Post on 04-Jun-2020
Effect of changes to agrochemical registration on product availability
Louise BrinkworthProduct Stewardship Leader EMEADow AgroSciences
Effect of changes to agrochemical registration on product availability
● EU
● Global Situation
● Future
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PPP EU Primary Regulations
Local Country Process
• Prior to 1993• Individual Country Rules
EU directive 91/414
• 1993:• To harmonise pesticide regulation across EU,
• A.S at EU level
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91/414• A.S at EU level
• Products at country level
• Re-registration
EU regulation EC
1107/2009
• 2011• Key change from risk to hazard
• Comparative Assessment and CFS
• Staged Renewals
EU : Loss of active substances over time
400
600
800
1000
Approved Active Substances EU 2003-2009
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0
200
1993 1995 1996 1999 2001 2003 2005 2007 2009
'Old' a.s New a.s. UK total
Estimated numbers- Source: European Commission-via NFU and BCPC
Important Elements of EU Regulation (EC) No 1107/2009
● applies the precautionary principle
● introduced concept of active substances with a less favourable
toxicological or environmental profile, but which still satisfy the criteria
for approval, being approved as candidates for substitution.
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● products containing active substances approved as candidates for
substitution are subject to comparative assessment.
| 6Source: CropLife International DOW AGROSCIENCES RESTRICTED
Important Elements of EU Regulation (EC) No 1107/2009
● applies the precautionary principle
● introduced concept of active substances with a less favourable
toxicological or environmental profile, but which still satisfy the criteria
for approval, being approved as candidates for substitution.
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● products containing active substances approved as candidates for
substitution are subject to comparative assessment.
● Renewals- AIR1, AIR2, AIR3, AIR4
Water
Framework
Directive
Many Other Regulations with Impact on Crop Protection Products
CAP 2014-2020
Sustainable use
Directive
Directive
2009/127/CEMachinery Directive
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Waste
Regulation
Bird Directive
+Nature 2000
Directive 2009/128/CE
Member State specific
Regulations
MRL Regulation
(EC)396/2005
Regulation (EC) Regulation (EC) 1107/20091107/2009
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Source: Global - Agrochemical and Seed Markets Industry Developments Presentation - Phillips McDougall - Aug 2015
DOW AGROSCIENCES RESTRICTED
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Source: PhillipsMcDougall AgChem R&D Report (2016)
DOW AGROSCIENCES RESTRICTED
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Source: PhillipsMcDougall AgChem R&D Report (2016)
DOW AGROSCIENCES RESTRICTED
R+D Spend
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Source: PhillipsMcDougall AgChem R&D Report (2016)
Sustainability of Approved Products
| 15Louise Brinkworth CAFRE Jan 2017 Draft
Name Discovery DevelopmentEst.
Launch*
Launched within 5 years
Enlist Duo™ Herbicide 2015-2018
Arylex™ Active 2015-2018
InatreqTM Active 2018-2019
Rinskor™ Active 2018-2019
Insecticide 1 2021-2022
Launched after 5 years
Fungicide 1
Fungicide 2
Fungicide 3
Insecticide 2
Crop Protection Pipeline Full with High-Value Solutions
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Insecticide 2
Insecticide 3
Insecticide 4
Herbicide 1
Fungicide 4
Fungicide 5
Fungicide 6
Insecticide 5
Herbicide 2
InsecticideHerbicideFungicide
*Subject to regulatory approvals and other assumptions; Represents first year of commercial sales in a significant market through the year when sales are
established in markets which represent 80% of the new product value. ™Trademark of The Dow Chemical Company (“Dow”) or an affiliated company of Dow
The Future?
?
NGOs
UK Ag. policy
CRD
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?Sterling
Customers
EU
Q&A
® Trademark of The Dow Chemical Company (“Dow”) or an affiliated company of Dow DOW AGROSCIENCES RESTRICTED
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