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Update efficacy requirements for PT19-products

Update efficacy requirements for PT19-products

Update of the guidance  for the evaluation of efficacy of biocidal products

 

ECHA published an update of the guidance (parts B + C) for the evaluation of efficacy of biocidal products in December 2021. This update relates only to the evaluation of repellents and attractants (PT 19). Harmonised test and evaluation criteria are added for a larger range of target organisms and uses. A transitional period of 2 years applies for this update (formal entry into application is December 2023). However, the CTGB advises applicants of product authorisations to use the new guidance also for applications before December 2023 in case target organisms and uses, not mentioned in the current guidance, are included.

It is also our advice to start using this new guidance when setting up new efficacy tests, for all target organisms. It will make life (slightly?) easier in the future. Costs for the studies will not be too different from the current ones. However, when looking into the details of the requirements, much more needs to be investigated and reported! But this is not typical for repellents only, it’s for all efficacy testing.

What’s new?

In the previous guidance (Version April 2018), repellents and attractants were included in the chapter on PT 18, Insecticides, acaricides and products to control other arthropods. The target organisms specified are listed in the first column below. The target organisms in the new guidance (December 2021, with a separate chapter on repellents and attractants) are in the second column.

2018 Guidance2021 Guidance
CockroachesAnts
AntsBed bugs
TermitesBiting midges
Bed bugsCockroaches
TicksFleas
MitesFlies on grazing cattle, horses and other livestock
FleasFruit flies and scuttle flies
Litter beetlesMosquitos
Textile attacking insectsStable flies indoor
Stored-goods attacking insects and mitesStored-goods attacking insects and mites
FliesTextile attacking insects
MosquitosTicks
WaspsWasps

Also new is in the section on mosquitos, a sub-section on “Products intended for use as spatial repellents”, including wristbands. One of the typical uses of geraniol.
Efficacy of spatial repellents should be proven in:

  1. a simulated-use test according to the instructions for use
  2. a field test according to the instructions for use.

Test design examples are given for both simulated-use and field tests.

Another section we want to highlight is “Norms and criteria for product authorisation” for products intended for use as general surface and spatial repellents:

Non-insecticidal efficacy has to be proven in a simulated-use test.

The required results for the different trials are:
Simulated-use tests:

  • ≥ 80% percent landing/probing inhibition within the test period according to the claim, from the beginning and until the end of the claimed efficacy period, or
  • ≥ 80% reduction of entry within the test period according to the claim, from the beginning and until the end of the claimed efficacy period.

Field trials:

  • ≥ 80% percent landing/probing inhibition within the test period according to the claim, from the beginning and until the end of the claimed efficacy period, or
  • ≥ 80% reduction of entry within the test period according to the claim, from the beginning and until the end of the claimed efficacy period.

 The chapter on repellents and attractants is “only” about 100 pages … not taking appendices, tables and figures into account.
The following link gets you to the ECHA website and the document:
https://echa.europa.eu/documents/10162/2324906/bpr_guidance_assessment_evaluation_part_vol_ii_part_bc_en.pdf/2c42983a-ee0b-9e35-c596-b172fee61115?t=1644567032606

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