Background
Efficacy testing and analysis must be carried by ‘Official’ or ‘Officially Recognised’ efficacy testing organisations. 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).
Full details of the requirements are given in following sections of EC directive 91/414 (as amended by 93/71).
- Sections 2.1 to 2.4 of the Introduction to Annex II
- Sections 2.2 to 2.4 of the introduction to Annex III
- Sections 6.2 to 6.7 of both parts A and B of Annex III
The UK introduced their scheme in October 1997. Efficacy data from trials in the UK which commenced after 1 January 1998 will only be accepted by CRD from Officially Recognised organisations. In other EU Member States, Official Recognition/ GEP schemes 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.
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 the UK. Full details can be found in our guidance on Experimental Permits.
To Apply for Official Recognition
The application form and associated guidance notes for UK certification of 'Official Recognition' are available as either pdf or MSWord files (see "Further Information"). The MSWord document can be filled in electronically and e-mailed with relevant supporting information to: applications@hse.gsi.gov.uk. However, please note that whilst electronic versions of the supporting information are acceptable a signed hardcopy of the application form (or an electronic one with a certified and encrypted digital signature) must be received before we can issue a certificate.
Contacts
General enquiries can be made to Paul Ashby; Tel: 00 44 (0)1904 455794, or by e-mailing: applicant-enquiries@hse.gsi.gov.uk
