uk national authorisations fay beacon pesticides branch

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UK NATIONAL AUTHORISATIONS Fay Beacon Pesticides Branch

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UK NATIONAL AUTHORISATIONS

Fay BeaconPesticides Branch

Topics

• Authorisation types and numbers

• Legislation

• Zonal process

• Applications to CRD

• Further information

Authorisation types

• Authorisations for products used in agriculture, horticulture, forestry, home garden

• Parallel permits (free trade within EU)

• Experimental permits (for R&D)

• Extensions of use (minor use – no efficacy)

• Emergency authorisations

• Adjuvants

August 2010

0

100

200

300

400

500

600

700

800

900

1000

Herbicides Insecticides Fungicides Others

Professional

Parallel Imports

Amateur

UK authorised products

3385 products (2735 Professional and 650 Amateur) Based on 270 active substances

Legislation

Applies directly in all MS from 14 June 2011

Applications received before 14 June 2011 still 91/414 (or national rules)

1107/2009 sets out procedures for most authorisation types. Adjuvants assessed under national rules as detailed rules not yet available.

Regulation 1107/2009

• Sets out assessment procedures and timelines

• Applications processed zonally

- 3 zones (North, Central, South)

- 1 zone for indoor use & seed treatments

• Gives rules for data protection

• Data requirements/ assessment standards currently same as 91/414

1107 zones

The Zonal Process

• Assessment by 1 MS (zonal RMS) comments by others (concerned MSs). Only national issues assessed by concerned MS

• MS co-operation essential

Developed by MS & COM

Agrees process for implementation including zonal steering committees

The Zonal Process - procedures under development

• Main difference between assessment by ‘concerned MS’ and Mutual recognition is timing of submission.

• EU database for management of product applications under development

• Approach to risk assessment not harmonised - National assessment required

• Choice of zonal RMS is industry’s, but high MS workloads making it difficult to agree zonal RMS

Application types

• Re-registration

- workload peaks 2011- 2015

- zonal procedures but national timelines

• New products & uses

- zonal procedures and timelines

- includes minor uses and mutual recognition

• Amendments (e.g. name change) and withdrawals

• Parallel permits

• Experimental permits

• Adjuvants (national rules)

No MS comments

Total apps. 1500-2000 each year

Overview of zonal timelines

Submission deadline

Completion deadline

0 m 12 m

- 6 m

Applicant alerts zonal reps,

pre-submission meetings etc

ZRMS initialevaluation

8 m 6 weeks

Comments by other MS

2.5 m

ZRMS finalEvaluation and authorisation

Identification by ZRMS of further requirements

6 m+ 120 d

‘Following’ Zonal

(and MR) deadline

Clock stops for up to 6 months where further data requested (Timelines also suspended if an equivalence check is required)

(+6 m)

APPLICATION

APPROVALS ADMIN

FINANCEREGISTRY

APRROVALS ADMIN FINANCE

SIFT

RESPONSIBLE OFFICER

SPECIALISTS

RESPONSIBLE OFFICER

APPROVALS ADMIN

Request clarification

Recommendation

Govt. Depts.

SIFT

EVALUATION

Further Information

• CRD Web Site

http://www.pesticides.gov.uk/– Public Information – Guidelines

• European Union http://ec.europa.eu/food/plant/protection/evaluation/index_en.htm

• ESFAhttp://dar.efsa.europa.eu/dar-web/provision - active substances