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Instruction for Submission

Presubmission

In preparation of an application for a national authorisation under transitional legislation, the general tools for pre-application support are available, i.e.:

  • Pre-submission meeting: the PSM can be used by potential applicants who have begun preparing their dossier to request assistance with dossier specific interpretations of procedural or technical guidance or assistance when guidance is not (yet) available.
  • Servicedesk: the service desk can inform on specific questions you have on requirements, procedures, etc.

Application forms and templates

The data content and structure of the dossier is defined in application form and appendices presented below.

Application forms, instructions and addenda

Form B
Form C: Form for the route of limited assessment

Instruction Letter of Access to the Active substance dossier

Addenda (attached to Form B):

Appendix A - Active substance
Appendix B – Product
Appendix CLP
Appendix D - WGGA
Appendix E - PGB – PUB
Appendix F- Composition Statement
Appendix Chemie
Appendix G - Reference list
Appendix WKZH - Efficacy studies per biocidal use claim

Conclusions on VIB request (in case of new animal testing)
Appendix Article 95

Addenda (attached to Form C):

Addenda (attached to Form C):

Appendix CLP – CLP classification
Appendix Cxx – Additional assessments
Appendix Chemie – Data on packaging, shelf life and analytics
Appendix S – Comparison to composition reference product
Appendix T – Comparison to application reference product
Appendix WKZ – Efficacy studies per biocidal use claim

Milestones for data submission

Submission of application

An application under transitional legislation or an extension can be submitted until 78 weeks before the approval date of an active substance under the BPR for a regular authorisation, and until 90 days before the re-registration date for a minor change.

Intake

When the intake indicates a data gap(s), the applicant is given a term to supply the missing data.

Additional questions

When the assessment indicates that on basis of the submitted data no safe use can be demonstrated or other requirements for an authorisation are not fulfilled, the applicant is given the opportunity to supply supplementary data to refine the assessment.

Check for completeness application

Application form

Complete application Form B. For the route of the limited assessment, complete in addition to Form B also Form C. Form can be found below.

Letter of Access to the active substance dossiers or Appendix A – dossier on the active substance(s)

Applicants who do not themselves own an active substance dossier used in support of the product application, should submit a Letter of Access to the active substance dossier. A Letter of Access permits Ctgb to use an earlier submitted substance dossier. In this case you don’t have to provide us with the active substance dossier. Alternatively, accompanying Appendix A, you may send us  a complete dossier on the active substance(s).

Please check ECHA's Article 95 list for companies that have submitted a dossier on the active substance for your product type. The entries which mention “RP Participant” refer to dossiers submitted under the review programme.

Ctgb has labelled a number of active substances as ‘bulk chemical’, indicating that for these active substance sufficient publicly available data sets are present at the Ctgb. For biocidal products appplications under transitional legislation based on a ‘bulk chemical’ as active substance , you do not have to submit an Appendix A or LoA. The following chemicals have been classified as ‘bulk chemical’:

  • Ethanol (CAS 64-17-5)
  • Salicylic acid (CAS 69-72-7)
  • Sodium dichloroisocyanurate dihydrate(CAS 51580-86-0)
  • Sodium hypochlorite (CAS 7681-54-3)
  • Calcium hypochlorite (CAS 7778-54-3)
  • Peroxyacetic acid (CAS 79-21-0)
  • Isopropanol (CAS 67-63-0) (approved : date of approval 01/07/2016)
  • Hydrogen peroxide (CAS 7722-84-1) (approved : date of approval 1/2/2017)

Appendix article 95

From 1 September 2015, a biocidal product can be sold on the EU market only if the manufacturer or supplier of the relevant substance in the biocidal product, or the manufacturer or supplier of the biocidal product for the applicable product type, is included on the Article 95 list of the Biocidal Products Regulation (Appendix Article 95). Please note that also for ‘bulk chemicals compliance with article 95 of the BPR is required after 1 September 2015.

Appendix B – dossier on the product product (not for the route of limited assessment)

In support of Appendix A - Active substance information needs to be supplied on the product, especially on efficacy of the product and the physical-chemical properties of the product. For example:

  • study to demonstrate storage stability during the claimed shelf life
  • validated analytical methods for the active substance in the product
  • studies to substantiate efficacy for the prescribed purpose in relation to contact time and concentration.
  • summary of the efficacy studies, in case multiple studies are provided.

More detailed information on data requirements for the various aspects of the assessment are available in our Evaluation manual part 3  Product authorisation under transitional legislation.

In case of an application via the route of limited assessment data on the product are part of application form C.

Appendix CLP

Provide the CLP classification of the product.

Appendix D- WG/GA – Legal Conditions for Use and the Directions for Use of the biocidal product.

The limits to the use of the product need to be carefully described in accordance with the instructions as given in enclosed guideline. Examples on what a valid WG/GA looks like can be found in the our pesticide database. The WG/GA should be in Dutch, and submitted in MS Word format.

Appendix E - PGB-PUB – a systematic description of the use of the biocidal product

The description of the Practical Use of the Biocide should be submitted in MS Excel format

Appendix F - Composition

A composition statement should be filled in to describe the formulation of the product. Along with the composition statement valid MSDSs of the biocidal product as well as all co-formulants of the biocidal product should be provided.  The MSDSs should be less than five years old.

Appendix Chemie

Use this appendix to submit physical and chemical data for the product.

Appendix WKZ

Efficacy data per claimed use.

Appendix G - Reference list

All documents you send us need to be mentioned, with reference to which part of the application the document is proof/justification for. A biocidal product application for the regular procedure consists of a cover letter, an application form and the above-mentioned appendices. A biocidal product application via the route of limited assessment consists of Form B plus Form C and the relevant appendices.

The application dossier can be submitted digitally by using an upload link (request through post@ctgb.nl) or by sending a CD or DVD to our postal address. Digital signatures on application forms and Letters of Access are accepted. 

It is possible to submit part of the dossier on paper and part digitally. Signed documents such as application forms and Letters of Access can be submitted in original paper version by sending to to Ctgb’s postal address. However we request you to send all other parts of the dossier digitally. When using CD-ROM/DVD:  Label the CD-ROM/DVD with the name of the product and application type and, if known, the application number (for example: ProductX, 20140122 TB). For all digital information submitted: make sure that the individual files have logical names; f.e. “submission letter”, “application form”, “legal conditions for use (WG)”. We accept Open format file but prefer Word files.

Application forms