The Applicant Guide: Voluntary re-registration work-sharing in the UK

Background

Voluntary re-registration work-sharing has been developed to facilitate the evaluation of the large number of product re-registration applications expected in the next few years in all Member States (MS). It is an initiative developed on a voluntary basis between competent authorities of MS in all three zones (Southern, Central and Northern) and is similar to the zonal application procedure included in Regulation (EC) 1107/2009 which will replace 91/414/EC.

The background and process is detailed in the EU Guidance Document which is available on the Commission website:

• Guidance document on a process for intra & inter-zonal work-sharing to facilitate the registration and re-registration of plant protection products following inclusion of an active substance in Annex I of council directive 91/414/EEC (SANCO/6896/2009).

In summary, the process is as follows:

• the applicant submits to all MS where they wish to re-register their products (the 'concerned' MS),
• one lead MS in each zone - the zonal RMS (ZRMS) - will complete the evaluation of a core assessment on behalf of and in advance of assessment by 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 by the ZRMS will be used by other MS in the zone as a basis for national regulatory decisions. The core assessment must reflect a Uniform Principle assessment 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.

What is the risk envelope approach and how shall it be used in the context of voluntary re-registration work-sharing

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 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).

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.

What types of products can be evaluated through this procedure?

The procedure can be used to re-register existing products and new product applications made before 14 June 2011. These procedures can be applied to products containing new and/or existing active substances. The only pre-requisite should be that all active substances in the product are included on Annex I.

Note that according to Article 80.5b of Regulation (EC) 1107/2009 re-registration of existing products will continue in accordance with Directive 91/414/EC. It should be noted however that from 14 June 2011 applications for new products will be assessed by the zonal procedure in Regulation (EC) 1107/2009 and further guidance on how to make applications under Regulation (EC) 1107/2009 and is available in the Applicant Guide.

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 Step 2 re-registration submission ‘deadline’ you should email CRD with information on the product(s) you wish to support through re-registration and your proposal(s) for ZRMS. CRD should be notified for all products where an application is intended in the UK.

In order for CRD to consider ZRMS requests the following information is required:

Product name (name(s) or product code(s), type of formulation, name and content of all active substances

• Applicant
• Intended zones and proposal for zonal Rapporteur(s) (ZRMS)
• Summary of intended uses in each MS – please complete table below:

You will receive an acknowledgment to all ZRMS requests and notifications 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 any products which are not being authorised in the UK

Do I have to submit to all MS at the same time?

By the Step 2 submission deadline applications should be submitted to all MS where an authorisation is to be maintained (in line with the EU Guidance Document). Where the UK are not the ZRMS these applications will be suspended pending the outcome of the ZRMS core assessment and once the core assessment is complete and available on CIRCA, the UK re-registration applications will be unsuspended and evaluation of the national addenda will commence.

What information do I need to submit?

When submitting voluntary work-sharing re-registration applications to the UK 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. 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.
• a completed application form (CRD 1)
• draft Registration Report Part A, detailing the risk management (and draft label) pertinent to the UK
• draft Registration Report Part B, detailing the core assessment submitted to the ZRMS and any national assessment
• 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

On completion of the evaluation 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.

How much will I be charged for voluntary re-registration work-sharing applications?

Applications 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.

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 each area of the risk assessment. If additional data/fate modelling 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.

What are the timelines?

Applications where we are the ZRMS will be streamed as data-plus applications with a 30 week target for processing. Applications where we are not the ZRMS will be streamed as data applications with an 18 week target which starts when you notify CRD that the ZRMS assessments are available on CIRCA. Fast tracking of these re-registration applications will not be an option due to the complexity of the evaluations.

Please note that these procedures relate to the voluntary work-sharing procedures for re-registration applications and not the zonal application procedure in Regulation (EC) 1107/2009. Further information on how to make applications under Regulation (EC) 1107/2009 is available in the Applicant Guide.