Regulatory Update: 06/2010
Issued: 23 February 2010
Introduction & Background
This Regulatory Update explains the new procedures in place to allow the submission and assessment of confirmatory data. These were recently clarified via the Commission guidance document of the same name (SANCO/5634/2009 rev. 3), which was noted by all MS at the Standing Committee on the Food Chain and Animal Health at their meeting on 2 October 2009. You should refer to the original document on the Commission website via the following link http://ec.europa.eu/food/plant/protection/resources/publications_en.htm#council.
What are confirmatory data?
A number of active substances are included on Annex I of Directive 91/414/EEC with a requirement for confirmatory data specified in Part B of the Inclusion Directive.
The confirmatory data may be either Annex II data (e.g. mancozeb DNT study), or more commonly Annex III data and associated risk assessments (e.g. bird and mammal risk assessment). The confirmatory data may also be required to fully establish the reference technical specification.
Note that whilst the confirmatory data are often based on the ‘data gaps’ listed in the EFSA conclusions (List of studies to be generated, still ongoing or available but not peer reviewed), these data gaps should not be considered as confirmatory data as such. The procedures in the guidance document and this Regulatory Update refer only to the specific confirmatory data requested in Part B of the Inclusion Directive.
Who should submit the data?
The notifier (who requested the original inclusion) is responsible for the submission of the confirmatory data (as stated in the inclusion directive). Where there was a task force for inclusion, the task force should determine which members are responsible for submission of the confirmatory data. There is no requirement for alternative notifiers to submit confirmatory data.
When should the data be submitted?
Notifiers should check Part B of the Inclusion Directive for details. The deadline is usually two years after entry into force, but may alternatively be specified at a particular date. Where the confirmatory data relate to establishing the reference technical specification, the submission date may be specified at the entry into force date.
Sometimes no specific deadline is set, instead the submission is ‘tied’ to the completion of EU guidance. In this case the notifier should discuss submission with the RMS.
In some cases there may be more than one deadline – each specified for different elements of the confirmatory data.
To whom should the notifier send the confirmatory data?
Whilst the Inclusion Directive specifies that the data should be sent to the Commission, this is clearly not practical. Guidance Document SANCO/5634/2009 rev. 3 thus clarifies that the submission should be sent to the Commission (who oversee the process), the RMS (who assess the data) and all other MS (to allow them to contribute to the commenting process).
What form should the submission take?
There is no form or specific template to use. The notifier’s submission must make clear how the data submitted address the outstanding issues (e.g. via a summary document). The notifier should restrict their assessment specifically to the areas required as confirmatory data in Part B of the Inclusion Directive.
The notifiers submission should refer to the uses/GAPs considered in the Annex I inclusion decision.
The data and summary document must be submitted in electronic format. This could be in the form of a DAR addendum (since this is the format that will be used by the RMS).
How does the confirmatory data link with the Step 2 submission?
Whilst the submission of confirmatory data is (in many cases) required at the same time as the administrative deadline for submission of Step 2 re-registration [Annex III] submissions, notifiers should not combine the two submissions. There must be clear separation between the confirmatory data and Step 2 submissions  (noting they may reflect different uses/GAPs). This is because they are assessed via two different procedures.
However, the notifier should clearly cross reference the data submitted in both cases, to prevent duplication of assessment by the competent authority(s).
Will there be a charge for the assessment of confirmatory data?
The UK will charge a partial dossier fee, calculated on the basis of the amount of data submitted and the type of assessment required.
The confirmatory data submission will be considered by the weekly sift in the usual way. If there is a significant overlap between the confirmatory data submission and re-registration (or new product) submission, it may be possible to avoid duplicate charging of fees if you make this clear in both submissions.
Please note you are advised to contact each MS separately to confirm charging of the assessment of confirmatory data.
What are the timescales for assessment?
The RMS will aim to prepare a DAR addendum within 6 months of the deadline for submission of the confirmatory data, alongside proposals on the acceptability of the confirmatory data. There is then a short (6 weeks) commenting period to allow all affected MS and EFSA to comment. The notifier will be invited to participate in that commenting period.
Ideally the UK would prefer that as RMS (assessing the confirmatory data) we should also be ZRMS (for the Step 2 re-registration/new product assessment), so that we can ensure that the two projects are well co-ordinated, ideally with a single project manager. Where the UK are not both RMS and ZRMS (and this may not always be possible), we will liaise closely with the other MS to ensure no duplication of assessment and timely delivery.
The timescales for the later stages of the process are less clearly defined, although it is hoped that the Commission will take forward any necessary regulatory action at the next possible Standing Committee on the Food Chain and Animal Health.
It is important that the assessment of the confirmatory data is conducted in a timely way, since the (later) re-registration assessments may be dependent on its outcome.
What will be the outcome of assessment?
The possible outcomes are detailed in SANCO/5634/2009. It is anticipated that (since they were specified as confirmatory data), there will be few implications from these data. Where any adverse issues are raised we will liaise with notifiers (and if necessary other approval holders) at the earliest opportunity.
Do confirmatory data attract protection?
No. Since no formal decision will be taken to maintain (or vary) the inclusion, Article 13 3 d does not apply, and no EU data protection will be afforded to the data. Thus other approval holders have no obligation to provide the data.
 Note from 2/10/2010, Annex III Step 2 re-registration submissions should be in the format of a draft registration report – see Guidance document on the presentation and assessment of Annex III dossiers SANCO/6895/2009. You can use the new format before that date if you wish
 The ZRMS conducts the core assessment of Annex III submissions on behalf of other MS in the zone - see SANCO Guidance on worksharing SANCO/6896/2009
If you have any questions about these procedures, please contact:
Darren Flynn by email (firstname.lastname@example.org) or on the telephone 01904 455898 or in writing.
Lesley McCartney by email (email@example.com) or on the telephone 01904 455760 or in writing.