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The new Regulation concerning the placing of plant protection products on the market

Herman FontierPesticide Risk Assessment Peer Review (PRAPeR) Unit

1EFSA Stakeholder Consultative Platform, Brussels, 05/06/09

Content

• EFSA and pesticides: PRAPeR Unit and PPR U itUnit

• New regulation: elements of importance from an EFSA perspective

- Data requirements- Procedure for approval of an active substance- Approval criteria- Acceptance of assessment methods- Other (guidance documents, treated seeds,…)

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PRAPeR Unit (peer review)

• The PRAPeR Unit is in charge of the peer i f d i ti ti b treview of new and existing active substances

and produces EFSA conclusions on Draft A t R t d b th R tAssessment Report prepared by the Rapporteur Member States

• The Commission bases its decision making (inclusion or not on the Annex I of Directive 91/414/EEC) on the EFSA conclusion

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PRAPeR Unit (MRLs)

• The PRAPeR Unit evaluates the safety of new MRL f MRL f d f i ti MRLMRLs, of MRLs of concern and of existing MRLs after a decision on inclusion or non-inclusion of an a.s.

• The PRAPeR Unit is in charge of the drafting of the Annual Report on Pesticide Residues

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Structure of the PRAPeR UnitHerman Fontier

Co-ordination EcotoxicologyResidues / Environmental Residues /Phys-chempropertiesMammalianCo-ordination

Team (7)Ecotoxicology

Team (5)peer review Team (3+2 50%)

fate and behaviourTeam (4+1 interim)

MRLsTeam (5)

properties,analytical methods

Team (3)

toxicologyTeam (5)

Jane Barling Manuela Tiramani Jeff Pim Jean-Pierre Hermine Reich Franz StreisslChris LythgoJane Barling

Jürgen Sturma

Manuela Tiramani

Danièle Court Marques

50%

Laszlo Bura

Cugier

Anja Friel

Hermine Reich

Daniela Brocca

Franz StreisslChris Lythgo

Alf AagaardJosé OriolMagrans

Ragnor Pedersen

Tünde Molnar Juan Manuel

Frédérique Istace Maria Ciaula50%

Maria Lusser

Bruno Dujardin

Aija Kazocina

Francisco JavierHerranz Montes

Jeff Pim50%

Domenica AuteriCsaba Szentes

Laura Padovani

BénédicteVagenende

Tünde Molnar

Laura Perati

Parra Morte Maria Lusser

Gabrielle Kubanski

Aija Kazocina

Maria Ciaula50%

Domenica AuteriCsaba Szentes

Silvia Scaglioni Maria ChiaraAddis

Alwyn Borg Myatt

Judith KappelSummary:Total number of staff 34AD 26AST 5y o g yatt AST 5CA 2Interim 1

PPR panel and WGs

Working GroupT i l

Working Group Residues

PPR Panel

Toxicology

Working Groups

Residues

Working Group Ecotoxicology

21 expertsupdating and developing the GDs

e.g. Persistence in soil,Terrestrial Ecotoxicology Working Group Terrestrial Ecotoxicology Working Group

Fate and behaviour

Supported by the EFSA Secretariat i

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=PPR Unit

Mandate of the PPR Panel

• To produce scientific opinions answering questions on risk assessment for specific pesticides (e g Q fromon risk assessment for specific pesticides (e.g. Q from Commission on deltamethrin) or related generic issues with regard to users, consumers and the environment ( Q f C i i th i i f th A(e.g. Q from Commission on the revision of the Annexes II and III)

• Responsible of EU Guidance Documents on pesticideResponsible of EU Guidance Documents on pesticide Risk Assessment (previously DG SANCO)– Revision of existing GDs– Development of new GDsAim: promotion of new and harmonized scientific

approaches and methodologies in the EUapproaches and methodologies in the EU7

Data requirements

• Directive 91/414/EEC: data requirements laid d i th A II ( ) d III (PPP)down in the Annexes II (a.s.) and III (PPP)

• New Regulation: data requirements to be adopted as separate regulations within 18 months of the entry into force of the new regulation; in first instance, these data requirements will be copied from the Annexes II and III of the Directive

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Data requirements

• Annexes II and III are under revision• However, it is the Commission’s intention to

copy the current data requirements into regulations by the end of 2009 (advisory procedure)

• These regulations will then be amended in order to take on board the ongoing revision of the data g grequirements (regulatory procedure with scrutiny)y)

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Data requirements

• The PPR Panel is working on an updated i i th i i f th A II d IIIopinion on the revision of the Annexes II and III

• Concerning the assessment of effects on honey bees, the Panel will reiterate its recommendation that the revised data requirements should be flexible enough to allow new risk assessment developments to be applied when available

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Data requirements

• New element in the Regulation: the dossier must b l t d ith i tifi i dbe completed with « scientific peer-reviewed open literature, as determined by the Authority,

th d it l t t b lit d lion the a.s. and its relevant metabolites dealing with side-effects on health, the environment and

t t i d bli h d ithi th l tnon-target species and published within the last ten years before the date of dossier

b i isubmission »• EFSA is working on a self-tasking in order to

develop guidance for applicants11

Approval of an active substance

• Directive 91/414/EEC: procedure of Annex I i l i i t d t il d l f RMS dinclusion is not very detailed; roles of RMS and EFSA are not clarified

• New Regulation: procedure of a.s. approval is laid down in detail, clarifying role of all parties involved, establishing clear time lines

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Approval procedure

• Application to a Member State (RMS)• RMS checks the admissibility of the application• Applicant makes dossier available to all MSs, pp ,

EFSA, Commission• EFSA makes the summary dossier available toEFSA makes the summary dossier available to

the public• The RMS assesses the dossier and prepares a• The RMS assesses the dossier and prepares a

draft assessment report (DAR); during the asessment the RMS may at any time consultasessment, the RMS may at any time consult EFSA 13

Approval procedure

• Once finalised, the DAR is sent to the C i i d EFSACommission and EFSA

• EFSA shall circulate the DAR for comments to the MSs and the applicant, and shall make it available to the public

• Where appropriate, EFSA shall organise a consultation of expertsp

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Approval procedure

• Within 120 days (150 days where an expert lt ti t k l ) EFSA h ll d tconsultation takes place), EFSA shall adopt a

conclusion on whether the active substance can b t d t t th l it ibe expected to meet the approval criteria

• EFSA shall address the risk mitigation options identified in the DAR

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Approval procedure

• EFSA shall establish the format for its l i hi h h ll i l d d t il thconclusion which shall include details on the

procedure and the properties of the a.s.• The Commission may at any time review the

approval of an active substance and may ask EFSA to provide an opinion or other scientific or technical assistance within 3 months

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Approval criteria

• Directive 91/414/EEC: it has to be demonstrated th t t ti f t l t PPPthat representative uses of at least one PPP containing the a.s. evaluated can be used safely;

id ti f th ff ti f th PPPno consideration of the effectiveness of the PPP• New Regulation:- same principle, but effectiveness to be considered in

view of approval (EFSA will have to address the ff ti f th PPP i it l i )effectiveness of the PPP in its conclusion)

- A.s. must comply with the criteria of Annex II of the Regulation (including the so called cut off criteria)Regulation (including the so-called cut-off criteria)

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Approval criteria

• Criteria CMR, endocrine effects, fate and b h i (POP PBT P B)behaviour (POP, PBT, vPvB):

- Where the assessment establishes that the approval it i t ti fi d th DAR h ll b li it d tcriteria are not satisfied, the DAR shall be limited to

these parts of the assessmentCMR endocrine effects: « an a s shall only be approved- CMR, endocrine effects: « an a.s. shall only be approved if, on the basis of (…) testing (…) and other available data and information, including a review of the scientificdata and information, including a review of the scientific literature, reviewed by the Authority, it is not or has not to be classified… »

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Approval criteria

• Honey bees: an a.s. can only be approved if its use:

- Will result in negligible exposure, or- Will not lead to unacceptable acute or chronic effects on

colony survival and development, taking into account effects on larvae and behavioureffects on larvae and behaviour

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Acceptance of assessment methods

• Residues shall have no harmful effects « taking i t t k l ti d i tiinto account known cumulative and synergistic effects »

• The use of PPPs (for instance in the workplace) shall have no harmful effects « taking into account known cumulative and synergistic effects »

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• The use of PPPs shall have no harmful effects th i t ( t i il i l dion the environment (water, air, soil, including

long-range transportation; non-target species, i l di b h i bi di it t )including behaviour; biodiversity; ecosystem)

=> « where the scientific methods accepted by the Authority to assess such effects are available »y

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• Concerning cumulative effects of residues:- The PPR Panel has adopted a first opinion in 2008- An opinion on the triazole fungicides will be adopted in a

f k ti (t t f diff t th d l ifew weeks time (test of different methodologies performed on a chemical class of pesticides)A call will be launched for follow up work (establishment- A call will be launched for follow-up work (establishment of related groups of pesticides for which assessment of combined toxicity is needed)combined toxicity is needed)

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Other elements important to EFSA

• The Commission may adopt through the l t d t h i l d thregulatory procedure technical and other

guidance documents and « may ask the A th it t t t ib t t hAuthority to prepare or to contribute to such guidance documents »

• Safeners and synergists: added in the scope of the Regulation; a review programme for the existing substances will be initiated within 5 years; EFSA will be involved

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• Basic substances = not of concern, d i tl d f th thpredominantly used for other purposes than

plant protection, not placed on the market as a l t t ti d tplant protection product

• No authorisation required if the basic substance is approved

• Approval of basic substance: any interested pp yparty can apply, no RMS involved, EFSA to deliver an opinion within 3 monthsp

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• Treated seeds:- Directive 91/414/EEC: no specific provisions at all;

potential conflict with EU legislation on seedsN R l ti i f i i k ibilit t- New Regulation: in case of serious risk, possibility to take measures (restriction or prohibition) in accordance with the regulatory procedure; Commission may requestwith the regulatory procedure; Commission may request an opinion from EFSA

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• 120 day authorisation in emergency situations in l t t ti th C i i k EFSAplant protection: the Commission may ask EFSA

to provide an opinion or other scientific or t h i l i t ithi 1 thtechnical assistance within 1 month

• Where the Commission is considering restriction or prohibition of an a.s., it may ask EFSA to provide an opinion

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• Co-formulants: negative list of co-formulants that t b d i PPPcannot be used in PPPs

• Detailed rules for co-formulants may be established in accordance with the regulatory procedure

• EFSA involvement not clear today (but probable)

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• Adjuvants: authorisation system to be put in l th h l ti d t d th h thplace through a regulation adopted through the

regulatory procedure with scrutiny• No time schedule• EFSA involvement not clear today (but probable)y ( p )

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Some other elements

• Zonal concept for the national authorisations• Identification of candidates for substitution • Application of comparative assessmentpp p• Placing on the market of low-risk PPPs=> It cannot be excluded that the Commission=> It cannot be excluded that the Commission

would ask EFSA to assist or to develop guidanceguidance

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