2016 - agrow · analysis of the product portfolio and the definition of new potential markets....

Service Company Guide 2016

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Contents

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.agrow.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 2016

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]

Correspondent Duncan Poupard (China) Email: [email protected]

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

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

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


02 Consultancies & other advisory bodies

08 Market research companies

09 Contract research organisations

22 Custom manufacturers

23 Formulation companies & additives suppliers

24 Biopesticides

26 Who’s Who in CROs

30-41 Biologicals becoming part of integrated crop protection offers

43-45 Biopesticides and the EU regulatory process

48 Index




2 www.agra-net.comService Company Guide 2016 | Agrow

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.

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

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 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.


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

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

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 services which have received sustained recognition from AGROW AWARDS independent judges since 2010, and of course from our many repeat customers.



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

EBRC’s services encompass the full range of regulatory support for plant protection products, biocides and industrial chemicals under REACH. Comprehensive toxicological, ecotoxicological and environmental fate expertise is provided together with data gap analyses and literature searches for compliance with regulatory data requirements. Electronic submissions (IUCLID, CADDY) supplement our scientific support as routine services.

Plant protection product registrations according to EU national member state legislations as well as EU requirements are processed for all EU member states following the zonal concept (dRR) and

also the requirements for the EU notification and EU renewal of active substances.

Full dossier compilation is performed in agreement with the requirements of the plant protection product regulation, the biocides regulation and the REACH regulation, including biological dossiers, complex exposure or risk assessments and computer modelling of environmental fate behaviour.

Task force management, project coordination and scientific monitoring of experimental investigations complete this package of services.

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

DHD-Consulting offers full scientific and regulatory services for Agrochemicals, Biopesticides (including German Plant Strengthener) and Biocides, for products

and active substances. Our clients benefit from our quality and timeliness, flexibility and reliability, looking back on 20 years’ experience:

• Our services for new projects start with a comprehensive data review and gap analysis, consultation on requirements and budget estimations.

• Our study monitoring group takes over the request for quotations at contract laboratories, auditing / review of study plans, results and reports.

• We have long term experiences in environmental fate modeling, ecological and toxicological exposure calculations as well as expertises (including QSAR and GHS CLP), and risk assessments.

• We prepare and submit draft

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

• DHD’s efficacy group offers enhanced expertise in placing, design, monitoring, and assessment of efficacy trials and preparation of Biological Assessment Dossiers (BAD).

• New DHD skills are an effective literature research for AIR substances (including documentation according to the EFSA guidance) and Comparative Assessments for products containing Candidates for Substitution.

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


GAB Consulting GmbHOttenbecker Damm 10. 21684 Stade, Germany Tel: +49 4141 80010 0 Fax: +49 4141 80010 20

Email: [email protected] Contact: Dr. Wolfgang Häußler, Managing Director www.gabconsulting.de

GAB Consulting is a leading consulting company offering comprehensive registration services for the chemical industry in Europe and overseas.

We meet your needs by providing competent and flexible regulatory and scientific expertise to ensure that 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 to answer any general questions you may have. Our goal is that you can sell your product as soon as possible.

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

JSC International Limited, a wholly owned subsidiary of ERM, provides expert independent regulatory and risk assessment services to the agrochemical, biocides and chemical industry. The team of scientists from regulatory, industry and contract research backgrounds has extensive experience in European regulatory affairs. Through its network of collaborators the company has 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.

Exponent International The Lenz, Hornbeam Business Park Harrogate, North Yorkshire HG2 8RE, UK & Kanzlerstr. 4, 40472 Düsseldorf, Germany 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.



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

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 dossiers PPP, REACH, Biocides in the European Union

• Preparation of National addenda for the all 28 Member states

• Contact or 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

LKC Switzerland LtdHauptstrasse 10 4414 Füllinsdorf, Switzerland Tel: +41 61 906 85 00 / +41 61 906 8509 Email: [email protected] Contact: Dr David Kane www.lkc-ltd.com/EU-services.html

Clients working with LKC benefit from independent regulatory experience and advice for cost effective global registration of specialty chemical products.

Manufacturing companies can optimise their strategic development in the European market with LKC‘s established contacts with Regulating Authorities, contracting and monitoring of key studies including higher tier studies;

impact and risk assessments, regulatory dossier preparation and submission including CADDYxml, IUCLID and METI 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 their regulatory challenges.

Phillips McDougallVineyard Business Centre, Saughland Pathhead Midlothian, EH37 5XP UK Tel: +44 (0) 207 551 9224 Email: [email protected] Email: [email protected] Contact: Jack Hopper (Sales), Matthew Phillips (Phillips McDougall) www.phillipsmcdougall.co.uk

Phillips McDougall has a respected reputation as the leading commentator on

the global agrochemical and seeds industries, regularly quoted by the industry and financial institutions. The company offers publications and consultancy across the crop protection, biotechnology and seeds industries.

The AgriService provides an authoritative and comprehensive analysis of the global crop protection and GM seed industries, incorporating profiles of the leading companies along with crop, chemistry, R&D and country market reviews and forecasts, all supported by basic market research through its global network of market research consultants. The AgriService includes a complete

product directory and company support service as well as the monthly research note, AgriFutura. The Seed Service provides a similar analysis of the seeds and traits industry. The GM Seed Product database provides information of GM traits on the market, those in development and a comprehensive analysis of patents worldwide.

AgreWorld is a daily web-based information service that provides data and analysis of recent strategically important events across all the major agricultural inputs industries, but particularly agrochemicals and seeds.In 2013 Phillips McDougall became part of Informa Group.


TSGE Consulting Concordia HouseSt James Business ParkGrimbald Crag CourtKnaresboroughNorth Yorkshire, HG5 8QBUnited Kingdom

Tel: +44 (0) 1423 799 633Email: [email protected] Contact: Steve Dobson 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 and Hungary.

SCC – Scientific Consulting CompanyEmail: [email protected] www.scc-gmbh.de

SCC is one of Europe’s largest privately owned and independent regulatory consulting companies. SCC’s scientific and regulatory experts support more than 250

global customers with their registration needs in compliance with all existing chemical regulations.

Our long-standing expertise includes defense 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, submission and defense of dossiers for biocidal active substances (> 70) and increasing number of biocidal product dossiers.

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.

We act internationally: Alongside with Headquarters in Bad Kreuznach and its second German office in Berlin, SCC has been running Liaison Office Japan for almost 10 years.

We care for your success


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

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

We have expertise in all the major categories needed for keeping operations running smoothly, including pesticides, seeds, soil and water management and farm machinery. We conduct tracking

studies for monitoring market trends, 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 specialists who understand the challenges impacting the agricultural industry. And with our international team of experts located around the world, no matter where you are, we can help.

Market Research

Dextra International Av. Corts Catalanes 9-11 08173 Sant Cugat del Vallés Barcelona, SpainTel: +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

Phillips McDougallVineyard Business Centre, Saughland, Pathhead Midlothian, EH37 5XP UK Tel: +44 (0) 207 551 9224 Email: [email protected] Email: [email protected] Contact: Jack Hopper (Sales), Matthew Phillips (Phillips McDougall) www.phillipsmcdougall.co.uk

Phillips McDougall has a respected reputation as the leading commentator on

the global agrochemical and seeds industries, regularly quoted by the industry and financial institutions. The company offers publications and consultancy across the crop protection, biotechnology and seeds industries.

The AgriService provides an authoritative and comprehensive analysis of the global crop protection and GM seed industries, incorporating profiles of the leading companies along with crop, chemistry, R&D and country market reviews and forecasts, all supported by basic market research through its global network of market research consultants. The AgriService includes a complete

product directory and company support service as well as the monthly research note, AgriFutura. The Seed Service provides a similar analysis of the seeds and traits industry. The GM Seed Product database provides information of GM traits on the market, those in development and a comprehensive analysis of patents worldwide.

AgreWorld is a daily web-based information service that provides data and analysis of recent strategically important events across all the major agricultural inputs industries, but particularly agrochemicals and seeds.In 2013 Phillips McDougall became part of Informa Group.


Agrolab Roejleskovvej 18 DK- 5500 Middelfart, Denmark Tel: +46 706 34 84 85

Contact: Jesper Yngvesson Email: [email protected] www.agrolab.dk

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.

Contract research organisations

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

BioChem agrar GmbHKupferstr. 6 04827 Gerichshain, Germany Tel: 00 493 429 286 314 Contact: Gernot Renner

Email: [email protected] www.biochemagrar.de

As an independent and GLP compliant CRO we offer expertise and capabilities to conduct studies for product registration of agrochemicals, biopesticides, fertilisers, chemicals, pharmaceuticals and feed additives. 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, Soil organisms, SMO, Non-target terrestrial plants testing), Field trials (residues, crop rotation, soil dissipation/ accumulation, variety evaluation, efficacy, fertiliser, GMO, demonstration trials) and Analytical chemistry.



Biotecnologie BT SRLFrazione Pantalla - 06059 Todi (Perugia) Italy Tel: + 39 075 8950045 Fax: + 39 075 888776 Email: [email protected] Contact: Business Development Manager (Mrs Alessia Aguzzi) 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.

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]

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, formulation support for a range of solid and liquid formulation types, 5-batch analysis, bee studies, ecotoxicology 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, aquatic screens 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]

Contact: 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.


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]

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.

EAG Laboratories Global Headquarters: 4747 Executive Drive Suite 700 San Diego, CA 92121, USA Tel: +1 800 538 5227 Contact: Dave Palmer 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.

CropTrials GmbHEhlbeek 230938 Burgwedel, GermanyTel: +49 5139 8393Fax: + 49 5139 27095Email: [email protected]

Contact: Dr. Paul Reh and Kirsten Heitsch www.croptrials.com

CropTrials GmbH is an independent and privately-owned company for agricultural field research, with GLP and GEP certification. CropTrials GmbH is the successor organisation of VERSUCHSWESEN PFLANZENSCHUTZ, which was founded in 1990. The firm has since then provided service for the development of agricultural chemistries. 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). We are very experienced in efficacy and selectivity studies as well as in residue, soil dissipation and rotational crop studies. The trials could be carried out in all agricultural and horticultural crops and in orchards, vineyards, ornamentals, forests and non-agricultural land.

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



Eurofins DeBredelaar Name: De Bredelaar B.V.Address: Reethsestraat 17b - 6662 PK Elst The NetherlandsTel: +31 481 462379Email: [email protected]: Frans Van Tilburg

Eurofins De Bredelaar based in Elst, The

Netherlands was founded in 1988 and is an independent research institute specialised in crop protection in agriculture and horticulture. It was acquired by Eurofins Agroscience Services in 2015. Areas of expertise include efficacy, phytotoxicity and residue studies in various crops along with demonstration trials. Eurofins De Bredelaar is both GEP and GLP certified.

Field trials are carried out at the fully owned and managed fields and glasshouses and also, at nurseries and

arable farms throughout the Netherlands.

This acquisition is an exciting development in EAS Group’s strategic growth plan - the portfolio of Eurofins De Bredelaar strengthens existing services whilst the location sees advancement into Benelux, an entirely new location for the Group.

It sees the addition of expert service delivered by an excellent and very experienced team in Benelux, working from a state of the art facility.

Eurofins TrialcampName: Trialcamp SLAddress: Pol. Ind. L’Alter, Avenida Antiguo Reino de Valencia, 25, 46290 Alcacer, Valencia - ESPAÑATel: +34 96 298 61 43

Email: [email protected]: Luisa Aznar

Spanning a history of over 20 years, Eurofins Trialcamp SL located in Valencia, Spain has developed a GLP and GEP accredited portfolio of test systems covering lab, semi-field and field studies in the area of ecotox as well as efficacy and residue trials.

Acquired by Eurofins Agroscience Services in 2015, the company is well-known for its expertise in post-harvest trials. Eurofins Trialcamp provide services to the crop protection and chemical industry all around the world by conducting developmental research to support their global regulatory submissions.

Eurofins PhyliaeName: Phyliae SASAddress: 3005 La Vieille Route, 76190 Valliquerville, FranceTel: +33 2 32 70 15 89

Contact: Thomas LevasseurEmail: [email protected]

Eurofins PHYLIAE is a service company specialising in GEP experimentation and the management of research and development projects in the sector of plant protection. Established since 2008, and acquired by Eurofins Agroscience Services in 2016, PHYLIAE offers GEP

biological tests for a wide range of crops and prides itself on exceptional project management skills.

This acquisition is an exciting development in EAS Group’s strategic growth plan – Eurofins Phyliae’s portfolio strengthens existing services whilst the location offers further coverage of France; one of Europe’s key agricultural producers.

Eurofins SCECName: SCEC Pty LtdAddress: PO Box 211 Northbridge NSW 1560Tel: 02 9958 1108 Fax: 02 9958 1109

Contact: Sally ColganEmail: [email protected]

Eurofins SCEC, specialises in the design, management and implementation of research projects for the veterinary industry.

The company was founded in 2002 by Dr Sally Colgan and acquired by Eurofins Agroscience Services in 2016. It has

extensive facilities in Sydney and Wallacia and offers services to the animal health industry in the development of veterinary and animal health products.

Eurofins SCEC undertakes work for the animal health industry, both nationally and internationally, working with multinational companies to perform studies for product registration in Australia and overseas.

Eurofins Agroscience Services Group

STRONGER TOGETHER

Eurofins AgroscienceTesting (Australia & NZ)+61 29 810 [email protected] Eurofins Agrisearch (Australia & NZ)+61 42 724 [email protected]

Eurofins AgroscienceServices Austria GmbH (Austria)Tel: +43 4224 [email protected]

Eurofins do BrasilAgroscience Services (Brazil)Tel: +55 19 2107 [email protected]

Eurofins AgroscienceServices EOOD (Bulgaria)Tel: +359 6941 [email protected]

Eurofins AgroscienceServices (China)+86 13 6025 [email protected]

Eurofins AgroscienceServices ApS (Denmark)Tel: +456 1140 [email protected]

Eurofins AgroscienceServices SAS (France)Tel: +335 6331 [email protected]

Eurofins AgroscienceServices Chem SAS (France)Tel: +334 6673 [email protected]

Eurofins Agroscience ServicesChem GmbH (Hamburg, Germany)Tel: +49 40 881 448 [email protected]

Eurofins Agroscience Services Ecotox GmbH (Niefern, Germany)Tel: +49 (0) 7233 9627 [email protected]

Eurofins Agroscience Services Field (Stade, Germany)Tel: +49 414 180 [email protected]

Eurofins Agroscience Services EcoChem GmbH (Niefern,Germany)Tel: +49 723 396 [email protected]

Eurofins AgroscienceServices Kft (Hungary)Tel: +362 2501 [email protected]

Eurofins AgroscienceServices Ltd (India)+91 90 0392 [email protected]

Eurofins AgroscienceServices Srl. (Italy)Tel: +39 051 [email protected]

Eurofins Agroscience Services Ltd (Philippines)Tel: +634 9521 [email protected]

Eurofins AgroscienceServices sp. z.o.o. (Poland)Tel: +486 1292 [email protected]

Eurofins AgroscienceServices S.L. (Portugal)Tel: +3512 5165 [email protected]

Eurofins AgroscienceServices Srl. (Romania)Tel: +402 5628 [email protected]

Eurofins AgroscienceServices S.L. (Spain)Tel: +349 5418 [email protected]

Eurofins AgroscienceServices Ltd (Thailand)Tel: +66 8178 [email protected]

Eurofins AgroscienceServices Ltd (UK & Ireland)Tel: +441 33286 [email protected]

Eurofins AgroscienceServices Inc. (USA)Tel: +147 8994 [email protected]

Eurofins Regulatory AG(Switzerland)Tel: +416 1836 [email protected]

MITOX Consultants(The Netherlands)Tel: +316 5155 [email protected]

MITOX BV(The Netherlands)Tel: +312 0751 [email protected]

MITOX Field OperationsSouthern Europe (France)Tel: +335 6229 [email protected]

Eurofins Agroscience Services are a global service provider of field, laboratory and regulatory programs. With proven expertise in managing global field studies, worker exposure studies, ecotoxicology, analytical services, physico-chemical property testing, 14C / environmental fate laboratory and field studies, the service offering is continuously developed by knowledge transfer initiatives between the Group’s various centres of expertise across the globe. By acquiring a carefully selected range of CRO’s, Eurofins Agroscience Services has created a unique portfolio of expertise that provides support to plant breeders, agrochemical, biopesticide, biocide and fine chemical manufacturers that spans over 25 years. www.eurofins.com/agroscienceservices

Eurofins Agroscience Services Group

STRONGER TOGETHER

Eurofins AgroscienceTesting (Australia & NZ)+61 29 810 [email protected] Eurofins Agrisearch (Australia & NZ)+61 42 724 [email protected]

Eurofins AgroscienceServices Austria GmbH (Austria)Tel: +43 4224 [email protected]

Eurofins do BrasilAgroscience Services (Brazil)Tel: +55 19 2107 [email protected]

Eurofins AgroscienceServices EOOD (Bulgaria)Tel: +359 6941 [email protected]

Eurofins AgroscienceServices (China)+86 13 6025 [email protected]

Eurofins AgroscienceServices ApS (Denmark)Tel: +456 1140 [email protected]

Eurofins AgroscienceServices SAS (France)Tel: +335 6331 [email protected]

Eurofins AgroscienceServices Chem SAS (France)Tel: +334 6673 [email protected]

Eurofins Agroscience ServicesChem GmbH (Hamburg, Germany)Tel: +49 40 881 448 [email protected]

Eurofins Agroscience Services Ecotox GmbH (Niefern, Germany)Tel: +49 (0) 7233 9627 [email protected]

Eurofins Agroscience Services Field (Stade, Germany)Tel: +49 414 180 [email protected]

Eurofins Agroscience Services EcoChem GmbH (Niefern,Germany)Tel: +49 723 396 [email protected]

Eurofins AgroscienceServices Kft (Hungary)Tel: +362 2501 [email protected]

Eurofins AgroscienceServices Ltd (India)+91 90 0392 [email protected]

Eurofins AgroscienceServices Srl. (Italy)Tel: +39 051 [email protected]

Eurofins Agroscience Services Ltd (Philippines)Tel: +634 9521 [email protected]

Eurofins AgroscienceServices sp. z.o.o. (Poland)Tel: +486 1292 [email protected]

Eurofins AgroscienceServices S.L. (Portugal)Tel: +3512 5165 [email protected]

Eurofins AgroscienceServices Srl. (Romania)Tel: +402 5628 [email protected]

Eurofins AgroscienceServices S.L. (Spain)Tel: +349 5418 [email protected]

Eurofins AgroscienceServices Ltd (Thailand)Tel: +66 8178 [email protected]

Eurofins AgroscienceServices Ltd (UK & Ireland)Tel: +441 33286 [email protected]

Eurofins AgroscienceServices Inc. (USA)Tel: +147 8994 [email protected]

Eurofins Regulatory AG(Switzerland)Tel: +416 1836 [email protected]

MITOX Consultants(The Netherlands)Tel: +316 5155 [email protected]

MITOX BV(The Netherlands)Tel: +312 0751 [email protected]

MITOX Field OperationsSouthern Europe (France)Tel: +335 6229 [email protected]

Eurofins Agroscience Services are a global service provider of field, laboratory and regulatory programs. With proven expertise in managing global field studies, worker exposure studies, ecotoxicology, analytical services, physico-chemical property testing, 14C / environmental fate laboratory and field studies, the service offering is continuously developed by knowledge transfer initiatives between the Group’s various centres of expertise across the globe. By acquiring a carefully selected range of CRO’s, Eurofins Agroscience Services has created a unique portfolio of expertise that provides support to plant breeders, agrochemical, biopesticide, biocide and fine chemical manufacturers that spans over 25 years. www.eurofins.com/agroscienceservices



Field Research Support Max-Planck-Str. 5 D–31515 Wunstorf, Germany Tel: +49 5031 5166999

[email protected] Contact: Helmut Zöllner www.field-research-support.de

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.

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 468351

Contact: Andreas Andreanidis Email: [email protected]: Eugenia Georgiadou Email: [email protected]

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.

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 an award winning, Good Laboratory Practice compliant (GLP), ISO 17025 accredited analytical contract lab. Our vision is to be the “most trusted analytical laboratory in the Ag industry”.

EPL BAS serves the global agricultural industry by analyzing feed and food ingredients, organic products, genetically

enhanced crops, bio-pesticides, plants, algae, plant protection agents and crop chemicals. With the goal of providing safe, healthy abundant food while protecting and improving the environment, EPL BAS uses advanced innovative technology in the areas of nutritional chemistry, agricultural chemistry including residue and product chemistry and molecular biology to provide excellent, timely support for the feed, food, fiber, and fuel industries. We don’t have an Ag Division …because we are Ag!


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.

James Hutton Limited Invergowrie Dundee DD2 5DA Tel: +44 (0) 1382 568 568 Contact: Laura Paterson Email: [email protected] www.huttonltd.com

James Hutton Limited (JHL) harnesses the scientific expertise, intellectual property, facilities and resources of the James Hutton Institute meaning we can access up to the minute research into alternative disease and pest control strategies, carried out by world-leading scientists.

JHL is committed to developing sustainable agriculture through advanced-marker assisted plant breeding, diagnostics, pathogen testing, fertiliser

optimisation and crop nutrition trials. Officially recognised by the UK Chemicals Regulation Directorate for crop protection efficacy trials to Good Experimental Practice standards, we regularly test new products, especially biocontrol and natural, in the open field, glasshouses or under tunnels and we are also involved in mode of action studies.



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

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.

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

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.

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]

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.


PROMOVERTNew website: www.promovert.com

IN FRANCERue d’Aste Béon, BP 27F-64121, Serres CastetFranceTel: +33 559 33 77 70Contact: Serge LAGRASSE

PROMO-VERT always on the move and offers you the best for your European projects:

• EU Project management• Agrochemical efficacy field trials• Plant and soil GLP residue studies• Full registration dossiers (dRRs and BAD)

according to Regulation 1107/2009.

IN SPAIN Polígono Industrial La ChozaCalle nuevas tecnologías, n°16E-41805, Benacazon (SEVILLA)SpainTel: +34 995 70 99 09 Contact: Emilio FERNANDEZ

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

Let us grow further together – 30 Years experience

IN ITALY Via Marzabotto, 51I-48024, Massa Lombarda (RA) ItalyTel: +39 347 140 11 94Contact : Massimiliano LANDINI

Full GEP certification for field efficacy and crop safety trials on major local crops: annual crops, vegetables, orchards, vines.

IN PORTUGALZona Industrial da Gandra Mazedo4950-297, Mazedo – MonçaoPortugalTel: +34 995 70 99 09 Contact: Emilio FERNANDEZ

• GEP field trials with agrochemicals for efficacy testing

• GLP residue studies

GEP and GLP certificates granted in 2012 by official Portuguese authorities.

IN EUROPE Ask your global European detailed estimate to:Gilles MOULONGUETEuropean directorMobile: +33 686 27 05 10 Email: [email protected]

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 effcacy 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



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

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 85’000 employees, SGS operates a network of over 1’800 offices and laboratories around the world.

Since 1988,We turn your ideas into value

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

www.flora-west-europa.euCEO 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)• Study monitoring of trial programs• Study direction throughout the EU• Residue trials GLP• Non Target Plant (NTP) Trials• DFR Trials• Drift• Soil Sampling…

Through its wide EU network of partners, REDEBEL is able to provide, in accordance with REDEBEL’s high quality standards:

• Act as a global Study Director for-EU GLP residue programs

• Act as Study Monitor for-EU efficacy & selectivity GEP programs

• Prepare core Biological Assessment Dossier (BAD) with specific national addenda

• In Belgium, 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) 809 275

Contact: 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.


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 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, toxicology services, 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 Pharmaceutical, Veterinary Industry 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 Verterinary 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.



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]

Steve Harrison (Seeds & Traits) Email: [email protected]

www.syntechresearch.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 29 countries worldwide, we conduct field and laboratory studies for over 100 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.

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

STAPHYT provides reliable solutions and high level of expertise to agro-chemical, bioproducts manufacturers and plant breeders for the development, registration and promotion of their products (conventional and biological).

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:- almost 30 years experience - over 400 team members - Access to all crops all over Europe

and Australasia (Peracto company)- 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• Biocontrol 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 also offers services, for Chemical, biocontrol products, fertilisers, growing 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


Regulatory Affairs, Market Intelligence, Field Management and Hosting services

Vigna BrasilAvenida 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

Vigna Brasil is a 20 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.

Versuchswesen Pflanzenschutz Please find details under CropTrials GmbH on page 11


Custom Manufacturers

Agri LifePlot No.154/A5, SVCIEIDA Bollaram – 502325Medak Dist., Hyderabad

Telangana, India Tel: +91 98854 38365 Fax: +91 8458 279904 Email: Dr [email protected] Mobile: +91 9885 446278 Contact: Dr Devanur Venkatesh www.agrilife.in

Manufactures BioPesticides viz. Bt-K, Bt-I, Trichoderma viride, Trichoderma harzianum, Beauveria bassiana,

Metarhizium anisopliae, Verticillium lecanii, Azadirachtin, Karanjin – supported by basic data package. Agri Life offers BioFertilizers like Nitrogen Fixing Bacteria, Phosphorous Solubilizing Bacteria, Potash Mobilizing Bacteria, Ferrous Mobilizing Bacteria, Zinc Mobilizing Bacteria, Mn Mobilizing Microbe, Sulfur Mobilizing Bacteria, VAM etc; BioNematicides: Bacillus Firmus and Paecilomys Lilacinus

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

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.


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

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.

Formulations companies & additives suppliers

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.

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/products

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.


Formulations companies & additives suppliers

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

STAPHYT provides reliable solutions and high level of expertise to agro-chemical, bioproducts manufacturers and plant breeders for the development, registration and promotion of their products (conventional and biological).

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:- almost 30 years experience - over 400 team members - Access to all crops all over Europe

and Australasia (Peracto company)- 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• Biocontrol 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 also offers services, for Chemical, biocontrol products, fertilisers, growing 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

Biopesticides

SBM-FormulationC.S. 621 – Z.I. Avenue Jean Foucault 34535 Béziers Cedex, France Tel: +33 4 91 24 44 35 Contact: Denis Barlet General Manager 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, RB or GB by wet processing, EW, SE, SC with dedicated lines for hot insecticides. SBM provides services to a wide range of crop protection companies including many of the majors.

SBM offers a full formulation and packing service from early development stage.

The main manufacturing and packaging plant is ISO 9001, ISO 14001 and OHSAS 18001 certified.

SBM pays special attention to safety, environment and housekeeping aspects through a policy of continuous investment.

Iris, sister company of SBM-Formulation, is specialized in toll-packing for small packs (from 1g/mL to 1kg/L) for Ag. or Home and garden Business.


TSGE Consulting Concordia House, St James Business ParkGrimbald Crag Court, KnaresboroughNorth Yorkshire, HG5 8QB, United KingdomTel: +44 (0) 1423 799 633Email: [email protected]

Contact: Steve Dobson 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 and Hungary.

LKC Switzerland LtdHauptstrasse 10 4414 Füllinsdorf, Switzerland Tel: +41 61 906 85 00 / +41 61 906 8509 Email: [email protected] Contact: Dr. David Kane www.lkc-ltd.com/EU-services.html

Clients working with LKC benefit from independent regulatory experience and advice for cost effective global registration of specialty chemical products.

Manufacturing companies can optimise their strategic development in the European market with LKC‘s established contacts with Regulating Authorities, contracting and monitoring of key studies including higher tier studies;

impact and risk assessments, regulatory dossier preparation and submission including CADDYxml, IUCLID and METI 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 their regulatory challenges.

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

The smart way to grow. Stockton specializes in the development, manufacturing and marketing of botanical based biopesticides. The core focus is on the integration of these plant extracts with conventional chemical products into conventional agricultural spraying and tank mix programs, and creating a sustainable agricultural environment.

Established in 1994, Stockton is global company, with headquarters in Israel, and over 20 subsidiaries worldwide.Stockton’s commitment to developing new solutions by integrating innovation and sustainability provides important benefits to agriculture and the cause of environmental conservation. The company’s R & D center in Israel is positioned at the forefront of biosciences development and innovation, producing highly effective protection solutions that are eco-friendly, safe, residualfree and non-staining.

Stockton Research and Development Innovation Center is constantly developing natural crop protection solutions that are effective and environmentally friendly, preventing and / or overcoming the effects of pests, weeds and plant diseases in a manner suitable for conventional IPM and/or organic farming.

Stockton’s flagship product Timorex Gold®

is used to control a broad spectrum of crop diseases. The product demonstrates

an efficacy similar to that of chemical fungicides, and is suitable for use with both conventional and organic crops. Timorex Gold® is registered and/or sold in over 30 countries, and is a leading biofungicide throughout Latin America and some countries in APAC. The brand is both an effective biofungicide and bactericide, working effectively for the protection of a variety of crops, including tomatoes, grapes, berries, cucurbits, peppers, peanuts, onions, soybeans and others.Timorex Gold® is a plant extract (Meluleuca alternifolia), and belongs to the Frac 7 Group, meaning it has a superior environmental profile and performs especially well for resistance management.

Stockton 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.

Biopesticides


Whos Who in CRO’s2016

Sébastien DUMONT de [email protected]

Tanguy DUMONT de [email protected]

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

20 HIGLY [email protected]


Tanguy DUMONT de [email protected]

Philippe REYNENSField Trials ManagerDemo, R&D, [email protected]

Sébastien DUMONT de [email protected]

Camille DORCIEREUM GEP Trials Program-Project [email protected]

Thierry DOCLOTIT ManagerARM Sales & Support [email protected]

Pierre LORIAUGLP residue Trials [email protected]

We turn your ideas into value

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Congress & Exhibition24-25 October 2016Amsterdam RAI, Netherlands

CROPWORLDGLOBAL 2016

Hear from over 50 renowned international speakers including:

Andre Laperriere, Executive Director, Secretariat for Global Open Data for Agriculture & Nutrition

Dr Adrian Percy, Global Head of R&D, Bayer CropScience

Professor Jon West, Principal Investigator & Senior Scientist, Rothamsted Research

Theo Ahane, CEO, NSure

Julien Smith, Lead, International Partnerships, Fera Science

Amit Vasavada, Ph.D, VP R&D, Marrone Bio Innovations

Professor Janet Bainbridge OBE, Head of Agricultural Technology, UK Trade & Investment

Coast Sullenger, GAIA Capital Advisors

Marc Sadler, Agriculture Global Practice, The World Bank

Matteo Tricacca, Business Development & Product Manager, SenseFly

Professor Jurgen Denecke, Centre for Plant Sciences, Faculty of Biological Sciences, University of Leeds

Dr Maximillian Safarpur, Head of Department, Sr Director of Global Regulatory & Government Affairs, BASF Corporation

Martin Grantley Smith, Sector Strategy Director, AHDB Cereals & Oilseeds

Choose from 4 Congress Tracks

Seed: New developments in plant breeding, biotechnology/gene editing and seed treatments

Crop Production & Protection: The latest in crop protection, biological control, crop nutrition, plant growth regulation, biostimulants and microbial inoculants

AgriFood Chain Management: Partnerships, organic developments, supermarket-led agricultural development, secondary regulation and food safety

Precision Agriculture & ICT: Sensors, Robotics, Data, UAVs, Variable Applications & Monitoring

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Why Attend CropWorld Global in 2016?

What’s new

CropWorld Global brings the exhibition closer than ever.

Official Launch platform for 2017 Agri24Seven Week – the only international B2B festival of agriculture including the first ever Young Agriculture Initiative showcasing the next generation of agricultural leaders.

Launch of the Young Ag Initiative

Hear from over 50 leading speakers from across industry, research and policy

Attend a two day engaging, strategic-level platform in which to showcase solutions to the challenge of the increasing demand for food and how to do so in an environmentally sustainable way.

Get the latest on achieving sustainable intensification, pesticides availability, policy updates, accelerating crop biotech and new research on resistance

Dedicated precision agriculture content

Easily navigable exhibition format and networking space on the show floor

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UK and Dutch showcase pavillions

CropWorld Global 2016 Partners & Exhibitors include:

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Register now at www.cropworld.com



Welcome to the fifth instalment in Agrow’s series of annual biopesticide reviews. An obvious change this time round is in the name of the supplement, which we call the “Biologicals supplement” rather than “Biopesticides supplement”. The reasons are obvious. The boundaries between biopesticides and microbial solutions impacting plant vigour are blurring, with many companies within the crop protection industry offering both kinds of biological solutions. That was the reason for Agrow’s decision to expand the scope of this supplement while also expanding our news coverage to include all biologicals.

Agrow came up with the first review in 2012, when biopesticides were just beginning to be viewed by some multinationals as a possible component of crop protection solutions. That was before the advent of a flurry of acquisitions by the big agrochemical players seeking to give a jump start to their biopesticide programmes.

That period of intense activity began around the middle of 2012 and went on until 2014.

That was followed by a comparatively relaxed phase when companies focused more on licensing deals. Does that mean that the excitement has subsided from the peak witnessed a couple of years ago?

“I believe the excitement is still there,” says Guy Cooper, managing director of Cooper Consulting. “The current slowdown is due to a weaker economic cycle and the need to digest the various technologies and extract the added value.” He believes that there will be continued opportunities for biopesticide innovators who are able to add significant value to the multinational pipelines.

Peter May, managing director of Australian consultancy Xavca, concurs with the view. “Although there may not have been the large M&A’s that we saw in 2012, smaller acquisitions,

By Sanjiv Rana

Biologicals becoming part of integrated crop protection offers

Guy Cooper, Cooper Consulting

Peter May, Xavca


distribution deals and licensing arrangements have continued in the biologicals sector.” He points to Agrow’s list of M&As and deals since last year, which indicates activity by players of varying sizes and geographical locations. “These distribution deals in particular, demonstrate the ‘roll-out’ of a number of bio-products through commercial collaborations, often between mid-sized companies, aimed at expanding the use and market coverage of these products.”

There also seems to have been a change in the approach towards biopesticides. From being used as specialist products for use on specialty crops, they are increasingly being amalgamated into integrated product offerings, often combining a chemical active ingredient and a biopesticide.

For BASF, developing complementary chemical and biological modes of action that can work in combination is a research and commercial priority. The company points out that farmers are looking for additional and alternative solutions to be more competitive, productive and efficient in the global marketplace. “They are not primarily concerned with whether a product is biological or chemical, but rather how it addresses their problems,” says BASF Crop Protection’s vice-president of global business management for Functional Crop Care, Alyson Emanuel. She points to the “particular benefits” of biologicals such as resistance management, additional modes of action, and flexible pre-harvest intervals.

Bayer CropScience concurs. “We at Bayer are convinced that combining chemicals with biological crop protection products helps farmers around the globe to produce high-quality food in a sustainable manner,” says Bayer Biologics’ vice-president of global marketing, Ashish Malik. He says that the company is enhancing its portfolio by new and advanced products based on chemical and biological modes of action and is concentrating on integrated crop solutions. “With integrated crop solutions, farmers will be able to address unmet needs, for example reducing losses, increasing yields, enabling global trade (residue management), resistance management and flexibility in use,” Mr Malik points out.

Monsanto says that agricultural biologicals can be used to complement or replace agricultural chemical products. The company feels that microbial technologies could offer real benefits to growers such as season-long insect control and disease protection that defends plant vigour, in ways that some chemical solutions cannot provide. “The emerging agricultural biological technologies can be a supplement to every farmer’s toolbox and complement the integrated systems approach that is necessary in modern agriculture, combining breeding, biotechnology and agronomic practices to improve and protect crop yields.”

Dow AgroSciences points out that when evaluating the needs of farmers in the future, it is important to look at where there are gaps today. “Certainly combination products are a good way to fill gaps in control as each product brings strengths.” The company feels that in future, farmers will need as many tools as possible to handle tough challenges for their crops, which means that combinations are a good option.

Arysta LifeScience (part of Platform Specialty Products) claims to have been a pioneer in creating offers that combine conventional crop protection with biosolutions, including biopesticides, biostimulants and innovative nutrition, through its ProNutiva focus. “We expect this trend to continue. Specifically in regards to combinations of chemical actives with biopesticides, these can help growers manage residues while maintaining the desired level of protection to their crops,” says Arysta’s vice-president, global portfolio management, Paula Pinto.

“We believe that the best biological products will be those that can survive in the presence of standard chemical inputs and bring a significant yield increase above current agronomic practice,” says

Bioconsortia chief executive officer, Marcus Maedows-Smith. But he feels that it is unrealistic to think that growers will replace their reliable chemistries altogether at this point in time. “Biologicals offer an innovative and effective solution, but to gain that necessary trust from the grower and traditional industry players, we believe it’s essential to show superior efficacy in standard agricultural conditions - with treated seeds and application of fertilisers.”

“I strongly believe the future lies in the combination of biopesticides with chemicals,” says Mr Cooper. He points out that biopesticides add new values such as reduced chemical loads, lower risk of resistance development and enhanced yields. “All this is achieved without increasing the cost of the spray programme, but this is only possible when the two segments are carefully and professionally combined together.”

Mr May has a slightly different view. “In mainstream agriculture, biopesticides will be used together, not as mixtures but used to complement the use of conventional pesticides as part of integrated pest management programmes,” he says. He adds that full acceptance of biopesticides in field crops will rely on their ability to effectively compete with conventional pesticides in terms of efficacy and cost effectiveness. “Intensive managed crops currently might present the best opportunity for biopesticides, but as agronomic practices and pest management in field crops becomes more advanced, with more intensive crop monitoring, improved yields, more effective cultural pest control programmes, then the use of biopesticides will become more viable.”

Company portfoliosBayer acquired US biopesticide company AgraQuest in 2012 and followed that up with German biopesticide company Prophyta the following year. Then came expansions at its US biologicals site in West Sacramento, California and German site at Wismar. In 2014, Bayer acquired Argentine seed treatment business Biagro Group, which had a portfolio of seed-applied inoculants and plant growth-promoting micro-organisms based on bacterial and fungal strains.

Its current portfolio comprises: the nematicides, Votivo (Bacillus firmus + clothianidin) and Flocter (B firmus strain

Paula Pinto, Arysta LifeScience

Ashish Malik, Bayer CropScience

Alyson Emanuel, BASF “the best biological

products will be those that can survive in the presence of standard chemical inputs and bring a significant yield increase above current agronomic practice”

http://www.staphyt.com



I-1582); the biofungicides, Serenade (B subtilis strain QST 713) and Sonata (B pumilus QST 2808); the bioinsecticides, Requiem (extract of Chenopodium ambrosioides), Contans (Coniothyrium minitans) and BioAct (Paecilomyces lilacinus 251); the insecticide-based trap, Decis Trap (deltamethrin + attractants); and the inoculant, Biagro 10 (Rhizobium spp). “In March 2016, we launched Serenade in Australia,” says Mr Malik.

BASF has been giving a lot of indications about its focus on biologicals. Following the acquisition of US specialty products company Becker Underwood in 2012, the company formed its Functional Crop Care division with a focus on biologicals and seed treatments. The company set a target of over €500 million ($565 million at the current rate) by 2020 out of the target of €8,000 million ($9,040 million) for the entire crop protection division. Last year, BASF doubled its capacity at its facility in Littlehampton, UK, increasing production volumes of beneficial nematodes and inoculants. Last month, it put into operation an R&D centre at its crop protection headquarters in Limburgerhof, Germany.

BASF launched the biofungicide, Serifel (B amyloliquefaciens strain MBI600), in the US last year and plans to launch in key countries in South America, Asia, and Europe from 2016. It is registered for use in a range of fruit and vegetable crops in the US, while in additional regions in coming years, Serifel will also cover a wide range of agricultural and specialty crops.

The company points out the positive response to the fungicide, Xanthion, comprising the strobilurin fungicide, pyraclostrobin (trade-marked as F500), and the biofungicide, Integral (B subtilis strain MBI 600). It was launched in the US last year. “It signals market interest in combinations of complementary chemistry- and biology-based solutions,” says Ms Emanuel.

BASF has also launched the biofungicide, TrichoPlus (Trichoderma asperelloides strain JM41 R 5.5%), in South Africa. The US EPA proposed its approval last year. Other biological products in its portfolio include: the bioinsecticide/acaricide, BroadBand (Beauveria bassiana strain PPRI 5339 4.3%), with the global trade name, Velifer; the inoculants, HiStick, HiCoat and Vault; the biofungicide, Integral (B subtilis strain MBI 600); and

beneficial nematodes for insect management under the brand name Nemasys.

BASF claims to be one of the few companies that can provide a seed treatment with a mixture of both biological and chemical compounds. Apart from Xanthion as an example of such complementary products, it highlights the insecticide/fungicide seed treatment, Standak Top (pyraclostrobin + thiophanate-methyl + fipronil), and the biological inoculant, HiCoat HC S30. “These two products work well together and are typically applied all at once by a retailer or seed company into the slurry mix along with a functional coating to cover the seed,” says Ms Emanuel.

Monsanto acquired US agricultural biotechnology company, Agradis, which has a collection of thousands of plant-associated micro-organisms; formed the BioAg Alliance with Danish company Novozymes to develop and commercialise biopesticides worldwide; and supported the establishment of a US company, Preceres, aimed at the development of delivery methods for RNAi-based biopesticides.

In January this year, Monsanto agreed a North American distribution agreement with Sumitomo Chemical’s US-based biologicals subsidiary, Valent BioSciences, for the Streptomyces lydicus strain WYEC 108-based Actinovate biofungicide range. Meanwhile, in April, Sumitomo Chemical started the process of integrating Valent BioSciences with its crop protection business. Sumitomo will form a Biorational Business Unit with responsibility for business target setting and related research, manufacturing and supply chain management.

“The BioAg Alliance has several products that are actively promoted and distributed through Monsanto’s channels, including our newest US soybean extra concentrated inoculants, Optimize XC (Bradyrhizobium japonicum, lipo-chitooligosaccharide) and TagTeam LCO XC (Penicillium bilaii),” the company says. It is also excited about the microbial product, Quickroot

(Trichoderma virens + B amyloliquefaciens), which provides plant health benefits to wheat, maize and soybeans.

Among products in its pipeline, the company highlights an enhanced maize inoculant product that has been advanced to phase four (pre-launch) this year, with an anticipated US launch in 2017. The “advanced formula” will deliver high on-seed stability and convenient upstream microbial application to help enable microbial growth along plant roots improving nutrient access, enhancing root and shoot development and unlocking yield potential.

Syngenta gained access to Pasteuria spp-based bionematicides when it acquired Pasteuria Bioscience. The company has since launched the P nishizawae-based bionematicide, Clariva, in the US and Canada. It estimates peak sales potential for the product at over $200 million. Last year, it agreed a deal with Dutch life sciences firm DSM Food Specialties to develop microbial-based agricultural solutions, including biological controls, biopesticides and biostimulants. In March, Syngenta sold its predatory mites-based biological control subsidiary, Bioline, to the French InVivo co-operative group. But the company did reiterate its commitment to the broader field of biological solutions.

http://www.milagrochem.com


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Dow AgroSciences believes that microbe-based biological products are a logical extension of its “leadership in the natural products market space”. “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”. It points to its R&D collaboration with US genomics company Radiant Genomics and its deal with UK bio-engineering company Synthace for development of fermentation-based production of crop protection products as representing its long-term commitment to natural products.

Arysta LifeScience was an early entrant in the biocontrol sector and consolidated its presence in 2014 by acquiring French sustainable agricultural technology company Goemar. Earlier this year, Arysta 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. “We will continue to explore internal and external opportunities to grow the BioSolutions portfolio, which we define as biocontrol (or biopesticides), in addition to biostimulants and innovative nutrition,” says Ms Pinto.

Arysta’s biocontrol portfolio is comprised of around 30 products. “It includes our IPM range of natural enemies for the Japanese market, Carpovirusine, which is a virus-based insecticide with over 20 registrations globally,” says Ms Pinto. She goes on to list: Beauveria bassiana-based products, such as Ostrinil, launched inside the company’s TechniPalm technology to protect palm trees against red palm weevils (Rhynchophorus ferrugineus);

Biomite, a residue-free acaricide suitable for resistance management; and Vacciplant, a seaweed-based product derived from the Laminaria digitata algae that stimulates the natural defence of plants against a wide variety of pests.

Arysta produces a portion of the portfolio in-house (such as Carpovirusine, Ostrinil and Vacciplant), while sourcing other elements of the portfolio, such as its IPM range in Japan, from key partners.

The company also highlights multiple biopesticide products in the pipeline. It points to the deal with the Chinese Institute of Plant Protection. It intends to bring products for the control of viral and bacterial diseases to market from that deal by 2022. “We also have numerous launches planned for our biostimulants and innovative nutrition portfolio, including the geographic expansion of our seaweed based PhysioActivator portfolio that came with the 2014 acquisition of Goemar,” says Ms Pinto.

Marrone Bio Innovations was appointed Isagro USA’s distributor for Isagro’s biofungicide, Bio-Tam 2.0 (Trichoderma asperellum strain ICC012 + T gamsii strain ICC080), to agricultural crop markets in the US states of California, Oregon, Washington and Arizona. “Isagro

chose MBI because they think a product such as Bio-Tam 2.0, as with most biologicals, needs a technical sales force that understands how to educate, position, and sell a biological versus a chemical,” explains Dr Marrone. Sales forces specialised in biologicals know how to provide this technical education and can focus the time needed for this education, she adds.

The company’s highest-selling products in 2015 were the bioinsecticide, Grandevo (Chromobacterium subtsugae strain PRAA4-1T), and the biofungicide, Regalia (Reynoutria sachalinensis extract). “We expect this to change as Venerate (Burkholderia spp strain A396 94.5%-based bioinsecticide/acaricide/nematicide) and Majestene (Burkholderia rinojensis strain A396-based bionematicide) ramp up,” says chief executive officer Dr Pamela Marrone.

Among products that are near to launch, the company mentions the biofumigant, MBI-601 (Muscador albus strain SA13), for which it expects to have US registration this year. MBI has not set a specific launch date for the anti-transpirant, MBI-505, but expects a small targeted placement with a few customers later this year. The company expects US approval in the second half of next year for the biofungicide, MBI-110, which is based on a new strain of the bacterium, B amyloliquefaciens. It plans to do an initial small targeted placement with a few early adopter customers after it receives EPA registration.

“We expect to grow well by ramping up sales of existing products, launching a few near-term products, and increasing our international business,” says Dr Marrone.

Chinese chemical company Hebang Group acquired a majority 51% stake in Israeli

Dr Pamela Marrone, Marrone Bio Innovations

“most biologicals needs a technical sales force that understands how to educate, position, and sell a biological versus a chemical”

http://www.yngf.com



Winning Science.Winning Solutions.Biological Crop Protection from BASF.

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biopesticide company Stockton for $90 million last year. “The investment has naturally brought us into the next phase in the company’s journey with significant resources to accelerate our plans,” says Stockton’s chief executive officer, Guy Elitzur. That would help in research and development activities and the ability to accelerate different projects in the company’s pipeline. The investment would also provide it increased ability to penetrate into new countries such as the US and China. “Obviously, having a strong Chinese shareholder will assist in a successful penetration in China for the biological segment,” Mr Elitzur points out.

The company also intends to allocate some of the funds to M&A opportunities. “We will aim at various levels of collaboration, from full M&A (purchasing a product), to distribution agreements, focusing on biocontrol registered products which comply with sustainable agriculture, mainly in the US, EU and Brazil.”

Stockton has agreed many licensing deals during the last couple of years for its Melaleuca

alternifolia extract-based biofungicide, Timorex Gold. The company has chosen its partners “carefully” around the world. “Thus, in some countries we have chosen to license-in for Timorex Gold, while in other regions we employ other methods to go to market.”

US company BioConsortia was established in 2013 with the former chief executive officer of AgraQuest and Bayer Biologics Marcus Meadows-Smith as CEO. “While no specific product is at a market-ready stage, multiple consortia are in their second year of large-scale field testing and are being trialled by partners as well,” he says. The seed treatment and in-furrow products in field trials are for drought tolerance, cold tolerance, fertilizer use efficiency and yield increase, he adds.

Brazilian company Ihara started to invest in biological products in 2009 and at the end of 2014, it created a separate Bio division. The company has four biopesticides in its portfolio, comprising three bioinsecticides and one biofungicide. By the end of this year, it will launch Eco-shot (Bacillus

amyloliquefaciens strain D747) for use on fruits and vegetables.

The company feels that the approvals are obtained faster for biopesticides. “It happens because the authorities are using a specific team to evaluate biopesticides with a different waiting list for such ais,” says Ihara’s crops and biologics manager, Evandro Macente Sasano. The process itself is not different, but once the dossier is submitted, it is evaluated faster than conventional chemicals.

Regional regulatory systemsAgrow sought views on the approval process for biopesticides from the industry associations in the EU, US and Brazil

EU: Comments were sought from David Cary, executive director, International Biocontrol Manufacturers Association, who provided the following answers:

Guy Elitzur, Stockton

Marcus Meadows-Smith, BioConsotria

David Cary, IBMA

Evandro Macente Sasano; Ihara

http://www.agro.basf.com


How different is the approval process of a biopesticide compared with a chemical ai?There is, in fact, no mechanism within the EU regulatory process to differentiate between biopesticides and chemical pesticides unlike in the US where a separate stream with distinct evaluators and timelines is in place. There is, however, provision under the EU legislation to facilitate differentiated pathways for low-risk active substances and products. Most of these low-risk active substances and products will be biopesticides.

However, the criteria are being revised and the procedures need repair as currently status can only be granted after the full process of approval has occurred. The low-risk biopesticide would currently be evaluated in the same timeframe as any chemical active substance despite EU regulation calling to favour them. The Netherlands under its EU Presidency has identified this anomaly and is proposing that procedures are amended to facilitate more biopesticides to enter the market quickly.

How many biopesticides are approved in the EU?There are five low-risk active substances only listed through the EU system. There would be just over 120 biopesticide active substances and this is about half of those that have been through the US EPA process.

What are the IBMA’s recommendations for the EU registration process for biopesticides?IBMA would ideally welcome a totally separate set of legislation for biological inputs into the environment to enhance agricultural production. This regulation would be proportionate to the risk that these substances pose to human health and the environment and evaluations undertaken by experts with knowledge and experience of these biological inputs rather than with chemical expertise. This, however, is a long-term goal and things need to be done now rather than waiting several years for any outcomes of a full review to be brought into legislation.

In the meantime, we urgently need some repairs to the legislation and these can be simply done. We would strongly advise bringing back the provisional approvals and authorisations for low-risk substances and plant protection products to allow products to be brought onto the market when the evaluator is sure that the data exists through conducting a low-risk completeness

check. We also see no reason to re-evaluate substances and products classified as low-risk and would therefore support an unlimited approval and authorisation. So, IBMA has a two-phase approach to optimal regulation of biopesticides.

US: Comments were sought from Keith Jones, executive director, Biopesticide Industry Alliance, who provided the following answers:

How different is the approval process of a biopesticide compared with a chemical ai?New biopesticide ais can be reviewed and a decision made in just over a year, while new conventional pesticide registrations are reviewed and a decision made in about two years. The fundamental process of making an application to the EPA Office of Pesticide Programs’ (OPP) Biopesticide and Pollution and Prevention Division (BPPD) is the same as for a conventional chemistry, However, there are usually less data or fewer studies needed to support a biopesticide application than required for a conventional pesticide.

The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) requires that the data and risk assessments address the same primary toxicity concerns as conventional pesticides but a reduced data set is justified by the preliminary requirements that the biopesticide must either be microbial or a biochemical with a non-toxic mode of action and a history of safe use. For instance, caffeine would not be accepted as a biopesticide with a reduced data set because it has a toxic mode of action. It would have to be reviewed as a conventional product. The process can get complicated depending on the product and the results of the data. If there are issues in the data or because of a lack of data, it may trigger the requirement for more studies or may not be able to pass the risk assessment. In that case, EPA may not be able to make a safety finding for a biopesticide registration.

How many biopesticides are approved in the US? According to the EPA website, as of April 2016, there are 299 registered biopesticide ais and 1,401 active biopesticide product registrations. The number of registrations of chemical ais is fluid as new pesticides are registered and some are cancelled. However,

through various reports it is estimated that there are somewhere between 600 and 900 registered ais.

What are the BPIA’s recommendations for the registration process for biopesticides?BPIA’s recommendations are that the EPA continues to facilitate biopesticide registrations and use science-based decisions that are commensurate with the risks. The OPP already has three divisions responsible for regulatory activities: Antimicrobial Division (disinfectants and sanitizers); Registration Division (conventional pesticides); and BPPD (biologically-based pesticides). The Agency is unique in the world in that it has developed a regulatory group that specialises in biopesticides. The independent unit was created in 1996 to facilitate the registration of low-risk biopesticides. BPPD also has reduced timelines and fees compared to conventional pesticides.

Brazil: Comments were sought from Amalia Piazentim Borsari, exec-utive consultant of the Brazilian association of biological control companies, the ABCBio, who provided the following answers:

How different is the approval process of a biopesticide compared with a chemical ai?Biopesticides fall under the same legislation as conventional pesticides. Due to the intrinsic characteristics of biopesticides, the number of toxicology tests demanded is generally lower than with conventional agrochemicals. That leads to a lowering of time and costs. Besides, biopesticides enjoy priority of analysis through law. Another major difference is that biopesticides in Brazil are registered by biological targets and not by crop, as is the latter case with conventional agrochemicals.

How many biopesticides are approved in Brazil?The number of biopesticide products and the comparative with conventional products has been steadily increasing over the years as is evident in the table below:

BiologicalsWhile the focus during the earlier supplements was solely on microbial biopesticides, the sector has evolved and expanded, making it difficult to subsume the entire industry based on products derived

Keith Jones, BPIA

Amalia Piazentim Borsari, ABCBio


from microbial or natural sources within the term, biopesticides. The term, biologicals, is increasingly being used to define the sector comprising microbials and biostimulants.

The US EPA has always had an expansive view of biopesticides, which it defines as “certain types of pesticides derived from such natural materials as animals, plants, bacteria, and certain minerals”. The definition includes substances such as canola oil and baking soda that have pesticidal applications and are considered biopesticides. The EPA classes biopesticides into three types: biochemical pesticides, microbial biopesticides and plant-incorporated protectants. The Agency makes no mention of biostimulants, which in the US as well as in the EU are clubbed together with fertilisers.

BiostimulantsBiostimulants occupy a somewhat confusing domain as the industry and regulators try to make up their minds about whether they lie closer to fertilisers or to crop protection. Industry associations insist that they lie within neither and occupy a distinct space. But for regulatory purposes, they have been aligned with fertilisers.

The European Biostimulant Industry Council (EBIC) points out that biostimulants operate through different mechanisms than fertilisers, regardless of the presence of nutrients in the products. Biostimulants also differ from crop protection products because they act only on the plant’s vigour and do not have any direct actions against pests or disease. Crop biostimulation is thus complementary to crop nutrition and crop protection, the EBIC says.

The EBIC has proposed the definition of biostimulants as: “A material that contains substance(s) and/or micro-organisms whose function, when applied to plants or the rhizosphere, is to stimulate natural processes to benefit nutrient uptake, nutrient efficiency, tolerance to abiotic stress, and/or crop quality, independent of its nutrient content.”

In March, the European Commission published a proposal for a fertilising products regulation and amending EU agrochemical Regulation 1107/2009 and Regulation 1069/2009 relating to animal by-products and derived products not intended for human consumption. Under the proposal, plant biostimulants would be eligible for European conformity CE (Conformité Européene) marking for free movement and marketability within the EU. Although the EBIC has reservations about the scope of the new regulation, it hailed the regulation as a key step towards the development of a truly European market for biostimulants.

The definition of the US-based Biostimulant Coalition, while similar to EBIC’s on several key points, differs slightly from the proposed EU definition: “A biostimulant is a material that, when applied to a plant, seed, soil or growing media - in conjunction with established fertilisation plans, enhances the plant’s nutrient use efficiency, or provides other

SCC Scientific Consulting Company Chemisch-Wissenschaftliche Beratung GmbH Am Grenzgraben 11 55545 Bad Kreuznach [email protected] www.scc-gmbh.de

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Product approvals in BrazilYear 2009 2010 2011 2012 2013 2014 2015 20161

Biopesticides 1 4 13 16 10 30 29 9

Conventional 101 60 69 87 56 59 65 19

1 until April 2016.

CONTINUED ON PAGE 41

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As Regulatory Scientist for China you will work closely with their established team in Ireland and assist with the localisation of the companies regulatory approval strategies for the Chinese market and optimise the process to ensure product approvals are achieved to meet commercial targets. The Regulatory Scientist role will also involve network building and relationship management with regulatory, official authorities and specialist consultancies and you will also project manage local phases of the product approval process.

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SCC Scientific Consulting Company Chemisch-Wissenschaftliche Beratung GmbH Am Grenzgraben 11 55545 Bad Kreuznach [email protected] www.scc-gmbh.de

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direct or indirect benefits to plant development or stress response.” As examples, the Coalition points to biological or naturally derived additives and/or similar products, including but not limited to bacterial or microbial inoculants, biochemical materials, amino acids, humic acids, fulvic acid, seaweed extract and other similar materials.

In the US, fertilisers are not registered at the federal level. Instead, each state has its own fertiliser regulatory programme. Thus, there are a number of different – and often conflicting – standards for managing fertilisers, plant or soil amendments and/or biostimulants, says the Biostimulant Coalition. The fact that there is no single, existing framework for how to register or label these products makes it difficult for many companies to register them in a number of US states, it adds.

The Coalition has come to an agreement about definitions with the Association of American Plant Food Control Officials (AAPFCO), an organisation of fertiliser control officials from each US state. The AAPFCO defines “beneficial substance” as any substance or compound other than primary, secondary, and micro plant nutrients that can be demonstrated by scientific research to be beneficial to one or more species of plants, when applied exogenously. It has agreed with the Coalition to develop a process by which subcategory definitions under the Coalition’s concept of “biostimulants”

would be able to apply for their own respective definitions. For example, a specific fulvic acid definition could be developed that would be defined and placed under the Beneficial Substances category. Each subcategory material will have to go through a similar process.

2015 market and outlookThe global chemical-based crop protection market in 2015 fell by 9.6% to $51,210 million at the distributor level, according to figures from Agrow parent company Informa’s seed and agrochemical consultancy, Phillips McDougall. The situation is not as clear cut for biopesticides because of a variety of estimates for market size and differing definitions of biopesticides.

Monsanto believes that the biologicals market continued to see annual growth globally, benefiting from product enhancements as well as a growing demand for additional sustainable solutions. BioConsortia concurs with the estimate, pointing out that many farmers were adding biologicals to their tool kit for the first time and experienced users were continuing to expand their usage.

Other companies point to a slight dip but not as drastic as for agrochemicals. “I believe that overall biologicals suffered a lower impact. On the one hand they were less exposed to soft commodity pricing but on the other hand were impacted by the negative economic situation as well as dry weather conditions,” says Mr Cooper. Dr Marrone points out that the adoption of biologicals in large acreage crops such as soybeans and maize slowed down in the US and Brazil, but in high- value specialty crops they continued to grow. “The high plantings of nut crops in California (thus reducing nut prices) and

the reduction in citrus production in Florida are having an effect on all inputs,” she adds.

Talking about Brazil’s market, Ihara says that it suffered a drastic decrease in insecticide sales. That happened after two seasons with very high pressure of bollworms (Helicoverpa armigera), which decreased “a lot” during the last season. There was a lot of inventory build-up for chemical as well as biological products. Despite that, in specialty markets such as fruit and vegetables, pre-harvest sprays increased in many crops for biologicals. There was an increase in the use of bionematicides as well. “So, although the biopesticides market decreased last season. However some specific markets for biologicals, which are still small compared with Bt, increased, says Mr Sasano.

Estimates vary about the size of the biologicals markets in 2015 although the consensus figure was around $3 billion. Out of that, microbial biopesticides accounted for some $2 billion while biostimulants made up the rest. The market is expected to grow by over 10% annually in the coming years. “We expect that biologicals’ integration into tank mix and chemical spraying programmes will only keep increasing,” says Stockton.

Mr Smith believes that there is a much bigger market for the next generation of microbials that will demonstrate significant benefits across a wide range of traits in the $40 billion traits and seeds business. He also point to an even larger market for products that drive nutrient use efficiency in the $170 billion fertiliser market.

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CONTINUED FROM PAGE 38

“A biostimulant is a material that contains substance(s) and/or micro-organisms whose function, when applied to plants or the rhizosphere, is to stimulate natural processes to benefit nutrient uptake, nutrient efficiency, tolerance to abiotic stress, and/or crop quality, independent of its nutrient content”

http://www.stockton-ag.com


Do biopesticides exist in EU legislation? The regulatory approach in Europe, according to EU plant protection Regulation 1107/2009, does not recognise “biopesticides” as a regulatory category of plant protection active ingredients. In the lack of an unequivocal regulatory definition of biopesticides, many countries around the world use this term. In many cases, they have to decide on a case-to-case basis if an ai falls under this category, for instance, if an ai is not a natural biochemical but only biochemical-like. To avoid any confusion or discrimination of ais with similar favourable characteristics ascribed to “biopesticides”, a risk based approach was chosen in the EU under which, irrespective of the origin of an ai, categories of basic substances and low risk substances were introduced. Nevertheless the term “biospeticide” is widely used also in the EU by all participants in the regulatory system.

What about special characteristics of the different biopesticide categories such as microorganisms or plant extracts?The characteristics of specific substances such as plant extracts or microorganisms and

differences between them regarding data requirements and points to be addressed in a registration dossier are considered by respective guidance documents.

How different is the approval process of a biopesticide compared with a chemical ai? In general the approval process is identical for biopesticides and chemicals, at least regarding the ai approval, with the exemption of basic substances for which the approval process and the requirements differ hugely compared with low risk or conventional ais. Differences exist between conventional and low risk plant protection products after the low risk status of an ai is confirmed by an approval. Authorisation of low risk plant protection products for example only takes 120 days compared with the 12 months process for conventional ais. Furtehrmore, very often the authorisation fees are less for low risk ais and respective products.

What is so special about basic substances?Basic substances are substances with a low toxicity profile such as foodstuffs, that are not already placed on the market as plant protection product or are not

By Lars Huber, Senior Manager Regulatory AffairsHead of Biostimulants, Fertiliser, IPMSCC Scientific Consulting Company GmbH

Lars Huber, Senior Manager Regulatory Affairs, Head of Biostimulants, Fertiliser, IPM

Biopesticides and the EU regulatory process


predominantly used for plant protection purposes but, nevertheless, could be useful in plant protection. Application for approval is made by a member state or by any interested party. The evaluation is mainly based on already existing evaluations for a substance carried out in accordance with other EU legislation regarding possible effects on human or animal health or the environment. Should studies be necessary, no data protection is granted.

And what about low risk substances?Low risk substances have to fulfil certain criteria such as being not carcinogenic, mutagenic or toxic to reproduction. The criteria are listed in Annex II of Regulation 1107/2009, but are currently under review and will be adapted to the technical and scientific progress, for example, regarding sensitisation potential of micro-organisms.

As already mentioned, the general approval process is similar to conventional chemical ais, but a more scientific approach can be used including the use of literature data to demonstrate the natural occurrence or the natural background levels for the use in risk assessments and scientific justifications in place of formal studies.

Is it simpler? How are the requirements for making an application for a biopesticide different from that of a chemical ai? Due to the huge variety of substances falling under the category biopesticides such as plant extracts, micro-organisms, pheromones etc, this question is not easy to answer. This is a problem each country in which the “biostimulant approach” is used encounters. In the US for example there is a special committee which decides on a case-to-case basis, if a substance is eligible as a “biostimulant”. This is why the EU approach is

easier to handle, because it deals with the actual risk of a substance not with artificial categories. Being a biological substance is not automatically the same as being harmless. The same applies vice versa for chemicals.

Special “biological features” are accounted for by the respective guidance documents as far as they are already available. For example, plant extracts very often consist of a variety of components which cannot be characterised in a way a synthetically produced chemical ai can be. In such cases, the main constituents can be identified and used for scientific argumentation in a registration dossier.

I already referred to the huge variety of substances and the differences between them if they are of natural origin. There are still guidance and guidelines missing but a sound scientific approach is to be recommended and the way forward to a successful registration.

Is the time frame for the approval of a new biopesticide ai shorter compared with a chemical ai?Regrettably not, and this is one of the reasons, why many companies still refrain from a registration. One of the main

improvements, and a huge incentive for industry, would be a shorter time frame or prioritisation schemes for the approval of low risk ais. This, as well as lower registration fees which are already reduced in many member states, but not yet everywhere.

How many biopesticides are currently approved in the EU?Difficult to tell as there is no “biopesticide stream” as in other countries. The low risk and basic substance concept was only introduced with Regulation 1107/2009 some years ago, but we expect the number of low risk ais will increase in future, not only due to new substances to be approved, but also due to substances evaluated as low risk in context of the currently on-going or outstanding renewal process for many substances. Potential candidates are many substances included in the fourth list for first Annex I inclusion according to Directive 91/414/EEC.

Currently, eleven basic substances and five low risk substances are approved. The fourth list for first Annex I inclusion according to Directive 91/414/EEC contains about 90 ais and a lot of them possibly qualify as low risk ais. Therefore, an increase in the number of low risk ais could be expected in the next years. It remains to be seen if the number of new approvals will increase in future. That will mainly depend on whether the regulatory and scientific requirements are adapted in a way to attract industry to apply for approval of new low risk ais, that is, “biopesticides”.

What are SCC’s recommendations for the EU registration process for biopesticides?SCC’s recommendation is very clear. In any case, use a sound scientific approach incorporating studies, if necessary, as well as scientific peer reviewed literature and start

http://www.lierchem.com



communication with the possible rapporteur member state as early as possible. At best, discussions should already start during R&D of an ai. In addition, consideration of regulatory requirements for ais as well as products is often made too late. In our experience, many companies invest a lot of time and money in studies, especially regarding the efficacy of their ais and the respective products, without having sufficient regard for guidelines and regulatory needs. This is unfortunate, since very often small changes and amendments in a study design and the study programme would be sufficient to cover the scientific and regulatory requirements and make a study eligible and valid for the use in a registration dossier. That can save a lot of time and money.

Do you recommend a separate regulation for biopesticide registration or amendments to certain aspects of EU Regulation 1107/2009?In our opinion, a separate regulation for biopesticides is neither required nor would it be productive. To the contrary, we would have favoured, if plant biostimulants would

also have been included in the plant protection regulation – by applying adequate registration requirements of course – and not in the fertiliser regulatory framework. With the inclusion of biostimulants in the fertiliser regulation many substances and products most likely will not be deployable to their full beneficial potential.

The problem we currently encounter with biopesticides is not the joint regulation, but mostly the harmonisation of the implementation of Regulation 1107/2009. Certain amendments, of course, would be beneficial, as well as absolutely necessary, if the sustainable use of plant protection products is to be fostered further and European agriculture is to be advanced.

Some improvements are already under way, such as the modification and adaption of low risk criteria by separate guidance for example, others are not.

As already mentioned, the time frame for approval of a low risk ai is currently similar to that of the approval of a conventional ai. That should be remedied. Also, a

two-step approval process would be helpful to give companies a solid basis that the active they want to register is really a low risk substance. In step one, which should be as short as possible, the low risk criteria could be assessed. In a second step, the full evaluation should be conducted as needed to fulfil the complete regulatory requirements in order to safeguard the special safety requirements characterising such low risk substances. By using a scientific approach, as described above, this can be already done today, but there is no certainty that such a concept will be approved by all member states in the end - an insufficient basis for business decisions especially for small companies.

In other areas, more clarification is required, for example, regarding the differentiation of basic substances and active substances. This also applies for certain data requirements stipulated in various guidelines which are not binding and can be interpreted differently by the parties involved in the approval/authorisation process.



http://www.baochenagro.com

46 www.agra-net.comService Company Guide 2016 | Agrow 14 www.agra-net.com/ Biopesticide (SE Asia) | Agrow

The biopesticide industry is a $1.6 billion industry. The industry is projected to grow at a compound annual growth rate of 16% through 2019. This industry’s growth is fueled by two major factors including consumers’ demands for safer pest control products that can be used in both conventional and organic agricultural programs. The second major impetus to growth comes from innovation and technology, adding science-based jobs and contributing to the economy while at the same time providing growers, pest control applicators and public health officials with effective and safe pest control options.

Biopesticides are low risk pesticides that are naturally derived from or synthetic equivalents of plants, bacteria, fungi, and minerals, generally posing little risk to humans or the environment. Growers use biopesticides to control plant disease, insects, weeds and other pests. Biopesticides can be used to protect our food supply in food processing establishments as well as protect the public from pest-borne illness and disease by controlling or repelling rats, fleas, ticks and mosquitoes. The members of this industry segment, from small start-up to large established companies, have active research and development programs to address a broad array of pest problems on the farm as well as emerging threats such as Zika virus.

Generally, biopesticides are not persistent and pose little risk to people, birds, fish, bees and other wildlife. They help to maintain beneficial insect populations, break down quickly in the environment, and provide low risk alternative tools for conventional growers in integrated pest management programs.

Benefits of BiopesticidesGrowers, pest control applicators and public health professionals are increasingly turning to biopesticides because they provide the following significant benefits:

n Biopesticides are versatile and functional in both organic and conventional production systems.

n Biopesticides allow organic growers to control pests while maintaining USDA National Organic Program (NOP) certified status.

n Biopesticides fit with integrated pest management systems and contribute to environmentally responsible production systems – while not compromising crop yield and quality.

n Biopesticides may offer greater flexibility when harvesting crops because of short pre-harvest and restricted entry intervals or waiting periods before individuals can enter a treated area.

n Biopesticides are important public health protection tools. They are used in food processing establishments to protect our food supply and in mosquito and tick control programs to protect the public from diseases like West Nile virus, Lyme disease and other pest-borne illness.

n Because naturally derived biopesticides often control pests through multiple modes of actions they can be less prone to pest resistance.

Biopesticide RegulationThe United States has one of the world’s most robust programs to review and register biopesticides and is unique in that specific expertise has been developed within a single division of the Environmental Protection Agency (EPA). The EPA’s Office of Pesticide Programs houses the Biopesticide and Pollution Prevention Division (BPPD), which conducts vigorous reviews of biopesticide products before they can be registered and brought to market. The Federal Insecticide Fungicide and Rodenticide Act (FIFRA) and Pesticide Registration and Improvement Act (PRIA) ensure that the highest safety standards are met while including specific incentives to encourage the adoption of these beneficial pest control products through tiered data requirements, significantly reduced registration fees and shorter timelines compared to conventional pesticides.

There are some instances where regulation could unnecessarily limit growers’ ability to use biopesticides. Three such examples are 1) EPA’s proposal to Mitigate Exposure to Bees from Acutely Toxic Pesticides, 2) when science-based risk decisions for exemptions from tolerance are trumped by legal interpretations and policy considerations that do not give priority to lower risk pesticides and 3) the U.S. Department of Agriculture National Organic Program (USDA-NOP) work with EPA to address inert ingredients allowed in pesticides approved for organic production without industry’s input on the effect of their decisions.

EPA Proposal to Mitigate Exposure to Bees from Acutely Toxic Pesticide ProductsIn some cases, “catch-all” pesticide policies, which do not distinguish between types of pesticide products, fail to recognize the significant benefits associated with biopesticides and actually create obstacles to product registration. EPA’s proposal to Mitigation Exposure to Bees from Acutely Toxic Pesticides is one such example.

In May 2015, EPA proposed mitigation measures for pesticides that are considered acutely toxic to bees. The biopesticide industry is concerned that EPA’s proposed approach to pollinator mitigation departs from FIFRA’s risk-based standard and simply applies a hazard-based bright line number standard which leaves little or no room for varying interpretation. The proposed hazard classification is an indiscriminate trigger that could result in unnecessary restrictions on the use of biopesticides. This approach would deprive conventional growers from using some biochemicals in an integrated pest management program and severely diminish the already limited number of tools organic growers can use to control pests.

Overview of the Biopesticide Industry

ADvERtoRIAL

Agrow_Biopesticide.indd 14 19/05/2016 17:24

Agrow | Service Company Guide 2016 47www.agra-net.com14 www.agra-net.com/ Biopesticide (SE Asia) | Agrow

The biopesticide industry is a $1.6 billion industry. The industry is projected to grow at a compound annual growth rate of 16% through 2019. This industry’s growth is fueled by two major factors including consumers’ demands for safer pest control products that can be used in both conventional and organic agricultural programs. The second major impetus to growth comes from innovation and technology, adding science-based jobs and contributing to the economy while at the same time providing growers, pest control applicators and public health officials with effective and safe pest control options.

Biopesticides are low risk pesticides that are naturally derived from or synthetic equivalents of plants, bacteria, fungi, and minerals, generally posing little risk to humans or the environment. Growers use biopesticides to control plant disease, insects, weeds and other pests. Biopesticides can be used to protect our food supply in food processing establishments as well as protect the public from pest-borne illness and disease by controlling or repelling rats, fleas, ticks and mosquitoes. The members of this industry segment, from small start-up to large established companies, have active research and development programs to address a broad array of pest problems on the farm as well as emerging threats such as Zika virus.

Generally, biopesticides are not persistent and pose little risk to people, birds, fish, bees and other wildlife. They help to maintain beneficial insect populations, break down quickly in the environment, and provide low risk alternative tools for conventional growers in integrated pest management programs.

Benefits of BiopesticidesGrowers, pest control applicators and public health professionals are increasingly turning to biopesticides because they provide the following significant benefits:

n Biopesticides are versatile and functional in both organic and conventional production systems.

n Biopesticides allow organic growers to control pests while maintaining USDA National Organic Program (NOP) certified status.

n Biopesticides fit with integrated pest management systems and contribute to environmentally responsible production systems – while not compromising crop yield and quality.

n Biopesticides may offer greater flexibility when harvesting crops because of short pre-harvest and restricted entry intervals or waiting periods before individuals can enter a treated area.

n Biopesticides are important public health protection tools. They are used in food processing establishments to protect our food supply and in mosquito and tick control programs to protect the public from diseases like West Nile virus, Lyme disease and other pest-borne illness.

n Because naturally derived biopesticides often control pests through multiple modes of actions they can be less prone to pest resistance.

Biopesticide RegulationThe United States has one of the world’s most robust programs to review and register biopesticides and is unique in that specific expertise has been developed within a single division of the Environmental Protection Agency (EPA). The EPA’s Office of Pesticide Programs houses the Biopesticide and Pollution Prevention Division (BPPD), which conducts vigorous reviews of biopesticide products before they can be registered and brought to market. The Federal Insecticide Fungicide and Rodenticide Act (FIFRA) and Pesticide Registration and Improvement Act (PRIA) ensure that the highest safety standards are met while including specific incentives to encourage the adoption of these beneficial pest control products through tiered data requirements, significantly reduced registration fees and shorter timelines compared to conventional pesticides.

There are some instances where regulation could unnecessarily limit growers’ ability to use biopesticides. Three such examples are 1) EPA’s proposal to Mitigate Exposure to Bees from Acutely Toxic Pesticides, 2) when science-based risk decisions for exemptions from tolerance are trumped by legal interpretations and policy considerations that do not give priority to lower risk pesticides and 3) the U.S. Department of Agriculture National Organic Program (USDA-NOP) work with EPA to address inert ingredients allowed in pesticides approved for organic production without industry’s input on the effect of their decisions.

EPA Proposal to Mitigate Exposure to Bees from Acutely Toxic Pesticide ProductsIn some cases, “catch-all” pesticide policies, which do not distinguish between types of pesticide products, fail to recognize the significant benefits associated with biopesticides and actually create obstacles to product registration. EPA’s proposal to Mitigation Exposure to Bees from Acutely Toxic Pesticides is one such example.

In May 2015, EPA proposed mitigation measures for pesticides that are considered acutely toxic to bees. The biopesticide industry is concerned that EPA’s proposed approach to pollinator mitigation departs from FIFRA’s risk-based standard and simply applies a hazard-based bright line number standard which leaves little or no room for varying interpretation. The proposed hazard classification is an indiscriminate trigger that could result in unnecessary restrictions on the use of biopesticides. This approach would deprive conventional growers from using some biochemicals in an integrated pest management program and severely diminish the already limited number of tools organic growers can use to control pests.

Overview of the Biopesticide Industry

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Science-Based Risk AssessmentsBiopesticides are usually exempt from tolerances because of their negligible risk based on general lack of adverse health effects and low dietary exposure. An exemption from tolerance allows the biopesticide to be broadly labeled and used on any crop without the need for costly residue testing. However, over the past few years EPA has asserted that exemptions from tolerance for biopesticides cannot incorporate limitations from the label such as preharvest intervals and application rates to minimize exposure because FDA cannot enforce that label. Enforcement of the pesticide label has always been the responsibility of EPA and its state partners. EPA’s new legal interpretation is unnecessarily restrictive. Moreover, it is at odds with EPA’s past practice with biopesticides, its current practice with other pesticide product ingredients, and with the manner in which FDA has implemented the food safety provisions of the Federal Food, Drug, and Cosmetic Act for decades.

The label is the law and a fundamental compliance tool for all pesticide products. EPA and FDA can - and have in the past - worked together to ensure enforcement of tolerances and the biopesticide industry sees no reason that a label cannot be used effectively with tolerance exempt biopesticides when necessary. Moreover, EPA’s narrow legal interpretation without the context of science drives unnecessary cost and time to a biopesticide registration. Since most biopesticides are targeted to minor crops such as vegetables and fruit, the expected revenues are considerably smaller. Unnecessary regulatory hurdles for low risk pesticides stifl e the innovation the biopesticide industry seeks to foster.

The biopesticide industry is keenly supportive of stringent safety standards to protect consumers as well as our industry and reputation. The biopesticide industry has raised the issue of “exemptions with label imitations” to EPA and provided recommendations. The biopesticide industry understands that this matter as well as other concerns relating to biopesticide risk assessment are under active discussion at EPA with the goal of developing Offi ce of Pesticide Program-wide guidance so that substances such as biopesticides, antimicrobials and inert ingredients are assessed in a consistent manner.

Inert Ingredients Allowed by the National Organic ProgramInert ingredients are an integral part of effective biopesticide formulations, which require years of research to provide stability, crop safety and effi cacy. Inerts are reviewed to stringent safety criteria by the EPA. In order for biopesticides to be used in organic production, the pesticide active ingredient and any inert ingredients in the formulation must be approved by the USDA National Organic Program (NOP). Because biopesticide active ingredients are often fragile, naturally derived ingredients, the inerts in the formulation are a vital part of making the product stable and effi cacious. If certain inert ingredients are no longer allowed in organic production, growers could be left without critical tools to produce NOP compliant organic crops.

The National Organic Program regulations, 7 CFR Part 205, allow for the use of synthetic inert ingredients in pesticide formulas which appear on the EPA’s List 4 –Inerts of Minimal Concern. Because EPA no longer maintains this list, the NOP is also looking at future criteria for the review of inert ingredients. Although under consideration, the NOSB does not yet have a

draft process nor has it approved a new inert in 12 years making it diffi cult for industry to innovate new products with the desirable characteristics of biopesticides.

Unfortunately, the biopesticide industry is not adequately represented in discussions on appropriate new criteria even though we are the only industry that can provide important technical guidance about the current inert ingredients used in organic pesticides and the feasibility of formulation changes. The USDA NOP and its National Organic Standards Board (NOSB), established under the Federal Advisory Committee Act (FACA), works with EPA on policy and procedures to assist the development and adoption of an alternative inert evaluation that adheres to the National Organic Program philosophy. The biopesticide industry would like to be a part of that discussion, since it will have a major effect on our business, and FACA’s requirements support our participation in that effort.

ConclusionThe rapidly growing biopesticide industry is adding jobs and contributing to the economy while also providing organic and conventional growers, pest control applicators and public health offi cials with effective pest control tools that are safe for the environment and help reduce pesticide resistance. In order for the industry to continue to provide the world with these pest control solutions, it is essential that regulations recognize the signifi cant benefi ts associated with these products.

the BPIA (Biopesticide Industry Alliance), in association with tSGE Forum brings you two events in one location – the BPIA 2016 Fall Meeting and the BPIA Registration Workshop.the two day BPIA 2016 Fall Meeting (September 15-16) will cover the current and most important issues facing biopesticide manufacturers and service providers. there will also be opportunities to network with colleagues including leaders of the biopesticides industry.Prior to the BPIA 2016 Fall Meeting, the BPIA Registration Workshop (September 13-14) will provide an additional opportunity to gain a further understanding of the requirements involved in registering a biological pesticide in the United States and will include seasoned regulatory professionals and Environmental Protection Agency, Biopesticide division staff. to register, express your interest or to discuss sponsorship opportunities for the BPIA 2016 Fall Meeting or the 2016 BPIA Registration Workshop contact us by phone: +44 (0) 1423 863 522 or visit www.bpiaconference.com



Service Company Guide

Consultancies & other advisor bodies APC 2

ARCHE Consulting 2

CSI (Compliance Services International) 3

Dextra International 3

DHD-Consulting GmbH 4

EBRC Consulting GmbH 4

Exponent International 5

GAB Consulting GmbH 5

JSC International Limited 5

LKC Switzerland Ltd 6

Phillips McDougall 6

Redebel Regulatory Affairs SCRL 6

SCC – Scientific Consulting Company 7

TSGE Consulting 7

Market Research

Kynetec 8

Dextra International 8

Phillips McDougall 8

Contract Research OrganisationsAgrolab 9

ANADIAG 9

BioChem agrar GmbH 9

Biotecnologie BT SRL 10

AGROBLU BUL OOD 10

CEM Analytical Services Limited 10

CropTrials GmbH 11

EAG Labs 11

Entomologia Applicata 11

Eurofins SCEC 12

Eurofins Phyliae 12

Eurofins DeBredelaar 12

Eurofins Trialcamp 12

EPL Bio Analytical Services 14

Field Research Support 14

AGROBLU HELLAS Ltd. 14

Innovative Environmental Services 15

James Hutton Limited 15

AGROBLU SRL 16

Mambo-Tox Ltd 16

Oxford Agricultural Trials 16

Peracto 17

Promovert 17

REDEBEL SA 18

AGROBLU ROMANIA Srl. 18

SGS Group 18

Smithers Viscient 19

Staphyt 20

Syntech Research 20

Vigna Brasil 21

Custom ManufacturersAgri Life 22

Industrias Químicas del Vallés 22

Formulations companies & additives suppliersCroda Europe Ltd 23

Eastman Taminco BVPA 23

Exwold Technology Ltd 23

SBM-Formulation 24

Biopesticides

Staphyt 24

LKC Switzerland Ltd 25

Stockton (Israel) Ltd. 25

TSGE Consulting 25

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