Annual Report 2022
The EU and the Netherlands have far-reaching ambitions about improving the sustainability of plant protection products and biocidal products. For example, a draft EU regulation aims at reducing the use and risk of chemical plant protection products by 50% before 2030. Ambitious policies are also being developed for biocidal products. This requires much commitment and effort from all parties in the chain, especially competent authorities such as the Ctgb. For competent authorities in the Netherlands and other Member States, this commitment to sustainability comes in addition to the need to improve turnaround times. This is a complex issue that is determined not only by the way applications are processed, but also by the increasing complexity of dossiers and the increasing number of aspects that must be taken into account during assessment. Consider, for example, the increasing attention to possible neurodegenerative effects (such as Parkinson's disease) of products. And the political pressure to make rapid progress in all these areas is – understandably – high.
This is reflected in the complex challenges faced by the Ctgb in the year under review, which will continue in the coming years. In 2022, we began developing a multi-year strategy that will help us meet these challenges. We are discussing this – as we are accustomed to – with all our partners, including ministries, scientific institutes, nature and environmental organisations, industry and the agriculture and horticulture sectors. In the spring of 2023, we will adopt and publish this multi-year strategy.
In 2022, in addition to our core task – assessing and deciding on the use of substances and products – we also played an active role in various consultations in Europe, we advised ministries and we contributed to the development of sustainable strategies. For example, our experts led workshops for European colleagues on assessing "green products", and we hosted a well-attended workshop on innovation. Innovation was also the theme of the annual Ctgb client contact day. Another milestone was the Board's decision to simplify extended authorisations of low-risk products with minor uses (without extensive assessment).
Where safety was at stake, however, we did not hesitate to intervene. In 2022, we therefore decided to limit the use of rodenticides to uses within an IPM system performed by certified professional pest controllers. And for restrictions on the use of phosphides, a public viewpoint procedure has been initiated.
We were able to do all this within the available budget: we ended 2022 with a positive financial result. In 2022, the statutory five-year evaluation of the Ctgb as an autonomous administrative authority (ZBO) was completed. AEF (Andersson Elffers Felix) concluded that the Ctgb is a professional, effective organisation that provides high quality service. This positive assessment was due in part to the quality and commitment of our staff, to whom I also want to express my sincere appreciation.
On June 15, 2023, we will host our annual Ctgb client contact day. This year's theme is "enforcement". This is an important issue, because only rules that are complied with – and enforced if necessary – will contribute to our great political and societal sustainability ambitions! I hope to see many of you at this event.
And I want to end this foreword with many thanks to our previous Chairman, Johan de Leeuw. For ten years he has led the Ctgb with great commitment and administrative insight and, together with the executive management and staff, has brought our organisation to where it is today.
Rob van Lint, Chairman
2022 in a nutshell
The Board for the Authorisation of Plant Protection Products and Biocidal Products (Ctgb) is an autonomous administrative authority (ZBO) that deals with consumers, special interest groups for nature and the environment, industry and politics, farmers and growers, pest controllers and hospital hygienists. As an independent competent authority we ensure that the biocidal products and plant protection products that we use in our households and our living environment – and those that are authorised for food production – are safe for humans, animals and the environment according to the applicable European safety standards. To ensure the best possible assessment of the risks of these products and substances, we stay in touch with the world around us, follow scientific and societal developments, and maintain relationships with interest groups – including international ones – from society, industry and government agencies. As part of our role, we also provide solicited and unsolicited advice to various ministries.
Global current events also impacted the Ctgb. Just as with the outbreak of the corona pandemic resulting in rapid risk assessments for disinfectant exemptions, we noticed that concerns about scarcity of feed and food after the outbreak of the war in Ukraine in early 2022 immediately led to a request for an increase in the maximum residue limit (MRL) for maize in animal feed. We subsequently advised the relevant ministry positively on increased MRLs at the national level for a number of substances to enhance the possibilities for import from outside the EU – but still within safe levels, of course. In retrospect, this change turned out to be unnecessary.
The Ctgb assesses the risks of active substances and products and makes decisions on the products within the European frameworks of the Plant Protection Products Regulation and the Biocidal Products Regulation. These regulations are based on the precautionary principle: a product may only be placed on the market if it has been shown to be safe. For these risk assessments, we work closely in the EU with the European Food Safety Authority (EFSA), the European Chemicals Agency (ECHA), the competent authorities of the other Member States, and in the Netherlands we work with various ministries, the Dutch Food and Consumer Product Safety Authority (NVWA), the Human Environment and Transport Inspectorate (ILT) and research institutes such as the National Institute for Public Health and the Environment (RIVM) and Wageningen University & Research (WUR). For the implementation of European regulations, guidance documents are developed and regularly updated to take account of the latest advances in science and technology. The Ctgb actively contributes to this process.
European ambition for sustainable plant protection
The European ambition for more sustainable agriculture was reinforced this year by the European Commission's proposal for a regulation that would aim to reduce the use and risk of chemical plant protection products by 50% by 2030. The proposed regulation would also require Member States to regulate how specific crops are grown and protected with an integrated approach and would prohibit the use of plant protection products in vulnerable areas. Many Member States were concerned about the impact of the proposal and asked the Commission to perform an additional impact analysis. As a result, the exact impact of the proposed regulation on the work of the Ctgb is still difficult to determine. However, it is clear that biological approaches to plant protection are preferred and that this is bound to lead to further growth in the number of applications for such products in the future.
The Netherlands holds chairmanship of CZSC and DCG
During the past year, the Netherlands chaired the Directors Coordination Group (DCG) and the Central Zone Steering Committee (CZSC), in which agreements are reached on the assessment of applications for the authorisation of plant protection products in the central zone. During the Dutch chairmanship, the subsequent steps to several actions formulated during the REFIT of Regulation 1107/2009 were initiated. These included actions to promote the authorisation of low-risk products, reduce differences in assessment by Member States and minimise national elements where possible. To encourage harmonised implementation, preparations have begun on a central zone manual that compiles the agreements harmonised by the zone on aspects such as protected cultivation. In recent years many discussions on this topic have been held in the CZSC due to the variations between greenhouses in EU Member States. Last year, clear agreements were made – also with the other zones – on which types of greenhouses will henceforth be assessed interzonally for the use of plant protection products, and which types will be assessed zonally.
Biocidal products in agriculture and horticulture
In agriculture and horticulture, biocidal products are also used alongside plant protection products. For example, for disinfecting benches, containers, pots or knives. It is not always clear whether such uses fall under the regulations for biocidal products or plant protection products. The vast majority of these disinfectants are still authorised as biocidal products under transitional legislation in the Netherlands. The active substances in these products are not assessed under the Plant Protection Regulation, so they cannot be authorised as plant protection products. A new, Europe-wide description of the interface between biocidal products and plant protection products means that these biocidal products will remain usable in agriculture and horticulture, even if they are authorised in the future under the Biocidal Products Regulation. Consequently, many of the disinfectants now being used on farms and in greenhouses will continue to be available.
Within the implementation programme for the Vision of the Future of Plant Protection 2030 (Toekomstvisie Gewasbescherming 2030), the role of the Ctgb is to contribute to the availability of "green" products. Over the past year, we have taken several initiatives to this end, especially for micro-organisms. For example we included the new EU data requirements for micro-organisms in our Evaluation Manual Biopesticides, we expanded this manual considerably and we submitted it to the other Member States for peer review. Our manual can then be adopted as "explanatory notes" (a type of guidance) in the SCoPAFF (Standing Committee on Plants, Animals, Food and Feed), and can then be used as a harmonised practice in all Member States for the assessment of micro-organisms. Just before the end of the year, we published the revised manual on our website.
At about the same time, we held workshops on the new data requirements and our methodology to help applicants prepare dossiers for substance applications for fungi, bacteria or viruses. Due to great interest, we will repeat this workshop in 2023. We also provided several training sessions (Better Training for Safer Food) during which three experts from our GreenTeam trained colleagues from the Netherlands and abroad about the assessment of micro-organisms.
Due to its "green" expertise, the Ctgb assesses a relatively large number of "green" substances compared to competent authorities in other Member States. Of the 29 new substances we are assessing, about 70% are "green". These active substances consist mainly of micro-organisms, such as bacteria, and plant extracts. A number of peptides are also being assessed.
Promising innovative techniques can also lead to sustainability gains. To learn how to incorporate them into our risk assessment and review framework, we held an interactive workshop that provided valuable new insights with which we can structure our European assessment framework to harness the sustainability gains from innovative techniques.
Products authorised within the European Union and by the Ctgb are safe, if used according to instructions. They have been assessed according to the current assessment framework and are regularly reassessed, within the timelines established by the regulations. However, due to advancing insights or new developments, new information can always emerge about approved substances or authorised products. Authorisation holders are obliged to report these insights or developments, and such a report can also come from a third party, such as the NVWA or ILT, the NVIC (National Poisons Information Centre) or from an operator. But it can also involve a publication in a scientific journal or information from an article in a newspaper. The European Union and the Ctgb therefore keep a finger on the pulse even after approval and authorisation.
All this new information must be studied to assess whether the approved active substance or authorised product still meets the safety requirements. If not, it may be that the approval or authorisation has to be amended, for example by adapting the approval conditions of the substance or legal conditions for use of the product, or – in an extreme case – that the use or authorisation has to be withdrawn. The Reports Information Coordination Team (MIC) at the Ctgb processes these reports and analyses the new information. In 2022, 12 reports were processed. Of these, five are still pending and seven have been completed. A number of notifications led to amendment of the label. In other cases, analysis or assessment of additional data did not justify amendment of the authorisation.
Because of safety concerns, after years of preliminary work, the Ctgb intervened in the authorisations of rodenticides – products to control rats and mice – and plans to intervene in the legal conditions for use of phosphides. At the end of the year, public viewpoint procedures were underway for both types of products.
Curtailing rodenticide use
Blood-thinning products to control rats and mice are in principle no longer authorised due to the risk of toxicity for non-target species such as birds of prey, mustelids and pets. However, due to the societal importance of effective rodent control, the Biocidal Products Regulation still allows authorisation of these types of active substances and products containing them if each Member State takes suitable risk mitigation measures. In the Netherlands, the products may thus only be used by certified professionals as a last resort within a system of IPM (integrated pest management). As of 1 January 2023, a new certification requirement, based on the recently published IPM Rodent Control Manual, will apply to the control of rodents, including rats and mice, both indoors and outdoors. Products based on alphachloralose are not covered by this Regulation, so private citizens can continue to use them to control mice.
Amendment of instructions for use of phosphides
Due to the risks of phosphine poisoning during and after transport, the Ctgb plans to amend the instructions for the use of aluminium and magnesium phosphide. Phosphine (hydrogen phosphide) is a colourless, odourless and flammable gas that is used to fumigate silos, containers and storage areas as well as ships, trains and trucks. The gas forms when aluminium or magnesium phosphide (a solid) comes into contact with air and moisture. Phosphine gas is highly toxic, and in recent years there have been accidents involving barge operators exposed to phosphine residue from fumigated cargoes. In other Member States, barge operators have even died as a result of exposure to the gas. To prevent such incidents in the future, discussions are taking place across the EU on the necessary amendments to the instructions for use for phosphide-based plant protection products and biocidal products. All uses must meet strict requirements and all residue must be removed by a qualified professional. Additional measures in transportation legislation are under preparation.
Societal developments and Ctgb
Political debate on plant protection
The topic of plant protection also attracted political attention in 2022. At the beginning of the year the Dutch House of Representatives hosted a round table discussion on Healthy Crops and Healthy Soil. Representatives from the Ctgb were invited to participate in the discussion. They explained the authorisation and risk assessment procedure and how new scientific insights about the safety and risks of chemical and biological substances are dealt with. The Standing Parliamentary Committee on Agriculture, Nature and Food Quality accepted our offer to provide a technical briefing in which we provided more information to the Members of Parliament on this issue. These meetings helped to prepare the House of Representatives for the two debates of the plant protection committee that took place in 2022: one with Minister Staghouwer and one with Minister Adema. Ctgb employees attended these debates to support the ministry in answering questions from MPs about the Ctgb's sphere of activity. Committee discussions included glyphosate and the possible link between plant protection products and neurodegenerative diseases. The European and national ambition to make crop protection more sustainable and reduce use and risk was also discussed in detail.
Conversations with scientists
With some regularity, scientists from various disciplines speak out about the risks of plant protection products. In most cases, we will then seek contact for a preliminary discussion. On the one hand, this gives us the opportunity to explain the authorisation system, and on the other hand, we can provide access to information or contacts from the Ctgb. For example, last year we spoke with a number of scientists about the possible relationship between plant protection products and neurodegenerative diseases, and about combinations of plant protection products in the environment.
Ctgb Client Contact Day
The Ctgb client contact day with the theme "innovation" was well appreciated and attended – by more than 200 participants – and resulted in contacts on several innovations in substances and substance uses. Moreover, the meeting brought various innovators together.
Johan de Leeuw stepped down as Board chairman, and his successor Rob van Lint was introduced. The agricultural trade magazines in particular were very interested in the new chairman: he was interviewed by two magazines.
For years, the Ctgb has published its decisions and the complete justifications of these decisions on its website. These publications demonstrate our continued policy of transparency and active disclosure. On 1 January 2022, we also began publishing the Board agenda and Board report every month on our website. On 1 May, the Open Government Act (Woo) went into effect. Of the categories specified in the Act, we already actively disclose most of them. In compliance with its legal requirements, the Ctgb has appointed a Woo contact person (effective 1 May 2022), the Woo desk is explicitly mentioned on the website, and we have added a transparency section to the annual report and budget.
National government programme
We are participating in the government-run Sustainable Digital Information Management (RDDI) programme in the project group initiated by the Ministries of Economic Affairs and Agriculture, Nature and Food Quality. The project should be completed by 2026. In the measurement taken in late 2022 we scored slightly higher on average than in the baseline measurement. We expect that the implementation of the organisation-wide ICT collaboration environment (OBSO) in 2023 will lead to a major step forward with more efficient archiving and improved access.
In 2022 the Ctgb was re-evaluated for ISO certification, which was extended to 2024. In addition, other quality assurance studies were conducted, such as the periodic efficiency and effectiveness evaluation and the stakeholder survey.
Last year, AEF (Andersson Elffers Felix) evaluated the Ctgb in terms of efficiency and effectiveness in fulfilling its public tasks. This is a periodic evaluation that is conducted once every five years for all autonomous administrative authorities (ZBOs). In its report AEF concluded that the Ctgb is a professional and effective organisation that offers high quality services, both in the primary process of risk assessments and in policy advice and collaboration in the EU context. The reputation of the Ctgb also corresponds with this evaluation. Furthermore, AEF concluded that the organisation has a clear governance structure and maintains good relations with the responsible ministries. The internal organisation is also effective, with a pleasant work culture, satisfied employees and a healthy general financial reserve.
AEF made the following recommendations for the Ctgb: provide more insight into the turnaround times and capacity problems; look for measures to increase productivity and shorten turnaround times; discuss these aspects with the ministries; look for opportunities to make more risk-based assessments; and invest in recruiting and retaining staff.
The responsible Minister forwarded the report with our responses to the recommendations made to the House of Representatives. In the accompanying letter to parliament, the Minister wrote: "With due pride, we can state that the Ctgb is the leading competent authority in the Netherlands and the EU for the authorisation of plant protection products and biocidal products."
The Ctgb is constantly working to maintain and improve quality. Listening to how our stakeholders perceive our organisation and performance helps us identify and address opportunities for improvement in processes, contacts or communication, for example. That is why we hold a stakeholder survey every four years. In survey conducted in late 2022, respondents said they were positive about our expertise, quality, reliability and integrity. They were more negative about our long turnaround times and asked us to take a more harmonised approach where possible. We are incorporating these results into our plans for the future. Reducing our turnaround times is a key priority.
As in previous years, the workload exceeded our available risk assessment capacity, which impacted predictability and application turnaround times. Another consideration is that the Ctgb previously accepted more than its fair share of applications for plant protection products, biocidal products and active substances, which led to a backlog. To reduce this backlog and encourage a more proportionate distribution of the workload within Europe, the influx of applications has been limited where possible for several years, for biocidal products as well as plant protection products. Every year we consider whether this influx limitation is still necessary.
A positive development is the substantial increase in the number of "green" active substances – and thus indirectly the number of "green" products – for which the Ctgb is approached as a potential assessing Member State. To broaden the knowledge within the Member States and to account for the limited capacity at the Ctgb, we have referred some of these applicants to other competent authorities in Europe – which we also do for chemical substances. This also ensures a more balanced distribution of tasks, which is an important priority. Incidentally, the number of applications for "green" products in Europe and the Netherlands is still small compared to the number of applications for chemical products.
Experiences in recent years have shown how complicated it is to reduce the backlog and become more predictable as an organisation. This also applied to 2022. Due to the more limited available risk assessment capacity as a result of high absenteeism, staff shortages and induction of new employees, the hours specified in the work plan were not achieved. Applications were processed reasonably in line with the budget, and in terms of numbers of applications, the backlog remained more or less stable. However, pending applications have become larger and more complex (due to increasing data requirements and refinements), and for biocidal products we are dealing with an ever-changing assessment framework. As a result the previously estimated hours were unrealistically low and the historical data had less predictive value. In terms of hours, the backlog increased in 2022. Given this backlog, which is probably even larger than we currently estimate, reducing turnaround times will require a long-term commitment.
We have also taken important steps to improve this situation: in our role as competent authority, we continue to influence external factors such as the quality of files and timely identification of lack of guidance, and we are addressing employee turnover due to the tightening labour market. To accommodate fluctuations in capacity, we used external Evaluating Bodies (EIs) for nearly 4,000 hours in 2022 and the number of EIs was again increased. We energetically pursued the Dutch contribution to the assessment of the application for renewal of glyphosate, making tremendous progress. The assessment is now waiting for European decision-making. The operational planning methodology has been modified, giving us greater insight into the work to be carried out and allowing more control over its completion.
Within the line organisation, mutual cooperation in the chain was again encouraged and we prepared for an organisational development process that will take effect in 2023. This process focuses on working in standing multidisciplinary teams with manageable application portfolios in order to increase efficiency and decisiveness, reduce backlogs and shorten turnaround times.
Trends in authorised products and active substances
The Ctgb reports every year on how many products are authorised in the Netherlands and how many different active substances they contain. For plant protection products, a downward trend in the number of active substances has become apparent, while for biocidal products the number of active substances has remained essentially stable. See the figures below. However, these figures provide only limited information on the number and types of products available per sector.
Autorised Plant Protection Products and Biocides
|Plant Protection Products
|Active subsances PPP
|Active substances Biocides