry, government and research, we can provide effective support and guidance for ensuring and gaining regulatory compliance for active substances and plant protection products.

We have offices located across Europe, offering local knowledge and forging relationships with the authorities in the different European regions. This network is fundamental in achieving the regulatory and commercial objectives for our clients.

TSGE has offices in the UK, Ireland, France, Spain, Germany, Slovenia, Slovakia, Poland, Hungary and Romania.

Stockton (Israel) Ltd. 17 Ha’Mefalsim St., P.O.B. 3517 Petach Tikva 49134, Israel Tel: +972 72 257 0000 Fax: +972 72 257 0001 Email: [email protected] Contact: Judy Jamuy www.stockton-ag.com

STK creates breakthrough biologic formulations from plant extracts that effectively protect agricultural and aquafarming harvests and significantly reduce their exposure to chemicals.

STK applies cutting-edge science and technology to commercialize the naturally-occurring, disease-resistant qualities in a variety of plants. Our bio-agro food protection solutions enhance the safety, yield and quality of multiple crops.

With operations in 35 countries and licensed product registrations for its nature-sourced bio innovations, STK is an enabler in the global sustainable agriculture movement, offering a transformative solution for 21st century food protection challenges.

STK is interested in In-Licensing Partners, including small bio companies to broaden the company’s portfolio through exploration, development, acquisition and commercialization of innovative and sustainable modern agriculture.


Consultancies & other advisor bodies

APCOffices worldwide including: UK, France, Poland, Czech Republic Hungary, Australia and BrazilTel: +44 (0) 1937 587 962Email: [email protected]: Chris O’HaraEmail: [email protected] www.apc.eu.com

APC provides regulatory services to the Agrochemical, Biocide and Chemical industries. APC’s worldwide team can help you achieve National, European and International registrations and maximise your regulatory product portfolio and associated sales potential. We deliver timely, cost effective solutions in all aspects of the regulatory process.

Our consultancy has 3 main strengths:• Scientific: Chemists, agronomists, toxicologists & environmental experts.• Regulatory: Each member of APC’s worldwide team has extensive knowledge and expertise

in their market sector and of country specific and regional regulatory requirements.• Strategic & project managers: APC’s regulatory experts have professional knowledge

coupled with business acumen and hands-on experience.

APC provides a complete range of dossier compilation services for active substance approval, product registration / re-registration and active substance renewal in all EU Member States:

• Preparation and submission of active substance and product dossiers in accordance with EU and national requirements

• Preparation of active substance renewal supplementary dossiers and updating statements• Preparation of biological assessment dossiers (BAD)• Monitoring of regulatory studies and field trials• Data Gap Analysis (DGA)• Assessment of registrability of intended uses according to new EU risk assessments• Literature searches / study summaries• Data Matching evaluations• Technical Equivalence submissions• Project management throughout the evaluation processes• Co-ordinating multi-company Task Forces• MRL/Import tolerance applications

APC can also offer a complete service for development and product registrations in many key countries throughout Asia, Australasia, Eastern Europe and South America.


Since 1988, CSI has been specialising in regulatory and scientific consultation to the crop protection and allied industries.

CSI’s services include agrochemical, biocide, chemical and cosmetic registration, hazard assessment (including QSAR and GHS CLP), exposure assessment (including modelling), risk assessment (including for human and veterinary medicines, and relating to endangered species), study monitoring, data compensation evaluations, and M&A regulatory due diligence.

In the EU, CSI can assist with Member State (including Mutual Recognition) or pan-EU regulatory compliance (e.g. via zonal authorisations) with key Regulations, e.g. EC 1107/2009 (Plant Protection), EC 528/2012 (Biocides) and EC 1907/2006 (REACH). CSI can also provide support for global regulatory strategies (including under the OECD Joint Review Process for Pesticides).

CSI’s staff combine a wealth of experience, derived from regulatory authorities, industry and CROs, to provide quality consultancy services to both new and our many repeat customers around the world.

ARCHE Consulting is a regulatory service provider offering high quality support to the crop protection, biocides, cosmetics and chemicals industry.

OUR PPP EXPERTISEWe offer a tailored approach to our customers, assisting them from the early stages onwards (strategic advice, data gap analysis, pre-submission discussions with authorities) to compiling registration dossiers (technical equivalence reports, core dRRs and national addenda, renewal applications etc.).

We assist clients with registrations, not only of chemical actives substances/products, but also plant extracts, micro-organisms, low-risk substances. In addition, we support clients in related industries such as fertilizer and biostimulant companies.

OUR PPP TEAMARCHE Consulting has a dedicated team of project managers and technical experts, including several ‘European Registered Toxicologists’ as well as ‘SETAC Europe Certified Environmental Risk Assessment Assessors’. ARCHE Consulting has participated in several European research projects and updates of guidance documents.

ARCHE ConsultingBelgium Tel: +32 16 28 49 03 Email: [email protected] Contact: An Vanden BoschContact: Inge Huygens www.arche-consulting.be

CSI (Compliance Services International)European HeadquartersContact: Warren ScottTel: +44 131 445 6053Email: [email protected] HeadquartersContact: Jeremy WilsonTel: +1 541 516 1277Email: [email protected]: [email protected] www.complianceservices.com


DHD-Consulting offers full scientific and regulatory services mainly for Agrochemicals and Biopesticides (including German Plant Strengthener), and for Fertilizer and Biocides. Our clients benefit from our quality and timeliness, flexibility and reliability, looking back on more than 20 years’ experience:

• Data gap analysis, consultation on requirements and budget estimations.

• Study monitoring: Request for quotations at contract laboratories, auditing / review of study plans, results and reports.

• Environmental fate modelling, ecological and toxicological exposure calculations as well as expertise (including QSAR and GHS/CLP), and risk assessments.

• Registration Reports / National Addenda (including CADDY) for zonal and national registrations in the EU as well as for (re-)registrations of active substances on EU level (AIR).

• Specialized staff dealing particularly with regard to the German authorisations.

• Placing, design, monitoring, and assessment of efficacy trials and preparation of Biological Assessment Dossiers (BAD).

• Effective literature researches for AIR substances (including documentation according to the EFSA guidance)

• Comparative Assessments for products containing Candidates for Substitution.

Client focus and service quality are our foundations for enduring relationships.


DHD-Consulting GmbH Lilly-Reich-Str. 8, D-31137 Hildesheim, Germany Tel: +49 5121 91873-0 Fax: +49 5121 91873-49 Email: [email protected] Contact: Dr. Dorothee Heimann www.dhd-consulting.de

Dextra International Av. Corts Catalanes 9-11 08173 Sant Cugat del Vallés Barcelona (Spain)Tel: +34 93 583 9553 Fax: +34 93 583 9574Email: [email protected]: Ana Santillana www.dextrainternational.com

Dextra International is a leading strategic consultancy firm specialized in the crop protection business at an international level.

Our target focuses on our client’s international growth, starting with a deep analysis of the product portfolio and the definition of new potential markets. Dextra strategies are based on detail market analysis and cost-effective registration processes.

Dextra provides you with country-basis market survey to take the right decision on registration investment and distribution channels. Our Regulatory consultant advice you on the strategic registration decision and oversee the whole process, from dossier preparation fulfilling local requirements until registration obtaining.

Our main Markets are Europe and Americas, giving all our services from our Headquarters in Spain or from our branches in Colombia and United States.

Dextra provides Due diligence services, and strategic advice on new acquisitions.

Dextra International is the right key for your internationalization






Exponent International LtdThe Lenz, Hornbeam Business Park Harrogate, North Yorkshire HG2 8RE, UK Tel: +44 (0) 1423 853203 Email: [email protected] Contact: Nicholas Pear www.exponent.com

Exponent International’s regulatory specialists have extensive European expertise gained with the regulatory agencies, independent consultancies, contract research organisations and industry. Our expertise is in all technical aspects relating to the regulation of plant protection products, biocides and industrial chemicals, including regulatory strategy and project/task force management. We can assist clients with the preparation of dossiers for both EU and national registrations, support discussions on regulatory documents, import tolerance applications, submissions to panels such as JMPR & JMPS, classification and labelling and study monitoring. We are also able to manage all aspects of REACH, including data review, SIEF discussions, generation of CSRs and IUCLID dossiers, as well as manage consortia.

EBRC is a privately-owned consulting organisation based in Hannover, Germany, providing consulting services with a focus on chemical, biocidal and agrochemical industries. Specialised scientific experience is available in all key disciplines relevant for product safety with respect to human health and environment. Task force management and coordination of industry consortia is another important aspect of our work.

EBRC Consulting GmbHRaffaelstrasse 4, 30177 Hannover, Germany Tel: +49 511 898389 0 Fax: +49 511 898389 10 Email: [email protected] Contact: Torsten Grewe www.ebrc.de


JSC International Limited provides expert regulatory and risk assessment services to the agrochemical, biocides and chemical industry. The team of scientists from government, contract research and industry backgrounds have extensive experience in European regulatory affairs. As an ERM Group company we have the capability to extend this to global regulatory support.

JSC provides expert advice in the development of regulatory strategies, data gap analysis, study monitoring, dossier preparation and submission under Council regulation 1107/2009, BPR and REACH (including CADDY and IUCLID5) and has an excellent track record in post-submission support leading to many successful active substance approvals. JSC has extensive experience in developing strategies for agrochemical active substance renewals and product authorisations for agrochemicals and biocides.


JSC International LimitedThe Exchange, Station Parade, Harrogate North Yorkshire, HG1 1TS, UK Tel: +44 1423 520245 Fax: +44 1423 520297 Email: [email protected] Contact: Richard Elsmore

Kerona Scientific LtdHeadquarters:30 Thomas Hand Street, Skerries, Co Dublin, K34 RX24, Ireland Tel: +353 1 849 5284Email: [email protected]

Kerona Scientific LtdPaseo de la Castellana, 179C.P. 28046, Madrid, EspañaTel: +34 912 865667www.kerona.ie

Kerona Scientific is an award winning regulatory consultancy headquartered in Ireland and with offices in Spain. Our experience spans all areas from plant protection products to plant biostimulants, fertilisers, and agronomic additives at European and Member State level, working equally with chemical, microbial and low risk active substances. Our services include:• Strategic advice on product development programmes• Comprehensive data gap analysis• Task force management• Study commissioning and monitoring• Preparation of full zonal dRR dossiers and national addenda including all necessary

risk assessments• Project Management of AIR renewal programmes• Preparation of biological assessment dossiers (BAD)• Data matching and technical equivalence applications• Literature searches• Classification and labelling advice

Our native English, German, Spanish, Lithuanian, Polish and Arabic speakers can assist with registrations across the Middle Eastern and all European regions.


Clients working with LKC benefit from independent regulatory advice from an experienced international team for the cost effective registration of specialty chemical products.

Manufacturing companies can optimise their strategic development in the European market with LKC‘s established contacts with Regulating Authorities, technical skills for key studies; impact and risk assessments, dossier preparation, submission including CADDYxml, VNEES and IUCLID formats and technical support post submission.

With a diverse network of regulatory advisors and a focus on major regions of agronomic importance, clients receive scientific and practical solutions to resolve regulatory challenges.

LKC Switzerland LtdPostfach 167 4414 Füllinsdorf, SwitzerlandTel: +41 61 906 85 00 Fax: +41 61 906 8509 Email: [email protected] Contact: Dr. David Kane www.lkc-ltd.com/EU-services.html

Phillips McDougallSuites 1 - 4 Vineyards Business Centre Saughland, Pathhead Midlothian, EH37 5XP Tel +44 207 017 4308 Email: [email protected] Contact: James Keady www.phillipsmcdougall.co.uk

For over 15 years, Phillips McDougall has been providing independent, accurate and informed data and analysis regarding the agrochemical industry to a client base spread around the world, including all the major crop protection companies and investment banks. The services supplied include multi-client reports, detailed databases, daily news/analysis service and single client confidential consultancy.

Phillips McDougall is unique in linking global industry analysis with basic market research, providing unsurpassed knowledge and experience to answer your questions and fulfil your consultancy needs. Phillips McDougall services range from the broadest global analysis to consultancy around specific issues at the individual, crop and country level.



SCC – Scientific Consulting CompanyAm Grenzgraben 11 55545 Bad Kreuznach Germany Tel: +49 671 298 460 E-mail: [email protected] Contact: Dr Albrecht Heidemann www.scc-gmbh.de

SCC is one of Europe’s largest privately owned and independent regulatory consulting companies. Since 1989, we have been supporting our international customers with cost-efficient solutions for their scientific and regulatory needs. Our expertise extends over a broad range of areas, including agrochemicals and biologicals, chemicals and biocides, feed and food additives, food contact materials, cosmetics and consumer products.

Our long-standing expertise includes defence of more than 75 agrochemicals (chemicals and biologicals) under Directive 91/414/EEC and Regulation 1107/2009, compilation of plant protection product dossiers (> 500), filing of LEAD dossiers (> 250), several hundred registrations for phase-in-substances under REACH, submission and defence of dossiers for biocidal active substances (> 70) and increasing number of biocidal product dossiers and management of more than 25 task forces.

SCC stands for meeting every single deadline: we are the experts for regulatory challenges – large and small. More than 130 highly skilled, team-focused employees, mostly academics, form the backbone of our company.

Alongside with Headquarters in Bad Kreuznach and the second German office in Berlin, SCC has been running Liaison Office Japan for 10 years.

We care for your success

Redebel Regulatory Affairs SCRLRue de Chassart 4B 6221 Saint Amand BelgiumTel: +32 71 85 33 92Email: [email protected]: CEO Sébastien Dumont de Chassart

Since the 1st of March, 2016, Redebel Regulatory Affairs SCRL, RRA, has taken over all the regulatory activity from Redebel. A highly qualified international team with experts coming from universities and industry can support you in a various range of premium quality services:• Preparation, redaction and submission of PPP, REACH and Biocides dossiers in the

European Union• Preparation of National addenda for the all 28 Member states• Contact and organize meetings with competent authorities through the European Union• Monitoring of the regulation• General regulatory support and advice• Consortium Management…

Our strengths towards Registration• Tailor made services• Confidentiality• Flexibility• Privileged contacts with EU competent authorities• Presence at international meetings• Close working relationships and communication with the client• Good experience in Study Monitoring• Focused on the objective: Registration for the best Return on Investment


TSGE Consulting Concordia House, St James Business Park, Grimbald Crag Court, Knaresborough, HG5 8QBTel: +44 (0) 1423 799 633 Fax: +44 (0) 1423 797 804 Email: [email protected] Contact: Steve Dobson, Tracy Roberts, Gareth Marshall, Hermann Wilhelmy www.tsgeconsulting.com

TSGE Consulting is a leading European consultancy providing scientific and regulatory services to the chemical industries.

With a wealth of expertise, gained from industry, government and research, we can provide effective support and guidance for ensuring and gaining regulatory compliance for active substances and plant protection products.

We have offices located across Europe, offering local knowledge and forging relationships with the authorities in the different European regions. This network is fundamental in achieving the regulatory and commercial objectives for our clients.

TSGE has offices in the UK, Ireland, France, Spain, Germany, Slovenia, Slovakia, Poland, Hungary and Romania.

STAPHYT Regulatory is a consulting company specializing in chemical regulatory affairs.

Operating in the agro chemistry, biologicals, biocides and chemical sectors, our mission is to keep manufacturers informed about the regulations that apply to their business. We help our clients to achieve the smooth entry to the market of their substances and products in compliance with national and European regulations.

Our expertise covers all areas related to chemical risk assessment: physico-chemistry, analysis, toxicology, ecotoxicology, residue, biological efficacy, etc.

Our team brings together the expertise of scientific and regulatory experts, and we can rely on a network of consultants to cover the whole of Europe.

Plant Protection & Nutrition expertise:

We can assist you in all regulatory procedures required to obtain active substance approval and/or product authorisation for both conventional and biological products (EC 1107/2009, EC 2003/2003,...).

Benefits of working with us:

Both agronomic experimentation and regulatory affairs expertise gathered in one service company!

We offer you real added value by taking charge of your projects from the earliest stage all the way through registration.

Staphyt Regulatory23 Rue De Moeuvres 62860–Inchy En Artois, France Tel: 00 33 3 21 21 45 21 Fax: 00 33 3 21 21 45 19 Contact: Fanny Vanel (Marketing Manager) Email: [email protected] www.staphyt.com/regulatory


Contract research organisations

Agrolab Roejleskovvej 18 DK- 5500 Middelfart, Denmark Tel: +46 706 34 84 85 Contact: Jesper Yngvesson Email: [email protected] www.agrolab.dk

ANADIAG16, rue Ampère F-67500 HAGUENAU, France Tel: +33 3 90 59 00 00 Email: [email protected] www.anadiag.fr

ANADIAG is one of the leading CROs in Europe and provides a wide range of services for the registration of existing or new Plant Protection Products.

With more than 25 years experience in the agricultural business market, more than 50 field trial stations all over Europe and in-house regulatory experts and laboratories, ANADIAG is the most reliable choice to lead your registration projects to success.

Your project – Our services

Field Experimentation Services We own one of the largest European GEP and GLP certified field networks which provide efficacy, residues and development trials for registration as well as marketing trials.

Laboratory Services We manage complex studies in analytical chemistry, physical measurements, environmental fate, residue analysis and methods development under GLP and other accepted industry test protocols.

Regulatory Affairs and program handling We are managing a regulatory group with excellent connections at EU and National level and can arrange the preparation and submission of your EU Annex II and Annex III dossiers as well as National applications, equivalence/specification dossiers.

YOUR PRODUCT REGISTRATION – OUR SUCCESS

Agrolab is the leading CRO in the EU North Zone, with facilities in Denmark, Sweden, Latvia and Lithuania. Agrolab provides an independent and confidential service of the highest quality.

First established in Denmark in 1984, Agrolab has more than 30 years of experience as a CRO. Since 2007, our activities has expanded to Sweden (2007), central Sweden (2011), Latvia (2012) and Lithuania (2016). Agrolab has been GLP- certified since 1989 and GEP- certified since 1996. Our regulatory team specialises in the EU North Zone requirements and the 1107/2009 directive. Agrolab is a highly qualified partner for planning the registrations of your PPPs in EU, with extensive experience in all parts of the dRR for application.


BioChem agrar GmbHKupferstr. 6 04827 Gerichshain, Germany Tel: +493 429 286 325 Contact: Gernot Renner, Markus Barth Email: [email protected] [email protected] www.biochemagrar.de

As an independent and GLP/GEP compliant CRO we offer expertise and capabilities to conduct studies for product registration of agrochemicals and chemicals. Our services include a broad range of regulatory testing on laboratory, semi-field and field scale at different sites in Germany and Europe.

We provide you with studies necessary for registration including but not limited to Ecotoxicology (Aquatic organisms, Non-target arthropods, Honey Bees/Pollinators, Soil organisms, SMO, Non-target terrestrial plants), Field trials (residues inclusive processed crops, crop rotation, soil dissipation/accumulation, variety evaluation, efficacy, fertilizer, demonstration trials) and Analytical chemistry (plants, soil, water, bee relevant matrices).

Biotecnologie BT SRLFrazione Pantalla - 06059 Todi (Perugia) Italy Tel: + 39 075 8950045 Fax: + 39 075 888776 Contact: Roberto Cimaschi (Sales Manager) Email: [email protected]

Contact: Stefania Morandi (BioTecnologie BT Research Centre Manager) Email: [email protected] www.biotecnologiebt.com

Biotecnologie BT is an Italian CRO, certifed in Good Laboratory Practice (GLP) and Good Experimental Practice (GEP). Biotecnologie BT, with its two Test Facilities, situated in Central and Northern Italy, is able to provide services in support of the registration dossier in EU, USA and South America of different kind of products:

• Plant Protection Products (biological and chemical)• Biocides • Veterinary Medicinal Products• Chemicals• Pharmaceutical Products

performing a wide range of tests on the chemical-physical, ecotoxicological (terrestrial and aquatic), and microbiological field.

All tests are performed in compliance with current International Guidelines (OECD, IOBC/WPRS, ESCORT, CIPAC, ICH etc.) BioTecnologie BT, thanks to a long experience, consolidated know-how, highly qualified staff and cutting-edge equipment can guarantee a quality performance to suit customer needs.



CropTrials GmbH is an independent and privately-owned company for agricultural field research, with GLP and GEP certification. The firm provides service for the development of agricultural chemistries, fertiliser and biostimulants.

We are very experienced in efficacy and selectivity studies as well as in residue, soil dissipation and rotational crop studies since 1990. The trials are carried out in all agricultural and horticultural crops and in orchards, vineyards, ornamentals, forests and non-agricultural land.

We offer the whole project management from planning trials to the preparation of the biological assessment dossier for the Central and South European Registration Zone (zone B and C).

For further information, please contact us: [email protected]

CropTrials GmbHEhlbeek 2, 30938 Burgwedel, GermanyTel: +49 5139 8393Fax: + 49 5139 27095Email: [email protected]: Dr. Paul Reh and Kirsten Heitsch www.croptrials.com

CEMAS is a GLP-compliant contract research organisation established in 1989 that specialises in multi-site residue studies, pesticide residue analysis, analytical method development, method validation, livestock feeding studies, agrochemical product and biocide analysis, elemental analysis, formulation support for a range of solid and liquid formulation types, 5-batch analysis, bee studies and human risk assessment including operator exposure, worker re-entry, bystander exposure, dislodgeable foliar residues and drift monitoring. Experience in agrochemical research in the company is extensive and includes soil dissipation and accumulation studies, analytical and environmental sciences, product chemistry, formulation work, soil characterisation and the generation of regulatory dossiers. Experienced personnel and state-of-the-art equipment allow CEMAS to generate quality data on time for all of our clients.

AGROBLU BUL OOD22, Bogomil str., 4000 Plovdiv, BulgariaTel/Fax: +359 32 51 60 14EIK/BULSTAT BG202997647Contact: Stefano Cassani Email: [email protected]: Gospodin KolevEmail: [email protected]: Albena Stoyanova Email: [email protected] website www.agroblu.com

It is the latest of six companies of the AGROBLU Group for PPP and Biocides Registration consultancy and GEP and GLP field studies. Funded in Sofia in 2014 under the thrust of the Greek and Romanian staffs, which has collected the technical know-how, AGROBLU BUL has two locations: one in Plovdiv (South) and the other in Veliko Tarnovo (North), which has been the ancient and beautiful capital of Bulgaria. Despite his young age, he has already achieved the GEP certification and is implementing the process of GLP certification. Bulgarian staff has been carefully selected among highly experienced technicians and has nothing to envy to the more established companies of the Agroblu Group in Europe. The staff is fully operative and started to archive the first tens studies.

CEM Analytical Services LimitedImperial House, Oaklands Business Centre Oaklands Park, Wokingham Berkshire, RG41 2FD Tel: 01344 887103 / 01344 887100 Contact: Alan Jutsum Email: [email protected]


Modern, Laboratory established in 2013 near Milano, carry out official Studies for determining the efficacy of Biocide Products, any kind of formulation. Prof. Luciano Süss (already Director of the Institute of Entomology of the University of Milan) manages and develops Research activities on Biological and Integrated pest Management for Crop Protection, Stored Products, Food Productions and Food Distribution. Studies on food packaging are also included. A peripheral facility of this Laboratory has been established in Fondi, Central Italy, where under the direction of Dr. Giuseppe Carbone, bred Parasites and Useful species of insects (Beneficial) for Laboratory and Field Studies.

ENTOMOLOGIA APPLICATA collaborate with governmental Institutes, Universities and Private Laboratories on Studies of International en/or mutual interest. The Personnel of this Laboratory support by consultancy all the 9 AGROBLU Facilities in Europe.

AGROBLU Srl. (Laboratory)Via Isonzo 20 - ingresso via Curiel 198/220098 Rozzano (MILANO), ITALYC.F. e P.I. 11112800153Tel: +39 02 8254491Contact: Prof. Luciano Suss Email: [email protected] Contact: Luciana Fabris Email: [email protected]

EAG Laboratories Global Headquarters: 4747 Executive Drive Suite 700 San Diego, CA 92121, USA Tel: +1 800 538 5227 Contact: Robert Gurley Email: [email protected] www.eag.com

EAG Laboratories is a global scientific services company that offers the broadest capabilities and largest capacity for GLP-compliant testing of any North American CRO. Our scientists are experts at translating regulatory guidelines into novel field and laboratory study designs. They are known for developing innovative test systems and applying advanced analytical methodologies to answer complex product development, crop protection, and environmental questions. Services include the full suite of residue analysis; aquatic, terrestrial and avian toxicology; environmental fate; plant and animal metabolism, pollinator testing; product chemistry and in-house radiolabelling.

How do you drive R&D productivity and at the same time keep pace with evolving environmental regulations?

Turn to EAG. WE KNOW HOW.

EPL Bio Analytical Services 9095 West Harristown Blvd. Tel: 217 963 2143 Contact: Robin King Email: [email protected] www.eplbas.com

EPL Bio Analytical Services (EPL BAS) is a contract agricultural laboratory, operating in full compliance with Good Laboratory Practice (GLP) standards.

EPL BAS provides testing of food ingredients, organic products, genetically modified crops, biopesticides, plant protection agents and crop chemicals using advanced technology such as Sciex 6500+ with SelexION in the areas of product chemistry (eg. 5 Batch Analysis), residue chemistry, pollinator health, nutritional chemistry (eg. Nutritional Composition Equivalence and Simulated Gastric Fluid analysis for GMOs), molecular biology (eg. RT-PCR with QuantStudio™ 6, Southern Blot Analysis with 32p) and method development and validation







Field Research Support (FRS) was founded in 1997 as a local operator for Europe-wide multi-site studies for agricultural field trials. Since then, FRS obtained GEP recognition in 1997, as well as GLP certifcation in 2000. The company now offers GLP and GEP field studies in southern, middle and eastern Europe under GLP and GEP recognition by the national authorities.

Field studies are conducted by the company’s experts in all main arable crops and a wide range of vegetables, fruits, vines, ornamentals and industrial crops in open field or greenhouses. From 2005 onwards, Field Research Support began a registration and dossier preparation service.

Field Research Support Max-Planck-Str. 5 D–31515 Wunstorf, Germany Tel: +49 5031 5166999 Email: [email protected] Contact: Helmut Zöllner www.field-research-support.de

STRONGER TOGETHER

Please see pages 46-47 for details of our global locations and contacts

e: [email protected]: www.eurofins.com/agroscienceservices


Agroblu is a privately, owned and independent Service Company that provides consultancies on the Registration of PPP, Research and Field Studies in all the Regions of Greece and even Cyprus by facilities and technicians located in the most important Agricultural areas of the Countries. Agroblu Hellas has professional and ownership connections with the facilities in Italy, Romania, and Bulgaria. GLP and GEP certified AGROBLU HELLAS has been designed to enable smart, swift and effective communication with clients, wherever their location, and between scientists and Consultants of the Company. Over 2000 Trials in 23 years on 98 crops, 238 Active ingredients and 540 formulated products tested, no complain by the clients are the number that make AGROBLU HELLAS tip of the Agroblu organization diamond.

AGROBLU HELLAS Ltd.20th. km N.R. Thessaloniki-Polygiros Po. Box 888 57001 Nea Redestos, (Thessaloniki), GreeceVAT EL095681806 Tel: +30 2310 466455 Fax: +30 2310 468351Contact: Andreas Andreanidis Email: [email protected]: Eugenia Georgiadou Email: [email protected]

Innovative Environmental Service (IES) LtdBenkenstrasse 260, 4108 Witterswil Switzerland Tel: +41 61 705 10 31 Email: [email protected] Contact: Dr. Stefan Höger www.ies-ltd.ch

Innovative Environmental Services (IES) Ltd is an independent and privately owned GLP-certified contract research organisation (CRO) which performs environmental fate, metabolism, aquatic and terrestrial ecotoxicology, and analytical chemistry testing to support the development, registration and stewardship of pharmaceuticals as well as agrochemical, biocidal and chemical products in a prompt, flexible and cost-efficient manner.

At IES Ltd, we cooperate with authorities, research institutes and clients on a regular basis to improve existing test systems and guidelines, and to develop alternative and more cost-effective studies to satisfy the stringent and demanding regulatory requirements. Participation in ring-testing, scientific working groups and workshops is an integral part of our company philosophy.

IES’ GLP testing facilities and equipment are state of the art. All laboratories, incubation rooms, growth chambers, cooling and freezing facilities are temperature and, if required, humidity controlled. Our outdoor facilities consist of greenhouses, crop metabolism areas and agricultural land.

e: [email protected]: www.eurofins.com/agroscienceservices

46 www.agrow.com

STRONGER TOGETHER

- Field Base - Laboratory - Regulatory

- Combined Field & Laboratory

- Partner

WORLDWIDE LOCATIONS

In South America, EAS can offer a broad portfolio of services including field residue and efficacy studies; field and lab ecotoxicology studies; e-fate and crop residue analysis; method development and validation; stability studies.

Regional contact: Luiz Zotarelli [email protected] Tel: +55 19 2107 5371

South America

EAS has a large network of field and laboratory facilities throughout the ANZ region which offer a full range of CRO services to the crop protection and animal health industries. The laboratories provide pesticide and veterinary medicine residue testing. The public health portfolio in ANZ is comprehensive.

General contact for:

• Field: Andrew Wells [email protected] Tel: +61 418 328 322• Analytical: Susan McKeon [email protected] Tel: +61 401 673 917• Animal Health: Sally Colgan SCEC [email protected] Tel: +61 299581108• Regulatory: Kathryn Adams [email protected] Tel: +61 428601049

Australia and New Zealand

With facilities in Thailand, India & the Philippines, and partners in Vietnam and Indonesia, EAS Group conducts GLP field trials to test crop protection compounds for bio-efficacy, selectivity, vigour and residual activity. In addition to field trials, public health services, resistance monitoring and ecotoxicology studies are offered throughout the region.

Regional contact: Jean-Louis Allard [email protected] Tel: +66 929925666

Asia

Europe

Europe is home to a highly developed network of Eurofins field facilities and laboratories. All field and laboratory services for development, registration, and post-registration support can be provided in the European zone. Animal health and public health services are also available and rapidly growing.


• Regulatory: Miriam Köttig [email protected] Tel: +41 61 83620 83• Consumer safety & biological assessment (efficacy and screening); David Clark [email protected] Tel: +44 1332864800• Environmental safety, product chemistry & animal health; Jeffrey Kolkman [email protected] Tel: +31 622489680

North America

EAS has an advanced portfolio of services in North America to include all field studies, ecotoxicology studies, E-fate and metabolism studies in the lab and field. Our residue laboratory is dedicated to GLP residue and metabolism analytical services. In addition, our public health department provides a full range of services on mosquitos and other pests.

Regional contact: Martin Feyerabend [email protected] Tel: +1 717327785

Biological Evaluation

Consumer Safety

Product Chemistry

Environmental Safety

Regulatory Support

47www.agrow.com

STRONGER TOGETHER

- Field Base - Laboratory - Regulatory

- Combined Field & Laboratory

- Partner

WORLDWIDE LOCATIONS

In South America, EAS can offer a broad portfolio of services including field residue and efficacy studies; field and lab ecotoxicology studies; e-fate and crop residue analysis; method development and validation; stability studies.

Regional contact: Luiz Zotarelli [email protected] Tel: +55 19 2107 5371

South America

EAS has a large network of field and laboratory facilities throughout the ANZ region which offer a full range of CRO services to the crop protection and animal health industries. The laboratories provide pesticide and veterinary medicine residue testing. The public health portfolio in ANZ is comprehensive.


• Field: Andrew Wells [email protected] Tel: +61 418 328 322• Analytical: Susan McKeon [email protected] Tel: +61 401 673 917• Animal Health: Sally Colgan SCEC [email protected] Tel: +61 299581108• Regulatory: Kathryn Adams [email protected] Tel: +61 428601049

Australia and New Zealand

With facilities in Thailand, India & the Philippines, and partners in Vietnam and Indonesia, EAS Group conducts GLP field trials to test crop protection compounds for bio-efficacy, selectivity, vigour and residual activity. In addition to field trials, public health services, resistance monitoring and ecotoxicology studies are offered throughout the region.

Regional contact: Jean-Louis Allard [email protected] Tel: +66 929925666

Asia

Europe

Europe is home to a highly developed network of Eurofins field facilities and laboratories. All field and laboratory services for development, registration, and post-registration support can be provided in the European zone. Animal health and public health services are also available and rapidly growing.


• Regulatory: Miriam Köttig [email protected] Tel: +41 61 83620 83• Consumer safety & biological assessment (efficacy and screening); David Clark [email protected] Tel: +44 1332864800• Environmental safety, product chemistry & animal health; Jeffrey Kolkman [email protected] Tel: +31 622489680

North America

EAS has an advanced portfolio of services in North America to include all field studies, ecotoxicology studies, E-fate and metabolism studies in the lab and field. Our residue laboratory is dedicated to GLP residue and metabolism analytical services. In addition, our public health department provides a full range of services on mosquitos and other pests.

Regional contact: Martin Feyerabend [email protected] Tel: +1 717327785

Biological Evaluation

Consumer Safety

Product Chemistry

Environmental Safety

Regulatory Support


Since 1984, Oxford Agricultural Trials (OAT) has been a leading contract research organisation specialising in agrochemical field trials: residue (crop residue and rotation, soil dissipation and accumulation) efficacy, crop safety, variety evaluation, fertiliser and demonstration. The main base in Oxfordshire is equipped with glasshouses and a cold store, whilst regional bases in Devon, Wiltshire, Essex, Cambridge, Lincolnshire, Warwickshire, Yorkshire and Scotland ensure products are tested under a variety of environmental conditions. There is close co-operation with research organisations in Europe for many projects.

The company has an excellent reputation for providing a service which is independent, confidential and of the highest quality. Residue trials are conducted in accordance with Good Laboratory Practice (GLP) guidelines and OAT has been an “Officially Recognised Efficacy Testing Facility” (ORETO certifcated) since 1998.


Peracto 16 Hillcrest Road, Devonport Tasmania 7310, Australia Tel: +61 3 6423 2044 Email: [email protected] Contact: Ian Macleod www.peracto.com

Operating since 1976, Peracto is the leading Australasian agricultural contract research organisation with a growing international client base. We provide superior design and conduct of GLP and efficacy studies in all crops grown in Australia and New Zealand (tropical to cool temperate). Our focus is on quality and timeliness of reports for our clients. Experienced and fully qualified staff bring a wealth of national and international experience with the company offering out of-season opportunities for northern hemisphere clients. With continuing growth of our business we welcome enquiries from those wishing to discuss opportunities to work with us. For more information visit www.peracto.com

Since July 2016, Peracto has been part of the Staphyt company.

Oxford Agricultural TrialsWest Farm Barns Stratton Audley, Bicester Oxfordshire OX27 9AS, UK Tel: +44 1869 278172 Contact: Chris Kay Email: [email protected] www.oxagtrials.co.uk

With over 30 years’ experience in ecotoxicological research, Mambo-Tox is an independent, GLP-compliant, contract research organisation specialising in terrestrial ecotoxicological studies.

We evaluate the effects of pesticides and biocides on non-target arthropods, soil invertebrates and honeybees/bumblebees. Bioassays following the relevant international testing guidelines are carried out under laboratory, extended laboratory or semi-field conditions, utilising our extensive controlled-environment and glasshouse facilities. We have also carried out many full-scale field trials to assess the impact of pesticides on NTA populations in both arable and orchard crops.

Mambo-Tox understands the importance of delivering quality studies to tight deadlines and can normally offer a rapid turnaround for urgent projects.

Mambo-Tox Ltd 2 Venture Road, The University Science Park, Southampton, SO16 7NP, UK Tel: +44 (0) 23 8076 2580 Email: [email protected] Contact: Mike Mead-Briggs www.mambo-tox.co.uk


FRANCERue d’Aste Béon, BP 27, F-64121, Serres Castet, FRANCETel: +33 559 33 77 70Email: [email protected]: Serge LAGRASSEwww.promovert.com

PROMO-VERT always on the move and offers you the best for your European projects:• EU Project management• Agrochemical and Bio-pesticide efficacy field or greenhouse trials• Plant and soil GLP residue studies• Full registration dossiers (dRRs and BAD) according to Regulation 1107/2009.

SPAIN Polígono Industrial La ChozaCalle nuevas tecnologías, n°16, E-41805, Benacazon (SEVILLA), SPAINTel: +34 995 70 99 09 Email: [email protected] Contact: Emilio FERNANDEZwww.promovert.com

Regional offices in the major agricultural regions in Spain providing:• Efficacy work for agrochemical testing under GEP • GLP residue studies for field and processing facilities: olive oil, taint tests.• Nematode analysis

PORTUGAL Zona Industrial da Gandra Mazedo4950-297, Mazedo – Monçao, PORTUGALTel: +34 995 70 99 09 Email: [email protected]: Emilio FERNANDEZ www.promovert.com

• GEP field trials with agrochemicals for efficacy testing• GLP residue studies

ITALIA S.R.L.Via Marzabotto, 51I-48024 Massa Lombarda (Ravenna), ITALYTel: +39 347 140 11 94Email: [email protected]: Massimiliano LANDINI www.promovert.com

Field studies according to local GEP on major local crops: annual crops, vegetables, orchards, vines.

PROMO-VERT

EUROPE Let us grow further together! 32 Years experienceFor overall European inquiries please contact:Yvonnick JAMBON, CEOMobile: +33 620 528 809 Email: [email protected] www.promovert.com



Since 1988,We turn your ideas into value

REDEBEL SARue de Chassart 4B 6221 Saint Amand, BelgiumTel: +32 71 85 33 92Email: [email protected]: CEO Ir Tanguy Dumont de Chassart

Since it was founded in 1988, REDEBEL has become a leading company in the EU in the following areas:• Field trials (demo platform, R&D, GEP)• Resistance to herbicides trials• Study monitoring of trial programs• Study direction throughout the EU• Residue trials GLP a Non Target Plant (NTP) Trials a DFR Trials a Drift Trials a Soil Sampling…

Through its wide EU network of partners, REDEBEL is able to provide following services:• Act as a global Study Director for-EU GLP residue programs• Act as Study Monitor for-EU efficacy & selectivity GEP programs• Carry out all types of Residue, Efficacy & Selectivity trials • Provide clients with high quality platform, R&D & demo programs

AGROBLU ROMANIA Srl.Calea Bucureștilor 30 B Săftica, IlfovRomaniaVAT: RO32914685Tel: +40 (21) 313 22 41Contact: Victor PectuMobile: +40 (787) 809 275 Email: [email protected] Tel: +40 (787) 809 275Contact: Guglielmo Cassani Email: [email protected]

Operating in Romania since 2014 for PPP Registration Consultancy and GEP field Studies. AGROBLU Romania benefits of the 25 years experience in the Mediterranean Countries such as Italy, Spain Greece and Bulgaria.

The company is GEP certified, and its shared experience with Agroblu Europe leads to high level demo and launch trials.

Besides 3 peripheral operating units – each located within big farm – spread in the most strategic areas of the Country, Agroblu Romania can count on an extended net of 59 reliable farmers growing the most typical crops of the Central Zone of Europe .

The convenient vision of Agroblu Romania, as it is in all Europe is to provide the Sponsor client with high quality data, passionate observations by personnel trained to analyse the reaction of the Nature broad-spectrum to any action onto the Crops.


SGS Seed & Crop Services provides a global network of R&D facilities with more than 600 experts in 28 countries for clients’ research and product development programmes in Europe, North America, Latin America, Africa and Asia-Pacific.

Our experienced team provides project, program, GLP study management services to support the development of new pesticides, fertilizer, biostimulants and seeds as well as seed treatment solutions globally. With many years of experience in the field of R&D, analytical chemistry, regulatory affairs / registration services and project management, SGS processes laboratory and field studies within the scope of regulatory testing, such as efficacy, crop tolerance, residue, environmental, operator, consumer safety, along with bio safety and nutritional compositional testing of new seeds. The testing is based on international guidelines, including EPPO, OECD, EPA and SETAC and in compliance with GLP (Good Laboratory Practice) or GEP (Good Efficacy Testing).

SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognised as the global benchmark for quality and integrity. With more than 90’000 employees, SGS operates a network of over2’000 offices and laboratories around the world.

SGS Group 1 Place des Alpes 1201 Geneva, Switzerland Tel: +41 22 739 91 11 Fax: +41 22 739 98 00 Email: [email protected] Contact: Andreas Zumdick www.sgs.com/SeedAndCrop



Smithers Viscient 790 Main St. Wareham Massachusetts 02571 United States Tel: +1 508 295 2550 Contact: Hope Aubin

108 Woodfield Drive Harrogate, North Yorkshire, HG1 4LS United Kingdom Tel: +44 (0) 1423 532 710 Contact: Fiona Brook-Rogers Email: [email protected] www.smithersviscient.com

Smithers Viscient provides environmental and consumer safety contract research and regulatory services for the crop protection, pharmaceutical, industrial chemical, and the consumer product industries.

Smithers Viscient has performed standard guideline and higher-tiered environmental studies for over 45 years. We conduct studies to satisfy all regulatory requirements globally. We continue to expand our facilities, locations, and capabilities to provide the most comprehensive environmental safety solutions.

Offerings include environmental fate, plant and animal metabolism, aquatic and terrestrial ecotoxicology, honeybee and pollinator testing, avian toxicology, residue, analytical, and product chemistry, mammalian toxicology, endocrine testing (including in vivo toxicology and in vivo ecotoxicology), and regulatory risk assessment.

For the crop protection industry we offer a variety of services to support regulatory submissions in: • The United States (Federal Insecticide, Fungicide, and Rodenticide Act – FIFRA)• Europe (Regulation (EC) No 1107/2009 concerning the placing of Plant Protection

Products on the market)• Canada (Pest Control Products Act and Regulations)• Japan (Agricultural Chemicals Regulation Law

We have the capacity and expertise to test difficult materials and confirm exposure levels in the low parts per trillion range in a variety of sediment, soil and aquatic matrices. We support the pharmaceutical, veterinary medicine, personal care, and household product industries through:• Environmental assessment testing • Endocrine disrupter studies • Consulting services • Advanced analytical instrumentation and novel study designs

For the human pharmaceutical and animal health industries, we offer testing and regulatory services to support product registrations in:• The United States under FDA Regulations in 21 CFR Part 25• In Europe under Directive 2001/83/EC relating to Medicinal Products for Human Use• In Europe under Directive 2001/82/EC relating to Veterinary Medicinal Products• In Europe and the US under the VICH guidance (International Cooperation

on harmonistaion of Technical Requirements for Registration of Veterinary Products)

For the chemical and biocidal product industry, we conduct testing to support regulatory submissions in:• The United States, Toxic Substances Control Act (TSCA) and the Federal Insecticide,

Fungicide, and Rodenticide Act (FIFRA) • Canada, under the Canadian Environmental Protection Act (CEPA)• Europe, under the REACH and the BPR

Smithers Viscient has worked with many of the chemical industry task forces, trade associations, and product working groups over the decades to solve unique exposure and testing requirements for different chemistries.


STAPHYT provides reliable solutions and high level of expertise to agro-chemical, bioproducts manufacturers and plant breeding companies for the development, registration and promotion of their products.

The strength of our network combined within the expertise of our people guaranteed the success of the studies, in complete safety and within the time limits allowed.

These key points show our commitment to provide the best quality and to succeed in your trials, their management and registration issues:- 30 years experience- over 400 team members- Access to all crops all over Europe, Australasia (Peracto), in Americas through partners.- GEP, GLP certified and CIR Agreement

From screening to registration, Staphyt offers the most complete area of expertise:• GEP trials (efficacy & dose response, crop safety, practical value, rotational, drift studies, …)• GLP studies (residue, OPEX, soil dissipation and accumulation, DFR…)• Screening trials in field and glasshouse• Biologicals screening/testing and consulting (Bioteam)• Sales support and development trials• Seed variety testing on all crops, including silage & compositional analysis• Processing laboratory (+100 different processes available)• Ecotox field & tunnel studies for honey/ bumble bees• Research studies (rain fastness…)• Fungi resistance monitoring for pre and post registration purpose

Staphyt regulatory & consulting provides support for registration of chemicals, biologicals, fertilisers, growth media and adjuvants:• Consulting and strategy• Pan-European registration program• Active substance (CA) and preparation (CP) dossier’s (study management, write up of

dossier’s according to dRR format including Risk Assessments and BADs)• Mutual recognition, Bis application, Second trade name…• Direct contact with National Authorities in Europe• Trial permits

Staphyt23 Rue De Moeuvres 62860–Inchy En Artois, France Tel: 00 33 3 21 21 45 21 Fax: 00 33 3 21 21 45 19 Contact: Fanny Vanel (Marketing Manager) Email: [email protected] www.staphyt.com



SynTech Research delivers a competitive advantage to our clients by providing expert product development, specialized testing and registration services for agrochemicals, biocides and seeds.

This is based on the company’s agronomic knowledge and technical expertise in field, greenhouse and laboratory studies.

Operating in 40 countries worldwide, we conduct field and laboratory studies for over 200 clients, in efficacy, environmental chemistry, biotechnology, and ecotoxicology, in strict adherence to GLP/GEP standards.

SynTech Research also provides or contributes to creation and submission of registration dossiers to EPA, EU, PMRA, South America and other national regulatory authorities.

Syntech ResearchGlobal Headquarters: 17745 South Metcalf Avenue Stilwell, KS USA 66085

For general enquiries please contact us at: [email protected], or contact one of our Global Account Managers:

David Marsden, PhD (Efficacy/GEP) Email: [email protected]

Daniel Mourad, MSc (Field & Analytical Residue) Email: [email protected]

Eric Ythier, MSc (Ecotoxicology) Email: [email protected]

Mariana Krugner (Seeds & Traits) Email: [email protected]

www.syntechresearch.com


is the founder of AGROBLU European group, active since 1993 as European Regulatory Consulting and Test facility for GEP and GLP field Studies. Agroblu has long and deep experience in coordinating European projects of Regulatory, Efficacy and Selectivity Studies, GLP Studies including Environmental Fate, Exposure and Magnitude Residues.

All studies – over 2000 in 25 years – have been conducted in a wide range of crops for testing Chemicals, Natural and Biological Crop Protection Products. AGROBLU has established and developed its own laboratories for conducting sponsored researches of Entomology and Microbiology for conducting sponsored researches along the food production chains, from crop protection to packaging and distribution.

In this respect Agroblu breeds a range of Insects parasites and Beneficials to implement IPM studies. In parallel, owns a collection of diseases to test solutions on plants and cultures inoculated.

AGROBLU SRLVia San Bernardo 35, 20017 Rho (MI) - ItalyC.F. e P.I. 11112800153Tel: +39 02 935.06.336Fax: +39 02 935.06.333Contact: Anna Maria Garzia Email: [email protected]: Stefano.Cassani Email: [email protected]

Vigna Brasil is a 21 years-old CRO that works as a facilitator in Brazil rendering services as “one stop shop”. We’re a full services provider, offering any kind of support regarding to the segments below, since the establishment of a legal entity in Brazil; company licenses and products registrations (Regulatory Affairs); strategic operational issues and market intelligence studies (Business Advisors); field trials research and development for crop protection, fertilizers, inoculants and GMO (Field Management) and then keeping the company and products in full operation. We also offer services for products and/or dossiers hosting and importation in most of segments attended by the Group, through our local company called PROPHYTO.We are able to attend companies interested in the following segments: Crop Protection, Biopesticides, Adjuvants, GMO, Fertilizers, Inoculants, PCO, Public Health, Household, Lubricants, (Bio)Remediator, Wood Preservatives, Home&Garden, Aquatics, Food, Beverages and Food Additives. We provide business facilitator services, helping your company to reduce bureaucracy or operational barriers for starting up and maintaining your operations in Brazil. Vigna Brasil is also able to work in other Latin-American countries as your focal point, intermediating with local confident consultants and CROs in order to register products and execute R&D projects in each country.

Regulatory Affairs, Market Intelligence, Field Management and Hosting services

Vigna BrasilHeadquarterAvenida Ipiranga, 318, cj 1601 Bloco A - 16º Andar, Republica Sao Paulo-SP 01046-010, Brazil Tel: (+5511) 3124.4455Skype: vignabrasilEmail: [email protected]: Fabio Domingues www.vignabrasil.com.br


IQV (Industrias Químicas del Vallés, S.A.) founded in 1935 is a recognized world leader in copper fungicides, the 1st world producer of Bordeaux mixture and the 2nd of Copper Oxychloride.

IQV is involved in the development, production, commercialization and distribution of Plant Protection Products to provide safer products for healthier crops worldwide. IQV has focused, basically but not only, on the development of Copper salts and mixtures thereof as fungicides for crop protection. Other products, sectors, activities, new production facilities, subsidiaries and markets abroad, partners and customers make up for the actual presence of IQV in all continents.

IQV offers full toll manufacturing and logistic services. Certified according to ISO 9001, 14001 and EMAS; IQV has been approved by many multinationals and is proud to have them among its customers or partners.

IQV produces active ingredients, develops and improves recipes, formulates and conditions both liquid and solid pesticides, and offers purchase of packaging and raw materials, warehousing and distribution services. IQV listens to customers’ need and is completely flexible regarding processes. In its two manufacturing units, IQV deals with more than 100 active ingredients, produces more than 30,000 mt of the different TG copper salts and more than 26,000 mt of ready-to-use formulations.

IQV owns around 450 registrations worldwide, mostly straight copper products, mixtures thereof and Metalaxyl-based fungicides.

IQV’s most well-known trademarks (Caldo Bordeles Vallés®, Bordo®, Cuprosulf®, Cupertine®, Curenox®, Vitra®, Americop®, Armetil® and Mevaxil®) are our cover letter in many countries.

At the EU level, IQV has defended Copper (the three main Copper salts: Bordeaux mixture, Oxychloride and Hydroxide) as member of the European Copper Task Force and Metalaxyl on its own. Both are now included in Annex I. Copper and Metalaxyl are IQV’s present and near future bets, while opportunities of new active ingredients are always welcome.

Custom Manufacturers

Industrias Químicas del Vallés, S.A.Av. Rafael Casanova 81, 08100 Mollet del Vallés, Barcelona, Spain Tel: +34 93 579 66 83 Fax: +34 93 579 17 22 Email: [email protected] Contact: Iolanda Balasch www.iqvagro.com

Agri LifePlot No.154/A5, SVCIE, IDA Bollaram – 502325Sangareddy District, Telangana, India Tel: +91 98854 38365 Email: [email protected] Contact: Dr. Venkatesh Devanur www.agrilife.in

Agri Life, is a research based agri-biotech manufacturing enterprise based in Hyderabad, India. The Company is focused on bio solutions for crops and soils, Agri Life manufactures BioPesticides, BioFertilizers, BioStimulants and other Agri inputs. The enterprise is promoted by technocrats having experience in similar agri-biotech industry.


Croda Europe Ltd Cowick Hall Snaith, Goole East Yorkshire DN14 9AA, UK Tel: +44 (0) 1405 860551 Fax: +44 (0) 1405 861767 Email: [email protected] Contact: Claire Lindleywww.crodacropcare.com

Taminco BVBA– a subsidiary of Eastman Chemical Company Pantserschipstaat 207 9000 Gent, Belgium Tel: +32 9 254 1586 Email: [email protected] Contact: Guy Van Den Bossche www.eastman.com/agriculture

Croda is a global company with operational locations specifically chosen to facilitate close customer working. We are constantly investing in our existing markets and expanding into emerging markets to give our customers the best, most responsive service.

Our unique formulation expertise helps crop protection customers get the best performance out of their active ingredients, enabling farmers to get the best yields for their crops.

Our adjuvants and formulation aids under the renowned brands, Atplus™ and Atlox™, are well known in the industry as high performance, reliable products. Our value adding technology helps our customers achieve more complex, efficient, safer formulations that minimise impact on our environment.

Our partners in agrochemicals value our role in the industry as influential contributors applying scientific expertise from the bench top to the field to support unmatched innovation.

Applications include emulsifiable concentrates (EC), microemulsions (ME), suspension concentrates (SC), concentrated aqueous emulsions (EW), soluble liquids (SL), suspoemulsions (SE), water dispersible granules (WG), wettable powders (WP), oil dispersions (OD) and seed coatings.

Our crop protection division offers clients 30 years’ experience in toll processing of WDG. The company’s processing technique, registered under the trade name Granuflo®, is based on the ‘spray-dry’ method and produces high quality water-dispersible granules. We have also invested in the production of flowable formulations both for seed treatment and for foliar uses. By making use of our Granuflo or flowable technology, clients can outsource their existing or develop their own WG, FS or SC formulation. The process includes an in-line filling system into the end users’ packaging, such as boxes, bags, drums or cans. For new contracts, tailor-made formulations are developed in our laboratory and trial quantities can usually be obtained within three months from their pilot plant.

We are also a leading supplier in specialized niche markets of soil fumigation and foliar fungicides. Contact us or visit our website for more info.

Exwold Technology Ltd PO Box 270, Brenda Road, Hartlepool TS25 2BW, UK Tel: 00 44 1429 230340 Email: [email protected] Contact: Sam Price www.exwold.com

Exwold Technology Ltd is a contract processing and formulation company dedicated to servicing the Crop Protection & Speciality Chemical markets.

We are recognised as specialists in the formulation and supply of low pressure extruded granules primarily for use as WDGs in the agrochemical market & have an established capability in high potency herbicide formulation. We also supply a wide range of powder and granule processing technologies including granule impregnation and coating, compaction granulation and powder blending.

We provide a trusted, fast and flexible service to companies around the world. With our pilot facilities, we are able to support our customers through product development and finding solutions and are proud to be partners in chemical processing.

Formulations companies & additives suppliers


Formulations companies & additives suppliers

SBM-FormulationC.S. 621 – Z.I. Avenue Jean Foucault 34535 Béziers Cedex, France Tel: +33 4 91 24 44 35 Contact: Denis Barlet Email: [email protected] www.SBM-formulation.com

SBM-FORMULATION is a leading European toll formulation company providing an extended range of sophisticated technologies, including WG using fluidized bed or extrusion (basket granulator), RB or GB by wet process, EW, SE, SC, for fungicides and insecticides .

SBM offers a full formulation and packing service from early development stage and is certified ISO 9001, ISO 14001 and OHSAS 18001 .

Iris, sister company of SBM-Formulation is specialized in toll packing for small packs for CPP or Home and garden Business and implemented in 2017, a new line for formulation of biocontrol herbicides, as well as new lines for rodenticides (paste and cereals).

From October 2017, SBM group will operate its recently acquired plant for Home and Garden products in Pasadena, Texas .


Market Research

As the leading research specialists in agriculture, Kynetec helps companies around the world understand the dynamics of the industry, turning research into business opportunities and enabling clients to create winning strategies.

We have expertise in all major categories needed for keeping operations running smoothly, including crop protection, seeds, soil treatment, plant nutrition, farm machinery, water management and amenity. We conduct tracking studies for monitoring market trends, perform customized research for answering unique business challenges and provide market forecasts to support the long-term vision.

Everything we do is delivered by a team of more than 600 specialists who understand the challenges impacting the agriculture industry. And with our international team of experts located around the world, no matter where you are, we can help.

Kynetec1807 Park 270 DriveSuite 300, St. Louis, Missouri 63146, USA Tel: +1 314 878 7707 Contact: Keri McBride Email: [email protected] www.kynetec.com

Dextra International Av. Corts Catalanes 9-11 08173 Sant Cugat del Vallés Barcelona (Spain)Tel: +34 93 583 9553 Fax: +34 93 583 9574Email: [email protected]: Ana Santillana www.dextrainternational.com

Dextra International is a leading strategic consultancy firm specialized in the crop protection business at an international level.

Our target focuses on our client’s international growth, starting with a deep analysis of the product portfolio and the definition of new potential markets. Dextra strategies are based on detail market analysis and cost-effective registration processes.

Dextra provides you with country-basis market survey to take the right decision on registration investment and distribution channels. Our Regulatory consultant advice you on the strategic registration decision and oversee the whole process, from dossier preparation fulfilling local requirements until registration obtaining.

Our main Markets are Europe and Americas, giving all our services from our Headquarters in Spain or from our branches in Colombia and United States.

Dextra provides Due diligence services, and strategic advice on new acquisitions.

Dextra International is the right key for your internationalization


Market Research

Phillips McDougallSuites 1 - 4 Vineyards Business Centre Saughland, Pathhead Midlothian, EH37 5XP Tel +44 207 017 4308 Email: [email protected] Contact: James Keady www.phillipsmcdougall.co.uk

For over 15 years, Phillips McDougall has been providing independent, accurate and informed data and analysis regarding the agrochemical industry to a client base spread around the world, including all the major crop protection companies and investment banks. The services supplied include multi-client reports, detailed databases, daily news/analysis service and single client confidential consultancy.

Phillips McDougall is unique in linking global industry analysis with basic market research, providing unsurpassed knowledge and experience to answer your questions and fulfil your consultancy needs. Phillips McDougall services range from the broadest global analysis to consultancy around specific issues at the individual, crop and country level.


Bio pesticides Agri Life 28

GAB Consulting GmbH 28

Kerona Scientific Ltd 29

LKC Switzerland Ltd 29

Staphyt 30

Stockton (Israel) Ltd. 31

TSGE Consulting 31

Consultancies & other advisor bodies APC 32

ARCHE Consulting 33

CSI (Compliance Services International) 33

Dextra International 34

DHD-Consulting GmbH 34

EBRC Consulting GmbH 35

Exponent International 35


JSC International Limited 36

Kerona Scientific Ltd 36

LKC Switzerland Ltd 37

Phillips McDougall 37

Redebel Regulatory Affairs SCRL 38

SCC – Scientific Consulting Company 38

Staphyt Regulatory 39

TSGE Consulting 39

Contract Research OrganisationsAgrolab 40

ANADIAG 40

BioChem agrar GmbH 41

Biotecnologie BT SRL 41

AGROBLU BUL OOD 42

CEM Analytical Services Limited 42

CropTrials GmbH 42

EAG Labs 43

Entomologia Applicata 43

EPL Bio Analytical Services 43

Eurofins Agroscience Services Group 44

Field Research Support 44


AGROBLU HELLAS Ltd. 45

Innovative Environmental Services 45

Mambo-Tox Ltd 48

Oxford Agricultural Trials 48

Peracto 48

Promovert 49

REDEBEL SA 50

AGROBLU ROMANIA Srl. 50

SGS Group 51

Smithers Viscient 52

Staphyt 53

Syntech Research 54

AGROBLU SRL 55

Vigna Brasil 55

Custom ManufacturersAgri Life 56

Industrias Químicas del Vallés 56

Formulations companies & additives suppliersCroda Europe Ltd 57

Eastman Taminco BVPA 57

Exwold Technology Ltd 57

SBM-Formulation 57

Market Research

Dextra International 59

Kynetec 59

Phillips McDougall 60

Service Company Guide


Whos Who in CRO’s2017

Sébastien DUMONT de [email protected]

Tanguy DUMONT de [email protected]

Benjamin DIERYCKRegulatory Project Manager, PPP, [email protected]

Hervé LEGROSRegistration & Regulatory A� airs ManagerPPP, BCA, Adjuvants, Biocides, REACH, [email protected]

Thomas RAASRegulatory Project Manager, [email protected]

20 HIGLY [email protected]

Benjamin DIERYCKRegulatory Project Manager, PPP, [email protected] [email protected]


Tanguy DUMONT de [email protected]

Philippe REYNENSField Trials Manager - Demo, R&D, [email protected]

Sébastien DUMONT de [email protected]

Camille DORCIERStudies Director - European [email protected]

Thierry DOCLOTIT Manager - ARM Sales & Support [email protected]

Raphaël ROBYNS DE SCHNEIDAUERStudies Director - European [email protected]

Pierre LORIAUGLP residue Trials [email protected]

Charlotte LAIRERegional [email protected]

We turn your ideas into value

www.redebel.com

Since 1988


http://www.xingyuchemical.com.cn


http://www.biochemagrar.de




http://www.chinalimin.com



http://www.kqbiotech.com


Welcome to the fifth instalment in Agrow’s series of annual biologicals reviews. Biologicals, especially biopesticides, came into prominence in the first half of the current decade when a mix of political and regulatory pressures led to the big players looking at biologicals as possible components of crop protection solutions. That was followed by a flurry of acquisitions and deals during the period 2012-2014 by the big agrochemical players seeking to give a jump start to their biopesticide programmes.

But during the last couple of years, the limelight has moved to mega deals and acquisitions involving the Big Six themselves: DuPont and Dow Chemical agreeing to merge their businesses; Syngenta’s board accepting ChemChina’s acquisition offer; and Monsanto accepting Bayer’s acquisition offer. What could be the potential impact of these on the biologicals sector?

Bayer points out that its combined R&D portfolio with Monsanto would have exceptional depth, reach and great commercial potential. Both companies have complementary pipelines over short-,

medium- and long-term with potential for further incremental innovation to address key challenges in the agricultural area in a new way, it adds.

Do the companies not involved in the mega deals perceive them as a threat?

BASF, the only one among the Big Six that was not involved in a big-ticket deal, feels “very comfortable” about its position. “Our crop protection business – with approximately €5.6 billion ($6.1 billion at the

current rate) in sales, industry leading margins (FY 2016: 29.9%) and supported by about one quarter of BASF’s entire R&D budget – has the critical mass to remain competitive in a changing industry environment,” says BASF Crop Protection’s vice-president of global strategic marketing for Functional Crop Care, Alyson Emanuel. She points to its “well filled” innovation pipeline, with peak sales potential of €3 billion ($3.3 billion) from products launched between 2015 and 2025.

By Sanjiv Rana

Agrow biologicals review 2017

Alyson Emanuel, BASF


28 www.agra-net.comLatin America 2016 | Agrow

Brazilian biopesticide approvals strongly upRegistrations in Brazil rose strongly in 2015, news agency Noticias Agricolas reports. It cites figures from the Brazilian association of biological control companies, the ABCBio, showing that 20 new products were approved, a 135% increase on the average previous six years.

The newswire notes the rising share in major companies’ portfolio of such products. Concerns about sustainable production are more and more evident among consumers, companies and growers.

DuPont seed subsidiary DuPont Pioneer and Monsanto have agreed a licensing deal for the latter’s genetically modified glyphosate-tolerant and insect-resistant Intacta RR2 Pro (MON87701xMON89788) soybeans in Brazil. DuPont Pioneer will receive a royalty-bearing licence to the technology, subject to approval by Brazilian regulatory authorities.

DuPont anticipates launching the technology “as early as” the 2017 season. “The combination of technology, genetics, and DuPont’s Dermacor [(chlorantraniliprole - trade-marked as Rynaxypyr) insecticidal] seed treatment will help advance the productivity of soybean growers while providing enhanced insect control and strengthening their integrated pest management practices,” DuPont Pioneer

vice-president, global commercial business, Alejandro Muñoz, says. Monsanto vice-president, chief commercial officer, Mike Frank, welcomes the deal. “[Intacta] has achieved rapid grower adoption and is providing an important new choice in insect control and convenience to growers in South America,” he notes.

The companies agreed major GMO licensing deals in 2013 on dropping litigation for alleged misuse by Pioneer of Monsanto’s GM crop technology. Those deals covered the US and Canada. Monsanto debuted Intacta soybeans in Brazil that year. Plantings in South America are expected to reach 35 million acres (14.2 million ha) this year, with a projected 75 million acres by 2019.Additional terms and financial details of the agreement have not been disclosed.

DuPont/Monsanto agree Brazilian deal for Intacta

Aquatic Ecotoxicology

Terrestrial Ecotoxicology

Metabolism

Environmental Fate

Analytical Chemistry

Early-Stage Screening

Innovative Environmental (IES) Ltd | Benkenstrasse 260 | 4108 Witterswil | Switzerland | T: +41 61 705 10 31 | www.ies-ltd.ch

Innovative Environmental Services LtdIES Ltd is an independent and privately owned GLP-certified contract research organisation (CRO). We support our international clients by offering scientific studies not only to ensure the safety of the tested products, but also to confirm that the products adhere to the applicable international environmental guidelines.


http://www.staphyt.com


The company keeps a close watch on potential acquisition opportunities. “As a general practice, we constantly review acquisitions and divestitures opportunities as part of our active portfolio management.” The company has “clearly defined” key criteria. “We focus on innovative business segments that offer specific customer benefits, segments that can grow above market average and enable growth in attractive regions, especially in emerging markets, as well as segments that can make our portfolio even more countercyclical.”

Arysta LifeScience (part of Platform Specialty Products), which was an early entrant to the biologicals segment, says that most companies currently undergoing an M&A process have a clear strategy on biologicals. “It will be interesting to see if synergies are found by the combined companies,” says Paula Pinto, vice-president, global portfolio management.

Specialist biologicals companies such as Marrone Bio Innovations (MBI), Stockton and BioConsortia also do not seem to perceive the industry restructuring as a threat. “The bigger you get the slower you get,” says MBI chief executive officer Dr Pamela Marrone. “The combination of research programmes within the soon to be ‘big four’ is expected to expand the spend on biological research but, historically, large organisations have a harder time with rapid innovation,” concurs the chief executive officer of BioConsortia, Marcus Meadows-Smith.

Dr Marrone also points out the opportunities for small, nimble, fast companies to be innovators. Mr Meadows-Smith has a similar view. “There will probably be a lull in the M&A of the SMEs, but this will give time for the SMEs to develop superior products and prove efficacy and grower acceptance.” He sees potentially more opportunity for smaller players to have an impact in the biologicals market with the upcoming consolidations. “There are still many well-established, independent, small and mid-sized companies working on biologicals that have shown recent success in the market or that have been building up their portfolios and pipelines for some time.”

Mr Meadows-Smith also points out that “most of the industry leaders have made research investments or acquisitions in the

biologics space at this time, and thus are primed to support and advance acceptance and usage of biologicals in standard commercial agriculture”. Stockton CEO Guy Elitzur is in agreement. “Regardless the mega M&As, biopesticides will keep growing and be integrated into the conventional programmes in the short and long run.”

Product launches and pipelineBayer CropScience’s bioinsecticide, Contans WG (Coniothyrium minitans), received regulatory approval in South Africa last year. The biofungicide, Serenade ASO (Bacillus subtilis strain QST 713), received use expansions in a number of markets. Bayer CropScience’s head of biologics R&D, Benoit Hartmann, says that apart from combating diseases such as Botrytis spp, bacterial infections and black sigatoka on bananas as well as soil-based syndromes, the product also shows strong effects on improved plant growth and stimulation of plant defence. Serenade Prime was launched in Australia in May 2016 with a focus on plant growth and yield effects. The bionematicide, BioAct Prime (Paecilomyces lilacinus 251), which received Greek approval in April, will be launched there this year with many other countries around the globe to follow.

In terms of forthcoming launches, Bayer’s bioinsecticide, Requiem Prime (extract of Chenopodium ambrosioides), will be launched in 2017/2018 in many European countries. The seed treatment, Votivo (Bacillus firmus + clothianidin), will be launched in Europe in 2018.

Bayer has production sites for biologicals at Tlaxcala, Mexico and Wismar, Germany. Bacterial microbials are produced in Tlaxcala while Wismar produces fungal microbials.

BASF launched the biofungicide, Serifel (Bacillus amyloliquefaciens strain MBI600), in South America and Central America. The biofungicide, Integral (B subtilis strain MBI 600), was launched in Asia. In the EU, an emergency measure based on the EU Regulation 1107/2009 was granted for use of the bioinsecticide, Velifer (Beauveria bassiana strain PPRI 5339), in Germany and Austria on potatoes to protect against wireworms in February 2017. Under the

trade name Broadband, Velifer was initially developed for and is on the market in South Africa, the company says.

Velifer is currently under evaluation in Australia and the company expects that to be completed by the end of 2017. Velifer will be launched in Asia in 2017. The seed-applied biofungicide for oilseed rape, Integral Pro (Bacillus amyloliquefaciens MBI 600), is in the final stages of regulatory approval in France and Germany.

The company has also recently submitted applications with the US EPA to register the biofungicidal seed treatments, Velondis Flex (Bacillus subtilis strain BU1814), Velondis Extra (B subtilis strain BU1814 + B amyloliquefaciens strain MBI 600) and Velondis Plus (B subtilis strain BU1814 + B amyloliquefaciens strain MBI 600).

Nodulator Duo is a combination of inoculant and biofungicide and will be launched in Canada in 2018. It will have the Nodulator rhizobia inoculant (Bradyrhizobium japonicum) along with the biofungicide, Velondis Flex (B subtilis strain BU1814).

In 2016, BASF agreed a deal with French plant biotechnology company Plant Advanced Technologies for the discovery and development of novel biopesticides. Some promising starting points have been identified although BASF points out that development time will take about ten years.

BASF has several production sites for biologicals solutions, from foliar- and seed-applied bioncontrols to seed-applied biostimulants or inoculants. The facility at Somersby, Australia produces the Nodulaid range of inoculants. Expansion is underway at the site for Velifer production, which is expected to come online this year. Other facilities include: Littlehampton, UK for beneficial nemotodes-based insect management Nemasys products and the inoculants, HiCoat and HiStick; Durban, South Africa for HiCoat, Broadband and Velifer; Saskatoon, Canada for Nodulator inoculants; Ames, Iowa, US for Serifel and Integral; and additional sites in the US and South America that produce a range of biologicals products including Gelfix, HiStick, HiCoat, Rhizoflo, Nodulaid, Nodulator, Vault and Integral.

Dow AgroSciences points out that the majority of its activity in the biologicals space

Benoit Hartmann, Bayer CropScience


has involved natural products, such as the insecticide, spinosad. Microbial-based biological products are a logical extension of its leadership in the natural products market space, it says. “We have expertise both inside the company and with collaborators that can help us grow in this area.” The company has an “active testing programme” to work with multiple third parties in the biological technology space, but does not currently offer any products in this area.

Two of Arysta’s bioinsecticides based on B bassiana strain 147 and strain NPP111B005 have recently been cleared for EU approval. The company plans to launch them in 2018 in France and southern Europe, contingent upon regulatory approvals.

A licensing agreement last year with the Chinese Academy of Agricultural Sciences’ Institute of Plant Protection for protein-based plant disease control technology has led to a biological product being under evaluation. The next step will be the development and regulatory phases, with an expected launch around 2020-2021.

An exclusive licensing agreement with US biostimulant company Beem Biologics for novel plant-derived biostimulant technology has led to a product that is currently under field testing with aim of having it registered with the US EPA as a plant growth regulator in 2019.

Arysta has production sites at: St Malo, France for the production for seaweed extract-based biostimulants and biofungicides; Pau, France mainly for the production of virus-based bioinsecticides, including carpovirusine and B bassiana-based products; and Saltillo, Mexico for various biostimulants and nutrition products with a strong focus on natural plant extracts.

Among recently launched products, MBI highlights: the bionematicide, Majestene (Burkholderia rinojensis strain A396), in the US; the bioinsecticide/acaricide, Grandevo (Chromobacterium subtsugae strain PRAA4-1T), in Mexico; the biofungicide, Regalia (Reynoutria sachalinensis extract), in Chile; and the anti-transpirant product, Haven, in the US. The company has also launched an unnamed bioinsecticide/nematicide for seed treatment applications in collaboration with Albaugh, which is marketing the product. The deal between the two companies covers all crops in the US and Canada.

Among new active ingredients in its pipeline, MBI points to its biofungicide, MBI 110, based on a new strain of B amyloliquefaciens, for which is being considered for US approval. The company has also agreed a deal with Nufarm to develop Grandevo for Australia and New Zealand. MBI expects a launch in New Zealand in 2018 and in Australia in 2019.

MBI produces Grandevo, Regalia and Zequanox at its facility in Michigan and has contractor sites for its other products.

During 2016, Stockton’s Melaleuca alternifolia extract-based biofungicide, Timorex Gold, was approved in Brazil, South Africa, Serbia, New Zealand, China, Ecuador, Spain and several additional states in the US. In 2017, the company expects approvals in Colombia, Argentina, Guatemala, Serbia, Peru, Nicaragua and Dominican Republic. Stockton’s combined biological and chemical fungicide, Regev (M alternifolia extract + difenoconazole), was registered in Israel and is in the process of registration in Colombia.

Belgian company Biological Products for Agriculture (Bi-PA) received EU approval in 2016 for its biofungicide based on Trichoderma atroviride strain SC1 for use on grapevines. Vintec, the product based on that ai, has been launched in five European countries (France, Belgium, Germany, Austria and Luxembourg). Registrations in other European countries are ongoing. As France was the zonal rapporteur member state for the southern zone, the company expects that registrations in Spain, Portugal, Greece and Italy will shortly follow. Bi-PA has other uses in development for the product.

Earlier this year, Bi-PA acquired a 25% stake in Australian company Innovate Ag. Bi-PA will develop and register Innovate Ag’s bioinsecticide, Sero-X (Clitoria ternatea extract), outside Australia and New Zealand. The product has received Australian approval. The generation of data for its development outside Australia is ongoing and the dossier will be submitted as soon as possible, Bi-PA says. The companies, Belchim, American Vanguard and Unifert, hold stakes in Bi-PA, which gives it access to their marketing channels in Europe, Americas and North Africa/Middle East, respectively.

BioConsortia is in its research and development phase. “Certain leads for are in second or third year field trials with major partners, as well as self-funded trials, for drought tolerance, nutrient use efficiency and yield improvement in stressed and standard agronomic conditions,” says Mr Meadows-Smith. Some new consortia for biofungicide activity are moving into their first year of field trials.

Combination productsBASF’s view is that most often, biocontrols will be used along with and to complement chemistry-based solutions in IPM programmes, although it is possible circumstances may arise where a biocontrol can address a need for which there is no chemistry-based solution available. The company’s research directions include development of combinations of biological and chemistry and it also has such commercial offers on the market, such as the fungicide, Xanthion (pyraclostrobin - trade-marked as F500 + Integral - Bacillus subtilis strain MBI 600).

“Chemistry will always be more relied upon due to the typically wider spectrum of control and efficacy under most environmental conditions, but we see biologicals growing to be an important factor in coming years,” says Ms Emanuel. Biological products extend BASF’s portfolio and are not substitutes for BASF chemical crop protection products, she says.

Arysta LifeScience has more than 50 stand-alone biosolutions products, covering biocontrol, biostimulants and innovative nutrition. The company has also developed numerous ProNutiva crop production input programmes, which are integrated solutions consisting of protection, stimulation and/or nutritional inputs, derived from natural biosolutions and conventional crop protection. It is also in the process of developing ProNutiva pre-mixes, creating specific combinations of biological as well as conventional ais.

MBI is also looking for partners for pre-mixed combination products. Albaugh is already stacking MBI’s microbe with its chemicals, points out Dr Marrone.

Registration processA more streamlined regulatory process for

Guy Elitzur, Stockton

Marcus Meadows-Smith, BioConsotria


the approval of biologicals has been high on the wish list of biopesticide companies across the world irrespective of their location. The system in the EU has often been a cause of complaint and the European Commission has been under pressure over the last year from the European Parliament, which passed several resolutions calling for faster biopesticide approvals.

Progress has been made in the EU just as this article was being written. The Commission will soon clarify and extend the scope of ais that may be considered as “low-risk” substances, in a bid to boost approvals of biological and naturally occurring pesticides. Micro-organisms, baculoviruses and semiochemicals will be considered as low risk, unless specific concerns are identified, while naturally occurring substances will be exempted from certain hazard-based criteria. The proposed amendments will be made to the identification criteria for low-risk pesticides in the EU agrochemical registration Regulation (1107/2009). They have been voted through by EU member states and will come into effect following publication in the EU Official Journal.

Bayer says that there are some jurisdictions where the regulatory frameworks for biopesticides are well established, with data requirements that are specific and appropriate for the various biological product types. The company is working through various industry associations including CropLife International and its regional/country affiliates, as well as the International Biocontrol Manufacturers Association (IBMA) and the Biological Products Industry Alliance (BPIA), to advocate for globally harmonised regulations and data requirements. Mr Hartmann points out ongoing activities such as the OECD’s Expert Group on Biopesticides (EGBP), which is developing a harmonised approach specific to biopesticide registration through numerous

projects. He also mentions the UN FAO/WHO JMPM, which has recently drafted a new guidance document for biological pest control agents that covers micro-organisms, botanicals and semiochemicals.

Dr Marrone says that the US still has the most streamlined and efficient process. There are initiatives in Europe to provide a faster track for biologicals, but Europe and Canada still remain quite difficult, she adds. She places Brazil in between the US and Europe in difficulty.

Mr Meadow-Smith also vouches for the US registration system “where the registration for natural products is significantly less complicatedand lengthy than chemical actives”. Biopesticides are still regulated federally by the EPA with the registration timelines usually taking 18-22 months and costing between $6,000 and $50,000 depending on the level of field trials and development put in by the manufacturing company.

Talking about the situation for biostimulants, the Bioconsortia CEO says that many biostimulants fall into the category of plant growth regulators and are also regulated by the EPA, having similar times and costs for development. For biofertilisers, the control lies at the state level. Each state has its own registration programme for fertilisers so standards and timelines may vary, but development and registration is generally cheaper than that of biopesticides, and registrations can often be granted within a few months for US microbes, he explains.

Compared with the decade-long development timelines of synthetic chemistries and genetically modified crop traits, biological products generally take 3-7 years to develop and get to market, informs Mr Meadows-Smith. The natural products

cost $5-25 million rather than $100-300 million for the alternative, he adds.

2016 marketArysta estimates the global market in 2016 to be around $3.4 billion for biocontrol/biopesticides and some $1.8 billion for biostimulants.

BioConsortia has similar estimates and Mr Meadows-Smith places the biologicals market at $4-6 billion globally. Some $3-4 billion of that would be accounted for by biopesticides with biostimulants/biofertilisers making up $1-2 billion.

OutlookBASF predicts increasing use of biologicals to complement chemistry-based products over the next five years. The company estimates an annual biologicals market growth of 10-12%. It sees an increasing market driven need for nematicides/nematode control as available chemistries are phased out for reasons including registrations that are expired or withdrawn. BASF estimates the annual losses from nematodes at $100 billion globally.

Arysta expects the biologicals market to grow at a more accelerated pace than 2016, in line with the expected moderate improvement of the crop protection market.

Dr Marrone views biologicals as a bright spot with continued good growth due to the global drivers of residues, resistance, labour efficiency and environmental safety. BioConsortia expresses certainty about the “amazing strength of interest” in microbials from conventional growers for biopesticides, and also more recently for fertiliser use efficiency as well as for soil health, plant health, and cost effective methods for significant yield increase. “It remains a very exciting time in the industry,” affirms Mr Meadows-Smith.



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JANUARYSumitomo Chemical’s US-based biopesticide and biorational products subsidiary, Valent BioSciences, entered into a North American distribution agreement for the Streptomyces lydicus strain WYEC 108-based Actinovate biofungicide range with the BioAg Alliance between Monsanto and Danish company Novozymes.

MARCHUS agrochemical company American Vanguard acquired a 15% stake in the Belgian biological products company, Biological Products for Agriculture (Bi-PA), and gained distribution rights to Bi-PA’s Trichoderma spp-based grapevine biofungicide, Vintec, in the Americas and access to products in development.

Arysta LifeScience (part of Platform Specialty Products) signed a licensing agreement with the Chinese Academy of Agricultural Sciences’ Institute of Plant Protection for exclusive global access (excluding China) to certain protein-based plant disease control technology.

Mitsui & Co’s US subsidiary, Certis USA, appointed UAP Canada as exclusive distributor of its biofungicide, Double Nickel (Bacillus amyloliquefaciens strain D747), in Canada.

The Swiss sustainable technology company, Evolva, expanded a collaboration with the US Center for Disease Control to use the plant extract, nootkatone, for the control of mosquito-borne diseases.

The French InVivo co-operative group acquired Syngenta’s biological control subsidiary, Bioline.

Italian agrochemical company Isagro’s US subsidiary, Isagro USA, appointed US biopesticide company Marrone Bio Innovations as the distributor of Isagro’s biofungicide, Bio-Tam 2.0 (Trichoderma asperellum strain ICC012 + T gamsii strain ICC080), to agricultural markets in four US states.

Italian biostimulants company Valagro acquired Indian biostimulant and biopesticide company SriBio.

Sumitomo Chemical’s US-based biopesticides and biorational products subsidiary, Valent BioSciences Corporation, reached a global licensing agreement with the US company, LidoChem, for a Bacillus amyloliquefaciens-based bionematicide for use on maize, soybeans and other crops.

APRILBelchim Crop Protection agreed to acquire French biologicals company Jade, a subsidiary of the group, Alidad Invest.

Dow AgroSciences agreed to collaborate with US company TeselaGen Biotechnology to produce a “state-of-the-art” biological design automation platform aimed at accelerating the discovery of crop protection and seed products.

Sumitomo Chemical’s US-based biopesticides and biorational products subsidiary, Valent BioSciences, entered into a research and development agreement with the Argentine seed treatment and inoculants specialist, Rizobacter, initially for the NAFTA region.

JUNEUS biopesticide company Marrone Bio Innovations and the Israeli mycorrhizal inoculants firm, Groundwork BioAg, agreed to collaborate on the development of a

seed treatment combining biopesticides and a mycorrhizal biostimulant.

Marrone Bio Innovations (MBI), granted exclusive rights to US fertiliser company Koch Agronomic Services and its biostimulant affiliate, Koch Biological Solutions, to sell MBI’s Reynoutria sachalinensis-based biofungicides, Regalia Rx and Regalia Maxx, for use on arable crops in the US and Canada, respectively.

Stockton agreed a distribution deal with Syngenta for Stockton’s tea tree (Melaleuca alternifolia) oil-based biofungicide for use on ornamentals.

Canadian biological crop care supplier Stoller’s Brazilian subsidiary, Stoller do Brasil, acquired Brazilian biotechnology company Rizoflora Biotecnologia.

JULYThe US agricultural biotechnology business, AgBiome Innovations, entered into an agreement with US specialty agrochemical company SePRO Corporation to introduce a new biofungicide to the turf and ornamentals market.

Syngenta entered into an agreement with the US information solutions company, Iteris, to use the latter’s ClearAg Mobile

Biologicals-related mergers, acquisitions and deals in 2016

72 www.agrow.comService Company Guide 2017 | Agrow Latin America 2017 | Agrow

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grower analytics application in biologicals research.

AUGUSTThe US biopesticide company, Marrone Bio Innovations (MBI), entered into an agreement with US agrochemical and specialty chemical company Albaugh to develop and market an unnamed MBI bioinsecticide/nematicide for seed treatment applications.

The US biopesticide company, Vestaron, entered into a multi-year agreement with Italian contract manufacturing firm Capua BioServices to produce Vestaron’s peptide-based Spear (GS-omega/kappa-Hxtx-Hv1a – trade-marked as Versitude) family of bioinsecticides.

SEPTEMBERBASF and French plant biotechnology company Plant Advanced Technologies agreed a collaboration for the discovery and development of novel agricultural biopesticides.

Bayer and German research institute Forschungszentrum Julich entered into a five-year research collaboration on the effects of microbial seed treatments on root growth and microbial colonisation of root systems.

French crop protection company De Sangosse acquired a majority stake in Spanish biologicals company Servalesa.

Israeli biotechnology company Evogene entered into an agreement with the US University of Missouri to collect and sequence soil samples to provide leads for Evogene’s microbial database supporting its insect control and other agricultural biological programmes.

The US biopesticide companies Phyllom BioProducts and Vestaron extended a 2014 research collaboration aimed at developing novel bioinsecticides.

Italian biostimulants company Valagro and French co-operative group InVivo agreed a co-development and distribution deal.

OCTOBERThe Dutch bioproducts company, Koppert Biological Systems, acquired certain microbial biopesticides from Swedish firm Lantmannen BioAgri.

NOVEMBERPlatform Specialty Products’ agrochemical business, Arysta LifeScience, entered into an exclusive licensing agreement with US

biostimulant company Beem Biologics for novel plant-derived biostimulant technology.

DECEMBERBelgian biological pest control company Biobest agreed to acquire Kenyan biocontrol solutions provider Real IPM Kenya.

UK-based biocontrol and micro-encapsulation technology company Eden Research signed an exclusive commercialisation agreement for its nematicide formulation with Belgian chemical company Taminco, a subsidiary of US specialty chemical firm Eastman Chemical.

Dutch bioproducts company Koppert’s Brazilian subsidiary, Koppert do Brasil Sistemas Biologicos, and the Brazilian Sao Paulo Research Foundation, the Fapesp, agreed to co-develop biological pest and disease control products.

The US-based, UK-listed bioproducts company, Plant Health Care, entered into distribution agreements for its disease resistance activator, Harpin aß, with US company Talc USA, Portuguese firm Edaf Unipessoal and South African company DuxAgri.

JANUARYUS biostimulant company Agrinos entered into a distribution partnership with US distributor Van Diest Supply Company.

Monsanto and Danish company Novozymes’ BioAg Alliance granted exclusive distribution rights in the US and Canada for its biofungicide, Taegro 2 (Bacillus subtilis var amyloliquefaciens strain FZB24), to Italian agrochemical company Isagro’s US business, Isagro USA.

The Canadian company, Bee Vectoring Technologies, entered into formal agree-ments with several leading US strawberry growers to conduct large-scale commercial demonstrations of its proprietary growing system for its bee-delivered biofungicide, Vectorite with CR-7 (Clonostachys rosea strain CR-7).

Nufarm and US biopesticide company Marrone Bio Innovations (MBI) agreed to develop MBI’s bioinsecticide/acaricide, Grandevo (Chromobacterium subtsugae strain

PRAA4-1T), for Australia and New Zealand.

US biological products provider Vegalab and El Salvadorean pesticide and fertiliser supplier Fertica Group agreed an exclusive distribution deal in Guatemala.

FEBRUARYThe Belgian biological products company, Biological Products for Agriculture (Bi-PA), acquired a 25% stake in Australian company Innovate Ag. Bi-PA will develop and register Innovate Ag’s bioinsecticide, Sero-X (Clitoria ternatea extract), outside Australia and New Zealand.

Israeli biopesticide company Stockton agreed a long-term, non-exclusive distribution deal for its Melaleuca alternifolia extract-based biofungicide, Timorex Gold, with Chinese company Chongqing Shurong Crop Science.

Spanish biological pesticides company Symborg agreed a deal with Japanese CBC group’s European subsidiary, CBC Europe’s

bioproducts company, Biogard, for distribution rights in Italy for Symborg’s biofungicide, McyoUp (Glomus iranicum var tenuihypharum).

The US biopesticide company, Vestaron, entered into a marketing agreement with US greenhouse and nursery specialist OHP for Vestaron’s peptide-based bioinsecticide/acaricide, Spear-O (GS-omega-Hxtx-Hv1a – trade-marked as Versitude), for use on greenhouse ornamentals.

MARCHDutch bioproducts company Koppert Biological Systems, Brazilian pest management company ISCA Technologies and Dutch remote sensing firm TEC-IB joined forces on a project to control red palm weevils (Rhynchophorus ferrungineus) on date palms in the Middle East.

Israeli biopesticide company Stockton entered into an agreement with New Zealand distributor Grosafe Chemicals to sell Stockton’s biofungicide, Timorex Gold (Melaleuca alternifolia extract), in the country.

Mergers, acquisitions and deals in 2017


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BIOPESTICIDES & OTHERSAEF GlobalBacillus thuringiensis var [bioinsecticide] Various Proposed approval in US as Bioprotec kurstaki strain EVB-113-19

AgBiTechSpodoptera frugiperda multiple Various including maize, sorghum, Approved in US as Fawligen nucleopolyhedrovirus strain 3AP2 oilseeds, pulses, potatoes, fruit, [bioinsecticide] vegetables, turf & ornamentals

Agro-Levures et DérivésSaccharomyces cerevisiae Grapevines, tomatoes, strawberries, Approved in EU strain LASO2 [biofungicide] pome & stone fruit

Andermatt BiocontrolCydia pomonella granulovirus [bioinsecticide] Almonds, walnuts, pome & stone fruit Approved in Spain as Madex Twin

Helicoverpa armigera nuclopolyhedrovirus Soybeans, beans, tomatoes, rice, cotton, Approved in Brazil as Verpavex & [bioinsecticide] peanuts, maize, potatoes & other crops Spain as Helicovex

BASFBacillus amyloliquefaciens strain MBI600 Grapevines Proposed approval in EU [biofungicide]

Bayer CropScienceBacillus firmus strain I-1582 [bionematicide] Maize, sweet corn, cereals, Approved in New Zealand as Poncho Votivo forage brassicas & grass (with clothianidin)

Bi-PATrichoderma atroviride strain SC1 Grapevines Approved in EU [biofungicide]

Certis Europe (Mitsui & Co)ethyl-2E,4Z-decadienoate [pheromone] Fruit Approved in Spain as Cidetrack CM &

Cidetrack OFM

Certis USA (Mitsui & Co)Bacillus mycoides isolate J [biofungicide] Fruit & vegetables Approved in US as BmJ WG or LifeGard WG

& approved in Canada as BmJ WG

Chinese Academy of Sciences’ Institute of Applied EcologyBacillus methylotrophicus strain Cucumbers Approved in China BAC-9912 [biofungicide]

Danstar FermentPhlebiopsis gigantea strain VRA 1992 Conifers Approved in US as Rotstop C [biofungicide]

Innovate AgClitoria ternatea extract [bioinsecticide] Cotton Proposed approval in Australia as Sero-X

Eden Research eugenol/geraniol/thymol [biofungicide] Grapevines Approved in Bulgaria & Italy as 3AEY

New active ingredients registered or launched in 2016


New active ingredients registered or launched in 2017


Inner Mongolia Jinto Pharmaceutical Industry alkaloid of Sophora alopecuroides Cabbages Approved in China [bioinsecticide]

LidoChem Bacillus amyloliquefaciens strain Maize, sorghum, soybeans, cotton, Proposed approval in US as Varnimo ST PTA-4838 [bionematicide] small-grain cereals, canola, sunflowers, oilseeds, potatoes, sugar beet, vegetables & fodder crops

Marrone Bio Innovations Chromobacterium subtsugae strain Fruit & vegetables Approved in Mexico as Grandevo PRAA4-1T [bioinsecticide/acaricide]

Burkholderia rinojensis strain A396 Fruit & vegetables Approved in Mexico as Majestene [bionematicide]

Muscodor albus strain SA13 [biofumigant] Strawberries, lettuces & other crops Approved in US as MBI-601 EP

Reynoutria sachalinensis extract [biofungicide] Grapevines & blueberries Approved in Chile as Regalia Maxx

Rizoflora Biotecnologia Pochonia chlamydosporia isolate Cotton, maize, soybeans, Approved in Brazil as Rizotec PC10 [bionematicide] vegetables & fruit trees

SenesTechtriptolide + 4-vinylcyclohexene [rodenticide] Rat contraceptive Approved in US as ContraPest

Stockton Melaleuca alternifolia extract [biofungicide] Grapevines, bananas, broccoli Approved in New Zealand & Brazil as & lettuces Timorex Gold

Suterra ((3S,6R)(3S,6S)-3-methyl-6- Citrus crops & other orchards Approved in US as CheckMate CRS isopropenyl-9-decen-1-yl acetate [pheromone]


BIOPESTICIDES & OTHERSAgBiome Innovations/SePRO Corporation Pseudomonas chlororaphis strain AFS009 Turf & ornamentals Approved in US as Zio [biofungicide]

Bayer CropScience Paecilomyces lilacinus strain 251 Fruit & vegetables Approved in Greece as BioAct Prime [bionematicide]

Eden Research eugenol/geraniol/thymol [biofungicide] Grapevines Approved in France as 3AEY

Simbiose Agro Trichoderma harzianum strain Cepa Launched in Brazil Simb-T5 [biofungicide]


demonstrated adverse effects on non-target insects. Semiochemicals, which include pheromones, will be considered low-risk, unless they trigger any hazard criteria.

A further amendment stipulates that ais that have been defined as priority substances under rules on preventing water pollution will not be considered as low-risk ais.

The changes are limited to identification criteria, and there are no amendments reflecting the MEPs’ call for a separate “fast-track” approval process for biopesticides. In previous debates with MEPs, the Commission pointed out that low-risk pesticides are to be given priority in the next round of renewing existing EU approvals. EU Health and Food Safety Commissioner Vytenis Andriukaitis also noted that the effectiveness of incentives, such as longer approval periods, is to be assessed during the review of agrochemical legislation under the REFIT “fitness check” programme.

The European Commission is to clarify and extend the scope of active ingredients that may be considered as “low-risk” substances, in a bid to boost approvals of biological and naturally occurring pesticides. Micro-organisms, baculoviruses and semiochemicals will be considered as low risk, unless specific concerns are identified, while naturally occurring substances will be exempted from certain hazard-based criteria. The proposed amendments will be made to the identification criteria for low-risk pesticides in the EU agrochemical registration Regulation (1107/2009). They have been voted through by EU member states and will come into effect following publication in the EU Official Journal. The Commission has been under pressure over the last year from the European Parliament, which passed several resolutions calling for faster biopesticide approvals.

Regulation 1107/2009 introduced the “low-risk” category, under which ais could benefit from a longer 15-year approval period. The existing identification criteria are largely based on a long list of hazard

characteristics that must not be present. For the sake of clarity, more details should be provided, says the Commission. It notes that hazard criteria on persistence and bioconcentration could prevent approval of certain naturally occurring substances, such as botanicals and minerals, even though they present “considerably less” of a risk than other ais.

The changes stipulate that a half-life in soil of more than 60 days or a bioconcentration factor higher than 100 would normally exclude an ai, other than a micro-organism, from being considered low-risk. However, a naturally occurring substance that exceeds these levels may still be considered low-risk, provided that it does not trigger any other hazard criteria.

Micro-organisms will be assessed at strain level for compliance with low-risk criteria. They will be considered low-risk unless the strain has demonstrated multiple resistance to antimicrobials used in human or veterinary medicine. Baculoviruses will be considered low-risk, unless a strain has

EU to set new approval criteria for low-risk pesticides


EU member states have supported proposals for new EU approvals of three biopesticides and renewed authorisation for a fourth. Two approvals are for Platform Specialty Products business Arysta LifeScience’s Beauveria bassiana bioinsecticides: strain 147 and strain NPP111B005. Arysta submitted the two applications in November 2012, for strain 147 for use on ornamental palm trees, and for NPP111B005 for use on bananas and ornamental palm trees. Arysta sells B bassiana products under the Ostrinil trade name.

The third new authorisation is for Danish company Novozymes Biologicals’ biofungicide, Bacillus amyloliquefaciens strain FZB24, as a “low-risk” active ingredient, making it eligible for a 15-year approval period, rather than the standard ten years. Novozymes applied in June 2013, for use on cucurbits, potatoes and grapevines. Novozymes and Monsanto’s BioAg Alliance sells the ai as Taegro 2, and recently granted US and Canadian distribution rights to Italian company Isagro’s US business, Isagro USA.

The renewed approval is for Bayer CropScience’s biofungicide, Coniothyrium minitans strain CON/M/91-08, which also grants it “low-risk” status. It is sold as Contans, for soil decontamination against Sclerotinia sclerotiorum in oilseed rape, lettuces, cucumbers, beans and sunflowers.

The approval decisions require publication in the EU Official Journal before coming into force.

Four biopesticides cleared for EU approval

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The topic of the future of the crop protection industry often incorporates the vision of a crop protection toolbox incorporating biopesticides and biostimulants in addition to conventional active ingredients. But the industry seeks the simplification of the registration process for biologicals.

The European Commission is in the process of extending the scope of ais that may be considered as “low-risk” substances, in a bid to boost approvals of biological and naturally occurring pesticides. But Regulation 2003/2003 relating to fertilisers only focuses on inorganic (mineral) fertilisers. There are 28 national fertiliser regulations which, to a varying extent, offer the possibility for registration of biostimulants or biostimulant-like products. In addition, in certain countries, the national plant protection laws cover at least some type of biostimulants, for instance, in Germany.

A vote of the European Parliament on a new

EU fertiliser Regulation, which will also cover biostimulants, is foreseen for September 2017 with a possible applicability in 2019. It is expected to expand the scope and also include organic fertilisers, soil improvers and biostimulants. As the progress to bring this new piece of legislation to life has been delayed and stopped several times already, it is likely that these target dates will be postponed again, making it unclear when biostimulants can be marketed on an EU-wide basis and what will be the expense in time and money for the manufacturer.

The current proposal of the new fertiliser Regulation allocates biostimulants a special Product Function Category (PFC 6), defining them as: “certain substances, mixtures and micro-organisms, commonly referred to as plant biostimulants, [which] are not as such nutrients, but nevertheless stimulate plants’ nutrition processes. Where such products aim solely at improving the plants’ nutrient use efficiency, tolerance to abiotic stress, or

By Lars Huber

Lars Huber is senior manager regulatory affairs, head of biostimulants, fertiliser and IPM at SCC - Scientific Consulting Company

Moving towards a simpler EU biostimulant registration regime


crop quality traits, they are by nature more similar to fertilising products than to most categories of plant protection products. Such products should therefore be eligible for CE marking (Conformity marking under general principles of Regulation 765/2008) under this (the new) Regulation and excluded from the scope of [agrochemical registration] Regulation 1107/2009”.

Whereas there seems to be a common understanding of the basic definition for biostimulants, several topics regarding their registration are currently under discussion. As for fertilisers, thresholds for heavy metals are being debated. Also, a shelf-life proposal of at least six months for microbial biostimulants, as proposed by the Council, is to be removed. For non-microbial biostimulants, there is no differentiation foreseen between organic and inorganic components, which would be a clear and highly welcomed simplification compared with the current situation. There are discussions ongoing on the accepted extraction methods for non-processed or mechanically processed plants, plant parts or plant extracts [Component Material Category (CMC) 2], which is to be extended from water extraction only. It is emphasised that only processing methods will be allowed that will not affect the chemical nature of the substance. For micro-organisms (CMC 6), a positive list is being compiled and there will be a mechanism to amend the list, with individual quality criteria still to be addressed. Various discussions on these lists and how to amend them are ongoing. Due to the complexity of that issue, a new expert group on microbial biostimulants has to be launched and will include participation by the European Food Safety Authority (EFSA), other experts and industry. Micro-organism identification will be at the strain level. The prioritisation criterion for such amendments to the list will be the market potential for a proposed micro-organism.

An issue not currently addressed in the draft Regulation is that of maximum residue limits (MRLs) for biostimulants. Requirement for implementation of MRLs is an authorisation system, which is not foreseen for biostimulants according to the draft of the upcoming Regulation.

A grave concern for industry is the still unsolved question of data protection. No data protection provisions are foreseen in

the new Regulation. Data protection could only be awarded under the EU Registration, Evaluation and Authorisation of Chemicals (REACH) Regulation. A possible blueprint to address this issue could be the handling of medical devices Class 1, which are also handled under a CE system.

According to the draft Regulation, “products with one or more functions, one of which is covered by the scope of Regulation (EC) No 1107/2009, are plant protection products covered by the scope of that Regulation”. This regulatory differentiation of substances and products with more than one function does not mirror the scientific conditions. As several substances clearly show effectiveness against abiotic as well as biotic stresses, it remains to be seen if feasible possibilities will arise to include “abiotic” functions under the framework of Regulation 1107/2009 if not under the framework of the future fertiliser regulation. In view of the farmer’s toolbox, the loss of valuable functions of substances “only” due to regulatory and legislative obstacles seems very unfortunate.

As already indicated, when the new legislative framework for biostimulants at EU level will come into force is uncertain. As biostimulants are already an acknowledged tool in parts of the agricultural practice, several national authorities have adapted their national legislation in the recent past to cover this gap and make more biostimulating substances available to their farmers. For example, in Spain, the national fertiliser regulation (Real Decreto 506/2013) was amended to include products containing micro-organisms that increase the availability of nutrients for plants. The French Decree No. 2016-532 of April

27th 2016 on the procedure for national authorisation of natural biostimulant substances was published on April 30th 2016. Natural biostimulant substances are authorised without further procedures provided they fulfil certain conditions related to effects on human and animal health or the environment, the origin of the substance (e.g. plant, animal or mineral origin), or the manufacturing process.

This “non-harmonisation” is in line also with the draft of the new EU fertiliser regulation that stipulates that “contrary to most other product harmonisation measures in Union legislation, Regulation (EC) No 2003/2003 does not prevent non-harmonised fertilisers from being made available on the internal market in accordance with national law”. It is foreseen that this possibility should remain. In liaison with the adaptions of the national fertiliser laws regarding biostimulants as described above, the upkeep of national biostimulant registrations even after implementation of the EU framework, increase the importance of national registrations for biostimulants regarding business strategies for registration and rollout of new biostimulant products in EU.




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