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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