Chemicals Regulation Directorate,
Environment Branch, Room 108, Mallard House,
Kings Pool, 3 Peasholme Green, York. YO1 7PX
Tel No: (01904) 455794 Fax No: (01904) 455711
E-mail for applications*: applications@hse.gsi.gov.uk
E-mail for enquiries: applicant-enquiries@hse.gsi.gov.uk
CRD website: www.pesticides.gov.uk
*applications from Northern Ireland must be sent to the address
specified in section 9 of this form.
Notes for
Guidance
Official Recognition of Efficacy
Testing Facilities or Organisations
(under Commission Directive 93/71/EEC)
Background
It is a requirement of Commission Directive 93/71/EEC, which
amends Council Directive 91/414/EEC, that the tests and
analyses required to demonstrate the efficacy of plant protection
products must be conducted by ‘Official’ or ‘Officially Recognised’
testing facilities or organisations. The data to be generated
demonstrating efficacy in support of plant protection product
authorisations are outlined in Annex Ill of Commission Directive
93/71/EEC.
Efficacy trials/tests for those products that fall within the scope of
the Biocides Directive 98/8/EEC, do not require to be carried out
by 'Officially Recognised' efficacy testing facilities or
organisations.
The requirements that organisations conducting efficacy trials
within the EC must satisfy in order to become ‘Officially
Recognised’ are outlined in paragraph 2.2 of Annex II of
Commission Directive 93/71/EEC. Organisations must report to
the national authority all the necessary details to demonstrate
that they satisfy these requirements. In addition, each Member
State (MS) is required to organise regular inspections of
organisations to verify compliance with these requirements.
Organisations must accept such inspections at any time. This
form has been laid out to reflect paragraph 2.2 of Annex II of
Commission Directive 93/71/EEC and is divided into relevant
sections.
Further guidance on Good Experimental Practice (GEP) can be
found in the latest version of EPPO Guideline PP 1/181, ‘Conduct
and reporting of efficacy evaluation trials.’
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COMPLETION OF THE FORM
1
Facility/Organisation details
In most cases you will only need to complete one application
form. However, you may need to complete more than one form if
the management of the efficacy related work is not centrally coordinated. That is, all trials conducted on different sites must be
carried out to the same Standard Operating Procedures (SOPs)
and protocols, with a single officer in overall control (as identified
in SOPs and protocols), who must sign the form as the
responsible officer.
At question (f) you are asked to indicate which categories of
‘Official Recognition’ you wish to apply for. This should be based
on the type of trials/tests carried out by the facility/organisation.
The categories divide into the four major disciplines, based on
pesticide application technique. Ticking more than one box is
permitted (and will not increase the fee to be paid), but evidence
will be required to demonstrate proficiency in each category
selected. The categories ‘ticked’ will appear on the ‘Official
Recognition’ certificate, (see Section 8 for advice on adding
further categories at a later date.)
The categories are:
●
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.
●
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: includes 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.
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 or their
natural enemies.
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Other “Bio-pesticides” such as plant, fungal or bacterial extracts,
natural or synthesised metabolites or toxins produced during
growth of micro-organisms will need to be certificated under one
or more of the other three categories (see above) depending
upon the area of use.
Note: laboratory, glasshouse or semi-field studies/screens must
be included in the relevant categories above.
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 “Biological trials/tests” to their current
certification, CRD will re-issue their certificate including this new
category, on request. There will be no additional fee for this.
2
Facility/Organisation details
You must provide:
Directive requirements
“have at their disposal
sufficient scientific and
technical staff, having the
necessary education,
training, technical
knowledge and experience
for their assigned
functions”
“have at their disposal
appropriate experimental
fields and, where
necessary glasshouses,
growth cabinets or storage
rooms. The environment in
which the tests are
undertaken shall not
invalidate their results or
adversely affect the
required accuracy of
measurements
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(a)
Names of current permanent staff. This must include all
staff involved in efficacy testing and report writing, from
laboratory studies through glasshouse and semi-field
studies to field testing, including all out-stationed/off-site
staff. Also required in conjunction with this list is a
description of their relevant formal qualifications and/or
previous relevant experience.
(b)
Current details of the organisation and functional
management relationships between staff. This could be
provided in the form of an organisational chart or
organogram. This will provide evidence to demonstrate
appropriate management control, and that one person is
ultimately responsible for overall control efficacy tests.
(c)
A list of current permanent facilities/structures (including
owned, leased or rented field testing sites). This must
include: offices; equipment storage facilities; and facilities
where trials/tests are conducted. Do not include locations
of field trials carried out on land belonging to
farmers/growers which are not owned by, officially
leased to or rented by the organisation.
(d)
The name of the person responsible for the GEP archive
must be provided.
(e)
The name(s) of the person responsible for the chemical
store(s) must be provided.
Note:
Subsequent changes in management control may require a
new application. Details of other changes within sections
(a) to (e) may be requested by CRD prior to or at
inspection.
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3
Equipment, maintenance and calibration
Directive requirements
“have at their disposal
suitable items of
equipment required for
correct performance of the
tests and measurements
which it claims to be
competent to carry out.
This equipment shall be
properly maintained and
calibrated where
appropriate before being
put into service and
thereafter according to an
established programme"
(a) to (e) Requires provision of evidence that the facility or
organisation have suitable items of equipment to carry out
efficacy testing within the categories designated in section
1(g). A number of options, with tick boxes, are included on
the form, plus one category where provision of a list is
required. Please tick all relevant boxes. In 3(e) where a list
is required, this should only include equipment that
requires regular calibration and maintenance. Examples
of such equipment are: spore samplers; vacuum samplers;
photo-analytical equipment; centrifuges; controlled
environment rooms etc. Information on numbers of pieces
of equipment is not required on the form, but see Section
9(c) with respect to maintenance and calibration records.
Rented or hired equipment requiring regular calibration and
maintenance must be included in this list. Do not include
cars, tractors or other vehicles used for transporting
such equipment.
(f)
4
Standard Operating Procedures
Directive requirements
“make available to relevant
personnel operating
procedures and protocols
used for trials/tests”
(a) to (d) Requires a list of all SOPs relevant to efficacy testing and
copies of those specific SOPs relating to:a) the writing and maintenance of SOPs
b) chemical control procedures and
c) procedures for archiving raw data/other records relating
to efficacy work
"maintain records of all
original observations,
calculations and
transformations, calibration
records and the final test
report for as long as the
product is authorised by
the community”
5
Is an assurance statement, plus tick box, requiring
confirmation that equipment outlined in 3 (a)-(e) is regularly
calibrated/maintained. This will be verified at the inspection.
Trial/test protocols and detailed trials/test information
If your organisation is simply renewing its existing certification
(e.g. renewing for the same categories and other aspects remain
unchanged), ignore part (a) and move to part (b). If as a new
applicant you have yet to undertake any efficacy trials/tests,
please seek assistance from CRD.
Directive requirements
“make available, where
requested by the
competent authority, prior
to the commencement of a
trial/test, detailed
information on it,
containing at least its
location and the plant
protection products
included in it”
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(a)
Requires a recent copy of a trial/test protocol/study plan,
associated raw data and final report. Organisations vary in
their reporting methods, but what is required is an example
of the information used to compile reports, efficacy overview
or biological assessment dossiers for submission to CRD.
(b)
Requires a list of all efficacy work, which could be used in
support of product approvals/authorisations undertaken in
the last two years.
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6
Re-newal applications
If the application concerns the renewal of certification, please include in the covering letter an
explanation of the steps taken to address any issues raised in the last inspection report.
7
Payment of fee
Details of current fees can be found on the CRD website (www.pesticides.gov.uk).
On receipt of your completed application, CRD (or DARD for organisations based in Northern
Ireland) will raise an invoice for the appropriate fee and send it to your organisation for payment.
Work on the application will not commence until payment of the invoice has been received.
8
Declaration
.
A signature is required to certify that all the details contained in the application form are correct.
Photocopies of signatures are not acceptable. All enclosures should be signed and dated.
You are advised to keep a copy of your completed form and enclosures before sending them off.
(A warning has been included in the declaration regarding falsification of information.)
9
Address for submissions
.
Applications from organisations based in England, Scotland and Wales should be sent to CRD
using the contact details specified at the top of this guidance document.
Applications from organisations based in Northern Ireland must be sent to the Department of
Agriculture and Rural Development (DARD) using the following address:
Deborah Currie
Department of Agriculture and Rural Development (DARD) Room 652,
Dundonald House,
Upper Newtownards Road,
Belfast,
BT4 3SB
Tel: 02890 524728
e-mail: deborah.currie@dardni.gov.uk
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FURTHER INFORMATION
10 Issue of an ‘Official Recognition’ Certificate
Satisfactory completion of this form and payment of the fee [see section
7], will result in ‘Official Recognition’ of the efficacy testing facility or
organisation. Within eight weeks of receipt of payment and the
completed form demonstrating compliance, a certificate will be issued,
confirming ‘Official Recognition’ within the categories requested. If any
further information or clarification is required, the facility/organisation will
be given eight weeks to provide a satisfactory response. If no satisfactory
response is received and compliance in any of the categories cannot be
demonstrated, these categories will not appear on the certificate. If
compliance cannot be demonstrated in any of the categories requested,
a certificate will not be issued and no refund will be given.
‘Official Recognition’ will be for a period of five years. During the period
of recognition an inspection of the facility/organisation will be carried out,
by CRD’s inspection team, in order to verify the details on the application
form. The inspection will take place on an agreed date, when ‘key’
personnel in the facility/organisation are available. A written report
confirming the findings of the inspection will be sent to the
facility/organisation within eight weeks. ‘Official Recognition’ will be
confirmed after a successful inspection.
Where the inspection discovers certain deficiencies which do not
compromise the quality of the work, 'Official Recognition' certification
may be deferred. Where this occurs, rectification of these deficiencies
must take place within a specified timescale, for certification to continue.
Where major deficiencies which could compromise the quality of the
work are identified, the facility/organisation will be informed that they
have failed the inspection. The facility/organisation will be given a period
to correct those deficiencies (normally eight weeks). Once the
deficiencies identified during the initial inspection have been satisfactorily
addressed, a re-inspection will take place, [see the current fees
information on the CRD website for the re-inspection fee]. Following a
successful re-inspection, ‘Official Recognition’ will then be given from the
time of that re-inspection until the expiry date on the original certificate.
Revocation of ‘Official Recognition’ will occur if the facility/organisation
fails to comply with the requirements within the specified timescale.
There will be no refund to applicants where ‘Official Recognition’ is
revoked.
The addition, at a later date, of any further categories (under Section 1(f)
of the application form) will be subject to a new application, including an
inspection, and will attract a further full fee. This is necessary in order to
demonstrate that the particular requirements outlined in paragraph 2.2,
Annex II of Commission Directive 93/71/EEC have been satisfied. The
only exception to this will be the addition of the biological/semiochemicals
category to an existing certificate, which will be performed free of charge
(see section 1 above).
A list of ‘Officially Recognised’ facilities/organisations will be held by CRD
and updated periodically on the CRD website.
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Note: CRD requires prompt notification of any details of company
mergers, restructuring or name changes. The information must
include dates when such changes came into force, together with
any other relevant details (i.e. a new organogram, details of any
changes to management structure and personnel, CV’s, etc.). Where
such changes do not require a new application, a new certificate will be
issued as appropriate, free of charge.
11
Information that must be available at the time of an ‘Official Recognition’
inspection
All details that constitute an efficacy testing programme must be
available for inspection by CRD if required. Guidance on the types of
information required is detailed in (a) to (j) below. The extent and nature
of the information required at inspection will only become apparent
during the inspection of the facility/organisation. As a result, this may
require the provision of examples of records or all such records, in any or
all of the items detailed in (a) to (j) below.
(a)
An up to date list of all permanent and temporary staff involved
in efficacy testing.
(b)
Copies of all job descriptions, relevant qualifications, previous
relevant experience and training records for all permanent and
temporary staff associated with efficacy trials. Details of training
programmes for such staff.
(c)
Copies of all equipment calibration and maintenance records.
(d)
Copies of all efficacy related Standard Operating Procedures.
(e)
Copies of all efficacy related trial/test protocols/study plans, raw
data and reports.
(f)
Evidence of possession of relevant EPPO or CRD guidelines
associated with efficacy trials/tests.
(g)
Evidence of archiving facilities for all information relating to
efficacy trials/tests.
(h)
A list and details of all efficacy trials/tests for registration
purposes.
(i)
Evidence of a chemical store control system and associated
records.
(j)
Evidence that where certain phases of efficacy trials/tests are
sub-contracted, these facilities or organisations work to the
requirements of Commission Directive 93/71/EEC.
NB: other information relating to the execution of efficacy testing may be
required during the inspection.
Items (a) and (b)
●
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The Directive requires that the facility/organisation demonstrate how
those staff involved in efficacy testing are suitably qualified to carry
out their jobs. This can be done by giving examples of job
descriptions, relevant qualifications and training programmes for each
grade/job title of staff involved in efficacy testing. This will be dealt
with as part of the inspection.
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Item (c)
●
Calibration and maintenance records should include details of what
was done, by whom and when (i.e. they should summarise the
operations carried out, clearly specify the piece of equipment, and be
signed and dated). Where multiples of identical equipment are used,
these should be uniquely identified.
Item (d)
●
SOPs should include reference to all supporting documentation (i.e.
relevant EPPO guidelines, expert keys and manuals). They should
also include sufficient detail to enable the task to be successfully
undertaken. This is especially relevant to SOPs relating to application
and assessment methodologies.
Item (e)
●
Assessment sheets should be signed and dated, and include the type
of assessment undertaken. Application sheets should refer to the
equipment used and any unique identification code.
Item (f)
●
Copies of CRD efficacy guidelines are available on our website or can
be obtained on request from the Chemicals Regulation Directorate
(Environment Branch) at the address given on page 1. EPPO
guidelines are available electronically. Further details are on the
EPPO website: www.eppo.org
Item (h)
●
A list and details of any completed or ongoing efficacy trials/tests for
registration purposes must be available when requested or at the time
of inspection. As a minimum this must include, the trial/test codes,
locations of the trials/tests, the crop (if applicable), the intended
purpose and the plant protection product(s) used.
Item (i)
●
A system for the control of chemicals must be evident for the chemical
store. As a minimum this should include a recording system, based
on; the unique identification of chemical samples, a booking in/out
system, and a system of chemical disposal.
Item (j)
●
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Sub-contracting certain operations (e.g. plot drilling, harvesting, potato
cyst nematode counts, etc., but not qualitative assessments) to non‘Officially Recognised’ organisations is acceptable, both for planned
operations and under emergency circumstances. However, it is the
responsibility of the 'Officially Recognised' facility or organisation to
ensure that the sub-contractor meets the requirements detailed in
Directive 93/71/EEC. For example; equipment must be regularly
calibrated and maintained, staff suitably qualified and trained, and
such operations are carried out to written procedures. Evidence must
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be available to support any sub-contracting carried out.
Where sub-contracting is carried out under direct supervision (e.g.
grower application of chemicals) they must use the ‘Officially
Recognised’ organisation's SOPs. Where sub-contracting is carried
out without direct supervision (i.e. potato cyst nematode counts),
relevant information should be made available to the ‘Officially
Recognised’ organisation to demonstrate that the work is carried out
to a written procedure by suitably qualified staff, and using
appropriately maintained and calibrated equipment.
In all cases where sub-contracting is undertaken, a suitable record
and appropriate evidence should be included as part of the raw data
package of that particular trial/test.
Note: Prior to an inspection, provision should be made if possible, for
a separate room, to enable the inspector(s) to carry out trial/test
audits.
Further guidance can be obtained from members of the UK Official
Recognition team, within the Environment Branch of CRD. (Contact
address, e-mail, telephone and fax numbers are provided on page 1 of
these Notes for Guidance) and on the CRD website at:
www.pesticides.gov.uk.
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CHECKLIST OF ATTACHMENTS FOR OWN USE
(a)
A completed application form
(b)
A list of names (plus qualifications), of all permanent staff
involved or associated with efficacy testing
(c)
Details of the management/supervisory chain, including functions
and responsibilities relevant to the efficacy testing work
(d)
A list (including addresses) of all owned/leased/rented facilities
used for efficacy testing
(e)
Information about assessment/Sampling and Other Specialist
Equipment
(f)
A copy of the SOPs requested in Section 4 (a) to (c)
(g)
A list of all SOPs for efficacy related work
(h)
A list of all efficacy work which could be used in support of
product approvals/authorisations undertaken in the last two years
and where applicable
(i)
A recent example of a trial/test protocol/study plan, associated
raw data and the related trial/test report
(j)
An explanation of the steps taken to address any issues raised in
the last inspection report
You are advised to keep a copy of your
completed application form and signed enclosures
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