Comparative assessment in the zonal system (Trybou) (ppt. 220Kb)

Report
Belgian Federal Public Service of PUBLIC HEALTH, SAFETY OF THE FOOD CHAIN and ENVIRONMENT
Comparative assessment in the zonal system
Maarten Trybou
Service Pesticides & Fertilisers - Belgian authority for
the authorisation of plant protection products
ECPA/ECCA Conference, 12-13 March 2014, Brussels
Belgian Federal Public Service of PUBLIC HEALTH, SAFETY OF THE FOOD CHAIN and ENVIRONMENT
Overview
Legal basis
Zonal procedure
Criteria for comparative assessment
Impact of comparative assessment
Some specific cases
Belgian Federal Public Service of PUBLIC HEALTH, SAFETY OF THE FOOD CHAIN and ENVIRONMENT
Legal basis
Art. 40 of 1107/2009 :
Comparative assessment required for every application for
authorisation, renewal or amendment if the PPP contains a CfS
Substitution required if
- A significantly safer and economically and technically feasible
alternative is available
- Enough alternatives are available to keep risk for resistance low
- Minor uses are taken into account
For new active substances : possibility to wait for 5 years
In exceptional cases “voluntary” substitution (without CfS) with a
non-chemical method in general use
Belgian Federal Public Service of PUBLIC HEALTH, SAFETY OF THE FOOD CHAIN and ENVIRONMENT
Legal basis
Art 41 :
Zonal procedure with zRMS
Mutual recognition not obligatory
Belgian Federal Public Service of PUBLIC HEALTH, SAFETY OF THE FOOD CHAIN and ENVIRONMENT
Zonal procedure
As soon as the list with CfS is applicable
Evaluation on a case by case by cMS :
- Which a.s. are authorised for uses applied for ?
- Which non chemical method is in use ?
- Is experience of 5 year needed ?
- List of uses for which substitution is feasible
- Comparative assessment : risks versus benefits of substitution
- Authorisation restricted to uses without acceptable alternatives
- In case of renewal : restriction/refusal to take place after 3
years, for all PPP with this CfS
Add information into (national) part A of dRR
Belgian Federal Public Service of PUBLIC HEALTH, SAFETY OF THE FOOD CHAIN and ENVIRONMENT
Criteria for comparative assessment
• EPPO Standard for comparative assessment
• Draft Guidance document for comparative assessment
• Commission Note with instructions
Belgian Federal Public Service of PUBLIC HEALTH, SAFETY OF THE FOOD CHAIN and ENVIRONMENT
Criteria for comparative assessment
EPPO Standard PP1/271 of 2011
Main principals :
• Restricted to efficacy, resistance and minor uses
• Efficacy to be compared on pest level
• Resistance : keep 2-4 substances available (if any !) with
different mode of action/resistance mechanism
• Minor use : keep a major use to maintain the product on the
market (will not happen for minor uses alone)
Belgian Federal Public Service of PUBLIC HEALTH, SAFETY OF THE FOOD CHAIN and ENVIRONMENT
Criteria for comparative assessment
Draft Guidance document
Main principals :
• Complementary to EPPO Standard PP1/271
• Restricted to health and environment
• Includes technical formulation issues (art 29,1 d)
• Both mandatory and optional comparative assessment
• Step-wise approach
Belgian Federal Public Service of PUBLIC HEALTH, SAFETY OF THE FOOD CHAIN and ENVIRONMENT
Criteria for comparative assessment
Draft Guidance document (2)
Step 1 - assessment in relation to Article 29(1)(d)
• Obligatory for every authorisation : the technical formulation is
limiting exposure (e.g. labelling solvent/ formulation type)
Step 2 - optional assessment in steps I-IV (Article 50(2))
• Optional comparison with non-chemical or prevention method,
also for PPP without candidate for substitution
Step 3 – mandatory assessment starting with agronomic aspects
(EPPO standard PP1/271)
Belgian Federal Public Service of PUBLIC HEALTH, SAFETY OF THE FOOD CHAIN and ENVIRONMENT
Criteria for comparative assessment
Draft Guidance document (3)
Step 4 - first step of assessment for health and the environment
• Comparison for the criteria used for classification as candidate
for substitution (ADI, ARfD, NOAEL, persistence, etc..)
Step 5 – second step of assessment for health and the environment
• Comparison for other aspects of risk assessment
Step 6 – balance disadvantages against risk reduction
• Substitution or amendment of authorisation/application (or not)
Belgian Federal Public Service of PUBLIC HEALTH, SAFETY OF THE FOOD CHAIN and ENVIRONMENT
Criteria for comparative assessment
Commission Note with instructions
Note presented on WG Legislation of June - Main principals :
• A list of candidates for subsitution will be published, together
with an implementation date
• From this date, comparative assessment will be obligatory
• Two steps : first list for active substances approved before end
of January 2013, second list with the rest
• Substances applied for after 14/06/2011 will directly at approval
be classified as candidates for substitution or not
• Mandatory or optional comparative assessment on national level
(after zonal evaluation)
• Mutual recognition : up to the Member States
Belgian Federal Public Service of PUBLIC HEALTH, SAFETY OF THE FOOD CHAIN and ENVIRONMENT
Impact of Comparative assessment
1. Black list of CfS
2. Number of formulations involved
3. Less predictability
Belgian Federal Public Service of PUBLIC HEALTH, SAFETY OF THE FOOD CHAIN and ENVIRONMENT
Impact of comparative assessment
Black list of CfS
List of CfS as soon as published
Black list for NGOs and media
Secundary requirements of distribution sector
Belgian Federal Public Service of PUBLIC HEALTH, SAFETY OF THE FOOD CHAIN and ENVIRONMENT
Impact of comparative assessment
Number of formulations involved
Draft Commission list as far as Belgium concerns :
In total 324 a.s. of which 71 CfS (22 %)
Professional use 320 a.s. of which 69 CfS (21,5 %)
Non professional use 71 a.s. of which 17 CfS (24%) (7 HE, 6 FU, 4 IN)
Consequence :
Workload for reviewing active substances every 7 year
Workload for reviewing formulations every 7 year + CA
Belgium : 367 (of 1700) renewals every 7 year
= 182 renewals/year in stead of 170/year (+ 6,6 %)
Belgian Federal Public Service of PUBLIC HEALTH, SAFETY OF THE FOOD CHAIN and ENVIRONMENT
Impact of comparative assessment
Less predictability
Entry into force of CA vs development time for formulation
Incertainties are build in into the procedure
Which available alternatives at time of submission/evaluation ?
Which alternative uses at time of submission/evaluation ?
Belgium : 13 404 combinations of crop – pest – a.s.
Will there be return for the investment ?
Belgian Federal Public Service of PUBLIC HEALTH, SAFETY OF THE FOOD CHAIN and ENVIRONMENT
Some specific cases
Application for a PPP with CfS
New authorisation, renewal, extension of use
For every single use (crop-pest combination) applied for :
If same CfS already authorised : authorisation possible (no benefit
in refusing authorisation)
If other CfS already authorised : authorisation if the other CfS is not
significantly safer (step 4 and 5)
If non-CfS already authorised :
- Comparable Mode of Action : no authorisation as no benefit in
authorising CfS
- Other MoA : no authorisation if already 2-3-4 MoA authorised,
depending on risk for resistance development
Belgian Federal Public Service of PUBLIC HEALTH, SAFETY OF THE FOOD CHAIN and ENVIRONMENT
Some specific cases
Application for a PPP with CfS (2)
For every single not yet authorised use : authorisation possible
- Apply for non authorised (minor) uses
- Indicate major use needed to keep PPP on the market
Belgian Federal Public Service of PUBLIC HEALTH, SAFETY OF THE FOOD CHAIN and ENVIRONMENT
Some specific cases
Application for a PPP with a CfS and a nonCfS with other MoA
Same principles
If same non-CfS already authorised : no authorisation if already 2-34 MoA authorised, depending on risk for resistance development
Belgian Federal Public Service of PUBLIC HEALTH, SAFETY OF THE FOOD CHAIN and ENVIRONMENT
Some specific cases
Application for a PPP with a CfS for home
and garden use
No such thing as minor uses for home and garden
If a non chemical method is economically and practically feasible
for non-professional users => no authorisation
Manual or mechanical weed-picking is feasible : no future for home
and garden herbicides with CfS ?
Belgian Federal Public Service of PUBLIC HEALTH, SAFETY OF THE FOOD CHAIN and ENVIRONMENT
Thank you for your attention !
[email protected]
Service Pesticides & Fertilisers - Belgian authority for
the authorisation of plant protection products
ECPA/ECCA Conference, 12-13 March 2014, Brussels

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