PPR Panel’s Work on Cumulative Risk Assessment of Pesticides

ECPA – IBMA- EFSA Workshop Parma, 26th April 2012

Committed since 2002 to ensuring that Europe’s food is safe

• Over the last decades – growing concern in Europe on

combination or cumulative effects of chemical substances

• Ever growing number of EU and Member State reports, publications and studies on the issue:

“Chemical cocktails – a serious matter of concern”

published 10 February 2012

http://www.norden.org/en/publications/publikationer/2012-711

Regulation EC 396/2005 on maximum residue levels (MRLs)

Art 14 (Decision on applications concerning MRLs) “ …account shall be taken of… the possible presence of pesticide residues arising

from sources other than current plant protection uses of active substances, and their known cumulative and synergistic effects, when the methods to assess such effects are available…”

Whereas (6) “It is also important to carry out further work to develop a methodology to take

into account cumulative and synergistic effects. In view of human exposure to combinations of active substances and their possible aggregate and synergistic effects on human health, MRLs should be set after consultation of the European Food Safety Authority…”

Legislative background for CRA

7th EFSA Scientific Colloquium, 28 - 29 November 2006, Parma, Italy

• 2007 The EFSA's 7th Scientific Colloquium Report – Cumulative Risk Assessment of pesticides to human health:

The Way Forward http://www.efsa.europa.eu/en/supporting/pub/117e.htm Participation from experts from EU member states and

Accession Countries

7th EFSA Scientific Colloquium, 28 - 29 November 2006, Parma

Conclusions/Recommendations: • Develop a methodology for assessment of cumulative hazards

preferably on bases of existing approaches • Develop criteria for grouping substances • Consider also dissimilar mode of action • Develop guidance for probabilistic exposure modeling • Prioritise compounds (organophosphates, carbamates, triazoles,

pyrethroids, dithiocarbamates) • PPR Panel to prepare an opinion based on the outcome of the

colloquium

PPR Scientific Opinions on CRA

• 2008 PPR Scientific Opinion to evaluate the suitability of existing methodologies and, if appropriate, the identification of new approaches to assess cumulative and synergistic risks from pesticides to human health with a view to set MRLs for those pesticides in the frame of Regulation (EC) 396/2005 http://www.efsa.europa.eu/en/efsajournal/pub/705.htm

PPR Scientific Opinions on CRA

Principles established : • Dose addition (similar action) response addition (dissimilar action) and interaction not

considered

• Criteria grouping of substances for CRA

• Tiered approach for hazard assessment

• Tiered approach for exposure assessment

PPR Scientific Opinions on CRA

• 2009 PPR Scientific Opinion for a selected group of pesticides from the triazole group to test possible methodologies to assess cumulative effects from exposure through food from these pesticides on human health http://www.efsa.europa.eu/en/efsajournal/pub/1167.htm

PPR Scientific Opinions on CRA

11 Triazole pesticides (fungicides) Structure (diniconazole)

• Target organism: inhibition of ergosterol synthesis

(inhibition of CYP51)

• Laboratory rodent (rat): – Acute: Cranial malformations (inhibition of CYP26 in

embryo) – Chronic: Liver toxity (inhibition/induction of CYPs)

Current PPR/PRAS activities on CRA

Completion of PPR work on cumulative risk

assessment - similar MoA (dose addition)

• Article 36. grant on Identification of cumulative

assessment groups of pesticides - initial deadline of December 2010 delayed to October 2011

Current PPR/PRAS activities on CRA

Completion of PPR work on cumulative risk assessment - similar MoA (dose addition)

• PPR Scientific Opinion on the identification of pesticides to be included in cumulative assessment groups on the basis of their toxicological profile

• Groups for all active substances approved in EU • Criteria for addition of new groups/substances • Grouping essentially based on common effects + mode of action • Adoption foreseen for June 2013

Current PPR/PRAS activities on CRA Cumulative risk assessment - dissimilar MoA

(response addition): • Procurement on Investigation of the state of the science on

combined actions of chemicals in food through dissimilar modes of action and proposal for science-based approach for performing related cumulative risk assessment

- published January 2012 http://www.efsa.europa.eu/en/supporting/pub/232e.htm

Current PPR/PRAS activities on CRA Cumulative risk assessment - dissimilar MoA

(response addition): • PPR Scientific opinion on the relevance of

dissimilar mode of action (response addition) and its appropriate application for cumulative risk assessment of pesticides in food

- activities to commence last trimester 2012 - deadline December 2013

Current PPR/PRAS activities on CRA

• PPR guidance on the use of probabilistic methodology for modelling dietary exposure to pesticide residues - deadline for adoption: September 2012 Currently posted for second public consultation in order to get the views of EU Member State Authorities and other stakeholders: http://www.efsa.europa.eu/en/consultations/call/120125.htm

Timeline for activities on cumulative risk assessment for pesticide residues in the diet

2 0 0 7 2 0 0 8 2 0 0 9 2 0 1 0 2 0 1 1 2 0 1 2 2 0 1 3

PPR opinion - methodology for CRA

PPR opinion – CRA triazoles

Project - CAGs similar MoA

PPR opinion – CAGs similar MoA*

Project - CRA dissimilar MoA

PPR opinion – CRA dissimilar MoA*

PPR guidance - probabilistic modelling for dietary exposures to pesticides

“Non-dietary” CRA– Legislative background Regulation (EC) No 1107/2009 concerning the placing of plant

protection products on the market “A plant protection product, consequent on application consistent

with good plant protection practice and having regard to realistic conditions of use, shall meet the following requirements: it shall have no immediate or delayed harmful effect on human health,…, or consequences in the workplace or through other indirect effects, taking into account known cumulative and synergistic effects where the scientific methods accepted by the Authority to assess such effects are available;….”

“Non-dietary” CRA – PPR/PRAS activities

• Procurement contract for collection and assessment of data relevant for non-dietary cumulative exposure to pesticides and proposal for conceptual approaches for non-dietary cumulative exposure assessment

- deadline June 2012

- Collection of data from application and use of pesticides (e.g. arable, vineyards, greenhouses, orchards, amateur uses) – involving 9 organisations in different EU countries

“Non-dietary” CRA – PPR/PRAS activities

• PPR Scientific Opinion on non-dietary cumulative risk assessment of pesticides

- Development of a methodology - Start of activities foreseen for end of 2012

Thank you for your attention!