Introduction
The UK Official Recognition scheme currently recognises three categories trials and tests conducted by recognised organisations;
- Agricultural/Horticultural trials/tests
- Stored crops trials/tests
- Vertebrate controls/trials tests
Following consultation with a number of organisations developing biological based plant protection products, it has been decided to introduce a further category to the UK scheme for ‘Official Recognition’, that of ‘Biologicals and Semiochemicals trials/tests’.
This will allow organisations conducting work on micro-organisms (bacteria, fungi, viruses etc) or semiochemicals (such as pheromones) to apply for Official Recognition in a more limited and specialist category of work than was previously possible. The existing categories will continue to encompass appropriate work that may be done with biologicals or semiochemicals so the companies that are Officially Recognised in one of the existing categories will also be permitted to conduct registration studies on ‘Biologicals’ or semiochemicals.
Official Recognition requirements
Efficacy testing and analysis for the registration of plant protection products conducted in the UK must be carried by ‘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 Council Directive 91/414/EEC (as amended by Commission Directive 93/71/EC).
- 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 scheme will from now on include the following four categories of efficacy testing:
- Agricultural/Horticultural trials/tests: in addition to agricultural and horticultural crops (outdoor and protected), this also includes the following situations; amenity, home and garden, forestry, aquatic, land not intended to bear vegetation (including industrial situations), space and structural applications in interior landscapes, set-a-side, seed treatments and biological pesticides (Including biopesticides and semiochemicals).
- Stored crops trials/tests: includes pre or post-harvest applications to grain, vegetables, fruit or other propagules, where assessments are carried out during or after storage, as well as space and structural applications in storage facilities.
- Vertebrate control agents trials/tests: includes vertebrate killing agents in a plant protection situation and vertebrate repellents
- Biologicals and Semiochemicals trials/tests: Include all tests on preparations or active substances that include micro-organisms, as defined in Part B of Annex III of Directive 91/414, or using semio-chemicals to modify the behaviour of pests.
Definition of Biologicals and Semiochemicals
‘Biologicals’ for the purposes of the UK scheme for ‘Official Recognition’ are preparations or active substances consisting of micro-organisms, including viruses. The term micro-organism is defined in Council Directive 91/414/EEC (as amended by Commission Directive 2001/36/EC) as follows: A microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material. The definition applies to, but is not limited to, bacteria, fungi, protozoa, viruses and viroids. It does not include multicellular organisms, such as nematodes or insects.
Semiochemicals for the purposes of the UK scheme for ‘Official Recognition’ are chemicals such as pheromones, kairomones and allomones that act to modify the behaviour of pests ot their natural enemies.
Other ‘Bio-Pesticides’, such as plant, fungal or bacterial extracts, naturally or synthesised metabolites or toxins produced during growth of micro-organisms will need to be certificated under one or more of the original three categories (see above) depending upon the specific area of use.
To apply for Official Recognition in the ‘Biologicals trials/tests’ category
All current UK certification for ‘Official Recognition’ will automatically also allow efficacy testing of ‘Biologicals’. However, if any currently certificated UK efficacy testing facility or organisation wishes to add ‘Biologicals trials/tests’ to their current certification, PSD will re-issue their certificate, including this new category, on request. There will be no additional fee for this.
If you are a new applicant wishing to gain ‘Official Recognition’ for efficacy testing in the category of ‘Biologicals and Semiochemicals trials/tests’, you will need to complete the relevant application form. The application form and associated guidance notes for UK certification of 'Official Recognition' are available as either pdf or MSWord files. The MSWord document which can be filled in electronically and e-mailed to: offrec@hse.gsi.gov.uk
Contacts
General enquiries (including those for contact details of UK 'Officially Recognised' organisations) and enquiries on how to receive a copy of the MSWord application form can be made to Paul Ashby; Tel: 01904 455794 (International: + 44 1904 455794), Fax: 01904 455722 or e-mail: offrec@hse.gsi.gov.uk
Update Reference
Regulatory Update: 11/2006
Issued: 11 April 2006
