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Review of the Regulatory Process and Procedures for Plant Protection Products

Regulatory Update: 11/2016
Issued: 17th June 2016

Background 

HSE has conducted a review of its regulatory procedures for the consideration of plant protection product applications under Regulation (EC) No 1107/2009.

The key objective of the review was to improve the efficiency of the processes and procedures in order to increase the predictability in the delivery of regulatory decisions and ensure HSE fully recovers the costs of all work involved in the evaluation process.

Information on the new process was highlighted in the e-bulletin (07/2016) on 24th March 2016: Initial Guidance on Changes to the regulatory process and procedures for plant protection products.

This Regulatory Update outlines further details to the new procedures for processing applications. The new processes and procedures were due to apply from 1 June 2016. In order to give applicants sufficient time to review the information, the implementation of the new process has been delayed until 29 June 2016.

From 29 June 2016

1. Changes to application streams and timelines

HSE will no longer define application types and timelines in terms of the quantity of data submitted (no data, data, data plus etc); all applications and timelines will now be defined in accordance with the Regulation.  Table 1 details the revised application streams that will be implemented as a result of the review.  The new streams and deadlines will come into effect from 29 June 2016.

Table 1: New application streams to be implemented as a result of the review

Evaluation Type

Article Number of Regulation 1107/2009

Timeline

Comment

Authorisation or amendment of an authorisation

33, 34, 51* and 54

12 months

Timeline defined by legislation

Additional information request

33, 47 and 51*

-

A total of 6 month given for the provision of further information

Following zonal, mutual recognition and Low risk products

33, 40 and 47

120 days

Timeline defined by legislation

Art 43 Renewals

43 and 51*

26 weeks

Timeline defined by legislation/guidance

Parallel permit

52

45 days

Timeline defined by legislation

Import Tolerance

Regulation (EC) No 396/2005

12 months

No timeline in Regulation – align with timeline for other applications

Emergency authorisations

53

As agreed with HSE

Once we have accepted an application as an emergency, we will contact the applicant to discuss the date by which the authorisation is required and arrange a suitable processing target time for your application.

Whilst, in moving to the legislative deadlines, the timelines for some of the current streams have increased, HSE will endeavour to complete all applications as soon as possible, and for certain application types this is likely to be well within the legislative deadline. Applications of a purely administrative nature, for example, will be processed within 6 weeks.  HSE will still accept cases for urgent consideration of applications eg urgent extensions of authorisation for minor uses (EAMUs). 

2.  Changes in procedures

Application sift

A new, more detailed, sift procedure will be introduced on 29 June 2016, in order to further improve the quality of the applications accepted for evaluation.  An initial completeness check of the application (validation check) will be undertaken to ensure that all the required documentation has been submitted with the application. 

If the application is accepted following the validation check, where appropriate (eg for lead zonal, mutual recognition and Article 43 product renewal applications) it will then undergo a new, more substantive detailed technical sift, to ensure that the application is of sufficient quality to move on to the detailed evaluation.  A fee of £2101 will be charged to cover both the validation check and the detailed technical sift.

If the application passes the new detailed technical sift, it will be charged the appropriate specialist module fees and the detailed evaluation will begin.

If the application fails the detailed technical 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 incurring a further fee of £2101.

Improving the quality of applications accepted for evaluation will expedite the evaluation of applications, increasing the predictability in delivery of regulatory decisions. It will also ensure applicants receive early feedback on their application where it does not meet the regulatory requirements without being charged for a full evaluation.

Requests for additional information

Currently, HSE write to applicants to request additional information when deficiencies or gaps are identified in each specialist area.  This often results in multiple requests for additional information.  From 29 June 2016 HSE propose to limit this to only two requests for further information, the first following the chemistry, residues, toxicology and environmental fate assessment, and the second following the operator exposure, ecotoxicology and efficacy assessment.

The Regulation allows a maximum period of six months to provide additional information, so under the new procedure 3 months (13 weeks) will be allowed for applicants to respond to each of the two requests for additional information.

3.  Application forms

Revised application forms reflecting the new application streams are now available on the HSE website. These should be used where possible for applications submitted from 29 June 2016, but must be used for all applications from 3 October 2016. 

As well as the revision to the current application forms, HSE has introduced two new application forms. A CRD8 application form must be completed for technical equivalence applications and a CRD-R application form must be completed for renewal of authorisation (Article 43) applications.

4. Electronic submission of information

Until now, some information submitted in support of an application such as letters of access to supporting data and compatibility assurance statements had to be submitted as hard copy.  This need for hard copy resulted in information being submitted at different times to the application, and made it difficult and time-consuming to collate the entire application and present to the weekly applications sift.  This is unproductive and can lead to a delay in processing the application.

Changes in the process

In future, HSE will accept the application and all supporting information in electronic form.  Duplicate hard copy documents must not be sent if electronic copies are submitted.  Accepting electronic information in this way will make it easier for applicants to submit complete applications, and avoid non-acceptance due to incomplete submissions.

What action is required by applicants?

Each application should be received by HSE in a single submission.  If information needs to be supplied from more than one source, multiple submissions should be co-ordinated, cross-referenced and submitted to reach CRD to be processed together in the same weekly sift.  Where this does not happen, the application may be deemed incomplete and rejected.

5.  Formulation comparisons and technical equivalence assessments

Applications for formulation comparisons and technical equivalence assessments will be processed under Article 33 of Regulation (EC) No 1107/2009 and the associated timelines. The general process of considering two stage applications will be the same as they are now.

6.  Further information on the new processes

An overview document of the new process is available on the HSE website along with relevant FAQs. 

Links to Further Information and Application Forms

Overview of new guidance is available on  the Applicant Guide Contents Page.

Updated 2017-01-06