How do I introduce a biocide on the Dutch market?
In order to ascertain whether it is possible to apply for an authorisation for your biocidal product some information needs to be gathered:
- Which active substances does the product contain?
- Under which producttype(s) should the product be classed?
- What is the status of the active substance(s) in the product?
Now follows an explanation of the importance of this information and links to where the required information can be found.
Which substances are the active substances in the product?
The biocides regulation provides the following definition of an active substance: ‘active substance’ means a substance or a micro-organism that has
an action on or against harmful organisms. Therefore any substance in your product which has an action on or against harmful organisms is an active substance.
The product type indicates for which uses the biocidal product is intended. It is not an instructions for use however. The product type classification is a tool to facilitate the assessment of active substances and biocidal products.
(More information on product types can be found here: http://www.echa.europa.eu/nl/web/guest/regulations/biocidal-products-regulation/product-types)
The status of the active substance
The status of approval of the active substance product type combination determines which legislation and which procedures are applicable for your product.
If one or more of the active substance product type combinations are included in the review program, then article 89 of the Biocidal Products Regulation is appliccable. This article determines that the member states can apply their national regimes for those biocides which fall under article 89. Dutch national law applies for these biocides (transitional law).
( More information on the review program can be found here: http://www.echa.europa.eu/web/guest/regulations/biocidal-products-regulation/approval-of-active-substances/existing-active-substance )
( Please check the status of your active substance product type combinations here: http://www.echa.europa.eu/web/guest/information-on-chemicals/biocidal-active-substances )
If one of the active substances is neither included in the list of approved active substances nor included in the list of substances included in the review program for the relevant product type then an active substance approval procedure has to be finalised first.
(More information on active substance approval can be found here: http://www.echa.europa.eu/regulations/biocidal-products-regulation/approval-of-active-substances )
If the active substance producttype combinations for your product are all approved, Biocidal Products Regulation procedures apply.
(More information on product authorisation under the Biocidal Products Regulation can be found here: http://www.echa.europa.eu/web/guest/regulations/biocidal-products-regulation/authorisation-of-biocidal-products )
If transitional law (Dutch national law) applies:
1. If you wish to put a product on the market which is identical to a product which is already authorised in NL it is possible to apply for a derived authorisation under certain conditions:
- either the parent authorisation holder and the applicant for the derived authorisation are linked to each other
- or the applicant for a derived authorisation provides a Letter of Access to the dossier of the original product.
The use and the mode of application of the biocide needs to be the same or more restricted than the use and mode of application of the original product.
The procedure is relatively simple and can be finalised within 10 weeks.
(more information on derived authorisations can be found here: http://www.ctgb.nl/en/biocidal-products/types-of-applications-for-biocidal-products/derived-authorisation )
The following forms need to be submitted:
- Letter of access for applicants
- Formulier AB / Form AB
- Appendix article 95
(The application forms can be found here: http://www.ctgb.nl/en/biocidal-products/application-forms)
2. If you wish to put on the market a product which is not identical to an already authorised product or you have no Letter of Access then the procedure regular authorisation biocidal product applies.
(Please note that Dutch national (transitional) law does not provide a relatively simple notification process for these biocides. You are required to obtain a regular authorisation which entails a full risk asessment. The requirements are described below.)
The forms you need to fill out are the following:
- Application form B – application form
- Appendix A – dossier on the active substance(s), or a Letter of Access to the substance dossiers
- Appendix B - dossier on the product
- Appendix C - if comparative assessment is possible (explanation below)
- Appendix PGB-PUB - a systematic description of the use of the biocidal product
- Appendix Composition - along with a valid MSDS of the biocidal product and all components of the biocidal product. The MSDSs should be less than five years old.
- Appendix 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.
- WG/GA, which is a Legal Conditions for Use and the Directions for Use of the biocidal product. Examples on what a valid WG/GA looks like can be found in the pesticide database on our website. The WG/GA should be in Dutch.
- Appendix article 95
Ad Appendix A
It is necessary to either send us a complete dossier on the active substances (accompanying Appendix A) or you can send us a Letter of Access which permits Ctgb to use an active substance dossier which has already been submitted. In that case you don’t have to provide us with the dossier yourself. Ctgb has labelled a number of active substances as 'bulk chemical'. For bulk chemicals you do not have to submit an Appendix A or LoA under transitional law. For these active substances you are allowed to refer to the substance information available at the Ctgb. It concerns the following chemicals:
Ethanol (CAS 64-17-5)
Isopropanol (CAS 67-63-0) (approved for Pt1 ,Pt2 and Pt4 : date of approval 01/07/2016)
Salicylic acid (CAS 69-72-7)
Sodium dichloroisocyanurate dihydrate(CAS 51580-86-0)
Sodium hypochlorite (CAS 7681-52-9)
Calcium hypochlorite (CAS 7778-54-3) ( approved for Pt2, Pt3 ,Pt4 , Pt5 : date of approval 1/1/2019 )
Peroxyacetic acid (CAS 79-21-0) (approved for Pt1, Pt2, Pt3, Pt4, Pt5 and pt6 date of approval 01/10/2017; Pt11 and Pt12 1/7/2018
Hydrogen peroxide (CAS 7722-84-1) (approved for Pt1, Pt2, Pt3, Pt4, Pt5 and pt6: date of approval 01/02/2017)
Please note that compliance with article 95 of the BPR is required after 1 September 2015 also for bulk chemicals. (More information on the approach for article 95 compliance in the Netherlands can be found here: http://www.ctgb.nl/en/biocidal-products/assessment-framework-biocidal-products/laws-regulations/article-95-list )
Ad Appendix B
In support of Appendix B information needs to be supplied on the product, especially on efficacy of the product and shelf life tests. Evaluation manuals on what tests should be performed and what the procedures should be for these tests are available on our website. (The evaluation manuals can be found here: http://www.ctgb.nl/en/biocidal-products/assessment-framework-biocidal-products/evalution-manual ) Please also read the pages on guidance.
Ad Appendix C
For an application for authorisation of a product based on active substance product type combinations that are not yet approved, it is sometimes possible for a number of aspects of the risk assessment (eg the risk to the operator, risk to the environment) to use a comparative assessment. A comparative assessment means that the risks associated with the use of the new product are compared with the risks associated with the use of a product already authorised in the Netherlands (the reference product). If the risk profile of the new product is "more favorable" than the profile of the existing authorisation, it can be concluded that the new product may be authorised as well.
If you believe that comparative asessment is possible, you can submit form Appendix C with your application. In a separate document or in the submission letter, you must explain/support why you believe a comparative assessment is possible. It is up to Ctgb to determine whether a comparative assessment is indeed possible for one or more aspects.
The application dossier can be submitted digitally by using an upload link (request through email@example.com) 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.
The entire application procedure for a regular authorisation under transitional law at the moment requires about 78 weeks, depending on the completeness of your application at the moment we receive it. Costs will normally be around € 15,000.- / € 20,000.- in total. You will receive an invoice for the application and the assessment fee. After authorisation you will be required to pay an annual fee for each authorised product. (Please find our tariff decree at http://www.ctgb.nl/en/what-is-the-ctgb-/fees-and-charges)
If you have questions about this information please contact the Servicedesk. Please note that depending on resources required to answer your questions the Servicedesk may require compensation for it's services.