Rationalizing a bio iocidal products portfolio to comply wit ith BPR requirements: Case study of insecticides Hélène Cawoy Redebel Regulatory Affairs, BELGIUM CIR & Agbio Summit, 7-8 September, Nice, France 1
How do we translate a in insecticide portfolio to authorized biocidal products ?
Outline Portfolio strategical analysis Evaluate the Adjust to Know what balance reach the you have Data Gap efficacy/risk balance Analysis and regulatory Product strategy Studies and authorization dossier preparation Dossier submission and evaluation
Outline Portfolio strategical analysis Know what you Evaluate the Adjust to have balance reach the Data Gap efficacy/risk balance Analysis and regulatory Product strategy Studies and authorization dossier preparation Dossier submission and evaluation
To know what you have and rationalise A product is a combination of composition and use Rationalize these combinations 5 Hélène Cawoy
To know what you have and rationalise Composition o 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. 6 Hélène Cawoy
To know what you have and rationalise Composition o Insecticides are often mixes of several active substances o 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… 7 Hélène Cawoy
To know what you have and rationalise Composition Do not underestimate the impact of formulation o 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 8 Hélène Cawoy
To know what you have and rationalise Composition Do not underestimate the impact of formulation o 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 9 environment. May 2014
To know what you have and rationalise Do not underestimate your label ! It contains more uses than you think ! 10
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). 11
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). Stay in room Spray room Leave room Indoor Spray flying insect Spray insect Spray sitting insect Product Stay in area Spray area Leave area Outdoor Spray flying insect Spray insect Spray sitting 12 insect
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). Stay in room Spray room Leave room Indoor Spray flying insect Spray insect Spray sitting Definition of precise uses impacts on evaluation insect Product of Efficacy and Risk Stay in area Spray area Leave area Outdoor Spray flying insect Spray insect Spray sitting 13 insect
Outline Portfolio strategical analysis Evaluate the balance Adjust to Know what efficacy/risk reach the you have Data Gap balance Analysis and regulatory Product strategy Studies and authorization dossier preparation Dossier submission and evaluation
Evaluate the balance of efficacy and risk The historical approach Acceptable efficacy & acceptable risk The BPR approach Acceptable risk & acceptable efficacy
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. 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.) Test on flying insects and Tests on standard flying insects Additional test on tiger but claiming flying insect, mosquito including tiger mosquitos. => 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 Risk 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). Stay in room Spray room Leave room Indoor Spray flying insect Spray insect Spray sitting insect Product Stay in area Spray area Leave area Outdoor Spray flying insect Spray insect Spray sitting Reference: insect 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 Stay in room Scenario 1: Room spray, indoor Spray room Leave room Indoor Spray flying insect Spray insect Spray sitting insect Product Stay in area Spray area Leave area Outdoor Spray flying insect Spray insect Spray sitting insect
Evaluate the balance of efficacy and risk Risk Worked example : environmental evaluation Stay in room Scenario 1: Room spray, indoor Spray room Leave room Indoor Scenario 1bis: Spray Spray flying flying insect, indoor insect Spray insect Spray sitting insect Product Stay in area Spray area Leave area Outdoor Spray flying insect Spray insect Spray sitting insect
Evaluate the balance of efficacy and risk Risk Worked example : environmental evaluation Stay in room Scenario 1: Room spray, indoor Spray room Leave room Indoor Scenario 1bis: Spray Spray flying flying insect, indoor insect Spray insect Spray sitting Scenario 2: Surface insect spray, indoor Product Stay in area Spray area Leave area Outdoor Spray flying insect Spray insect Spray sitting insect
Evaluate the balance of efficacy and risk Risk Worked example : environmental evaluation Stay in room Scenario 1: Room spray, indoor Spray room Leave room Indoor Scenario 1bis: Spray Spray flying flying insect, indoor insect Spray insect Spray sitting Scenario 2: Surface insect spray, indoor Product Stay in area Spray area Scenario 3: Spray air, outdoor Leave area Outdoor Spray flying insect Spray insect Spray sitting insect
Evaluate the balance of efficacy and risk Risk Worked example : environmental evaluation Stay in room Scenario 1: Room spray, indoor Spray room Leave room Indoor Scenario 1bis: Spray Spray flying flying insect, indoor insect Spray insect Spray sitting Scenario 2: Surface insect spray, indoor Product Stay in area Spray area Scenario 3: Spray air, outdoor Leave area Outdoor Spray flying Scenario 4: Surface insect spray, outdoor Spray insect Spray sitting insect
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