Application submission
Applications Sift,
Chemicals Regulation Division,
Room 1A, Mallard House, Kings Pool,
3 Peasholme Green,
York, YO1 7PX, UK
or
Email: / CRD contact details
Telephone: 020 3028 1101 (International: (+44) 20 3028 1101)
Fax: 01904 455763; (International: (+44) 1904 455763
Enquiries email:
Website:
Application Form CRD8
Submitted under Regulation (EC) No 1107/2009
When to use this form
Applications for:
  • Standalone consideration of the technical equivalence of a newsource of technical material.
  • Change or update the existing specification of a source of technical material.
  • Change to the manufacturing process for an existing source of technical material to demonstrate that the specification is unaffected (e.g. pilot plant to full scale production).

When not to use this form
Applications for:
  • New commercial authorisation, permit for trial purposes (use form CRD1).
  • Administrative authorisation (use form CRD2).
  • Extension of authorisation for minor uses (use form CRD3).
  • Official Listing of an Adjuvant (use form CRD4).
  • Permit for Parallel Trade (use form CRD5 or CRD6 [own-use]).
  • Administrative permit for trial purposes, (use form CRD7).
  • Emergency authorisations (use form CRD9).
  • Renewal of an existing plant protection product (use form CRD-R).
  • Biocidal product approval(see
NB: if a CRD1 form is required for an application there is no need to submit a separate CRD8 form.
How to complete this form
  • Complete all parts of A to c and appropriate appendices.
  • All correspondence and enquiries will be sent to the contact named in the applicant section (Part A) of this form unless otherwise informed.
  • 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 Parts D/E and Appendices.
  • For questions about this form, contact
  • All forms with supporting information must be submitted to the Applications Sift (see contact information above).

1

Form CRD8 ver. 3(March 2017)

/ Chemicals Regulation Division
Application for standalone technical equivalence assessment of a new source of active substance
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 / Contact name / Title
Company name
Address
Telephone
e mail
3 / Purchase order number (if needed)
4 / Owner of Source / Contact name / Title
Company name
Address
Telephone
E mail
Part B – Type of application
5 / Tick the box that best describe your application
Application requiring technical assessment:
New active substance (a.s.) manufacturing site
Change to the technical specification of an existing source of technical material
Change to existing manufacturing process / going from pilot plant to full scale production
6 / Tick the boxes reflecting how you are supporting this application in each assessment area (this will help to calculate the fee to be charged)
Evaluation module / Not relevant / Case / Data / Comments (if required)
Chemistry
Mammalian toxicology
Ecotoxicology
Part C –Declaration
7 / Must always be completed where 5-batch data are supplied with a submission
I confirm that the batch data submitted to support the consideration of equivalence of this source of technical material are representative of usual production. / (please tick to confirm)
Part D –Data ownership
8 / Active substance data
Data owner(s)
Specification and 5 batch analysis data
Other a.s. data
Enclosures – to be completed by all applicants
Covering letter / Draft Technical Equivalence Reportin the format of SANCO/10597/2003 Appendix VII
Application Overview / Data

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.

1

Form CRD8 ver. 3(March 2017)

/ Chemicals Regulation Directorate
Application for standalone technical equivalence assessment of a new source of active substance
Appendix - Technical specification of active substance-mustalways be completed
Active substance name:
Manufacturing site(s), name and address:
5 batch analysis data owner:
Component (CAS/IUPAC name) / CAS number / Content (state min or max) / Chemical structure / Chemical group/
family name

Add additional rows above as necessary (‘copy and paste’ or use press ‘tab’ key with cursor in bottom right cell.

1

Form CRD8 ver. 3(March 2017)