Final addendum to the Renewal Assessment Report

1357 Pages·2014·14.92 MB·English

Final addendum to the

Renewal Assessment Report
- public version -

Risk assessment provided by the rapporteur Member State Germany and
co-rapporteur Member State Belgium for the active substance

PYMETROZINE

according to the procedure for the renewal of the inclusion of a second
group of active substances in Annex I to Council Directive
91/414/EEC laid down in Commission Regulation (EU)
No. 1141/2010

June 2014
Table of contents

Revised Vol 1 to the RAR March 2014 ...........................................................

Revised Vol 1 to the RAR June 2014 ............................................................3

Revised Vol 3 to the RAR March 2014 .....................................................156
Annex B
B.5 Methods of analysis

Revised Vol 3 to the RAR March 2014 .....................................................200
Annex B
B.6 Toxicology and metabolism

Revised Vol 3 to the RAR March 2014 .....................................................471
Annex B
B.7 Residue data

Revised Vol 3 to the RAR March 2014 ...........................................................
Annex B
B.8 Environmental fate and behaviour

Revised Vol 3 to the RAR June 2014 ........................................................693
Annex B
B.8 Environmental fate and behaviour

Revised Vol 3 to the RAR March 2014 ...........................................................
Annex B
B.9 Ecotoxicology

Revised Vol 3 to the RAR June 2014 ........................................................990
Annex B
B.9 Ecotoxicology

Revised Vol 4 to the RAR March 2014 ...................................................1357
Annex C
Confidential information
Renewal

Assessment Report

31 May 2013
Revised 20 March 2014
(perviously named 27 February 2014)
Revised 25 June 2014

Pymetrozine

Volume 1

Report and
Proposed Decision

RMS: Germany Co-RMS: Belgium
- i -
Pymetrozine – Volume 1, Contents revised 25 June 2014
Contents
1 Statement of subject matter and purpose for which this report has been
prepared and background information on the application .................................... 2
1.1 Context in which the renewal assessment report was prepared ................................... 2
1.1.1 Purpose for which the renewal assessment report was prepared.................................. 2
1.1.2 Arrangements between rapporteur Member State and co-rapporteur Member
State .............................................................................................................................. 3
1.1.3 EU Regulatory history for use in Plant Protection Products ........................................ 3
1.1.4 Evaluations carried out under other regulatory contexts .............................................. 4
1.2 Applicant(s) information .............................................................................................. 4
1.2.1 Name and address of applicant(s) for approval of the active substance ...................... 4
1.2.2 Producer or producers of the active substance ............................................................. 4
1.2.3 Information relating to the collective provision of dossiers ......................................... 4
1.3 Identity of the active substance .................................................................................... 4
1.3.1 Common name proposed or ISO-accepted and synonyms ........................................... 4
1.3.2 Chemical name (IUPAC and CA nomenclature) ......................................................... 4
1.3.3 Producer's development code numbers ........................................................................ 5
1.3.4 CAS, EC and CIPAC numbers..................................................................................... 5
1.3.5 Molecular and structural formulae, molecular mass .................................................... 5
1.3.6 Method of manufacture (synthesis pathway) of the active substance .......................... 5
1.3.7 Specification of purity of the active substance in g/kg ................................................ 5
1.3.8 Identity and content of additives (such as stabilisers) and impurities .......................... 5
1.3.8.1 Additives ...................................................................................................................... 5
1.3.8.2 Significant impurities ................................................................................................... 5
1.3.8.3 Relevant impurities ...................................................................................................... 6
1.3.9 Analytical profile of batches ........................................................................................ 6
1.4 Information on the plant protection product ................................................................ 6
1.4.1 Applicant ...................................................................................................................... 6
1.4.2 Producer of the plant protection product ...................................................................... 6
1.4.3 Trade name or proposed trade name and producer's development code number
of the plant protection product ..................................................................................... 6
1.4.4 Detailed quantitative and qualitative information on the composition of the
plant protection product ............................................................................................... 6
1.4.4.1 Composition of the plant protection product ............................................................... 6
1.4.4.2 Information on the active substances ........................................................................... 7
1.4.4.3 Information on safeners, synergists and co-formulants ................................................ 7
1.4.5 Type and code of the plant protection product ............................................................. 7
1.4.6 Function ....................................................................................................................... 7
1.4.7 Field of use envisaged .................................................................................................. 7
1.4.8 Effects on harmful organisms ...................................................................................... 7
1.5 Detailed uses of the plant protection product (to be included for each
preparation for which documentation was submitted) ................................................. 7
1.5.1 Details of representative uses ....................................................................................... 7
1.5.2 Further information on representative uses .................................................................. 8
1.5.3 Details of other uses applied for to support the setting of MRLs for uses beyond
the representative uses .................................................................................................. 9
1.5.4 Overview on authorisations in EU Member States .................................................... 10
- ii -
Pymetrozine – Volume 1, Contents revised 25 June 2014
2 Summary of active substance hazard and of product risk assessment ............... 12
2.1 Identity ....................................................................................................................... 12
2.1.1 Summary of identity ................................................................................................... 12
2.2 Physical and chemical properties ............................................................................... 12
2.2.1 Summary of physical and chemical properties of the active substance ..................... 12
2.2.2 Summary of physical and chemical properties of the plant protection product ......... 12
2.3 Data on application and efficacy ................................................................................ 12
2.3.1 Summary of effectiveness .......................................................................................... 12
2.3.2 Summary of information on the development of resistance ...................................... 12
2.3.3 Summary of adverse effects on treated crops ............................................................. 12
2.3.4 Summary of observations on other undesirable or unintended side-effects ............... 12
2.4 Further information .................................................................................................... 13
2.4.1 Summary of methods and precautions concerning handling, storage, transport
or fire .......................................................................................................................... 13
2.4.2 Summary of procedures for destruction or decontamination ..................................... 13
2.4.3 Summary of emergency measures in case of an accident .......................................... 13
2.5 Methods of analysis .................................................................................................... 13
2.5.1 Methods used for the generation of pre-authorisation data ........................................ 13
2.5.2 Methods for post control and monitoring purposes ................................................... 14
2.6 Effects on human and animal health .......................................................................... 16
2.6.1 Summary of absorption, distribution, metabolism and excretion in mammals .......... 16
2.6.2 Summary of acute toxicity ......................................................................................... 18
2.6.3 Summary of short-term toxicity ................................................................................. 22
2.6.4 Summary of genotoxicity ........................................................................................... 26
2.6.5 Summary of long-term toxicity and carcinogenicity .................................................. 29
2.6.6 Summary of reproductive toxicity .............................................................................. 35
2.6.7 Summary of neurotoxicity .......................................................................................... 41
2.6.8 Summary of further toxicological studies on the active substance ............................ 42
2.6.9 Summary of toxicological data on impurities and metabolites .................................. 43
2.6.9.1 Impurities and metabolites in residues ....................................................................... 43
2.6.9.2 Metabolites predicted to occur in groundwater in concentrations of above
0.1 µg/L ...................................................................................................................... 49
2.6.10 Summary of medical data and information ................................................................ 50
2.6.11 Toxicological end point for assessment of risk following long-term dietary
exposure - ADI ........................................................................................................... 50
2.6.12 Toxicological end point for assessment of risk following acute dietary exposure
- ARfD (acute reference dose) ................................................................................... 51
2.6.13 Toxicological end point for assessment of occupational and bystander risks –
AOEL ......................................................................................................................... 51
2.6.14 Summary of product exposure and risk assessment ................................................... 51
2.7 Residues ..................................................................................................................... 52
2.7.1 Summary of storage stability of residues ................................................................... 52
2.7.2 Summary of metabolism, distribution and expression of residues in plants,
poultry, lactating ruminants, pigs and fish ................................................................. 55
2.7.3 Definition of the residue............................................................................................. 57
2.7.4 Summary of residue trials in plants and identification of critical GAP ..................... 58
2.7.5 Summary of feeding studies in poultry, ruminants, pigs and fish .............................. 58
2.7.6 Summary of effects of processing .............................................................................. 59
2.7.7 Summary of residues in rotational crops .................................................................... 59
- iii -
Pymetrozine – Volume 1, Contents revised 25 June 2014
2.7.8 Summary of other studies ........................................................................................... 61
2.7.9 Estimation of the potential and actual exposure through diet and other sources ....... 61
2.7.10 Proposed MRLs and compliance with existing MRLs............................................... 61
2.7.11 Proposed import tolerances and compliance with existing import tolerances ........... 61
2.8 Fate and behaviour in the environment ...................................................................... 62
2.8.1 Summary of fate and behaviour in soil ...................................................................... 62
2.8.1.1 Aerobic soil degradation ............................................................................................ 62
2.8.1.2 Anaerobic soil degradation ........................................................................................ 63
2.8.1.3 Soil photolysis ............................................................................................................ 64
2.8.1.4 Field dissipation ......................................................................................................... 64
2.8.1.5 Adsorption and desorption ......................................................................................... 64
2.8.1.6 Predicted environmental concentrations in soil (PEC ) .......................................... 65
soil
2.8.2 Summary of fate and behaviour in water and sediment ............................................. 67
2.8.2.1 Hydrolysis .................................................................................................................. 67
2.8.2.2 Photolysis ................................................................................................................... 67
2.8.2.3 Ready biodegradability ............................................................................................... 67
2.8.2.4 Water-sediment system .............................................................................................. 68
2.8.2.5 Predicted environmental concentrations in surface water, sediment and
groundwater (PEC , PEC and PEC ) ............................................................... 68
SW SED GW
2.8.3 Summary of fate and behaviour in air ........................................................................ 72
2.8.4 Summary of monitoring data concerning fate and behaviour of the active
substance, metabolites, degradation and reaction products ........................................ 72
2.8.5 Definition of the residues relevant to the environment .............................................. 72
2.8.6 Summary of exposure calculations and product assessment ...................................... 73
2.9 Effects on non-target species...................................................................................... 73
2.9.1 Summary of effects on birds and other terrestrial vertebrates .................................... 73
2.9.2 Summary of effects on aquatic organisms ................................................................. 75
2.9.3 Summary of effects on non-target arthropods ............................................................ 78
2.9.3.1 Effects on bees ........................................................................................................... 78
2.9.3.2 Effects on other non-target arthropod species ............................................................ 78
2.9.4 Summary of effects on non-target soil meso- and macrofauna .................................. 80
2.9.5 Summary of effects on soil nitrogen transformation .................................................. 81
2.9.6 Summary of effects on terrestrial non-target higher plants ........................................ 81
2.9.7 Summary of effects on other terrestrial organisms (flora and fauna) ......................... 81
2.9.8 Summary of effects on biological methods for sewage treatment ............................. 81
2.9.9 Summary of product exposure and risk assessment ................................................... 81
2.10 Classification and labelling ........................................................................................ 83
2.10.1 Active substance......................................................................................................... 83
2.10.2 Representative formulation Plenum/Chess 50WG (A9364J) .................................... 86
2.11 Relevance of metabolites in groundwater .................................................................. 87
2.11.1 STEP 1: Exclusion of degradation products of no concern ....................................... 87
2.11.2 STEP 2: Quantification of potential groundwater contamination .............................. 89
2.11.3 STEP 3: Hazard assessment – identification of relevant metabolites ........................ 91
2.11.3.1 STEP 3, Stage 1: screening for biological activity ..................................................... 91
2.11.3.2 STEP 3, Stage 2: screening for genotoxicity .............................................................. 94
2.11.3.3 STEP 3, Stage 3: screening for toxicity ..................................................................... 94
2.11.4 STEP 4: Exposure assessment – threshold of concern approach ............................... 95
2.11.5 STEP 5: Refined risk assessment ............................................................................... 95
2.11.6 Overall conclusion ..................................................................................................... 95
- iv -
Pymetrozine – Volume 1, Contents revised 25 June 2014
2.12 Consideration of isomeric composition in the risk assessment .................................. 96
2.12.1 Identity and physical chemical properties .................................................................. 96
2.12.2 Methods of analysis .................................................................................................... 96
2.12.3 Mammalian toxicity ................................................................................................... 96
2.12.4 Operator and Worker exposure .................................................................................. 96
2.12.5 Residues and Consumer risk assessment ................................................................... 96
2.12.6 Environmental fate ..................................................................................................... 96
2.12.7 Ecotoxciology ............................................................................................................ 97
2.13 Residue definitions ..................................................................................................... 97
2.13.1 Definition of residues for exposure/risk assessment .................................................. 97
2.13.2 Definition of residues for monitoring ........................................................................ 97
3 Proposed decision with respect to the application .............................................. 110
3.1 Background to the proposed decision ...................................................................... 110
3.1.1 Proposal on acceptability against the approval criteria – Article 4 and Annex II
of Regulation (EC) No 1107/2009 ........................................................................... 110
3.1.2 Proposal - Candidate for substitution ....................................................................... 129
3.1.3 Proposal – Low risk active substance ...................................................................... 130
3.1.4 List of studies to be generated, still ongoing or available but not evaluated ........... 131
3.1.5 Issues that could not be finalised ............................................................................. 138
3.1.6 Critical areas of concern ........................................................................................... 139
3.1.7 Overview table of the concerns identified for each representative use
considered ................................................................................................................ 140
3.1.8 Area(s) where expert consultation is considered necessary ..................................... 142
3.1.9 Critical issues on which the Co-RMS did not agree with the assessment by the
RMS ......................................................................................................................... 143
3.2 Proposed decision .................................................................................................... 144
3.3 Rational for the conditions and restrictions to be associated with any approval
or authorisation(s), as appropriate ............................................................................ 145
3.3.1 Particular conditions proposed to be taken into account to manage the risks
identified .................................................................................................................. 145
APPENDICES ...................................................................................................................... 146
Appendix 1 - Guidance documents used in this assessment .................................................. 146
Appendix 2 - Reference list .................................................................................................... 148
Level 1

Pymetrozine

Statement of Subject Matter and
Purpose of Renewal Assessment Report
- 2 -
Pymetrozine – Volume 1, Level 1 revised 25 June 2014
1 Statement of subject matter and purpose for which this report has been
prepared and background information on the application
1.1 Context in which the renewal assessment report was prepared
1.1.1 Purpose for which the renewal assessment report was prepared
This application is for the renewal of the active substance pymetrozine, according to
Commission Regulation (EU) No. 1141/2010 and as such is based on representative use
patterns, which reflect the range of uses for the formulated product A9364J (500 g/kg
pymetrozine) in the EU.

Syngenta submits this dossier according to Commission Regulation (EC) No. 1141/2010 of
7 December 2010 under Commission Regulation (EC) No. 1107/2009 (the so-called ‗AIR 2 –
programme), in order to allow a decision on the renewal of the approval of the active
substance pymetrozine.

Pymetrozine was included in Annex I of Council Directive 91/414/EEC (Reference: Inclusion
Directive 2001/87/EC of 12 October 2001). The active substance is currently approved under
Commission Regulation (EC) No. 1107/2009 (repealing Commission Directive 91/414/EEC);
Reference: Commission Implementing Regulation (EU) No. 540/2011 of 25 May 2011.
Commission Directive 2010/77/EU of 10 November 2010, amending Council Directive
91/414/EEC as regards the expiry dates for inclusion in Annex I of certain active substances,
prolongs the approval of pymetrozine until 31 December 2015.

Syngenta makes this submission in the capacity of manufacturer and registration data holder
of pymetrozine. Syngenta limited is the sole notifier for the renewal of the active substance
pymetrozine

Germany as RMS for Pymetrozine tried to combine the old assessments from the original
DAR (1998) with the assessments in the subsequent addenda and the new submitted data into
one document. Additionally, the final outcome of the peer-review process from the first
assessment procedure was included. The section headings were adapted to current standards.

Were no new studies were submitted (mainly health section) the previously available studies
were re-evaluated. Current criteria were applied. For the old study summaries, when
considered necessary, the wording was changed for better comprehension and/or data tables
were added

Sections fate and behaviour and ecotoxicology primarily summarises new information. Where
appropriate these documents refer to the Annex I Inclusion Directive for pymetrozine
(2001/87/EC of 12 October 2001) and to the European Commission review report
(Pymetrozine 7455/VI/98-FINAL, 02 July 2002) together with its background documents A, B
and C, which are considered to provide the relevant review information.

This document covers data and risk assessments which were not part of the original dossier
and which are necessary to reflect changes (e.g. Regulation 544/2011 and 545/2011, scientific
and technical knowledge). Beyond that, detailed summaries of previously submitted studies
- 3 -
Pymetrozine – Volume 1, Level 1 revised 25 June 2014
have been added by the RMS in selected cases to increase the transparency and
comprehensibility of the overall assessment.

The representative formulation for the renewal of Annex I inclusion/approval is the product
Plenum/Chess 50WG (Code number A9364J) containing 500 g/kg pymetrozine. Since this is
a different product from Plenum 25WP (Code number A-8811 B) that was evaluated as the
representative formulation for the initial Annex I inclusion, a complete Annex III data package
for the product Plenum/Chess 50WG was submitted by the notifier.

The notifier submitted a report about a literature search (Mattock, 2012, ASB2012-6402).
However, it cannot be judged whether the articles were screened for a possible impact on the
risk assessment. In any case, the notifier did not include into its updated toxicological
assessment the information of any published article nor did it submit any published articles.

Considering that the notifier had performed a literature search, no literature search was
performed by the RMS.
1.1.2 Arrangements between rapporteur Member State and co-rapporteur Member
State
According to an agreement reached by the respective designated authorities, the RMS
Germany conducted the full evaluation and prepared a draft of this report. The co-RMS
Belgium then reviewed a first draft for commenting. After further evaluation taking into
account the received comments from belgium and the notifier a second draft was sent to
Belgium before it was submitted to the Commission and EFSA.

1.1.3 EU Regulatory history for use in Plant Protection Products
Pymetrozine, at that time considered as a new active substance in the EU, was included in
Annex I of EU Directive 91/414/EEC (Commission Directive 2001/87/EC of
12 October 2001). Germany was the designated rapporteur Member State which carried out
the assessment of pymetrozine on the basis of the dossier submitted by the notifier (Syngenta).

The review concluded that only uses as an insecticide against whiteflies, aphids and pollen
beetle for fruits, vegetables, potatoes, oilseeds, hops, ornamentals and tobacco may be
authorised. The overall conclusions of the evaluation of pymetrozine for Annex I inclusion, as
finalised by the Standing Committee on Plant Health on the 29th June 2001, were provided in
the Review Report (pymetrozine SANCO/7455/VI/98-final, 02 July 2002).

In the original submission Plenum 25 WP (Product code: A-8811 B) was used as the
representative formulation, for the Annex I renewal A9364J (Plenum/Chess 50WG) is used.

The EU MRLs for pymetrozine are established in Annexes II and IIIB of Regulation (EC)
No 396/2005 under Commission Regulation (EC) No 524/2011 (Corrigendum).