Newsletter March 2024

In late 2023, the NVWA reported that about one-third of the users of plant protection products are not following the instructions for use. This worries me greatly. And this is not about using a drop too much or spraying a day too early, but about not following basic instructions such as spraying with 75% drift-reducing nozzles, for example. My concern is not just about the use of plant protection products. In an ECHA report dated November 2023, I read that a substantial number of biocidal products on the market do not comply with the prevailing requirements and regulations. ECHA reported finding unauthorised products on the market that were based on unauthorised active substances and with labels that were incomplete or unclear.  

As the Director of the Ctgb, this concerns me. After performing a careful assessment, we establish strict rules for using a product. The authorisation process and the corresponding instructions for use ensure that products are both effective and safe at the prescribed dose. This is how we guarantee the safety of the products for all links in the chain: from the user to the consumer and the environment. However, the reverse is also true: if these strict rules are not observed, there can be risks for all links in the chain. 

As producers, users and policy-makers, we must all realise that both the authorisation process and the instructions for use are based on the assumption that regulations will be observed and the instructions on the label will be followed. If compliance is poor, the instructions for use and restriction phrases do not provide the necessary safeguards for humans, animals and the environment, and this may have consequences, also for authorisation policy. It is therefore in everyone's interest to use plant protection products and biocides correctly and as directed.

Ingrid Becks
Secretary/Director

As a governmental organisation, the Ctgb is transparent in its decision-making. There is also a lot of interest in society for the work of the Ctgb. For many years, the Ctgb has published the scientific assessments on which authorisation decisions are based. From now on, the Ctgb will not only publish the authorisations but also the negative decisions on authorisations. By doing so, we show that products are assessed very carefully and that authorised products therefore meet the required high level of protection with certainty. Since these are products that have applied for but have not been granted authorisation, we publish a more general description of the product, e.g. 'A herbicide based on the substance xxx was not authorised'.

The Ctgb is preparing the transition to a case-oriented working environment for the entire application process. The application dossier is the basis for this. In order to use this dossier optimally in the new process environment, we have drawn up a new working method for applicants so that the folder structure of the file fits seamlessly with our IT environment. But also consider, for example, (mandatory) standardized file names. 

From May 1, 2024, applicants must submit application dossiers according to our new file requirements. As usual, we offer help via the Service Desk and a transition period of three months applies until July 1, 2024. During this period, dossiers may still be submitted in the old way. Please keep in mind that this may cost more and take longer. 

An extensive manual will soon appear on our site. 

With effect from 1 January 2024, the practices of the Board and the Secretariat have been updated in several policy regulations. For instance, the new Administrative Regulations stipulate that our decisions will no longer be signed.

These Regulations inform applicants about how specific competences of the Ctgb are implemented. This is how we ensure legal certainty and equality in law. It is important to take note of the relevant policy regulations when preparing an application. You can find these regulations on our website next to the information about how to submit an application.

The 21st Adaptation to Technical Progress (ATP) of the CLP Regulation lists substances for which the Risk Assessment Committee (RAC) of the European Chemicals Agency (ECHA) has published an opinion. The classification of 24 substances has been updated, 11 of which are relevant to plant protection products or biocides. Of the 28 new substances included in the harmonised list, five can be used as active substances in plant protection products.As a result, producers may have to change their product label, or there may be consequences for the authorisation. Producers are expected to keep track of these changes themselves.

On 12 June we will hold the annual Ctgb Client Contact Day at the Pathé congress centre in Ede. 'Digitisation' is the central theme of the day. The central questions for the programme are: 'What are the current developments in the sector?', 'How can the various links in the chain support each other?' and 'What data should the Ctgb provide?'. The specific topics on the agenda are: 'What possibilities does a digital label offer?' and 'Who owns the data?'.

The Ctgb Client Contact Day (in Dutch) takes place Wednesday ,12 June in Ede. In early May the digital invitation with the final programme will be send to our Dutch relations. If you are interested, please contact our communication team.

With a policy decree, the Ctgb provides more detail about an existing competence. The policy decree provides applicants with information on how the Ctgb exercises that competence. This is how we ensure legal certainty and equality in law. It is important for applicants to take note of the relevant policy decrees when preparing an application. On the website, we now provide separate overviews of policy decrees for applicants of plant protection products or biocides.

Following the modification of the soil degradation endpoints for metabolite 1,2,4-triazole (CRD, 2013), in 2016 we published an instruction for modelling the biphasic degradation of this metabolite. Since this publication, the endpoints for 1,2,4-triazole have been used, among others, in the dossiers for the approval of the active substances ipconazole and tebuconazole. In the EFSA conclusion about these substances, only the simulation in which the metabolite is formed from the active substance was used. Therefore, the Ctgb has decided to stop using the work instruction. For modelling the biphasic degradation of 1,2,4-triazole in soil, applicants can use the approach followed in the EFSA conclusion for ipconazole and tebuconazole. The work instruction has now been removed from our website.

When a plant protection product is sprayed on a crop, the active substance on the soil surface may be exposed to sunlight for a period of time. In a process known as photolysis, this can generate certain metabolites that are not formed by degradation (microbial or otherwise) in soil outside the reach of sunlight. EFSA has published a new guidance document on this topic. Explanations on the use of this guidance are included in an update of the evaluation manuals. Dossiers for active substances and applications for plant protection products submitted from 1 January 2024 are covered by this guidance.

In December 2023, Wageningen Environmental Research published a new version of the Groundwater Atlas on the website Pesticidemodels.eu. This repaired a number of bugs in the user interface and made improvements to the output (all the changes are summarised in the release notes). Version 4.3.2 contains the same measurement results as the previous version, but due to the resolved bugs it provides different results for the descriptive statistics reported from the data. From 1 January, the Ctgb will use this version in risk assessments of pending and new applications. If the assessment shows that additional information is needed to reach a decision, the applicant will be given the opportunity to provide this information.

The update involves Chapter 2 and Chapter 6. Chapter 2 Physical-Chemical properties) and chapter 3 Analytical Methods have now been combined into one chapter 2 Physical-Chemical properties and Analytical Methods. This was done together with a revision of the chapter focusing on the assessment. The numbering of the other chapters was adjusted accordingly. 

Chapter 5 (formerly chapter 6) - Fate and Behaviour – is updated on the following points: drift reduction for non-agricultural use (DTG8.1), reference concentration Kom in TOXSWA (water), interim spraying times GEM (water and groundwater). In addition, clarification was provided on model versions, exclusion criteria Tier 1, Tier 1 protected cultivation, multiple GeoPEARL runs (groundwater). 

Update Evaluation Manual March 2024

• Chapter 2. Physical Chemical Properties
  • Chapter 2. Physical Chemical Properties EU part version 2.4
  • Chapter 2. Physical Chemical Properties NL part version 2.3
• Chapter 5 Environmental Fate & Behaviour
  • Behaviour in soil; leaching; EU part version 2.8
  • Behaviour in soil; leaching; NL part version 2.8

The current criteria for the warning sentence for bees to be applied for biocidal products have been adapted, as agreed at the 90^th CA meeting. The warning sentence for bees will remain in use, but will be applied more in relation to hazard. This implies that the warning sentence: “This biocidal product contains (active substance name) which is dangerous to bees” will be applicable solely based on the toxicity of the active substance to all products (indoor or outdoor use, and any product type) containing an active substance with an acute toxicity to bees (LD50 < 11 µg/bee). The information used for this assessment can be based on data from biocide dossiers, but can also be obtained from other regulatory frameworks (e.g., PPPR) and reliable literature data. It was agreed that the warning sentence should be included in the Union, national and simplified authorisations of biocidal products containing hazardous substances to bees granted or renewed from 1 January 2024, except for mutual recognition in sequence or simplified notification, unless the warning sentence was included in the authorisation granted by the reference Member State or evaluating Competent Authority.

On 14 February, ECHA published the guidance document for the risk assessment for bees when biocides and their active substances are used. The main focus is on insecticides (PT18), but repellents/attractants (PT19) and wood preservatives (PT8) are also covered. For the time being the risk assessment focuses only on honey bees. This is because protection targets have not been established for other species of bees. At a later stage the European Commission and EU Member States will decide when the guidance will go into force for the assessment of biocides.

Recently, the efficacy working group has added two agreements to the Technical Agreements Biocides document for efficacy (EFF-TAB):

• EFF-TAB # 25 is a clarification on how to deal with different doses for different target organisms. This agreement was also established in CG-55. This agreement takes effect immediately, also for pending dossiers.
• EFF-TAB # 26 is about determining growth in a control treatment, which is important primarily for products used for preservation. This agreement provides guidelines to determine what growth is within the parameters of the test. This agreement will be enforced for dossiers submitted from 12-12-2025.

See Working Groups of the Biocidal Products Committee

Update Evaluation Manual March 2024:

• European evaluation framework v3.8
• Product authorisations under transitional legislation v3.4