Background
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).
Zonal authorisations
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. Wherever possible the voluntary procedures have been aligned with the zonal authorisation procedure in Regulation (EC) 1107/2009 to allow a smooth transition between the two processes.
In summary the process is as follows:
- the applicant submits to each MS where the plant protection product is intended to be placed on the market and should include all intended uses for the zone (see Appendix 1 for definition of zones)
- the applicant identifies the MS (the zonal RMS or ZRMS) they would like to carry out the assessment and the other MS in the zone should refrain from evaluating the application until that MS has completed the assessment
- the ZRMS will complete the assessment of a core dossier on behalf of the other MS in the zone
- the ZRMS will then make this assessment available to all other MS. Other MS then complete their national assessments based on the ZRMS core assessment.
What does the core assessment look like?
The core assessment prepared by the ZRMS will be used by other MS in the zone as a basis for national regulatory decisions. 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). 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 will be available on the CRD website shortly.
What is the risk envelope approach and how shall it be used in the context of zonal authorisations
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 (e.g. use on apples at 2N rate will cover use on pears at N rate in certain risk assessment areas)
- within a group of products (e.g. use of 'Product 100EC' will cover use of 'Product 50 EC' where the in-use rates are the same)
- across the zone (e.g. the use of Product X on cereals at 100g/ha in DE will cover the use of Product X on cereals at 80 g/ha in UK in some areas of the risk assessment)
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 is available on the Commission website (SANCO/11244/2011).
Can these principles be applied between the zones?
Yes. There are some areas of the assessment which clearly apply to all MS, irrespective of the zone (e.g. physical, chemical properties and formulation toxicity). There are also some types of uses (e.g. 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.
Where do I submit my ZRMS proposals and what information is required?
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. Details of the central zone contact points can be found in the Commission’s Contact points list (click on ‘Contact Points’ near the bottom of the page, this will be updated to include northern and southern contact points in due course).
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).
The form can be downloaded (Link to Form) and should be used from now on. Where you have previously notified CRD of your ZRMS proposals you are not required to retrospectively submit this form, however you are advised to contact each MS separately to confirm their requirements.
You will receive an acknowledgment to all ZRMS requests/notification received by CRD and where you have requested that the UK is the ZRMS we will contact all MS within the relevant zones for agreement. We will then contact you again with details of the ZRMS and if CRD are the ZRMS we will 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 where necessary, and ultimately will be responsible for the overall co-ordination of the application.
All ZRMS requests and notifications should be emailed to zonal.proposals@hse.gsi.gov.uk.
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.
What information do I need to submit?
You must submit a draft Registration Report (dRR) as detailed in the EU Guidance document which is available on the Commission website:
- Guidance document on the presentation and evaluation of dossiers according to annex III of Directive 91/414/EEC in the format of a (draft) Registration Report (SANCO/6895/2009).
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 other additional documentation is required and these along with the dRR requirements are summarised below:
- a covering letter clearly explaining how the application is being supported in each area of the risk assessment (this may be in the form of an application overview)
- a completed application form (CRD 1)
- draft Registration Report Part A, detailing the risk management (and draft label) pertinent to the UK (this should be submitted for new products and amendments to existing products)
- draft Registration Report Part B, detailing the core assessment submitted to the ZRMS and any national assessment (for amendments to existing products only the relevant Part B’s are required e.g. where there is data to evaluate or if a detailed case has been submitted; for other areas it is acceptable to refer back to the previous assessment(s))
- draft registration report Part C
- data underlying the core assessment (and national assessment if required)
- a valid letter of authorisation to third party data, where necessary
- any previous relevant correspondence
All data evaluation will be undertaken by the ZRMS and further guidance on what should be included in the core dossier and national addenda will be available on the CRD website shortly.
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/approval holder. Please note that the RR will not distinguish between different data owners and the complete evaluation will be released to the applicant.
Please note you are advised to contact each MS separately to confirm their precise national submission requirements.
These applications should be emailed to applications@hse.gsi.gov.uk.
Do I have to submit to all MS at the same time?
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.
If I wish to make a label extension do I have to go through the original ZRMS?
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.
How much will I be charged for zonal applications?
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. This partial dossier fee will be a minimum of £7500 and 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.
Further guidance on our fee structure is given in the Applicant Guide noting that this is currently under revision and the fees for these applications may change at a later date.
What are the EU timelines for zonal authorisations?
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’ which is available on the Commission website. 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.
What are the UK timelines be for zonal authorisations?
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 (i.e. we will suspend the applications for the agreed commenting period). 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.
Applications where we are not the ZRMS will be evaluated in 120 days in line with the requirement in Regulation (EC) 1107/2009.
What happens if further information is required?
Regulation (EC) 1107/2009 states that MS shall set a period for the applicant to provide further information and this shall not exceed 6 months. Where we 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.
It will not be possible to ‘stop-the-clock’ for applications where we are not the ZRMS as the 120 day target cannot be extended.
What is the commenting period?
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.
In order to fulfil this regulatory requirement it is necessary to amend our current procedures. We will allow a 6 week commenting period for applications in the data-plus or data stream (including data fast-track applications) and a 2 week commenting for applications in the no-data stream. During this commenting period your application will be suspended and 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.
What happens if MS have differing opinions on technical issues?
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.
What happens if the ZRMS does not grant an authorisation due to a specific local need?
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.
Can I still make a two-stage applications?
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 14 June 2011, however, these will provide the UK view only. At the end 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 application. As these are being submitted ahead of the full product dossier these will be evaluated in the stream appropriate to the information submitted (i.e., if 5-batch data is submitted these will be in the data stream). We will allow MS 6 weeks to comment on these applications and at the end of the evaluation our assessment will be made available to other MS via CIRCA. If the new source if for a currently approved product then these will be evaluated in 60 days in accordance with Article 38 and subject to a 2 week commenting period. At the end of the evaluation the assessment will be made available to other MS via CIRCA.
Two-stage applications
Can I still fast-track applications?
Currently CRD have a process whereby each approval holder can request fast-tracking of one application each financial year. However, zonal applications for which a 'zonal surcharge' has been applied cannot be fast-tracked. Also zonal aplications where we are not the ZRMS cannot be fast tracked
Mutual recognition
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.
When can I apply for mutual recognition?
Authorisation holders can apply for mutual recognition of the same product, the same use and under the comparable agricultural practices when (Article 40(1)):
- the authorisation was granted by a MS which belongs to the same zone;
- for example a UK authorisation can be mutually recognised by Sweden however Denmark may only mutually recognise this same product from the UK and not Sweden to avoid the ‘domino’ effect;
- the authorisation was granted by a MS for use in greenhouses, or as post-harvest treatment, or for treatment of empty rooms or containers used for storing plant or plant products, or for seed treatment, regardless of the zone to which the reference MS belongs.
There are a number of cases for which mutual recognition is optional (Article 41(2)):
- an application has been submitted for an authorisation that has been granted in accordance with case 2 above;
- the product contains a substance that is included in the list of candidates for substitution;
- the application concerns a provisional authorisation;
- the application concerns a product that contains a substance that has been approved under the derogation of Article 4(7) (substances for which there are no alternatives).
Mutual recognition according to article 40(1) and 41 is also applicable to minor uses (Article 51(7)).
What information do I need to submit?
Your application will need to contain appropriate information so that we can determine whether the use of the product in the other MS is comparable to the proposed use of the product in the UK. Data do not need to be submitted in support of your application (and will not be evaluated if they are) as we will assess the comparability using the expert judgement of our specialists.
In support of your application you must submit the following (see The Applicant Guide for further information):
- This must 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; and
- A signed and completed application form ; and,
- One copy of the draft label for your product; and,
- A copy of the authorisation issued for the product in the other MS with a translation into English; and,
- A copy of the approved label for the product in the other MS with a translation into English; and,
- A declaration that the technical specification and formulation recipe of your product are the same as those for which approval has been granted in the other MS; and,
- Evidence that a Maximum Residue Level for the active substance(s) has been set in accordance with Regulation 396/2005/EC
Further information is available on the particular requirements for each area of the risk assessment and this is currently in the process of being updated.
How much will I be charged
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.
What are the UK timelines?
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.
Can I fast-track mutual recognition applications?
Fast-tracking of mutual recognition applications will not be permitted.
What aspects need to be addressed for each area of the risk assessment?
Details of the UK specific requirements which need to be addressed are provided in the Applicant Guide.
Appendix 1 - Definition of zones for the authorisation of plant protection products as referred to in Regulation (EC) 1107/2009
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
