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The Applicant Guide: Checklist For Applications

Outlined below are common omissions in applications. Those marked with a cross are considered in the detailed sift conducted for applications submitted up to 28 June 2016.

Additional information on the criteria assessed for applications submitted from 29 June 2016 is available in the Overview of Processes and Procedures for the Authorisation of PPPs in the UK from 2016.
 
The application types that will be subject to a detailed technical sift can be found under The Applicant Guide: How will my application be processed?

What happens after I submit my application?

Where these highlighted items are not adequately addressed then the application will not be accepted. Further details can be found in The Applicant Guide: How will my application be processed?

Links to specific sections:

General

X

Is there a covering letter which clearly summarises the application?

Guidance at The Applicant Guide - What should I include in an application ?

X

Is there an Application form?

Guidance at: The Applicant Guide - What should include in an application ?

X

Are full formulation details present in the application form?

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

Are the formulation details complete and expressed in the correct units?

eg are all the tradenames, chemical names 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 dRR.

Have full details of the proposed packaging been included?

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, etc and 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

X

Is there a draft label?

Guidance at: Labelling Handbook contents

X

Is there an application overview?

Guidance at: The Applicant Guide: General information on completion of the application overview

X

Is there a Draft Registration Report?

Guidance at: The Applicant Guide: Zonal Authorisations and Mutual Recognition under Regulation EC 1107/2009

X

Have you made reference to the fact that further studies/trials reports will be available shortly?

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.

X

Have you included draft reports/studies as part of your submission?

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. So wait until these are available before submission.

X

Are there discrepancies in the proposed GAP between the draft label/dRR Parts A and B?

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

X

Are the proposed formulation details different from those currently authorised?

If there are then explain your proposed formulation change.

Are you seeking a ‘full’ zonal assessment or UK only assessment?

Under a ‘full’ zonal assessment, CRD will conduct an assessment of all relevant areas of the core assessment including those that are not relevant for a UK authorisation (eg German operator exposure model and groundwater assessments for scenarios not relevant to the UK). An additional partial dossier fee will apply as detailed in: The Applicant Guide: Zonal Authorisations and Mutual Recognition under Regulation EC 1107/2009 . Have you made it clear that you understand that this fee will be applied and indicated your agreement to this?

Have you asked that your application be supported by the use of data for which the protection period has expired for unnamed UK products?

You must give full details of any UK 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 see link for guidance: The Applicant Guide: The Protection of Data

If a full zonal assessment are you requesting that CRD assess uses that are not sought in the UK?

Providing UK authorisation of the product is sought, CRD can assess non UK uses. Please note that an additional fee applies as detailed in the The Applicant Guide: Zonal Authorisations and Mutual Recognition under Regulation EC 1107/2009 Have you made it clear that you understand that this fee will be applied and indicated your agreement to this?

Has the zRMS been agreed before submission of the application?

If you are requesting that the UK are zRMS, we will only accept your application when it has already been agreed zonally that other MSs are content for the UK to undertake this work. Such agreement should be sought in the pre-submission period as detailed in The Applicant Guide: Zonal Authorisations and Mutual Recognition under Regulation EC 1107/2009 Have you made it clear that you understand that this fee will be applied and indicated your agreement to this?

X

Have you made clear that you accept the zonal surcharge where you have requested that UK is the zonal RMS?

Please also confirm whether the most critical GAP is that for the UK or if this is not the case explain which uses or GAPs are more critical and in which concerned MS. Detail this information in the application overview.

X

Does the submission address all of the UK specific elements?

This applies to all zonal submissions but particularly when the zRMS is not the UK (ie following zonal submissions). For details of UK specific requirements please refer to Specialist guidance for mutual recognition.

These should be addressed within national addenda to the dRR and a UK specific Part A.

X


Is the application for mutual recognition?

Have you supplied all the relevant supporting documentation eg copy of other MS label and authorisation along with translation into English? Have you confirmed that the formulation and technical specification is the same for the UK 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 UK addenda eg operator and consumer exposure, environmental fate and ecotoxicology?

For guidance see: The Applicant Guide: Zonal Authorisations and Mutual Recognition under Regulation EC 1107/2009

Is the application for re-registration? If so does it include a formulation change or new uses?

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

Was the formulation and/or uses considered in the DAR or has it been subject to a previous uniform principles assessment?

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

Is your application for re-registration of a national provisional authorisation?

If so, a full Uniform Principles Assessment will have been conducted previously, using end points agreed at a Member State level. Please compare the end points used in the previous UK assessment with those detailed in the EFSA conclusion. Your application should focus on addressing any data gaps and reassessing areas of the risk assessment where underlying end points have changed. A dRR should be submitted but part Bs only need to be provided where new data evaluation or risk assessment is required. Please also address any open points in the EFSA conclusion. Your must submit a draft label.

Are there any confirmatory data requirements?

Please detail whether the inclusion is subject to confirmatory data requirements. Have the requested data been submitted to the RMS and if so when is the assessment expected?

X

Are all MSDSs in accordance with (link to toxicology guidance)

If it is not possible to obtain an MSDS less than 2 years old and in EU format, please detail this in the application overview and provide evidence from the supplier that this is the most recent MSDS and is an accurate description of the current classification.

Have you explained how each area of the assessment is being approached eg by data/ case or reference to a previous assessment and highlighted any salient points?

Detail this in the application overview

Have you explained the basis for end points used in your risk assessment (particularly if different to those detailed in the EFSA conclusion)?

If you are not using the Annex I agreed end points please explain how your proposed end points are supported (ie 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.

Are all sections of the dRR in word format?

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

Have you considered the outstanding areas/data requirements highlighted in the Inclusion Directive, review report and/or ESFA conclusion?

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.

Have you included original copies of all necessary letters of access?

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.

X

Does your product contain a candidate for substitution?

Please ensure that you include an assessment of comparative assessment and substitution in line with the guidance on comparative assessment. Link to UK guidance Document

Chemistry

X

Have you included monitoring methods to support the proposed crops (eg high water, high acid, high oil and dry commodities), products of animal origin, environmental matrices (soil, water and air) and body fluids and tissues in accordance with SANCO 825/00 rev 8.1 in the dRR?

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.

NB - Reference should be made to the monitoring methods available in a uniform principle assessment (eg 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.

Section 2 of part B of the RR is for monitoring methods only. Pre-registration methods should be summarised in the appropriate section of the RR alongside the study in which they have been used to collect data.

Have all the relevant properties been determined for the formulation type?

Ensure this is clear in the dRR.

For those technical properties that are concentration dependent, have they been determined at concentrations that support the in use concentrations being supported in the central zone?

Include in the dRR, Part B, section 1.

For annex point IIIA 2.7 have all the relevant properties been determined before and after storage and have these been fully summarised?

Ensure this is clear in the dRR

Are the ambient storage data sufficient to support the proposed packaging?

NB - 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

Are there any relevant impurities present in the formulation? Do these impurities need to be determined on storage and are fully validated methods of analysis available?

The validation data should comply with SANCO 3030/99 rev 4.

X

For Technical equivalence evaluations, have you provided full name and address details for the applicant, manufacturer and the location of the manufacturing plant?

  • Full name and address details of the applicant
  • Full name and address details of the manufacturer
  • Full name and address details of the location of the manufacturing plant

X

Have you included the proposed technical specification either in the CRD application form, Document J or a technical equivalence report?

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.

X

Have you included a method of manufacture that includes a chemical reaction scheme and brief details (including reaction conditions, temperature etc) for each step?

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

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

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

X

Have you included the following details of the batches?

  • 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, ie 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 hence should have been analysed for.

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

X

Is the batch analysis study done to GLP?

A GLP batch analysis study must include:

  • A signed and dated GLP and 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 OECD/ MAD (mutual acceptance of data) scheme, eg China the GLP certificate must be provided by a country that is.

X

Have you included a statement on how the confirmation of the identity of the active and impurities was addressed?

Guidance on Technical equivalence can be found in SANCO/10597/2003– rev. 10.1

Mammalian Toxicology

X

Is more than 1 active present in the formulation? Is a consideration of combined toxicity provided?

This is required – see Combined Toxicity for products with multiple active substances in Pesticide Toxicology Guidance PPPs. In the absence of an acceptable case CRD will assume combined toxicity.

X

Does your submission include any studies conducted on vertebrates?

If yes, have you justified the requirement for these studies? Please refer to the “Guidance Document on Data Protection” (SANCO/12576/2012) available under ‘procedures’ from the commission website

X

Is this a new/revised formulation? Have appropriate MSDSs been provided?

see Safety Data Sheets in Pesticides Toxicology Guidance PPPs.

X

Are you extrapolating from other products that your company owns? Have you explained the formulation details of those products and the impacts of any differences from a mammalian toxicology perspective?

Please address in the application overview.

X

Has the basis for the proposed classification been set out in accordance with our guidance in Chapter 4 of the Data Requirements Handbook regarding Toxicity ?

Explain in the application overview and dRR.

X

Do the classification on the label and that proposed in the dRR section A/covering letter/overview match?

If not, clarify which is correct.

X

Have you provided a justification for the choice of dermal absorption value?

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 EFSA guidance see: Dermal Absorption in Pesticides Toxicology Guidance PPPs.

X

Is the density of the product in the application form?

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

X

Are you submitting new vertebrate data?

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

Operator, Bystander and Worker Exposure

X

Is your assessment relating to the risk to operators addressed in accordance with our guidance located in Non-dietary Human Exposure data requirements

?

Include in the dRR.

X

Is your product is applied as a spray and the active substance(s) contained in your formulation of low volatility?

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.

X

Is your assessment of post-application exposure to workers and the public addressed in accordance with our guidance and worked examples located in Guidance for Post-Application (Re-Entry Worker) Exposure Assessment? Found in Worker Exposure guidance

Include in the dRR.

Consumer Exposure

X

Have you have referred to the MRL compilation dossier and/or the EFSA reasoned opinion on the Article 12 review?

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 1107/2009.

X

Have you have referred to the unprotected residues data in the DAR to support your proposed uses?

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

Have you provided a UK addendum for section 4 of the dRR?

This must be provided and include the consumer intake assessments using UK models.

X

Have you given a clear explanation of how each GAP is being supported in the central zone?

This must be in IIIA 8.3 and be clearly outlined by reference to data in the DAR/for approval of the active, a previous uniform principles evaluation, unprotected data, new trials data or an acceptable extrapolation as outlined in SANCO 7525/VI/95 –rev 9. (NB – Reference to the MRL compilation dossier and/or EFSA RO on the Article 12 review under Regulation 396/2005 is not acceptable as this does not represent a uniform principles assessment and data protection must also be assessed under regulation 1107/2009).

For each annex point of the residues assessment have you clearly stated how the data requirement is being addressed?

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

NB – Only new data should be fully summarised.

X

Have the maximum length of freezer storage periods for each crop in any new residues trials data been stated in Section IIIA 8.1 and is it clearly outlined that these storage intervals are covered by the available freezer storage stability data?

Make sure that this is clear in your draft Registration Report.

Do the available plant metabolism data cover the crop group, application method, rate and PHI for the proposed uses?

Ensure that this is clear to the evaluator in your draft Registration Report

Have the details of all new residue trial data relied upon been tabulated including full details of the application method, rate and timings?

Check you have included suitable summary tables.

Is the relevant residues trial data summarised? including the following:

Ensure it includes the following:

  • residue trial values
  • STMR, HR
  • Source of the data (DAR , EFSA Conclusion, existing UP assessment, new data (eg Smith et al., 2014))
  • Procedural recoveries

If extrapolations have been relied upon are these clearly stated on a crop by crop basis?

Extrapolations must be in accordance with SANCO 7525/VI/95 –rev 9.

X

For any new residue trials data are the details of the supporting methods of analysis outlined in Section IIIA 8.3?

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. The validation data should comply with SANCO 3029/99 rev 4.

Has all mention of southern EU trials been removed from the dRR for the outdoor uses in the central zone?

NB - Outdoor uses in the Central Zone are supported by residue trials conducted outdoors in the Northern EU. Therefore, the dRR for the Central Zone should not contain any mention of residue trials conducted outdoors in the SEU apart from on rare occasions where the data are specifically required to support the use. Under these circumstances, a clear justification must be provided illustrating why this is appropriate.

If relevant, has a specific dietary burden for livestock (with clearly defined input values) been presented and compared to the feeding studies to assess the residues that may arise in products of animal origin for the proposed uses?

See Residues Guidance for further information.

Has the need for processing data for each crop been assessed?

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

Do the available rotational crop data cover the crops and maximum application rate for the proposed uses?

See Residues Guidance for further information.

X

Have the specific MRLs (for products of plant and animal origin) required for the proposed uses been stated and compared to the current MRLs?

The MRLs determined should be fully justified

X

Have the relevant consumer intake assessments (with clearly defined input values) been provided?

NB – This should include PRIMo and the UK models. The UK models can be presented in the core assessment and a section 4 UK national addendum is not required.

Environmental Fate

X

Have you provided an environmental exposure assessment which is clearly linked to the specified GAP?

Include in the dRR. Further guidance at: Environmental Fate Guidance

X

Have you stated how you intend to address each area of environmental exposure, ie soil, groundwater, surface water/sediment and air (if appropriate)?

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

Environmental Fate Guidance

X

Have you supplied environmental exposure calculations using UK specific methodology to support the UK authorisation?

Details of environmental fate and behaviour data requirements can be found in

Environmental Fate Guidance

X

Have you stated whether any precedents are being relied upon to address environmental exposure?

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

X

Have you have submitted new environmental fate data and/or modelling?

You must clearly explain why you are submitting this – new Annex II data particularly needs to be explained.

Ecotoxicology

X

Is more than 1 active present in the formulation? Is a consideration of combined toxicity provided?

This is required – see Regulatory Update 05/2012: Ecotoxicological risk assessment for plant protection products with multiple actives substances

and Ecotoxicology Guidance pages

X

Are you are extrapolating from other products that your company owns? Have you explained the formulation details of those products and the impacts of any differences from an ecotoxicology perspective?

Address this in the dRR and/or application overview.

X

Is there a UK specific aquatic risk assessment (spray drift and drainflow) provided for the crop(s)?

Include in the dRR.

X

Has a risk assessment for eg non-target plants been provided?

Include in the dRR.

X

Submitting new vertebrate data?

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

Efficacy

X

Do any of your proposed target pests occur/are considered to cause economic damage warranting control measures?

OR

Are the [targets] not considered to be pests warranting control under UK conditions?

OR

Are all the crops considered to be commercially grown in the UK?

If not please provide further justification supporting the need for control.

OR

If so, you may wish to submit additional justification and evidence.

OR

If not then you may wish to submit additional justification and evidence with this application to explain the relevance of the crop to the UK.

X

Is this application for the re-registration of an existing UK product following completion of the review conducted to 91/414 standards?

If so, you are referred to Efficacy guideline 103

which details the requirements and approach for Efficacy. You are required to provide an explanation comparing the proposed label uses to the relevant existing UK product, including highlighting any proposed changes: changes in GAP, new uses, existing uses no longer being supported. Note for voluntary work share re-registration applications CRD will only consider the efficacy of UK uses, not any additional uses required for other concerned MSs.

X

If your application is for a UK-only authorisation, and includes in the BAD/dRR data generated from outside the UK

Have you provided any justification for the relevance of the data to UK conditions (see ‘Chapter 8’ of the ‘Data Requirements Handbook’) for more details?

X

Does your application address the outstanding COPR efficacy data requirements?

If not provide an explanation for this omission.

X

Does your BAD/dRR proposed uses differ from those on the draft label/application overview, in particular [changes in rates, targets, references to using unprotected data including different named products, is intention to use a bridging approach clearly explained]?

If so, explain why or correct this.

X

Applications for UK only authorisation:

Does your BAD/dRR include trials that have used reference products not authorised in the UK?

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 in the MS where data were generated.

X

Zonal application where UK is zRMS:

Does your BAD/dRR include details of the authorised uses for the reference products used?

This is to determine the relevance of the reference products: whether it is authorised for the target, and has been used at the authorised rate in the MS where data were generated. The details provided can either be the whole label, or the relevant sections for the particular target in the trials.

Zonal application where UK is zRMS:

Does your BAD and/or dRR provide the background information required to conduct a zonal assessment?

You are referred to EPPO guideline PP1/278 which details the requirements and approach for Efficacy.

Does your BAD and/or dRR encompass all of the uses specified in the GAP table and/or proposed label?

Ensure that the BAD and/or dRR does include this information/data.

Where UK is cMS (following zonal):

Have you provided a national addendum?

OR

Does your national addendum address all UK specific issues?

Ensure the UK addendum, section 7 of the dRR is provided.

OR

Ensure the national addendum, section 7 addresses all UK specific issues, guidance can be found in the data requirements handbook.

Mutual recognition applications:

Does your application include evidence that the agricultural, plant health and environmental (including climatic) conditions relevant to the use of the product in the other MS are comparable to those in the UK?

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

Does your application include information to indicate the levels of performance of the product against the relevant target pests?

The UK operates 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 products performance can be aligned with the current UK labelling system.

Where the label in the other MS claims control for a group of pests (eg aphids, caterpillars) have you provided information on which species were tested?

Where appropriate also include information on the relevance to the UK of the species tested.

X

Does your BAD/dRR include information on the Official Recognition status of all the testing organisations and relevant Official Recognition Certificates?

NB for UK organisations, reference to the relevant ORETO number is sufficient

X

Does your BAD/dRR address all the Regulation (EC) 1107/2009 efficacy data requirements?

Ensure this is included in the BAD/dRR.

X

Are the summary tables in an appropriate format with sufficient detail for an evaluation to be conducted?

If not, ensure that they are. You are referred to the ECPA Technical guidance paper No. 2011/1 'Technical guidance for applicants in preparing a concise efficacy summary as part of a draft registration report (dRR)' which provides guidance on the information and the level of detail required.

X

Is the summary of the efficacy data in an appropriate format for submission to the EU?

You may either use a dRR Section 7 to submit and summarise all data and relevant appendices, or submit a Biological Assessment Dossier (see Efficacy Guideline 101) and then use the dRR template to provide a concise summary.

A dRR template is available on the European Commission website at this link: Guidelines on Active Substances and Plant Protection Products

In addition to the checklist above, you may also wish to consult the ecotoxicology and environmental fate lists of common reasons for requests for further information.

Back to What should I Include In an application?

Updated 2017-03-22