HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL
Directorate E – Safety of the food chain
Unit E.3 - Chemicals, contaminants, pesticides
SANCO/12592/2012 –rev. 0
November 2012
Template to be used for
Assessment Reports
This document was elaborated by representatives of some of the Member States. It does not represent the official position of the Commission. It does not intend to produce legally binding effects.
Contents
Background3
Implementation schedule 3
Volume 1 4
Volume 217
Volume 3 – Active Substance18
Volume 3 – Plant Protection Product 26
Volume 433
Background
This template is intended to align the current structure of the assessment report with the dossier as well as the revised data requirements. It also aims to reduce duplication of information in different parts of the assessment report and to separate out the active substance part from product related exposure and risk. In this way transparency and consistency in the documentation submitted and assessed in light of an application for an approval of an active substance will be increased.
Furthermore it is envisages that this structure will support the risk envelope approach for products and that it will facilitate the setting of Maximum Residue Levels (MRLs), the preparation of a "Conclusion on the peer review of the pesticide risk assessment of an active substance" as prepared by the European Food Safety Authority (EFSA), as well as a "Proposal for Harmonised Classification and Labelling" (CLH report) as prepared by the European Chemicals Agency (ECHA).
An Assessment Report shall consists of the following parts: Volume 1, Volume 2, Volume 3 Active Substance part, Volume 3 Plant Protection Product part(s), Volume 4, as well as a List of Endpoints as a stand-alone document separated in an Active Substance part and Plant Protection Product part(s). The template for the List of Endpoints is in preparation.
This template should be used in conjunction with the TEMPLATE TO BE USED FOR ASSESSMENT REPORTS REGARDING LEVEL 3 OF VOLUME 1 (SANCO/11114/2012).
Implementation schedule
This document has been finalised in the Standing Committee on the Food Chain and Animal Health on 20 November 2012. This template should be used for assessment reports prepared for active substances covered by Commission Regulation (EU) No 844/2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the marketand for active substances for which an application for the approval has been submitted as from 1 January 2014.
TABLE OF CONTENTS - VOLUME 1
General guidance on content of Volume 1
Volume 1 should have a cover page, version history page (see guidance for version control – under development) and a table of content page.
Volume 1 contains an overall summary of the active substance assessment and concise view of the conclusions reached in relation to the risk posed by the representative product and uses. Coupled with a Level 3 addressing the approval criteria (as set out in Article 4 and Annex II of Regulation (EC) No 1107/2009) and proposed regulatory outcome, this allows both risk assessors and risk managers to more clearly identify the key areas for further consideration.
All section-wise summaries of study evaluations (e.g. summary of all metabolism data, summary of all data relevant for reproductive toxicity, summary of all degradation half-lives etc) are presented exclusively in Level 2 of this volume.
Also derivation of assessment end-points, reference values, MRLs, and definition of the residues are presented exclusively in Level 2 of this volume. It should be clearly identified in the respective section of Level 2 whether or not an endpoint meets one of the approval criteria.
Assessment end-points, in particular those established for environmental fate and behaviour and ecotoxicology, may occasionally be derived from both data on the active substance and data on formulated products. Therefore, Level 2 summaries needs to cover all study end-points - as presented in Volume 3 (AS) and Volume 3 (PPP) - relevant for the establishment of assessment end-points for the active substance.
Level 3 provides a concise presentation of the outcome of the evaluation and consideration against the approval criteria including a proposal for the decision and any conditions or restrictions associated with it.
Since it needs to be established, in order to decide on the approval, that risks are acceptable under realistic conditions of use it is necessary to reflect also data on representative products and exposure and risk assessment for representative areas of use in Volume 1. However, these elements (in particular, the exposure and risk assessments) should be kept to the minimum necessary to allow conclusions relevant for the approval of the active substance. Brief summaries of the higher tiers of exposure and risk assessment are therefore expected under the relevant sections of Level 2.
Level 1
1Statement of subject matter and purpose for which this report has been prepared and background information on the application
1.1Context in which the draft assessment report was prepared
1.1.1Purpose for which the draft assessment report was prepared
Information should be provided if the draft assessment report is prepared for a new active substance (NAS) or for the Renewal of the approval. It should also be indicated if a proposal for MRL-setting is included and/or a proposal for Classification & Labelling.
1.1.2Arrangements between rapporteur MemberState and co-rapporteur MemberState
1.1.3EU Regulatory historyfor use in Plant Protection Products
If applicable, information should be provided on the approval of the active substance and subsequent renewals. It should also be indicated if relevant Reasoned Opinions, EFSA-conclusions, MRL-proposals are available.
For renewals the history should indicate where possible:
- Whether the substance was first evaluated as part of a programme for Existing Active Substances (review list 1,
2, 3A, 3B, 4) or New Active Substance indicating specifically if an EFSA-conclusion is available;
- All decisions and review reports available for the respective active substance;
- Any changes in RMS, Co-RMS, applicant;
- If and when confirmatory data has been submitted and considered.
1.1.4Evaluations carried out under other regulatory contexts
Information should be provided if there are any other relevant EU-evaluations of the active substance carried out in the framework of other relevant EU-legislation (e.g. biocides, flavourings, food additives, cosmetics). Also information should be provided on relevant and recent evaluations of countries other than EU (e.g. US-EPA, PMRA) and international organisations like JMPR, WHO/FAO as well as on information exchange within OECD.
1.2Applicant(s) information
1.2.1Name and address of applicant(s) for approval of the active substance
1.2.2Producer or producers of the active substance
1.2.3Information relating to the collective provision of dossiers
Information should be provided related to (the forming of) Task Forces.
1.3Identity of the active substance
The information under point 1.3.1 – 1.3.9 should be provided in a table compatible with Vol. 3 and LoEP.
1.3.1Common name proposed or ISO-accepted and synonyms
1.3.2Chemical name (IUPAC and CA nomenclature)
1.3.3Producer's development code numbers
This itemshould be included in the LoEP.
1.3.4CAS, EC and CIPAC numbers
1.3.5Molecular and structural formulae, molecular mass
1.3.6Method of manufacture (synthesis pathway) of the active substance
1.3.7Specification of purity of the active substance in g/kg
1.3.8Identity and content of additives (such as stabilisers) and impurities
Isomers not covered by the common name should be listed here, as impurities.
1.3.8.1Additives
1.3.8.2Significant impurities
1.3.8.3Relevant impurities
1.3.9Analytical profile of batches
1.4Information on the plant protection product
The information under point 1.4.1 – 1.4.8 should be provided for all Plant Protection Products in an overview table.
1.4.1Applicant
1.4.2Producer of the plant protection product
1.4.3Trade name or proposed trade name and producer's development code number of the plant protection product
1.4.4Detailed quantitative and qualitative information on the composition of the plant protection product
1.4.4.1 Composition of the plant protection product
1.4.4.2 Information on the active substances
1.4.4.3 Information on safeners, synergists and co-formulants
1.4.5Type and code of the plant protection product
1.4.6Function
E.g. herbicide, insecticide, fungicide, plant growth regulator.
1.4.7Field of use envisaged
E.g. crops, orchards, seed treatmen.t
1.4.8Effects on harmful organisms
E.g. systemic, protective or curative, mode of action, range of target organisms.
1.5Detailed uses of the plant protection product (to be included for each preparation for which documentation was submitted)
1.5.1Details of representative uses
The GAP table for the representative uses should be inserted here.
1.5.2 Further information on representative uses
Information should be provided like:
- Details on method of application for specialised applications e.g. soil fumigants;
- Details on number and timing of applications and duration of protection, in case the GAP table gives ranges;
- Necessary waiting period or other precautions to avoid phytotoxic effects on succeeding crops;
- Proposed instructions for use.
1.5.3Details of other uses applied for to support the setting of MRLs for uses beyond the representative uses
This information should also be provided in the format of a GAP table; however these uses should not be covered by the GAP table under 1.5.1.
1.5.4Overview on authorisations in EU Member States
This would apply for renewal submissions and it is expected that information in line with the Guidance Document on the renewal of approval of active substances to be assessed in compliance with Regulation (EU) No 844/2012 Appendix II Point 5 would be included here.
Level 2
2Summary of active substance hazard and of product risk assessment
In every section a conclusion should be drawn, deficiencies indicated and any problems togetherwith their regulatory consequences listed.
2.1Identity
2.1.1Summary of identity
Any issues related to e.g. impurities, isomers, pilot plant, full scale production should be listed here.
2.2Physical and chemical properties
2.2.1Summary of physical and chemical properties of the active substance
2.2.2Summary of physical and chemical properties of the plant protection product
2.3Data on applicationand efficacy
For efficacy it is intended that limited summary information is placed under each of the headings here to address the requirements of Article 4(3) of Regulation (EC) No 1107/2009. The information should be in line with the relevant guidance:
– for new active substances “SANCO E3 WORKING DOCUMENT (Data requirements on efficacy for the dossier to be submitted for the approval of new active substances as defined under Regulation (EC) No 1107/2009 contained in plant protection products)";
-for renewals - Guidance Document on the renewal of approval of active substances to be assessed in compliance with Regulation (EU) No 844/2012 Appendix II (SANCO/2012/11251).
2.3.1Summary of effectiveness
2.3.2Summary of information on the development of resistance
2.3.3Summary of adverse effects on treated crops
2.3.4Summary of observations on other undesirable or unintended side-effects
2.4Further information
2.4.1Summary of methods and precautions concerning handling, storage, transport or fire
2.4.2Summary of procedures for destruction or decontamination
2.4.3Summary of emergency measures in case of an accident
2.5Methods of analysis
2.5.1Methods used for the generation of pre-authorisation data
2.5.2Methods for post control and monitoring purposes
2.6Effects on human and animal health
2.6.1Summary of absorption, distribution, metabolism and excretion in mammals
2.6.2Summary of acute toxicity
2.6.3Summary of shortterm toxicity
2.6.4Summary of genotoxicity
2.6.5Summary of longterm toxicity and carcinogenicity
2.6.6Summary of reproductive toxicity
2.6.7Summary of neurotoxicity
2.6.8Summary of further toxicological studies on the active substance
Where appropriate this will include a summary of:
- toxicity studies of metabolites as referred to in the introduction;
- supplementary studies on the active substance;
- endocrine disrupting properties.
2.6.9Summary of toxicological data on impurities and metabolites
2.6.10Summary of medical data and information
2.6.11Toxicological end point for assessment of risk following long-term dietary exposure - ADI
2.6.12Toxicological end point for assessment of risk following acute dietary exposure - ARfD (acute reference dose)
2.6.13Toxicological end point for assessment of occupational, bystander and residents risks – AOEL
2.6.14Summary of product exposure and risk assessment
A concise high level summary of exposure and risk assessment is expected here, with reference to the appropriate Volume(s) 3 (PPP) in which the complete calculations are presented. Sub-headings may be introduced as appropriate.Conclusions drawn regarding the anticipated risk should be clearly stated for each representative use. Any risk mitigation measure taken into account, such as personal protective equipment, waiting period for workers etc. should be clearly indicated for each representative use.
2.7Residues
2.7.1Summary of storage stability of residues
2.7.2Summary of metabolism, distribution and expression of residues in plants, poultry, lactating ruminants, pigs and fish
2.7.3Definition of the residue
2.7.4Summary of residue trials in plants and identification of critical GAP
2.7.5Summary of feeding studies in poultry, ruminants, pigs and fish
2.7.6Summary of effects of processing
2.7.7Summary of residues in rotational crops
2.7.8Summary of other studies
2.7.9Estimation of the potential and actual exposure through diet and other sources
2.7.10Proposed MRLs and compliance with existing MRLs
2.7.11Proposed import tolerances and compliance with existing import tolerances
2.8Fate and behaviour in the environment
2.8.1Summary of fate and behaviour in soil
2.8.2Summary of fate and behaviour in water and sediment
2.8.3Summary of fate and behaviour in air
2.8.4Summary of monitoring data concerning fate and behaviour of the active substance, metabolites, degradation and reaction products
2.8.5Definition of the residues in the environment requiring further assessment
2.8.6Summary of exposure calculations and product assessment
For each compartment (soil, groundwater, etc) provide a summary ofthe exposure assessments done for each representative use, with reference to the appropriate Volume(s) 3 (PPP) in which the complete calculations are presented. Sub-headings may be introduced for each compartment.
For soil, surface water and sediment, the PEC values should be presented together with the corresponding TER in section 2.9.9. For these compartments it would therefore not be necessary to present any PEC values here.
Soil: For each representative use,the method (tier) used to estimate the exposure and any risk mitigation measure taken into account should be stated. Whether or not PECplateau was triggered should be indicated.
Groundwater: For each representative use, the method (tier) used to estimate the exposure and any risk mitigation measure taken into accountshould be stated. Conclusions on the risk for exceedence of the 0.1 µg/l limit value should be clearly stated. The need for an assessment of the relevance of metabolites should be clearly indicated, with reference to section 2.11. Individual PECgw (for active substance and metabolites) needs to be presented for each FOCUS scenario only in case the estimated PECgw is > 0.001 µg/l for any of the scenarios.
Surface water and sediment: For each representative use, the method (tier) used to estimate the exposure and any risk mitigation measure taken into account should be stated.
Air: For the case exposure via air has been estimated, state method used and the estimated values.
Other routes of exposure: State whether or not it has been shown that exposure via other routes (e.g., by deposition of dust; indirect exposure of surface water from Sewage Treatment Plant; from amenity use) can be excluded. If this has not been shown, state the method used to estimate the exposure and any risk mitigation measure taken into account. Since the estimated levels of exposure are expected to be presented in the risk assessment (i.e., under 2.9.9) there would be no need to repeat the values here.
2.9Effects on nontarget species
2.9.1Summary of effects on birds and other terrestrial vertebrates
2.9.2Summary of effects on aquatic organisms
2.9.3Summary of effects on arthropods
2.9.4Summary of effects on nontarget soil meso- and macrofauna
2.9.5Summary of effects on soil nitrogen transformation
2.9.6Summary of effects on terrestrial non-target higher plants
2.9.7Summary of effects on other terrestrial organisms (flora and fauna)
2.9.8Summary of effects on biological methods for sewage treatment
2.9.9Summary of product exposure and risk assessment
For each group of organisms (terrestrial vertebrates, aquatic organisms etc) provide a summary ofthe risk assessment done for each representative use, with reference to the appropriate Volume(s) 3 (PPP) in which the complete calculations are presented. Sub-headings may be introduced for each group of organisms.
Conclusions drawn regarding the anticipated risk should be clearly stated for each representative use.State clearly the method (guidance andtier) used for risk assessment, method and assumptions used for refinements, and any risk mitigation measures taken into account.
For each use representations of risk (TER values, HQ etc.) together with the corresponding PEC values or other expressions of exposure should be presentedfor:
- one standard calculation without refinement or risk mitigation (eg Step 3 for aquatic organisms);
- one calculation for the highest Tier necessaryto draw conclusions for the most sensitive organism within each group of organisms.
2.10Classification and labelling
The following structured tables - in line with the ECHA-report- should be included here.
Proposed classification according to Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures
CLP Annex I ref / Hazard class / Proposed classification / Proposed SCLs and/or M-factors / Current classification 1) / Reason for no classification 2)2.1. / Explosives
2.2. / Flammable gases
2.3. / Flammable aerosols
2.4. / Oxidising gases
2.5. / Gases under pressure
2.6. / Flammable liquids
2.7. / Flammable solids
2.8. / Self-reactive substances and mixtures
2.9. / Pyrophoric liquids
2.10. / Pyrophoric solids
2.11. / Self-heating substances and mixtures
2.12. / Substances and mixtures which in contact with water emit flammable gases
2.13. / Oxidising liquids
2.14. / Oxidising solids
2.15. / Organic peroxides
2.16. / Substance and mixtures corrosive to metals
3.1. / Acute toxicity - oral
Acute toxicity - dermal
Acute toxicity - inhalation
3.2. / Skin corrosion / irritation
3.3. / Serious eye damage / eye irritation
3.4. / Respiratory sensitisation
3.4. / Skin sensitisation
3.5. / Germ cell mutagenicity
3.6. / Carcinogenicity
3.7. / Reproductive toxicity
3.8. / Specific target organ toxicity –single exposure
3.9. / Specific target organ toxicity – repeated exposure
3.10. / Aspiration hazard
4.1. / Hazardous to the aquatic environment
5.1. / Hazardous to the ozone layer
1) Including specific concentration limits (SCLs) and M-factors
2) Data lacking, inconclusive, or conclusive but not sufficient for classification
Labelling:Signal word:
Hazard statements:
Precautionary statements:
Proposed notes assigned to an entry:
Notes in accordance with CLP Regulation, Annex VI, Section 1.1.3
Proposed classification according to Dangerous Substances Directive (Directive 67/548/EEC)
Hazardous property / Proposed classification / Proposed SCLs / Current classification 1) / Reason for no classification 2)Explosiveness
Oxidising properties
Flammability
Other physico-chemical properties
[Add rows when relevant]
Thermal stability
Acute toxicity
Acute toxicity – irreversible damage after single exposure
Repeated dose toxicity
Irritation / Corrosion
Sensitisation
Carcinogenicity
Mutagenicity – Genetic toxicity
Toxicity to reproduction – fertility
Toxicity to reproduction – development
Toxicity to reproduction – breastfed babies. Effects on or via lactation
Environment
1) Including SCLs