In Regulation (EC) No 1107/2009 there are two basic approaches to product authorisation – zonal authorisation (Articles 33 – 39) and mutual recognition (Articles 40 – 42). These have specific and directly binding timelines and procedures which are set out in more detail in an EU Guidance Document which is available on the Commission website (SANCO/13169/2010).
The CRD processes and procedure for the Authorisation of PPPs in the UK changes on 29 June 2016:
Overview of the operation of the zonal evaluation process in the UK from 29 June 2016
Zonal authorisation in Regulation (EC) 1107/2009 is the standard procedure to be followed for product authorisation or amendment to an authorisation and applies to all applications made from 14 June 2011 not covered by the transitional arrangements.
The zonal authorisation procedure is similar to the voluntary re-registration work-sharing procedure developed under Directive 91/414/EEC to facilitate product re-registration.
In summary the process is as follows:
The core assessment must reflect an assessment to Uniform Principle for a product and its uses, and should cover all the uses required in the zone (see section on risk envelope below). It will be used by the other MS as a basis for national regulatory decisions.
Assessments must be supported by appropriate Annex III data, or access to the same.
Further guidance on what should be included in the core dossier is available on the the European Commission website.
The risk envelope is a concept which exploits the idea that within a group of products and uses, there will be certain uses which represent the worst-case situation in each area of assessment. The assessment of this worst-case product/use will cover all other situations where the Good Agricultural Practice (GAP) is less critical or the same. This is applicable to all sections except efficacy and residues for which assessment will be based on individual crops (although even in these areas, there may be some scope for extrapolation) and pesticide chemistry.
By establishing the risk envelope, it is possible to minimise the number of individual product/use assessments that need to be completed. The concept of risk envelope can be applied:
within products (eg use on apples at 2N rate will cover use on pears at N rate in certain risk assessment areas)
within a group of products (eg use of 'Product 100EC' will cover use of 'Product 50 EC' where the in-use rates are the same)
Applicants should propose the use which establishes the risk envelope across the zone in each area of the assessment (whilst also highlighting all the uses authorised/required within the zone). Assessors will consider the proposal to establish the risk envelope as part of their assessment.
An EU Guidance Document on risk envelope (SANCO/11244/2011) is available on the Commission website (in Procedural Guidance list).
There are some areas of the assessment which do clearly apply to all MS, irrespective of the zone (eg physical, chemical properties and formulation toxicity). There are also some types of uses (eg greenhouses, products to be applied in storage areas, post-harvest treatments, seed treatments) where the same assessment will apply across the whole EU. If you think this is the case, you should highlight this possibility prior to/at submission.
At least 6 months before the application is due to be made it is recommended that you email all 'concerned' MS with information on the products for which authorisation is to be sought and a proposal for ZRMS.
A new form to notify intended zonal applications under Regulation (EC) No 1107/2009 has been agreed by the interzonal steering committee. This form should be completed as far as possible and accompany requests for ZRMS proposals. This form incorporates a new GAP table agreed by the post-Annex I expert group and this new GAP table will be included in the next revision of the draft Registration Report (dRR) Guidance Document (SANCO/6895/2009) available on the Commission website - see Procedural Guidance list.
The form can be downloaded (Link to Application Notification Form) and should be used from now on. Please submit to email@example.com
After you submit a notification, we will send you an acknowledgement, and where you have requested that the UK is the ZRMS we will contact all MS in the relevant zones for agreement.
We will then contact you again with details of the ZRMS and if the UK are the ZRMS provide contact details of the project manager who will handle any pre-submission questions you may have, either via e-mail, teleconference or pre-submission meetings, and ultimately will be responsible for the overall co-ordination of the application.
Please note that CRD will not evaluate products for which an authorisation or an amendment to an existing authorisation will not be requested in the UK.
It is not compulsory to have a pre-submission meeting before making a zonal submission, although CRD actively encourages such meetings for complex applications and groups of applications. Please note that if CRD agree to a pre-submission meeting (either at our offices in York or via telephone or video conference) a fee will be charged.
Before requesting a pre-submission meeting you are advised to consider the complexity of your proposed application or group of related applications and also any issues which arise as part of your own risk assessment. This will enable you to make an informed decision regarding the benefits versus costs of holding a pre-submission meeting.
For straightforward applications (eg single products which pass all areas of the risk assessment at the first tier) a pre-submission meeting may not be appropriate.
For groups of related products or products with a large number of uses a meeting may be useful, particularly in relation to areas such as the risk envelope, or fees rationalisation.
Similarly if you know there are complex areas of the risk assessment which you are proposing to address using a non-standard technique or method, a pre-submission meeting would allow you to discuss your proposed approach in detail with CRD specialists.
If you think a pre-submission meeting may be beneficial you should discuss this with your CRD contact for the pre-submission phase. The agenda of any meeting will be proposed by you as the applicant. However, CRD will also take the opportunity in the meeting to outline the criteria and standards required in any submission.
An indication of the risk assessment areas you wish to discuss should be provided at an early stage as this will determine which CRD specialists are required. Additional specialists may also attend the PSM if a need is identified by CRD.
A detailed agenda and supporting papers must be provided no later than 2 weeks ahead of the meeting. CRD will not make a record of the meeting and it is advised that you write up notes which can then be agreed with the CRD attendees.
In the initial application (made to zRMS and all concerned MSs) you must submit a draft Registration Report (dRR) as detailed in the EU Guidance document which is available on the Commission website (see Procedural Guidance list):
The dRR presents the same information as the traditional Annex III dossier and as a result you are no longer required to submit an Annex III dossier. Please note that for efficacy you may still submit a Biological Assessment Dossier, with an overview summary in the dRR. Guidance is still under development but the summary should indicate how each data requirement was addressed, relate the relevant sections to the proposed application, and signpost any issues in National addenda. You are still required to provide the actual studies (doc K) which are referenced and summarised in the dRR. If you wish you can provide this in caddy format, placing the dRR where docs M and N would normally be, and Part C of the dRR where doc J would be. There is no equivalent to doc O in the dRR, but this is not a requirement for a product submission in the UK.
In addition to the dRR the UK require further additional documentation summarised below:
After submission, your application will go through the sift process (see What Happens at The Application Sift? below)
Note that on completion of the assessment CRD will routinely release the completed Registration Report (RR) to applicants (with the exception of Part C). In some .instances, there may be data provided from parties other than the applicant/authorisation holder. Please note that the RR will not distinguish between different data owners and the complete evaluation will be released to the applicant.
Once the core assessment has been completed by the zRMS, additional national assessment is required in each of the concerned Member States.
Please note you are advised to contact each MS separately to confirm their precise national submission requirements.
In the UK we ask you to notify CRD when the zRMS has completed their zonal core assessment (including the commenting procedure), this notification should include a copy of the zRMS authorisation (or justification for non-provision eg if the zRMS has not granted authorisation due to national concerns but had recommended authorisation in other MSs may be possible). At the time of notifying please provide a short summary, detailing any changes in the proposed use as a result of the core assessment. At this time it may also be necessary to provide an updated label, Part A and National addenda to the zRMS core assessment. These applications should be emailed to firstname.lastname@example.org.
The following procedure will apply to applications received from 29 June 2016.
1. Validation check:
When HSE receives the application, an initial assessment of the information will be made to determine if the submission is complete. The information checked at this stage is outlined in Criteria for Validation Check in Appendix 3 of Overview of the process and procedures for the authorisation of PPP in the UK
A fee is charged for this step whether the application is accepted or not. If the submission is regarded as incomplete it will be rejected and the application closed. Any subsequent application will need to be submitted in full. Details of the reasons for rejection will be provided.
2. Detailed technical sift
If the application is accepted following the validation check it will undergo a detailed specialist sift, to ensure that the application is of sufficient quality to undergo a full evaluation.
A fee is charged for this step.
The criteria applied in each specialist area for the detailed technical sift are outlined in Criteria for the detailed sift and includes additional explanation. This has been provided to assist in understanding what key information is required in each specialist area. Applications will be assessed against these criteria, but the list is not exhaustive.
If the application fails the detailed sift, it will be rejected and closed, with full details of the reasons for rejection being provided. There will be no opportunity at this point to provide the missing information to complete the original application; instead, a new application will be required. As for applications rejected at the validation step, any subsequent application must be submitted in full and a new COP number will be allocated.
Passing the detailed technical sift does not guarantee that an application will result in an authorisation.
The detailed application sift in most cases will be completed within 4 weeks of receiving the application at HSE’s weekly sift.
What Happens if Further Information is Required At the Evaluation Stage ?
As outlined in Regulation (EC) No 1107/2009 and the EU guidance document, if additional information is required to complete the assessment, the evaluating MS shall set a period for the applicant to supply the additional information, with the total time not exceeding 6 months.
For evaluations received up until the 28 June 2016, where additional information is required to complete the assessment (and the UK are the ZRMS), we will continue with our current 'stop-the-clock' procedure of making only one request for further information in each area of the risk assessment and will ask for this to be provided within 8 weeks.
From the 29 June 2016 new processes and procedures will be introduced as follows:
Within HSE the total time of 6 months will automatically be given to applicants when additional information is required. The total period will be split into two separate requests that in general will be divided into the following areas:
1st Request – Chemistry and Analytical methods, Toxicology, Residues and Fate and Behaviour.
2nd Request – Operator Exposure, Ecotoxicology and Efficacy
An applicant will have 3 months (13 weeks) to respond to each request.
When additional information is requested the application is suspended for the time taken by the applicant to submit the requested information.
You must make your application in each MS where an authorisation is envisaged at the same time (the 'concerned' MS). The application must also include a list of all intended uses in each MS of the zone and differences within the same use for different MS should be justified.
A label extension for an additional use should preferably be dealt with by the ZRMS. If the new use is not intended in the original ZRMS another MS may be proposed and in principle the choice of the applicant should be followed unless another MS in the same zone agrees to examine it.
Applications for new products where we are the ZRMS will be charged using the standard modular fee system based on the data/information submitted and in addition a partial dossier fee will be charged for each* of these applications. If you request a UK assessment of additional uses or a different GAP to support a use in another MS (for example) we may charge a higher partial dossier fee. If the additional uses fall within the UK risk envelope then this additional fee may not be required, however it is up to you to provide justification that the higher fee is not required. This should ideally be discussed at the pre-submission stage with the project manager or be made clear in your covering letter.
* With regards to charging for groups of related products, you may be able to support a submission with an argument that one product falls broadly within the risk envelope of another that is supported by the same basic data package. For example a set of products which contain the same active substance, are the same formulation type and are applied at the same rate may only require a single partial dossier applied to the group. This will be considered on a case-by-case basis and should be discussed at the pre-submission stage.
Applications for amendments to existing products where we are the ZRMS will be charged using the standard modular fee system based on the data/information submitted.
For applications where we are not the ZRMS you will be charged using the standard modular system which will normally reflect at least a case fee in most areas of the risk assessment. If additional fate modelling or higher tier assessment pertinent to the UK evaluation is required then you will be charged a data fee in the relevant areas. All other data evaluation should be presented in the core dossier for ZRMS evaluation.
The acceptance and charging of applications where we are not zRMS will be carried out once you have provided a copy of the zRMS authorisation and confirmed that the core assessment (post commenting) is available.
Further guidance on our fee structure is given in the Applicant Guide.
Regulation (EC) 1107/2009 specifies one year to complete the ZRMS evaluation from the date the application is submitted and this must include a commenting period. This period may be extended by 6 months if further information is requested and the timelines can be suspended if the procedure in Article 38 (assessment of equivalence) is necessary. The timelines and procedures are being set out in more detail in an EU Guidance Document on 'Zonal authorisations and mutual recognition' (SANCO/13169/2010). This Guidance Document suggests the ZRMS completes their initial assessment in 8 months, followed by a 6 week commenting period and a further 10 weeks for the ZRMS to make their final decision on authorisation. The 'concerned' MS then have 120 days from receipt of the assessment report and the copy of the authorisation to decide on the application.
Regulation (EC) 1107/2009 does not distinguish between new product applications and applications for amendment to authorisations. However, it has been recognised that the timelines for amendments should be appropriate to the amendment being requested and this is set out in more detail in an EU Guidance Document on 'Renewal, amendment and withdrawal of authorisation'. This is available on the Commission website.
Up until 28 June 2016
Applications where we are the ZRMS will be streamed in accordance with our current procedures based on the data/information submitted and will include additional time for the zonal commenting requirement. Applications for existing products and applications for new back-to-back products which require no technical consideration will be considered in the 'Admin' stream and no commenting period will be required for these types of applications.
From the 29 June 2016:
Applications will be streamed in accordance with the timelines defined in Regulation (EC) No 1107/2009. See Overview of new processes and procedures being implemented from the 29 June 2016 for the authorisation of plant production products. for all details of the new processes.
See table below for the time period for each part of the process:
|Time period (week)||Milestone|
0 - 4
Application sift completed
0 - 30
Initial evaluation completed.
Requests for additional information sent to the applicant.Application can be put on hold for up to 6 months. The clock will only be re-started once a response has been received from the applicant.
30 - 43
Additional information submitted by the applicant is evaluated
43 - 52
Commenting round and preparation of final documentation
Regulatory decision delivered by HSE
Applications where we are not the ZRMS will be evaluated in 120 days in line with the requirement in Regulation (EC) 1107/2009.
A commenting period is a legal requirement of Regulation (EC) 1107/2009 and allows all MS the opportunity to submit comments to be considered in the ZRMS assessment.
This commenting phase must take place before the authorisation is issued and applies to all new products and amendments to existing products regardless of whether the product/use is for the UK only. It also applies to applications for minor uses but not to administrative applications, applications based on mutual recognition, applications for parallel trade permits or permits for research and development.
There will be a 6 week commenting period for most applications. At the same time as providing the assessment to MS for commenting the assessment will also be sent to you to provide comments on matters of factual accuracy only. In the case of minor uses the assessment will only be sent to the applicant where the application was made by the authorisation holder. The commenting procedure for voluntary re-registration work-sharing remains unchanged.
In the case of differing opinions on technical issues, the ZRMS and the MS concerned shall try to reach a compromise. If a compromise is not possible, this shall be recorded in a Reporting Table and ultimately the ZRMS decides the conclusion in its assessment. In cases of disagreement the Reporting Table will be included as a supplement to the Registration Report, for transparency reasons.
The question on whether a decision of the ZRMS not to authorise a product could be used as a basis for an authorisation under Article 37(4) is currently being explored by the Commission. As soon as the Commission consolidates its position, this guidance will be revised accordingly.
Currently we allow certain application types to be made in two stages – for example to consider the acceptability of a key study. Such applications will still be possible after after 28 June 2016. However, such applications will be processed under Article 33 of Regulation No 1107/2009. Details are available.
The initial assessment will provide the UK view only. . At the end of the assessment of the first stage we will let you know the outcome of our assessment and at the second stage a zonal application will be required and the process as outlined above (including commenting) will be followed.
Applications for new sources of active submitted ahead of the full Annex III dossier will also be accepted as the first of a two-stage process. We will allow MS 30 days to comment on these applications and at the end of the evaluation our assessment will be made available to other MS via CIRCABC..
As outlined in Regulatory update 07/2016 (24 March 2016) fast –track applications are being phased out in the financial year 2016 – 2017.
Applicants will have the opportunity to apply for one fast track application between 1 April and 31 December 2016, after which the fast track procedure will be withdrawn. The current criteria will apply, although in line with the proposed new streams and timelines , a 26 week processing time will apply to any fast track applications submitted after 1 June 2016. Zonal applications for which a ‘zonal subcharge’ has been applied cannot be fast tracked.
Further information is given under Zonal authorisations – following zonal procedures under Regulation (EC) 1107/2009.
The procedure for mutual recognition of an authorisation is described in Articles 40-42 of Regulation (EC) No 1107/2009. As of 14 June 2011, mutual recognition in the sense of Article 40 applies to all authorisations in MS, which were either granted under Directive 91/414/EEC in compliance with Annexes II, III and VI of that Directive or under Regulation (EC) 1107/2009.
From 29th June 2016 these applications will be subjected to the validation check and the detailed sift outlined above for Zonal submissions to ensure UK specific requirements are addressed. Further details are given in Criteria for Validation Check in Appendix 3 of Overview of the process and procedures for the authorisation of PPP in the UK and Criteria for the detailed sift in the Appendix 4 of the Overview document and the Checklist for applications page.
Authorisation holders can apply for mutual recognition of the same product, the same use and under the comparable agricultural practices when (Article 40(1)):
There are a number of cases for which mutual recognition is optional (Article 41(2)):
Mutual recognition according to article 40- 42 is also applicable to minor uses (Article 51(7)).
Your application will need to contain appropriate information so that we can determine whether the use of the product in the reference Member State is comparable with the proposed use of the product in the UK. These applications should not involve data evaluation (except where data are required to address the national specific requirements or demonstrate comparability of environmental / agricultural conditions). If additional data are required to support any aspect of the core assessment, an Art 33 application is required instead.
In support of your application you must submit the following (see The Applicant Guide for further information):
Details of the UK specific requirements which need to be addressed are provided in the Applicant Guide and summarised below.
All the proposed uses, rates and timings and packaging (ie the conditions for sale, supply and use) for your product must be within those authorised for the product in the other MS. In the Application Overview you should detail all the proposed conditions of use for your product and those approved for the product in the other MS. You should include information on:
To be considered comparable to UK conditions, only applications for products holding an authorisation in a 'northern region' MS, or for a use in a protected environment (such as a glasshouse), can be considered via the MR procedure. Guidance on which member states are in the northern region can be found in Appendix D- Comparability, extrapolation, group tolerances and data requirements. (SANCO 7525/VI/95, 24/3/2011) The following will need to be provided:
In demonstrating the comparability of agricultural, environmental and plant health conditions, you should consider those factors relevant to the product which may affect performance or crop safety. You should also consider any differences in the biology and pathogenicity of the target organism. Where differences have been identified, you should not be deterred from submitting a MRapplication. For example it may be possible to demonstrate that the supporting data were generated under conditions relevant to, or more challenging than, the UK. You should also ensure that the label claims made on the UK product label reflect the performance demonstrated in the trials work supporting the authorisation of the product.
The case should include:
There are two other areas where further information supporting the mutual recognition application may be necessary:
As a general guide, the factors that may be important are detailed in Efficacy Data Requirements (Overseas Evidence) (available from the 'UK Government Web Archivesection of 'The National Archives' website ). This guidance discusses the relevant climatic, edaphic, agricultural and plant health factors that may need to be considered. However, you only need to relate these factors to the product under consideration. To illustrate these areas, a few working examples are given below:
Climatic differences may be important to the crop, the target organism, or the active substance(s). Discussion of the location of trials with reference to EPPO standard PP 1/241 Guidance on comparable climates would be required.
Edaphic factors are particularly important for soil-applied pesticides and information on the range of soil types tested in the trials would be appropriate eg blackgrass is a major UK weed because it is particularly widespread on heavy soil types not generally common elsewhere in Europe.
Further information relating to UK product labelling and UK national issues is available in the document '1107/2009 Efficacy Assessments: UK product labelling and National Issues/Addenda'.
Information relating to the comparability of climate and agricultural conditions is also relevant when demonstrating that the environmental risk assessments carried out by the other MS are appropriate to UK conditions. The following information should be provided:
The following information should be provided:
Alternatively the application must include a risk assessment that addresses this route of entry into the environment. See current guidance on calculating the surface water PECs required to complete such an assessment.
Further guidance is included in the data requirements for Environmental Fate.
If this groundwater exposure assessment was completed using the FOCUS groundwater modelling and standard scenarios, the scenarios considered pertinent to UK conditions are Chateaudun, Hamburg, Kremsmunster and Okehampton. If this evidence is not available the applicant must submit appropriate PEC groundwater calculations with the application for the UK geoclimatic situation. Further guidance is included in the data requirements for Environmental Fate.
Details of the UK specific requirements which need to be addressed are provided in the Applicant Guide.
You will be charged using the standard modular system which will normally reflect at least a case fee in each area of the risk assessment requiring specialist consideration. If additional fate modelling or higher tier assessment pertinent to the UK evaluation is required then you will be charged a data fee in the relevant areas.
Further guidance on our fee structure is given in the Applicant Guide.
MS to which the application under Article 40 is submitted have 120 days to decide on the application. The same timeline will apply in the UK and will not be possible to 'stop-the-clock' for these applications. Therefore, no requests for further information can be issued once the 120 day processing time has commenced.
Zone A — North
Denmark, Estonia, Latvia, Lithuania, Finland, Sweden
Zone B — Centre
Belgium, Czech Republic, Germany, Ireland, Luxembourg, Hungary, Netherlands, Austria, Poland, Romania, Slovenia, Slovakia, United Kingdom
Zone C — South
Bulgaria, Greece, Spain, France, Italy, Cyprus, Malta, Portugal, Croatia.