louise brinkworth effect of changes to agrochemical ... brinkworth effect of changes to... ·...
TRANSCRIPT
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
| 2
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
| 3
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
| 4
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.
| 5
● 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.
| 7
● 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
| 8
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
| 9DOW AGROSCIENCES RESTRICTED
| 10DOW AGROSCIENCES RESTRICTED
| 11
Source: Global - Agrochemical and Seed Markets Industry Developments Presentation - Phillips McDougall - Aug 2015
DOW AGROSCIENCES RESTRICTED
| 12
Source: PhillipsMcDougall AgChem R&D Report (2016)
DOW AGROSCIENCES RESTRICTED
| 13
Source: PhillipsMcDougall AgChem R&D Report (2016)
DOW AGROSCIENCES RESTRICTED
R+D Spend
| 14DOW AGROSCIENCES RESTRICTED
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
| 16
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
| 17
?Sterling
Customers
EU
Q&A
® Trademark of The Dow Chemical Company (“Dow”) or an affiliated company of Dow DOW AGROSCIENCES RESTRICTED
| 19
Thank You