Checklist for pesticide product applications

Guidance at: Documents and information needed for a pesticide application

Guidance at Documents and information needed for a pesticide application

Guidance at Data Requirements: Physical and Chemical Properties. Note for re-registration applications that these details are required in all cases.

Refer to the unacceptable co-formulants register. Formulations containing unacceptable co-formulants cannot be authorised.

For example, are all the tradenames, chemical names and CAS numbers present in the application forms? Concentrations for liquid formulations should be presented in g/l or w/v (not w/w). Please ensure that the formulation details are the same as in Part C of the draft Registration Report (dRR).

For layered packaging materials, please make it clear which layer is in contact with the product. Please check the packaging on the application form and within the dRR are the same.

For refillable/returnable packaging, have you provided details on how the product will be returned, cleaned, and so on, as well as details of whether it is a top mounted discharge valve for bulk containers? Have you provided the appropriate labelling advice? Guidance at Pesticide containers: guidance on operator exposure considerations

Guidance at: Labelling Handbook contents

Guidance at: How to complete a pesticide product application overview.

Guidance at: Draft registration reports (dRRs) for pesticide product applications

All the data to support the application must be present from the outset and cannot be submitted later. You will need to decide whether you wish to continue with this application using only the existing data. The alternative is to delay the application until more trials/studies are available.

This is not acceptable and we will only consider that the application is complete and ready for acceptance once the final trials/study reports are submitted. Please wait until these are available before submission.

Ensure that the correct GAP is clear and that it includes clear details of the earliest time of application to be considered for assessment.

If there are, then explain your proposed formulation change.

You must give full details of any GB/NI products (including MAPP numbers) where you wish to access unprotected data and detail how they support your request. Note you can only make reference to one product, for guidance read Data protection: pesticide product authorisation.

Have you supplied all the relevant supporting documentation, for example, a copy of other MS label and authorisation along with translation into English? Have you confirmed that the formulation and technical specification are the same for the NI and other MS product? Is the other MS assessment to uniform principles using the agreed Annex I endpoints?

Have you supplied a Part A and relevant NI addenda, for example, non-dietary human and consumer exposure, environmental fate and ecotoxicology?

For guidance see Pesticide product authorisation in Northern Ireland: Article 40 Regulation (EC)1107/2009.

If it does, detail the changes and how they are supported.

Give details of any previous assessments, for example, COP number, product name.

Please detail whether the inclusion is subject to confirmatory data requirements.

A SDS that is 2 years old or less will be automatically accepted as the most recent.

For older SDSs detail this in the application overview. Provide evidence from the supplier that this is the most recent SDS and is an accurate description of the current classification.

Detail this in the application overview.

If you are not using the Annex I agreed end points, please explain how your proposed end points are supported (for example, new studies which require evaluation or reference to applications where the revised end point has previously been accepted). Where new data/information have been submitted, you should justify why the new data/information are required. This is particularly critical for the fate and behaviour area of the risk assessment.

You may submit PDF versions, but if you do, we additionally require Word document versions.

Please consider these previously identified issues and determine whether they are relevant to your application. Please provide details as to how these have been addressed or are not relevant in the application overview.

Please ensure that data access is clearly explained. If you are relying on letters of access that were submitted previously or are due to follow, please explain this.

For previously submitted letters of access, detail the date and application they were previously submitted for.

Please ensure that you include a comparative assessment and substitution in line with the Guide for UK applicants for Plant Protection Product authorisation.

Refer to Tank-mix recommendations on pesticide product labels.

Please provide these, if applicable. Details of the residue monitoring methods available for all crop groups being supported, products of animal origin, environmental matrices (soil, water and air) and body fluids and tissues should be summarised. Where a method is not required, a reason should be stated.

Note: Reference should be made to the monitoring methods available in a uniform principle assessment (for example, considered for the approval of the active in the DAR).

There is no need to re-summarise methods that have been fully considered and accepted in a previous uniform principle assessment and only new methods and validation data, when they are required, should be summarised.

Ensure this is clear in the dRR.

Ensure this is clear in the dRR.

Note: For liquid formulations this should take into account if it is solvent- or water-based. For solid formulations sold in flexible packs the impact of storage under pressure should be addressed.

The validation data should comply with SANCO/3030/99 rev5.

Provide the full name and address details of the:

• applicant
• manufacturer
• location of the manufacturing plant

The specification details must also include the following information for the active and impurities:

• Full chemical names
• ISO name for active
• CAS numbers
• CIPAC number (active only)
• Molecular weights
• Molecular formula
• Molecular structures
• Min level of the active
• Max level for impurities, inactive isomers and additives

For standalone technical equivalence applications, the application form CRD8 must be completed.

The method of manufacture should include a list of the starting materials, including process solvents used in the manufacture, along with details such as:

• Purity of all the starting reagents and process reagents
• Maximum levels of impurities present in the starting materials where applicable (for example, dioxins, furans, nitrosamines)

A statement on the commercial availability of each of the starting materials is also required.

• Are recovered solvents used in the subsequent manufacture of the batches?
• Were the 5-batches manufactured with recycled solvents?
• If the batches are to be manufactured with recycled solvents, how do you ensure that the recycled solvents comply with the minimum purity stated in the raw material specification?

• Dates of manufacture
• Batch weights

All representative batches should have been produced within the last 5 years of manufacture. If batches from the last 5 years are not available, a statement is required to confirm that they are still representative of the manufacturing process along with confirmation that no changes to the method of manufacture, including the purity of the starting reagents used, have been made.

If any changes have been made, a case to demonstrate they are minor and will not impact on the analytical profile of the batches must be made.

Batches should not be produced consecutively, in other words, they should be representative of different production runs.

If batch sizes are particularly small, then a case confirming that the batches are still representative should be submitted.

Consideration should be given to what solvents are used in the manufacturing process, and whether they are predicted to be in the final material, and therefore should have been analysed.

Quality Control (QC) data can be used to support the specification, or support claims that the batches are representative.

A GLP batch analysis study must include:

• A signed and dated GLP and Quality Assurance (QA) statements
• A GLP certificate

The certificate must cover analytical chemistry and the date of the certificate must cover the date of the batch analysis study.

For countries that are not signed up to the Organisation for Economic Co-operation and Development (OECD) or MAD (mutual acceptance of data) scheme, for example, China, then the GLP certificate must be provided by a country that is.

Guidance on confirmation of identity can be found in SANCO/3030/99 – rev.5

This is required, read Combined toxicity for products with multiple active substances in the pesticide toxicology guidance. In the absence of an acceptable case HSE will assume combined toxicity.

If yes, have you justified the requirement for these studies? Please refer to the guidance on data protection.

Read Safety Data Sheets in Pesticides Toxicology Guidance PPPs.

Please address this in the application overview.

Explain this in the application overview and dRR.

If not, please ensure each document is corrected with the correct classification.

Just saying 'value from the DAR' without stating why it is applicable in the specific case is not acceptable. When extrapolating from another product then a full formulation comparison explaining why the data can be extrapolated must be provided. Any extrapolations should take account of the most recent guidance, see: Dermal absorption in pesticides toxicology guidance PPPs.

This is required to convert from g/l to %w/w for the classification calculations.

Please provide a justification to explain why in line with Regulation (EC) 1107/2009, Article 33/3c.

Include this in the dRR.

If so, an assessment of bystander/resident exposure must be undertaken in accordance with our guidance and worked examples available in the Bystander and resident exposure page.

Include this in the dRR.

This is not appropriate. It must either be demonstrated that the residues data have previously been evaluated to uniform principles or the data supporting the requested use(s) must be submitted accompanied by appropriate summaries for all the uses requested. The summaries should be in the dRR. In addition, data protection issues are not established under Regulation 396/2005 and must be fully assessed under Regulation (EC) 1107/2009.

If so, you must outline clearly how the residues data in the DAR support your requested uses, for example, 'metabolism in x crops were evaluated for Annex I inclusion, 8 trials on wheat at the following GAP are available in the DAR', and so on.

This must be provided and include the consumer intake assessments using GB/NI models.

Reference must be made to data from the approval of the active substance, a previous uniform principle assessment, unprotected data or new data.

Note: Only new data should be fully summarised.

Make sure that this is clear in your dRR.

Ensure that this is clear to the evaluator in your dRR.

Check you have included suitable summary tables.

Ensure it includes the following:

• residue trial values
• STMR, HR
• source of the data (DAR, EFSA Conclusion, existing UP assessment, new data (for example, Smith et al, 2014))
• procedural recoveries

Extrapolations must be in accordance with residues guidance.

An appropriate reference to a Uniform Principles assessment of validation data for an appropriate crop matrix must be made or the details of the new validation data must be summarised. Read the methods of analysis guidance for further information.

Read the residues guidance for further information.

Where data are required a clear reference to the source of the available data must be given.

See Residues guidance for further information.

The MRLs determined should be fully justified.

Note: This should include PRIMo and the GB/NI models.

Include in the dRR. Further guidance at: Environmental fate and behaviour: Information for pesticide registration in Great Britain and Northern Ireland.

Include in the dRR and/or application overview. Further guidance can be found at:

Environmental fate and behaviour: Information for pesticide registration in Great Britain and Northern Ireland.

Details of environmental fate and behaviour data requirements can be found at:

Please note that precedents set under COPR are unlikely to be appropriate for post Annex I inclusion authorisations.

You must clearly explain why you are submitting this; new Annex II data in particular need to be explained.

This is required, read the ecotoxicology guidance.

Address this in the dRR and/or application overview.

Include this in the dRR.

Include this in the dRR.

Please ensure that you have provided a justification for these data in line with Regulation (EC) 1107/2009, Article 33/3c.

If not, provide further justification in supporting the proposed uses, including evidence of impacts in GB/NI. (Further information on GB/NI crops/pests is in our guide Efficacy evaluations and guidelines).

If not a crop established as commercially grown in the UK then you may wish to submit additional justification and evidence with this application to explain the relevance of the crop to the GB/NI.

If so, please provide an updated resistance risk analysis and management strategy, with specific reference to GB/NI conditions. Where there has been a significant shift in sensitivity and/or development of resistance, you should provide further justification on the relevance of the use to GB/NI.

If a change in GAP is unavoidable (i.e. If it is driven / triggered by a change in end points and/or guidance documents) then this should be highlighted. A justification for continued effectiveness and crop safety at the revised GAP should be provided.

Please provide an appropriate comparative assessment (read Comparative assessment and substitution for further details).

Please provide appropriate justification for the relevance of the data to GB/NI conditions (see relevant EPPO standards for further information).

Ensure that the BAD and/or dRR include this information. Further guidance is provided in Draft registration reports (dRRs) for pesticide applications.

If so, explain why or correct this.

You must provide the relevant translated labels. This can be either the whole label, or the relevant sections for the particular target in the trials. This information is required to determine the relevance of the reference products, whether it is authorised for the target and has been used at the authorised rate where data were generated.

Ensure that your BAD and/or addendum to the dRR contains this information.

Great Britain/Northern Ireland operate a system of tiered claims depending on the level of control provided. Ensure that you provide a summary of the level(s) of control achieved so that your product's performance can be aligned with the current GB/NI labelling system.

Further information is provided in guide GB and NI efficacy advice and product labelling.

Note: for GB/NI organisations, reference to the relevant ORETO number is sufficient.

Ensure this is included in the BAD/dRR.

Ensure appropriate explanation of the methodology is provided.

Refer to EPPO PP 1/306 ‘General principles for the development of co-formulated mixtures of plant protection products’.

Refer to the following relevant group:

• The Fungicide Resistance Action Group (FRAG-UK) | AHDB;
• The Insecticide Resistance Action Group (IRAG) | AHDB
• The Weed Resistance Action Group (WRAG) | AHDB

You may either use a dRR Section 3 to submit and summarise all data and relevant appendices, or submit a Biological Assessment Dossier (read Efficacy Guideline 101) and then use the dRR template (Draft registration reports (dRRs) for pesticide applications) to provide a concise summary.