Requirements on data and format for Zonal Authorisation and Re-Authorisation

Contents
General requirements
Draft registration report
Part B National – North
Confidential data
Section 0 Product background, regulatory context and GAP information
Section 1, 2, 4 Identity of the plant protection product, Physical and chemical properties and Further information on the plant protection product
Section 3 Efficacy Data and Information
Section 5 Analytical Methods
Section 6 Mammalian Toxicology
Section 7 Metabolism and residues
Section 8 Fate and behaviour in the environment
Section 9 Ecotoxicology
Section 10 Assessment of the relevance of metabolites in groundwater

General requirements 
The application must meet the following criteria:
-	Preferably to be submitted in Caddy.xml
-	Using a maximum of 100 letters in the file directory (including the file name)
-	Contain a cover letter including application form and description of number of CDs and a brief description of the content of each CD.
-	Contain 3 copies of each CD
-	Must be submitted on CD (not USB-stick e.g.)

Description of the document	Provided	Data gap	Resp 
	ok
X	
Application form in English and/or in the language in the relevant MS	Y/N/n.a	Y			
Covering letter, or printed first page of the application					
List of intended uses					
Danish GAP 	                                                               	                                             					
Zonal core GAP , if relevant						
Complete zonal GAP (indicating relevance for which Member State)                       					
Proposal as to which Member State to act as zRMS					
Copy of conclusion of the Member State assessing equivalence, where relevant					
Justifications of steps taken to avoid animal testing and duplication of such testing					
Reasons for necessity for submission of tests and study reports					
Data for the identification of the plant protection product, including its composition and and declaration on co-formulants					
Data for the identification of the active substance(s), safener or synergist					
Letter of Access					
For Annex II -data 					
For Annex III –data					
Registration certificate					
Applicant					
Permanent representative					
Letter of authorisation 					
Temporary representative					
Permanent representative					
Draft Labels					
Master label in English					
DK label					
FI label					
EE label (three Baltic states language label)					
LT label(three Baltic states language label)					
LV label (three Baltic states language label)					
SE label					
NO label					
Document K-III – individual test and study reports in accordance with the requirements specified in Annex III					
A list of references to new AnnexII data if applicable					
Draft Registration Report					

Draft registration report
Description of the document	Provided	Data gap	Resp 
	ok
X	
Version of the Northern Zonal Guidance followed in the evaluation	Write version				
Part A - Risk management					
Part B core - North					
0. Product Background, Regulatory Context and GAP information					
1, 2, 4.  Identity, Physical and chemical properties, further information					
3.  Efficacy data and information					
5.  Analytical methods					
6. Mammalian toxicology 					
7. Metabolism and residues 					
8. Environmental fate 					
9.  Ecotoxicology					
10. Assessment of the relevance of metabolites in ground water					

Part B National – North
Description of the document	Provided	Data gap	Resp 
	ok
X	

State MS: 	MS					
0. Product Background, Regulatory Context and GAP information					
1, 2, 4.  Identity, Physical and chemical properties, further information					
3.  Efficacy data and information					
5.  Analytical methods					
6. Mammalian toxicology 					
7. Metabolism and residues 					
8. Environmental fate 					
9.  Ecotoxicology					
10. Assessment of the relevance of metabolites in ground water					
 Copy and paste table, in case of more MS
Confidential data
dRR
part	Description of the document	Provided	Data gap	Resp 
	ok
X	
Part C 
1.1	Producer of the plant protection product and of the active substances					
Part C
1.1.1	Producer(s) of the preparation					
Part C, 
1.1.2	Producer(s) of the active substance(s)					
Part C, 
1.1.3	Statement of purity (and detailed information on impurities) of the active substance(s)					
Part C, 
1.2	Detailed quantitative and qualitative information on the composition of the preparation					
Part C, 
1.2.1	Composition of the plant protection product					
Part C, 
1.2.2	Information on co-formulants					
Part C, 
1.2.3	Description of formulation process					
Part C, 
1.2.4	Description of the analytical methods for the determination of relevant formulants					
Part C, 
1.3	Data on the formulants					
Part C, 
1.3.1	Material safety data sheets					
Part C, 
1.3.2	Available toxicological data for each formulant					
Part C, 
2	Statement of the regulatory status of formulants					
Part C
Appendix 1	List of studies considered in support of the evaluation					
	Confidential data and information, to include:					
	Safety data sheet prepared in accordance with Directive 67/548/EEC					
	File containing confidential data and information					

Section 0 Product background, regulatory context and GAP information
dRR point	Information, test or study 
(according to OECD Dossier Guidance Document, Appendix 6, Part 1)	Optional	Provided	Justified	Data gap
	Resp 
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0.1	Introduction							
0.1.1	Reason for application							
0.1.2	Details of zRMS(s) and concerned MS							
0.1.3	Regulatory history of the active(s)							
0.1.3.1	Active substance 1							
0.1.3.2	Active substance 2							
0.1.4	Regulatory history of the product (if relevant)							
0.2	zRMS conclusion							
Appendix 1	All intended uses 							

Section 1, 2, 4 Identity of the plant protection product, Physical and chemical properties and Further information on the plant protection product
dRR point	Information, test or study 
(according to OECD Dossier Guidance Document, Appendix 6, Part 1)	Optional	Provided	Justified	Data gap
	Resp 
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Identity of the plant protection product	
1.1.	Applicant (name, address, contact, telephone and telefax numbers)							
1.2.	Producer of the preparation and of the active substance 							
1.2.1.	Producer(s) of the preparation
(name, address, contact, telephone and telefax numbers)							
1.2.2.	Producer(s) of the active substance(s) 
(name, address, contact, telephone and telefax numbers)							
1.2.3.	Statement of purity (and detailed information on impurities) of the active substance(s)							
1.2.3.1	Active substance 1							
1.2.3.2	Active substance 2							
1.3.	Trade name and producer’s code number(s), for the preparation 							
1.4.	Detailed quantitative and qualitative information on the composition of the preparation							
1.4.1.	Composition of the plant protection product Contents of :							
1.4.1.	- Active substance(s)							
1.4.1.	- Safener and synergists							
1.4.1.	- Relevant impurities							
1.4.2.	Information on the active substance(s)							
1.4.2	- ISO common name proposed or accepted for active substances, and synonyms							
1.4.3.	Information on safeners, synergists and co-formulants							
1.4.3.	- ISO common name proposed or accepted for formulants, and synonyms							
1.5	Type and code of the plant protection product							
1.6	Function (herbicide, insecticide etc.)							
Physical, chemical and technical properties of the plant protection product	
2.1	Description of the physical state of the preparation (formulation) and its colour and odour							
2.2.1	Explosive properties of the preparation							
2.2.2	Oxidizing properties of the preparation							
2.3.1	The flash point of the preparation							
2.3.2	The flammability of the preparation							
2.3.3	The self-heating of the preparation							
2.4.1	Acidity or alkalinity and pH value							
2.4.2	pH of a 1 % aqueous dilution, emulsion or dispersion							
2.5.1	Viscosity of the preparation							
2.5.2	Surface tension of the preparation							
2.6.1	Relative density of the preparation							
2.6.2	Bulk or tap density of the preparation							
2.7.1	Stability after storage for 14 days at 54 °C							
2.7.2	Stability after storage for other periods and/or temperatures 							
2.7.3	Minimum content after heat stability testing							
2.7.4	Effect of low temperature on stability							
2.7.5	Shelf life following storage at ambient temperature							
2.7.6	Shelf life in months							
2.8.1	Wettability							
2.8.2	Persistent of foaming							
2.8.3.1	Suspensibility							
2.8.3.2	Spontaneity of dispersion							
2.8.3.3	Dispersion stability							
2.8.4	Degree of dissolution and dilution stability							
2.8.5.1.1	Particle size distribution/nominal size range of granules							
2.8.5.1.2	Wet sieve test							
2.8.5.2.1	Dust content							
2.8.5.2.2	Particle size of dust							
2.8.5.3	Attrition							
2.8.5.4	Hardness and integrity							
2.8.6.1	Emulsifiability							
2.8.6.2	Emulsion stability							
2.8.6.3	Re-emulsifiability							
2.8.7.1	Flowability							
2.8.7.2	Pourability (including rinsed residue)							
2.8.7.3	Dustability following accelerated storage							
2.9.1	Physical compatibility of tank mixes							
2.9.2	Chemical compatibility of tank mixes							
2.10.1	Adhesion to seeds							
2.10.2	Distribution to seeds							
2.11	Other/special studies							
Further information on the plant protection product	
4.1	Packaging and compatibility with the preparation							
4.1	- Description and specification of the packaging and materials used in packaging, size, capacity, size of openings, types of closure and seals							
Appendix 1	List of data considered in support of the evaluation							
Appendix 2	Additional data on the physical, chemical and technical properties of the active substance							
A 2.1	Active substance 1							
A 2.2	Active substance 2							

Section 3 Efficacy Data and Information 
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point	Information, test or study 
(according to OECD Dossier Guidance Document, Appendix 6, Part 7)	Optional	Provided	Justified	Data gap
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3.2	Efficacy data						
3.2.1.	Preliminary range-finding tests						
3.2.2	Minimum effective dose tests						
3.2.3	Efficacy tests						
3.3	Information on the occurrence or possible occurrence of the development of resistance						
3.4	Adverse effects on treated crops						
3.4.1	Phytotoxicity to host crop						
3.4.2	Effects on the yield of treated plants and plant products						
3.4.3	Effects on the quality of plants and plant products						
3.4.4	Effects on the transformation processes						
3.4.5	Impact on treated plants or plant products to be used for propagation						
3.5	Observations on other undesirable or unintended side-effects						
3.5.1	Impact on succeeding crops						
3.5.2	Impact on other plants including adjacent crops						
3.5.3	Effects on beneficial and other non-target organisms						
3.6	Other/special studies						
3.7	List of test facilities including the corresponding certificates						
Appendix 1	List of data considered in support of the evaluation						

Section 5 Analytical Methods
dRR
point	Information, test or study 
(according to OECD Dossier Guidance Document, Appendix 6, Part 2)	Optional	Provided	Justified	Data gap
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5.1	Conclusion and summary of assessment						
5.2	Methods used for the generation of pre-authorization data						
5.2.1	Analysis of the plant protection product						
5.2.1.1	Determination of active substance and/or variant in the plant protection product						
5.2.1.2	Description of analytical methods for the determination of relevant impurities						
5.2.1.3	Description of analytical methods for the determination of formulants						
5.2.1.4	Applicability of existing CIPAC methods						
5.2.2	Methods for the determination of residues						
5.3	Methods for post-authorization control and monitoring purposes						
5.3.1	Analysis of the plant protection product						
5.3.2	Description of analytical methods for the determination of residues of active substance 1						
5.3.2.1	Overview of residue definitions and levels for which compliance is required						
5.3.2.2	Description of analytical methods for the determination of residues in plant matrices						
5.3.2.3	Description of analytical methods for the determination of residues in animal matrices						
5.3.2.4	Description of methods for the analysis of soil						
5.3.2.5	Description of methods for the analysis of water						
5.3.2.6	Description of methods for the analysis of air						
5.3.2.7	Description of methods for the analysis of body fluids and tissues						
5.3.2.8	Other studies/ information						
5.3.3	Description of analytical methods for the determination of residues of active substance 2						
Appendix 1	List of data considered in support of the evaluation						
Appendix 2	Detailed evaluation of submitted analytical methods						
A 2.1	Analytical methods for the active substance 1						
A 2.1.1	Methods used for the generation of pre-authorization data						
A 2.1.2	Methods for post-authorization control and monitoring purposes						
A 2.2	Analytical methods for the active substance 2						

Section 6 Mammalian Toxicology 
dRR
point	Information, test or study 
(according to OECD Dossier Guidance Document, Appendix 6, Part 3)	Optional	Provided	Justified	Data gap
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6.2	Toxicological Information on Active Substance(s) 						
6.3	Toxicological Evaluation of Plant Protection Product						
6.4	Toxicological Evaluation of Groundwater Metabolites						
6.4.1	Metabolite 1						
6.4.2	Metabolite 2						
6.5	Dermal Absorption						
6.5.1	Justification for proposed values - active substance 1						
6.5.2	Justification for proposed values - active substance 2						
6.6	Exposure Assessment of Plant Protection Product						
6.6.1	Selection of critical use(s) and justification						
6.6.2	Operator exposure						
6.6.2.1	Estimation of operator exposure						
6.6.3	Measurement of operator exposure						
6.6.4	Worker exposure						
6.6.4.1	Estimation of worker exposure						
6.6.4.2	Refinement of generic DFR value						
6.6.4.3	Measurement of worker exposure						
6.6.5	Bystander and resident exposure						
6.6.5.1	Estimation of bystander and resident exposure						
6.6.5.2	Measurement of bystander and/or resident exposure						
6.6.6	Combined exposure						
6.6.6.1	Exposure Assessment of active substance 1 and active substance 2 in Product name/Product code						
Appendix 1	List of data considered in support of the evaluation						
Appendix 2	Detailed evaluation of the studies relied upon 						
A 2.1	Statement on bridging possibilities						
A 2.2	Acute oral toxicity						
A 2.3	Acute percutaneous (dermal) toxicity						
A 2.3.1	Study 1						
A 2.4	Acute inhalation toxicity						
A 2.4.1	Study 1						
A 2.5	Skin irritation						
A 2.5.2	Study 1						
A 2.6	Eye irritation						
A 2.6.1	Study 1						
A 2.7	Skin sensitization						
A 2.7.1	Study 1						
A 2.8	Supplementary studies for combinations of plant protection products						
A 2.9	Data on co-formulants						
A 2.9.1	Material safety data sheet for each co-formulant						
A 2.9.2	Available toxicological data for each co-formulant 						
A 2.10	Studies on dermal absorption						
A 2.11	Other/Special Studies						
Appendix 3	Exposure calculations						
A 3.1	Operator exposure calculations						
A 3.1.1	Calculations for active substance 1						
A 3.1.2	Calculations for active substance 2						
A 3.2	Worker exposure calculations						
A 3.2.1	Calculations for active substance 1						
A 3.2.2	Calculations for active substance 2						
A 3.3	Bystander and resident exposure calculations						
A 3.3.1	Calculations for active substance 1						
A 3.3.2	Calculations for active substance 2						
A 3.4 	Combined exposure calculations for active substance 1 and active substance 2						
Appendix 4	Detailed evaluation of exposure and/or DFR studies relied upon 						

Section 7 Metabolism and residues
dRR point	Information, test or study 
(according to OECD Dossier Guidance Document, Appendix 6, Part 4)	Optional	Provided	Justified	Data gap
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7.1.1	Critical GAP(s) and overall conclusion						
7.1.2	Summary of the evaluation						
7.1.2.1	Summary for active substance 1						
7.1.2.2	Summary for active substance 2						
7.1.2.3	Summary for product code						
7.2	Active substance 1						
7.2.1	Stability of residues						
7.2.1.1	Stability of residues during storage of samples						
7.2.1.2	Stability of residues in sample extracts						
7.2.2	Nature of residues in plants, livestocks and processed commodities						
7.2.2.1	Nature of residues in primary crops						
7.2.2.2	Nature of residues in rotational crops 						
7.2.2.3	Nature of residues in processed commodities						
7.2.2.4	Conclusion on the nature of residues in commodities of plant origin						
7.2.2.5	Nature of residues in livestock						
7.2.2.6	Conclusion on the nature of residues in commodities of animal origin						
7.2.3	Magnitude of residues in plants						
7.2.3.1	Summary of European data and new data suporting the intended uses						
7.2.3.2	Conclusion on the magnitude of residues in plants						
7.2.4	Magnitude of residues in livestock						
7.2.4.1	Dietry burden calculation						
7.2.4.2	Livestocke feeding studies						
7.2.5	Magnitude of residues in processed commidities (Industrial Processing and/or Household Preparation)						
7.2.5.1	Available data for all crops under consideration						
7.2.5.2	Conclusion on processing studies						
7.2.6	Magnitude of residues in representative succeeding crops 						
7.2.6.1	Field rotational cro studies						
7.2.7	Other/ special studies						
7.2.8	Estimation of exposure through diet and other measn						
7.2.8.1	Input values for the consumer risk assessment						
7.2.8.2	Conclusion on the consumer risk assessment						
7.3	Active substance 2						
7.4	Combined exposure and risk assessment						
7.4.1	Acute consumer risk assessment from combined exposure						
7.4.2	Chronic consumer risk assessment from combined exposure						
7.5	References						
Appendix 1	Lists of data considered in support of the evaluation						
Appendix 2	Detailed evaluation of the additional studies relied upon						
A 2.1	Active substance 1						
A 2.1.1	Stability of residues						
A 2.1.2	Nature of residues in plants, livestock and processed commodities						
A 2.1.3	Magnitude of residues in plants						
A 2.1.4	Magnitude of residues in livestock						
A 2.1.5	Magnitude of residues in processed commidities (Industrial Processing and/or Household Preparation)						
A 2.1.6	Magnitude of residues in representative succeeding crops						
A 2.1.7	Other/special studies						
A 2.2	Active substance 2						
Appendix 3	Pesticide Residue Intake Model (PRIMo)						
A 3.1	TMDI calculations						
A 3.2	IEDI calculations						
A 3.3	IESTI calculations – Raw commodities						
A 3.4	IESTI calculations – Processed commodities						
Appendix 4	Additional information provided by the applicant						

Section 8 Fate and behaviour in the environment
dRR
point	Information, test or study 
(according to OECD Dossier Guidance Document, Appendix 6, Part 5)	Optional	Provided	Justified	Data gap
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8.1	Critical GAP and overall conclusions						
8.2	Metabolites considered in the assessment						
8.3	Rate of degradation in soil						
8.3.1	Aerobic degradtion in soil						
8.3.1.1	Active substance 1 and its metabolites						
8.3.1.2	Active substance 2 and its metabolites						
8.3.2	Anaerobic degradtion in soil						
8.4	Field studies						
8.4.1	Soil dissipation testing on a range of representative soils						
8.4.1.1	Active substance 1 and its metabolites						
8.4.1.2	Active substance 2 and its metabolites						
8.4.2	Soil accumuation testing						
8.5	Mobility in soil						
8.5.1	Active substance 1 and its metabolites						
8.5.2	Active substance 2 and its metabolites						
8.5.3	Column leaching						
8.5.4	Lysimeter studies						
8.5.5	Field leaching studies						
8.6	Degradation in the water/sediment systems						
8.6.1	Active substance 1 and its metabolites						
8.6.2	Active substance 2 and its metabolites						
8.7	Predicted Environmental Concentrations in soil (PECsoil)						
8.7.1	Justification for new endpoints						
8.7.2	Active substance(s) and relevant metabolite(s)						
8.7.2.1	Active substance 1 and its metabolites						
8.7.2.2	Active substance 2 and its metabolites						
8.7.2.3	PECsoil of formulation						
8.8	Predicted Environmental Concentrations in groundwater (PECgw)						
8.8.1	Justification for new endpoints						
8.8.2	Active substance(s) and relevant metabolite(s)						
8.8.2.1	Active substance 1 and its metabolites						
8.8.2.2	Active substance 2 and its metabolites						
8.9	Predicted Environmental Concentrations in surface water (PECsw)						
8.9.1	Justification for new endpoints						
8.9.2	Active substance(s), relevant metabolite(s) abd the formuatin						
8.9.2.1	Active substance 1 and its metabolites						
8.9.2.2	Active substance 2 and its metabolites						
8.9.2.3	PECsw/PECsed of formulation						
8.10	Fate and behaviour in air						
Appendix 1	List of data considered in support of the evaluation						
Appendix 2	Detailed evaluation of the new Annex II studies						
A 2.1	Study 1						
Appendix 3	Additional information provided by the applicant (e.g. detailed modelling data)						

Section 9 Ecotoxicology
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point	Information, test or study 
(according to OECD Dossier Guidance Document, Appendix 6, Part 6)	Optional	Provided	Justified	Data gap
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9.1	Critical GAP and overall conclusions						
9.1.1	Overall conclusions						
9.1.1.1	Effetcs on birds, Effects on terrestrial vertebrates othe rthan birds, Effects on other terrestrial vertebrate wildlife (reptiles and amphibians)						
9.1.1.2	Effects on aqautic organisms						
9.1.1.3	Effects on bees						
9.1.1.4	Effetcs on athropods other than bees						
9.1.1.5	Effects on non-target soil meso- and macrofauna, Effects on soil microbial activity						
9.1.1.6	Effects on non-target terrestrial plants						
9.1.1.7	Effetcs ob other terrestrial organisms (flora and fauna)						
9.1.2	Grouping of intended uses for risk assessment						
9.1.3	Consideration of metabolites						
9.2	Effects on birds						
9.2.1	Toxicity data						
9.2.1.1	Justification for new endpoints						
9.2.2	Risk assessment for spray applicatins						
9.2.2.1	First-tier assessment (screening/generic focal species)						
9.2.2.2	Higher tier risk assessment						
9.2.2.3	Drinkning water exposure						
9.2.2.4	Efffects of secondary poisoning						
9.2.2.5	Biomagnification in terrestrial food chains						
9.2.3	Risk asssessment for baits, pellets, granules, prills or treated seed						
9.2.4	Overall conclusions						
9.3	Effects on terrestrial vertebrates other than birds						
9.3.1	Toxicity data						
9.3.1.1	Justification for new endpoints						
9.3.2	Risk assessment for spray applicatins						
9.3.2.1	First-tier assessment (screening/generic focal species)						
9.3.2.2	Higher tier risk assessment						
9.3.2.3	Drinkning water exposure						
9.3.2.4	Efffects of secondary poisoning						
9.3.2.5	Biomagnification in terrestrial food chains						
9.3.3	Risk asssessment for baits, pellets, granules, prills or treated seed						
9.3.4	Overall conclusions						
9.4	Effects on other terrestrial vertebrate wildlife (reptiles and amphibians)						
9.5	Effects on aquatic organisms						
9.5.1	Toxicity data						
9.5.1.1	Justification for new endpoints						
9.5.2	Risk assessment						
9.5.3	Overall conclusions						
9.6	Effects on bees						
9.6.1	Toxicity data						
9.6.1.1	Justification for new endpoints						
9.6.2	Risk assessment						
9.6.2.1	Hazard quotients for bees						
9.6.2.2	Higher-tier risk assessment for bees (tunnel test, field studies)						
9.6.3	Effects on bumble bees						
9.6.4	Effecst on solitary bees						
9.6.5	Overall conclusions						
9.7	Effects on arthropods other than bees						
9.7.1	Toxicity data						
9.7.1.1	Justification for new endpoints						
9.7.2	Risk assessment						
9.7.2.1	Risk assessment for in-field exposure						
9.7.2.2	Risk assessment for off-field exposure						
9.7.2.3	Additional higer-tier risk assessment						
9.7.2.4	Risk mitigation measures						
9.7.3	Overall conclusions						
9.8	Effects on non-target soil meso- and macrofauna						
9.8.1	Toxicity data						
9.8.1.1	Justification for new endpoints						
9.8.2	Risk assessment						
9.8.2.1	First-tier risk assessment						
9.8.2.2	Higher-tier risk assessment						
9.8.3	Overall conclusions						
9.9	Effects on soil microbial activity						
9.9.1	Toxicity data						
9.9.1.1	Justification for new endpoints						
9.9.2	Risk assessment						
9.9.3	Overall conclusions						
9.10	Effects on non-target terrestrial plants						
9.10.1	Toxicity data						
9.10.1.1	Justification for new endpoints						
9.10.2	Risk assessment						
9.10.2.1	Tier-1 risk assessment (based on screening data)						
9.10.2.	Tier-2 risk assessment (based on dose-response data)						
9.10.2.3	Higher-tier risk assessment						
9.10.2.4	Risk mitigatin measures						
9.10.3	Overall conclusions						
9.11	Effects on other terrestrial organisms (flora and fauna)						
9.12	Monitoring data						
9.13	Classification and labelling						
Appendix 1	List of data considered in support of the evaluation						
Appendix 2	Detailed evaluation of the new studies						
A 2.1	Effects on birds and other terrestrial vertebrates						
A 2.1.1	Effects on birds						
A 2.1.2	Effects on terrestrial vertebrates other than birds						
A 2.1.3	Effects on other terrestrial vertebrate wildlife (reptiles and amphbians)						
A 2.2	Effects on aquatic species						
A 2.2.1	Acute toxiticy to fish, aquatic invertebrates, or effects on aqauatic algae and macrophytes						
A 2.2.2	Additional long-term and chronic toxicity studies on fish, aqautic invertebrates and sediment dwelling organisms						
A 2.2.3	Further testing on aquatic species						
A 2.3	Effects on arthropods						
A 2.3.1	Effects on bees						
A 2.4	Effects on non-target soil meso- and macrofauna						
A 2.4.1	Earthworms						
A 2.4.2	Effects on non-target soil meso- and macrofauna (other than earthworms)						
A 2.5	Effecst on soil nitrogen transformation						
A 2.6	Effects on terrestrial non-target higher plants						
A 2.6.1	Sumamry of screening data						
A 2.6.2	Testing on non-target plants						
A 2.6.3	Extended laboratory studies on non-target plants						
A 2.7	Effects on other terrestrial organisms (flora and fauna)						
A 2.8	Monitoring data						

Section 10 Assessment of the relevance of metabolites in groundwater
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point	Information, test or study 
(according to OECD Dossier Guidance Document, Appendix 6, Part 6)	Optional	Provided	Justified	Data gap
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10.2.	Relevance assessment of metabolie 1						
10.2.1.	STEP 1: Exclusion of degradation products of no concern						
10.2.2.	STEP 2: Quantification of potential groundwater contamination						
10.2.3.	STEP 3: Hazard assessment – identification of relevant metabolites						
10.2.3.1	STEP 3: Stage 1: screening for biological activity						
10.2.3.2	STEP 3: Stage 2: screening for genotoxicity						
10.2.3.3	STEP 3: Stage 3: screening for toxicity						
10.2.4	STEP 4: Exposure assessment – threshold of concern approach						
10.2.5	STEP 5: Refined risk assessment						
10.3	Relevance assessment of metabolie 2						
Appendix 1	List of data considered in support of the evaluation						
Appendix 2	Additional information