ECPA/ECCA Regulatory conference on
12-13 March 2014
Developments in the area of pesticide
residues – Commission update
Almut Bitterhof, head of sector pesticides residues, European Commission DG Health and
Consumers, Unit E.3
Health and
Consumers
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Overview
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Legislation – MRL setting and review programme
International dimension
Control and Enforcement
New areas and challenges
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Cumulative risk assessment
Revision of the IESTI equation
Endocrine disruptors
Biocides
Evaluation and possible review of Regulation (EC)
No 396/2005
Health and
Consumers
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Legislation – Routine MRL setting
• Reg. (EC) No. 396/2005, Art. 10
• Evaluation of new applications to set or
modify specific MRLs (Art. 10), including
import tolerances
• Management of unforeseen situations:
residues arising from dual use
substances or from other sources than
plant protection product use
Health and
Consumers
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Legislation – Review of existing
MRLs - Reg. 396/2005 Art. 12
• Priority for DG SANCO to speed up the review
that is much delayed
• Review of complete set of existing MRLs for
more than 300 substances (Art.12 review)
• Scientific input: EFSA reasoned opinions and
advice of EU Reference Laboratories on
analytical aspects
• In 2013 MRLs for about 50 substances were
reviewed
Health and
Consumers
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Revision of Annex 1 to Regulation
(EC) No 396/2005
• Annex I setting the food commodities for
which MRLs apply was recently reviewed
• Proposal voted in February 2014
• Application date: 1st January 2015
• Introduction of 2 parts, Part A and Part B
• Part A: Products of plant and animal origin referred to
in Article 2(1) to which MRLs apply
• Part B:
Other products referred to in Article 2(1)
Health and
Consumers
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International dimension
• Codex Alimentarius
• Presenting EU positions in Codex
Committee on pesticides residues
(CCPR)
• Active participation in electronic working
groups
• Implementation of CXLs in EU legislation
annually (second half of each year)
Health and
Consumers
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Control and Enforcement
• Coordinated EU multiannual programme
• Follow up of the Rapid Alert System on Food
and Feed
• Art. 15(5) of Regulation 882/2004 – updating
the list of pesticides in food/feed of non-animal
origin with increased level of official control at
point of entry
• FVO audits- input into mission programme
Health and
Consumers
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Control and Enforcement – Coordinated
EU multiannual programme
• Dual purpose: a) Check for compliance
with MRLs and b) dietary exposure
assessment
• 2015 – 2017 programme voted in
February 2014
• Adoption in second half of 2014
• Basis for national monitoring
programmes of the Member States
Health and
Consumers
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Control and Enforcement – Food and
Veterinary Office
• FVO audits on pesticide controls in Member
States:
• Audit series on pesticide residues controls from
2007-2011: Overview Report published on
SANCO homepage
• 2012-2014: audit series on controls for
marketing and use of plant protection products
(PPP); follow-up on recommendations for
pesticide residues
Health and
Consumers
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Control and Enforcement – Food and
Veterinary Office
• FVO audits on pesticide conrols in Third
Countries:
• Audits to countries with identified risk:
High trade volume
RASFF notifications
Member State control data via EFSA
• Examples of audits in 2013: Morocco,
Turkey, China, Kenya
• New focus on herbs and spices
Health and
Consumers
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New areas and challengesCumulative risk assessment (CRA)
• Why do we need CRA?
• Effects from active substances with
similar mode of action may add up
• Strong concerns from citizens and
European Parliament as cumulative
efects are not considered so far
• CRA will enable COM to respond to such
concerns
Health and
Consumers
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New areas and challengesCumulative risk assessment (CRA)
• Legal basis for CRA:
• Art. 14 and 36 of Regulation (EC) No
396/2005 on maximum residue levels,
Recital (6)
• Art. 4 of Reg. (EC) No 1107/2009 on
the placing on the market of PPPs
Health and
Consumers
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CRA in Reg. (EC) No. 396/2005
• Art. 14 (Decision on applications concerning
MRLs)
• "…account shall be taken of:
• (a) the scientific knowledge available
• (b) the possible presence of pesticide residues
arising from other sources than current plant
protection uses of active substances, and their
known cumulative and synergistic effects,
when the methods to assess such effects
are available…"
Health and
Consumers
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CRA in Reg. (EC) No. 396/2005
• Rationale for Art. 14 in Recital (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 cumulative and possible
aggregate and synergistic effects on human
health, MRLs should be set after consultation of
the European Food Safety Authority…"
Health and
Consumers
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CRA in Reg. (EC) No. 1107/2009
• Art. 4 (Approval criteria for active
substances):
• The residues of plant protection products …. shall
not have any harmful effects on human health,
including that of vulnerable groups, …,taking
into account known cumulative and
synergistic effects where the scientific
methods accepted by the Authority to
assess such effects are available, …
Health and
Consumers
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Current Status of CRA (1)
• Close collaboration between EFSA and
DG SANCO established
• EFSA: 2 cumulative assessment groups
(CAGs) established focussing on effects
on thyroid and nervous system
• EFSA work is ongoing
• Cumulative risk assessment carried out
as pilot project in EFSA monitoring
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report
Health and
Consumers
Current Status of CRA (2)
• SANCO established en electronic WG for
risk managers of the Member States
• RTD funded project (ACROPOLIS)
finalised (FP 7) – follow up being
discussed
Health and
Consumers
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Considerations for future implementation of
CRA in risk management
• When?
• Once all the Cumulative risk assessment
groups have been established by EFSA
• How?
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Define detailed procedures
Evaluate impact of change of methodology
Consideration of international trade
Define communication strategy
Health and
Consumers
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Revision of the IESTI equation
• Recent SCOFCAH identified the need to take up
earlier discussions on the revision of the IESTI
equation
• The approach to be taken currently discussed
internally in DG SANCO
• Close collaboration between risk assessors and
risk managers needed, discussion at
international level needed
Health and
Consumers
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New areas and challenges
• Endocrine disruptors and cut-off
criteria
• COM is developing criteria to identify
endocrine disruptors, as required by
Reg. 1107/2009 on plant protection
products and by Reg. 528/2012 on
biocides
• Criteria may impact MRL and import
tolerance setting
Health and
Consumers
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New areas and challenges – Biocides
• Legislation and responsibilities:
• Legislation is managed by DG ENV
• If MRL need to be set, this will be
SANCO responsibility
Health and
Consumers
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New areas and challenges – Biocides
• Next steps (1):
• Define a strategy to identify biocides for
which MRLs are necessary
• BfR workshop on 18-19 March 2014
• Define the legal framework under which
MRLs should be set in case appropriate
• Interplay between legislation for dual
use substances
Health and
Consumers
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New areas and challenges – Biocides
• Next steps (2):
• Possible legal frameworks:
Regulation 315/1993 on contaminants
Dir. 2002/32 undesirable substances in feed
Reg. 396/2005 on pesticides residues
Reg. 470/2009 on veterinary medicinal products
• Define procedural aspects between 3
different agencies (ECHA, EMA and
EFSA) and 2 Commission DGs
Health and
Consumers
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New areas and challenges- Review of
Reg. 396/2005
• Way forward:
• As a first step: Evaluation study for Reg.
396/2005 planned for 2015
• Depending on the outcome further steps
• No immediate review of Reg. 396/2005
Health and
Consumers
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New areas and challenges- Review of
Reg. 396/2005
• Items for consideration:
• Alignment with Reg. 1107/2009, e.g.
cut-off criteria, procedural alignments
• Lisbonisation
• Biocides?
• Addressing legal gaps and clarifications
e.g. dual use substances, presence from other
sources than PPP use, Art. 12 procedures,
Consolidation of Annexes, need for t-MRLs, etc. 25
Health and
Consumers
Questions?
• Contact: Almut. Bitterhof@ec.europa.eu
Health and
Consumers
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