Newsletter February 2023

First of all to all respondents: Thank you for filling in our stakeholder questionnaire! We are extremely pleased that you value our expertise, quality, reliability and integrity so highly. We cherish it, and aim to keep it that way. Conversely it is true that we score poorly on our lead times – not unexpectedly. We are very well aware of this and have taken it to heart. Shortening our lead times will be an extremely high priority in our new long-term strategy, and we are fully committed to this in the continued development of our organisation.

Another point that came up is that we should evaluate in a more harmonised way – in accordance with European Union legislation. We are not unaware of this signal as well, which refers in particular to mutual recognition of plant protection products and zonal applications for which we are a concerned member state. Perhaps we do in fact try a little too hard and should be able to ‘follow’ a bit more – we are going to take a very good look at this. On the other hand, the European evaluation is frequently not fully complete. Parts of the evaluation are shifted to member state level. We see this for example if there is still no harmonised method, or because refinement studies are not representative of other member states, such as assessing risk for birds. For whatever reason, the signal is clear. This means that we will continue to examine our methods with a critical eye and continue to work within the European Union for harmonisation that is as thorough as possible.

In sum, we do not conduct our stakeholder survey without reason. The results keep us sharp and stimulate us to examine our existing methods. With your signals, you show us the direction we should and will take. We intend to do our best to achieve better scores in four years’ time!

Ingrid Becks

Secretary/Director

Applicants appreciate the Pre-Submission Meeting (PSM) that the Ctgb offers for discussing a dossier before it is submitted. This emerged from the stakeholder survey at the end of last year. Companies with experience of a PSM gave an 8.3 to the discussion. In a PSM, the applicant receives substantive advice on the dossier that has yet to be submitted, with the aim that it’s quality improves to the extent that it goes smoothly through the application process. A PSM is obligatory for biocidal product applications (under BPR) and is strongly recommended for plant protection product applications.

The Biopesticides Evaluation Manual sets out in detail the data requirements and risk assessment for biopesticides. It is made up of three sections. The sections on plant extracts and pheromones (semiochemicals) have not been changed. The section on the assessment of microorganisms has been completely revised. Microorganisms (including viruses) have specific data requirements. The European Commission adopted four implementation regulations for their risk assessment in 2022. These reflect the latest scientific developments and are based on their specific biological properties. The Ctgb has incorporated the revision of the Uniform Principles and the new data requirements in the Biopesticides EM.

The section on microorganisms has been sent to the European Commission following a peer review by Denmark. The European Commission has also asked the other member states for their comments. The expectation is that, following incorporation of comments from the member states, the Dutch Biopesticides EM will be accepted as explanatory notes in the SCoPAFF across Europe later this year, so that all member states will be able to use them for the risk assessment of microorganisms.

Evaluation Manual Biopesticides

Following coordination with the model developers among others, it recently became clear that the standard parameter reference concentration according to which the K_om is measured for calculations with the TOXSWA v 1.2. model had to be corrected. The adjusted reference concentration can be used in (national) calculations for emissions to surface water using TOXSWA v 1.2. with immediate effect. We request that applicants implement this in dossiers to be newly submitted and in dossiers that have been submitted following supplementary questions on surface water calculations at the latest before 1 April. See example below. Read more.

6. Fate behaviour in water NL part EM2.6

Chapter 7 of the Evaluation Manual, Ecotoxicology terrestrial non target arthropods and plants EU EM 2.7 and Ecotoxicology terrestrial non target arthropods and plants NL EM 2.7, is up to date again from 15 February.

7. Ecotoxicology

The Biocidal Products Committee Efficacy Working Group (EFF-WG) of ECHA has worked hard over recent years on updating and further harmonising the guidance for efficacy. The update of the BPR volume II Part B + C was published in November 2022. This update contains amendments for the PTs 1 to 5. The agreements reached previously in the Technical Agreements Biocidal Products document for efficacy have now been incorporated in the guidance, and clarification has been added for virus claims, spatial disinfection by nebulisation and textile / washing machine disinfection, among others.

Appendices 2, 3 and 4 have also been amended. New, available, tests for efficacy have been added, and the requirements for efficacy and the specification of test organisms have been amended. Appendix 1 has been amended based on the amendments in the guidance and the appendices. Apart from an update of the guidance, the technical agreements on efficacy (EFF-TAB, efficacy technical agreements biocides) have been amended and published (November 2022). Several EFF-TAB proposals have been included in the update of the guidance but are retained in the EFF-TAB document on account of their publication or implementation date. Recently submitted EFF-TAB proposals have been added to the EFF-TAB publication. 

For further information, see also:

Harmonised practices

A proposal has recently been accepted in the Efficacy Working Group (EFF-WG) that allows making an enveloped virus claim for PT4 (disinfection agents for use in the food and animal feed sectors). This proposal has been officially published in the EFF-TAB (Efficacy Technical Agreements Biocides) of November 2022. This agreement applies to all areas of use falling under PT4, for both professional and non-professional use, and for viruses and/or enveloped viruses.

Agreement was reached during the recent Coordination Group meeting (CG-54) that, in the description for the use of a product, the use frequency – the maximum or typical number of uses per day – must be indicated specifically. Terms such as ‘use as required’, ‘daily use’, ‘according to disinfection protocols’ are too vague here. The maximum or typical number of uses per day will be included in the risk assessment. In those cases where an applicant is unable to supply specific information on the number of uses per day, they must substantiate why this cannot be done. This substantiation will be looked at during the assessment and a decision taken on whether it is well-founded or not.

The 3.7 EU biocides evaluation manual is up to date again from 15 February.

Evaluation Manual