tg_efficacy_pt18pt19_superseded_en

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Transitional Guidance on PT18 + PT19
September 2016
2.3 Assessment of authorisation
2.3.1 Norms and criteria
A biocidal product may only be authorised if it “possesses a sufficient level of efficacy”.
For products with general claims the performance criteria per tested organism are the
same as those for products with a specific claim for the test species. I.e. for crawling
insects the criteria are the same as for cockroaches and ants, for flying insect the same
as flies, mosquitoes and wasps, etc. The criteria can be found in the sections dedicated
to these insects/acarids.
3. Cockroaches
3.1 Introduction
Cockroaches are a common and persistent problem in many households. These crawling
insects (although several species can also fly) are scavengers allowing them to readily
adapt to changing food availability. Cockroaches can carry bacteria such as Salmonella in
areas co-inhabited by humans. Cockroaches are also identified as a major cause of
allergies and asthma, particularly in children. Amongst the crawling insects, cockroaches
are the most difficult to control.
The effect of biocides on these insects is mainly based on either contact, both dermal
and tarsal, or the ingestion of bait products.
3.1.1 Biology
Cockroaches belong to the (sub) order Blattodea. There are over 3500 species of
cockroaches, but only a few are considered domestic pests in the EU. The German
cockroach, Blattella germanica, is the most common.
Upon hatching from an egg capsule, cockroaches begin their nymphal stage (smaller
version of adults minus fully developed wings and sex reproduction organs) and moult
through various instars until reaching the adult stage. Time of development can take
weeks or months depending upon the species and the surrounding environmental
conditions. For instance the eggs of German cockroaches hatch after 3 to 5 weeks
(depending on the temperature), the nymphal stage (5 to 7 moultings) can be 40 days
to 6 months and the adults live about 6 month (longer under lab conditions).
In temperate European countries most cockroach species will almost never be found
outside, with foraging activities almost entirely within human-made structures.
3.2 Dossier requirements
A clear label with comprehensive claims should be submitted. The study results of trials
should demonstrate the efficacy of the product based on the submitted label claim.
Requirements can differ for products for professional use and for consumer products. For
professional use a field trial is always required, for consumer products in some cases
laboratory and simulated-use tests are sufficient. If the product is applied as a bait, the
entire bait (formulated, including the bait box if applicable) should be tested, not only
the active substance which is contained in the bait.
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. Appendix 4 gives an example of a test guideline that can be
used. If the available guidelines are not suitable, industry standard or a company’s own
protocols are acceptable, 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