Mallard House, Kings Pool,
3 Peasholme Green,
York, YO1 7PX,
UK / Telephone: 020 3028 1101 (International: (+44) 20 3028 1101)
Fax: 01904 455763; (International: (+44) 1904 455763)
Email:pesticides&
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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 each active substance, authorisation holders should submit an applicationto reneweach product that contains 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 identifythe administrative back to back (identical) products and Extensions of Authorisation for Minor Use supported for renewal by the product applicant.
Where a delayed submission on the basis of Cat 4was previously agreed with CRD,an updated version of this form must be supplied withthe complete dossier, before the agreed submission deadline.
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 biocidal product approval (see
How to complete this form
- 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&.
Where to send this form
Save a copy of your completed form and submit it to HSEwith all other relevant supporting information/dataat:
- ; or
- Applications, Chemicals Regulation Division, Mallard House, Kings Pool, 3 Peasholme Green, York YO1 7PX.
Form CRD R ver. 4(November 2016)
1
/ Chemicals Regulation DivisionApplication for the renewal of an existing authorisation of a plant protection product
Part A – Applicant details
1 / Applicant / Contact name / Title
Company name
Address
Telephone
E mail
Date
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)
2 / Address for invoicing (if different) / Contact name / Title
Company name
Address
Telephone
e mail
3 / 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)
4b / Formulation type
4c / MAPP number
4d / Authorisation holder / Company name
Address
Co. Reg. No.
4e / Marketing company (if different) / Company name
Address
Co. Reg. No.
5 / Current authorisation(s) NANUM(s)
6 / Identity of the Renewed Active substance and content / Renewal Date
7 / Other active substance(s) present in formulation, content & current active date of expiry / Expiry Date
Expiry Date
Expiry Date
8 / Field of use / Professional / Amateur
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 NANUM / Authorisation Holder (if different)* / Marketing Company (If 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 supported under this application? / Is the EAMU also authorised on any products detailed in table 9 – please list
(Insert extra rows if necessary)
Part C – Declarations
11Must 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 requirements (conditions and restrictions) set out in the Annex to the Regulation on the renewal of the approval of the active substance detailed in box 6.
OR
I confirm that I am requesting a restriction to the existing GAP to enable the existing use to comply with specific restrictions in the Annex to the renewal Regulation (give details in the application overview / (please tick to confirm)
(please tick to confirm)
I confirm that the source(s) of technical material of the renewed active substance currently authorised in the plant protection product(s) above comply with the requirements (conditions and restrictions) set out in the renewal Regulation forthe active substance detailed in box 6.
AND/OR
I am referencing a different technical specificationthan currently authorised in this product. I confirm that this specification complies with the requirements (conditions and restrictions) set out in the renewal Regulation for the active substance detailed in box 6 (give details in the application overview). / (please tick to confirm)
(please tick to confirm)
This application includes a necessary change in GAP to comply with changes in endpoints, data requirements or guidance. Full details of the proposed change and a robust justificationMUST be provided below AND in your application overview.
This must detail;
- the specific endpoint(s)or data requirement(s) that have changed,
- how the change(s) made your existing GAP unsupportable,
- how you have settled upon your proposed new GAP.
Part D – Type of renewal
12zRMS details - Must always be completed
The UK has agreed to act as zRMS for the renewal of this product. / (please tick to confirm) / Listagreed cMS
Another MS has agreed to act as zRMS for the renewal of this product. The UK is a cMS. / (please tick to confirm) / Confirm zRMS identity
13Nature of submission - Must always be completed
This renewal includes a complete risk assessment in dRR format updated to the latest endpoints. / (please tick to confirm)
The submission of a complete risk assessmentfor this product is delayed as the product contains another active due for renewal within the next 12 months. / (please tick to confirm) / Please confirm the expiry date of the second active
The submission of a complete risk assessment in dRR format for this product will be delayedpending data that falls under Category 4 of section 3.3 of SANTE/2010/13170. The appendix to this application form has been completed.
Tick this box if you are reliant on a letter of access and you are aware the data owner is citing Cat 4 data relevant to your product. Include an explanation in your application overview. / (please tick to confirm) / Please confirm proposed submission deadline
14 Delayed submission - Must only be completed where a delayed dossier submission for this application has previously been agreed with CRD on the basis of Cat 4.
Please confirm the submission deadline that CRD previously agreed.
Please confirm the COP No. for the delayed submission decision.
Part E – Where an updated risk assessment has been provided
15 / 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
Part F –Data ownership16 / Active substance data
Active substance(s) names(s)
Are all data on the active substance owned by the authorisation holder? / Yes
No A Letter of Access and/or a completed data matching table has been supplied. An explanation MUST be provided in your application overview
17 / 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. An explanation MUST be provided in your application overview
Part G - Enclosures – to be completed by all applicants
Covering letter / Application Overview
Data matching / Data access table (required when you do not have access to the data relied upon at renewal) / A report on the monitoring information, where the authorisation was subject to monitoring.
Supporting Data. Only data being relied upon to support the updated risk assessments are required. (You do not need to resubmit data previously assessed by HSE) / dRR containing complete product risk assessment which clearly indicates where the assessment has been updated to reflect new data requirements or criteria.
Draft label highlighting any changes proposed from existing label. Where relevant a supporting Compatibility Assurance Statement (CAS) / 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 (Please use same basic template as detailed in the Appendix for identification of Category 4 data)
Copy of the existing UK authorisation / Letter(s) of access (where applicable)
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 General Data Protection Regulation (GDPR) (Regulation (EU) 2016/679), 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 [ 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.
Form CRD R ver. 4(November 2016)
1
/ Chemicals Regulation DirectorateApplication 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 / Study duration / Completion date/report number (if available) / Justification including proof of (or commitment to) initiation of study
XX / Field trials….. / 2017-10-15 / Efficacy data required following change in endpoint for AI_ Cat 4 study
Form CRD R ver. 4(November 2016)
1