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CEUREG XX Brno 2016-10-10
Background & DifficultiesIn decision making of active substances
Gábor Tőkés, Adél Janka
National Food Chain Safety OfficeDirectorate of Plant Protection , Soil Conservation and Agri-environment
HUNGARY, Budapest
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PPP can be registered in EU member states only if the active
substance is taken to the positive list
Applicant
RMS
(Rapporteur
member
State)
EFSA
COM
(MS vote)
Positive
list Refusal
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If no qualified majority….
Appeal comittee - attachee
Appro-
val
With-
drawal
COM
decision
deadlock
deadlock
deadlock
With-
drawalAppro-
val
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Updated data requirements (DR)
Old DR
544/2011/EU
For dossiers submitted forrenewal
(AIR I & II) and new approval until
31.12.2013
New DR
283/2013/EU
For dossiers submitted forrenewal
(AIR III & IV) and new approval from
01.01.2014
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Updated EFSA Guidancesduring the review
Ecotoxicity: • Aquatic GD – 2015• GD on birds and mammals – 2015• Draft GD on Bees – officially not accepted !
…but used by EFSA as ‘new scientific evidence’ (1st Tier) (not harmonised approach)
Human toxicity:• Updated OECD testing guidelines, EFSA Scientific opinion 2011
on genotox. testing strategies• Operators, workers, residents and bystanders GD – 2014• Dermal absorption GD - 2014
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Active substance withdrawals
2012: diphenylamine , novaluron2013: didecyldimethylammonium chloride –
bitertanol, flusilasole, potassium-iodideand potassium-thiocyanate
2014 fenbutanin-oxide ethoxysulfuron, oxadiargyl,warfarin, cyfluthrin, carbendazim
2016: isoproturon, triasulfuron, amitrol, tryciclazole3-decen-2-one, (Z,Z,Z,Z)-7,13,16,19-Docosatetraen-1-yl
isobutyrate,, (Z)-13-Hexadecen-11-yn-1-yl acetate,
2017: Further negative conclusions published by EFSA for AIRII and AIRIII ASs:
diquat, linuron, maleic-hydrazide, fenamidone, isoxaflutole, imazamox,2,4-DB, famoxadone, mesotrione, pendimethalin, picoxystrobin...
Drastic increase in the near future ?
0
2
4
6
8
10
12
20
12
20
13
20
14
20
15
20
16
20
17
?
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Serious restricions
Chlorpyrifos – accute consumer riskMRL to LOD – more crops deleted(apple, pear, cabbage, savoy cabbage, brussels sprouts,
cauliflower, broccoli, grapes)
Neonicotinoides – use restrictions referring tobee health
Glyphosate – withdrawal of PPPs with tallow-amine
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Reasons for negative EFSA conclusions on a.s. dossiers
• 2015/2016: EFSA changes towards a more conservative approachRMS →← EFSA
• Weight of evidence approach not followed
• Endpoints are not set referring to lack of data
• EFSA does not accept new data after application
• New scientific results → new GDs - from whatdate to be applied? (dossier preparation is beforeimplementation date, how to conduct new studies?)
• Genotoxicity and new bee GD are two criticalissues
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• Genotoxicitydifferent approach between RMS and EFSAEFSA needs new in vivo trials but no way for submissionCOM will send a mandate to EFSA for clarifying thedifferences in conclusions
till then no decisions
• Bee GDmore detailed GD was necessary(recent GD is too short and weak)irrealistic requirements – 7% protection goalif Tier 1 fails, almost no chance for field trials
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7% difference can not be detectedstatistically in a field trial with bees –
only in extreme large areas and number of replicates
100 93
55
0
20
40
60
80
100
120
Control PPP1 PPP2
living bee number
If CV< 7% → it is a good plant trial but not a bee trial
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Politically influenced decisions 1Neonicotinoids
• Clothianidin(Bayer)
• Thiametoxam(Syngenta)
• Imidacloprid(Syngenta)
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SCIENCE conclusionsAfter neonic feeding with neoconcentration occuring on fields:
• Decrease in number of queens
• Disturbance of orientation ability
• Reproductibility of trials is questionable
• Feeding was carried out in laboratory , not in field !
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485/2013/EU regulationin lack of qualified majority of MSs
• Since 1st December 2013 seed dressing and use of such seeds is prohibitedin spring cereals and all bee-attractive crops(e.g. sunflower, maize, rape)
• Soil desinfection is prohibited in attractivecrops
• No evidence for harmful effect in field
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Number of bees in Hungary
colonies
beekeepers colonies
beekeepers
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0%
20%
40%
60%
80%
100%
120%
140%
160%
180%
200%
BE BG CZ DK DE EE IE EL ES FR HR IT CY LV LT LU HU MT NL AT PL PT RO SI SK FI SE UK E
u-
25
Number of bee colonies in EU 25 between 2004-2013
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Healthy
Infected
PPPVarroa destructor
Why did we oppose restrictions?• Bee density is highest in Europe >1 100 000 colonies, 12 hives /km2
• Number of bee mortality : 150-200.000 colonies / year
• 5-10 % of mortality is caused by pesticides (0,5-1% of total hives)
• Reasons are mostly inappropriate use
• Most of mortality is caused by pests, deseases (Varroa mite, nosema disease)
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Result of two yearswithout neonics in HU
• No emergency use in 2014 and 2015
• No inprovement in bee health – more diseaseproblems
• Increase of leaf spray in sunflower, maize and rape
• Extreme increaseof chlorpyriphos
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Use of chlorpyriphos in Hungary
0
50000
100000
150000
200000
250000
300000
350000
400000
2010 2011 2012 2013 2014 2015
chlorpyriphos kg
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GLYPHOSATE
N-(phosphonomethyl)glycine
Politically influenced decisions 2
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Wide spectrum herbicide
Post-emergent
‘Clears all’
Use for cleaning of stubble and non-agricultural lands
Minimum tillage
Use: as isopropil-amine, potassium or ammonium saltspray
Also used as dessiccant
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Properties
• Binding to soil granules
• No uptake through root
• Not bioaccumulative, depletes fom body
• Can occure in urine
• Metabolit: amino-methyl-phosphonic acid (AMPA)
• DT 50: 1-2 weeks (but AMPA more months)
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GMO• Effective weed killing of glyphosate tolerant
crops
• More spray onto crop !
• Risk of weed resistency
2004
Fejér m. NTSZ
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Renewal of glyphosate
Annex I. inclusion: 2002.07.01
Expiry: 2012.06.30 2015.12.31 2016.06.30
RMS: Germany co-RMS: Slovakia
Dossier submission : 2012. May
RMS assessment (RAR): 2013. December 20.
Member state comments : 2014. Jan-Apr
Supplementary data, evaluation
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Unexpected turn in renewal
IARC 2015.03. :(probable carcinogenity, Carc.Cat. 2 = EU Carc1B ekv.)
Expert meeting (EFSA + MSs): 2015. September
RAR addenda: 2015. October
EFSA summary: 2015. November 12. carcinogenity not justified and no other cut-off reason
27 MSs agree with EFSA opinion
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EFSA & IARC conclusions
EFSA• GLP studies
• Relevant scientific articles
• Legally binding datarequirements and assesmentprinciples
IARC• Based on articles
(nonreproducible, missingmethodics etc.)
• Not known assesment criteria
• Uncontrollable studies – withunproportional weight
ECHA
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POE tallow-amine
• Properties of PPPs are much worse than of a.s.
• Reason: POE tallow-amine
• Plan: ban of this additive in glyphosate PPPs
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Green lobby (Greenpeace, PAN etc.)
IARC study
Increasing use
glyphosate in beer
glyphosate in urine
1000 l/day?
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Attempts for and against renewal2016. March 7-8. SCOPAFF
COM proposal: renewal for 15 years, ban of tallow-amine
No qualified majority
2016.April 5. European Parliament
Declaration for withdrawing COM proposal
2016. May 16.
Joint Meeting for Pesticide Residues (JMPR) - glyphosate is notcarcinogenic
2016. May 17.
Green NGOs call for ignoring JMPR opinion
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Attempts for and against renewal
2016. May 18-19. SCOPAFF
COM proposal : renewal for 15 years, ban of tallow-amine-No qualified majority
2016. June 6. SCOPAFF
COM proposal : Prolongation till end of 2017. - No qualified majority
2016. June 24. Appeal Comittee
COM proposal : Prolongation till end of 2017. - No qualified majority
2016. June 27. SC Plant Health
COM proposal : restriction of tallow-amine
-No qualified majority (64,69% instead of 65 %) voting postponed
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Decision
• 2016. June 29. (1 day before expiry)COM prolongation till end of 2017 or 6 monthsafter ECHA RAC opinion (2016/1056 EU r.)
• 2016.July 11-12 SCOPAFF voting on restrictions
• 2016. August 1.
• COM regulation about restrictions(2016/1313 EU)
1. Ban of POE tallow-amine (CAS 61791-26-2)
2. Dessiccation is not good agricultural practice
3. Attention to ground water
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Health reasons?
• 3 evaluations excluded carcinogenity: RMS, EFSA, JMPR
• Real reason for fight against the substance:
If no glyphosate,
fight against GMO
production can
stregthen
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Glyphosate in Hungary• Authorisation certificates
37 basic + 16 clone (2nd brand name) = ∑53• With POE tallow-amine
15 basic + 10 clone = ∑ 25
PPPs with POE tallow-amine will be withdrawn in
November 2016
Grace period: 6 month trade + 12 month use
(1107/2009 EC r. Art. 46.)
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Change of tallow-aminein existing PPP?‘minor change’ GD
• Under 0,5 % yes (2 PPPs in HU)
• Under 10% : (1 PPP in HU)phys-chem data for new compositiontox-ecotox data during renewal
• Above 10% – new authorization
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Revision of certificates
• Withdrawal of POE tallow-amine containingproducts
• Ban of use on playgrounds, hospitals and other sensitive areas
• Ban of dessiccation (diquat nonrenewal?)
• Weed killing before harvest?
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Renewal in 2017 ?
ECHA assessment
Positive vote of Germany
can decide
In case of deadlock –
COM decides
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Photo: Greenfo
Moving towards successful agriculture….