RRA feedback from CTGB Seminar on
comparative assessment - May 17, 2016
17/11/2016
Agenda
• Short introduction
•CA evaluation
• Agronomic aspects
• Risk assessments
•Procedure and fees
Intro: CA at EU level
• Regulation 1107/2009
◦ Art. 24 - Candidates for substitution
◦ Art. 50 – CA of PPP containing CfS
◦ Annexes II and IV – CA – defines the criteria to be considered as CfS
• EC Guidance (Oct. 2014) – SANCO/11507/2013
• List of 77 Candidates for Substitution (Mar. 2015) – Reg. 2015/408
• EPPO guidance (Sept. 2015) - PP 1/271
Intro: Starting up in the NL
 Public consultation in Nov. 2015
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Impact on the workload
When and how to apply CA
Minor use
Assessment of agronomic aspects
 Public consultation in Apr. 2016
 Assessment on agronomic aspects
 Pilot project for implementing the guidance
 4 products
 Entered into force in NL in Sept. 2016
Intro: When applying CA
• Categories of authorisations for CA :
1. New authorisation
2. Re-registration of a PPP
3. Extension of a PPP (but CA only for the requested uses)
Intro: When applying CA
• No
CA for the following authorisations:
1. Derived authorisation
2. Parallel trade
Intro: When applying CA
• No
CA at all (yet):
1. Mutual recognition attached to the original authorisation (but CA maybe
after a year extended to this type of authorisation)
2. Authorisations for private use
3. Authorisation with only minor uses (NLKUG)
4. Necessity to acquire experience (new products)
◦
1107/2009 – granted once for a period up to 5 years
Intro: After a careful start
• Evaluation after a year (Sept. 2017)
◦ Dutch list of non-chemical alternatives…
◦ Adding mutual recognitions to CA…
◦ Checking the pace by MS…
◦ Experience of the applicants and CtgB
◦ Time lines
◦ Average costs
Intro: Checking the funnel
77 candidates for substitution according to strict criteria
Assessment on agronomic aspects : modes of actions
Assessment on other agronomic aspects
Risk assessment
?
Assessment of agronomic aspect
•
Process
◦ Carry out by NPPO
◦ National Plant Protection Organisation
◦ Netherlands Food and Consumer Product Safety Authority
◦ Ministry of Economic Affairs
◦ NPPO advises the CtgB
◦ CtgB takes the decision
Assessment of agronomic aspect
• Steps of the assessments
◦ Defining the uses
◦ Determining the alternatives
◦ Alternatives are assessed on:
◦ Efficacy and crop safety
◦ Risk of developing resistance
◦ Practical or economic disadvantages, and effects on minor uses
Assessment of agronomic aspect
• Steps of the assessments
◦ Defining the uses – assessment for major uses
◦ Determining the alternatives
◦ Alternatives are assessed on:
◦ Efficacy and crop safety
◦ Risk of developing resistance
◦ Practical or economic disadvantages, and effects on minor uses
Assessment of agronomic aspect
• Steps of the assessments
◦ Defining the uses – assessment for major uses
◦ Determining the alternatives
◦ Alternatives are assessed on:
◦ Efficacy and crop safety
◦ Risk of developing resistance
◦ Practical or economic disadvantages, and effects on minor uses
Assessment of agronomic aspect
•Determining the alternatives
◦ Another PPP (without CfS)
◦ Non chemical alternatives :
◦ Inventory from UK (Defra document)
◦ In general, no assessment on a system of several PPP and nonchemical methods: too complex (Pilot) for risk assessment –
deviation from EPPO
Assessment of agronomic aspect
• Steps of the assessments
◦ Defining the uses – assessment for major uses
◦ Determining the alternatives
◦ Alternatives are assessed on:
◦ Efficacy and crop safety
◦ Risk of developping resistance
◦ Practical or economic disadvantages, and effects on minor uses
Assessment of agronomic aspect
• Steps of the assessments
◦ Defining the uses – assessment for major uses
◦ Determining the alternatives
◦ Alternatives are assessed on:
◦ Efficacy and crop safety
◦ Risk of developping resistance
◦ Practical or economic disadvantages, and effects on minor uses
Assessment of agronomic aspect
• Risk for developing resistance
◦ Is there an authorized PPP based on same mode of action?
◦ NL: at least 5 different MoA needed for a sustainable resistance management
◦ If a non-chemical method available = counts as one MoA
◦ Mechanical weeding
◦ Use of natural enemies
• Practical and economic disadvantages
◦ To be discussed and to be demonstrated
Assessment of agronomic aspect
• Negative
consequences on minor uses?
◦ NL only assess the major uses (even if also minor use on the label)
◦ Regulation : the consequences on minor uses are taken into account
Assessment of agronomic aspect
As soon as it is clear that substitution is not possible, the process for that use
is stopped.
 Based on the advise from NPPO, CtgB decides to stop CA or to start the risk
evaluation
Intro: Checking the funnel
77 candidates for substitution according to strict criteria
Assessment on agronomic aspects : modes of actions
Assessment on other agronomic aspects
Risk assessment
?
Risk assessment
Aim: to analyse if the identified potential alternatives have a
lower risk for the specific aspect for which the CfS criteria
apply
Risk assessment – mammalian toxicology
CfS:
- Lower AOEL
- Reason linked to the nature of the critical effects (e.g. developmentalneurotoxic, immunotoxic effects, …)
- Carcinogen cat. 1A or 1B
- Toxic for Reproduction cat. 1A or 1B
- Endocrine disruption
Risk assessment – mammalian toxicology
Two approaches:
 Intrinsic properties (alternative not classified for rep tox,
carcinogenicity and not considered as an endocrine disruptor)
 Significantly lower AOEL
Risk assessment – mammalian toxicology
- NL-AOEL not taken into account, comparison made based on the EU-AOEL
- Alternative products containing a CfS are not included in the RA
- New EFSA Opex model
- Re-assessment required
- Pilot:
- 75 alternatives formulations
- Full re-assessment impossible
- Select formulation with the lowest risk with the old exposure model and re-calculate
exposure with new EFSA model
Risk assessment – residues
CfS: ADI or ARfD significantly lower
-Comparison between RA of CfS formulation and already authorized alternative
- Alternative products containing a CfS are not included in the RA
 If alternative ADI or ARfD is 10x ≥ CfS, alternative acceptable
Risk assessment – environment
• CfS based upon:
◦ Persistence (PEC and/or PEC plateau)
◦ Bio-accumulation (food chain biomagnification and/or secondary poisoning)
◦ NOEC for marine or freshwater organisms
Check whether the alternatives result in higher risk
• RA will be performed using the current Guidances
Risk assessment – final step
Alternative PPP must show an overall lower or similar risk on all
aspects
Procedure and fees
• Application of CfS based product
◦ Notification of application
◦ Submit
◦ Complete dRR
◦ Application form G
◦ Application form Comparative assessment
◦ Advance payment for zonal application
• Real costs for CA will be charged
• Document available on the CtgB website
RRA feedback from CtgB Seminar on
comparative assessment - May 17, 2016
Any question(s)?
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