Download - Biopesticides European Mrkt
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NATURAL RESOURCES INSTITUTE
Knowledge to feed the world
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Welcome Address
Prof. Andrew Westby
Director, Natural Resources Institute,University of Greenwich
Biopesticide Market Opportunities:
Strategic brokerage and networking event
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Welcome
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NRI has a long history of research to develop IPM systems for developing country
agriculture and we still have active research groups developing IPM componenttechnologies such as pheromones, insect viruses and other biopesticides.
NRI undertakes research and consultancy
in all aspects of agriculture and natural
resource development.
We also run a number of postgraduate programmes and at any one time may have in
excess of 40 PhD programmes running based at the University’s Chatham Maritime
Campus in Kent.
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• MSc Agriculture for Sustainable Development
• MSc Sustainable Environmental Management
• MSc Food Safety and Quality Management
• MA Rural Development Dynamics
NRI postgraduate programmes
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• Pheromones in pest management
• Plant extracts in pest management
• Insect viruses in pest management
• IPM of whitefly in cabbage
• Biofumigation for management of soil-borne diseases
• Rodent management agriculture
See
Examples of IPM-related research topics at NRI
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• The European Centre for IPM was set-up at NRI, as a platform to promoteIPM in European Farming and to offer the IPM know-how at NRI to theagriculture and horticulture sectors in Europe.
• At a time when pesticide use is being curtailed through EU legislation andwider implementation of the principles of IPM is being advocated, our
capacity and expertise in IPM and IPM component technologies, can bereadily adapted to the needs of European agriculture.
See eucipm.org
The European Centre for IPM
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• The University of Greenwich is a key partner in the South East UKconsortia of the Enterprise Europe Network.
• This workshop has been organised byEEN South East UK, together with the
EUCIPM, NRI and the Society of Chemical
Industry Bio-Resources Group to further
the commercial opportunities for biopesticides
arising from the decreasing availability of
conventional pesticides for European agriculture.
Organisation of this meeting
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Not all insects are our enemies!
Thanks for your attention
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Natural Resources Institute
University of Greenwich
Medway campus
Central Avenue
Chatham Maritime
Kent ME4 4TB
Telephone: +44 (0) 1634 880088
Email: [email protected]
Website: www.nri.org
Twitter: @nrinstituteFacebook: facebook.com/naturalresourcesinstitute
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Bio-pesticide Market Opportunities 11 April 2013
Introduction to theEnterprise Europe Network
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Bio-Pesticides Market Opportunities 11 April 2013
What is the Enterprise Europe Network?A Unique network of >3000 local experts in ~600 organisations in
>50 countries throughout the EU and beyond, dedicated to
helping SMEs make the most of business opportunities in the EU.
Mission “We are the world’s largest network connecting business to
Europe. We help companies improve and innovate through
partnership, information and expert advice.”
An important part of the EU’s
Competitiveness and Innovation Programme (CIP)
Budget €320 million (2008-2014)
Enterprise Europe Network
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Bio-Pesticides Market Opportunities 11 April 2013
~600 Partners
Universities
Local Actors
Large
Companies
SMEs
Enterprise Europe Network
BSKEISC
EEN SE Consortium
UoG
Enterprise Europe Network
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Bio-Pesticides Market Opportunities 11 April 2013
Receive local business support and information services
Find business and technology partners using the business
and technology cooperation databases
Develop research and innovation capacity through links withUniversities and research institutes
Cooperate with Universities in RTD programmes
and application for funding, in particular FP7
EEN helps companies and academics
What does Enterprise Europe Network do?
We facilitate the formation of technical/business partnerships
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Bio-Pesticides Market Opportunities 11 April 2013
Bio-Pesticides?
Why is Enterprise Europe Network interested in Bio-Pesticides?
New EU legislation will mean a reduction in the use of chemical
pesticides and a rise in the application of new IPM technologies.
Impact – there are 13.7 million farmers in the EU.
A huge number of SMEs involved with all aspects of plant
protection will be affected by the change.
Opportunity - new technologies/businesses, commercial and
R&D partnerships.
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Bio-Pesticides Market Opportunities 11 April 2013
Use the EENetwork
Use it to let potential partners find YOU
Take advantage of free services to helpyou communicate via the Network
Use it to find YOUR
business/technology partners
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Bio-Pesticides Market Opportunities 11 April 2013
A profile is a succinct description of an ‘offer’ or a
‘request’
A Profile can be Technical or Commercial or both
Profiles
Profiles are published in the EEN database and can
be accessed by anyone
Responses to profiles lead to partnerships
Creating a Profile is an effective way to use the Network
The Network’s database contains ~14000 profiles
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Bio-Pesticides Market Opportunities 11 April 2013
What kind of opportunities can be posted and responded to?- Entry into a new market or region (supplier/distributor)
- Co-development of novel technology
- Licensing agreement
- Manufacturing agreement
- Joint ventures
- Franchise
- Research funding / consortium partner search
Most types of agreement and sector covered
Profiles – types of partnership
See profiles relatingto crop protection
on display in room
QA075
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Bio-Pesticides Market Opportunities 11 April 2013
Profiles - the process
Publication of a profile
Database searches and alerts, Partner
Intranet communication
Partnership AgreementsExpressions of interest
exchanged
Business
Agreement
Technology Transfer
Agreement
R&D
Proposal
Or….search the
database to find
offers and requests
that might be of
interest
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Bio-Pesticides Market Opportunities 11 April 2013
Keyword search
Profiles
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Bio-Pesticides Market Opportunities 11 April 2013
Thank you for your attention
Speak to me or one of mycolleagues today if you’d like
to know more about
Enterprise Europe Network
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Bio-Pesticides Market Opportunities 11 April 2013
Contact
Dr Jeff PedleyTel: 01634 883751
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Pesticide Reduction in Europe and
the role of IPM
Rory Hillocks
European Centre for IPM, NaturalResources Institute, University of
Greenwich [[email protected] ]
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New Opportunities
• If the EUCIPM sees EU pesticide legislation as anopportunity for more IPM research and development,then, for similar reasons, it is also a commercialopportunity for companies manufacturing and selling
biopesticides and other IPM-compatible technologies.• The EUCIPM is particularly keen to promote and
participate in adaptive research in partnership withbiopesticide companies and farmers.
• We see the need for a more participatory andcommercial approach to bring IPM theory into practice.
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IPM in EU Policy
• The EU’s Sustainable Use Directive [SUD]
requires Member States to develop National
Action Plans showing their strategy for
pesticide reduction and IPM implementation
• EU sees wider adoption of IPM as the main
pillar of their strategy to mitigate the negative
effects of pesticide withdrawals on foodproduction
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What does the EC ask us to do?
• Sustainable Use Directive: On the basis of Regulation (EC)No 1107/2009 and of this Directive, implementation of theprinciples* of integrated pest management is obligatory
•
Member States should describe in their National ActionPlan how they ensure the implementation of the principlesof IPM, with priority given wherever possible to non-chemical methods of plant protection and pest and cropmanagement.
[*8 principles of IPM are outlined in Annex III of the SUDDirective 2009/128/EC ]
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What are the main challenges?
Sustainable Intensification
Can economic, environmental and social sustainability all
de delivered at the same time and place.
How to produce more food in Europe with less pesticide?
How to produce more food, without major increase infood prices while at the same time enhancing food andenvironmental safety and biodiversity?
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Need for IPM systems
• While IPM is long accepted and widely practiced incovered crops, this is much less so in outdoor crops,particularly broad-acre crops.
• If the European Parliament is to realise its wish for a
substantial reduction in total pesticide use in farming,then IPM systems incorporating biological alternativesto conventional pesticides, must be widely available forall farming systems
• IPM technologies and systems will need to be
attractive to the arable sector, particularly cerealgrowers and for cereal/OSR rotations, where most ofthe pesticide is used.
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UK Wheat - disease a major problem in
2012
Fusarium diseases and Septoria were particularlysevere in the UK wheat crops in 2012 and the majorweed problem in cereal x OSR systems, blackgrass,is becoming increasingly difficult to control asherbicide options disappear under EU legislation
As a consequence, UK may be a net importer ofwheat for first time in 10 years
[Toby Bruce and Peter Kendall–
open letter toMinister of state for Agriculture, Dec 2012, asking
for more support for IPM R & D]
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R&D investment as percent of sales by sector
Source: Financial times, Phillips MacDougal
Crop Protection/Biotechnology business is innovation-driven
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Biopesticide market [2010]
• The European market for microbial- and nematode-basedpesticides is estimated to be approximately $54,485,000.
• The largest increases since 2005 were seen in non-Bt bacteria,notably Bacillus subtilis, and in fungal-based products,including Coniothyrium minitans and Trichoderma-based
products.• There were also significant increases in viral sales and a
steady rise in the nematode market.
• The largest individual European biopesticide market is Spain,followed by Italy and France.
• The potential remains high and opportunities exist whichcould raise the total market to $200 million by 2020.
[CPL Business Consultants (2010) Europe: Biopesticides Market. CAB
International ]
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Biopesticide Market cont…..
• 69% of new pesticide registrations in USA are
biopesticides
• Less in Europe due to registration hurdles
• Registration is 61% of development cost
• But ratio of development cost to sales still
favours conventional pesticides
• Solution lies in expanded markets and a more
facilitated registration process
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CROP Cultivated area[1000 ha] % of crop protectionmarket
Wheat [+ other cereals] 126,000 32.6
Vines 173,000 9.8
Maize 55,000 8.6OSR 16,000 7.9
Potato 57,000 5.1
Apples [+ other fruit] 4.6
Tomato [+ other vegetables] 12.9
Crop areas and pesticide use in main European crop groups
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Fungicide use in Wheat in UK
Fungicide Total kg x 1000
Chlorothalonil 689
Boscalid/epoxiconazole 134
Prothioconazole/tebuconazole 114
Epoxiconazole 64
Pyraclostrobin 51
Garthwaite DG (2011) Pesticide Usage Survey
Report 235 – Arable Crops 2010
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Reasons for fungicide application
Reason for use in winter wheat % applications
General disease control 76
Septoria 8
Rusts 6Ear diseases 3
Rusts + septoria 3
Mildew 2
Fusarium 1
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Section 16: Integrated Pest Management
• Sub-Section 16.4 Biopesticides have a number of benefits over
conventional chemicals including IPM compatibility and generally reducedrisk to non-target organisms including people.
• However, they are often more expensive and may have reduced efficacy.
Since they tend to be specific in their action development is also limited by
the small scale of the potential market.
• Given their wider benefits the UK Government has taken an active role in
encouraging the development of biopesticides through research anddevelopment and a special Biopesticides Scheme.
• Since 2006 approximately £2.1 million has been spent on research
(excluding R&D on semiochemicals) and £150,000/year spent on the
Biopesticides Scheme and related regulatory activities.
• Ten biopesticide active substances have been approved since the Scheme
started in 2006.• The Scheme is currently being reviewed and part of the review will
consider the scope for reducing the obstacles to biopesticide
development. The review is due to conclude in early 2013 with a view to
any changes to the scheme being introduced later in the year.
The UK National Action Plan – Published February 2013
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THANKS FOR LISTENING
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April 2013
Industry trade association Established in 1995/96 Over 200 members Global European based association Strong growth from 6 original founding
members Diverse membership
◦ SME’s to multinationals
◦ Organic & biocontrol only to traditionalinternational chemical companies
◦ Principally involved in agriculture & horticulture
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April 2013
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April 2013
Microbials
Viruses, Bacteria &
Fungal Pathogens
Macrobials
Predatory mites &
insects,
nematodes
Semiochemicals
Pheromones, Plant
volatiles
Natural
Products
Plant extracts,
Seaweed products
& Basic substances
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April 2013
Ensuring proportionate regulation ofmembers’ products
Promoting the interests and activities of thesector and its’ members
Most activity of members is in crop protection
Strong growth in the use of biocontrolproducts
Strong European focus Establishing a global network
Diversification into other areas
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April 2013
Size relative
to pesticide
market?
Growth ofthe market?
Future
potential
market size?
Formation
of the
market and
companies?
Availableinformation?
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April 2013
Conventional agriculture
•Is core to widespread adoption across
food value chain
•Is predominately where biocontrol
industry will grow
•Is where the greatest demand is for help
& support
•Is where most IPM tools exist
•Is where IPM tools are most needed
Organic agriculture
•Can and are important allies
•Represents some of the best farmers
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April 2013
Physical Control
Monitoring
Biocontrol
Bio stimulants
Bio fertiliser
Biotech
Interactive modelling
Application techniques
Mechanisation
Cultivation
Irrigation
FertiliserAg-chemicals
EnvironmentalIndex
Productivity Index
Where willwe see trueinnovation
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April 2013
High Growth industry >10% pa
High number SME’s >95%
Broad interests, attitudes & origins
High % level of investment in RD&R
Rapidly expanding list of ai’s
Multiple market access with limited infrastructure
Innovative novel MOA’s
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April 2013
OECD Activities FAO Activities
Minor Uses Summits / Forums
EU Parliament
EU Commission
EFSA
NGOs
Industry Bodies Whole Food Value Chain
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April 2013
Move the industry from fresh produce to major agriculturalcommodities
Ensure global availability and adoption◦ Global federation of regional biocontrol associations◦ Access to new solutions from all regions◦ Market access and use in all markets
Produce usable tools for farmers and advisors Communication of needs, solutions and knowledge with
farmers and advisors Formulation, Shelf-life & application technology Simplify the decision making process
◦ Basic systems based programmes
With tailoring for regional and local situations Work effectively with all partners from farmers to consumers
ensuring tools and research are fit for purpose
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April 2013
The future
is green
The future
is
productive
The future
balances
responsibiliti
es and
opportunities
The future
is true
innovation
Biocontrol
aims to be a
part of thisfuture
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April 2013
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Roma L Gwynn
Aspects of biopesticide regulation:
EU plant protection product regulatory situation
Biological Control Agents - role in food security
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Source: UN World Food Programme and the FAO
"The State of Food Insecurity in the World 2006" report.
Biological Control Agents - role in food security
In last 40 years farmable land per person has halved
30 - 40% of crops are lost before harvest and > 10% after harvest
Sustainable Use Directive
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DIRECTIVE 2009/128/EC
Chapter 1, GENERAL PROVISIONS, Article 1
“
This Directive establishes a framework to achieve asustainable use of pesticides by reducing the risksand impacts of pesticide use on human health and theenvironment and promoting the use of integrated pestmanagement and of alternative approaches or
techniques such as non-chemical alternatives topesticides.”
Sustainable Use Directive
What are biopesticides ?
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• Crop protection products derived from the flora and fauna
• No fixed global or EU definition
IBMA definition
• Macroorganisms – natural enemies, nematodes
• Semio-chemicals - pheromones
• Botanicals - plant derived compounds such as plant extracts,
• Microbials - micro-organism based products
What are biopesticides ?
Semio-chemicals
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• Pheromones are semiochemicals that modify the behaviour of other
individuals of the same species
• Semiochemicals “… chemicals emitted by plants, animals, and otherorganisms - and synthetic analogues of such substances - that evoke abehavioural or physiological response in individuals of the same or otherspecies”
• Straight-chained lepidopteran pheromones (SCLPs) … unbranchedaliphatics having a chain of 9-18 carbons, containing < 3 double bonds,ending in an alcohol, acetate or aldehyde functional group.
Semio chemicals
Botanicals
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• Includes compounds - physical mode of action
- essential oils- derived from plant material
Botanicals
Thyme sp. Tagetes sp.
CymbopogunSp.
Citrus.
Micro organisms
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• The active substance should be a viable micro-organism,e.g. live cells, spores etc.
Micro-organisms
Metarhizium anisopliae
Beauveria bassiana Bacillus thuringiensis
Bacillus subtilis
Microbial production
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Microbial production
Biopesticides – efficacy
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Biopesticides efficacy
0
10
20
30
40
50
60
70
80
90
100
C o n t a n
s W G
C y D -
X
D i P e l D F
E x o s
e x C M
M a j e s
t i k
M y c o t a l
N a t u r
a l i s - L
S e r e n
a d e A
S O
% e
f f i c
a c
Biopesticides – EU active substances
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Figures in bracket = pending
(Updated Jan 2013)
Biopesticides EU active substances
Insecticide Fungicide Herbicide Nematicide Other
Microorganism Bt 4 - - - 0
Microorganism non-Bt
12 (2) 15 (10) 0 1 (2) 0
Botanical 5 (4) 0 (4) 1 0 6 (1)
Semio-chemical +pheromones
29 - - - 2 (2)
Other 0 1 1 0
Total 52 (6) 16 (14) 2 1 (2) 8 (3)
Biopesticides – in crop protection
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Biopesticides in crop protection
• Amenable to use in IPM programmes
• Work best in population management
• New & multi modes of action:
useful for resistance management
• Potentially extend ‘life’ of some actives
• Many products with no MRL
• Often no harvest intervals
• Useful for residue management
Plant Protection Product Registration
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Why do we need regulation?
Plant Protection Product Registration
Why Regulate?
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Why do we need regulation?
• Protection of the natural environment
• Protection of human safety
• Maintain consumer standards
• Protect farmers and growers by having quality standards
• Protection of technological invention
• Protection of rights
• Maintain product standards
Why Regulate?
Conventional Chemical Pesticides
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Plant protection products containing chemical active substances
(Insecticides, nematicides, herbicides, fungicides, rodenticides, plantgrowth regulators, etc.)
• High levels of efficacy are obtained and expected by farmers >80%
•Usually have a toxic mode of action
• Usually patented synthetic substances with a mode of action that is wellunderstood
•Mature regulatory procedures
• Rigorous criteria for risk assessment and risk management must be metto ensure safety
Co e t o a C e ca est c des
What is the Biopesticide Regulatory Framework?
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• Protection of Intellectual Property Rights
• Protection of Biodiversity rights (www.cpd.in)
• Import/Export Restrictions (FAO guidelines)
• Plant Protection Product registrations
p g y
Plant Protection Product Registration
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Under Regulation 1107/2009 (replaces 91/414)
• Tier 1 – registration of active substance at EU levelOne member state evaluates application then 26 others discussand reach agreement for approval/non-approval.
• Tier 2 - national registration of product
For each country where product to be sold, need to registerso need efficacy data for each country/crop/pest
• Harmonise pesticide regulation across Member States – MutualRecognition
• Zonal product registration
• No biopesticide specific system but guidance notes provided byDG SANCO or by OECD – biopesticide harmonisation
http://ec.europa.eu/food/plant/protection/evaluation/index_en.htm
Plant Protection Product Registration
Plant Protection Product Registration
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Data requirements for the active substance
• Identity and purity
• Physical and chemical properties (biological properties)
• Analytical methods
• Toxicology (infectivity and pathogenicity)
• Residues in the plant
• Ecotoxicology
• Behaviour in environment
Plant Protection Product Registration
Plant Protection Product Registration
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Data requirements for the formulated product
• Identity and composition of the formulation
• Physical and chemical properties
• Labelling and packaging
• Analytical methods
• Efficacy data
• Toxicology
• Effects on non-target organisms
• Effect of operators and consumers
Plant Protection Product Registration
EU Registration – Low Risk
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Low-risk active substances
“1. An active substance complying with the criteria provided for inArticle 4 shall be approved for a period not exceeding 15 years by
way of derogation from Article 5, where it is considered a low-riskactive substance and where it may be expected that plant protectionproducts containing that substance will pose only a low risk to humanand animal health and the environment as provided for in Article47(1).”
EU Registration Low Risk
EU Registration – Low Risk
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EU 1107/2009 Low Risk Criteria
Approved for 15 years (c.f. 7-15 years) but NOT if:
• Carcinogenic, Mutagenic, toxic to Reproduction, sensitisingchemicals, very toxic or toxic, explosive, corrosive
• Persistent (½life in soil >60days)
• Bioconcentration factor >100
• Deemed an Endocrine disrupter
• Has neurotoxic or immunotoxic effect
g
EU Registration – Low Risk
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In EU - Low risk PPPs are when:
• All the actives are low risk substances
• There are no specific risk mitigation measures
• Meet Article 47 (1) requirements (e.g. approved underChapter II, no substances of concern, effective, etc)
Authorisations decided in 120 days (c.f.12 months)
13 years data protection (c.f.10 years)
Plant Protection Product Registration
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How to address data requirements ?
• Scientific investigations by the applicant or contract laboratories,generally to GLP standard
• Field trials to measure theo persistenceo residue behaviouro efficacy
• Published papers which contain findings relevant to answering theregulatory question – either single papers or the ‘weight of evidence’
• Specific pieces of information e.g. “The product will be applied to cereals”
• Waivers, also known as scientific justifications, where it is explainedthat the question is not relevant to this particular question because ofa specific reason – essential for biopesticides
Plant Protection Product Registration
Biopesticides – EU zones
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EU - Active substance (Annex II and III)
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Each country –
Product (Annex III + BAD)From John Dale, CRD
Regulatory pathway
developed for over 50 yearsfor chemical pesticides,
biopesticides relatively new
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Do we need a biopesticide specific registration ?
In EU no biopesticide specific system but guidance notes providedby DG SANCO or by OECD – biopesticide harmonisation
Microbials - types
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Rhizobium spp.
Coniothyrum sp.
Trichoderma spp.
New isolate
Beauveria bassiana
B.subtilis
New spp.
Bt. Spinosad
New spp.
Biopesticides -biorationals – grey products
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Registered
Biopesticides (microorganism,
semiochemicals, botanicals)
Biorational substances
(acetic acid, gibberelins,ferrous sulphate, fatty acids)
Out of scope for
registration
Plant strengtheners/growthpromoters/stimulants
Root symbionts
Registration Exempt
Entomopathogenic nematodes
Physically acting agents
Grey Products
Passing-off of ‘similar’microbial agents
Claiming ‘plant strengthener’but for crop protection use
Biopesticide Registration
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Why are these groups considered to pose a lower risk?
• Generally speaking this is the case (always exceptions)
• Some general characteristics of biopesticides make them suitable forstreamlined regulatory assessment
• This may be due to their high specificity, existing natural emissions andpresence in the environment
• There may be existing and acceptable exposure to them through otherroutes e.g. in food or in cosmetics
• Regulatory authorities require special systems to allow more effectiveregistration of these products
p g
Biopesticide Guidance Documents
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OECD – Biopesticide Steering Group (BPSG)
• Programme of work to develop harmonised approach to regulationsof biopesticides
• Development of guidance documents e.g.
OECD SERIES ON PESTICIDES
Number 18: Guidance for Registration Requirements for MicrobialPesticidesNumber 12: Guidance for Registration Requirements forPheromones and Other Semiochemicals Used for Arthropod PestControl
• EPPO: Principles of efficacy evaluation for microbial plant protectionproducts
• EPPO zonal guidance for 1107/2009
•
SANCO: developing Botanical Guidance Document
p
Microbial Guidance for the EU
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OECD Series on PesticidesNo. 43: Working document on the evaluation of microbials for pest
control
Efficacy: only the minimum necessary dose is applied.
Alternative control methods: performance is often low compared withconventional control methods e.g. synthetic chemicals = 95% control,
alternative can be less than 40%, and of shorter duration.
Biopesticides may reduce pest pressure, but not remove the pest.
Many countries accept reduced use claims: a lower level of efficacy canbe acceptable.
Key issue is that the level of pest control/reduction = measurablebenefit = a range of performance levels may be acceptable.
Label claim: control, moderate control or suppression, reduction, other
Biopesticide Registration
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Dossier development
• Dossier development time e.g. in Europe:
Active substance – 2.5 years (now)Product – 18 months
• For Annex I (active) = € 500,000 - 1,000,000 approximately
• For Annex III (product) - 1 zone/crop/pest situation = € 1-200,000
• Plus country fees
Costs of registration
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chemical biological
No. potential “actives” tested
>3.5 million 3000
Success ratio 1: 200,000 1:20
Development time 10 years 10 years
Development costs US$180 million US$ 2 million
Benefit per unitmoney invested
2.5 - 5 30
Risk of resistance large Small - nil
specificity low high
Harmful side effects many Nil / few
Comparison of chemical and biocontrol according to Bale et al., 2008
Bale et al. “Biological control and sustainable food production”. Philosophical
Transactions of the Royal Society B (2008), 363, 761 - 776
Aspects of Regulatory Good Practice - biopesticides
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• Specialist knowledge for each technology - especially Micro-organisms
• Expertise to have high-level discussions on all the technology, forall dossier specialist areas
• Familiarity with all available guidance documents
• Availability for clarification of minor points
• Dedicated biopesticide evaluators
• Free pre-submission meetings
• Openness to discuss non-typical features during dossier development
• Facilitating approach
• 1 day completeness check
Biopesticide registration in EU
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1107/2009 Year 1 Year 2 Year3
1 2 3 4 5 6 7 8 9 10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
A.S. DossierSubmission
Completenesscheck
Rapporteurevaluation
DAR completed
EFSA comment
on DAR
EFSA peerreview
Standingcommittee vote
Positive List(Annex I)
Application -
zonal product
Zonal evaluation
Countryevaluation
Product approval
Biopesticide Registration
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Summary of biopesticides registration
• Biopesticides require registration as plant protection products
• Mainly regulated using same system as for chemical pesticides
• In EU two stage process – active substance and product
• Registration takes ~ 4 years and costs from € 0.5 million up
• Some development of biopesticide specific guidelines
• OECD harmonisation for biopesticides
• Number of products increasing because of demand for them bygrowers and farmers
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Thank you for your attention
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‘
Farm ing w ith fewer pest ic idesEU IPM Centre wo rksh op on Bio pest ic id e Market Oppo rtun it ies
11th Apr il, 2013
Stephanie Williamson, PhD
PAN UK and PAN Europe
PAN E h ?
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PAN Europe: who are we?
• One of 5 regional centres of the PAN Internationalnetwork, established 1982
• 31 not-for-profit members in 19 European countries,from public health, environmental, trade union, farming& women’s organisations
• Working to replace use of hazardous pesticides withecologically sound alternatives
• Recognised stakeholder in EU pesticide policy arena
• Brussels-based with 4 part time staff
www.pan-europe.info
Hi h l H d P ti id (HHP )
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High ly Hazardous Pestic ides (HHPs)
• HHP approach launched 2007 by FAO + WHO to tacklecontinuing 21st century pesticide problems - despite
decades of legislation & ‘safe use’ training
• Aims to reduce risks and phase out use of HHPs, while
phasing in safer and more sustainable alternatives
• HHPs not just acute poisonings - also chronic health
effects and environmental hazard
• PAN International List of HHPs (2009, via www.pan-
germany.org and click on HHPs)
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P li d i f IPM i E
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Pol icy d rivers for IPM in Europe
Sustainable Use of Pesticides Directive:
Maximising natural control processes + Minimising
dependence on unsustainable external inputs
• Pest/weed/disease-suppressive crop husbandry and agro-
ecosystem design – more diverse crop rotations!
• Biological control (conserving & encouraging natural
enemies; using biopesticides & invertebrate biocontrol
agents)
Other policies:
• CAP reform; green growth; resource efficiency; innovation;
climate-friendly farming; public health
P i i t t h i l th d ?
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Prior i ty to non-chem ical methods?
• Weak SUDimplementation & poor
National Action Plans
(esp. UK)
• Trend towards ‘insurance’
pest control, e.g. neonics
• Strong lobby to ‘save ourpesticides’
• UK Pesticide Forum hasno indicators for IPM
uptake
• Disjointed & piecemealactions in research, policy
& practice on IPM in UK
• Little recognition ofexternal costs of harm
D i i i l l h i
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Drivers in commerc ial supply chains
• Greenpeace Germany campaign on illegal residues inSpanish peppers- led to biocontrol ‘revolution’ in
Andalucian protected horticulture
• PAN UK is promoting HHP approach to UKsupermarkets – powerful route for promotion of
alternatives, incl. biopesticides
• Neonics & bees debate triggering product withdrawals ingarden & ornamentals sectors & enthusiasm for
alternatives- + latest bird effects report (American Bird
Conservancy, 2013)
Opportunities in HHP ‘targets’ in UK
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Opportunities in HHP ‘targets’ in UK
Opportunities in alternatives for pests targeted with neonics:- Seed treatments, in OSR, maize, other cereals, beet, ornamentals
- Foliar applications in arables, orchards, vegetables
- Home & garden pests
Alternatives for chlorpyrifos- an insecticide on its way out…
Alternatives for pesticides frequently contaminating water sources (e.g.
several herbicides)
Alternatives for pesticides most frequently found in food (e.g. post-
harvest fungicides)
HHP approach needed in EU
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pp
pest ic ide author isat ion
• Regulation cut-off criteria- endocrine-disrupting pesticidedefinitions and debate in 2013…
• 50+ ‘failed’ actives still available under DG Sanco’s Re-
submission ‘loophole’ (e.g. bromuconazole, methomyl,
trifluralin)• ‘Essential use’ derogations, e.g. metam sodium for soil
fumigation (see PAN Europe reports Meet Chemical
Agriculture)
Taking a more precautionary approach will open doors
for safer alternatives.
PAN UK promot ion of IPM
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PAN UK promot ion of IPM
• Organic cotton in West Africa- adaptive research onusing food spray to attract beneficials
• Collecting farmer experiences in managing coffee berry
borer without endosulfan (incl. pros and cons ofBeauveria bassiana)
• Advice to Better Cotton Initiative; 4C Coffee; Unilever;
Marks & Spencer; Co-op
• Telling good IPM stories in our Pesticides News
international journal
Boost ing IPM up take
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Boost ing IPM up take
• To what extent are biopesticides being taken up by usersin UK?
• Do we know what the main obstacles are?
• Any research or market feedback on how and why
farmers/growers start to use biopesticides and otherbiorationals?
• Lessons for sharing success?
• Action planning for wider uptake of biopesticides and
IPM strategies?
Thanks for l is tening
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Thanks for l is tening
And maybe we can collaborate….
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IPM in orchards
- current perspectives and future needs
Jerry Cross
Angela Berrie
Integrated Pest Management (IPM)1
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A definition2
IPM is a decision-based process involving coordinated
use of multiple tactics (natural, genetic, cultural,
biological, biotechnological methods etc) for
optimising control of all classes of pests (insects,diseases, weeds etc) in an ecologically and
economically sound manner
IPM is a vital corn erstone of
sus tainable food p roduct ion
1Michelbacher & Bacon. 1952; 2Compendium of IPM Definitions www.ipmnet.org/ipmdefinitions
Key aspects of IPM
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Decision-based process
•Monitoring of pest and antagonist populationsand/or risks
• Economic, treatment or risk thresholds
Multiple, compatible suppressive tactics
• Priority given to natural, genetic, cultural, biological,
biotechnological control methods
• Integrated, minimum use of safest selective
pesticides
• Broad-spectrum, toxic/harmful, persistent pesticidesavoided
Ecolog ical ly and econom ical ly sound
Modern apple production
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Reliance on pesticide sprays
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• ~18 spray rounds
• Frequent tank mixing
• >20 fungicides/annum
• 3 - 4 insecticides/annum
• Plant Growth Regulators
• Pre-harvest spraying for rots
• Broadcast air assisted
sprayers
Pesticide residues
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UK government surveillance – apple 2003
301 samples analysed for 109 residues
82 UK produced - 219 imported
71% had pesticide residues > reporting limits
1% had 5 residues
3% had 4 residues
5% had 3 residues
5.3% had 2 residues
3 MRL exceedances (all on imported fruit)
UK indus try made big effor t to reduce but w ere demo t ivated
when goal posts m oved by reduct ion in repor t ing l imi ts !
How does apple IPM stack up?
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How does apple IPM stack up?
is it
Integrated Pest Management?
or
Integrated Pesticide Management?
Perennial fruit crops providestable ecological habitats
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Semi-permanent
canopy
Mown ground
herbage
Undisturbed bare
soil area
stable ecological habitats
Beehive for
pollination
Arthropod fauna apple
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Pests
Natural enemies
Benign2000 sp
Wild rosaceae
Apple
About 20 common arthropod pests
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Codling moth
Mussel scaleApple rust mite
Spider mites
Tortrix mothsRosy apple sphid
Green apple aphid Winter moth
Common green capsid Woolly aphid Blastobasis
Sawfly Rhynchites
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Apple pests
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Key pests
• Frequently cause damage at low densities
• Damage fruit directly• Recur after control with insecticides
• Not effectively regulated by natural
enemies
Secondary pests
• Natural enemy-regulated in unsprayed
situation
• Outbreaks caused by natural enemy
disturbance• Difficult to control/develop resistance
Minor pests
• Local or sporadic or attack foliage only
Communities of natural enemies
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Forfic ula auricu laria Episyrph us balteatus
Resident generalist predators Highly mobile specialist predators
Species specific parasitoids
Aphelinus m ali
Several important apple diseases
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Powdery mildew
ScabBrown rot
Orchard diseases Storage rots
Nectria rot
Control of apple diseases
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• Almost all commonly grown apple varieties are highly
susceptible to scab
• Many are susceptible to mildew
• Apples are stored long term to regulate supply of fruit
onto market
• Losses in store due to rots that invade fruit in the
orchard can be high
• As a result, apple orchards are routinely andintensively treated with fungicides
throughout the season
Major fai lure in IPM implementat ion
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Economic thresholds and actions
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Sampling unit Pest Threshold Action
(/tree for 25)
Dormant period
2 veg buds on Rust mite 10/bud Acaricide
1 yr shoots at mouse ear
Beat 2 branches Bloss weevil 5 adults/50 beats Chlorpyrifos
Green cluster
Whole tree Scab % trees infected Intensify prog
< 5% = low
5-20 = mod
> 20 = high
4 blossom truss RAA 1% infested Aphicide
In HDC Best Practice Guides
Agronomists score system
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0 = not detected1 = trace
2 = low level below threshold
3 = at or approaching threshold
4 = damaging level above threshold
5 = severe infestation
Orchards inspected for tn igh t ly throughgrow ing season by agronom is t
Sho rt of the ideal!
Monitoring pest and antagonist populations and/or risks
Pest specific monitoring traps
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Sex pheromone traps
for codling and tortrix
moths
Non-UV reflective white
visual traps for adult apple
sawfly
Monitoring pest and antagonist populations and/or risks
Phenological forecasting models
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• Web accessible networks of met stations
• Temperature sum phenological model predicts emergence and flight
• Dusk temps >15 ˚C used to determine periods of egg laying risk
Monitoring pest and antagonist populations and/or risks
Disease risk forecasting models
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Widely used for adjust ing sp ray t im ing but substant ive
reduct ion s in fun gic ide use are weather dependant and
seldom real ised in wet cl imates
Natural, genetic, cultural, biological, biotechnological controlsResistant varieties
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Resistant varieties
Scab
MildewRosy leaf curling aphid
Woolly aphid resistant MM rootstocks
Seriou s fai lure greatest need and challenge
Bramley Gala Braeburn
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O h d d t it
Natural, genetic, cultural, biological, biotechnological controlsExploiting and enhancing existing natural enemies
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Orchard predatory mite
Typhlod romu s pyr iPhytophagous mites
Great su ccess story
Common European earwig
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• Omnivorous
• Once considered important pest eat anthers and leaves
enlarge holes in ripening fruits
• Voracious nocturnal predator of
many important orchard pestspear psylla, aphids, codling moth
• Pear psylla and woolly aphid not pests
where earwigs abundant
• Large orchard to orchard variation in
earwig populations
• Bottle refuges
Effects of pesticides on earwigs
i EMR k Oth h
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a.i. EMR work Other researchers abamectin Safe Harmful
acetamiprid Safe - Bt - Safebifenthrin - Harmful
chlorantraniliprole Safe - chlorpyrifos Harmful Harmful
cypermethrin - Harmful (nymphs, knockdown) DDT - Harmful
deltamethrin - Harmful (knockdown) dimethoate - Harmful
fenitrothion - Harmful
flonicamid Safe Safe or harmful indoxacarb Harmful (adult males, knockdown) Harmful (knockdown) methoxyfenozide Harmful (nymphs) Harmful permethrin - Harmful
pirimicarb - Safespinosad Harmful (nymphs, adults, knockdown) Harmful (nymphs, adults) spirodiclofen Harmful (nymphs) - thiacloprid Harmful (nymphs, adults) Harmful
Conserv ing/enhancing earw igs is
impo rtant chal lenge for the future
Conservation biocontrol
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Ita l ian alder w indbreaks
and grass al leys
are poor forcons ervat ion biocon tro l !
Many better funct ional cho ices(bu t beware rosaceae)
Considerable scope for imp rovement!
Mutualism between ants and aphids
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• Ants defend aphids fromnatural enemies
• If ant protection of aphids is
removed, then aphids are
rapidly attacked and
consumed by generalist
insect predators
• Key to aphid control in
future?
Natural, genetic, cultural, biological, biotechnological controls
Introduced predators and parasites
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One-off introductions for alien invasivesWoolly aphid parasitoid Aphelinus mal i
Moving predators between orchards
Transfer predatory mites on summer prunings
Regular introductions of BCAs
Several developed in research but none in
common practice
Unreliable in outdoor environment
Disappo int ing ly l i t t le app l icat ion to date
Natural, genetic, cultural, biological, biotechnological controls
Biopesticides
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Microbial agents(registration required)
Baci llus thur ing iens is
Baci llus sub t i lis
Cand ida o leophi la
Codling moth granulovirus
Nematodes(registration not required)
Heterorhabditis, Steinernema sp
Codling moth granulovirus
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http://slidepdf.com/reader/full/biopesticides-european-mrkt 130/135
Advantages
Specific, fully
selective
Safe
Low chanceresistance
Carry over
No residues
Cost competitive
Disadvantages
Slow kill, superficial stings
UV degradation, shorter
persistence
Slightly lower efficacy
Tortrix not controlled
Resistance develops where
used intensively
Semiochemical based control methodsCodling moth sex pheromone mating disruption
8/12/2019 Biopesticides European Mrkt
http://slidepdf.com/reader/full/biopesticides-european-mrkt 131/135
• Extensively applied where codling
multigenerational & insecticide resistant• But not in the UK yet!
• Area wide application
• Numerous formulations
Twist tiesLaminate dispensers
Puffers
Sprayables
• Dose >50 g codlemone/ha/season• Effective for low-moderate populations
• In conjunction with other methods
Exosex autoconfusion
Selective insecticides
8/12/2019 Biopesticides European Mrkt
http://slidepdf.com/reader/full/biopesticides-european-mrkt 132/135
Insect growth regulatorsChitin synthesis inhibitors
Juvenile hormone analogues
Moulting accelerating compounds
Novel materials (new modes of action)
Chlorantraniliprole
Flonicamid
Spirodiclofen
Great prog ress in last 30 years
8/12/2019 Biopesticides European Mrkt
http://slidepdf.com/reader/full/biopesticides-european-mrkt 133/135
Future needs
8/12/2019 Biopesticides European Mrkt
http://slidepdf.com/reader/full/biopesticides-european-mrkt 134/135
• Disease resistant apple varieties that meet
market requirements
• Sensitive, pest specific monitoring traps
for more species
•Better understanding of effects ofpesticides on key natural enemies
• Conservation biocontrol
• Methods of disrupting ant-aphid mutualism
(without killing ants)• New innovative cost-effective biological
and biotechnological control methods
Thanks