portfolio to comply wit ith BPR requirements: Case study of - - PowerPoint PPT Presentation

Rationalizing a bio iocidal products portfolio to comply wit ith BPR requirements:

Case study of insecticides

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Hélène Cawoy Redebel Regulatory Affairs, BELGIUM CIR & Agbio Summit, 7-8 September, Nice, France

How do we translate a in insecticide portfolio to authorized biocidal products ?

Portfolio strategical analysis

Studies and dossier preparation Evaluate the balance efficacy/risk Adjust to reach the balance

Product authorization

Dossier submission and evaluation Data Gap Analysis and regulatory strategy Know what you have

Outline

Portfolio strategical analysis

Studies and dossier preparation Evaluate the balance efficacy/risk Adjust to reach the balance

Product authorization

Dossier submission and evaluation Data Gap Analysis and regulatory strategy

Outline

Know what you have

To know what you have and rationalise

Hélène Cawoy 5

A product is a combination of composition and use

Rationalize these combinations

To know what you have and rationalise

Hélène Cawoy 6

• Historically build portfolio, often many slightly different

compositions (due to different formulators etc.)

• Either define a range of concentration and keep products as they are

=> Product family;

• Or select a few common formulations and adjust products.

Composition

To know what you have and rationalise

Hélène Cawoy 7

• Insecticides are often mixes of several active substances
• This has multiple implications :
• Impact on deadlines (last approved active substance)
• Impact on risks of the products (additivity)
• Impact on efficacy (is it all justified ?)

It is not all about active substances…

Composition

To know what you have and rationalise

Hélène Cawoy 8

Do not underestimate the impact of formulation

• Formulation type : aerosol, gel, granule, bait box
• Large impact on Risk assessment
• e.g. Bait box is generally safer as aerosol
• Impact on other parts of dossier (physicochemical properties etc.)
• e.g. Foam aerosol and classical aerosol,

require different data package

Composition

To know what you have and rationalise

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Do not underestimate the impact of formulation

• Co-formulants => Substance of Concern (SOC)
• Other active substances (e.g. preservatives)
• Substances with impact on CLP
• Substances with community workplace exposure limits
• SVHC
• Synergists

Reference: Note for discussion with competent authorities for biocidal Products - Substances of Concern – Proposed Human Health (Toxicology) Assessment Scheme for Authorisation of Biocidal Product. CA-Nov14-Doc.5.11 Transitional Guidance on the Biocidal Products Regulation. Transitional Guidance on mixture toxicity assessment for biocidal products for the

• environment. May 2014

Composition

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To know what you have and rationalise

Do not underestimate your label! It contains more uses than you think !

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To know what you have and rationalise

Use

Worked example : label analysis

Effectively kills mosquitoes. Either spray directly on insects or vaporize the room for long lasting effect (up to 8 hours).

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To know what you have and rationalise

Use

Worked example : label analysis

• Effectively kills mosquitoes. Either spray directly on insects or

vaporize the room for long lasting effect (up to 8 hours).

Product Indoor Spray room Stay in room Leave room Spray insect Spray flying insect Spray sitting insect Outdoor Spray area Stay in area Leave area Spray insect Spray flying insect Spray sitting insect

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To know what you have and rationalise

Use

Worked example : label analysis

• Effectively kills mosquitoes. Either spray directly on insects or

vaporize the room for long lasting effect (up to 8 hours).

Product Indoor Spray room Stay in room Leave room Spray insect Spray flying insect Spray sitting insect Outdoor Spray area Stay in area Leave area Spray insect Spray flying insect Spray sitting insect

Definition of precise uses impacts on evaluation

• f Efficacy and Risk

Portfolio strategical analysis

Know what you have Studies and dossier preparation Evaluate the balance efficacy/risk Adjust to reach the balance

Product authorization

Dossier submission and evaluation Data Gap Analysis and regulatory strategy

Outline

The historical approach Acceptable efficacy & acceptable risk The BPR approach

Acceptable risk & acceptable efficacy

Evaluate the balance of efficacy and risk

• Usually well known as basis of commercialization
• Be careful on exact claims !
• If you are claiming a specific insect, you need a specific test !
• When testing, strictly follow PT18 guidance (reference insects, replicates,

etc.)

Tests on standard flying insects but claiming flying insect, including tiger mosquitos.

Reference: Product type 18 – insecticides, acaricides and products to control other arthropods and Product type 19. Guidance to replace part of Appendices to chapter 7 (page 187 to 200) from TNsG on Product Evaluation. CA-Dec12-Doc.6.2.a - Final

Evaluate the balance of efficacy and risk

Efficacy

• Usually well known as basis of commercialization
• Be careful on exact claims !
• If you are claiming a specific insect, you need a specific test !
• When testing, strictly follow PT18 guidance (reference insects, replicates,

etc.)

Tests on standard flying insects but claiming flying insect, including tiger mosquitos. Test on flying insects and Additional test on tiger mosquito

=> KNOW YOUR EXACT USES !

Reference: Product type 18 – insecticides, acaricides and products to control other arthropods and Product type 19. Guidance to replace part of Appendices to chapter 7 (page 187 to 200) from TNsG on Product Evaluation. CA-Dec12-Doc.6.2.a - Final

Evaluate the balance of efficacy and risk

Efficacy

• Both risks have to be analyzed : environment and human health
• Compare your label claims with standard risk models
• Spot redundancy, in use and formulation, to save effort !

Evaluate the balance of efficacy and risk

Risk

Worked example : environmental evaluation

Effectively kills mosquitoes. Either spray directly on insects or vaporize the room for long lasting effect (up to 8 hours).

Product Indoor Spray room Stay in room Leave room Spray insect Spray flying insect Spray sitting insect Outdoor Spray area Stay in area Leave area Spray insect Spray flying insect Spray sitting insect

Reference: Emission scenario documents https://echa.europa.eu/guidance-documents/guidance-on-biocides-legislation/emission-scenario-documents

Evaluate the balance of efficacy and risk

Risk

Worked example : environmental evaluation

Product Indoor Spray room Stay in room Leave room Spray insect Spray flying insect Spray sitting insect Outdoor Spray area Stay in area Leave area Spray insect Spray flying insect Spray sitting insect

Scenario 1: Room spray, indoor

Evaluate the balance of efficacy and risk

Risk

Worked example : environmental evaluation

Product Indoor Spray room Stay in room Leave room Spray insect Spray flying insect Spray sitting insect Outdoor Spray area Stay in area Leave area Spray insect Spray flying insect Spray sitting insect

Scenario 1: Room spray, indoor

Evaluate the balance of efficacy and risk

Risk

Scenario 1bis: Spray flying insect, indoor

Worked example : environmental evaluation

Product Indoor Spray room Stay in room Leave room Spray insect Spray flying insect Spray sitting insect Outdoor Spray area Stay in area Leave area Spray insect Spray flying insect Spray sitting insect

Scenario 1: Room spray, indoor

Evaluate the balance of efficacy and risk

Risk

Scenario 2: Surface spray, indoor Scenario 1bis: Spray flying insect, indoor

Worked example : environmental evaluation

Product Indoor Spray room Stay in room Leave room Spray insect Spray flying insect Spray sitting insect Outdoor Spray area Stay in area Leave area Spray insect Spray flying insect Spray sitting insect

Scenario 1: Room spray, indoor

Evaluate the balance of efficacy and risk

Risk

Scenario 2: Surface spray, indoor Scenario 1bis: Spray flying insect, indoor Scenario 3: Spray air, outdoor

Worked example : environmental evaluation

Product Indoor Spray room Stay in room Leave room Spray insect Spray flying insect Spray sitting insect Outdoor Spray area Stay in area Leave area Spray insect Spray flying insect Spray sitting insect

Scenario 1: Room spray, indoor

Evaluate the balance of efficacy and risk

Risk

Scenario 2: Surface spray, indoor Scenario 1bis: Spray flying insect, indoor Scenario 3: Spray air, outdoor Scenario 4: Surface spray, outdoor

Worked example : environmental evaluation

Product Indoor Spray room Stay in room Leave room Spray insect Spray flying insect Spray sitting insect Outdoor Spray area Stay in area Leave area Spray insect Spray flying insect Spray sitting insect

Scenario 1: Room spray, indoor

Evaluate the balance of efficacy and risk

Risk

Scenario 2: Surface spray, indoor Scenario 1bis: Spray flying insect, indoor Scenario 3: Spray air, outdoor Scenario 4: Surface spray, outdoor

For environmental perspective : Stay in the room or leave makes no difference For environmental perspective: Spraying on indoors or outdoors surfaces has a major impact. However, for air spray, indoor use is considered worst-case compared to outdoor use. For environmental perspective: Spray flying insect, Stay in room is redundant with Room spray, Stay in room Spray room is worst-case as higher quantity

Worked example : environmental evaluation

Product Indoor Spray room Spray insect Spray sitting insect Outdoor Spray insect Spray sitting insect

Scenario 1: Room spray, indoor Scenario 2: Surface spray, indoor Scenario 4: Surface spray,

• utdoor

Simplification is totally worthwhile! Careful on difference with human health approach!

Evaluate the balance of efficacy and risk

Risk

Product Indoor Spray room Stay in room Leave room Spray insect Spray flying insect Spray sitting insect Outdoor Spray area Stay in area Leave area Spray insect Spray flying insect Spray sitting insect

Scenario 1: Room spray Stay in room Scenario 3: Surface spray Scenario 2: Room spray Leave room Scenario 1bis: Spray flying insect, Stay in room

Worked example : human health evaluation

Evaluate the balance of efficacy and risk

Risk

Product Indoor Spray room Stay in room Leave room Spray insect Spray flying insect Spray sitting insect Outdoor Spray area Stay in area Leave area Spray insect Spray flying insect Spray sitting insect

Scenario 1: Room spray Stay in room Scenario 3: Surface spray Scenario 2: Room spray Leave room Scenario 1bis: Spray flying insect, Stay in room

For human health perspective : Outdoor totally redundant with indoor, as indoor is worst case. As for environmental assessment, room spray is worst case compared to spray insect

• r spray air outdoors

Worked example : human health evaluation

For human health perspective : Major difference is stay or leave the room. But stay in room is a worst case.

Evaluate the balance of efficacy and risk

Risk

Product Indoor

Spray room

Stay in room Spray insect Spray sitting insect

Scenario 1: Room spray Stay in room Scenario 3: Surface spray

Simplification is totally worthwhile also !

Evaluate the balance of efficacy and risk

Risk

Worked example : human health evaluation

Product Indoor Spray room Stay in room Spray insect Spray sitting insect

Scenario 1: Room spray, stay in room Scenario 3: Surface spray

Worked example : environmental and human health evaluation

Product Indoor Spray room Spray insect Spray sitting insect Outdoor Spray insect Spray sitting insect

Scenario 2: Surface spray, indoor Scenario 4: Surface spray,

• utdoor

Scenario 1: Room spray, indoor

Evaluate the balance of efficacy and risk

Risk

Product Indoor Spray room Stay in room Spray insect Spray sitting insect

Scenario 1: Room spray, stay in room Scenario 3: Surface spray

Worked example : environmental and human health evaluation

Product Indoor Spray room Spray insect Spray sitting insect Outdoor Spray insect Spray sitting insect

Scenario 2: Surface spray, indoor Scenario 4: Surface spray,

• utdoor

Scenario 1: Room spray, indoor

Evaluate the balance of efficacy and risk

Risk

Same simplification approach but different scenarios and potentially different conclusions

Portfolio strategical analysis

Know what you have Studies and dossier preparation Evaluate the balance efficacy/risk Adjust to reach the balance

Product authorization

Dossier submission and evaluation Data Gap Analysis and regulatory strategy

Outline

The product must pass all three criteria !

• Efficacy
• Risk to the environment
• Risk to human health

Adjust to reach the balance

What can you do about it ?

• Rethink your uses and formulations
• Are all uses commercially relevant?
• Is the formulation fully justified?
• Test efficacy to find the threshold.

Screening tests on relevant insects.

• Refine risk
• Fine tune your risk models
• Obtain additional data on active substance or product
• Define risk mitigation measures

Adjust to reach the balance

Portfolio strategical analysis

Studies and dossier preparation Evaluate the balance efficacy/risk Adjust to reach the balance

Product authorization

Dossier submission and evaluation Data Gap Analysis and regulatory strategy Know what you have

You finished rationalising and balancing your products ! What’s next ?

Thank you for your attention ! Any questions ? Need assistance on the next steps for your products?

www.rra.redebel.com h.cawoy@redebel.com