Download - Louise Brinkworth Effect of changes to agrochemical ... Brinkworth Effect of changes to... · Effect of changes to agrochemical registration on product availability Louise Brinkworth

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

| 9DOW AGROSCIENCES RESTRICTED

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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)


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R+D Spend



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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