Newsletter December 2022

December is a time for reflection. Looking back on the past year, we have taken several steps to enhance the availability of 'green' products. Of course, these are modest steps relative to the big goal of sustainability, but they are certainly not insignificant. Everyone contributes to this goal from their role and position, including the Ctgb.

For example, we implemented the new data requirements for micro-organisms and provided workshops on these requirements to help applicants prepare dossiers for active substance applications involving fungi, bacteria or viruses. As a result we have supported the availability of these 'green' products. Due to the great interest in this topic, we are going to repeat this workshop. In addition, we updated and significantly expanded the Ctgb Evaluation Manual for the assessment of micro-organisms. To ensure that the EU deals with the new data requirements in a harmonised way, we have made this manual available to serve as a European guidance document (explanatory notes), which may become available as early as the first half of next year. This year we also provided several training sessions for assessors from the Netherlands and abroad on the assessment of micro-organisms (Better Training for Safer Food), which were led by three of our experts.

Last week we hosted a well-attended workshop on innovative techniques in relation to the assessment framework. Lively discussions took place during interactive sessions and we received valuable input that we can use in the future.

Finally, a new administrative route for extending the authorisations of low-risk products with minor uses will go into effect early next year. The Board has decided that, in principle, no assessment is required for extending the authorisations of low-risk products with minor uses. This is a pragmatic approach that can easily and quickly make low-risk products more widely applicable. You can read more about it in this newsletter.

But first enjoy the holidays and then get back to work refreshed and fully recharged!

I wish you a very happy holiday and all the best for the new year!

Ingrid Becks

Secretary/Director

The Ctgb published the tariffs (fees and charges) for 2023 in the Government Gazette in early December. 

Fees and charges

Due to the risks of phosphine toxicity during transport, the Ctgb wants to amend the regulations on the use of aluminium and magnesium phosphide and to ban fumigation during transport.

The Ctgb proposes to intervene in the authorisations of products containing phosphides

In agriculture and horticulture, biocidal products are 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. From the end of November 2022, the Ctgb has therefore been following a new, EU-approved description of this borderline that enables continued use of these biocidal products in agriculture and horticulture, also if they are authorised in the future under the Biocidal Products Regulation (BPR).

Biocidal products in agriculture and horticulture

On 1 January 2023, a new, accelerated procedure goes into effect for extending authorisations of low-risk products with minor uses. As much as possible, these applications will be processed administratively – i.e. without a risk assessment.

Simplified procedure for extending authorisations of low-risk products with minor uses

From 2023 onwards the Global Herbicide Resistance Action Committee will transition from letter mode of action codes to a numerical classification system. The codes are part of resistance sentences and are therefore included in the legal conditions for use of authorised products. The Ctgb will not retrospectively amend the codes included in legal conditions for use, but has chosen to gradually phaseout the old letter codes. Therefore it is not required to submit applications to amend current authorisations.

There has been an update of the EFSA OPEX guidance on the assessment of exposure of operators, workers, residents and bystanders (EFSA Journal 2022;20(1):7032). This update of the guidance document includes additional scenarios for both indoor and outdoor application as well as revised default values based on the evaluation of additional information. To support users in performing the assessment of exposure and risk, an online calculator, reflecting the guidance content, has been developed. In May 2022, the Standing Committee on Plants, Animals, Food and Feed adopted the revised EFSA OPEX Guidance document with an implementation date of 1 January 2023.  Please note that for applications submitted from January 1^st 2023, the updated guidance and online calculator should be used for all exposure scenarios included in this model (EFSA Journal 2022;20(1):7032).

The EFSA Scientific Committee has published a guidance document on the assessment of potentially aneugenic substances. The document provides guidance on the most appropriate in vivo tests to follow up on positive in vitro results for aneugenicity, and on the approach to risk assessment for substances that are aneugenic but not clastogenic nor causing gene mutations. This EFSA guidance document applies to active substance dossiers submitted from 1 January 2023 onwards (EFSA Journal 2021;19(8):6770, 27 pp.)

The workshop on dossier requirements for applications involving active substances based on bacteria, viruses or fungi was attended by some 50 interested parties from the Netherlands and abroad. Due to the continued interest in this topic, we are repeating this workshop next year.

If you would like to be on the mailing list so you can be notified of new dates for this workshop, please email your name and that of your organisation to the communications team. Interested parties will be notified by email and can then register for the workshop.

On 1-1-2023 the Evaluation Manual will be updated. This update amends Chapter 4 Human toxicology; risk operator, worker and bystander EU EM 2.4 and Chapter 4 Human toxicology; risk operator, worker and bystander EN EM 2.4.

The Evaluation Manual for Biopesticides is now being updated to reflect the new data requirements.

Evaluation Manuals

The deadline for submitting applications under transitional legislation has been clarified on the Ctgb website. The ambiguous term 'timely submission' has been removed and the 1-year time period has been replaced by 78 weeks. This new deadline is based on our observation that almost all applications under transitional legislation also require an additional-questions phase (besides the assessment itself). As of 1 September 2022, the following policy in in force:

• Applications for new biocidal products and applications for major amendments to existing authorisations can be submitted to the Ctgb under transitional legislation in the Netherlands up to 78 weeks before the date of approval of the last not yet approved PT-substance combination of the biocidal product in question.
• Applications for derived authorisations and for minor changes to existing authorisations can be made under transitional legislation in the Netherlands up to 90 days before the decision on renewal (under the BPR) of the original authorisation.
• Administrative changes under transitional legislation in the Netherlands can be requested up to 4 weeks before the decision on renewal (under the BPR).
• Applications for renewal of the authorisation under transitional legislation must be submitted to the Ctgb no later than 78 weeks before the expiration date of the authorisation. As a service, the Ctgb sends a reminder to authorisation holders about 4 months before the submission deadline. However, applicants are still responsible for submitting the application for renewal on time.

More information on deadlines and dossier requirements can be found on the Ctgb website under 'application under transitional legislation' and 'market freeze'. If you have a question about the submission deadline for your specific application, please contact the Service Desk.

The Kennisnetwerk Biociden (Biocides Expertise Network) is holding an event on "Fumigation and misting with biocidal products;" on 31 January. Key questions addressed during the event include: How can you work safely with these gases and mists that are effective but often hazardous for humans and the environment? What safety measures are needed? Are there alternatives? See the KNB-website (only in Dutch).

On 1-1-2023, the Evaluation Manual will be updated. In particular the European evaluation framework was amended.

Evaluation Manual