This video provides information on how to apply for an authorisation from the Ctgb for a biocidal product such as a disinfectant.
Special attention will be paid to the limited assessment option.
If this is the first time you have applied for an authorisation, it is advisable to hire a consultant who can guide you through the process of compiling and submitting an application
As an example for this video, we will used a hand disinfectant that you believe is effective against the coronavirus.
Before such a product can be placed on the market and used in the Netherlands, you must have an authorisation from the Ctgb.
The only exception to this requirement are products that are exempted by the Ministry of Infrastructure and Water Management.
However, this exemption is always temporary, and if you want to keep your product on the market, you must apply for an authorisation from the Ctgb.
The product in our example contains two active substances: ethanol and 1-propanol
In order to submit an application for authorisation, you must first check whether these active substances have already been approved in the EU.
You can find the status of active substances in the ECHA database products (the link is provided below this video) https://www.echa.europa.eu
Active substances must also be approved for the correct product type (abbreviated as PT)
Hand disinfectants belong to PT01. Biocidal products are divided into 22 product types.
Surface disinfectants for use in homes, offices and hospitals belong to PT02
First, check the EU approval status of the active substances in your product
In our example, this would be the status – for PT01 – of ethanol and 1-propanol
If both active substances are approved in the EU for the relevant product type, then you must submit an application under the Biocidal Products Regulation.
This application process is outside the scope of this video.
If your product contains one or more active substances that are not yet approved in the EU, then Dutch transitional legislation (the Wgb) applies. This video is about submitting an application for authorisation under the Wgb.
According to the ECHA website, the active substance ethanol is not yet approved under PT01, but is still under review (initial application for approval is in progress)
According to the ECHA website, the active substance 1-propanol was approved for PT01 on 1 May 2019.
Because the product in our example contains one active substance that has not yet been approved (ethanol), Dutch transitional legislation applies
You can therefore submit an application to the Ctgb for authorisation of a biocidal product under this legislation.
To do this, go to the website of the Ctgb for information about how to submit an application for authorisation and download application form B.
You can use application form C to check whether you can choose the limited assessment option.
A biocidal product is authorised by the Ctgb only if it is safe for humans, animals and the environment. The product must also be sufficiently effective.
The Ctgb can carry out the assessment of these aspects only if all the necessary information has been provided with the application.
This information includes a detailed description of how the biocidal product will be used. It is important that the intended use is clearly and carefully defined.
Examples can be found in the legal conditions for use of authorised biocidal products in the database of the Ctgb.
Furthermore, data on the active substances is required, as included in the EU substance dossier.
Information about the product itself is also required… such as composition, efficacy and shelf life
The application process consists of 3 phases: intake, assessment and decision.
During the intake phase, the Ctgb checks whether all the necessary information is available to make a decision about efficacy and safety.
The Ctgb also checks whether a limited assessment is possible.
If a limited assessment is not possible for one or more aspects, then a full assessment is required.
Based on legislation and guidances, four aspects (chemistry, efficacy, toxicology and environmental considerations) are assessed to determine whether the product is effective and safe.
The final step in the application process is making a decision. The Board ultimately decides whether a product will be authorised or if the application will be rejected.
The limited assessment is the default option and is cheaper and faster than a full assessment.
To determine whether your product qualifies for a limited assessment, you can use application form C.
This application form will help you in four steps to determine whether a limited assessment is possible for your product.
You must determine for yourself whether you can use the limited assessment procedure by finding out if there is an authorised product that is comparable to your product.
All authorised products can be found in the database of the Ctgb and in an Excel file that you can download from the Ctgb website. The links are included below this video. https://toelatingen.ctgb.nl/en/authorisations
If you can find a comparable authorised product, the Ctgb may be able to use the assessment of that product for your product application.
That entails less work for Ctgb and is therefore cheaper and faster.
If a limited assessment is not possible, then a full assessment is required.
To make a valid comparison, you must choose one or two currently authorised reference products that are comparable to your product in terms of composition and use.
The point of the comparison is to demonstrate that the exposures of humans and animals from your product and its environmental emissions are no greater that the exposures and emissions from the reference product.
It is also important that the assessment of the reference product is still valid.
If there are new insights, such as indications that the active substances are more toxic than previously thought, then those insights must be reported so they can be included in the Ctgb assessment.
The Ctgb realises that applicants do not always know whether there are such new insights that are important for their product.
Therefore, the Ctgb always checks whether new insights should be included in the assessment.
Section B of Application Form C will help you find the correct information and include it in the application.
If a valid comparison cannot be made for all parts of the assessment, but you can still demonstrate for those parts that the use of your product is safe, then you can submit this reasoning with the application.
The Ctgb will then determine whether your reasoning is acceptable.
In this way, some flexibility is possible within the scope of a limited assessment.
Section C of Application Form C will help you find the correct information and include it in the application.
You must always submit a complete dossier with an application.
This means that you must provide all data that is required to make a full assessment, even if you are using the limited assessment procedure.
Regarding data on the active substance, in most cases this will be proof that you are permitted to access the EU dossier on this active substance. This is called a Letter of Access.
Section A of Application Form C will help you compile a complete dossier for the application.
After completing Application Form C in full, you can draw your own conclusion in Section D about whether the limited assessment procedure is feasible and therefore whether authorisation of your product is possible with this procedure.
Before you can formally submit an application, you must also complete application form B.
The table on page 1 of Application Form C indicates which appendices must be submitted with the application.
The appendices can be found on the website of the Ctgb in the information about Application Forms B and C.
The Member States of the EU have agreed that biocidal products may be placed on the market only if the suppliers of those products – or the suppliers of the corresponding active substances further up in the chain – have contributed to the EU dossier on the active substance.
For this purpose, an anti-free-riders article has been included in the Biocidal Products Regulation. That is Article 95.
The application must be accompanied by a declaration that you are purchasing your active substance from an Article 95 supplier.
A template for this declaration is available on the website of the Ctgb. The link can be found below this video. https://english.ctgb.nl/documents/instructions-biocides/2017/06/19/article-95-appendix
We will now return to the example of the hand disinfectant based on ethanol and 1-propanol.
Completing Sections A, B and C of Application Form C will help you to see what is required in the dossier for this product and whether you can make use of the limited assessment procedure.
For ethanol (which classified as a bulk chemical) it is possible to refer to the public dossier that is available at the Ctgb.
However, once ethanol has been approved in Europe, this option expires and you will have to acquire a Letter of Access to the EU dossier.
To comply with Article 95, you must also demonstrate that you or the supplier of your active substance is on the list of Article 95 suppliers, which establishes the relationship between your product and the owner of the substance dossier.
For 1-propanol you must provide a Letter of Access to the EU file.
If you conclude that you can use the limited assessment procedure, then you can make preparations to submit the formal application for authorisation.
In addition to application form C, you must complete application form B and the corresponding appendices.
Now that you know that you can use the limited assessment procedure and which data must be provided, you can prepare the formal application.
The limited assessment procedure requires both Application Form C and Application Form B, including all corresponding appendices.
From 1 January 2021, special fees and charges for applications via the limited assessment procedure will be included in the Ctgb Tariffs Decree.
We hope that after watching this video you now have a clear idea about the process of applying for authorisation of a biocidal product under Dutch transitional legislation.
If you have any questions at a later stage, you can always contact our Service Desk