Application Form CRD-R protection product

Chemicals Regulation Directorate
Mallard House, Kings Pool,
3 Peasholme Green,
York, YO1 7PX,
UK
Telephone: 01904 640500 (International: (+44) 1904 640500)
Fax: 01904 455763; (International: (+44) 1904 455763
Email: pesticides&[email protected]
Website: www.hse.gov.uk/CRD
Application Form CRD-R
Application for the renewal of an existing authorisation of a plant
protection product
Submission under Article 43 of Regulation (EC) No 1107/2009
When to use this form
Within three months of the Date of Application (DoA) of the renewal of an active substance, authorisation
holders should submit an application to renew each product containing the renewed active substance. Failure
to submit an application will result in expiry of the existing product authorisation within agreed timeframes. .
This form must also be used for the administrative back to back (identical) products and Extensions of
Authorisation for Minor Use supported for renewal by the product applicant.
When not to use this form
Applications for authorisation of a plant protection product as follows:
 New commercial authorisation or permit for trial purposes (use Form CRD1).
 Administrative authorisation (use form CRD2).
 Extension of authorisation of a minor use of a plant protection product (use form CRD3).
 Administrative permit for trial purposes, (use form CRD7).
 Permit for Parallel Trade (use form CRD5 or CRD6 [own-use]).
Applications for Official Listing of an Adjuvant (use form CRD4).
Applications for biocidal product approval (see http://www.hse.gov.uk/biocides/index.htm))
How to complete this form
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Complete all parts of A to G and the Appendix as required.
No sections of the form are protected. Take care not to delete or amend existing text.
To check ‘tick boxes’, double click on the box, select ‘checked’ and press ‘ok’.
‘Copy and paste’ to add additional rows/tables in the Appendix.
For questions about this form, contact pesticides&[email protected].
Where to send this form
Save a copy of your completed form and submit it to HSE with all other relevant supporting information/data
at:
 [email protected]; or
 Applications Sift, Chemicals Regulation Directorate, Mallard House, Kings Pool, 3 Peasholme Green, York
YO1 7PX.
1
Chemicals Regulation Directorate
Application for the renewal of an existing authorisation of a plant protection product
Part A – Applicant details
1
2
3
Applicant
Contact name
Company name
Address
Telephone
E mail
Date
Title
I confirm that the information given in this application form is
true to the best of my knowledge, information and belief.
(please tick to confirm)
Address for
Contact name
Title
invoicing (if
Company name
different)
Address
Telephone
e mail
Purchase order number (if needed)
Part B – Product identity
4
Details as currently authorised –must always be completed
4a
Product name (UK)
Product Code (across EU)
MAPP number
Authorisation
Company name
holder
Address
Co. Reg. No.
Marketing
Company name
company (if
Address
different)
Co. Reg. No.
4b
4c
4d
5
6
7
8
Current authorisation(s) NANUM(s)
Identity of the Renewed Active
substance and content
Other active substance(s) present in
formulation, content & current
active date of expiry
Field of use
Renewal
Date
Expiry Date
Expiry Date
Expiry Date
Professional
2
Amateur
Chemicals Regulation Directorate
Application for the renewal of an existing authorisation of a plant protection product
9
Administrative B2B products
If this product is currently authorised in the UK with administrative back to back products (i.e.
alternative tradenames for the product authorised with identical formulations and identical GAP) then
please detail below all such authorisations that you wish to maintain following renewal. Each product
listed will attract an additional sift & administrative charge. There is no need to submit separate CRD2
forms.
Product name
MAPP number
Current
Authorisation
Marketing Company (If
NANUM
Holder (if
different
different)*
(insert extra rows if necessary)
*Note that if the Authorisation Holder differs from the company detailed in box 4c and the application
relies upon a letter of access (LoA) you must ensure that the supplied LoAs encompass all authorisation
holders.
10
Extensions of Authorisation for Minor Use
If this product is currently authorised with any Extensions of Authorisation for Minor use (EAMUs)
please indicate these below and highlight whether the minor use is being supported under this
application. Each EAMU supported will attract additional fees for assessment based on the modular
system. There is no need to submit separate CRD3 forms.
Crop(s)
Current NANUM Data Owner
Use
Is the EAMU also authorised
supported
on any products detailed in
under this
table 9 – please list
application?
(Insert extra rows if necessary)
Part C – Declarations
11 Must always be ticked – If, for any reason, these declarations cannot be confirmed then in
principle the product is not suitable for consideration via the renewal process. An Article 33
application for amended application will be required.
I confirm that the plant protection product(s) detailed above comply with the
(please tick
requirements (conditions and restrictions) set out in the Regulation on the renewal of the to confirm)
approval of the active substance detailed in box 6.
I confirm that the source(s) of technical material of the renewed active substance that are
(please tick
currently authorised for use in the plant protection product(s) detailed above comply with to confirm)
the requirements (conditions and restrictions) set out in the Regulation on the renewal of
the approval of the renewed active substance detailed in box 6.
3
Chemicals Regulation Directorate
Application for the renewal of an existing authorisation of a plant protection product
Part D – Type of renewal
12 zRMS details - Must always be completed
(please tick
The UK has agreed to act as zRMS for the renewal of
to
confirm)
this product.
(please tick
Another MS has agreed to act as zRMS for the renewal
to
confirm)
of this product. The UK is a cMS.
List agreed cMS
Confirm zRMS
identity
13 Nature of submission - Must always be completed
(please tick
This renewal includes a complete risk assessment
to
confirm)
updated to the latest endpoints.
(please tick
The submission of a complete risk assessment for this
to
confirm)
product is delayed as the product contains another
active due for renewal within the next 12 months.
(please tick
The submission of a complete risk assessment for this
to
confirm)
product will be delayed pending data that falls under
Category 4 of section 3.3 of SANTE/2010/13170. The
appendix to this application form has been completed
Please confirm
the expiry date of
the second active
Please confirm
proposed
submission
deadline
Part E – Where an updated risk assessment has been provided
14
Tick the boxes reflecting which sections of the existing risk assessment (Registration
Report) have been updated following renewal of the active substance
Evaluation module
No
update
required
Updated
Risk
assessment
Detail of the update needed to risk assessment
(where required)
Chemistry
Methods of Analysis
Mammalian toxicology
Operator exposure
Residues
Fate & behaviour
Ecotoxicology
Efficacy
4
Chemicals Regulation Directorate
Application for the renewal of an existing authorisation of a plant protection product
Part F –Data ownership
15
Renewed active substance data
Active substance(s) names(s)
Are all data on the active substance owned by the
authorisation holder?
16
Yes
No
A Letter of Access and/or a completed data
matching table has been supplied.
Formulation/Annex III data ownership
Are all data owned by the authorisation holder?
Yes
No
A Letter of Access and/or a completed data
matching table has been supplied.
Part G - Enclosures – to be completed by all applicants
Covering letter
Application Overview
dRR containing complete product risk
assessment which clearly indicates where
the assessment has been updated to reflect
new data requirements or criteria.
Data matching / Data access table
Supporting Data
List of submitted data with justification
that each study supplied is to address a
data requirement or criteria that was
not in force when the authorisation
was granted.
Letter(s) of access (where applicable)
Draft label highlighting any changes
proposed from existing label. Where
relevant a supporting Compatibility
Assurance Statement (CAS)
Copy of the existing UK authorisation
(Where UK is zRMS a copy and translation
of the authorisation certificates from the
cMS(s) is also required).
A report on the monitoring
information, where the authorisation
was subject to monitoring.
Using personal data
HSE is under a legal duty to protect any personal information we collect and we will only use that
information in accordance with the law, including the Data Protection Act 1998, the Freedom of
Information Act 2000 and the Environmental Information Regulations 2004. We meet our
obligations as part of UK Government to safeguard data and prevent any unauthorised access to it
through use of technical, personnel and procedural controls. More details on Government security
may be found on the Gov.UK Web site [https://www.gov.uk/government/collections/governmentsecurity]. In order to carry out our functions and respond to enquiries effectively, we will sometimes
need to share information with other government departments, the emergency services, law
enforcement agencies, public authorities (such as local authorities and the Environment Agency) and
organisations acting on our behalf. However, we will only do this where it is required or permitted
by law.
5
Chemicals Regulation Directorate
Application for the renewal of an existing authorisation of a plant protection product
Appendix – Category 4 data (where applicable)
Please complete this table for applications for which a delayed submission is requested on the grounds of Article 43.6 and as detailed under
category 4 of section 3.3 of SANTE/2010/13170. Please summarise below those studies which are directly related to a (new) endpoint and
for which the time was too short from the publication of the EFSA conclusion to produce in time for the application deadline.
Annex Point
Study title (if available ) or study
type
XX
Field trials…..
Study duration
6
Completion date/report
number (if available)
Justification including proof of (or
commitment to) initiation of study
2017-10-15
Efficacy data required following change in
endpoint for AI_ Cat 4 study