Setting up a new register for biocide sales in the Netherlands

About this publication

This report presents an examination of available sales figures for biocides in countries neighbouring the Netherlands and of the conditions a national sales register would have to meet in the Netherlands. We propose setting up a pilot study for the purpose of developing a comprehensive sales register.

Summary

The CBS [Statistics Netherlands] conducted data exploration from October 2023 up to and including April 2024 for the purpose of setting up a possible 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”. This report discusses the findings for five research questions about setting up a biocide register:

  1. What biocide sales figures are included in the existing registers in Belgium and Germany?
  2. What can we learn from the existing European statistical system for the sale of plant protection products?
  3. How can the explored systems be adapted for the Netherlands? Can we include all product types right away, or would it be better to start off with a limited number?
  4. What are the starting points for a data registry system, and which institutional setting would be preferable?
  5. What scenarios can be used to set up a biocide sales register? The answers to these questions are briefly summarised below.

Approaches used in neighbouring countries

The first research question concerns the data, scope, classification and links used in the biocide registers in Belgium and Germany. The answers provided here are based on documentation and conversations.

Section 2.1 discusses the Belgian approach. Belgium has a requirement to register the sale of biocides (volumes per authorisation). A lot of information can be gleaned from the interactive annual reports that have been accessible since 2013. The Belgian system can be seen as an example of an existing national sales register. It provides yearly information about the amounts sold in Belgium by product type and main group, as well as by product name, active substance, and user category. This tells us which product types represent a large (or growing) share of biocide sales.

Section 2.2 describes the German approach. Germany set up a national register for biocide sales in 2022. Reporting biocide sales volumes is now mandatory. The German register has not been around long enough to provide the same information with the same level of detail for this report as the Belgian register.

Strategy for plant protection products

The second research question concerned the development of a plant protection products register in the Netherlands. Since plant protection products are similar to biocides, it is useful to include the information from this system in the recommendation. Section 2.3 explains what we can learn from the plant protection products system. For example, there is a basis under EU law for the registration of plant protection products, including the requirement for EU member states to provide sales figures. Biocides are not regulated at the European level (and only in a few cases at the national level: Belgium, Germany).

Second, we note that sales for plant protection products per kilogram of active substance are published annually, because these totals are relevant environmental information for the general public, policies and science. In light of this we can probably expect the publication of registered sales figures for active substances to become mandatory at some point as well.

And finally, the government is working with CropLife NL, an industry association that has been tasked with most of the data collection. To what extent this might also be useful for biocides is something that needs to be investigated further.

Lessons for the Netherlands

To answer the third research question, the lessons from the first two questions are restated in section 2.4 as a recommendation for a data exploration for a biocide sales register in the Netherlands. The sales data for two product types are currently available in the Netherlands as a result of an initiative by the Dutch Human Environment and Transport Inspectorate.

The recommendation is to always base a sales register on authorisations: without authorisation there is no basis on which to search the register for information. It would therefore make sense to have the authorising body manage the sales register, but this can also be done by an independent organisation that collects the information on behalf of the Ministry of IenW. There are national authorisations and international authorisations, granted by the Dutch Board for the Authorisation of Plant Protection Products and Biocides (Ctgb) and the European Chemicals Agency (ECHA), respectively. There is already a requirement that sales figures for authorisations must be included in the administration of the authorisation holders, but authorisation holders are not required to share these sales figures.

There appears to be little enthusiasm in the industry for a register that includes all product types. It is therefore advisable to provide a legal basis at some point for requests for information. It is advisable to start small with a pilot consisting of a few product types only. Section 2.4.12 lists considerations for selecting product types that would be appropriate for a pilot.

Practical aspects of setting up a register

The fourth research question concerns the practical aspects of a biocide sales register for monitoring purposes, and it is answered in Chapter 3 with a list of specifications for a well-designed register. This chapter includes recommendations for a description of the purpose, the target time frame, communication about the register, legal matters, data confidentiality, the structure of the register and quality control. The design of the register will depend on the legal requirements.

Planning stages

Chapter 4 includes a description of a pilot study conducted by an independent organisation. The study looked into practical experiences to find answers to unanswered questions and uncertainties in this report. The lessons from the pilot will also be used to determine the extent to which the planned register will become more comprehensive.

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.

1) See: biociden.nl, page with explanation of product types.
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.

2. Data exploration of biocide sales register content

This chapter covers the following questions from the research proposal:

  1. What biocide sales figures are included in the existing registers in Belgium (since 2011) and Germany (since 2021)? What is the scope of these registers (e.g. classifications, active substances, links to toxicity, observation methodology and output reports)? Who provides the biocide sales data? This is discussed in sections 2.1 and 2.2.
  2. What can we learn about monitoring biocide sales data in the Netherlands from the existing European statistical system for the sale of plant protection products?
    This is discussed in section 2.3.
  3. How can the explored systems be adapted for the Netherlands? What is feasible for the Netherlands, and what is not? Can we include all product types right away, or would it be better to start with a limited number, e.g. a “small start” including only those product types with the highest toxicity?
    Should the system include biocides for professional use only, or for non-professional use as well? This is discussed in section 2.4.

2.1 Sales registration in Belgium

Belgium already has a national sales register for biocides. The website biocide.be provides a lot of information. A conversation with the Biocide Department of the Belgian Federal Public Service for Health, Food Chain Safety and Environment yielded useful information about the approach of the Belgian biocide register. The following are the main conclusions from this conversation.

2.1.1 Purpose of the register

The Belgian register serves two purposes. The first purpose is to link the annual fee to sales volume and hazard classification of the products that are brought to the market. The second purpose is to comply with the various legal reporting requirements. The purpose of the system is not to monitor the effectiveness of policies, although it could be used that way in principle.

2.1.2 Legal basis

Biocides and other chemical products are subject to various safety laws and regulations. For example, biocides cannot be brought to the market unless they have been authorised by the Minister for the Environment. The website of the Federal Public Service for Health includes an overview of the main statutory provisions, such as Belgian Royal Decrees (Federal Public Service for Health, 2024).

The legal basis for the registration of sales is contained in the Royal Decree of 4 April 2019 concerning the making available on the market and use of biocidal products. The purpose of this decree is to guarantee a high level of protection for the health of humans, animals and the environment. The financial aspects, such as the calculation of the annual fee and assignment of a so-called score, are laid down in the Royal Decree of 13 November 2011. The Royal Decree of 26 October 2023 sets out the third federal reduction plan for biocides. An evaluation and update of this plan are scheduled for 2026.

2.1.3 Register holder

The register falls under the purview of the Biocide Department of the Belgian Federal Public Service for Health, Food Chain Safety and Environment.

2.1.4 Population

The term population refers to the units that are included in the register (see Section 3.6). The Belgian market is comprises approx. 3,600 legal products (authorisations, not including fifteen valid emergency authorisations). These products are supplied by approx. 700 authorisation holders. About two thirds of these were granted authorisation under national legislation in the Royal Decree of 4 April 2019, and one third was granted authorisation under the BPR regulation (European Parliament, 2012).

2.1.5 Data, method, and frequency

In Belgium, authorisation holders pay an annual tax based on sales volume and factors like the (eco)toxicity of the biocides (based on their hazard classification). Authorisation holders are asked every year to report the product quantities they brought to the market for each authorisation the previous year. The active substance concentrations are already known from the original application dossier. The calculation of product quantity based on active substance quantity assumes that one litre weighs the same as one kilogram. In other words, there is no distinction between solid and liquid formulations.

The requests for information are sent out in an automated email (in PDF format). Companies are asked every year to provide the data from the previous year before 31 January. If the data are not provided by that date, the annual fee goes up automatically. The same happens if payment of the fee is late (past 31 March). The calculation of the annual fee is based on the following formula:

amount due = 0.005*sales_volume*score

This fee was specified in the Royal Decree of 13 November 2011 (Federal Public Service for Health, 2024). The products are weighted on the basis of factors such as (eco)toxicity, which is expressed as a variable “score”.

This is done on the basis of the H(azard) Statements6) of the products. The more H Statements apply and the more serious the H Statement classification, the higher the score will be, and with that the higher the weighted (eco)toxicity of the product. The fee is a minimum of EUR 400 per year.

2.1.6 IT system

The current IT system for authorisation management is called “Gestautor”. This system was developed in-house by the Federal Public Service for Health in 2018 within the framework of the biocide innovation project. Gestautor is linked to Gestinfor, the Belgian SAS-based system that is used for quantities, for example. Volume is determined with volume Gestautor.

2.1.7 Output

In 2021, a report was published for the European Commission within the framework of compliance with the requirements of Art. 65 of the Biocidal Products Regulation (BPR), which applies to Germany and the Netherlands as well (European Parliament, 2012). The Commission praised this Belgian report covering the years 2013-2019 (European Commission, 2021) (Ministry of IenW, 2021). In its 2021 evaluation, the Commission noted the slow progress of the assessment due to a lack of resources and assessment capacity, and Belgium was a positive exception to this trend. A complete re-evaluation of the BPR at the European level will take place in 2025.

The collected information about the Belgian biocide market has been published annually since 2013 (Ministry of Health, 2024). The data have been made available online since 2018. The public report provides information about biocide quantities and active substances by group, product type(s), user types (professional, non-professional or both) and whether they are classified as free or closed circuit. The Federal Public Service for Health states the following on biocide.be:
“Biocides that pose a serious risk to one’s health belong in the closed circuit. These may be toxic, carcinogenic or harmful to the reproductive system. This is why these biocides are primarily reserved for a closed circuit of professional users. Individuals who use a biocide from the closed circuit should always wear personal protective equipment (e.g. gloves or a mask). The free circuit is for biocides that pose less of a risk and that do not require users to wear personal protective equipment.” (Federal Public Service for Health, biocide.be, 2024).7)

Public information is available for each product type, but not for each active substance. Confidential data may be viewed upon request, provided that the data will not be published. Quantities of active substances and biocides are publicly available for 2017-2022. Data on type of circuit and type of user are only available for 2017, 2018 and 2019.

To illustrate the Belgian system, Annex 2 contains a few tables that give an impression of what is published and what we might publish if we were to adopt such a system in the Netherlands. The Belgian output is available for active substance quantities and product quantities (per year, per product type and main group).

2.2 Sales registration in Germany

The German Ministry for the Environment took the initiative in 2021 to develop a national regulation on the sale of biocides. Among other things, the regulation includes rules for the mandatory reporting of biocide sales. The central German authorising body for biocides is the Bundesstelle für Chemikalien (BfC), which is part of the Bundesanstalt für Arbeitsschutz und Arbeitsmedizin (BAuA). The system falls under the purview of the BfC, which was closely involved in the development of the registration system. The national law was implemented in 2021 (Bundesamt für Justiz, 2021). Registration began in 2022.

As of 31 March 2022, manufacturers and importers of a biocidal product (intended for the German market or for export) must register the type and quantity in eBIOMELD. This provides the authorising body with up-to-date information.

Manufacturers and importers must provide specific sales information via an electronic form that can be submitted online (Bundesanstalt für Arbeitsschutz und Arbeitsmedizin, 2024). The form asks for information such as brand name, authorisation number, product quantity, active substance, product type and concentration of the active substance. The system was built with the standard internet software that was already being used by BfC. Initially there were some minor start-up problems, and the data analysis took more time than expected. We may experience the same issues when setting up a register in the Netherlands. There were also a number of software problems that resulted in reporting delays.

It is not clear to what extent the sales figures are complete. This is because many biocides on the German market fall within the scope of a transitional provision for existing substances. Authorisation was not required for these substances, so the authorities don’t have a lot of information about these biocidal products yet. However, it is clear that the reported information was not very complete at first. BfC responded by contacting the manufacturers and offering a workshop to address this issue. A German report for 2023 was not available yet at the time of this writing.

2.3 Sales registration for plant protection products in the Netherlands

In preparation for a possible biocide sales register, it is useful to learn from practical experiences with sales registration for plant protection products. Europe, including the Netherlands, Belgium and Germany, has an effective system for reporting plant protection product sales. This system has been in place for many years. It has developed into an annual European overview of product groups (main groups, product groups, chemical classes) by active substance.

The product classification is specified in a regulation (European Parliament, (EU) Regulation no. 1185/2009 on pesticide statistics, 25 November 2009). That means it is now possible to compare sales in different countries such as Belgium, Germany and the Netherlands. There is a clear-cut classification for each substance. The CBS publishes data about the sale of plant protection products in cooperation with the Ministry of Agriculture, Nature and Food Quality (LNV) (see below for more information). Similar possibilities with regard to biocides were discussed during a conversation with Platform Biociden (Dutch Biocide Platform).

Section 2.3 describes the background and design of the sales registration of plant protection products (2.3.1 - 2.3.8) and closes with a conclusion in section 2.3.9.

2.3.1 Purpose of the register

The purpose of the plant protection products register is to provide information about the national market and the European market of plant protection products. There has been a consistent series of reports in the Netherlands since 2010. The active substances are always classified the same way, based on main groups. The sale of plant protection products has been tracked in the EU since 2011, providing annual insight into the use of plant protection products.

2.3.2 Legal basis

The register is legally enshrined in three ways:

  1. The Plant Protection Products and Biocides Act. See Article 4 (on Ctgb duties) and par. 4 and 5 (about the Ministry of LNV): authorisation holders shall provide the Ministry of LNV with sales figures. If a par. 6 were to be added (for example: authorisation holders shall provide the Ministry of IenW with sales figures), this article could also apply to biocides.
  2. Article 67 of Regulation 1107/2009 (European Parliament, 21 October 2009) requires manufacturers to register sales figures for plant protection products and to specify a storage period.
  3. EU Directive 2009/128 on the sustainable use of pesticides (European Parliament, 2009) and EU Regulation 1185/2009 (European Parliament, 25 November 2009) on statistics for plant protection products (sales as well as usage).

2.3.3 Register holder

The Rijksdienst voor Ondernemend Nederland (RVO [Netherlands Enterprise Agency]) is the register holder. Every year, the RVO requests information from authorisation holders on the sale of active substances. Fytostat (product safety system) participants submit information via this system (see section 2.3.8).

2.3.4 Target population

The term target population refers to the units that are included in the register (see section 3.6). A large percentage of the data on sales by active substance (approx. 90%) is provided by CropLife NL via the Fytostat system. There are effectively 10 participants who submit reports on behalf of multiple authorisation holders. There are also approx. 100 other authorisation holders who submit data directly to the RVO.
Fytostat supplies data on the basis of active substance. The Fytostat database provides information about the underlying authorisation numbers, and it focuses on sales to professionals.

2.3.5 Data, method, and frequency

The data entry system is completely digital. Chemical and (micro)biological plant protection products are registered in the system. The system uses unique codes for the approved substances. The products are subdivided into four or six groups. The Ministry of LNV submits the data to CBS every year on 1 December t+1 (for example: the 2022 sales figures are submitted on 1 December 2023), and CBS and the Ministry of LNV publish the results six months later (i.e. the spring of 2024). The collaboration between these two organisations is governed by an agreement.

2.3.6 IT system

The current data delivery system was built in-house by DICTU. This is the IT organisation of the Ministries of LNV and EZK (Ministry of Economic Affairs and Climate Policy). A few new substances enter the market every year, and this needs to be incorporated in the reports. DICTU is responsible for the continual updating of the system as well.

2.3.7 Output

The output consists on the one hand of unweighted sales figures for each main product group, product group, chemical class, and active substance (implementation of EU Regulation 1185/2009), and on the other hand of authorisation regulation-weighted figures (trends) for four risk profiles and seven substance categories. The survey of unweighted sales figures is described in a survey description (CBS, 2024).

Annex 3 contains unweighted sales data for plant protection products for the Dutch market (by year, by main group, product group and chemical class). Eurostat publishes these unweighted sales figures as Agro Environmental Indicator (Eurostat, 2023). Every year, the Ministry of LNV publishes the unweighted sales figures for each active substance (Ministry of LNV, 2024). These details are being published in compliance with a court order following a lawsuit.

The Harmonised Risk Indicator (HRI) is published by Eurostat and by the Ministry of LNV (Ministry of LNV, 2024). In the European HRI (all plant protection products, including temporary exemptions) and in the Farm-to-Fork indicators (F2F; chemical products only) the market figures are weighted “toxicologically” based on authorisation group. The HRI is dropping faster than the sales volume.

Unweighted market figures for six risk groups are published by Eurostat in the detailed agri-environmental database (Eurostat, 2024). These risk figures (see Table G4 in Annex 3) lag a bit behind the sales figures (see Table G1 in Annex 3); the last two reporting years have not been added yet.

2.3.8 The Fytostat system

Manufacturers and suppliers of plant protection products have been registering their product sales on the Dutch market in the Fytostat system for many years. This was initially done on paper, but a digital system was implemented later. It registers “presentations”: products per packaging unit. The active substance concentrations are registered as well. The system also contains information about instructions for use and product safety sheets. This is consistent with the concept of Product Stewardship.

The system is owned by twelve companies, most of which are members of CropLife NL. Fytostat and CropLife NL are independent entities. The manufacturers in the Fytostat register represent a large market share in the Netherlands. Law Firm Brabers provides legal counsel.

The system underlying Fytostat will be fully digital by 2024. This means that administrative costs are low, according to Fytostat. For example, it does not take a lot of time to enter the data every month, also since the system can be linked to the manufacturer’s own systems. Information is entered digitally by the manufacturers. The data are then immediately processed in the system, without any intermediate steps.

Reports are generated by the system. Parts of the system are accessible to the participants. Competition-sensitive information, such as detailed sales figures for each authorisation, are not shared with the participants or external parties. An extract of the information (annual figures for the quantities of each active substance sold by all participating manufacturers combined) is shared annually with the Ministry of LNV via the RVO. The Ministry of LNV does not publish this information separately but as a component of all sales for that year.

2.3.9 Lessons from the plant protection products register

In this section we will discuss a few take-aways from the plant protection products register.

  1. The first thing we learned is that there is a solid legal basis for the registration of plant protection products and that providing sales figures is mandatory. It looks like it will be necessary to (eventually) have a legal basis for the mandatory provision of information for biocides as well.
  2. Second, we learned that the sales figures for individual active substance didn't use to be published, but these detailed sales figures are now being published as a result of litigation. It is therefore likely that the publication of sales figures for the active substances of biocides will become mandatory at some point as well.
  3. Third, the plant protection products are published annually by (main) group and by active substance. In other words, product quantities and weights are not published. A risk indicator is published as well. This indicator does not focus on the H(azard) Statements as such; instead, it follows the categories of EU Regulation 1107/2009. So the question is: what biocide groups would be useful, since there is no international European classification for these products yet?
  4. And finally, an IT system is already available for plant protection products. To what extent this system might work for biocides as well warrants further investigation.

While learning about plant protection products, we should not forget that the market for biocides is much larger than the market for plant protection products. There are 22 different product types, divided into four main groups. It is also much harder to gain insight into the import/export of biocides, because the international playing field for biocides is even more complex than that of plant protection products. The Fytostat system contains 600 plant protection products and 224 substances; the number of biocides is reportedly 3 times as high. The overlap between plant protection products and biocides is also unknown at this point. All in all, the biocide situation is much more complex.

2.3.10 European BPR work programme and SAIO Regulation

Plant protection products are an agriculture input. What is the current status of the European work programme for existing biocides as agriculture input (consideration 23 in Regulation 2022/2379) (European Parliament and the Council, 2022), cited below:
“Biocidal products constitute an important input in agriculture, for instance in veterinary hygiene and animal feed. Active substances authorised in plant protection products are often used in biocidal products. Regulation (EC) No 1185/2009 already identified the need to collect statistics on biocidal products for informed, science-based policies in the areas of agriculture, the environment, public health and food safety. Taking into consideration that the work programme for the systematic examination of all existing active substances contained in biocidal products under Regulation (EU) No 528/2012 of the European Parliament and of the Council (15) is still ongoing, with only 35 % of the related work completed, it is still premature to include biocidal products in the scope of this Regulation. As soon as the examination of active substances for use in biocidal products is finalised, the Commission should consider extending the coverage of this Regulation to include such products.”

When the SAIO was adopted in 2022, the BPR work programme was only 35% completed. The main agricultural concerns are veterinary hygiene and animal feed. The work programme will really have to pick up the pace if biocides in agriculture are going to be a topic of interest at the European level. As far as we can tell, there has not been much progress since 2022. The next evaluation of the implementation of the BPR (Article 65) is scheduled for 2025.

2.4 Towards a biocide sales register in the Netherlands

The authorisation registers of the Ctgb and ECHA are a logical starting point for a biocide sales register in the Netherlands. We spoke to the Ctgb to learn more about the Dutch authorisations. Discussions with Platform Biociden and Fytostat yielded insights into the Dutch supply sector for biocides. These insights into the authorisation register and supply sector are summarised below.

2.4.1 Purpose of the register

The State needs to be able to track the effect of implemented policies and make adjustments if necessary. The Ministry of IenW is therefore considering a monitoring system for the sale of biocides on the Dutch market.

2.4.2 Legal basis

If we want to have a sales register that is useful in terms of quality and quantity, there must be a clear legal requirement to report sales volumes for all biocidal product types to a government body, because there will probably be a certain amount of resistance to the idea of providing data. As a matter of fact, the Plant Protection Products and Biocides Decree (Article 24, administration of authorised biocides) already requires companies to keep records of the distribution and delivery/supply of authorised biocides, so the companies do have these data. The 2007 Plant Protection Products and Biocides Act and the Biocidal Products Regulation (BPR) could serve as the basis for the requests for and submission of information (Plant Protection Products and Biocides Act, 2024) (European Parliament, 2012).

2.4.3 Register holder

We will need a register holder to manage the register. It is not possible yet to select a register holder at this time. Since the Ctgb is already keeping a register of authorised products, it would make sense - and be consistent with the situation in Belgium - to place a biocide sales register within the purview of the authorising body as well. In that case, sales volumes could also be a factor in the reassessment of an authorisation. However, managing a biocide sales register is a lot of work and does not fall within the current scope of the responsibilities of the Ctgb. If the Ctgb is a candidate for implementation, we will have to take a good look at the financial and organisational preconditions.

The Rijksdienst voor Ondernemend Nederland (Netherlands Enterprise Agency, RVO) manages the sales register for plant protection products. So the RVO might be a logical candidate for biocide sales as well. It works together with the industry organisation for manufacturers with regard to the provision of information about the sale of plant protection products (see Section 2.3.4). It makes sense to talk to the manufacturers about their possible role with regard to biocides as well. More research needs to be done before the role of register holder is assigned to a particular party.

2.4.4 Target population

The term target population refers to the units that are included in the register (see Section 3.6). A registration system will be linked to the information that is available at the Ctgb and the ECHA about authorisation holders and authorisations. A growing number of authorisation holders are located abroad and may therefore be difficult to reach. We can also make a distinction between companies that are the authorisation holder and companies that are the first to bring a product to the national market. There is no information about the latter category, however.

2.4.5 Data, method, and frequency

The Ctgb database tells us if a biocidal product is authorised in the Netherlands for the professional or non-professional market. In addition to the information published by the Ctgb, we can find information in the ECHA database as well. This combined Ctgb and ECHA databases form the basis for the sales register.

The sales volumes are unknown and must therefore be requested. Biocides come in solid, liquid and gaseous form. Expressing a gas as a weight poses practical challenges. The concentration of active substance in a product is an important element in the calculation of output by active substance.

For biocides, the concentration is always expressed as a weight percentage: “weight of active substance / weight of product” (w/w). For plant protection products, g/L is also used for liquid formulations. At the European level, the SPC (Summary of Product Characteristics) lists the weight percentage of the active substance (including impurities). This information can be found in section 2 of the SPC. Volume percentage (%v/v) is not useful because it is not precise enough, but it is still used in rare cases (for ethanol).

There is also a nomenclature system in Dutch and in English. It would probably be best to use the English-language ECHA information, because they also implement REACH, the European regulation on the production and sale of chemicals.

It is important to make sure that confidentiality is ensured in any regulations on requesting information about sales volumes. This is a critical issue for businesses. The Netherlands is not considering a breakdown by closed versus free circuit as is the case in Belgium, so no additional information will be needed in this respect.

2.4.6 IT system

Because the Ctgb has no mandate at this time to develop a biocide sales register, a direct relationship with Ctgb software, like the relationships that exist in Belgium and Germany, is less likely here. Regardless of which party becomes the register holder, it would be wise to have a system that can automatically import ECHA database exports so the information can be easily updated.

2.4.7 Toxicity

The annual fee merchants pay for a registered biocide is EUR 1,425 (Ctgb, officielebekendmakingen.nl, 2023). This is a flat fee, regardless of the volume sold. This is different from the Belgian system, where the minimum fee is EUR 400 but the actual annual fee also depends on volume and toxicity.

If we want to link toxicity to biocidal product sales, it would probably be best to adopt the CLP (standard) classification. CLP stands for the European system for the Classification, Labelling and Packaging of chemicals. Hazard 3 and Hazard 4 statements are particularly important in this context. This information is easy to access as a download from the ECHA database.

Another way to link toxicity to sales is to base it on Article 19.5 of BPR authorisations. This refers to highly toxic products that do not meet the authorisation criteria but are authorised anyway because it is in the general public’s interest to do so. Unfortunately there is no way to search the databases using this criterion. In other words, you have to search through the authorisation decisions and the underlying considerations to get this information, which is a lot of work. Article 19.5 BPR applies in any case to PT14 products (on the basis of anticoagulants, cholecalciferol) and PT19 products (on the basis of DEET), but authorisation under Article 19.5 BPR could apply to other product types as well, such as P6 and P18 products for example.

Yet another way to link toxicity (as shown above) is through the publication of sales by active substance. Active substances have intrinsic properties, which may be a reason to approve the substance under strict conditions, for example if only small volumes are expected.

Another way to link toxicity is to look at scope of application, e.g. free or closed scope of application.

2.4.8 Market size

Every year, the Ctgb publishes an annual report on the state of affairs regarding the biocide register (Ctgb, 2022 Annual Report). During the past five years, the number of authorised biocides has steadily grown to more than 1,800 in 2022. The number of active substances, on the other hand, has grown only slightly to 160.

NL.1 Number of authorised biocides by product type in the Netherlands in October 2023
ProducttypeNumber of authorisationsNot professional use Professional useBoth user types
PT0113763596
PT0264387363193
PT03218020711
PT045101340592
PT05351268
PT0612801280
PT07180180
PT0811735856
PT09120120
PT10130112
PT11180015129
PT12165013827
PT13410410
PT14611582
PT152020
PT182151245635
PT1910290111
PT201010
PT214703017
PT220000
Total2 6453251 751569
Total excl. double countings1 8263121 133381
Source: Ctgb, public authorisations report, Oktober 2023

A report was also published for the Commission within the framework of compliance with BPR, Art. 65 for 2013-2019 (European Commission, 2021) (Ministry of IenW, 2021).8)

An overview of the classification of biocides by product type and main group can be found in Annex 1. As long as the sales volume of biocides is unknown, the number of authorisations by the Ctgb can provide a rough indication of the size of the market.

Table NL.1 shows that most of the authorisations, i.e. more than 60%, are for the professional market. The professional market also uses the highest concentrations of active substances. We note that categories PT02, PT04, PT18 and PT19 contain a lot of biocides, in absolute and relative terms, for non-professional use. In relative terms, PT19 has the highest number with 88%. Products for non-professional use often contain much lower concentrations of active substance. These products are ready for use. Professionals tend to use concentrates that have to be diluted before use. When looking at the total number, not including double entries, we note that more than 20% of the authorisations are for both types of users. In other words, the breakdown of the market is not absolute.

We also see in Table NL.1 that the total of almost 1,830 authorisations for the Netherlands is a lot lower than the 3,394 authorisations in Belgium in 2022; see Annex 2. Table NL.1 shows the figures for authorised products as of October 2023. Expired products are not included in the total of 1,830 authorisations for the Netherlands, even though recently expired products are often still allowed to be sold during that year. Or the parties may have agreed on a delivery period so the entire inventory can be purchased and the product phased out. More careful counts of PT14 in 2023 yield 23 expired authorisations for professional use that were still allowed to be sold that year. If we add these 23 to the 61 in the Table, we get a total of 84 authorisations and biocidal products.

NL.2 Number of authorisation holders by product type for simplified authorisations in the Netherlands in October 2023
Producttype Number of authorisation holdersNumber of simplified authorisations
PT01 429
PT02 715
PT03 12
PT04 412
PT14 22
PT19 2034
Total3894
Total excl. double countings3094
Source: ECHA, Oktober 2023

In addition to the number of authorisations by the Ctgb, we can also assess the biocide market size based on the number of simplified authorisations at the ECHA. The purpose of the simplified authorisation procedure is to authorise biocides with a low risk profile through a simplified process (ECHA website)9). To be eligible for the simplified authorisation procedure, a biocidal product must meet each one of the following conditions:

  • All the active substances contained in the biocidal product appear in Annex I of the BPR and comply with the specified restrictions;
  • The biocidal product does not contain any substance of concern;<
  • The biocidal product does not contain any nanomaterials;
  • The biocidal product is sufficiently effective;
  • The handling of the biocidal product and its intended use do not require personal protective equipment.

Under the BPR, applicants are allowed to register multiple product names under the same authorisation number. For example, the 29 simplified authorisations for PT01 cover about 180 different product names. Some of these are sold in the Netherlands, but some are not (this info is not available). You can often tell by the name whether the product is intended for the Dutch market, the German market or the Greek markets, for example.

The BPR provides for the authorisation of certain biocides at the European level. This enables companies to sell their biocides throughout Europe without having to obtain individual national authorisations. European authorisations grant the same rights and impose virtually the same obligations in all the members states as is the case for national authorisations. Many product types are eligible for authorisation by the European Union, with the exception of biocides that contain active substances that meet the exclusion criteria and belong to product types 14, 15, 17, 20 or 21 (ECHA website).10)

Table NL.3 shows the size of the biocide market by number of EU authorisations at the ECHA. Multiple product names per authorisation number are permitted here as well.

NL.3 Number of authorisation holders by product type for Union authorisations in the Netherlands in October 2023
ProductType Number of authorisation holdersNumber of Union authorisations
PT01 824
PT02 1995
PT03 15130
PT04 1890
PT06 26
PT08 11
PT11 23
PT12 12
PT13 12
PT18 45
Total71358
Total excl. double countings39358

And finally, Table NL.4 shows the size of the biocide market by number of authorisation holders with a focus on professional use, with a somewhat later reference date (February 2024) than the authorisations in Table NL.1 (October 2023).

NL.4 Number of authorisation holders by product type in the Netherlands in 2024 (not including authorisations for non-professional use only)
ProductType Number of authorisation holdersNumber of authorisationsAuthorisations per holder
PT01 611342,2
PT02 1915362,8
PT03 732092,9
PT04 1614702,9
PT05 30341,1
PT06 231195,2
PT07 4184,5
PT08 221195,4
PT09 5122,4
PT10 8131,6
PT11 93 1832,0
PT12 871681,9
PT13 12413,4
PT14 21 602,9
PT18 381143
PT19 7172.4
PT21 8 475,9
Total8442 294
Total excl. double countings3521 5214,3

Sales on the basis of more than 1,500 products could be reported by about 350 authorisation holders. Once again we see large numbers of double entries in the reporting by product type.

2.4.9 Human Environment and Transport Inspectorate for Chemical Substances

For the past 2 years, the Human Environment and Transport Inspectorate (ILT) has conducted a sales inventory for a number of product types within the framework of risk-oriented enforcement. One important risk aspect the ILT focuses on is volume. These are the first results for a register of sales in the Netherlands by kg of active substance. We now have sales information for PT14 (rodenticides) and PT21 (antifouling products).

So how much PT14 (rodenticides) is sold in the Netherlands?
Authorisation holders for PT14 biocides were asked by the ILT to provide the volumes they sold in 2020 and 2021. As a basis for the reporting, the ILT referred to Article 68 of the Biocidal Product Regulation BPR, which states that authorisation holders must keep records and provide the data if the relevant authority asks for it. The article does not prescribe a particular way of record keeping, so there are significant differences in the administration of the different authorisation holders. This makes requesting and processing the information more time-consuming. The ILT also referred to Article 6.1 of the General Data Protection Regulation (GDPR), which states that the processing of personal information is lawful if it necessary for the performance of a task of the controller.
Table NL.5 shows the observed quantities by active substance. In 2021 this was 244 thousand kg in products and 83 kg in active substance for PT14. The bulk of this is alpha-chloralose (69 kg). This survey will be repeated in 2022.

NL.5 Quantities of biocidal products and active substances for product type PT14 in 2020-2021 (in kg)
Active substance20202021Remarks
Alfachloralose63,8669,01approx, 10% increase
Brodifacoum2,102,39approx, 10% increase
bromadialone1,872,32approx, 20% increase
Cholecalciferol00,70
Coumatetralyl3,53,96crease with ca 10%
Difenacoum2,712,78stable sales, approx. 20% decrease for most product
Difethialone2,421,91decrease with ca 20%
Flocoumafen0,080,05
Active substance total76,5483,12approx, 10% increase
Total product248 024244 3104 thousand kg less in products

Reporting data that are requested by the ILT is required under the General Administrative Law Act. Requests for product sales information results in a lot of different units and a lot of different product names. For authorisation holders who cover the entire Benelux it was necessary to estimate the percentage representing NL sales. The industry organisations and other organisations like Platform Biociden did not participate in the request process.

Compared to the results for Belgium (see Annex 2), we note that more PT14 was sold in Belgium in 2020 (active substance: 120 kg in Belgium versus 77 kg in the Netherlands). The amount of product sold in Belgium was actually 3 times higher than in the Netherlands.

So how much PT21 antifouling was sold in the Netherlands? Data for 2021 and 2022 were collected from 8 authorisation holders.

NL.6 Quantities of biocidal products and active substances for product type PT21 in 2021-2022 (in kg)
Active substance20212022Remarks
Dicopper oxide263 467313 871increase
Copper thiocyanate6 5426 553increase stable
Copper pyrithione7 12113 095increase
4.5-chloro-2-octyl-2H-isothiazolin-3-one3 2232 038decrease
Zinc pyrithione688656increase stable
Zineb5 9537 402increase
Total active substance 286 991343 615increase
Total product840 000

Using paint as an example, based on Ctgb concentrations (w/w) and specific gravity, we calculate that 575,000 litres of paint is equivalent to 840,000 kg antifouling, which in turn contains about 340,000 kg active substance. So that is easily 40% of the products in kg. Compared to Belgium (see Annex 2), we note that less PT21 was sold in Belgium in 2021 (active substance: 55.1 tonnes in Belgium versus 287 tonnes in the Netherlands).

2.4.10 Other activities, plans, specifications

With regard to PT12 products (slimicides) that are used in the Netherlands, the ILT looks at the processing water of the paper industry, but slimicides are used in other sectors as well. Requesting volumes of slimicides will therefore not provide an accurate picture of amounts used in paper production. The amounts used in paper production are a hazard because they are discharged into the surface water, which is described as a risk by Wezenbeek and Komen (2023).

Other planned PT activities: inspection of the disinfection of public swimming pools (PT2), a quick scan of concrete preservation (PT10) and fuel preservation, and possibly inspection of ant control (PT18).

The ILT would welcome a register for biocide sales of PT14 and any biocides that are used in bulk. The ILT monitoring is explained on the website www.biociden.nl11) and the ILT website12).

In addition, the Netherlands Food and Consumer Product Safety Authority (NVWA) also monitors biocides by keeping track of the sale of biocides to private users, the use of biocides in a number of specific sectors, i.e. the food industry, the meat and fish processing industry (PT04), the hospitality industry and craft businesses: in particular products for professional and industrial use and the healthy/beauty sector (PTs 01 and 02), and the agricultural sector (PTs 03, 04, 14 and 18).

There are three other organisations besides the ILT and NVWA that are involved in enforcement and biocide monitoring. The DNetherlands Labour Authority (Ministry of Social Affairs and Employment, SZW), the Health and Youth Care Inspectorate (IGJ) and the (Association of) Regional Water Authorities.

2.4.11 Pros and cons of collaborating with the business sector on a sales register

Regardless of the content of the register, one option would be to collect data on volumes via the systems of the various industry sectors/ authorisation holders. During a conversation with the Platform for Biocides (PB), they indicated that they were open to a pilot for reporting biocide sales via (a system based on) Fytostat. Various benefits of collecting data at the industry level were mentioned.

Benefits for the government:
  • Reduced complexity and fewer implementation risks for the government department in question.
  • Potentially lower implementation costs, especially if we use Fytostat’s decades of experience as a starting point for further development.
Benefits for businesses:
  • Better options for improving product stewardship by sharing additional relevant information with the entire chain, such as the most up-to-date user instructions that are easy to find for users. This could promote proper use and fewer incidents, so the authorisation will continue to be renewed.
  • The numbers are aggregated by active substance when they are submitted to the government. This reduces the risk of disclosing the sales figures of individual authorisation holders, for example as a result of the Århus Convention.
  • Fewer people have access to the sales figures of individual authorisation holders, which reduces the chance of a leak.
  • The data can be used for market analysis, which will give companies insight into their relative market position. This will help companies who participate in Fytostat to improve their business operations.

A register in partnership with the Platform for Biocides will have a better chance of success if the industry organisation is a member already. This condition applies in any case to rodenticides (PT14).

Creating an inventory of sales figures will probably be more efficient if it can be done via the existing Fytostat system (see section 2.3.8 about the registration of plant protection product sales). The system would need to be populated with biocides in that case.

A disadvantage of collecting information via industry organisations is that product types whose authorisation holders are not as organised will not come into view until later, if at all. And these might be the most hazardous biocides. Another disadvantage could be that the industry becomes too influential and begins to steer policies to their own advantage.

2.4.12 Selection of product types

As a first step towards the goal of a national biocide sales register we could start small with a limited number of product types, or we could include all product types right from the start. If we opt for a “small” start with a focus on only (the most) toxic PTs, we could gain experience with the register first and then expand it later to include more product types. We could start with a pilot (see section 4.1), followed later by expansion to create a comprehensive register.

This section reflects a mix of assessments on the basis of conversations with Ctgb employees, RIVM findings, and comparisons with the Belgian market. Another factor is the extent to which authorisation holders should be involved in the inventory process. See Annex 1 for an overview of the different product types.

The smallest start would be with one product type, like PT14 for example. The sale of rodenticides is already strictly regulated in an IPM (integrated pest management) system. There are other reasons to focus on rodenticides. The authorisations fall under Article 19.5 of the BPR. The active substances are intrinsically toxic. Manufacturers who are part of Platform Biociden accept that sales of these products have to be registered.

Say we expand the start to include more PTs, such as PTs that are considered especially important, at least 1 per group, e.g. PT01 (human hygiene), PT08 (wood preservatives), PT14 (rodenticides), PT18 (insecticides, acaricides) and PT21 (antifouling products). The industry is already flagging practical challenges at that point, according to Platform Biociden. PT01, PT08 and PT18 are categories with a large number of authorisations (at least one hundred per product type), which would make this limited pilot a challenge.

The industry has also indicated that any sales registration would have to be mandatory. Making registration mandatory for some PTs but not others might come across as arbitrary, which can be avoided by imposing the registration requirement on all PTs.

The extent to which substances have been assessed at the European level could be a criterion. The RIVM report on potentially hazardous substances states in section 7.2 that the assessment process within the European framework has been completed for almost all active substances in PT08, PT14 and PT21 (Wezenbeek & Komen, 2024). On the other hand, biocides that have been authorised in the Netherlands under the transitional provision of the Plant Protection Products and Biocides Act (Wgb) have also undergone extensive assessment and their hazardous properties are therefore well known here.

Looking at biocide sales volumes in Belgium, it seems that we would need to include disinfectants and preservatives in the sales figures.

Another way to select the product types is to base it on the type of usage of biocides and how essential this is in relation to environmental safety/exposure. An example of this can be found in the report titled Meetstrategie Biociden (Biocide Measuring Strategy) about prioritising and selecting biocides for inclusion in monitoring programmes within the framework of water quality and risks for the aquatic environment (KWIK, 2022).

In the section below we will discuss different product types, ranked by the importance of their inclusion in a small start.

Biocide product types that are especially important:
  • It is extremely important for PT01 (human hygiene) sales figures to be available. We would like to know, after all, what chemicals we are applying to our skin in the context of proper human hygiene. During pandemics such as COVID, it is also important to have information about compliance with recommendations over time, which could be deduced on the basis of the sale of PT01 products.
  • Wood preservatives, PT08, have been an area of concern for the past 30 years because of their effects on the environment. Changes in the sale (and use) of these products may be relevant for comparative assessments and national policy. PT08 contains approved active substances that meet the substitution or exclusion criteria but that have been approved in the interest of the general public (Article 19.5 of the BPR). See also section 8.8 of the RIVM report, which recommends prioritising these substances, among others.
  • Many of the products in PT14 (rodenticides) were authorised in the interest of the general public (Article 19.5 of the PBR). These products are extremely toxic to humans and/or other organisms. An IPM system was introduced to limit their use. Sales figures are crucial to determine the effectiveness of the IPM system.
  • PT18 (insecticides, acaricides) includes many substances with relatively high toxicity. This affects insect populations, so sales trends are relevant for policy purposes. Serious incidents occur sometimes (e.g. the 2017 fipronil incident), so insight into sales figures can be very useful. If we collaborate with Fytostat, a focus on PT18 would make sense because the Fytostat database contains substances that are (or were) used as biocides and as plant protection products. This creates an opportunity to distinguish between causes (biocides or plant protection) when measuring substances in the environment.
  • PT21 (antifouling products) is important for water quality, since these products and substances end up directly in the surface water (through leaching). This is a limited group of products for which comparative assessments may become relevant in the future. Sales figures and trends are important information in that context.
Biocide product types that are very important
  • Animal disease and disease prevention using PT03 (veterinary hygiene) products are common issues, so sales info is likely to be important.
  • PT19 products (repellents and attractants) that are applied directly to the human skin are important. Some of these (DEET) are approved in the interest of the general public (Art. 19.5 BPR). These substances often have harmful effects (substitution or exclusion criteria).
    Sales trends may be useful for policy purposes and for comparative assessments.
Biocide product types that are somewhat important
  • PT02 (disinfectants and algaecides that are not used directly on humans or animals) is a tricky PT because it encompasses so many different applications. On the one hand, this means that there is a high likelihood that the sales data will be useful, but on the other hand these sales data will not tell us much about specific applications within this PT. In practice, it is difficult to distinguish between PT2 (disinfectants and algaecides that are not used directly on humans or animals) and PT4 (food and feed area).
  • PT05 (drinking water) is subdivided into drinking water for human consumption and drinking water for animals. Drinking water for human consumption is regulated by effective laws and quality/hygiene controls. The risk of incidents when treating drinking water for animals is much higher, and it could be useful to have sales information within this context.
  • Products that are used for the preservation of water or other liquids in cooling and processing systems by managing harmful organisms such as microbes, algae and mussels (PT11) are currently a cause of concern due to toxicity and the fact that these are sometimes discharged directly into the surface water. This concern also applies to PT12 (slimicides).
Biocide product types that are less important
  • PT04 (food and feed area) is important for the safety of our food supply. However, food preparation (especially at the industrial level) is already regulated by other provisions (e.g. HACCP (Hazard Analysis and Critical Control Points) regulations) that provide insight into the hygiene measures in this field.
  • Only a limited number of substances is available in PT06 (preservatives for products during storage), PT07 (film preservatives), PT09 (fibre, leather, rubber and polymerised materials preservatives), PT10 (construction material preservatives) and PT13 (working or cutting fluid preservatives). Relatively small amounts/concentrations are used for individual applications. Usage within these PTs is very specific. The importance of sales figures has more to do with insight into shifts in the use of these products than with a concern for risks or incidents.
  • Only 1 or no authorised products in PT15 (avicides), PT16 (molluscicides, vermicides and products to control other invertebrates), PT17 (piscicides) and PT20 (control of other vertebrates).
  • Almost no products in PT22 (embalming and taxidermist fluids) have been authorised in the Netherlands according to Table NL.1, but in practice they are used (and therefore sold). These substances are hazardous (e.g. formaldehyde) and very much in the interest of the general public. Sales trends and, at some point, a comparative assessment, are important for these substances. Three PT22 products were authorised for the first time in the Netherlands in March 2024, all on the basis of formaldehyde for professional use. The use of formaldehyde is not permitted for laying out a body at home.

There is very little support in the industry right now for a pilot that includes many or all PTs, and the same goes for the industries and companies that are Platform members. Industry support does not need to be a deciding factor, but it is something to take into account.

There is more support for a pilot with just a few PTs, which would still provide more information than a pilot with only one PT. A pilot should at a minimum include PT14 products (rodenticides). Broader experience with measuring sales would be gained if the pilot were to include at least one PT from each main group: PT01 (main group 1), PT08 (main group 2), PT14, PT18 (main group 3) and PT21 (main group 4). It is very important for us to know the sales figures for the included product types (PT01, PT08, PT14, PT18 and PT21).

In addition to these PTs, it is also very important to know the sales figures for PT03 (main group 1) and PT19 (main group 3) at some point. With regard to PT19, we should note that a large percentage of the sales is for non-professional use.

It is somewhat important for us to know the sales figures for PT02, PT05, PT11 and PT12. The following are of (very) limited importance: PT04, PT06, PT07, PT09, PT10, PT13, PT15, PT16, PT17, PT20 and PT22.

6) H(azard) Statements refer to health (H3) and/or environmental (H4) hazards associated with the biocide.
7)The Netherlands does not make a distinction based on circuits.
8)Reports from the Netherlands, Belgium,
Germany and other EU member states are available at https://health.ec.europa.eu/biocides/report-implementation-regulation-eu-no-5282012_en.
9)See: ECHA.
10) See: ECHA.
11)See: biociden.nl/toezicht
12)See:ilent.nl/onderwerpen/biociden

3. Practical aspects of monitoring biocide sales

This chapter discusses the practical aspects that are relevant for setting up a monitoring system for biocide sales. Conversations with (and specifications of) the Ministry of IenW have been included in this advisory report. The topics that are covered are based on research on important aspects of (meta)data quality and quality indicators for administrative data sources (Daas & Ossen, Metadata quality evaluation of secondary data sources., 2011) (Daas P., et al., 2011). These aspects are in line with most of the elements of question four in the research proposal:
d) What are the starting points for a data registration system (e.g. confidentiality)? In general terms, what software and hardware requirements (one or more intended uses, minimisation of administrative costs, etc.) and what institutional setting would be preferable (independence, private or public, etc.)?

3.1 Purpose and use

3.1.1 Purpose of the register

The purpose of the register is to gain insight into the use of biocides in the Netherlands and the resulting (toxic) burden on humans and the environment. Information about biocide sales is an important link in the learning process. This is because the use of biocides is difficult to measure, but biocide sales (via authorisation holders) are easier to track. Since there is a relationship between sales and actual use, one of the strategies is to develop a sales register. This will enable us to base our priorities and the direction of biocide policies on evaluations of the effects of previously implemented policy measures.

3.1.2 Intended use of the register

The register will be used to determine the quantities of biocides and/or active substances in biocides that are sold on an annual basis in the Netherlands. Data for multiple years will provide policy makers with insight into increases and decreases over time. In the long term, this will also help us make connections with environmental emissions.

3.1.3 Public access to the register

Microdata (data collected at the level of the authorisation holders) are usually considered confidential and are not available to the public. The totals of these figures, which cannot be used to identify individual authorisation holders, may be published, however. These totals represent relevant environmental information, which is in the interest of the general public. A legal basis, taking into account the Århus Convention, will be needed to determine exactly which totals (i.e. which aggregation level) can be published. If the information is competition-sensitive, we could opt for delayed publication, for example after a year or two. Section 3.5 discusses the confidentiality of (micro)data in greater depth.

3.2 Time frame for intended use and outcomes

3.2.1 Frequency of outcome calculations

We recommend adapting the frequency of outcome calculations to the frequency needs of policy makers. The maximum frequency depends on how often new data are submitted to the register. If there is a continual inflow of new information into the register, outcomes can be calculated more frequently. This process should always take into account statistical security (see section 3.5). For the time being, we are assuming a frequency of once a year, with reports covering the preceding concluded year. This will give the authorisation holders enough time to submit data and it gives the register holder enough time to process the data and make corrections if necessary. This frequency is sufficient for monitoring and for policy adjustments.

3.2.2 Publication date

Because the information may be competition-sensitive for authorisation holders, we recommend publishing the calculated totals no sooner than one (or two) years after the end of the period to which the data refer. Biocide sales for 2021 could be published in January 2023 (see also section 3.1.2).

3.2.3 Developments with regard to authorisation holders

As a group, the authorisation holders from the Ctgb and ECHA registers are a good source of information for the register. Tracking product types (PTs) and the start and end date of each authorisation gives an idea of how the market for biocides develops over time for each PT. This also tells us, once it’s time to request data, which (new) authorisation holders need to be approached. Some biocides are authorised for multiple PTs, which can in turn be used in other products as well. To prevent double entries, this will be taken into account in the structure of the different tables in the register and later calculations (see section 3.10.3). In some cases, an expired authorised product may be supplied (and used up) for a certain period after the end date. So it would be useful to approach authorisation holders for (recently) expired authorisations as well when requesting information.

3.3 Communication

3.3.1 Communication between register holder and respondents

The register holder must clearly explain the purpose of the biocide register and specify what it will not be used for. No competition-sensitive information will be shared with other authorisation holders, but the authorisation holders will receive general information, for instance via Platform Biociden, about statistically secure aggregated data. The most suitable mode of communication (e.g. via regular mail, email or telephone) will have to be investigated further and will depend on the budget.

3.3.2 Communication about data quality

The register holder will contact the authorisation holders if the submitted data are of insufficient statistical quality, for example because data are missing or because there are clear indications that the submitted data may be incorrect. In that case, the party in question will either be asked to supply additional data or to check whether the submitted data are correct. There may be additional communication about the situation if necessary. This communication may be orally and in writing, or in writing only for evidence purposes. Whether the register holder is legally authorised to initiate contact by telephone (or in writing) will have to be determined. This only works if there is a legal requirement stipulating who is authorised to initiate contact.

3.3.3 Communication about overdue data

The register holder has an active policy of reminding parties if data are not submitted on time. When reminders are issued and how (by mail, email or orally) will be specified.

3.4 Legal matters

3.4.1 Legal basis

The design of the register will depend on the legal basis, if any. Mandatory reporting may have a positive effect on the quality and quantity of the data. Voluntary reporting entails the risk of methodological challenges such as selective responses and varied response times.

There is a realistic chance that NGOs or the public will ask for the aggregated information to be made public. This is why we recommend stipulating from the start how the information will be made available. A useful starting point at the international level is the biocides regulation (European Parliament, (EU) Regulation no. 528/2012 concerning the making available on the market and use of biocidal products, 2012) and at the national level the Plant Protection Products and Biocides Act, (Wet gewasbeschermingsmiddelen en biociden, 2024). The requirement (based on Article 67 of EC1107/2009) to provide information to the competent authority about the sale of plant protection products may serve as inspiration (European Parliament, (EC) Regulation no. 1107/2009 concerning the placing of plant protection products on the market, 21 October 2009).

3.4.2 Purpose limitation

The purpose of the register is to collect aggregated information about biocides and emphatically not to impose fines. If the latter were the goal, this would not be conducive to the willingness of authorisation holders to provide accurate data. Enshrining the purpose in law will therefore promote data quality and data quantity.

3.5 Confidentiality of the (micro)data

3.5.1 What measures will be taken to protect the confidentiality of the microdata?

The following measures may be taken:

  • It is crucially important that microdata are never emailed (or otherwise communicated) outside the register holder’s IT environment.
  • Ensure that users of the register can only be identified by their own internal ID number and that no other identifying information is visible. The link between the authorisation holder’s number / Chamber of Commerce number and the user’s own ID number will be stored separately (in a different location). This will limit the damage in the event of a leak.
  • The register holder must be an independent, certified party. Further research is needed on the exact certifications that will be required; ISO 9001 and ISO 27001 are two possible certification options.
  • Ensure that the IT environment of the register cannot be accessed by more people than absolutely necessary: specify exactly who will have access. Specify which (direct) employees of the Ministry of IenW will have (remote) access to the data, and which employees of other government or research organisations will have (partial) access.
  • We also recommend specifying which (supervisory) organisations are explicitly not permitted to access the microdata. This is to reassure authorisation holders that the data will not be shared with supervisory authorities.

3.5.2 What measures will be taken to protect the statistical security of the data?

With regard to the security of public aggregated data, it is important to apply statistical security methods, such as non-traceable classification or rounding (Hundepool & de Wolf, 2010). Which of these methods is suitable for the microdata and which for the intended public output will be determined when more specific descriptions are available for both.

It would also be a good idea to think about the intended use of the microdata. Will the biocide data be combined with other data later on for the purpose of further breakdowns? For example, additional data on toxicity and other factors will be needed to make a connection with the environment. This is why it is important that any expansion of data to be included in the register is technically feasible. If there is a need later on to further categorise the authorisation holders (e.g. based on sector or size) in addition to the breakdown into professional and non-professional markets, the statistical security will have to be re-evaluated for each breakdown.

Every breakdown increases the risk of statistical disclosure and must be weighed carefully against the usefulness of the breakdown. The plant protection products register publishes results at the national level, not broken down by region. It is worth considering whether we should use the same approach for the biocide register. Sales in one region are not a guarantee that these products are used in that same region, so regional numbers may lead to false precision. The content of the data will have to be known in order to determine whether breakdown by region is useful.

3.6 Target population

The term target population refers to all units that would ideally be included in the register if we want to determine the total sales figures for biocides in the Netherlands.

3.6.1 Definition of administrative units

The target population of the register consists of all authorisations that apply to the sale of biocides in the Netherlands. There may be cases where one authorisation holder (a company that has been granted authorisation to sell biocides in the Netherlands) has multiple authorisations. An authorisation grants permission for the sale of one or more specific products of an authorisation holder.
This is why it is important that the register includes descriptions of the authorisations (units of the target population with specific products) as well as the authorisation holders and the relationship between the authorisations and the authorisation holder.

The authorisation holders are the appropriate units to ask for information for the purpose of collecting data on the sale of biocides. This is to prevent authorisation holders being contacted separately for each authorisation.

3.6.2 Subpopulation for the pilot

To gain experience with setting up the register and identifying potential issues, we recommend setting up a pilot with a subpopulation consisting of authorisations relating to a small selection of PTs. This selection could consist of one PT per main biocide group, for instance. A few considerations when selecting the product types are discussed in section 2.4.12.

3.7 Identification of units

Identifying target population units (the authorisations) and reporting units (the authorisation holders), hereinafter referred to as respondents, is important to be able to verify whether all (or the main) units have provided data. If there are changes in the structure of the authorisation holder’s company (split-ups, mergers, etc.), these developments must be clear in order to be able to link the correct units (respondents) to each other.

3.7.1 One identification variable

Ideally, the Chamber of Commerce number of each authorisation holder will be known to the register holder. These numbers can serve as unique identifiers for these units. Even so, companies may have complex structures and the Chamber of Commerce may establish and dissolve units. Names of authorisation holders can be found in the authorisation databases of the Ctgb and ECHA. If you know the name, you can look for the Chamber of Commerce number (via Google or web scraping, for example). Given the application procedure for authorisation, companies are probably motivated to make sure that the “in name of” part of the authorisation is properly established and not affected by structural changes.

Identification of the authorisations is just as important as identification of the authorisation holders (respondents). Authorisations are assigned a unique authorisation number and it is a good idea to include this number in the registration to prevent double entries (e.g. because they are listed in both the Ctgb and ECHA registers).

3.7.2 A combination of identification variables

If there is no single identification variable that is available for authorisation holders, the alternative is to use a combination of variables to refer to a unique unit. It is possible to identify authorisation holders on the basis of company name, address and telephone number, but this is not nearly as precise as a unique identification number because there is a risk of erroneous or missing links with the list of companies of the Chamber of Commerce or the general business register (ABR) of the CBS. So we can never be entirely sure that all the targeted respondents have reported the information.

3.8 Target variables

Target variables are variables (other than the identifying variable(s)) that should be included in the register and that can be used to publish aggregated information at a later point.

Some biocides appear in several product type categories, so it would be useful to specify the relationship between biocide and product type in a separate (key) table: the authorisation table. This would enable us to calculate totals by product type (see section 3.10.3). The authorisation table should be as consistent as possible with the information from the Ctgb and ECHA registers. A few examples of possible tables are shown below.

There are various variants we could use to structure the register. It makes sense to use different tables for each unit. There are three possible variants:

1. Asking for active substances quantities;
2. Asking for product quantities;
3. A hybrid variant where the respondent can choose which one to report.

One advantage of variants 1 and 2 is ease of processing. One advantage of variant 3 is the fact that the respondent can choose the option that is most feasible in terms of their own records, which optimises the quality of the submitted data. Variants 2 and 3 would require a conversion table for products and active substances. This table will be stable over time for each product, because active substance concentrations do not change during an authorisation period. For the plant protection register this is similar to the Fytostat database of manufacturers.

3.8.1 Authorisation holder table
VariabeleDescription
Authorisation-id Identification number of the authorisation
Authorisation-idIdentification number of the authorisation holder
Source of authorisationCtgb (Dutch authorisation board) or ECHA
Brand product quantities supplied to the
non-professional market
During the reporting period
Brand product quantities supplied to the
the professional market
During the reporting period
Brand product quantities supplied to the
both markets
During the reporting period
Brand name (or CAS-number)Brand name and quantity, if available
e.g. Racumin Foam, 500 ml

Registration of product quantities may provide additional information for policy makers (in addition to active substance quantities in kg), but that will also make the register more complex and expensive. The Ministry of IenW will have to decide whether the benefits outweigh the costs.

If the contact person for an authorisation holder is known, some of the requested information can be entered in advance.

3.8.2 Product table
Variabele (kolom in producttabel)Description
Authorisation-idIdentification number or the authorisation
AuthorisationCtgb or ECHA
Start dateDate on which the authorisation starts
End dateDate on which the authorisation expires
Grace market dateDate on which the authorisation may not be marketed anymore
Biocide producttypeBased on the standard list
Biocide main groupBased on the standard list
Biocide brand productBrand name (follows from the product )
Hazard indicationHazard-sentences
Total product quantityNumeric values
Product quantity unitEUnit or the above variable, e.g. grams or liters
Specific gravity or liquidif product is flowable, e.g. kg/l or g/l
Name active substance 1Chemical substancename, e.g. propiconazole
Content active substance 1Numerical value
Unit of content active substance 1For example g/kg or g/l
Amount of active substance 1 in productIn gram if possible, or kg
Name active substance 2Chemical name, e.g. tebuconazole
Content active substance 2Numerical value
Unit or content of active substance 2For example g/kg or g/l
Amount of active substance 2 in productIn gram if possible, or kg
This table would serve as an aid, for example for the conversion of submitted product quantities to active substance quantities.

A product may contain multiple active substances, so multiple columns are provided for active substance variables. Depending on the maximum number of active substances in one biocide, a column may appear more than twice. An alternative is to give each substance-product combination a row of its own, so we only need one column for the active substance variable. In that case, the number of rows in which a product appears for each authorisation holder corresponds to the number of active substances.

Many concentrations are expressed as a weight/weight ratio (e.g. grams/kilograms). Liquid products are expressed as grams/litre. If we want to be completely accurate, we will need specific gravity as well. These choices may affect the end totals. Getting information on this variable (amount of biocide in product) may prove challenging. This information is not publicly available in a way that is easy to find in the ECHA authorisation register. However, the information is available in section 2.1 of the Summary of Product Characteristics (SPC) in the Biocidal Fact Sheets, which are publicly available for every biocide. One option would be to use an automatic text analysis method to search these PDF files for this information. An alternative for “name of active substance” is the CAS number, which is also listed in the active substance table. The main purpose of this variable is to provide a link with the active substance table.

There is a standard list for biocide main group number, biocide main group name, biocide product number and biocide product name.

3.8.3 Active substance table
VariableDescription
Name active substanceChemical name, e.g. propiconazole
CAS-numberUnique identification number for chemical
ToxicityTo be defined

There are several ways to measure the toxicity of an active substance, for example based on human toxicity or environmental toxicity. Hazard Statements are associated with the product, so these can be found in the product table and not in the active substance table. Which method is most relevant depends on the requested variable: active substance quantity or product quantity. A pilot would help answer this question (see 4.1).

3.9 Comparability

We recommend asking for a minimum of two years’ worth of information when the information is first requested. At the next request, year t can then be compared with the available years t-1 or t-2, and over time a the quality of the data for this whole time period can be assessed.

3.10 Quality control

3.10.1 Quality control for (groups of) units

(Groups of) units, both respondents and authorisations, can be subjected to (automated) quality controls, for issues such as:

  1. Accuracy of the identifiable characteristics. Possible options are syntactic control, verification of correct authorisation, and inventory of missing values.
  2. Coverage ratio of the target population (over- or undercoverage, selectivity, duplicates, time delays and the addition of new units or removal of old units).

3.10.2 Quality control of target variables

The following (automated) controls can be performed by the register holder on target variables supplied by the respondent:<

  1. Do all the values fall within an accepted range (and is it zero for non-authorised products)?
  2. Are there any extreme values and if so, are they realistic?
  3. Are there inconsistencies between variables from one respondent?
  4. Are there any missing values?

Are there values that are expected to be the same over time (e.g. identification key, product type or certain active substances)?

3.10.3 Product type double entries

When working with statistics that are calculated at several levels, such as “active substance quantities in kg per PT” and “total active substance quantities in kg for all PTs”, we have to factor in overlap between PTs. There are products that appear in multiple product type categories, which results in double entries when the totals for each PT are added to calculate the total for all PTs. Adding up all biocides (individually, not by PT), allows us to calculate the total without any duplicates.

Double entries result in a lower total for active substance quantities in kg for all PTs than the sum of active substance quantities in kg in each PT.

Breakdown by product type is not possible if values are missing in the “biocide product type” variable, but the biocide can still be included in the calculation of the total. If there is uncertainty about the PT of a biocide (for example “PT02” or “PT04”), it might be possible to use weighted categories (for example 0.5 for PT02 and 0.5 for PT04) so it is partially counted for the different PTs.

3.11 Quality improvement

Upon completion of the (automated) quality control, the following steps can be taken to improve quality:

  1. Values with quality issues can be kept or deleted.
  2. The register holder can ask the respondent about the variables with quality issues.
  3. Values that contain obvious errors can be overwritten with correct data.
  4. Missing values can be imputed, for example by using historical data. There are several methods for imputing data. Which method is the most suitable will have to be determined for each variable individually.

3.12 Reproducibility

  1. The software used by the register holder must meet the following requirements:
  2. The software must have low error sensitivity with regard to human actions, for example by performing plausibility controls on entered data.
  3. The software must be well-documented. All components and their interrelation must be described in detail.
  4. The software must be easy to transfer between different colleagues, to prevent dependence on any one individual.

4. Planning stages

The level of implementation of the register depends on the available budget. We recommend starting with a small-scale pilot before setting up a full-scale register, because that will allow us to identify challenges involved in the development of a biocide register on a small scale. One advantage of this approach is that we can use this small-scale beginning as a basis to build upon. Once we have the pilot, there are various ways to scale up to a biocide register. This chapter presents three such scenarios.

The topics in this chapter are in part a response to the last question in the research proposal:

What can the CBS contribute in this regard (Ed.: setting up a system for biocide registration), in conformity with the CBS [Statistics Netherlands] Act, during the observation phase and the setting up of the register, and what scenarios could be adopted to that end?

This chapter will focus on the scenarios and less so on the role of the CBS.

4.1 Pilot

The purpose of the pilot is to examine the various choices that have to be made in setting up a biocide register, without using the registered data primarily for long-term goals such as policy monitoring. With regard to the selection of product types, such as PT14 (rodenticides) for example, we will follow the steps that are part of setting up a register. Authorisation holders will be asked to report voluntarily on the quantities of active substances and/or products sold during the reference year. Asking for both variables will enable us to find out which of these variables will lead to the best data quality.

Data can be collected by means of a template CSV file; the authorisation holders will be asked to enter the requested data and upload the file to a portal. The advantage of using a template CSV file is that it is relatively cost-effective. There is no need for a scalable software solution for data collection at that point. The data processing can be done manually at this scale, for example by using an R script.

The resulting tooling and code will not be scalable to a full register, but the obtained insights will most likely be valuable for the efficient structuring of scalable tooling for a complete register. The output of the pilot is a list with recommendations for setting up a biocide register, to supplement the recommendations in this report. The estimated runtime of this pilot is one year.

Fytostat has indicated that they are interested in participating in the pilot. Data collection can be done in full or in part by Fytostat, in cooperation with the CBS for example, and the aggregated data for active substances can be shared with the commissioning authority (Ministry of IenW). It is not clear yet what the pilot will look like, exactly.

The lessons from the pilot can then be applied to the implementation of a register for multiple PTs. If we decide to start with a complete register right away, we still recommend designing the first project phase as described above for the pilot. The following section describes three different variants of a register in order of size (minimal, medium and extended variant).

4.2 Minimal register variant

The purpose of the minimal variant is to provide information about the sale of active biocides in the Netherlands for a few selected PTs. Lists of authorisation holders who bring biocidal products to the Dutch market for professional use of certain product types (see section 2.4.12) are collected on the basis of the ECHA and Ctgb databases. These authorisation holders form the basis of the register.

A sample of authorisation holders will be approached and asked to voluntary report the quantities of active substances sold during the reference year by completing a web survey. If the expectation is that the data quality will be higher if we ask about product sales rather than the quantities of active substances sold, that is an option as well. To reduce post-processing costs for this minimal variant, we recommend choosing one of the two variables. One likely benefit of a survey as opposed to a template CSV file (as described in section 4.1 in the context of the pilot) is that this will be a more user-friendly experience for the authorisation holders.

The sample could consist of all “large” authorisation holders (based, for example, on number of employees or profit, taken from other sources), with another sample consisting of the other authorisation holders. At the start of the project we will ask for data from the past two years for reference purposes. Authorisation holders in the sample group will be asked to participate for several consecutive years (panel design) in order to promote the accuracy of the calculations of changes over time.

Only active substances, i.e. no products, will be registered (or the other way around if this would yield higher-quality data). This will be followed by a minimal (automated) check of the completeness and quality of the submitted data. If information is missing or does not appear to be plausible, the companies in question will not be contacted. The benefit of a sample approach is that it relieves many authorisation holders of the response burden. The smaller scale of the data collection will probably result in lower costs.

The output consists of statistically secure aggregates of the quantities of active substances that were sold. This sample approach does mean that further breakdown of the output is probably not an option (to prevent disclosure). The structure of this register is designed to make it possible at a later point to request data on active substance quantities (and/or product quantities) for more PTs and more authorisation holders.

4.3 Medium register variant

The purpose of the medium variant is to provide information about a large selection of PTs about the sale of active biocides in the Netherlands. The design of this “medium” variant is largely the same as that of the abovementioned minimal variant.

However, this register is populated with more data; it could include all PTs, for example, or a larger selection of authorisation holders than the minimum sample. All authorisation holders will be asked to report on the quantities of active substances or the quantities of (sub)products they sold. The authorisation holders can choose the option that is most feasible in light of their own administration, to promote submission of quality data.

The data collection is followed by extensive quality control where authorisation holders are contacted in the event of missing or potentially incorrect information. Since the respondents are given a choice on what to report, the next step is to convert all data to active substance quantity. One option would be to start with the minimal variant and then work towards the medium variant as more data are collected over time.

4.4 Comprehensive register variant

The purpose of the comprehensive variant is to provide information about all PTs about the sale of active substances and biocidal products in the Netherlands. The structure and design of this register variant is more comprehensive than that of the two variants above.

This register has as much information as possible and includes all PTs and authorisation holders. The most comprehensive version could also include products for non-professional use. All authorisation holders will be asked to report on the quantities of active substances or the quantities of (sub)products they sold. The authorisation holders can choose the option that is most feasible in light of their own administration, to promote submission of quality data. In addition to the authorisation holder table (see section 3.8.1), the register will have a product table (see section 3.8.2) and an active substance table (see section 3.8.3) as well. The toxic impact of each active substance is listed in the active substance table and the H statements for each product are listed in the product table.

The data collection is followed by extensive quality control where authorisation holders are contacted in the event of missing or potentially incorrect information. Since the respondents are given a choice on what to report, the next step is to convert all data to active substance quantity. The output consists of statistically secure aggregates of the quantities of active substances that are sold, with breakdowns by toxic impact (based on active substance) or, in the most comprehensive variant, by H statement (based on products).

5. References

Bundesamt für Justiz. (2021, 18 August). gesetze-im-internet.de/chembioziddv. From Verordnung über die Meldung und die Abgabe von Biozid-Produkten sowie zur Durchführung der Verordnung (EU) No. 528/2012 (Biozidrechts-Durchführungsverordnung - ChemBiozidDV):

Bundesanstalt für Arbeitsschutz und Arbeitsmedizin. (2024, March). Biozidrechts-Durchführungsverordnung - eBIOMELD. Bundesanstalt für Arbeitsschutz und Arbeitsmedizin. (2024, March). eBIOMELD - offene Suche.

CBS. (2024). Pesticide sales.

CBS, F. V. (2024, March 5). Discussion about a biocide register in the Netherlands. Discussion report. Ctgb & CBS. (2023, 15 December). Discussion about a biocide sales register. Discussion report.

Ctgb. (2022). Annual Report 2022. Ede.

Ctgb. (2023, 27 September). officielebekendmakingen.nl. From Decision of the Board on the authorisation of plant protection products and biocides, Annex III, Section 3:

Daas, P., & Ossen, S. (2011). Metadata quality evaluation of secondary Data sources. International Journal for Quality research 5(2), 57-66.

Daas, P., Ossen, S., M., T., Zhang, L.-C., Hendriks, C., Haugen, K., . . . B., W. (2011). List of quality groups and indicators identified for administrative data sources. Deliverable 4.1 of the ESSnet BLUE – Enterprise and Trade Statistics.

de Buck, A., & Knoben, N. (May 2023). Design of a system for the registration of biocide sales: insights from discussions, interim report May 2023. Ministry of Infrastructure and Water Management.

Denneman. (2023). Project proposal for data exploration for the monitoring of biocide sales. The Hague: CBS.

European Parliament. (11 March 2009). (EC) Regulation no. 223/2009 on European statistics.

European Parliament. (2012). (EU) Regulation 528/2012 concerning the making available on the market and use of biocidal products. EU. European Parliament. (2019). European Directive 2009/128/EC.

European Parliament. (21 October 2009). (EC) Regulation no. 1107/2009 concerning the making available on the market and use of biocidal products.

European Parliament. (25 November 2009). (EC) Regulation no. 1185/2009 on pesticide statistics.

European Parliament and the Council. (2022). (EU) Regulation no. 2022/2379 on statistics relating to the input and output of agricultural activities. Strasbourg.

European Commission. (2021, 7 June). Report from the Commission to the European Parliament and the Council on the implementation of Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal. Brussels.

Eurostat. (2023, May). Agri-environmental indicator - consumption of pesticides. From europa.eu/eurostat: Eurostat. (2024). Database Pesticide Risk.

Belgian Federal Public Service for Health. (2024, March). biocide.be. From Biocides in the free or closed circuit:

Belgian Federal Public Service for Health. (2024, April). Overview of legislative texts.

Hundepool, A., & de Wolf, P.-P. (2010). Statistical Methods. The Hague/Heerlen: CBS Standard Methods. KWIK. (2022). Measuring strategy for biocides: considerations and criteria. Kennisimpuls Waterkwaliteit [Water Quality Knowledge Impulse].

Ministry of IenW (2021, 8 July). EU: "Slow progress in biocide assessment”. Ministry of IenW (4 May 2023). Design of a system for the registration of biocide sales.

Ministry of LNV. (2024). Sales data for plant protection products in the Netherlands, Ministry of Agriculture, Nature and Food Quality. From Rijksoverheid.nl:

Ministry of LNV. (2024). Harmonised Risk Indicator (HRI) in Nederland.

Platform Biociden, Fytostat & CBS. (2024, 22 February) Discussion about a biocide sales register. Discussion report. Netherlands Enterprise Agency (Rijksdienst voor Ondernemend Nederland). (2023). State of affairs at RVO: We get more done with fewer regulations. Public Health, D. B. (2024, 02 23). Interactive annual report on the Belgian biocide market.

The Plant Protection Products and Biocides Act. (2024).

Wezenbeek, J., & Komen, C. (2024). Examination of risk factors associated with biocide use: Recommendations for monitoring, research and policy. Report 2023- 0376. RIVM.

Annex 1. Biocide product types

Source: biociden.nl, page explaining product types

Main group 1: Disinfectants.

  • PT1: Human hygiene. Products in this group are biocidal products used for human hygiene purposes, applied on or in contact with human skin or scalps for the primary purpose of disinfecting the skin or scalp.
  • PT2: Disinfectants and algaecides not intended for direct application to humans or animals. Products used for the disinfection of surfaces, materials, equipment and furniture which are not used for direct contact with food or feeding stuffs. Usage areas include, inter alia, swimming pools, aquariums, bathing and other waters; air conditioning systems; and walls and floors in private, public, and industrial areas and in other areas for professional activities. Products used for disinfection of air, water not used for human or animal consumption, chemical toilets, waste water, hospital waste and soil. Products used as algaecides for treatment of swimming pools, aquariums and other waters and for remedial treatment of construction materials. Products used to be incorporated in textiles, tissues, masks, paints and other articles or materials with the purpose of producing treated articles with disinfecting properties.
  • PT 3: Veterinary hygiene. Products used for veterinary hygiene purposes such as disinfectants, disinfecting soaps, oral or corporal hygiene products or with anti-microbial function. Products used to disinfect the materials and surfaces associated with the housing or transportation of animals.
  • PT 4: Food and feed area. Products used for the disinfection of equipment, containers, consumption utensils, surfaces or pipework associated with the production, transport, storage or consumption of food or feed (including drinking water) for humans and animals. Products used to impregnate materials which may enter into contact with food.
  • PT 5: Drinking water. Products used for the disinfection of drinking water for both humans and animals.

Main group 2: Preservatives.

Unless otherwise stated these product types include only products to prevent microbial and algal development.

  • PT 6: Preservatives for products during storage. Products used in the preservation of manufactured products, other than foodstuffs, feeding stuffs, cosmetics and medicinal products or medical devices by control of microbial deterioration to ensure shelf life. Products used as preservatives for the storage or use of rodenticide, insecticide or other baits.
  • PT 7: Film preservatives. Products used for the preservation of films or coatings through the control of microbial deterioration or algal growth in order to protect the initial properties of the surface of materials or objects such as paints, plastics, sealants, wall adhesives, binders, papers, art works.
  • PT 8: Wood preservatives. Products used for the preservation of wood, from and including the saw-mill stage, or the preservation of wood products through the control of wood-destroying or wood-disfiguring organisms, including insects. This product type includes both preventive and curative products.
  • PT 9: Fibre, leather, rubber and polymerised materials-preservatives. Products used for the preservation of fibrous or polymerised materials, such as leather, rubber or paper or textile products through the control of microbiological deterioration. This product type includes biocidal products which antagonise the settlement of micro-organisms on the surface of materials and therefore hamper or prevent the development of odour and/or offer other kinds of benefits.
  • PT 10: Construction material preservatives. Products used in the preservation of masonry, composite materials or other construction materials other than wood through the control of microbiological and algal attack.
  • PT 11: Preservatives for liquid-cooling and processing systems. Products used for the preservation of water or other liquids used in cooling and processing systems by managing harmful organisms such as microbes, algae and mussels. Products used for the disinfection of drinking water or of water for swimming pools are not included in this product type.
  • PT 12: Slimicides. Products used for the prevention or control of slime growth on materials, equipment and structures, used in industrial processes, e.g. on wood and paper pulp, porous sand strata in oil extraction.
  • PT 13: Working or cutting fluid preservatives. Products to control microbial deterioration in fluids used for working or cutting metal, glass or other materials.

Main group 3: Pest control.

  • PT 14: Rodenticides. Products used for the control of mice, rats or other rodents, by means other than repulsion or attraction.
  • PT 15: Avicides. Products used for the control of birds, by means other than repulsion or attraction.
  • PT 16: Molluscicides, vermicides and products to control other invertebrates. Products used for the control of molluscs, worms and invertebrates not covered by other product types, by means other than repulsion or attraction.
  • PT 17: Piscicides. Products used for the control of fish, by means other than repulsion or attraction.
  • PT 18: Insecticides, acaricides and products to control other arthropods. Products used for the control of arthropods (e.g. insects, arachnids and crustaceans), by means other than repulsion or attraction.
  • PT 19: Repellents and attractants. Products used to control harmful organisms (invertebrates such as fleas, vertebrates such as birds, fish, rodents), by repelling or attracting, including those that are used for human or veterinary hygiene either directly on the skin or indirectly in the environment of humans or animals.
  • PT 20: Control of other vertebrates. Used for the control of vertebrates other than those already covered by the other product types of this main group, by means other than repulsion or attraction.

Main group 4: Other biocidal products.

  • PT 21: Antifouling products. Products used to control the growth and settlement of fouling organisms (microbes and higher forms of plant or animal species) on vessels, aquaculture equipment or other structures used in water.
  • PT 22: Embalming and taxidermist fluids. Used for the disinfection and preservation of human or animal corpses, or parts thereof.

Annex 2. Output in Belgium

Table B.1 provides an overview of the total amount of active substances in tonnes (1,000 kg) per product type on the Belgian market during the period 2017-2022. Similar information is shown in Tables B.2 up to and including B.4. Table B.1 is the most relevant table for the assessment of toxicological environmental and health risks, because it lists quantities of active substance instead of product quantities (as in Tables B.3 and B.4), and it also contains more details (per PT instead of per group, as in Table B.2).

B.1 Quantities of active substances per product type (= PT) in Belgium during the period 2017-2022 (in tonnes)
Product type (PT)20182019202020212022
PT011,3909851,0486,3243,9121,641
PT024,9065,2337,54611,0469,57214,574
PT039505758731,5421,0096,545
PT044,4084,5846,6668,4996,5896,894
PT053,3282,9494,8814,9094,5434,535
PT066166951,1281,7601,1411,250
PT0728.130.536.944.148.525.5
PT086,6629,0034,6044,8774,7763,275
PT0942.735.130.530.234.639.6
PT10124106103118173234
PT113,3103,2625,2795,3214,8495,236
PT12727645687536425813
PT13273191179209142170
PT140.090.951.260.120.623)
PT1500002)2)
PT16000000
PT17000000
PT1849.746.136.859.564.543.2
PT1930.121.235.954.042.385.5
PT20000000
PT2158.151.029.225.855.13)
PT222)2)2)2)2)2)
Total excl. double counting1)14,72918,16517,17525,54521,32022,894
1) These totals correspond to the registered use. The totals per PT are an overestimate for all biocides if a biocide is authorised for multiple PTs.
2) The quantity of one of the products on the market cannot be published due to the risk of disclosure per PT.
3) Not published in the most recent public annual report due to the risk of disclosure per Group. Source: Public Health, 2024

B.2 Quantities of active substances per main group in Belgium from 2018 to 2022 (in tonnes)
Main group20182019202020212022
GR01 disinfectants (PT1-5)7 84110 98619 01015 02018 059
GR02 preservatives (PT6-13)13 07311 06211 75510 6179 572
GR03 pest control ( (PT14-20)68 274 0113 6107,4 128,9
GR04 other biocidal products (PT21-22)51 029 225 855 128 0
Total excl. double counting18 165 17 175 25 545 21 320 22 894

B.3 Quantities of biocides per product type in Belgium from 2018 to 2022 (in tonnes)
Product type 20182019202020212022
PT01 2 046 2 076 9 663 6 128 3 018
PT02 41 869 51 468 63 876 56 364 62 140
PT03 3 0923 424 4 518 3 872 9 953
PT04 33 630 42 277 44 352 40 065 41 921
PT05 28 601 36 910 37 307 35 528 35 738
PT06 2 939 3 373 4 501 3 884 3 668
PT07 174,7 237,2 251,1 250,5 176,6
PT08 10 776 6 510 7 195 7 108 5 343
PT09 264,4 295,9 304,0 292 1 287,0
PT10 1 056 990,5 1 047 1 1331 201
PT11 30 91639 868 40 179 38 405 39 373
PT12 4 0704 4414 4434 794 5 950
PT13 1 199 935 8 956 7 786 4 819 9
PT14 978 8 876 5 738 13) 3)
PT15 0 0 0 2) 2)
PT16 0 0 0 0 0
PT17 0 0 0 0 0
PT18 1 307 1 3151 531 1 467 1 172
PT19 106 1141 5 199 0 187 5 239 9
PT20 0 0 0 0 0
PT21 ??? ??? ??? 3) 3)
PT22 2) 2) 2) 2) 2)
Total excl. double counting1) 76 745 82 905 103 19992 868 94 688
1) These totals correspond to the registered use. The totals per PT are an overestimate for all biocides if a biocide is authorised for multiple PTs.
2) The quantity of one of the products on the market cannot be published due to the risk of disclosure per PT.
3) Not published in the most recent public annual report due to the risk of disclosure per Main Group.
Source: Public Health, 2024

B.4 Quantities of biocidal products per main group in Belgium during the period 2018-2022 (in tonnes)
Main group20182019202020212022
GR01 disinfectants (PT1-5)56 87066 87485 81775 40479 049
GR02 preservatives (PT6-13)45 61750 46252 52350 04948 958
GR03 pest control (PT14-20)2 3912 3332 4682 351 2 128
GR04 other biocidal products (PT21-22)127,871,174,5130,772,6
Total excl. double counting76 74582 905 103 19992 86894 688
Source: Public Health, 2024

It is important to note the following with regard to the listed quantities. If a biocide is authorised for multiple PTs, the quantity is counted for each of these PTs because we don't know which quantity applies to which PT. This means that the quantities for each PT are an overestimate if a biocide is authorised for other PTs as well. The quantities per group are overestimated for the same reason. These double entries are removed from the end total, so the total amount corresponds to the biocide quantities that were sold.

Table B.5 shows the distribution of active substance quantities for 2018 in tonnes by PT, by circuit type and by user type. We note that the vast majority of biocides, approx. 91% of the total amount, is for professional use only. Only 3% is for non-professional use only. With regard to PT14 (rodenticides), we note that the majority of the products (based on active substance quantity) are authorised for both professional and non-professional use and are available on the free circuit. Almost all of the preservative applications (PT6-9 and PT11-13) on the Belgian market are for professional use only. Only PT10 (construction material preservatives) contains products for both types of users. Virtually all of the products in PT21 (antifouling products) are for professional use only.

B.5 Active substance quantities per product type in Belgium in 2018 (in tonnes), with circuit type and user type
Product type TotalFree circuitClosed circuitNon-professionalBoth type usesProfessional
PT01 985 985 0 215 339 431
PT02 5 233 1 316 3 917 353 772 4 108
PT03 575 56 519 2) 2) 538
PT04 4 584 203 4 381 0 97 4 486
PT05 2 949 36 2 913 2) 2) 2 913
PT06 695 85 610 0 0 695
PT07 30,5 11,7 18,8 0 0 30,5
PT08 9 003 3 9 000 0 0 9 001
PT09 35,1 9,5 25,7 0 0 35,1
PT10 106 33,9 72,6 0 21,0 85,5
PT11 3 262 47,9 3 214 0 0 3 262
PT12 645 289 356 0 0 645
PT13 191 20,9 170 0 0 191
PT14 0,95 0,91 0,04 2) 0,76 0,08
PT18 46,1 23,9 22,1 3,6 14,3 28,2
PT19 21,2 21,2 0 2) 2) 20,9
PT21 51,0 19,4 31,7 2) 2) 50,9
Total excl. double counting1) 18 165 2 760 15 405 592 1 100 16 472
1) These totals correspond to the registered use. The totals per PT are an overestimate if a biocide is authorised for multiple PTs.
2) Some data are missing.
Source: Public Health, 2024

Breakdown by free and closed circuit is not being considered for the Netherlands. Breakdown by user type (professional or non-professional) does make sense for the Dutch market.

13) For non-zero biocidal products we can create tables similar to B1-B4 for active substance quantities and product quantities by PT and main group.

Annex 3. Output on plant protection products

Table G1 shows data from the Dutch market for plant protection products by main group during the period 2016-2022.

G.1 Plant protection product sales by main group: 2016 – 2022 (in 1,000 kg active substance)
Plant protection products 2016201720182019202020212022
Total of all active substances10,77010,5669,4039,2169,8849,3978,991
Fungicides and bactericides4,8684,7224,2913,8864,0013,3022,968
Herbicides, haulm destructors and moss killers2,7332,8832,9612,7212,6222,5882,708
Insecticides and acaricides2,6082,4911,6271,9712,4152,6552,263
Molluscicides20301114163119
Plant growth regulators459386386528560559718
Other plant protection products825312796270262316
Source: CBS Statline, March 2024

The market for plant protection products has been fairly stable over the years. There has been a slight downward trend the past few years. Fungicide sales are clearly going down.
There is some overlap between substances used in plant protection products and substances used in biocides. This overlap definitely applies to insecticides as well. Table G2 provides more details for insecticides in terms of breakdown by product group.

G.2 Plant protection product sales by product group, Insecticides: 2016 – 2022 (in 1,000 kg active substance)
Plant protection products 2016201720182019202020212022
I01 Insecticides, pyrethroids1214913131313
I02 Ins., chlorinated hydrocarbons23334
I03 Ins., carbamates, oxime carbamates328264676918193
I04 Ins., organic phosphates30414058100
I05 Ins., microbiological, botanical5153612144477
I06 Acaricides6443324
I99 Insecticides, other2,5232,3351,4721,8152,3122,4122,071
Source: CBS Statline, March 2024

We do see some developments in the different product groups, but what we are seeing primarily is that group I99 (Other insecticides) is extremely large compared to the other product groups. It would therefore be interesting to see a breakdown by chemical class for this product group I99. CBS has not published this information yet, but Eurostat did, see Table G3.

G.3 Plant protection product sales by chemical class, product group Other Insecticides I99, Insect control: 2016 – 2022 (in 1,000 kg active substance)
Plant protection products 2016201720182019202020212022
I99_01 Produced by fermentation11.112.713.312.511.913.811.3
I99_03 Benzoylurea1.71.31.21.60.400
I99_04 Carbazates1.01.40.80.80.70.90.7
I99_05 Diacylhydrazines1.51.92.52.70.60.61.0
I99_06 Insect growth regulators0.50.60.91.00.60.50.3
I99_08 Nitroguanidines4.63.82.30.7000
I99_10 Oxadiazines0.50.80.70.70.51.30.2
I99_11 Phenyl-ether ins.0.30.40.20.30.40.30.2
I99_12 Pyrazoles (phenyl) ins.2.22.95.51.91.31.91.9
I99_13 Pyridine ins.35.637.022.626.324.825.023.5
I99_14 Pyridyl methylamines16.822.725.242.735.819.419.8
I99_17 Tetronic acid ins.1.91.90.90.80.90.40.5
I99_18 Insect pheromones0.40.20.30.50.50.40.5
I99_99 Unclassified ins.2,444.52,247.81,395.31,722.32,233.32,347.72,010.9
Source: Eurostat, March 2024

We do see developments over time in this category as well, but what is most notable is the size of the Unclassified (I99_99) group. The amount of paraffin oil sold for insecticide and acaricide control in 2022 was fairy large at 1,776.9 tonnes. This sales figure dominates product group I99 (Other insecticides) and chemical class I99_99 (unclassified) in every year. However, there are no biocides that contain the active substance paraffin oil.

It is interesting to know what individual substances are sold on the market. Different substances have different effects. Following a lawsuit in 2019, sales figures for each substance have been published annually by the Ministry of LNV (Ministry of LNV, 2024).

G.4 Plant protection product sales by “pesticide risk group”: 2016 – 2020 (per 1,000 kg active substance)
Plant protection product20162017201820192020
Low-risk group (group 1)18.529.811.013.815.3
Approved substances (group 2)9,752.89,631.48,498.98,437.49,084.5
Candidates for substitution (group 3)726.7827.8843.6746.7705.6
Not approved (group 4)267.274.046.834.835.7
Non-chemical active substances (NCHAS)3.214.435.213.412.7
Chemical active substances (CHAS)10,494.010,474.49,318.49,184.69,792.6
Source: Eurostat, March 2024

In Table G4, most substances in the first 3 rows (groups 1, 2, 3) are approved substances and only 10% of the approved substances are candidates for substitution. Most substances in the last 2 rows (NCHAS and CHAS groups) are chemicals. We note that the “Not approved” (group 4) in row 4 has been steadily growing over time. Group 4 is not classified as either NCHAS or CHAS.

H(azard) Statements are not used systematically in the sale of plant protection products. Quantities of plant protection product sold are not published; the weight of excipients and the number of packages on the market are not included in the analysis.

And finally, Table G5 provides a comparison between the Dutch market and the Belgian and German markets. The German market for plant protection products is by far the largest of the three countries. The Dutch market is (slightly) larger than the Belgian market. The differences and similarities are different for each main group. If we look at Insecticides, we see that the Dutch market is 6 times larger than the Belgian market. Even if we subtract paraffin oil sales in the Netherlands and Belgium, the market for insecticides is still 2 times larger in the Netherlands.

G.5 Plant protection product sales by main group: 2021 (in 1,000 kg active substance)
Plant protection productsBelgiumGermanyNetherlands
Total of all active substances1)5,57648,7129,347
Fungicides and bactericides1,9999,6933,296
Herbicides, haulm destructors and moss killers2,45616,0892,588
Insecticides and acaricides2)41520,5752,611
Molluscicides1211531
Plant growth regulators4061,995559
Other plant protection products288247262
1) Not including biological substances in F06 and I05.
2) Including CO2 fumigation of stored product pests in Germany. This is not included in the German “pesticide risk groups”.
Source: Eurostat, March 2024