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Instruction for Submission

Changes in the authorisation of a biocidal product are defined according to Change Regulation (EU) 354/2013. In this chart below you will find instructions how to submit changes per application type. In the last column the estimated period of handling is given. Note: this is the common period for handling, not the maximum period.

Characteristics of application

Instructions for submission

Period of handling*

Changing of the production process of the product
This notification will be confirmed by e-mail. So you don’t receive  an official decision.

This notification is for free.

 Form W 4 weeks

Minor changes composition (product)
Examples of minor changes in the composition:
  • Replacing a co-formulant or auxiliary formula with a chemically comparable one that does not have a more severe classification
    and/or labelling than the original co-formulant.
  • Changing the percentage of co-formulant, auxiliary formula or active substance. This percentage must not change significantly.
    For an auxiliary formula, this change can be no more than 25% relative to the previous formula.
    The content of active substance can change by no more than 10%.

In general: for a minor change no studies have to be submitted and no risk assessments have to be prepared.

 Form W , choose Part 2.0

Composition statement

Instruction composition statement

 12 weeks

Change of labelling

The changes applied for have to be explained. When the CLH change is based on new studies with the formulation,
these have to be submitted, together with a reference list. Evaluation costs for these studies will be calculated according the Tariff Decree.

NOTE: for studies to be conducted with animals, a request for information has to be submitted to the Ctgb.
Conducting animal studies is not allowed without this request and the approval of the Ctgb.

 Form W , choose on this form:

Part 1.5 (change of labelling)

 8 weeks

Change of packaging
Information to be submitted: Form W , choose on this form:

Part 2.1 (change of packaging)
Studies to be submitted:
see chart below.

 8 weeks

Change of shelf life
Data are required to demonstrate that the product is stable in storage under the conditions and for the shelf life claimed for the product.

Data must be generated in the worst-case commercial packaging to support the ambient storage of the product for the claimed shelf life.

For all proposed packaging types, packaging suitability should be addressed. Technical characteristics applicable to the formulation type must be addressed.
Where relevant these must be generated to cover the maximum and minimum in use concentrations specified for the product.

Information on the relevant physical, chemical and technical properties for different formulation types is outlined in the FAO manual (FAO, 2010).

 Form W , choose on this form:

Part 2.2 (change of shelf life)

 8 weeks

Administrative changes
The following applications concerning administrative changes:
  • Name changes for products

NOTE: Information about acceptable product names can be found in the Policy note about naming (Goverment Gazette, in Dutch).

 Form W , choose Part 1.0 4 weeks
  • Name changes for companies
 Form W , choose Part1.1 4 weeks
  • Transfers of authorisations to a different company
 Form W , choose Part 1.2 4 weeks
  • Withdrawals of authorisations

free application

 Form W , choose Part 3.0 8 weeks
  • Minor changes WGGA: Amendment label instructions: Risk review is not necessary. Or restricted field of use.
 Form W , choose Part 1.3 4 weeks

*: No rights can be derived from these handling periods. Period starts when application and payment have been received.

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 bu 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 AG). 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.

Note: For this type of small applications, please do not include a cover letter if not necessary. Explanatory information can be submitted as an annex . Please refer to the annex in the application form.

Data to be submitted for a change in packaging:

Section No.

Information, test or study required for biocidal product

(for compulsory or conditional requirements, see TNsG on data requirements)

 Information, test/study provided Y(n)/P/N/n.a.

Justification
provided Y/N

 Confidential data Y/N Reliability indic. 0-4/n.a. Official use only Data Gap Y/N
3.7 Storage stability – stability and shelf-life
9 PACKAGING (type, materials, size, etc.)

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