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Implementation of comparative
assessment
-Portuguese Guidance -
Miriam Cavaco
Head of Authorization of Plant Protection Products Division
General Directorate of Food and Veterinary
CEUREG FORUM XIX, Zagreb, 5 th of November 2015 1
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Contents:
Portuguese specificities;
Sustainable Use Directive;
Comparative assessment in the Southern Zone;
Comparative assessment – Portuguese guidance;
Concluding remarks.
2
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Contents:
Portuguese specificities;
Sustainable Use Directive;
Comparative assessment in the Southern Zone;
Comparative assessment – Portuguese guidance;
Concluding remarks.
3
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The size of farms in Portugal is on average 5
hectares smaller than in the EU.
PT produces a broad range of fruits and
vegetables thanks to its varied climatic and
topographic conditions;
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SOUTHERN ZONE SPECIFICITIES
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•High demand of pesticides to protect crop productions due:
high number of pests raised by favourable climatic conditions
Eurosat (2005)
0
20
40
60
80
100
120
South Central Norh Total EU
Herb. 38.88 40.101 4.955 83.936
Fung. 84.042 22.368 1.153 107.563
Ins. 5.769 1.974 0.66 7.809
Ton
nes
of
acti
ve s
ub
stan
ce
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Importance of Minor uses in Portugal
•Total of aplications: 3284
• Extensions granted: 1774
•Minor use in major crop: 4%
total
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Number of authorisations granted in Portugal
7
0
50
100
150
200
250
2006 2007 2008 2009 2010 2011 2012 2013 2014
90 83
132
106
39 50
71
209
120
2006-2014
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Mutual Recognition in Portugal
0
10
20
30
40
50
60
70
2009 2010 2011 2012 2013 2014 2015
10
30
38
54
21
25
35
0
14 14
20
64
14
17
0 2 3 4
15
0 0
Applications made Authorizations Canceled
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Ministery of Agriculture and Sea
General directorate of
food and Veterinary
Fitossanitary Department
Authorization of PPP Division
…….
General Directorate….
………
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Risk Assessment
Equipment inspection
Forecast
Warning
Service
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Integrated Pest
Management
Plant Protection Products Authorisation Division
Minor Uses
Risk Management
1
1
1
1
6
SUD 2
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Contents:
Portuguese specificities;
Sustainable Use Directive;
Comparative assessment in the Southern Zone;
Comparative assessment – Portuguese guidance;
Concluding remarks.
11
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Promoting the use of IPM and alternative approaches or
techniques such as non-chemical alternatives to pesticides.
Sustainable Use Directive of pesticides
(Directive 2009/128/CE, 21 st Octobre)
Establishing a framework for Community action to
achieve the sustainable use of pesticides
Reducing the risks and impacts of pesticide
use on human health and the environment
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Contents:
Portuguese specificities;
Sustainable Use Directive;
Comparative assessment in the Southern Zone;
Comparative assessment – Portuguese guidance;
Concluding remarks.
13
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Comparative assessment in Southern Zone • CA should be donne at Member State level;
• Depends on nationally available alternatives;
• EU GD allows a very restrictive or flexible interpretation – different approaches
between MS;
• Restricted timelines:
• ZRMS: 9 months
• Concerned MS: 3 months Renewal
• ZRMS: 12-18 months
• Concerned MS: 4 months New apllications
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Contents:
Portuguese specificities;
Sustainable Use Directive;
Comparative assessment in the Southern Zone;
Comparative assessment – Portuguese guidance;
Concluding remarks.
15
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Comparative assessment
• A comparative assessment (CA) shall be performed by Member States (MS) when
evaluating an application for authorisation for a PPP containing an active
substance approved as a candidate for substitution.
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Article 24
approved active substances meeting one or more of the conditions
listed in Annex II point 4 of Regulation 1107/2009.;
have all been evaluated and are approved for use in the EU in
authorised PPP;
Uses of PPP considered under the CA process:
have all been evaluated all have an acceptable risk assessment
in accordance with Regulation
1107/2009.
the approval may be renewed once or more for periods not exceeding 7 years
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• Regulation (EU) 2015/408, 11 March 2015: Establishes a list of candidate
of substitution 77 active substances are candidates of substitution.
• Guidances:
SANCO/11507/2013 (rev. 12), 10 the October 2014: Guidance
Document on Comparative Assessment and Substitution of Plant
Protection Products in accordance with Regulation (EC) n.º 1107/2009 ;
EPPO standard PP 1/271: EPPO Guidance on CA;
Guidance for UK applicants for plant protection authorisations.
Comparative assessment
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tasked to ‘sort out how
to deal with it’
Developed ideas and
procedures
PT guidance
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Portuguese approach
DGAV
ANIPLA
Working group
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Comparative assessment
- Portuguese guidance -
• This guidance is provided for applicants seeking authorisation of plant
protection products in PT.
• Supplements the EU guidance for applicants.
• Explains:
what information is required for a CA;
when it should be submitted and;
how it should be presented.
• Keep it as simple as possible;
• Involves applicants;
• Reach a conclusion at the earliest possible step.
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When should be provide information for CA?
Comparative assessment
- Portuguese guidance -
•EU guidance on comparative assessment came into force on 1 April 2015.
•The list of Candidates for Substitution came into force on 1 August 2015.
• Applicants need to provide information for comparative assessment from 1
August 2015 (submission date at ZRMS).
•Applicants need to provide the information in this guidance for:
new authorization, extension of authorization, renewal and mutual recognition
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How should be provide information for CA?
Comparative assessment
- Portuguese guidance -
• Applicants detailed consideration of this, should be provided as the
supporting ‘data’. using the form attached to the guidance Annex 2
• The conclusion for comparative assessment and substitution should be
included:
national addenda to the draft Registration Report (dRR)
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What does the information needs to cover?
Comparative assessment
- Portuguese guidance -
• Consider steps 1-10 of Annex 2 and decide which steps need to complete for
the PPP;
• It is recommended to start the assessment in areas, where there might be a
problem, e.g., development of resistance;
• CA shall be performed to additional use or uses, the previous authorized uses
do not require comparative assessment;
• Any relevant conclusions will not be applied to other existing authorizations for
products containing the same candidate for substitution.
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How to address CA for zonal applications?
Comparative assessment
- Portuguese guidance -
• As comparative assessment and substitution is a Member State responsibility it
cannot be considered appropriately by the zRMS;
• It remains the responsibility of the individual Member States and applicants
should follow their advice and procedures;
• Applicants should include the PT comparative assessment information in their
application in PT National addenda in both cases:
PT - Rapporteur Member State or;
PT - Concerned Member State.
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Regulatory action in the end of CA
Comparative assessment
- Portuguese guidance -
•If PT concludes that a substitution for any of the uses of the PPP is appropriate:
that withdrawal or amendment shall take effect 3 years after the decision
or
at the end of the approval period of the candidate for substitution where
that period ends earlier.
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What if the availability of alternatives changes after a decision?
Comparative assessment
- Portuguese guidance -
•If the applicant believes that suitable significantly safer alternatives to the PPP
are no longer available and a comparative assessment would not reach the
conclusion that a substitution is appropriate:
may make an application for re-instatement of the product using the
appropriate regular application route.
this application should include a new consideration for comparative
assessment together with any other data or information that may be required
for re-instatement at that time.
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Final conclusion and Report
Comparative assessment
- Portuguese guidance -
• All steps of CA should be appropriately documented in dRR;
• A clear justification should be given for the conclusion of each step;
• The applicant should be given the possibility to comment.
Applicant information to support the
CA
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Concluding remarks
• We will have a lot to learn CA;
• Will need to share the experiences between applicants and CA;
• Expected that guidance will be updated in the light of experience!