Belgian Federal Public Service of PUBLIC HEALTH, SAFETY OF THE FOOD CHAIN and ENVIRONMENT...

Belgian Federal Public Service of PUBLIC HEALTH, SAFETY OF THE FOOD CHAIN and ENVIRONMENT

Comparative assessment in the zonal system

Maarten TrybouService Pesticides & Fertilisers - Belgian authority for the authorisation of plant protection products

ECPA/ECCA Conference, 12-13 March 2014, Brussels


Overview

Legal basisZonal procedureCriteria for comparative assessmentImpact of comparative assessmentSome specific cases


Legal basis

Art. 40 of 1107/2009 : Comparative assessment required for every application for authorisation, renewal or amendment if the PPP contains a CfSSubstitution 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 accountFor new active substances : possibility to wait for 5 yearsIn exceptional cases “voluntary” substitution (without CfS) with a non-chemical method in general use


Legal basis

Art 41 :Zonal procedure with zRMSMutual recognition not obligatory


Zonal procedure

As soon as the list with CfS is applicableEvaluation 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 CfSAdd information into (national) part A of dRR


Criteria for comparative assessment

• EPPO Standard for comparative assessment• Draft Guidance document for comparative assessment• Commission Note with instructions



EPPO Standard PP1/271 of 2011Main 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)



Draft Guidance documentMain principals :• Complementary to EPPO Standard PP1/271• Restricted to health and environment• Includes technical formulation issues (art 29,1 d)•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



Draft Guidance document (2)Step 1 - assessment in relation to Article 29(1)(d)• Obligatory for every authorisation : the technical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 substitutionStep 3 – mandatory assessment starting with agronomic aspects (EPPO standard PP1/271)



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 assessmentStep 6 – balance disadvantages against risk reduction• Substitution or amendment of authorisation/application

(or not)



Commission Note with instructionsNote 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


Impact of Comparative assessment

1. Black list of CfS2. Number of formulations involved3. Less predictability


Impact of comparative assessment

Black list of CfSList of CfS as soon as publishedBlack list for NGOs and mediaSecundary requirements of distribution sector



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 yearWorkload for reviewing formulations every 7 year + CABelgium : 367 (of 1700) renewals every 7 year = 182 renewals/year in stead of 170/year (+ 6,6 %)



Less predictability

Entry into force of CA vs development time for formulationIncertainties are build in into the procedureWhich 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 ?


Some specific cases

Application for a PPP with CfSNew authorisation, renewal, extension of useFor 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


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


Some specific cases

Application for a PPP with a CfS and a non-CfS with other MoASame principlesIf same non-CfS already authorised : no authorisation if already 2-3-4 MoA authorised, depending on risk for resistance development


Some specific cases

Application for a PPP with a CfS for home and garden useNo such thing as minor uses for home and gardenIf a non chemical method is economically and practically feasible for non-professional users => no authorisationManual or mechanical weed-picking is feasible : no future for home and garden herbicides with CfS ?


Thank you for your attention !

[email protected] 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...

Documents

Transcript of Belgian Federal Public Service of PUBLIC HEALTH, SAFETY OF THE FOOD CHAIN and ENVIRONMENT...