Regulatory Update: 23/2012
Date: 2 July 2012
Background
CRD’s ability to process applications to expected timescales can be hindered by applications with obvious errors or omissions. This does not reward applicants who submit good quality applications as it impacts on the overall efficiency of the system. CRD wants to reward good quality submissions and improve predictability in processing applications according to clear and understood timelines.
All applicants are responsible for submitting applications that meet the requirement to address health, safety and environmental issues for their products.
All applications for plant protection products received by CRD are considered at the weekly applications sift where a decision is made as to the appropriate fee and stream for each application. Information on the sift process can be found in the Applicant Guide. In 2003, CRD introduced ‘minimal sifts’, where only the fee and stream were decided upon at the sift, which allowed applications to be accepted more quickly following receipt, on the understanding that we may request further information at a later stage if key information is missing or that applications might be refused if significant omissions came to light. However, our experience over time is that the incentive to present good quality applications at the outset has been lost. CRD can then spend significant resources trying to rectify omissions at a later stage. This is inefficient and disruptive.
Changes to the sift
To allow CRD to address these issues and better manage applications we are introducing a more detailed sift for certain types of applications for plant protection products. Those applications which are missing key information or documentation will not be accepted until the missing items are received. Until applications are accepted by CRD they will not be processed further.
Criteria have been developed against which applications for re-registration and new products (based on new data in most areas of the risk assessment), will be assessed at the applications sift.
For those applicants that submit good quality applications these changes will not have an impact on their acceptance.
When will the new sift be introduced?
This detailed sift will be in place for the sift of date 24 July 2012, and therefore will apply to all relevant applications received at CRD from 12 pm on Thursday 12 July 2012.
Which applications will be affected?
All zonal applications for new products, voluntary work share zonal applications for re-registration, national assessments for new products and re-registration.
What criteria will we use at the applications sift?
Applications will be assessed against standard criteria. These have been devised on the basis of common errors and omissions that we have found hinder the evaluation of the application. A checklist based on these criteria is available in the appendix to this regulatory update and we recommend that you use this list to check your applications prior to submission.
Note: We require an application overview for all the types of applications that will be considered in the detailed sift. The overview greatly aids the sifting of the application as it briefly summarises what the request is and how it is supported. Appendix 1 includes a link to the relevant guidance.
What will happen to my application if it does not meet the criteria?
Where items are found to be missing or incorrect, the application will not be accepted. Instead a standard letter outlining the deficiencies will be sent and a sift fee will be charged. We ask that you submit the outstanding items in a single package within 4 weeks. When all the missing items are submitted then we will accept the application and charge another sift fee and the required fee modules. If the information is not received within this timeframe the application will be closed. The target date for completing the evaluation of the application will be measured from the date of acceptance following receipt of the additional information, excluding time waiting for responses to requests for further information from applicants or other Member States and the commenting process.
Reminder of Common omissions
In 2011 CRD issued a checklist of common areas that are not addressed in applications. You should check your applications against this list before submission. The criteria listed in the appendix below are those that will be specifically considered at the sift and therefore if you wish your application to be accepted promptly then you should ensure that all these items have been addressed fully. These criteria have also been highlighted in the existing checklist.
Please note that the checklist of common omissions for applications has been updated to include a reminder that you must used EU agreed end points and address the outstanding areas/data requirements that were highlighted in the substance approval, review report or ESFA conclusion.
Contact Information
If you have any questions regarding this issue, please contact CRD Applicant Enquiries:
Email: applicant-enquiries@hse.gsi.gov.uk
Postal address: Chemicals Regulation Directorate, Mallard House, Kings Pool, 3 Peasholme Green, York, YO1 7PX, UK
Appendix: Applicant checklist based on the Sift Criteria
| General |
| Is there are covering letter which clearly summarises the application? Guidance at: What should I include in an application ? |
| Is there an Application form? Guidance at: What should I include in an application ? |
| Are full formulation details present in the application form? Guidance at 2.1 and 2.2 of Data Requirements handbook - Chapter 3:Physical and Chemical Properties |
| Is there a draft label? Guidance at: Labelling handbook |
| Is there an application overview? Guidance at: The Applicant Guide General Information On the Application Overview |
| Is there a Draft Registration Report? Guidance at: The Applicant Guide Zonal-Authorisations and Mutual Recognition under regulation (EC) 1107/2009 |
| 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. |
| 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. |
| 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. |
| Are the proposed formulation details different from those currently authorised?If there are then explain your proposed formulation change. |
| 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 two products see link for guidance: The Applicant Guide - The Protection Of Data |
| Pesticide Chemistry |
| Have you included monitoring methods in accordance with SANCO 825/00 rev 8.1 in the dRR? Please provide these and those for products of animal origin, if applicable. |
| Mammalian Toxicology |
| Is there more than 1 active present in the formulation? Is a consideration of combined toxicity provided? This is required – see Regulatory Update 05/2005 Toxicity assessment of combinations of 2 or more compounds in a formulation |
| Is this a new/revised formulation? Have appropriate MSDSs been provided? – see Regulatory Update 07/2011 for our requirements. Requirements for material safety data sheets for co-formulants in pesticide products |
| 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? |
| 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 ? |
| Do the classification on the label and that proposed in the dRR section A/covering letter/overview match? If not, clarify which is correct. |
| Have you provided a justification for the choice of dermal absorption value (e.g. just ‘value from the DAR’ without stating why it is applicable in the specific case is not acceptable)? |
| 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. |
| Operator Exposure |
| Is your assessment relating to the risk to operators addressed in accordance with our guidance located in The Applicant Guide: Completing An Application Overview For Operator And Consumer Exposure ? |
| 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 Exposure Guidance. |
| Is your assessment of post-application exposure to workers and the public addressed in accordance with our guidance and worked examples located in the Guidance for Post-Application (Re-Entry Worker) Exposure Assessment? |
| Residues |
| Have you referred to the MRL compilation dossier? This is not acceptable. 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. |
| Have you referred to the unprotected residues data in the DAR to support your proposed uses? If so, you must outline clearly how the data in the DAR support your requested uses e.g. metabolism in X crops were evaluated for Annex I inclusion, 8 trials on wheat at the following GAP are available in the DAR , etc. |
| Environmental Fate |
| Have you provided an environmental exposure assessment which is clearly linked to the specified GAP? |
| Have you stated how you intend to address each area of environmental exposure, i.e. soil, groundwater, surface water/sediment and air (if appropriate)? |
| 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 Chapter 6 of the Data Requirements Handbook regarding Environmental Fate and Behaviour and in the Environmental checklist. |
| 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. |
| Have you have submitted new data and/or modelling? You must clearly explain why you are submitting this – new Annex II data particularly needs to be explained. |
| Ecotoxicology |
| Is more than 1 active is 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 |
| 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? |
| Is there a UK specific aquatic risk assessment (spray drift and drainflow) provided for the crop? |
| Has a risk assessment for e.g. non-target plants been provided? |
| Efficacy |
| Do any of your proposed target pests occur/are considered to cause economic damage warranting control measures? If not please provide further justification supporting the need for control. OR Are the [targets] considered to be pests warranting control under UK conditions? If not, you may wish to submit additional justification and evidence. |
| 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. |
| Is 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? |
| Does your application address the outstanding COPR efficacy data requirements? If not provide an explanation for this omission. |
| 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]? |
| 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 ascertain whether the non-UK product is authorised on the target in question, and has been used at the authorised rates. 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. |
| Does your BAD/dRR include information on the GEP status of all the testing organisations and/or relevant Official Recognition Certificates? (NB for UK organisations, reference to the relevant ORETO number is sufficient). |
| Does your BAD/dRR address all the Regulation (EC) 1107/2009 efficacy data requirements? |
| Are the summary tables in an appropriate format with sufficient detail for an evaluation to be conducted? |
| Is the summary of the efficacy data in an appropriate format for submission to the EU? You may either use dRR Section 7 [in the zip file under the title "Guidance on the presentation and evaluation of dossiers according to Annex III of 91/414/EEC in the format of a (draft) Registration Report" at this link: Guidance Documents for the implementation of Council Directive 91/414/EEC (Plant Protection Products) ] to submit all data and relevant appendices, or submit a Biological Assessment Dossier (see Efficacy Guideline 101) and then use the dRR template to provide a brief summary. |
