Newsletter February 2022

Government agencies have statutory tasks and competences. For the Ctgb, this involves the authorisation of plant protection products and biocidal products. According to European frameworks, the Ctgb assesses whether substances and products – when used according to the instructions – are effective and safe for humans, animals and the environment. Depending on the outcome of that risk assessment, it decides whether to authorise them or not. Other government agencies have other tasks and competences. Sometimes those tasks and competencies can clash; it is unclear which task and competency weighs most, or this leads to a lack of clarity or to misunderstanding. This happened last year when the court in Assen ruled against an environmental permit in the vicinity of a Natura 2000 area. The court ruled that the province had provided insufficient substantiation in issuing the environmental permit on the basis of its duties and competence. According to the ruling, the province should have collected objective data on plant protection products to exclude significant effects on the nearby Natura 2000 site. However, that ruling was interpreted in the media and elsewhere as if the court had banned the use of plant protection products.

That was not the case. The court pointed out to the provincial authority that it had inadequately implemented a competence arising from its duties, and did not refer to the task or competence of the Ctgb at all. This situation is comparable to the annual motor vehicle inspection. That is a task and competence of the corresponding agency (the RDW). The inspection determines whether a motor vehicle meets the safety and environmental regulations and will be allowed on Dutch roads for another year. Following this approval, the driver of the vehicle must still adhere to the traffic rules and obey the speed limit. And these rules and speed limits can differ depending on the situation. You can drive faster on the motorway than in built-up areas. But that has nothing to do with the vehicle safety inspection.

The Ctgb has a similar role in agriculture and horticulture. The risk assessment is comparable to the mandatory safety inspection for motor vehicles. If the Ctgb authorises a plant protection product, this means that it is safe for the birds, mammals, insects, plants, bees, soil organisms and aquatic organisms on, or immediately adjacent to, an agricultural parcel that has been treated. A decision on whether or not to grant an environmental permit is based on other legislation and considerations, while taking other aspects into account, including local circumstances. And that task and competency lies with the provincial authority.

Ingrid Becks

Secretary/Director of the Ctgb

Thursday 9 June is the annual Ctgb Client Contact Day. It appears that we will be able to meet in person again at the conference location in Ede. The theme of the day is ‘Innovation'. In the morning programme, speakers from the Ministry of Agriculture, Nature and Food Quality and the Ministry of Infrastructure and Water Management will discuss current policy developments and the corresponding requirements, as well as the space that is available for innovation. In the afternoon there will be presentations by the business community and the Ctgb. The speakers will also discuss the developments in innovation, the current opportunities and the space that is needed for innovation. From the perspective of the Ctgb, we will look at how innovation is related to assessment frameworks. Of course there will be ample time for questions, discussion and personal contact. Make sure you reserve 9 June in your diary. At the end of April/beginning of May you will receive a personal invitation to this event.

Eight ecotoxicologists at the Ctgb (out of a total of 17) have now been certified as Environmental Risk Assessors by the Society of Environmental Toxicology and Chemistry. The certification programme is still ongoing for four others. The intention is for all ecotoxicologists at the Ctgb to eventually be certified – if the evaluation is positive – in accordance with this first internationally recognised certificate for environmental risk assessors.

Restrictions on the legal conditions for use to protect groundwater are now easier to find in the our authorisations database. We have expanded the authorisations database with this information to benefit users as well as other parties who use the APIs. Because some restriction sentences are really tailor-made for the given situation, it is always important to refer to the sentence as it is included in the legal conditions for use.

The new version of the authorization database will be published this month. Then it is also possible to search for all operating instructions with a keyword. In addition, the layout has been made more user-friendly.

Authorised products database

When applying for authorisation of a plant protection product it is now mandatory to calculate the drift deposition figures with the Wageningen Drift Calculator (WDC). However, in some cases the previous assessment framework (from before 01-01-2022) is still in force.

Wageningen Drift Calculator implementation and applications under older assessment framework

On December 24 the Pesticide Atlas (Bestrijdingsmiddelenatlas) was updated with measurement data for 2018-2020 regarding the link with land use. From now on, the Ctgb will use these updated measurement data in risk assessments to determine whether the authorisation standard for surface water has been exceeded.

Monitoring data land use available in Pesticides Atlas

In the Ctgb Evaluation manual 'EU part - Plant protection products – Chapter 1 General Introduction and Generic aspects', Section 7 'Literature Review' includes a reference to an Appendix to the EFSA Guidance Document. The appendix contains additional instructions and guidance for both applicants and Rapporteur Member States on how to present the literature search in the dossier and the assessment reports, including a template. The reliability criteria for evaluating the publications are also discussed in more detail, along with and the literature search for dossiers of products based on micro-organisms.

1. General introduction EU part em2.7

In December 2021, ECHA published an update of the guidance (Part B+C) for the assessment of the efficacy of biocidal products. This update only affects the assessment of repellents and attractants (Product Type 19). Harmonised testing requirements and assessment criteria for a wider range of target organisms and uses have been added. A transition period of 2 years applies to this update (formal effective date December 2023). The Ctgb advises applicants to use the new guidance also for applications submitted before December 2023, which include target organisms or uses for which no specific requirements are included in the currently prevailing guidance.

In January, 25 disinfectants for hand disinfection (PT01) or disinfection of surfaces (PT02) were authorised. As a result, the exemption from the Ministry of Infrastructure and the Environment that permitted their temporary use has expired. For the exempted products for which no authorisation has been requested, the last exemption will expire on 28 February 2022. This also applies to products that were not authorised after an application was submitted. For 53 exempted products, the dossier had to be submitted no later than 1 February 2021. Twelve applications concerned a minor change, such as an extension with a virus claim or an authorisation for non-professional use. Fifteen applications were not taken into consideration because essential information was missing, and one application was withdrawn by the applicant. The other 25 applications were clustered on the basis of composition, use concentration or scope of use, which enabled the Ctgb to assess them within a year.