In situ generation of biocides

Exceptions to mandatory authorisation

Biocidal product legislation regulates the authorisation of biocidal substances and mixtures. Such substances or mixtures are subject to mandatory authorisation.

In principle, in-situ-generated biocides require authorisation from the Ctgb before they can be used in the Netherlands.
Two exemptions apply. As long as those exemptions are in place, these biocidal products do not require authorisation. The exemptions are described in Appendix 9 of the Regulations on plant protection products and biocidal products (Rgb) as in effect on 31 August 2013. That version of the Rgb remains in force until the relevant substances are subject to EU legislation.
The two exemptions are: 

• Ozone that is generated at the point of use by a device intended for that purpose is exempt.
• A chlorine compound that is generated from sodium chloride at the point of use by a device intended for that purpose is exempt unless the use involves the disinfection of pipes for drinking water for humans or animals.

The Ctgb interprets this last sentence as follows: "the disinfection of pipes for drinking water" means not only the disinfection of the pipes themselves (a PT04 use), but also disinfection via the drinking water (a PT05 use). This is because both the use for disinfection of pipes and the use in drinking water may potentially pose risks to human and animal health. In addition, in the near future, the exemption provided in Appendix 9 of the Rgb will expire because the EU Biocidal Products Regulation will take precedence. This means that authorisation will always be required for products used for disinfection of drinking water systems.

In the case of disinfection of drinking water systems for humans and animals with active chlorine generated from sodium chloride the Ctgb therefore recommends that an application for authorisation should be submitted not only for PT04 uses, but also for PT05 uses.

The exemption in the Netherlands will expire when the Dutch regulations are adopted in EU legislation. This occurs upon rejection of the active substance dossier by EU decision, upon approval of the EU substance dossier, or upon timely submission of an application for biocidal product authorisation after a decision has been made on this biocidal product application. If an application for authorisation of the biocidal product was not made on time (in case of approval of the active substance), then the exemption for this biocidal product expires on the date of approval of the active substance (see Article 89 of the Biocidal Products Regulation).

For an explanation of the current situation, see "EU approval of active substances" below.

In more specific terms, this means the following:

For ozone generated from air, water and oxygen, which is not marketed as an ozone precursor, timely submission of an EU substance dossier is required for PT2, PT4, PT5 and PT11. Once an EU decision has been made on approval, it will become clear when the exception for ozone will expire in the Netherlands (see "EU approval of active substances" below). Since 1 September 2017, ozone used as a biocide for other product types (PTs) or generated from substances other than air, water and oxygen, which is not marketed as a precursor, has not been allowed to be produced or used.

For chlorine compounds generated from sodium chloride, substance dossiers for PT1, PT2, PT3, PT4, PT5, and PT11 must submitted in the EU in a timely manner. Once an EU decision is made on approval, it becomes clear when the exemption for chlorine compounds generated from sodium chloride will expire in the Netherlands (see "EU approval of active substances" below). Since 1 September 2017, chlorine compounds that are generated from sodium chloride and that are used as biocides for other PTs have not been allowed to be produced or used.
Detailed information on this topic can be found in the ECHA database

 database of active substances(e.g. active chlorine or ozone).

EU approval of active substances, current situation

For some active substance/PT combinations that qualify for the above exemption, the review process has now been completed in Europe. These substance/PT combinations are included in the List of Approved Active Substances with the approval date (see Information on biocidal products – ECHA (europa.eu)). This means that the exemption for the Netherlands under the Rgb expires. As a result, an application for product authorisation is required.

Active substance	PT	Approvaldate	Implementing Regulation
Active chlorine generated from sodium chloride by electrolysis	1	1-7-2021	Commission Implementing Regulation (EU) 2021/364
	2-3-4-5	1-7-2022	Commission Implementing Regulation (EU) 2021/345
	11	Still under review
Ozone generated from oxygen	2-4-5-11	1-7-2024	Commission Implementing Regulation (EU) 2023/1078

Companies that market a biocidal product based on active chlorine or ozone in the Netherlands and wish to continue doing so after the expiration of the approval are required to submit an application for product authorisation before the approval date of the active substance/PT combination.

If an application for authorisation was submitted before the approval date of the active substance, and the product was already on the market in the Netherlands before that date, then the sale and/or use of the product may be continued during the assessment procedure.

If no application for authorisation was submitted, or it was not submitted until after the approval date, then the product may remain on the market for 180 days from the active substance approval date. After that, the biocidal product in question can no longer be on the market. One year after the approval date, this biocidal product may no longer be used.

Given the approval date of some active substance/PT combinations, there is currently a transition phase for these exemptions from the mandatory authorisation. In the interest of transparency, the table below shows the products for which an application for authorisation has been submitted on time.

• Please note that the Ctgb has no knowledge of which of these biocidal products are actually available on the market in the Netherlands.
• Keep in mind that neither the efficacy nor the safety of these biocidal products have been officially assessed since the products are subject to an exemption.
• Also note that products based on active chlorine that are used as PT11 are not yet subject to mandatory authorisation, as PT11 is still under review in the EU. This includes systems marketed for multiple uses, including PT11. For now, these products may continue to be marketed and/or used under the exemption provided in Appendix 9 of the Rgb (from 2013), regardless of whether the corresponding companies have submitted an application or not. 
• However, biocidal products for which an application for authorisation was submitted on time will be included on this list only after the expiration of the approval date of the active substance/PT combination.