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Official Recognition: introduction

Background

It is a requirement of Regulation EC No 1107/2009 as it applies in both Northern Ireland and Great Britain that the tests and analyses required to demonstrate the efficacy of plant protection products must be conducted by 'Official' or 'Officially Recognised' efficacy testing organisations. The data to demonstrating efficacy in support of plant protection product authorisations are outlined in Section 6 Part A and Part B of Commission Regulation (EC) No 284/2013 as it applies in Northern Ireland and Great Britain.

Efficacy tests and analyses include; field, glasshouse or laboratory trials and tests to determine the effectiveness and crop safety of plant protection products, plus its safety to other crops, plants and beneficial organisms. Official Recognition is also known as Good Experimental Practice (GEP).

The requirements that organisations conducting efficacy trials within the EC must satisfy in order to become 'Officially Recognised' are outlined in paragraph 3.2 and 3.3 of the Annex of Commission Regulation (EC) No 284/2013 as it applies in Northern Ireland and Great Britain.

The UK introduced their 'Official Recognition of Efficacy Testing Organisations and facilities' (ORETO) scheme in October 1997. Efficacy data generated from trials conducted in the UK which commenced after 1 January 1998 will only be accepted by HSE from Officially Recognised organisations. Official Recognition/GEP schemes of other countries came into operation at different dates. It is the responsibility of applicants to ensure that efficacy data to be submitted in support of product registrations have been generated by 'Officially Recognised' facilities/organisations and is supported by appropriate evidence.

Please note: Companies undertaking efficacy trials work must also ensure that they comply with the statutory requirements for carrying out research and development work involving the release into the environment of an approved or unapproved active substance and/or pesticide that is not approved for the proposed use in Northern Ireland and Great Britain. Full details can be found in our guidance on Trials Permits.

To apply for official recognition

The application form (ORET1) and associated guidance notes (ORET2) for certification of 'Official Recognition' in NI and GB.). The form can be filled in electronically and emailed with the required relevant supporting information to: [email protected]. An electronic submission is preferable.

Renewals

HSE will contact the registered facility 5 months prior to the expiry date of the current certificate reminding them of the expiry date and inviting that organisation to submit a new application if certification is to be retained. No further reminder will be sent. Failure to submit a renewal application will result in termination of the OR status of the facility at the expiry date of the existing certificate, at which time the name of the facility will be removed from the published list of testing facilities.

Upon receipt of a completed application an invoice will be sent as applications cannot be started or certificates issued unless payment has been received (the current fees page provides further information). To ensure unbroken certification, HSE must receive the application for renewal at least8 weeks before the expiry of the current certificate. All parts of the application form must be completed. For a renewal it is particularly important to complete Section 5, where a list of all efficacy work which could be used in support of product authorisations undertaken in the last 2 years is required, and also Section 6 where an explanation is required of the steps taken to address any issues raised in the last inspection report.

Contacts

The contact page. provides information on how to contact us.

Further information

Updated 2021-03-30