2024 CROs & CRAOs Manual - Published by AgroPages

COVER STORY
2024 FORMULATION & ADJUVANT TECHNOLOGY / 01

COVER STORY
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your crop protection products.
Battelle provides high-quality, innovative, and sustainable solutions that streamline

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+44 1245 450777

+1 800.201.2011
solutions@battelle.org
www.battelle.org
02 / 2024 FORMULATION & ADJUVANT TECHNOLOGY
CROs & CRAOs Digital Map
CONTENTS
Europe
Asia - China
CRO
CRO
Agrolab A/S (Scandinavia & the
Baltics)
RRL Global Services (China)
Battelle
Shanghai IPRO-DVA Inspection
Technology Co., LTD (China)
CropTrials GmbH (Germany)
EPP Ltd (UK)

CRAO
Eurofins Agroscience China National Chemical Information

Services Center (China)
Smithers knoell Germany GmbH (Germany)

Knoell Shanghai (China)
STAPHYT (France) REACH24H Consulting Group

(China)
North America Europe
North America Shanghai Hills Consulting Co., Ltd.
CRO CRAO (China)
Jinan Sunrise Agrotech Co., Ltd.

DHD-Consulting GmbH (China)
SynTech Research (US) China
(Germany)
Winhonor Consulting Company
Limited (China)
knoell Germany GmbH
(Germany) India
STAPHYT (France) Asia - India

SCC Scientific Consulting
South America Company GmbH (Germany) CRO
CRO Bioscience Research Foundation

TEAM mastery (Italy)
(BRF) (India)
South
Bioagri Laboratories (Merieux
NutriScience) (Brazil) America Eurofins Advinus
Agrosciences Services
India Pvt. Ltd. (India)
PLANTEC LABORATORIES
(Brazil) INTERNATIONAL INSTITUTE OF Oceania
BIOTECHNOLOGY AND TOXICOLOGY
(IIBAT) (India)
Oceania
CRAO JADE BIOSCIENCE (India)
CRO
Manexa S.A. (Argentina)
JDM Scientific Research
Organisation Pvt. Ltd. (INDIA)
P06
AgriFor Scientific (Australia)
Sordi AgroConsulting Ltda. (Brazil)
JRF Global (India)
Vigna Brasil (Brazil)
The "2024 CROs & CRAOs Digital Map” is released concurrently, bringing you a
comprehensive and interactive platform to connect with the right service providers
and partners for your needs. With this updated version, you can easily search by
service categories and locations, ensuring you find the perfect fit for your specific
requirements.
Industry Insight
PUBLISHER
STANLEY ALLIANCE INFO-
TECH LIMITED
P08 Borderline Substances in Europe: Plant

Protection Products or Fertilising Products?
The increasing demand for sustainable farming
practices has driven a rise in the use of biological or
natural or novel fertilising products in agriculture.
Scan to download it
However, placing such products on the market does
not come without challenges as their mode of action
TEL:+86-571-87245207 can often blur the line between the definition of a
EMAIL: agropages@vip.163.com fertilising product and a plant protection product.
COVER STORY
P12 Worldwide development of a P34 CRO Manual

biopesticide: where to start?
The market of new biocontrol products is currently
growing in multiple areas of the world. Europe is
known as a challenging region in terms of outcome P43 CRAO Manual
from the evaluation and the uncertainty on the
registration but also in terms of go to market time.
Other regions of the world are much more appealing
in these aspects to the industry, Brazil and USA
among others.
Advertisers
P16 The Fungi Opportunity: An analysis
of the Brazilian biopesticides
AgriFor Scientific P33/35
market, latest policies and trends
Agrolab A/S P35
The market for biologicals
Battelle P1/36
is undergoing a major
transformation in Latin America’s Bioagri Laboratories (Merieux NutriScience) P36/52
largest economy. What is role
Bioscience Research Foundation (BRF) Cover Page/P34
can fungi bioproducts play in the
industry? CropTrials GmbH P31/37
China National Chemical Information Center P43
DHD-Consulting GmbH P43
P22 Analysis of Pesticide Registration EPP Ltd P37
in China, the United States, and Eurofins Agroscience Services P4/38

Europe, and How to Make an Eurofins Advinus Agrosciences Services India Pvt. Ltd. P32/38
Action Plan INTERNATIONAL INSTITUTE OF BIOTECHNOLOGY P39/53
AND TOXICOLOGY (IIBAT)
The global key agrochemicals market layout
JADE BIOSCIENCE P20/39
has become a driving force for the growth and
expansion of China's agrochemical companies. JDM Scientific Research Organisation Pvt. Ltd. P40/49
Successful product layout and registration are
JRF Global Back Cover/P40
essential to yielding substantial returns for these
companies. This article focuses on analyzing the knoell Germany GmbH P44
registration requirements and considerations in key
Manexa S.A. P10/45
global agricultural chemical markets such as China,
the United States, and the European Union. PLANTEC LABORATORIES P41/50
REACH24H Consulting Group P27/44
RRL Global Services P15/41
P28 In Vivo Pig-a Gene Mutation Assay
SCC Scientific Consulting Company GmbH P46
using N-Nitroso-N-Ethylurea and
Shanghai IPRO-DVA Inspection Technology Co., LTD P42
Benzo(a)Pyrene
Smithers P42
The rodent Pig-A assay is being increasingly
STAPHYT P1/42
recognized in the scientific community for its unique
advantages. Notably, it requires minimal blood Jinan Sunrise Agrotech Co., Ltd. P1/47
volume, as even a microlitre contains millions of red
TEAM mastery P21/47
blood cells and a small proportion of reticulocytes.
This assay is particularly useful for repeated blood Vigna Brasil Group P11/48
sampling without euthanizing the animal, making it
Winhonor Consulting Company Limited P48
an ethical choice that aligns with the 3Rs principles
(Replacement, Reduction, and Refinement) in animal
testing.
04 / 2024 FORMULATION & ADJUVANT TECHNOLOGY

CROs & CRAOs
Digital Map Europe
Asia - China
CRO
CRO
Scan the QR code to find more Services Provides worldwide Agrolab A/S
and know more about their service categories, services RRL Global Services
applied markets and other detailed information through the Battelle
Real-Time updated <2024 CROs & CRAOs Digital Map> Shanghai IPRO-DVA Inspection
Technology Co., LTD
CropTrials GmbH
EPP Ltd CRAO
Eurofins Agroscience China National Chemical Information

Services Center
Smithers knoell Germany GmbH

Knoell Shanghai
STAPHYT
REACH24H Consulting Group
North America Europe
North America Shanghai Hills Consulting Co., Ltd.
CRO CRAO
Jinan Sunrise Agrotech Co., Ltd.
SynTech Research DHD-Consulting GmbH China
Winhonor Consulting Company
Limited
knoell Germany GmbH India
STAPHYT Asia - India

SCC Scientific Consulting
South America Company GmbH CRO
CRO Bioscience Research Foundation

TEAM mastery
(BRF)
South
Bioagri Laboratories (Merieux
NutriScience) America Eurofins Advinus
Agrosciences Services
India Pvt. Ltd.
PLANTEC LABORATORIES INTERNATIONAL INSTITUTE OF Oceania

BIOTECHNOLOGY AND TOXICOLOGY
(IIBAT)
STAPHYT Oceania
JADE BIOSCIENCE
CRO
CRAO
JDM Scientific Research
Organisation Pvt. Ltd.
AgriFor Scientific
Manexa S.A.
JRF Global
Sordi AgroConsulting Ltda.
STAPHYT
Vigna Brasil Group

INDUSTRY INSIGHT INDUSTRY INSIGHT
Plant biostimulants are further
Borderline Substances in Europe:

sub-categorised into two categories:
microbial plant biostimulants (PFC
6 (A)) and non-microbial plant
biostimulants (PFC 6 (B)). Currently the
Plant Protection Products or microorganisms allowed in microbial

plant biostimulants can only be based
on the following: Azospirillum spp .,
Azotobacter spp ., Mycorrhizal spp .,
Fertilising Products? and Rhizobium spp . Nevertheless,

the EU has appointed the Austrian
Institute of Technology as contractor
to assess other microorganisms that
could be considered as biostimulants
in the future. The source of non-
microbial plant biostimulants as
T
he increasing demand for ● A fertilising product is any product previously mentioned can be varied.
sustainable farming practices aimed at providing the plants By their nature, plant biostimulants
has driven a rise in the use of or mushrooms with nutrients or are more closely aligned with
biological or natural or novel fertilising improving their nutrition efficiency. fertilising products, but sometimes that are influencing the life processes registration under the PPPR. The
products in agriculture. However, ● A plant protection product is any their effects can be like those of of plants, other than as a nutrient or a possibility of declaring any additional
placing such products on the market product aimed at protecting plants plant growth regulators, which are plant biostimulant, are still considered biostimulant or fertilising function to
does not come without challenges as or plant products against harmful regulated under the Plant Protection within the scope of PPPR. a plant protection product is to be
Dr. Ana Bejarano their mode of action can often blur organisms, influencing the life Products Regulation (EC) 1107/2009 To navigate the intricate assessed under the PPPR and the
Regulatory Affairs Manager at the line between the definition of a processes of plants, preserving plant (hereinafter referred to as the PPPR). landscape of borderline products, the relevant national rules for fertilising
Knoell Consulting Group fertilising product and a plant protection products, or destroying undesired Prior to the entry into force European Commission developed products.
product. The determination as to plants or parts of plants. of FPR plant biostimulants have a working document “Regulation However, this does not
whether a product may or may not Under the available legislative been commonly regulated under (EC) no. 1107/2009 - Scope and completely exclude substances
fall within the scope of an applicable categories of fertilising products allowed national laws (where they exist), borderline issues” (SANCO 6621- or microorganisms with a known
regulation is not always straightforward. under the Fertilising Products Regulation thereby generating non-uniform 99 rev 75 January 2024) containing pesticidal, or other plant protection
Products that straddle the legislative (EU) 2019/1009 (hereinafter referred requirements at a national level. summaries of the conclusions taken use from being employed in a
line between being a fertilising product to as the FPR), the plant biostimulants In Italy, for instance, most plant by the Standing Committee on Plants, fertilising product. If a fertilising
and a plant protection product can Product Function Category (PFC) 6 is biostimulants are regulated under Animals, Food and Feed on products product containing such a component
be described as borderline products. probably one of the most diverse as it the Legislative Decree 75/2010 or active substance in relation to the complies with all requirements set
In general terms, the two groups of can contain a wide range of components on fertilising products. Likewise in PPPR and other sectorial product out in the FPR and the fertilising
products can be defined as follows: e.g., microorganisms, amino acids, Spain, many plant biostimulants may legislation. SANCO 6621-99 rev 75 is product does not have a pesticidal or
polysaccharides, humic acids, fulvic be considered as falling within the a useful reference document to assist other plant protection function within
acids, minerals, seaweed extracts and scope of Royal Decree 506/2013 on in determining whether a product the meaning of the PPPR, then it
Dr. Sean McCarthy plant extracts. fertilisers, although the legislation falls within the scope of PPPR or not can be potentially considered under
Head of Division - Regulatory In addition, the FPR provides does not specifically mention the as the case may be. Additionally, it the FPR. This would typically mean
Affairs Crop Protection, a common definition of plant term “biostimulant”. Alternatively, outlines the procedure for presenting that plant protection substances or
Nutrition & Biologicals at biostimulants and offers access to dependent on the claims associated new requests for interpretation in microorganisms could be used in a
Knoell Consulting Group the European Single Market. The with a plant biostimulant it could be cases not explicitly listed. different way to elicit a fertilising or
FPR defines plant biostimulant as EU registered as plant growth regulators Products that have a dual or biostimulant effect [1].
fertilising products whose function is under the PPPR. multiple functions, one of which is Hence, the same component may
to stimulate plant nutrition processes Plant biostimulants meeting covered by the scope of the PPPR fulfil different functions and be part
independently of the product’s the above FPR definition are are automatically excluded from the of either a plant biostimulant, a plant
nutrient content with the sole aim of consequently now out of the scope of scope of the FPR and would require protection product, or both (Figure 1)
improving one or more of the following the PPPR. Nevertheless, products that
characteristics of the plant or the plant were authorised as plant protection
rhizosphere: products before 15 July 2019 will
(a) nutrient use efficiency be considered as such until their
(b) tolerance to abiotic stress authorisations expire. After expiration,
(c) quality traits products that fall under the new
(d) availability of confined nutrients definition of plant biostimulants will
in the soil or rhizosphere have to follow processes under the
FPR (Article 47 of the FPR including a Figure 1. Categorisation of substances or microorganisms according to their function.
transitional provision in Article 80(8) Actives A and B display only primary function, active C display a dual function.
of the PPPR). Though those products
08 / 2024 CRO & CRAO MANUAL 2024 CRO & CRAO MANUAL / 09
depending on: definitions and categorisations of biostimulant components may be

● Relative concentration of plant biostimulants, specifies the subject to Commission Delegated
components and their exact procedures for the determination and Regulation 2022/973 laying down
combination; calculation of different parameters criteria on agronomic efficiency and
● The application rate(s), and and describe the principles to safety for the use of by-products in
application method; generate and analyse experimental EU fertilising products.
● The crop(s) and the growth stage data to demonstrate claimed effects In conclusion, although current
of the application; with the goal of ensuring consistency, legislation provides more clarity to the
● Mode of action; quality, and safety. definitions of fertilisers, biostimulants,
● Claimed effects. A very important consideration and plant protection products,
Accordingly, substances or with plant biostimulants, like any borderline cases will continue to
microorganisms with a dual function other fertilising product (i.e. final require in-depth analysis to ensure
require dual authorisation and must formulated product), is that their that all the legislative requirements
undergo the relevant procedure components may be subject to are respected.
applicable to plant biostimulants registration under Regulation For additional information and
(either at EU or national level) and (EC) 1907/2006 concerning the advice contact us on
plant protection products. Registration, Evaluation, Authorisation cropnutrition@knoell.com. AP
To demonstrate plant biostimulant and Restriction of Chemicals (REACH)
claims and prove compliance for the purpose of the FPR. This
with the requirements of the FPR, obligation is mandatory unless the
the European Committee for substances incorporated in the EU
Standardisation (CEN) is developing fertilising product are covered by
a series of harmonised standards. one of the registration exemptions
These standards establish clear stated in the FPR. Likewise, plant
REFERENCES M
[1] Regulation (EU) 2019/1009 – the Fertilising Products Regulation Frequently Asked Questions of 15 July 2022. Y
CM
MY
CY
CMY
2024 CRO & CRAO MANUAL / 11

Worldwide development of a
biopesticide: where to start?
Contacts: Héloise Stephan (hstephan@staphyt.com), Geoffroy MOULIN (gmoulin@staphyt.com)
A
s a GEP and GLP service Differences in understanding However, beyond this first
provider and a regulatory always lead to misleading consensus, regional differences exist,
affairs consultant, the particularly in regulatory processes
international French group Staphyt
advice. or in the details of what falls within
has been working for over 15 years the scope of biopesticides and
“Biopesticide” and “biocontrol”
with companies aiming to put on biocontrol. For example, the Plant
terms may be two words with
the market new biocontrol products. Incorporated Protectants (PIPs) in
definitions commonly agreed.
This market is currently growing in the USA or the use of genetically
“Biopesticide” is defined as
multiple areas of the world. When modified organisms in Brazil will not
pesticides made from natural
it comes to getting a fast return enter into the European definition of
substances whereas “biocontrol”
of investments on a R&D budget biocontrol.
refers to protection technologies
over 1 million €, it is essential to
originated from nature, intended to with, as a result, notable differences ● the European Commission will innovation’s efficacy; it leads to a
consider all available opportunities.
use natural mechanisms to protect
How can we get to the in evaluations: give the final decision. significant difference of budget and
Europe is known as a challenging market in 2 years in Brazil
plants. Both terms have a common 1/ In the USA, only the EPA is a much larger possibility of uses to
region in terms of outcome from the
evaluation and the uncertainty on
base: biopesticides grouping the 3 and the USA and need 7 evaluating. To a general extent, the highest cover on the same crop.
main categories of products (such years for Europe? 2/ In Brazil, 3 ministries or agencies truth in a registration dossier lies
the registration but also in terms of
as natural substances, microbials are distributing the work: in the data that will have to be Still, the data packages requested
go to market time. Other regions of
and semiochemicals) and biocontrol By analysing the regulations ● certification and efficacy at the generated in order (1) to identify in the various zones are not
the world are much more appealing
including in addition the macrobials that coordinate the registrations of Ministry of Agriculture (MAPA); the (eco)toxicological profile, (2) to sufficiently distinct to explain the
in these aspects to the industry,
(invertebrate agents) as fourth biopesticide in these various regions, ● toxicology at the Ministry populate the risk assessment and (3) distance in the time to market. Thus,
Brazil and USA among others.
protection technology. each of them has its own specificities of Health / National Health to demonstrate the efficacy. the processes of registration must be
Surveillance Agency (ANVISA); The set of the data package investigated to have the beginning of
● environmental fate and depends obviously on the nature clarification:
ecotoxicology at the Ministry of the item (microbial, extract -In Brazil and in the USA,
of Environment / Brazilian of microbial, botanical extract, biochemicals are registered with both
Institute for the Environment and semiochemical, etc.). active ingredient and formulated
Renewable Natural Resources About the studies monitoring, one product assessed at the same time.
(IBAMA). point differs from the 3 zones: This leads to a registration process of
3/ In Europe, the evaluation process ● Europe requires studies run 2-3 years.
is collegial, involving several actors: under OECD guidelines (even if -In Europe, the process is
● 1 Rapporteur Member State they accept or request OPPTS- sequential: first the active substance
(RMS), assessing the notifier based studies for microbials for has to be assessed for registration
dossier and preparing the instance); before the product enters into the
Assessment Report that will be ● In the USA, the rule is to follow evaluation process for authorization.
distributed to the other following OPPTS guidelines; If the product developed contains
European actors; ● In Brazil, both OECD and OPPTS a substance already approved,
● 26 other member states will give are accepted along with ABNT then the timing is about 1-2 years
their point of view; guidelines. to generate data and 1-2 years of
● EFSA (the European Food Safety A specific point in the USA to evaluation. However, as soon as the
Agency) will build the conclusions be highlighted is the absence of substance is new, the specific step of
of evaluation; regulatory demonstration of the the substance approval jeopardises
the timing (5 years at least to get a the development cost. Currently, upfront. Regardless of the priorities
substance approved) before having there is no possibility to get a mutual of registrations that are expected,
the product authorised. recognition of registration of active covering all the preliminary steps will
ingredient or formulated product be a way to make sure that, in due
Organizing a global launch between global regions. At least, it time, there will be no unnecessary
can be tried to have only one data hurdles on the way of the registration.
With a little perspective, it package that fits for all situations.
seems that (1) starting to reach for The second point to address More information, visit our
the registration in Brazil and/or in absolutely is to consider the website: staphyt.com or contact us
the USA and (2) then considering preliminary steps of all regions contact@staphyt.com. AP
the profitability of a registration
in Europe may look like the finest
strategy.
However, details from these
different procedures (EU, USA
or Brazil) lead to consider the
development in parallel rather than
sequential. Occurring at the early
stage in each of these procedures,
they must be considered very much
upfront. For example, advantageous
fees discount can be obtained in
the USA if the notifier company
is recognized as small and not
operating yet in pesticides. As well,
getting a biochemical classification
by the Biochemical Classification
Committee is also an important step
to get a reduced data package. On
the other hand, in the frame of the
European Transparency Regulation,
studies expected to be used for the
approval of a substance have to be
notified to the Authorities; more
particularly studies on vertebrates
have to be justified. The notification
process is now a prerequisite to
avoid any risk of rejection.
Various details have to be
considered in a global strategy;
these are small steps with large
consequences.
In the end, to summarise, here

are some key points to keep in mind.
Once the data gap analysis is
done, covering all the targeted
regions of the world, it is important
to identify the same studies
requested in the various regulations
(acute toxicity on algae for example)
and try to build a study plan that
will be acceptable under OECD and
OPPTS requirements (the two main
organisational guidelines to follow).
This will help clearly to reduce
doubling data and will decrease
In this last group, we see great

opportunities for the introduction of
new fungal-based biological assets.
The Fungi Opportunity: Currently, fungi still have a very

low prevalence in the biologicals
market. Of a total of 657 registered
An analysis of the Brazilian

inoculants, only thirteen products
have fungi as their active ingredient,
the remaining being bacterial-based.
The thirteen registered fungi- based
biopesticides market, latest

products belong to the genera
Trichoderma, Claroideoglomus,
Rhizoglomus and Rhizophagus .
According to these statistics there
policies and trends is a future that is still unexplored

by the industry, where fungi could
contribute a bigger role in the
segment of inoculants, biofertilizers,
and nutrient solubilizers. With more
The market for biologicals is undergoing a major transformation in Latin America’s PH: Dias, Waldir Pereira than 120,000 described species,
largest economy. What is role can fungi bioproducts play in the industry? the fungi kingdom could have more
than 1.5 million different species.
With its known potential to produce
biologically active metabolites, fungi
are primed to carve new market
niches, potentially even beyond
agriculture.
With regard to its application in
the realm of agriculture, the promises
The biologicals market in context seen particularly in the arbuscular
mycorrhizae are a great case study on
Brazil is currently the largest market for the use of phytosanitary how these microorganisms can offer a
products for crop protection in the world. Sales of biologicals have been series of significant benefits to plants,
growing at a rapid pace in the country, with an interannual growth rate especially in terms of nutrition and
of 38% in US dollars in the last half decade. resistance to stress.
In the 22-23 season, figures provided by the consulting firm, Kynetec, According to Marschner and Dell
Rose Rodriges showed that the biologicals market reached US$827 million, with a (1994), the external hypha of the
SRI - SOLUÇÕES REGULATORIAS predominance for bioinsecticides and bionematicides. These products arbuscular mycorrhizal fungus can
INTEGRADAS have been a complementary tool to the action of chemicals, mainly in provide a considerable amount of
PH: OLIVEIRA, Charles Martins de
rose@sribrasil.com.br the management of nematodes in soybean cultivation and the control of nutrients to plants, including up to
www.sribrasil.com.br/en/ Cigarrinha do Milho (Dalbulus maidis ) in corn. 80% of phosphorus needs, 25% of
The market intelligence consultancy, Blink, estimates that the total nitrogen, 10% of potassium, 25% of
market will reach US$2 billion in the 2026-27 season. These predictions
Inoculants and new products are the most widespread
zinc and 60% of copper. Furthermore,
opportunities example in the market, having
are based on the intention of farmers to continue adopting biological symbiosis with these fungi can also
reached 80% of the soybean
technologies, the expansion of cultivated land in the country, and the help protect plants against salt stress,
cultivated area.
growth in the number of products used in the same application. The Blink also stressed that 15% of the as observed in studies carried out by
• Associative bacteria: These are
increase in the market will promote the arrival of new companies to the total biologicals market in the 22-23 Giri and collaborators (2002).
free-living bacteria that do not
market, which Blink advised could put pressure on sales prices current season comprised of inoculants. When Research carried out by Augé
have an internal symbiosis but
margins. we specifically analyzed the legislation (2001) highlighted the importance
live in the rhizosphere interacting
This promising context of the use of biologicals for agriculture is on these microbial products, we of arbuscular mycorrhizae in
with plants. In this group are the
also reflected in registration numbers. According to Brazilian agency found that they fall within three mitigating water stress in plants.
distinct categories, depending on the
Azospirillum Sp bacteria, which
Matias Santipolo FAPESP*, biological products have for the first time surpassed This exhaustive review included
are used in more than 30% of
Gaia Agrosolutions traditional chemical pesticides in total product registrations for pest type of microorganism, behavior, and 147 scientific studies published up
soybean production.
msantipolo@gaiasol.com.br control. In the case of sugarcane, 90% of products registered for pest functionality: to 1999, which demonstrated the
• Growth promoting
www.linkedin.com/company/gaia-agrosolutions control come from products, such as microorganisms, biochemicals • Biological fixers of Nitrogen benefits of these mycorrhizae under
microorganisms: In this group
and semiochemicals. In Brazil, 55% of farmers have adopted biological in legumes: In this group are conditions of drought or water stress.
are all microorganisms, either
technologies, as opposed to just 6% in the United States. Nitrogen-fixing bacteria that carry Although whether this benefit was
bacteria or fungi, deployed to
out symbiosis with crops in the related to the greater absorption of
promote plant growth or solubilize
legume family. Bradyrhizobium Sp phosphorus or other nutrients was
nutrients.
procedures specially crafted for process, which is as important as nematodes. The effectiveness of this undergo a proper industrial process
the following categories: live the genetics of the selected fungi, final product will only depend on to produce active metabolites in
microorganism, live microorganism Santipolo argued. how it is produced in the industrial addition to the biomass, chances are
and metabolites or metabolites only. “In the industrial process, we can process. When we need this strain the product will have very low field
The regulations also include guidance activate or silence fungal genes,” he to be a bionematicide, the industrial efficiency for disease control or be
on GMO organisms or products explained. process will have to focus on highly variable.”
derived from GMOs. A conceptual, simplified scenario producing fungal biomass, because With farmers adopting these
“Biologicals continue to be a offered by Santipolo can illustrate the nematicide is applied directly to technologies more readily than their
government priority, with the average how important production processes the seed so that the hyphae can grow counterparts in other countries and a
approval timeline of 1 year after can be to the success of a biological alongside the root of the plant to new legal framework, Brazil is moving
submission, or even faster approvals product. protect it,” Santipolo described. towards a major revolution in the
if organic agriculture is in scope,” Dr. “Let's think of a fungal “On the other hand, if the same pesticide industry, food quality and
Rodrigues said. microorganism that genetically fungi, which we already established environmental footprint. AP
SRI has recently partnered with has the skills and gene load to also has all the genetic capabilities
Gaia Agrosolutions to generate control foliar diseases and control to control foliar diseases, does not
cost and time-effective solutions
for the technical and commercial
development of new technologies
for the agrobusiness market. Gaia’s
director, Matias Santipolo, whose *( https://agencia.fapesp.br/registro-de-produtos-para-controle-biologico-de-pragas-ultrapassa-o-de-agroquimicos-no-brasil/51431 )
credentials include more than 10 **PORTARIA CONJUNTA SDA/MAPA - IBAMA - ANVISA Nº 1, DE 10 DE ABRIL DE 2023
PH: Costa, Rogério Sebastião years in the segment in the Latin
American market, believes that a https://www.infoteca.cnptia.embrapa.br/bitstream/doc/276480/1/DOC156.pdf
favorable, opportunity-rich scenario is
afoot in Brazil, particularly in the face
initially discussed, it is undeniable, and Simpson and Daft (1990). of these new regulations.
and the symbiosis can alter the water The effects of these “There will be a great paradigm
balance of plants independently microorganisms are nothing new, shift in the biocontrol market,”
of the acquisition of phosphorus in they have been known since Albert Santipolo asserted. “Until now,
certain circumstances, the author Bernhard Frank described them in companies differentiated their
stated. Of the 147 studies reviewed, 1885. The novelty of this topic is the products in the field by biological
55 empirically demonstrated that method of manufacturing mycorrhizae asset and its concentration. These
increased drought resistance in plants since it is a biotrophic fungus that can changes in the law can be used by
colonized by mycorrhizal fungi occurs only multiply in a living host. Recently, companies to set themselves apart.
independently of the increase in companies that have evolved the Fungi, with its known potential
phosphorus uptake capacity, another traditional production system now to produce biologically active
agronomic benefit provided by this manage to produce at low cost and metabolites, is primed for the
symbiotic relationship. achieve high quality spores. The introduction of innovative solutions to
When comparing plants spores' compact size allows them to the market,” he added.
inoculated with mycorrhizae to be highly effective and resistant to Both executives agree these
non-inoculated populations under environmental stress. conditions offer great opportunities
drought conditions, several significant for companies seeking to enter the
differences are observed. For Biodefensives: A path Brazilian market and innovate.
example, inoculated plants tend forward One possible avenue are
to have greater stomatal sensitivity products combining metabolites
to humidity, which is reflected in and living organisms, “which can
In light of newly enacted
greater stomatal conductance. They now be registered under the new
regulations by Brazilian government,
also exhibit a higher photosynthetic framework”, according to Dr.
we turned to Dr Rose Rodrigues, a
rate due to a prolonged stomatal Rodrigues. A suggested approach for
Brazil and Latam market veteran of 35
opening period, as well as greater such innovation is fermenting fungi in
years and director of SRI’s (Soluções
efficiency in water use and carbon a liquid medium to deliver products
Regulatórias Integradas), a Brazilian
assimilation. Furthermore, they show not only with fungal biomass, but also
boutique consultancy specialized
greater enzymatic activity and a biologically active metabolites, as
in biological and chemical product
lower amount of abscisic acid in the opposed to solid fermentation where
registration, to better understand the
xylem, which contributes to a lower outputs are highly concentrated in
landscape.
rate of leaf abscission and other signs fungal biomass but low in bioactive
Rodrigues explained the new act
of foliar stress, as demonstrated by metabolites.
recognizes that new technologies
various studies, such as Augé (2001) The key lies on the industrial
require the adoption of new
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Analysis of Pesticide
Registration in China, the United
States, and Europe, and How to
Make an Action Plan
REACH24H Consulting Group China：Frank, Jinping GUO; Ivy, Jingjing ZHANG; Nancy, Jin'er SHEN.
The pesticide registration rodenticides and avermectins. behavior, conducting necessary

review criteria differ to some extent b. Pesticide formulations with toxicological tests, environmental
among China, the United States, dermal acute toxicity classified behavior studies, and ecotoxicological
and the European Union. The US as highly toxic or above, and tests, an evaluation of the toxicity of
1.The Necessity of China's Agrochemical Industry in Abstract: Chinese agrochemical Environmental Protection Agency indoor hygiene formulations with active ingredients and environmental
Global Key Agrochemicals Market Layout companies have deeply integrated (EPA) adopted a risk assessment dermal acute toxicity classified as risks can be performed. Reasonable
into the international market. approach, where products with moderately toxic or above. deductions can be made for major
While focusing on the domestic appropriate control measures and c. Pesticide formulations that are metabolites, and main impurities can
The global key agrochemicals market layout has become a driving
market, they are accelerating their low risks to human health and corrosive to the eyes and hygiene be inferred through synthetic routes.
force for the growth and expansion of China's agrochemical companies.
expansion into overseas markets, environment are deemed acceptable. formulations directly applied to Evaluation of the genetic toxicity of
Successful product layout and registration are essential to yielding
especially global key agrochemicals The European Union has the the skin that cause severe eye impurities and metabolites can be
substantial returns for these companies. Overseas multinational
markets such as China, the strictest evaluation system globally, irritation. conducted using tools such as (Q)
agrochemical corporations strategically plan registrations in global
United States, and the European considering both environmental and d. Pesticide formulations that are SAR, read-across, and data bridging.
key markets for their new products. They forecast product market and
Union. This article examines the health risk assessments. There are corrosive to the skin and hygiene This helps assess the registration
peak number, establish global registration core data, and swiftly initiate
necessity of strategic positioning certain data evaluation criteria under formulations directly applied to risk and increase the success rate of
registrations in key markets.
in key global markets, product which a product cannot be registered the skin that cause moderate skin pesticide registrations.
Currently, it is important for agrochemical companies to pay attention
market analysis, pre-registration when evaluating its toxicity and irritation or above.
to risk mitigation in registration with increase of the pesticide registration
risk assessment, registration environmental data, including: e. Pesticide formulations with 4.Registration Regulations
difffculty. This article focuses on analyzing the registration requirements
data review criteria in different Health Toxicity: 1A and 1B sensitization intensity classified
and considerations in key global agricultural chemical markets such as and Procedures in Different
countries. The article analyzes carcinogens; 1A and 1B mutagens; as strong or above, and hygiene
China, the United States, and the European Union, in order to help Chinese Countries
pesticide registration in China, 1A and 1B reproductive toxicants; formulations directly applied to
companies reduce risks and successfully register their products.
the United States, and Europe, as Endocrine Disrupting Chemicals. the skin with sensitization intensity
well as provides insights on how to Environmental Concerns: PBT classified as mild or above. The registration regulations
2. Product Market Analysis effectively make a plan and execute (Persistent, Bioaccumulative, and f. Pesticides with delayed and management of pesticides in
the registration process. Toxic); POP (Persistent Organic neurotoxicity and/or mutagenicity the United States, the European
It is important to perform thorough market analysis when conducting Union, and China have their own
Pollutants); vBvP (very Persistent, and/or teratogenicity and/or
product research and selection, The United States, China, the European characteristics, summarized as follows:
Keywords: Registration Regulations very Bioaccumulative); Endocrine carcinogenicity.
Union, and Brazil are key global agrochemicals markets. Companies should
and Strategies in China, the United Disrupting Chemicals. g. Microbial pesticides with
analyze major crops, target pests, pesticide usage, key competitors, sales 4.1 The European Union
States, and Europe; Analysis of Key In addition to conducting health pathogenicity.
volume, and prices in each market. This analysis helps evaluate potential EU pesticide management
Challenges. assessment and environmental risk
registration countries and regions, target crops and pests, post-launch includes two major categories: plant
evaluation, China also examines the 3.2 Pre-registration risk
sales and market potential, and assists in making decisions regarding protection products and biocidal
toxicological data of products during assessment for product
product investment and future prospects. products, regulated respectively
the registration process. There are registration
certain data evaluation criteria under Pre-registration for environmental by the European Food Safety
3.Pay Attention to the Registration Data Review Criteria which a product cannot be registered and health risk assessment is an Authority (EFSA) and the European
of Each Country and Conduct Pre-registration Risk in China, including: essential measure to ensure pesticide Chemicals Agency (ECHA). The EU
Assessment for Product Registrations. a. Products with acute toxicity registration. By analyzing similar is responsible for the registration of
are classified as highly toxic compound products, understanding active substances, while member
3.1 Different registration data review criteria or extremely toxic, except for their health toxicity and environmental states in the registration process
are responsible for the approval
Data Categories: of Agriculture and Rural Affairs pesticides, and plant-derived National Pesticide Registration
A. Exclusive Use Data: For (ICAMA) is specifically responsible pesticides. Technical registrations Evaluation Committee in biannual
the initial registration of products for the review of pesticide are classified as new technical committee meetings, while other
containing new active ingredients or registration data. Since 2017, registration, non-identical technical registrations with already approved
newly formulated active ingredients, the new "Data Requirements for registration, and identical technical active ingredients are reviewed by the
as well as for the registration of Pesticide Registration" have been registration, while formulations Executive Committee of the National
changes to these initially registered implemented. China's pesticide are classified as new formulation Pesticide Registration Evaluation
products. The data protection registration follows a risk-based registration, identical formulation Committee at monthly meetings. The
period is 10 years from the date of approach for pesticide safety registration, and similar formulations review period generally takes 8-12
approval, and authorization and data assessment and implements domestic registration. Different registration months.
of formulations. The EU pesticide 4.2 USA compensation are required for data Good Laboratory Practice (GLP) types have different requirements for
regulation, Regulation (EC) No Pesticide registration in the referencing. testing management procedures. registration data, emphasizing the 4.4 The main similarities
1107/2009, categorizes pesticides United States is divided into B. Compensable Data: Data Currently, only domestic GLP reports integrity and scientific review of the and differences in pesticide
into the following groups: chemical federal registration and state submitted for applications such as are accepted as registration data. data. registration between the
pesticides, microbial pesticides registration. The United States new product registration, new use Pesticide registration in China is According to the current European Union (EU), the United
(including viruses), basic substance Environmental Protection Agency registration, or change registration. categorized into chemical pesticides, pesticide approval process, new States, and China are as follows:
regulation, and candidates for (EPA) is responsible for federal The data protection period is 15 years biochemical pesticides, microbial pesticides are reviewed by the
substitution. The scope of regulation pesticide registration. The relevant from the date of data submission, and
includes active substances, safeners, pesticide registration regulations data compensation is required for
synergists, authorization of formulated include the Federal Insecticide, data referencing.
The main similarities and differences in pesticide registration between the European Union (EU), the United States, and China
products, and adjuvants. In August Fungicide, and Rodenticide C. Other Data: Registered
2017, Regulation 2017/1432 Act, the Pesticide Registration data that has passed the data
introduced the category of "low-risk Improvement Act, the Federal Food, protection period, publicly available Pesticide registration matters The European Union USA China
active substances". This regulation Drug, and Cosmetic Act, and Title literature, and data generated by the Chemical pesticide
revised Regulation 1107/2009 and 40 of the U.S. Code of Federal government.
Biocide
set out criteria for low-risk active Regulations. Pesticide registration Formulation Registration:
Low-risk pesticide
substances, which enjoy faster review in the United States is classified R310: For the registration of new
Chemical pesticides for risk
times compared to conventional into two types: biopesticides and products with active ingredients that
reduction
products, a registration validity chemical pesticides. To encourage have already been registered. The
Basic substances
period extended to 15 years upon biopesticide registration, the data review period for this registration
category is 7 months. Microbial pesticides
approval, an extended period of data requirements for registration are
protection for up to 13 years, and relatively minimal. The pesticide R300/R301: For the registration Biochemical pesticides
the completion of the review process registration process in the United of identical or similar products. The Safeners, adjuvants, and inert
within four months. States includes establishment review period is 4 months for cases ingredients
The European Union adopted a registration, pesticide product where complete data referencing Currently, China only accepts
OECD-GLP report
'hazard-based' approach to determine registration, and distributor (R300) or selective data referencing China-GLP reports.
whether pesticide active substances registration. The registration (R301) is used. Product registration is
will be approved. The EU active process begins with establishment State Registration: State overseen by the Ministry of
Active substance - at the
substance registration is divided into registration, followed by determining registration is required before a Agriculture and Rural Affairs,
EU level Federal registration - EPA
the approval of new substances, the the product registration type, product can be placed in the market Registration process with data evaluation by ICAMA
Formulation - at the State registration
of a specific state. The review (Institute for the Control of
Technical Equivalence (TE) review of conducting data gap analysis, member state level
Agrochemicals, Ministry of
existing substances, and substance and obtaining the necessary data. period for state registration can vary
Agriculture and Rural Affairs).
reassessment. In theory, the review There are three types of pesticide from a few days to several months,
In addition to risk
period for conventional pesticides is registration: R332, for active depending on the specific state's In addition to risk assessment,
assessment, there are also
2.5-3.5 years, with an initial approval ingredients with unregistered requirements and procedures. Registration data review criteria Risk assessment there are also criteria for review
criteria for review and
validity period of 10 years and a sources, requiring the submission The primary registrant of a product and rejection.
rejection.
subsequent registration period of of a complete set of new data, registration certificate is the owner
In addition to OECD-
15 years. For basic substances, once with a review period of 24 months; of the registration, while distributors GLP data, other types of
approved, they are theoretically R333, for active ingredients with are considered secondary registrants. In addition to OECD-GLP
data such as data citation,
Each distributor is required to have its data, other types of data
registered indefinitely. The TE unregistered sources, allowing either data bridging, (Q)SAR Only China-GLP test data is
Data requirements such as data citation, data
review process takes approximately full or selective data referencing and own company identification number (Quantitative Structure- accepted.
bridging, and read-across
4 months. However, the EU's review requiring the applicant to have a and apply for distributor registration. Activity Relationship), and
data are also accepted.
process has experienced significant complete set of data or authorization read-across data are also
4.3 China accepted.
delays in recent years. letter for data referencing, with
Formulation registration is a review period of 11 months; The Ministry of Agriculture and Sample sealing and test record
conducted at the member state level R334, for active ingredients with Rural Affairs of China is responsible filing
and involves member state product unregistered sources, allowing for pesticide registration in China, Registration data protection period 10-15 years 10-15 years 6 years
registration, mutual recognition selective data referencing, with a and the Institute for the Control Compensation for authorized use There is no existing
within the region, and formulation review period of 12 months. of Agrochemicals, the Ministry of registration data regulation.
reassessment.
5.Preparation of registering in different countries, investigation and assessment should

Registration Data additional country-specific data may be conducted for the registration
need to be provided. Currently, China test laboratories. It is recommended
does not accept overseas OECD-GLP to select 2-3 laboratories to carry
5.1 Preparation of Registration
reports and requires testing to be out the experiments. For OECD-
Data of Multinational Companies
conducted in China-GLP laboratories. GLP laboratories and Chinese GLP
One common requirement for
laboratories, REACH24H conducts
registration data in various countries
worldwide is for companies to 5.2 Notice for Experimental reviews and establishes a laboratory
provide information on the product's Arrangements database to select the appropriate
5.2.1 When arranging experiments laboratory for the experiments.
chemistry, toxicology, efficacy,
for the registration of a new pesticide, 5.2.4 Experiment Supervision:
residues, and environmental behavior
it is advisable to conduct them in Experiment supervision is a critical
to assist regulatory authorities in
batches based on the results of factor in the successful completion of
assessing the product's impact
preliminary risk assessments in order experiments. It involves reviewing the
on human health, food safety,
to reduce registration risks. experiment protocol, staying updated
and environmental safety. When
5.2.2 When simultaneously on the progress of the experiments,
multinational companies prepare
arranging China-GLP and OECD- effectively communicating with
registration data for new products,
GLP experiments, considerations the laboratory, and reviewing the
they typically follow the data
should be given to the specific experiment’s reports and providing
requirements of the European Union
considerations for each type of test. timely feedback. AP
(EU) and the United States (US) when
5.2.3 Laboratory Selection: Prior
preparing OECD-GLP core data for
to arranging the experiments, a site
global registration. However, when
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In Vivo Pig-a Gene Mutation

Assay using N-Nitroso-N-
Ethylurea and Benzo(a)Pyrene
Jai Research Foundation (JRF)：Jay Ranade, Karishma Desai, Manish Patel and Rajendra Nagane.
Vehicle Control (PBS) 20 mg/ kg body weight of ENU
Introduction: The Pig-a assay is effective phosphatidylinositol (GlcNAc-PI), the

for investigating somatic gene foundational compound in GPI anchor
The rodent Pig-A assay is being mutations and complements bacterial biosynthesis. The GPI anchor is vital
increasingly recognized in the mutation assays in regulatory safety for attaching proteins to blood cell
scientific community for its unique evaluations. It integrates well into surfaces. While GPI anchor synthesis
advantages. Notably, it requires various toxicology studies, as outlined involves around 30 genes, the Pig-A
minimal blood volume, as even a by OECD Test Guidelines, making it gene, located on the X-chromosome,
microlitre contains millions of red a vital tool for assessing mutagenicity is unique in being a single functional
blood cells and a small proportion of and exploring genotoxic potential copy.
reticulocytes. identified in other in vitro systems. Mutations in the Pig-A gene
This assay is particularly useful Our study focuses on evaluating the primarily cause the absence of GPI
for repeated blood sampling without Pig-a gene mutation in Wistar rats anchors and associated proteins.
euthanizing the animal, making it an exposed to N-Nitroso-N-Ethylurea The assay employs fluorescent
ethical choice that aligns with the 3Rs and Benzo(a)Pyrene following three antibodies to detect these proteins
principles (Replacement, Reduction, days of consecutive dosing. on reticulocytes and red blood cells,
and Refinement) in animal testing. measuring mutant cell frequencies
Its compatibility with standard Principle: using flow cytometry. Vehicle Control (Corn Oil) 125 mg/kg body weight of B(a)P
rodent models and its application
in regulatory safety assessments The assay is centered around Materials and Method:
enhance its appeal for in vivo the Pig-A gene, crucial for
mutation studies. producing N-acetylglucosaminyl We sourced N-Nitroso-N-
Ethylurea and Benzo(a)Pyrene from
Sigma-Aldrich, and materials for
the Pig-a assay from Muta Flow®
PLUS 25-R kit (Litron Laboratories),
including specific antibodies and
reagents. Additional equipment like
the Octo-MACS™ separator and
MS-Columns were obtained from
Miltenyi-Biotech. Male and female
Wistar rats, sourced from Jai Research
Foundation's Animal Breeding
Facility, were used in experiments
adhering to OECD TG 470 guidelines
and the Muta-Flow PLUS kit manual.
Result and Conclusion: safety assessments.

The results obtained in this experiment are promising
The study observed a statistically significant increase in and highlight the robustness of the rodent in vivo Pig-a
RBCCD59- per 106 total RBCs and RETCD59- per 106 total RETs assay under our laboratory conditions. Therefore, this assay
in both male and female rats treated with 20 mg/kg body can be utilized as an independent or follow-up test for in GmbH
weight of ENU and 125 mg/kg body weight of benzo(a) vitro genotoxicity assessments, as well as an integrated
pyrene for three days, compared to the control group. This test alongside routine sub-acute or sub-chronic toxicology
finding underscores the assay's effectiveness in detecting studies. AP
mutagenic effects and its potential in broader regulatory
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02 / 2023 CRO & CRAO Manual
COMPANY DIRECTORY COMPANY DIRECTORY
CRO
Agrolab A/S
AgriFor Scientific EU North Zone CRO specialized in field research and

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AgriFor Scientific Pty Ltd is a Contract Research Agrolab provides consulting and field trial services
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Bioscience Research Foundation (BRF)
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chemistry, agrochemical registration, regulatory affairs fungicides
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Five Batch analysis: Identify
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impurities in five representative
Battelle batches of the technical product
Bioagri Laboratories (Merieux with validated method. It is one of
Battelle is a global applied NutriScience) the key studies to be submitted for CropTrials GmbH EPP Ltd
science and technology organization
registration of agrochemical products.
that delivers innovative and Bioagri is the largest CRO in Physical-chemicalstudies: melting CropTrials GmbH is an independent and privately- EPP is an established OECD-GLP compliant contract
sustainable scientific solutions to Latin America, as part of one of the point, vapor pressure, stability, owned company for agricultural field research with GLP research organisation (CRO), based near Edinburgh,
the agrochemical industry. Battelle largest laboratories groups Mérieux oxidizing properties and and GEP (93/71/EEC) certification. Since 1990 we have Scotland, supporting the agrochemical sector.
Crop Protection Solutions offers NutriSciences in the world, whose approximately 60 other physical developed a strong experience in efficacy and selectivity With over 30 years’ experience, EPP offers an excellent
comprehensive, turn-key solutions South American headquarter is chemical studies. studies as well as in residue, soil dissipation, rotational level of customer service and satisfaction, combining
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and biological products, including of analytical services required by toxicity, skin sensitization, acute We offer all studies in Northern and Southern Germany as We assist our clients by providing GLP analytical and
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solutions@battelle.org different countries to review whether physico-chemical, toxicological and close to Hanover. The field station in South Germany is in hard-to-find impurities and metabolites related to active
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Bioagri follows the studies Ehlbeek 2, 30938 Burgwedel, Germany stock of synthesized reference standards. Full details at
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Ltd.
Eurofins Agroscience Services brings together global, INTERNATIONAL INSTITUTE OF
multi-disciplined research capabilities with market leading With 30+ years of proven track record, we offer wide BIOTECHNOLOGY AND TOXICOLOGY (IIBAT) JADE BIOSCIENCE
product development and technical support services to the range of GLP services to support Agrochemicals (Pesticides,
crop protection industry. Fertilizers, Bio-stimulants, Biopesticides); industrial and The International Institute of Biotechnology and JADE BIOSCIENCE is an independent Contract Research
Our ability to deliver a full range of regulatory research speciality chemical sectors geared towards developing Toxicology (IIBAT), a Scientific Industrial Research Organization located in Vapi, Gujarat, India which provides
services and professionally managed scientific solutions registration packages for global regulatory submissions Organization (SIRO) and OECD GLP Certified Lab is the services for the data generation for the regulatory
sets us apart as the ideal partner for Agroscience research. (following USEPA, EEC, OECD and CIPAC guidelines). offering regulatory data generation services in the area of submission and generates non GLP, GLP/OECD GLP
As a global service provider we have proven expertise in We ensure scientific comfort to sponsors during the Physical and Chemical analysis, Toxicology, Ecotoxicology, data in the field of agrochemicals, bio-stimulants, herbal,
managing global field studies, worker exposure studies, study and post submission, through simplification of Bio efficacy, Environmental fate and Radioisotope studies nutraceuticals, pharmaceuticals, medical device etc, following
ecotoxicology, analytical services, physico-chemical complex matters with sound scientific inputs. Data from since 1985. IIBAT is serving as a link between Industry and various regulatory guidelines. All OECD GLP studies
property testing and 14C / environmental fate laboratory. our laboratories has been successfully submitted to Regulatory System in providing Non-Clinical health and are conducted with collaboration of OECD GLP partner
Our service offering is continuously developed by global regulatory agencies. Our team of scientists are well Environmental Safety data generation with agrochemicals, labs. JADE BIOSCIENCE is also supporting our client for
knowledge transfer initiatives between the Groups’ various experienced and work with state-of-the-art equipment biocides, biopesticides, drugs and pharmaceuticals, public other services such dossier preparation, safety data sheet
centres of expertise across the globe. The acquisition of following strict GLP quality system. health products, PPE, genetically modified products, preparation and technical guidance.
a carefully selected range of CROs’ means that Eurofins Our services include - Process chemistry and Scale- medical devices etc.
Agroscience Services has created a unique portfolio of up, Analytical Method development & validation, Services
expertise that provides support to agrochemical and Physicochemical studies, 5 batch, Impurity profiling, Main services: OECD - GLP CONTRACT RESEARCH Toxicology;
Biopesticide manufacturers, the seed industry and plant Residue, Persistence, Environmental fate; Soil metabolism CENTER Toxicology (Acute Toxicity, Repeated Dose Toxicity,
breeders, spanning over 30 years. & mineralization, radiolabeled (C14); household & public Main markets: INDIA, EUROP, CHINA, JAPAN, KOREA Reproductive Toxicity);
health lab & field trials (Entomology), bio-efficacy & AND USA Mutagenicity;
Slade Lane, Wilson, DERBYSHIRE, DE73 8AG, UNITED phytotoxicity field trials, Safety evaluation covering range of Ecotoxicology;
toxicological and eco-toxicological studies. IIBAT, PADAPPAI , TAMIL NADU , INDIA , PIN - 601301 Physiochemical Testing ;
KINGDOM
5 Batch Analysis;
http://www.eurofins.com/agroscienceservices WWW.IIBAT.COM
#21 & 22 Phase II, Peenya Industrial Area, Bangalore Dossier preparation;
Lou Williams DR A RAMESH; DR G. CHANDRASEKHAR; DR P.K. MSDS preparation;
560058, India
SARANGI; DR. A VIJAYALAKSHMI Technical and strategic guidance to client for registration of
louwilliams@eurofins.com www.advinus.com
DIRECTOR@IIBAT.COM products.
+44 (0)1332 864800 bd@advinus.com
+ 91 44 27174246/66
+91 80 6655 2700 E310 to E315, M Cube the Business Hub, Opp. Taluka
seva Sadan, Balitha, Vapi- 396191, Gujarat, India
www.jadebioscience.in
Virendra Kumar Tiwari, Ph.D.
Virendra.tiwari@jadebioscience.in ; info@jadebioscience.in
+91 9958111713; +91 9999461069.
JDM Scientific Research Organisation Pvt. Ltd.

PLANTEC LABORATORIES RRL Global Services
OECD GLP | Compliance | AAALAC | SENASA | ISO- JRF Global
17025 (NABL) | CCSEA | DSIR High tech structures and constant quality assurance RRL Global Services is an independent OECD & ICAMA
JRF Global offers fast, transparent, cost-effective, hassle- and improvement allow PLANTEC Laboratories to provide GLP-certified contract research organization (CRO) that
JDM Scientific Research Organisation Pvt. Ltd. (JDM free integrated services for evaluating products for their studies recognized by GLP Principles and according to NBR possesses full practical experience and the capability to
Research) is a state-of-the-art, fully integrated R&D Toxicity, In-Vitro toxicity, Eco-toxicology, R&D, Chemistry, ISO/ IEC 17025. Through modern In Vitro Toxicological provide one-stop registration services for clients for crop
Center and Contract Research Organisation (CRO). This Synthesis, Environmental Fate and Metabolism, and other and Ecotoxicological studies, Physico-Chemical and protection products. Following its core values of “Expertise,
test facility has accreditation of OECD GLP, AAALAC, regulatory testing requirements. Our experienced and Five 5 batches studies Plantec performs analysis that Quality, Reliability, Convenience”, its powerful team of
SENASA, SENAVE, CCSEA, ISO 17025 (NABL), CIB&RC, knowledgeable scientists have worked with agrochemical, monitor the agrochemicals effects on the environment scientists has been providing high quality reports for
etc. It is recognised by the Department of Scientific and pharmaceutical and biopharmaceutical, specialty chemical, and living organisms, evaluating the safety of their use regulatory submission and offering professional laboratory
Industrial Research (DSIR, Govt. of India). industrial biotech, biocidal, cosmetic, and veterinary and also quality of technical and formulated products. and regulation consultancy services since 2007.
Located near the city of Vadodara in Gujarat state of products. With presence in different continents, we are the The Residue laboratory has the most modern equipment
INDIA, the CRO is spread over 10 acres of land, having obvious partner-of-choice of over 800 companies for non- to reach minimum values of MRL and to develop new Main Services:
more than 120,000 sq feet of build-up area, empowered clinical safety data generation. In addition, we also provide methodologies of analysis. All Plantec laboratories use Identification & quantitative analysis of the active ingredient
by more than 100 highly experienced scientific and regulatory guidance to minimize the testing time and internationally recognized guidelines by regulatory and or impurities;
technical staff. It is designed and executed as One Stop efforts. surveillance agencies. Our differential is that we value 5 batch analysis;
Solution of Research, Toxicology and Analytical needs The JRF Group of companies’ boast of 300+ dedicated personalized service, so you can make decisions quickly to Physical & chemical property analysis;
for new product development from inception to final employees spread across the globe, with a collective positively impact your business. Storage stability test;
registration of the product. You are requested to digitally experience exceeding a few thousand years. In addition, E-fate study;
visit the test facility at : https://youtu.be/ynX97VC32BA (this we have a prestigious panel of a dozen global experts, on Main Services: Ecotoxicological study;
is about 7 minutes video where you can see our test facility infrastructure). our Research Advisory Committee, who are the leading Toxicological/Mutagenic studies (in vivo and in vitro Genetic toxicology study;
lights in their respective fields of expertise, e.g., regulatory studies) In vitro toxicology study.
JDM Research’s key areas of operations: affairs, chemistry, toxicology, pathology, and Environmental Ecotoxicological studies
1. GLP/Preclinical Services: sciences. Physico-chemical studies Main Markets:
a.Chemistry (phys chem, 5-Batches), JRF Global boasts of purpose built laboratories with the 5 Batch analysis USA, Brazil, Argentina, EU
b.Toxicology (acute 6 pack, sub-chronic, chronic), total floor area exceeding 158,000 ft2. The laboratories Efficacy field trials
Genotox, Ecotox are constructed in accordance to the state-of-the-art global Residue Analysis No. 233, Songjiagang Road, Kunshan,
c.Biocompatibility Testing of Medical Device, etc. norms. The animal rooms have multiple barriers and HEPA 215313, Jiangsu, China
2. R&D Synthesis filtered clean air with pressure gradients ensuring quality of Rod. SP 147, km 128 - Chácara Palmeiras
Mr. Kent Xin; Ms. Rebecca Li
3. R&D Formulation air in the clean corridor, animal rooms, and return corridors, Iracemápolis/SP, Brazil - 13499-899
respectively. These laboratories are equipped with state kenxin@albaughllc.com
4. Pilot Plant (with both GMP and Non-GMP facilities) www.planteclab.com
of art research instruments equipped with electronic data rebeccali@albaughllc.com
capture facility. comercial@planteclab.com
We serve various industries in the areas of Speciality +86-15821664012
Chemicals, Pharmaceuticals, Agrochemicals, etc. to meet All studies conducted at JRF Global are in accordance +55 19 98151-9338
+86-13809062209
their business needs. You can reach us at: with the regulatory requirements of the OECD, OCSPP,
EMA, US FDA, ICH, and JMAFF. Our professionalism
JDM Scientific Research Organisation Pvt. Ltd, Block and exceptional customer oriented skills have given us
no 58, Village Lasundra 391775, Taluka - Savli, Dist.- a competitive edge and we have become the chosen
outsourcing partner for a diverse set of customers.
Vadodara Gujarat - INDIA
https://www.jdmresearch.com NH. 48, Near Daman Ganga Bridge, Valvada, Gujarat,
enquiry@jdmresearch.com India 396105.
+91 9099992873 www.jrfglobal.com
SUMIT TIVARI
sumit.tivari@jrfonline.com
+91-990-990-0943
Mr. Lary Liu

Winhonor1@winhonor.com.cn
+86-139-543-88891
CRAO
Smithers
Shanghai IPRO-DVA For over 50 years, our regulatory- STAPHYT
Inspection Technology Co., compliant laboratories have assisted
LTD Staphyt was created in 1989. China National Chemical Information Center
global product registrations, supporting
our clients with the deepest expertise, Contract Research Organisation
The China National Chemical Information Center (CNCIC),
IPRO-DVA was founded in 2011. unparalleled service levels, efficient and Regulatory Affairs consultant,
formerly the Scientific and Technological Information Research
We are a comprehensive third-party technologies, and transparent Staphyt operates internationally in the DHD-Consulting GmbH
Institute of the Chinese Ministry of Chemical Industry, has
testing institution with CNAS (ISO/ communication. agroscience, biocide, chemical and
become a highly reputable and authoritative information Regulatory Affairs of Biocides and Agricultural
IEC 17025) and CMA certificates, Whether a full physical chemistry, pharmaceutical sectors. Our +700
consultant and information service organization in the Chinese Chemicals
specializing in the quality inspection fate, metabolism and ecotoxicology employees are based in Europe, Latin
chemical industry, after more than 60 years of development. DHD-Consulting GmbH is an independent
of exported chemicals (pesticide, package for a new conventional or America, North Africa and we work
CNCIC.Agro is a business unit dedicated to agricultural and regulatory consulting company with 25 years+
fertilizer, etc.). We could provide biological active ingredient registration, everywhere else through partners.
agrochemical business research, supported by its professional of experience in agrochemicals, biopesticides,
the Sampling Inspection, Cargo gap-filling studies for product renewals, Our scientific, technical and
and experienced expert team, and utilizing rigorous scientific biocides, biostimulants and fertilizers in Europe.
loading supervision, Pre-Shipment or a critical suite of tests for new regulatory experts are combining
methodologies, global database resources and a multi-discipline From initial completeness check and study
Inspection etc. Service to our formulation, Smithers supports our their expertise to support our clients
advisory group. Its scope of services covers consultancy, product monitoring to dossier submission and registration
customer. The test report issued clients as they innovate using our in the development, registration
registration, patent protection, publication, convention, and tracking: For our highly skilled staff of scientists,
by our lab is legally valid and decades of experience and expertise. and marketing of their products
exhibition, providing customers with full-scale solutions and client focus, service quality, and continuity are the
internationally recognized, which With labs in Europe and North and substances, whether they are
excellent value-promotion services. foundations for work.
fully meets the clients’ requirements America, and customer-centric client chemical or biological in nature.
for product sales at home and services in the UK, USA, and Japan, Staphyt provides a full range We offer full scientific and regulatory services.
Primary Services Clients are able to choose modular support or
abroad. Smithers is the first-choice partner of services in order to secure our
Customized consulting services turnkey-service:
for leading pesticide developers and client’s development:
● Strategic consultancy data gap analysis, study monitoring, IUCLID
Building 1, No.16299 Puwei formulators around the world. ● Field trials services: Efficacy,
selectivity, residue, seeds, biotech, ● Domestic and foreign marketing consultations study notification, modelling and risk assessment,
Road, Shanyang Town, Jinshan Learn more about our tailored ● New pesticide introduction and commercialization services
solutions for the whole life cycle of an GEP & GLP literature research, dossier preparation for active
District, Shanghai, China ● Business benchmarking
active ingredient at www.smithers.com. ● Laboratory studies services: substances and products (plant protection and
www.ipro-dva.com Test, screen and evaluate efficiently biocides), efficacy trial design and evaluation,
Product Registration biological assessment dossier, comparative
Mrs. Helen (Quality Manager) Services: all substances and products
(physical chemistry, ecotoxicology, ● China pesticide registration assessment for candidates for substitution,
zhelen@ipro-dva.com Ecotoxicology ● Overseas pesticide registration
Endocrine Testing environmental fate, analytical expanded CADDY capacities, etc.
+86-21- 67291008/67291009 ● China fertilizer registration Further DHD provides complete regulatory
Environmental Fate chemistry, ED, controlled conditions
trials…) ● China veterinary drug registration support including lead management of your
Plant and Animal Metabolism ● China fodder and fodder additive registration
Product Chemistry ● Regulatory Affairs & company’s registration process and task force
Residue Analysis Consultancy: Define the best management.
Patent Services
Formulation Testing regulatory strategy together with our
clients and successfully bring their ● Patent advisory services Lilly-Reich-Str. 8, D-31137 Hildesheim, Germany
products to market. ● Patent retrieval and patent analysis
www.Smithers.com https://www.dhd-consulting.de
Staphyt’s communities, alongside ● Patent protection system building
infoERS@Smithers.com Stephan Gessinger (Managing Director)
its clients, contribute to the marketing
● 790 Main St. Wareham, Massachusetts Principal Markets info@dhd-regulatory-affairs.de
of innovative and environmentally
02571, United States, Tel: +1-508- friendly products. ● Domestic market +49 5121 928 790
Our “raison d’être ”: Acting ● Overseas markets: Asia, Europe, South America, and North
295-2550 America
together to sustainably feed the
● 108 Woodfield Drive, Harrogate,
world of tomorrow
North Yorkshire HG1 4LS, United No. 53, Xiaoguan Street, Andingmenwai, Beijing /Unit 1
Kingdom, Tel: +44 (0) 1423 532710 23, rue de Moeuvres, 62860 South,4th Floor, Sinochem International Plaza, No.233
● 8 Jubilee Parkway, Derby, Derbyshire Inchy-en-Artois, FRANCE ChangQing North Road, Pudong New Area, Shanghai
DE21 4BJ, United Kingdom, Tel: (44) (Headquarter) www.chemconsulting.com.cn
(0) 1332 987480 www.staphyt.com Yu Chunying / Tao Min
● Tokyo, Japan, Tel: +81-3-6862-7082 contact@staphyt.com yucy@hse.cncic.cn / taom@cncic.cn
Héloïse STEPHAN 86-10-64411345 / 86-21-58582128
(Communication Officer)
hstephan@staphyt.com
knoell Germany GmbH REACH24H Consulting Group Manexa S.A. STAPHYT
knoell is a leading regulatory consultancy specialising in REACH24H Consulting Group is an internationally Manexa S.A. is an independent private company Staphyt Regulatory Affairs department provides
the registration of both conventional and biocontrol crop renowned technological services company with headquarter dedicated to ag research and development services. services in chemical regulatory affairs. Operating in the
protection products, and crop nutrition products including in Hangzhou, China and branches in UK, Ireland, the United Provides field services in seed breeding, digital farming, agrochemicals, biologicals, biocides and general chemical
biostimulants. In addition, we can provide regulatory States, Korea, Japan and Taiwan. By creating a 24-hour nursery and the entire development of seed supply chain sectors, our mission is to keep manufacturers informed
support for biocides, industrial chemicals, food and food global consulting service network and a technical expert solutions. We provide B to B services in seed care, crop about the regulations that apply to their businesses. We
contact materials, cosmetics, veterinary medicines, and team, REACH24H provides one-stop international market protection performing efficacy and residue studies in crop help our clients to achieve smooth entry to the market of
medical devices. knoell is a privately owned company, entrance services, and has helped over 13,000 companies chemicals and biologicals technologies in on site facilities. their substances and products, in compliance with national
with over 25 years of experience, has over 600 employees worldwide overcome technical trade barriers to smoothly Engaged in a trialing platform of different CROs and regional regulations.
worldwide and an extensive network of partners. The navigate the global market. throughout Argentina and Uruguay provides research and Our expertise covers all areas related to chemical risk
majority of knoell team are scientists covering the key development for field scouting and crop management assessment: Physico-chemistry, analytical, toxicology,
technical disciplines such as toxicology, ecotoxicology, Our Services: in the agtech ecosystem. Offering advisory from the trial ecotoxicology, environmental fate, residues, efficacy, etc.
environmental fate, residues, and chemistry. knoell offers China Pesticide/Fertilizer/Bio-stimulants/Disinfectant planning to the final report, we engage with our clients Our team of 120+ employees brings together the
regulatory consultancy services with a local touch to help Registration adding value in testing, and technology design. expertise of scientists and regulatory experts, and we can
you plan, gain, and maintain the marketability of your EU Pesticide/Biocide/Bio-stimulants Registration Regulated Crops operations under ISO 9001:2015 also rely on a network of external consultants worldwide.
products. US Pesticide /Disinfectant/Inert Ingredient/Device Quality system provide stewardship for National and
Registration International requirements. Plant Protection & Plant Nutrition - Chemical and
Main services: GB Pesticide/Biocide Registration Located in the best land area of Argentina offers a Biological products:
● Strategic and Regulatory Consulting Korea Pesticide/Biocide Registration capacity of excellent trialing quality while providing an
● Task Force and Consortia Management Australia Pesticide Registration extensive processing facility for counter season operation We can assist you in all regulatory procedures required
● Data Gap Analysis (DGA) Canada Pesticide Registration involving all steps of seed pipeline development. Manexa to obtain active substance approval and/or product
● Dossier Preparation (incl. IUCLID) & Submission China Reach and EU Reach Registration S.A. focuses its services in most extensive crops, Maize, authorisation for both chemical and biological products.
● Preparation of Biological Assessment Dossiers (BADs) Global Pesticide Registration Consulting Service Soybean, Wheat, Barley, Oats, Sorghum, Canola, among
● Literature Search & Evaluation Marketing and Regulatory Compliance Analysis Report others. Benefits of working with us:
● Study Management & Monitoring In Silico Prediction (QSAR, read-across, structural alert The main Experimental Field is located in Rojas, Buenos
● Classification & Labelling Proposals (CLH) analysis, metabolite prediction, quantitative limits for Aires province, Argentina. Field agronomic experimentation, laboratory testing
● Technical Equivalence Assessments control of impurities, molecular docking for endocrine and regulatory affairs expertise gathered in one service
● Import Tolerance & MRL Submissions disruptors) www.manexa-sa.com company! We offer you real added value by taking charge
● Risk & Exposure Assessments Modelling (incl. Endocrine Risk Assessment Report Nicolas Gear of your projects from the earliest stage all the way through
Disruptors and Higher Tier Approaches & Refinements) Test Arrangement and Supervision to registration.
+549-2475-411051
● ef;am (Environmental Fate Automated Modelling) -A fully Training Course of Pesticide/Fertilizer Registration
automated surface water and ground water EU Focus ngear@gear-sa.com Staphyt Regulatory Affairs
modelling software tool developed by knoell. Main markets: 23 Rue De Moeuvres, 62860-Inchy En Artois, France
● Quantitative Structure-Activity Relationship Modelling China, Europe, USA, Korea, Australia and Canada etc.
www.staphyt.com
(QSAR)
14th Floor | 3 Building | Haichuang Technology Center | 00 33 3 21 21 45 21
Main markets: Global (offices located in Asia, Europe, and 1288 West Wen Yi Road | Hangzhou | China contact@staphyt.com
the USA) Héloïse STEPHAN (Communication Officer)
Zip code: 311121
www.reach24h.com hstephan@staphyt.com
Eastsite XII, Konrad-Zuse-Ring 25, 68163 Mannheim,
Germany Daisy Hu
www.knoell.com huke@reach24h.com
Dr Julia Hügelschäffer + 86-571-87007033
Head of Division Regulatory Affairs Crop Protection &
Nutrition
JHuegelschaeffer@knoell.com
+49 6235 455968
SCC Scientific Consulting Shanghai Hills Consulting Co., Sordi AgroConsulting Ltda. Jinan Sunrise Agrotech Co., Ltd. TEAM mastery
Company GmbH Ltd.
Sordi AgroConsulting – SUNRISE AGROTECH is a third party service & Founded in 2008 as REACH mastery, as a consulting
SCC is a privately owned and Hills Consulting aims to be the founded by a professional with consulting company with the head quarter in Jinan, company dedicated to the REACH Regulation.
independent regulatory consulting top consultant for excellence in more than 16 years of experience China and subsidiary in Cambodia, Myanmar, Vietnam Today TEAM mastery provides a wide range of services
company. Since 1989, we have been Chinese pesticide international - has the purpose of being the and the Philippines. Focusing on the overseas regulations related to several European Regulations on chemical
supporting our international customers trading business, providing best consulting company in the &registration of agrochemicals, SUNRISE AGROTECH substances.
with full-scale services and cost- marketing research service based regulatory area, working with solves the regulatory issues of agrochemicals for the Our commitment is to assist customers in cost efficient
efficient solutions for their scientific on the agricultural needs and methods that seek a performance purpose of entering the target market through one-stop implementation of European and Global regulations on
and regulatory needs. Our expertise registration service based on the very closely to the day to day of efficient and accurate overseas registration service. chemicals with maximum professionality and sustainable
extends over a broad range of areas, technical equivalence and risk our customers, always aiming prices.
such as agrochemicals and biorationals, assessment system for the Chinese to offer high quality services, Main services: The staff is composed of a multi-disciplinary, highly
including biostimulants and fertilisers, clients to access Brazil, EU and other quick responses and customized - Overseas registration service motivated team with specific expertise in chemistry,
biocides and chemicals, medical devices, important market. solutions for each client. Our - GLP test supervision biology, toxicology, pharmacology, human health,
pharmaceuticals, cosmetics, consumer solutions are mainly recommended - Registration data generation environmental toxicology, and risk assessment. PhD
products, food contact materials, feed Main Service: for foreign companies that need -Target market research scientists, process engineers, and highly specialized
additives, and genetically modified crop. - International market research and to start their operations in the resources in specific fields enable the evaluation of
registration consulting Brazilian market. We present quick Main markets： customer concerns from a comprehensive, 360-degree
Main services: - EU technical equivalence and objective responses helping Indonesia, Vietnam, Cambodia, Laos, Myanmar, perspective.
- Data compliance reviews assessment submission our clients to achieve their goal Philippines, Thailand, Pakistan, Australia, New Zealand, The technical excellence and the high professional skills
- Testing strategies and study monitoring - Representing Sordi in the area of Registration and etc. of our team allow us to provide innovative and responsible
- Alternative testing strategies/ (Q)SAR AgroConsulting, Brazil Regulatory Affairs of Agrochemicals solutions, with timing responses and the highest scientific
- Scientific waivers, read-across and - Registration and market training in Brazil. 3-2422, Hisense Wisdom Center, No 63 Gongye quality.
group approaches The TEAM mastery crew are experts in the registration
South Road, High-Tech District, Jinan, Shandong,
- Scientific risk assessment and Main Markets: Brazil, EU Main Service: of Plant Protection Products and Active ingredients.
modelling China.
- Registration of Agrochemicals, Regulations are covered by nine divisions: REACH,
- Dossier preparation, submission and 22-101, Building 6, 1800 Biochemicals and Biologicals Tina.Yang；Nancy Xu BIOCIDES, COSMETIC, PHARMA, FEED/FOOD,
defense at national and international - Opening and legalization of tina.yang@scichiho.com.cn PRODUCT-SAFETY, AGRO, PHYTO, WORLD
Dayingpulu, Shanghai, 201700,
level foreign companies in Brazil
China nancy.xu@scichiho.com.cn
- GLP and non-GLP regulatory archiving - Training about Registration of Via Giuseppe Ferrari 14-B, 22100 Como, ITALY
concepts Mr. Chris Wu +86 15189934630
Agrochemicals www.team-mastery.eu
- Maintenance of product registrations 705478130@qq.com - Holding Registration +86 18868791241
- Task force/ consortia management Monica Locatelli
+ 86 13764174757
Main Markets: Brazil Head of Agro & Pesticide regulatory and scientific
Main Markets: Europe, Asia, NAFTA affairs
Av. Dr. Gastão Vidigal, 1132 – monicalocatelli@team-mastery.eu
Am Grenzgraben 11 / 55545 Bad
Conj 705A – São Paulo/SP - +39 031 269 513
Kreuznach / Germany
Brasil
www.scc-gmbh.de
https://sordi.agr.br
Dr Dagmar Heibertshausen, Head of
Mrs. Erika Lopes Sordi
Agriculture Regulatory & Scientific
contato@sordi.agr.br
Affairs
+ 55 (11) 98694 8712
dagmar.heibertshausen@scc-gmbh.de
+49 671 298460
Vigna Brasil Group

Winhonor Consulting Company Limited
Vigna Brasil is a 28 years-old CRO that works as
Winhonor Consulting Company Limited, started
a facilitator in Brazil rendering services as a “One-
in 2009, as one of the first consulting companies for
Stop Shop”. We´re a full services provider, offering
pesticide oversea registration service. We are always
any support regarding the segments below, since
devoted to “Create a Regulatory Service Network”.
the establishment of a legal entity in Brazil; Company
With internal and external partners support, we
licenses and product registrations (Regulatory Affairs);
successfully performed Thousands of Projects over the
Strategic operational issues and market intelligence
past 10 years to provide a System Service including
studies (Business Intelligence); Field trials execution and
Product Investigation, Data Generation, Dossier
management performed with crop protection products,
Preparation, Registration Holding, Efficacy Trial Studies,
fertilizers, inoculants, and GMO (Field Management) and
Registration Application Submission, and Registration
then, keeping the company and product in full operation,
Renewal according to the regulatory. Up to now, we have
keeping all the licenses and permits in force.
collaborated with multiple OECD GLP Laboratories, and
We also offer hosting services for products and/
we owned 5 branch companies and a Service Network
or dossiers and also for the importation of samples to
in over 30 countries. We have served many well-known
Brazil for most of the segments attended by the Group,
companies and received Rave Reviews.
through our local company called PROPHYTO. We can
Good Communication, Stable Service and Continuous
attend companies interested in the following segments:
Improvement are our conceptions. And we do will give
Crop Protection, Biopesticides, Adjuvants, Seeds, and
strong support for you.
GMOs, Fertilizers, Biostimulants, Inoculants, Animal
Nutrition and Veterinary, PCO, Public Health, Household,
Our service includes:
Lubricants, (Bio)Remediator, Wood Preservatives,
1.OECD GLP Studies.
Home&Garden, Aquatics, Food, Beverages, Food
2.Registration Application.
Additives, Chemicals, and Medical Devices.
3.Supporting Services:
We provide services to help your company to reduce
a)Application Dossiers Preparation.
bureaucracy or operational barriers for starting up and
b)Branch Companies Setting up in Other Countries.
maintaining your operations in Brazil, Latin America and
c)Registrations Transferring.
any other country worldwide (International Division).
d)Formulation Recipes Authorization.
e)Customs Data Searching and Service Selling, etc.
Main Services:
• Regulatory Affairs
• Market Intelligence No.302, 3rd Floor, No.7 Building Tiancheng Garden,
• Field Management No.398 Huanghe 8 Road, Binzhou City, Shandong
Province, China, 256600
Avenida Ipiranga, 318 – Bloco A - Cj. 1601 16º Andar www.winhonor.com.cn
- República – São Paulo – SP Larry Liu; Summer Zhang
01046-010, Brazil (Headquarter) winhonor1@winhonor.com.cn winhonor3@winhonor.
www.vignabrasil.com.br com.cn
(+5511) 3124-4455 +86-13954388891 +86-18366866719
vignabrasil
Mr. Fabio Domingues
fabio@vignabrasil.com.br
COMPANY DIRECTORY
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COVER STORY

2024 FORMULATION & ADJUVANT TECHNOLOGY / 01

End-to-end turnkey solutions for

Battelle provides high-quality, innovative, and sustainable solutions that streamline

+44 1245 450777

EPP Ltd (UK)

Eurofins Agroscience China National Chemical Information

Smithers knoell Germany GmbH (Germany)

STAPHYT (France) REACH24H Consulting Group

Jinan Sunrise Agrotech Co., Ltd.

STAPHYT (France) Asia - India

CRO Bioscience Research Foundation

JRF Global (India)

Vigna Brasil (Brazil)

P08 Borderline Substances in Europe: Plant

P12 Worldwide development of a P34 CRO Manual

in China, the United States, and Eurofins Agroscience Services P4/38

04 / 2024 FORMULATION & ADJUVANT TECHNOLOGY

EPP Ltd CRAO

Eurofins Agroscience China National Chemical Information

Smithers knoell Germany GmbH

STAPHYT Asia - India

CRO Bioscience Research Foundation

PLANTEC LABORATORIES INTERNATIONAL INSTITUTE OF Oceania

Vigna Brasil Group

Plant biostimulants are further

Borderline Substances in Europe:

Plant Protection Products or microorganisms allowed in microbial

Fertilising Products? and Rhizobium spp . Nevertheless,

depending on: definitions and categorisations of biostimulant components may be

2024 CRO & CRAO MANUAL / 11

In the end, to summarise, here

In this last group, we see great

The Fungi Opportunity: Currently, fungi still have a very

An analysis of the Brazilian

biopesticides market, latest

policies and trends is a future that is still unexplored

The pesticide registration rodenticides and avermectins. behavior, conducting necessary

5.Preparation of registering in different countries, investigation and assessment should

Leading global Website

Integrate global agribusiness resources for

In Vivo Pig-a Gene Mutation

Vehicle Control (PBS) 20 mg/ kg body weight of ENU

Introduction: The Pig-a assay is effective phosphatidylinositol (GlcNAc-PI), the

Result and Conclusion: safety assessments.

Shanghai IPRO-DVA Inspection Technology Co., LTD Our Partners

is the largest demostic third-party institution in China,

specializing in the quality inspection of exported chemicals

(pesticide, fertilizer, etc.), food and agricultural products

with CNAS (ISO/IEC 17025) and CMA certificates.

Our Services Contact

Development and validation of analytical method

AgriFor Scientific EU North Zone CRO specialized in field research and

Environmental fate studies) under one roof. At BRF, studies

Dr. C. Tamilselvan Chemical storage and shipping:

Agrochemicals GLP Services:

Eurofins Agroscience Services Eurofins Advinus Agrosciences Services India Pvt.

JDM Scientific Research Organisation Pvt. Ltd.

Mr. Lary Liu

2024 CROs & CRAOs Manual - Published by AgroPages

2024 CROs & CRAOs Manual - Published by AgroPages

2024 CROs & CRAOs Manual - Published by AgroPages