Ctgb Newsletter July 2021

At the beginning of June we held our annual Ctgb Contact Day – for our Dutch-speaking clients and other contacts. Last year it was cancelled due to the corona pandemic and the corresponding measures. This year we held an online event from a temporary ‘television studio’ at our office. It took some getting used to, but it was a successful experiment with almost two hundred participants. The afternoon session was devoted to 'transparency and communication'. According to the survey that was held afterwards, the participants were pleased that the Contact Day could take place digitally this year. They valued the programme, and the content of the afternoon session received a more than satisfactory score. We shared these positive impressions and were pleased with the reactions and suggestions of the participants. The event was appreciated, but everyone agreed that a digital meeting is not ideal for communication and networking. In 2022 we will therefore again focus on a physical meeting in Ede.

In any case we took note of the wishes from stakeholders and applicants for more transparent and intensive communication from the Ctgb. This was discussed constructively during the workshop 'Communication moments in the assessment process', and we incorporated the suggestions into our plan to communicate 'quickly but always carefully' during the application process. The idea of a 'my Ctgb portal' also received a lot of support, and as we stated during the session, we are working on a suitable solution. Other suggestions – such as greater international openness about the voting in the SCoPAFF – coincide with current European developments. The coalition government in the Netherlands is also working on greater transparency in a broad sense. It has rightly been pointed out that transparency must go hand-in-hand with clarification. Transparency can enhance trust, but is not helpful if you do not understand what you are seeing. This has our full attention, and we want to effectively meet the demand for transparency from society, because this can contribute to trust in the Ctgb and enhance its position and image. The suggestions that were made during the Contact Day are helping us to achieve this aim. The Ctgb wants to be understanding, without trying to persuade, and to be open and transparent about itself, its actions and its decisions.

Ingrid Becks
Secretary / Director of the Ctgb

In some browsers (Edge, Chrome  it recently is possible to generate a QR code from the URL of a web page. The Ctgb authorisations database (https://toelatingen.ctgb.nl/en/authorisations) has a unique URL for each registered product. This means that it is relatively easy to print a QR code on the packaging of a product that refers to the authorisation of the Ctgb. To do this, go to the Ctgb authorisations database with f.e. Micorsoft Edge, Google Chrome and open a product detail page. Click on the right mouse button and a pop-up window will appear with the option to generate a QR code. Click on this option and download the generated QR code to your PC. This code is then available for you to print on packaging, display on a website or make available in an app.

If the classification of a substance changes, manufacturers of a product based on such a substance are obliged to determine whether this has consequences for their product. Producers are responsible for this and must take any required action themselves. They may have to modify the label, or this could have consequences for the authorisation. Labels of plant protection products and biocidal products can be modified by requesting an administrative change from the Ctgb or via R4BP, the portal of ECHA. This year, two amendments to the CLP Regulation (the Classification, Labelling and Packaging Regulation) were published.

Reporting substance classification changes

Following the first three certifications, two more Ctgb ecotoxicologists have been certified as internationally recognised Environmental Risk Assessors by the Society of Environmental Toxicology and Chemistry (SETAC). The Ctgb will continue this process within its Ecotox team, so that more assessors acquire this certification. 

Two additional ecotoxicologists certified

The Wageningen Drift Calculator (WDC) is a tool for calculating drift deposition figures for all specific combinations of crop, cultivation-free zone (TVZ) and drift reduction class (DRT). The tool contains the most recent drift figures based on application parameters and crop parameters. This makes it possible to determine – without a specific drift report – which DRT class and cultivation-free zone are required for safe use. The WDC will be implemented in the assessment framework as of 01-01-2022.

Implementation of Wageningen Drift Calculator

The Evaluation Manual (EM) for Biopesticides has been revised (v. 1.2) and published. This contains the current assessment system for plant protection products based on microbial, botanical or semiochemical active substances. The EM for Biopesticides is an operational document that refers to framework documents for the detailed content. For the active substances and products referred to in this EM, the current regulatory assessment framework is still limited and can therefore often be interpreted broadly. For microbial active substances and products containing these substances, the sections 'specification', 'product properties' and 'analytical methods' have been expanded and, where necessary, provided with guidelines. The additions are mainly derived from scientific knowledge accumulated in recent years. The Evaluation Manual for Biopesticides thus offers standardisation, specification, predictability and effectiveness, where the assessment framework does not yet provide this.

Evaluation Manual Biopesticides

A number of new EPPO standards have become available for assessing the efficacy of low-risk products. The Evaluation Manual (EM) for Biopesticides has been revised accordingly.

There is a new standard (PP1/319) for products whose primary mechanism of action is to activate plant defences (elicitors). This also contains information on how the assessment of these products in a tank mix or in a spraying programme can be incorporated into a series of tests. Because low-risk products are often used in an IPM system, this is an important addition. Provided that it is well substantiated, this approach can also be used for other low-risk products.

In addition, the section on semiochemicals has been amended for efficacy. This is because there are two new EPPO standards for mating disruption in pome and stone fruits and grapes (PP1/314 and PP1/323). The existing pheromone guidance, EPPO standard PP1/264, has also been adapted accordingly.

New EPPO standards do not normally result in a stricter assessment framework and can be used immediately.

A new guidance document applies from 1 May 2021 for the assessment of antibiotic resistance of active substances based on micro-organisms. For approval as a low-risk substance according to the Plant Protection Products Regulation (EC 1107/2009), this guidance document prescribes how the antibiotic resistance of micro-organisms and the risk of increasing spread and its impact on human and animal health must be assessed.

It also explains how applicants can demonstrate whether adequate treatment methods are available if a micro-organism that is used as a plant protection product causes an infection. It includes definitions, clarifies the data that are needed and describes the available research methods to determine whether a micro-organism has acquired a resistance gene to medically important antimicrobials and whether this gene is transferable. The guidance document also contains scenarios for interpreting results and for follow-up research.

For applications submitted before 1 May, more genotypic testing or confirmatory data may be required if phenotypic testing cannot rule out the possibility that the micro-organism in question carries a functional antimicrobial resistance gene.

Since 1 March 2021, the guidance document SANTE/2020/12830 - rev. 1 has been in effect as a framework for the validation of both pre-registration and post-registration analysis methods. Pre-registration analysis methods are used to support studies regarding fate, efficacy, toxicology, residues, ecotoxicology and physical and chemical properties, and post-registration analysis methods are used for monitoring or enforcement purposes. The SANTE document combines – and thus replaces – the two previously separate guidance documents for validation criteria: SANCO/3029/99 - rev. 4 (pre-registration) and SANCO/825/00 - rev. 8.1 (post-registration).

By combining these documents, the new guidance document aims to achieve greater clarity and harmonisation. In addition, it provides more detailed explanation for each validation criterion, adds the honey matrix to the existing animal matrices, specifies an unambiguous subdivision of all regular crops into corresponding matrix groups, and clarifies the minimum requirements of 'old' pre-registration analysis methods (which were used in 'old' studies). In addition, the guidance document has been brought more into line with the related frameworks OECD ENV/JM/MONO(2007)17 and SANTE/12682/2019.

As previously announced, active substance dossiers submitted from 1 August are subject to the EFSA guidance document for stereoisomers. It describes the consequences and methods for each assessment aspect. The general chapter of the Evaluation Manual (EU part, Chapter 1, general introduction) states that this guidance must be followed.

On the labels of biocidal products for the control of insects (PT 18) the following warning sentence appears: ‘This biocidal product contains (active substance name) which is dangerous to bees’.

The current Guidance on BPR, Vol IV, part B and C (2017) does not yet contain a specific risk assessment for bees and other pollinators. ECHA and a number of Member States (including the Netherlands) are currently working on a pollinator guidance document. In December, the meeting of the competent authorities (CA meeting) of the European Member States decided that in the meantime – with effect from December 2020 – the warning sentence must be included on the label of products containing active substances that are possibly toxic for bees.

There is still discussion at EU level about which products this warning sentence applies to. As an interim solution – because the sentence is now obligatory – the Ctgb has decided to use the warning sentence for products with neonicotinoids (clothianidin, imidacloprid and thiamethoxam), substances that are toxic to bees (threshold value for acute toxicity is 11 µg/bee as proposed by the expert group that is working on the pollinator guidance document) and other PT18 substances for which no data are available for bees. This also concerns PT18 products that are sprayed and products with PT18 substances that are used outdoors.

Until now, when assessing environmental risks for disinfectants and insecticides in livestock housing (Product Types 3 and 18) under Dutch transitional law, it was assumed that emissions to the environment only take place via the spreading of manure. However, under the European Biocidal Products Regulation, discharge into the sewage system is also included as an emission route to the environment.

Modification of environmental emission pathways from livestock housing

From 5 March 2021, only authorised products and products that are explicitly mentioned in the exemptions may be marketed and used for hand and surface disinfection against the coronavirus.