1. Introduction
The CBS [Statistics Netherlands] conducted data exploration from October 2023 up to and including April 2024 for the purpose of setting up a monitoring system for the sale of biocides. The exploration was based on the following research assignment formulated by the Ministry of Infrastructure and Water Management (IenW): “Find the available sales figures for biocides and find out what conditions a national register would have to meet” as described in the project proposal. Once the final decision has been made to create the register, this report will be used as a starting point for a possible approach.
The Ministry of IenW is looking to gain further insight into the burden that biocides place on humans and the environment. One aspect that would be good to start with is the quantities of biocides that are sold on the market. Insight into biocide sales is essential if we want to monitor whether our policies are on track to achieving the goal of reducing exposure to harmful substances to negligible levels by 2050.
Neighbouring countries like Belgium and Germany have already implemented systems for the registration of biocide sales. This report takes a page from their approach by exploring what a sales register might look like in the Netherlands. In light of the cross-border effects of biocides it would makes sense to create such a register for the entire EU, but we are not at that point yet. Such a sales register will not be implemented in Europe any time soon, as it is not part of the current EU work programme under the Biocidal Products Regulation (BPR) (European Parliament, 2012). A European usage register will not become a reality any time soon, either.
In order to gain insight into the possibilities for a national registration system for biocide sales, the Ministry of IenW organised a series of discussions with parties in the Netherlands and abroad. They concluded that it is possible to create a biocide sales register, but that choices will have to be made with regard to its structure and place in the policy cycle. The results were summarised in an IenW notice, which served as an important starting point for the project described in this report. The CBS then had follow-up discussions with several of these discussion partners.
1.1 National register of authorised biocides
Biocides must be authorised for sale on the market. The website www.biociden.nl. is an important source of information about biocides. It is the central website for government information about biocides. Biocide manufacturers, suppliers and users can find information on this website about the authorisation process for biocides and regulations for labelling, use and supervision. This website also explains the different kinds of products (hereinafter product types) that are regulated under the Biocidal Products Regulation (BPR).1) This overview is also found in Annex 1. There are 22 product types (PTs) divided into four main groups, to which we will refer this report.
It is important to mention that in addition to biocides authorised under European law (BPR), there are also biocides on the national market that fall within the framework of Dutch transitional law (Wet gewasbeschermingsmiddelen en biociden [Plant Protection Products and Biocides Act]). This pertains to biocides that contain an active substance that has not yet been introduced/assessed in Europe and are therefore not currently subject to the BPR. Products under transitional law are beyond the purview of the European Chemicals Agency (ECHA) and they can be found in the database of the Board for the Authorisation of Plant Protection Products and Biocides (Ctgb). Products under European law can be found in both databases.
For technical information about the European authorisation process for biocides, please refer to the ECHA; see also their website echa.europa.eu, in particular the page on product regulations.2) The ECHA not only implements the BPR but other European laws on chemical substances as well.
Biocides that are sold in the Netherlands are subdivided into three types by the ECHA3):
- National authorisation: biocides that must be granted national authorisation or renewal of the authorisation (i.e. not for all of the European Union at once);
- Union authorisation: biocides that are granted regular European Union authorisation;
- Simplified authorisation: biocides that are granted simplified European Union authorisation.
National authorisations are listed in the registers of the Board for the Authorisation of Plant Protection Products and Biocides (Ctgb) and the ECHA. Union authorisations and simplified authorisations can be found in the ECHA register. In the future, all biocides that are authorised for the Netherlands will be registered with the ECHA, i.e. including national authorisations. It will be a while before this is the case, however. This is why it is necessary for the time being to include the Ctgb registrations in addition to the ECHA registrations.
The Ctgb website has two sections that are relevant for our purposes: the public authorisations report with basic information about the authorisations4), and the authorisations database with basic information about the authorisation and usage. The authorisations database contains detailed information about authorisations and approved applications of biocides and plant protection products.5) The authorisations database only contains information related to Ctgb decisions. In other words, if there is no Ctgb decision on an authorisation, the information will not be available on the website.
This means that we will have to use information from the Ctgb and the ECHA for the foreseeable future to compile a list of all national authorisations (and respective authorisation holders), and the results will then have to be cleaned up to remove double entries. This makes for a complex starting point for a register of all biocides. Some of the information that is published by the different databases is the same, but in some respect it is different. For example, the ECHA publishes the Hazard Statements (H Statements) as an extra variable in the download, while the Ctgb does not. On the other hand, the Ctgb publishes the “concentrations of active substances” as information you can download, while the ECHA does not. At the beginning of 2024, the ECHA stated in response to a CBS question that they did not have time to add the concentrations to their database or provide it as separate information.
If a product is not registered yet it cannot be sold either. This is why it is not included in the sales register.
1.2 Dangers of biocide use
Although biocides are useful and necessary, they contain substances that may be harmful to humans, animals and the environment. In October 2023 the National Institute for Public Health and the Environment (RIVM) published a report titled “Exploration of the risk factors for biocidal use: recommendations for enforcement, research and policy” (Wezenbeek & Komen, 2024). An important observation in this report is that there is no information on the quantities of biocides that are used in the Netherlands. The most hazardous substances can be found in products to control rat and mice populations, insecticides, and wood preservatives. Biocides are authorised for and used in many sectors, so this report focuses on the sale of biocides.
1.3 Structure of the report
The exploration conducted by the CBS consists of two activities, in conformity with the assignment. The results of the first activity are described in Chapter 2, which focuses on a substantive examination of biocide sales. The chapter discusses the biocide registers in neighbouring countries Belgium (section 2.1) and Germany (section 2.2). Section 2.3 compares these registers with the older European register for the sale of plant protection products. Section 2.4 is about the authorisations and sales that are known in the Netherlands, including an explanation of certain product types that are especially important to focus on first. The results of the second activity are described in Chapters 3 and 4. Chapter 3 provides an overview of the specifications for a well-designed (biocides) register. Chapter 4 presents several different scenarios for setting up a biocide register. The report ends with a list of works cited and three annexes.
2) See: echa.europe.eu, BPR: biocidal products regulations
3) See: echa.europe.euj authorisation of biocidal products. A data-rich website with the option of downloading authorised biocides as an Excel file.
4) See: Ctgb authorisation and use, public authorisations report, Excel file with basic information on all authorised and expired products.
1,840 biocides have been authorised as of January 2024. 322 biocides will expire in 2024.
5) See: Ctgb authorisations database, various filter options.