Directions for submission biociden

Requirements authorisation holder

Transitional legislation and the Regulation (EC) no 528/2012

How to submit an application

How an application should be submitted depends on the status of the active substance. If the active substance is approved under Regulation (EC) no 528/2012, applications and notifications must be submitted to ECHA and the national authorities by using the R4BP application. If the active substance is not yet approved under the Regulation then National rules apply. In that case it is possible to have the products assessed under transitional law and the application should be submitted to Ctgb directly.

For more specific information about application types see: specific application types for biocides.

Language

The language for communication or correspondence with Ctgb is English or Dutch. The decisions of the Ctgb however are written in Dutch. The working language for the preparation and assessment of registration reports is English. This to facilitate the exchange of evaluations between the EU Member States. The language in objection and appeal procedure however is Dutch.

Requirements authorisation holder

The authorisation holder must be established within the European Union.

Product names

The name of a biocidal product must not be confusing for the consumer. A few criteria for this are:

• the name of the product must not be confusing;
• the pronounced name of the product must not be confusing;
• the name must not cause confusion about the composition of the product;
• the name of the product shall not be misleading with regard to the hazards/risks of the product;
• there must be a clear distinction between the product name and the regular name of the active substances or how the actives substance works or a regular description of the action of the product. It must be prevented that regular designations (including numbers and other punctuation marks) can be monopolized by use as a trade name.

In case of doubt, the Board takes a decision. This information can be found in the Goverment gazette: Staatscourant 2016, nr 54661 (only in Dutch).

Notifications under article 47 of the BPR

Preferably send immediate notifications by the authorisation holder (article 47 BPR: Obligation for notification of unexpected or adverse effects ) for products authorised under either transitional law or the BPR to us by e-mail. 

Transitional legislation

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 Ctgb’s 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 them 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, if known, the application number and application type (for example 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.

Administrative and minor applications under transitional law

These administrative and minor applications can be submitted by e-mail: post@ctgb.nl 

For administrative applications and applications for minor changes, applications for (changes to or renewal of) derived authorisations, applications for (changes to or renewal of) parallel trade authorisations, information requests for animal testing, export certificates , preferably send the application by e-mail. 

Please mention in the subject line of the e-mail: the application type, product/active substance name and company name. Make sure the individual files have logical names. For example: “application form’’, “legal conditions for use/WG”.

For this type of application please, instead of submitting a cover letter, mention the changes on the application form clearly. If necessary, provide more  explanation in an appendix. When using an appendix to submit explanatory information: Refer to the appendix on the application form . For a more specific instruction see the specific application types for biocides.

More names for one product

Under transitional law requesting an authorisation for a same product under a different (trade) name can be done by applying for a derived trade permit. The derived product will receive it's own authorisation number, but will remain legally dependent of the reference product. Any desired changes that go beyond the properties of the reference authorisation must be changed and authorised in the reference authorisation before they can be requested for the derived product.

Please note that for a derived permit an annual fee is owed.

Regulation (EC) no 528/2012

Requirements Article 95

If you intend to submit an application for authorisation, a prolongation of an authorisation or a change to an authorisation, please always check whether the application meets the criteria of Article 95 of Regulation 528/2012.

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.
Non-compliance with Article 95 means that the Ctgb will not grant a new authorisation or an extension, amendment or renewal of an existing authorisation. 

SPC and SPC editor

See for information the page on Summary of Product Characteristics (SPC) and the SPC editor.

More names for one product

Under the Regulation there are more possibilities to bring products on the market with multiple (trade)names:

• applying for a second name (or third, fourth… and so on)
  Application for a second name must be submitted by sending an NA-ADC application to R4BP. In this case you are allowed to bring the product on the market under two different names, and the same authorisation number. In this case you have to pay the annual fee only for one product.
• applying for a Same Biocidal Product
  In this case you become a new authorisation number for this product. Please realize; for a Same Biocidal Product you will be charged also with the annual fee.
• applying for a product family
  Under the Biocides Regulation, it is possible to admit multiple products under a single entry. This is important for producers, to facilitate market access and reduce administrative burdens. For authorisations based on the same active ingredient(s), the regulation describes the concept of the ‘biocidal product family’.

Fees and charges

The application costs are specified in the Ctgb Tariffs Decree. The application will not be taken into consideration until the application form has been received and the application fee has been paid. When the application is not accepted for consideration or when it is no longer being considered or when it is rejected, the application fee will not be refunded.

Payment method

Once your application has been received by the Ctgb, you will receive a confirmation letter with an invoice. You do not pay the fee until after you have received the confirmation letter with invoice. As a rule we only start processing your application once we know that the fee has been paid.

Direct debit payment of invoices

The Ctgb encourages applicants to arrange direct debit payment of your Ctgb invoices. This payment uses the European successor to the national direct debit system: Euro direct debit (Euro-incasso). By arranging direct debit payment of your invoices, you no longer have to worry about timely payment, and we reduce your administrative burden. You still maintain control of your own bank account, and you can cancel direct debits beforehand or reverse the payment afterwards.

If you would like to pay your Ctgb invoices using European direct debit (Euro-incasso), please contact the Finance & Control department. We will then go through the procedural steps with you and prepare the necessary contracts.

See our page on Tariffs for specific information about our fees.