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.

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.

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.

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).

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.

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.

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.