1. RRA feedback from CTGB Seminar on comparative assessment - May 17, 2016
17/11/2016
The aim of this talk is to provide you a feedback from the Seminar on the Comparative assessment held in Ede at the CtgB in May 2016.
This was a 1-day seminar providing information on how the CtgB will assess the CA.
I ‘ll try to summarise this day in the next 20 minutes

2. Agenda CA evaluation Agronomic aspects Risk assessments
Short introduction
CA evaluation
Agronomic aspects
Risk assessments
Procedure and fees
I’ll give you a short introduction on the CA,
then I’ll present you how the comparative assessment will be performed by CtgB and finally I’ll present you some inputs on the administrative procedure and the fees.
So, the idea is to give you the feedback from the CtgB as well as the useful documents needed to manage comparative assessments in The Netherlands.

3. Intro: CA at EU level Regulation 1107/2009
Art 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
Comparative assessment is regulated through the regulation 1107, specially the articles 24 and 54 as well as the Annex 4.
In 2014, a guidance document was drafted giving elements on how to conduct the comparative assessment.
In March 2015, the EU-com published a list of 77 candidates for substitution. This entered into force on the first of August 2015.
Finally the EPPO guidance 1/271, provides guidance for comparative assessment to determine whether the substitution of a PPP is appropriate in view of agronomic considerations. However, this guidance doc don’t address comparative safety from the human and environmental perspective. (It covers also comparison with chemical and non-chemical pest control alternatives).

4. Intro: Starting up in the NL
Public consultation in Nov. 2015
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
CtgB organized a first consultation in November 2015 focusing on Impact on the workload of the involved parties, When and how to apply comparative assessment, the case of the Minor uses and the Assessment of agronomic aspects.
As second consultation was done in April 2016, mainly on the assessment of agronomic aspects.
A Pilot project was also organized. It was based on 4 products and was done to implement the comparative assessment guidance in the Netherlands

5. Intro: When applying CA
Categories of authorisations for CA :
New authorisation
Re-registration of a PPP
Extension of a PPP (but CA only for the requested uses)
Comparative assessments must be applied in the case of a new PPP authorization for PPP with an active icluded in the CfS list, a re-registration of a PPP and for the extension of use of a PPP but only for the requested uses

6. Intro: When applying CA
No CA for the following authorisations:
Derived authorisation
Parallel trade
Comparative assessments are not mandatory for a derived authorisation or for parallel trade.

7. Intro: When applying CA
No CA at all (yet):
Mutual recognition attached to the original authorisation (but CA maybe after a year extended to this type of authorisation)
Authorisations for private use
Authorisation with only minor uses (NLKUG)
Necessity to acquire experience (new products)
1107/2009 – granted once for a period up to 5 years
Comparative assessments are not mandatory for Mutual recognition attached to the original authorisation (but CA maybe after a year extended to this type of authorisation), authorisations for private use (amateur use?), authorisation with only minor uses or in the case of Necessity to acquire experience (new products)

8. 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
The ongoing procedure will be evaluated after one year with the following…
Developement – proposition of a Dutch list of non-chemical alternatives… probably in the line of the one already proposed by the UK.
Adding mutual recognitions to CA
Checking the pace by MS…
Altering the scope of CA…

9. 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
Very difficult to know at the moment how many product will be impacted by the comparative assessments but what is clear is that only a limited number of product should be impacted
Tiered approach ?

10. 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
The evaluation is carried out by the National Plant Protection Organisation which give its advice to the CtgB that takes the final decision based on agronomic aspect but if needed also on risk assessment (human and environmental. The steps of the agronomic assessments are the following : Defining the uses (as a reminder, only the major use are considered for Comparative assessment) and then determining alternatives .These alternative propositions are based on the efficacy and crop safety, the risk to develop resistance, the potential economic impact and finally the impact on minor uses. At the end of the day, the idea is of course that only alternatives that presents an overall better profile is valid.

11. 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

12. 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
Definition of the uses is very important because NPPO will only assess the major uses. If a major use of a Candidate has alternatives, it is perhaps not the case of a minor use and if this candidate is substitute, then no more solution for the minor use.
Should be discussed in the CA

13. 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
Definition of the uses is very important because NPPO will only assess the major uses. If a major use of a Candidate has alternatives, it is perhaps not the case of a minor use and if this candidate is substitute, then no more solution for the minor use.
Should be discussed in the CA

14. 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 non- chemical methods: too complex (Pilot) for risk assessment – deviation from EPPO

15. 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
In principle, another PPP has a comparable efficacy
But, if applicant thinks it is not the case, it should be demonstrated with data

16. 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

17. 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
If an alternative has same mode of action, the number of mode of action doesn’t change, so, it means that the candidate is not necessary for resistance management,,,
But, in the NL, at least 5 MoA…

18. 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
Regarding the minor uses, ….

19. 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

20. 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 ?

21. Risk assessment
Aim: to analyse if the identified potential alternatives have a lower risk for the specific aspect for which the CfS criteria apply

22. Risk assessment – mammalian toxicology
CfS:
Lower AOEL
Reason linked to the nature of the critical effects (e.g. developmental- neurotoxic, immunotoxic effects, …)
Carcinogen cat. 1A or 1B
Toxic for Reproduction cat. 1A or 1B
Endocrine disruption
Looking at the mammalian toxicology, the reason to be candidates for subsitution are…

23. 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
CtgB categorized the CfS following two approaches:
1. CfS for their intrinsic properties
2. CfS due to a lower Acceptable Operature Exposure Level (AOEL)
For the comparison based on intrinsic properties, an overview should be given. If one of the alternatives is not classified … provides lower risk… suitable alternative
For comparison for CfS based on significantly lower AOEL, risk assesment must be presented. It has been decided to use a factor of 10 to expresse a significant difference of risk.This factor is based on the Pilot study. It could change in the future. The comparison have to be carried out for operator, bystander, resident and worker.

24. 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
Since the first of January, the new EFSA Opex Guidance is used which was not applied fro the alternative formulations. A pragmatic approach is to select the formulation which gives the lowest risk based on the old exposure model and to carry out an exposure assessment with the EFSA model.

25. 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
Looking at the residues, the reason to be candidates for subsitution are…
Lower acceptable daily intake or acute reference dose

26. 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
Looking at the environment, the reason to be candidates for substitution are…
No Observed Effect Concentration

27. Risk assessment – final step
Alternative PPP must show an overall lower or similar risk on all aspects

28. 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

29. RRA feedback from CtgB Seminar on comparative assessment - May 17, 2016
Any question(s)?
The aim of this talk is to provide you a feedback from the Seminar on the Comparative assessment held in Ede at the CtgB in May 2016.