tg_efficacy_pt18pt19_superseded_en

46
Transitional Guidance on PT18 + PT19
September 2016
accumulate in the lowest areas such as deep in fibres of carpets, cracks in the floor, or
crevices in furniture and furnishings.
Larvae require high protein food for their survival. This protein comes from feeding on
the dry faeces of the adult fleas. The adult flea takes in more blood from the host than
necessary for nourishment and excretes the remaining blood in almost pure form. Once
dried, the faeces falls off the host animal where the larvae can feed. The larvae spin a
cocoon and begin the pupal state.
An adult flea emerges from the pupae after stimulation from external cues that indicate
an animal host is near. Once emerged, a flea must usually find a host (located using
visual and thermal cues) within a week, or it risks death due to desiccation. Complete
development from egg to adult occurs in as little as two weeks, but this can take much
longer depending on environmental conditions.
9.2 Dossier requirements
A clear label claim should be submitted. The study results of laboratory. simulated-use
tests and field trials should demonstrate the efficacy of the product, based on the
submitted label claim.
Laboratory and field trials with fleas are needed to assess the efficacy of the product.
Ideally, the studies should be performed according to established guidelines where these
are available. These may be international, EU or national guidelines. See appendix 3 for
a list of available guidelines. If there are no guidelines available or the guidelines are not
suitable, the applicant may use their own methods, on condition however, that the study
is scientifically robust, well reported and provides a clear answer to the question. In
addition, the test methods applied and the test conditions should be clearly and fully
described and must address the efficacy claim that appears on the product label. In the
case of field trials where true replication is almost certainly impossible to achieve and
where normal control methods are not restricted to use of a single insecticidal product, a
full description of any factors that might be expected to influence product performance
should be given. These may include the risk of re-invasion from adjacent areas, general
levels of sanitation, treatment history etc. and are intended to provide the authorities
with information to assist with the interpretation of the results obtained.
9.2.1 Test species
A product against fleas should normally be tested on the cat flea (Ctenocephalides felis)
or the dog flea (C. canis).
9.2.2 For claims made for products intended for use as general
surface treatments
For the evaluation of biocides against fleas different types of laboratory, simulated-use
tests and field tests can be used.
Examples of the types of data that may be available when considering the efficacy of
insecticide products intended for use as surface treatments are given below.
9.2.2.1 Laboratory studies
The product is applied to representative surfaces (e.g. carpet discs). Information on the
fibre length and density should be provided, as this has a bearing onto flea survival.
Long fibres enable fleas to hide and, thus, protect fleas from getting their share of the
insecticide applied, Fleas are transferred to the surface, either before (direct contact) or
after (residual performance) application of the product, to assess inherent contact
toxicity or knockdown effect of the active substance.
Alternatively, ovicidal or larvicidal products can be tested in flea rearing medium