Ctgb Newsletter May 2021

Transparency means that you can see the other. If you look through a glass window, you see the person on the other side, and they see you. The visibility is mutual. It should not be like a scene in a police series with a one-way mirror in the interrogation room.

In society and politics, both national and European, the call for transparency is growing louder. In our field too, transparency – especially in the form of disclosure – is now the order of the day: transparency is gaining more and more prominence. Major steps to achieve transparency have been taken with the Freedom of Information Act, the new Open Government Act and the European General Food Law. Even while an application for approval of an active substance is still being processed, EFSA publishes the underlying studies in the application dossier, so that everyone can see them. And we also publish a lot of information via the Ctgb website.

This transparency is a great asset. Previously, the mere fact that the information in the application dossier was confidential led to suspicion in society. Does an applicant want to withhold information? Have the competent authorities performed a critical and correct assessment? The fact that everyone can now watch the assessment process itself shows the enormous progress in transparency. It is important, however, that we exchange ideas with each other on the basis of a comparable level of knowledge and comparable starting points. And as far as I am concerned there must be some kind of reciprocity in this process. Otherwise we will have a situation comparable to the one-way mirror in the interrogation room at the police station. When applicants and competent authorities share information, but others are unwilling to disclose what they are going to do with this information, there is no real transparency and reciprocity. When we make facts public, we can expect that the facts continue to speak, that the window remains clear and does not become obscure.

In short, we can expect transparency about everyone’s intentions, be they applicants, competent authorities, journalists, NGOs, politicians or consumers. Framing facts in a spurious context that changes the meaning should not be part of this process. We stand for transparency, but we also expect it from others. If everyone is transparent, this promotes the broad sharing of information. Then we will continue to trust each other. Isn't that the underlying goal?

Ingrid Becks
Secretary / Director of the Ctgb

The 2020 annual report of the Ctgb has been published. In 2020, the Board made 123 decisions on applications for plant protection products and 71 decisions for biocidal products, of which 6 and 10 applications, respectively, were completely rejected. In addition, for a substantial proportion of the authorisations in 2020 – 50% of plant protection products and 62% of biocidal products – the instructions for use became more restrictive. This was done so that consumers and professional growers can be confident that the products they buy and use are safe when used as directed.

Annual Report 2020

To meet the demand for assessment capacity, the Ctgb has invested heavily in expanding its capacity in recent years. Despite this investment, the required capacity in 2021 will be insufficient to work on all pending applications and to deal with new applications immediately. Read more.

Progress in applications for plant protection products and biocidal products

Since the corona outbreak, the Ctgb service desk has been receiving many questions, particularly about disinfectants. Many answers can already be found on our website, and if you cannot find what you are looking for, please email your question to the Service Desk. Due to the corona crisis, fewer service desk employees than normal are answering the telephone, but we are fully accessible by e-mail.

Service Desk

On 3 March 2021, Annex III (the list of unacceptable co-formulants) was published as an extension of Article 27 of the Plant Protection Products Regulation. The corresponding Regulation (EU) 2021/383 entered into force on 24 March 2021. As a result, from 24 March 2023, any plant protection products and adjuvants that are co-formulated with the substances on the list can no longer be on the market. The Ctgb is required to amend or withdraw these authorisations/permits. A formulation change request is required for this. The Ctgb is contacting the companies concerned, but the authorisation holders are responsible for submitting this request. If the Ctgb does not contact a company, but their product does contain unacceptable substances, they must also submit a request for amendment or withdrawal before the deadline.

Prohibition of products with unacceptable co-formulants

As a result of discussion during the Central Zone workshop in Brno, Ctgb has drafted a first version of the Central Zone Evaluation Manual, a Working document on Risk Assessment of Plant Protection Products in the Central Zone (CZ). This CZ Evaluation Manual is a compilation of all the agreements reached in the CZ in the past years, including the EFSA recurring issues. After a commenting round with the member states in the CZ the first version is finalised. We have the intention to update the CZ Evaluation Manual once every year, if necessary, which should cover updates of relevant guidance documents and additional agreements. On the public part of CircaBC the CZ Evaluation Manual is published.

Publication first version Central Zone Evaluation Manual Ecotoxicology

Adsorption of substances to soil particles can significantly affect their availability for degradation in the soil. Recent studies have shown that the sorption process often increases with time. On April 1, an European guidance went into force (SANTE/12586/2020 – REV 0) that specifies a refinement for the increase in sorption over time. This enables us to measure time-dependent sorption (aged sorption) and derive model input parameters for the existing FOCUS models with which – as a refinement – it can be included in the FOCUS leaching models.

Therefore, the Ctgb now accepts assessments in which the process of aged sorption has been included in accordance with the instructions from the guidance, and evaluates this refinement in accordance with the recommendations and indications from the guidance. This refinement can also be implemented in the Netherlands-specific leaching model GeoPEARL v. 3.3.3. The use of this guidance document in the risk assessment for leaching into groundwater is explained in an update of the evaluation manual; chapter 6 Fate and Behaviour in soil: Leaching. This refinement can be presented as a higher tier for calculating the concentration in groundwater.

European guidance for 'aged sorption'

The information requirements as laid down in Annexes II and III of the Biocidal Products Regulation (BPR) for active substances and biocidal products have been amended. This was initially due to the new criteria for endocrine disruption, but at the same time other points for improvement have been included. This has led to the revision of the following aspects: 

• the data requirements
• underlying study
• whether a requirement is mandatory or conditional (CDS or ADS, respectively) 
• whether or not to replace animal testing with cell testing

The changes will take effect on 15 April 2022. For data that is submitted before this date, applicants can choose whether or not to comply with the new requirements. For an overview of the changes, see EUR-LEX.

On 13 January 2021, ECHA published a notice on determining the representative worst-case test product for the efficacy core assessment for a biocidal product family (BPF). The efficacy of a product is determined by the amount of active substance, the co-formulants present and the physico-chemical properties. The document went into force on the date of publication and describes a harmonised approach to support the choice of the worst-case representative test product for the efficacy core assessment of disinfectant product families (PT1-5) and indicates how bridging studies should be designed.

The worst-case product is defined as the product with:

• the lowest concentration (in use) of active substance,
• the lowest concentration (in use) of co-formulant with a positive effect on efficacy,
• the highest concentration (in use) of co-formulant with a negative effect on efficacy,
• the physico-chemical properties (e.g. pH) that are most unfavourable to efficacy.

After the worst-case test product has been identified, it should be used to substantiate the efficacy of all uses in the Biocidal Product Family. For more information, see 'Harmonized approach to determine a worst-case (or a representative) test product to be taken into account for efficacy core assessment for a disinfectant BPF' on the ECHA website.

The ECHA BPR Efficacy Guidance parts B + C (April 2018) states in footnote 15 to Appendix 4 that phase 2 step 2 tests with viruses should be submitted for applications for surface disinfectants in PT2 with a virus claim from the moment a test standard is available for this test requirement. The relevant test standard (EN16777) was published on 1 December 2018. Because a transition period of two years applies when a new test standard is published, the obligation to supply this test data goes into force for applications submitted from 1 December 2020.

For applications under the BPR, the Ctgb uses 1 December 2020 as the transition date, in line with the other Member States. For applications under Dutch transitional law, the submission of phase 2 step 2 tests with viruses is mandatory for applications submitted from 1 July 2021.

In recent months, the Ministry of Infrastructure and Water Management has issued several exemptions for hand sanitisers and surface disinfectants. See our topic dossier on Corona virus COVID-19.