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41

hoc statistical test, it includes all of the findings on the dose-dependent

effect, biological significance, reproducibility and consistency of the

toxic effects, the plausibility of the key events, the tumour frequency

among untreated test animals and the significance of various statistical

methods.

Special significance of the mixture toxicity

In its glyphosate assessment, IARC also took into consideration stud-

ies conducted on plant protection products containing glyphosate, the

results of which cannot be causally attributed to the active substance

glyphosate. The BfR took this circumstance into account by making a

clear distinction between effects caused by the active substance and

observations made with plant protection products containing glypho-

sate. This distinction is essential as, due to co-formulants or interac-

tions between co-formulants and active substances, plant protection

products can be more toxic than would be assumed on the basis of

the active substance concentration. The two-stage EU process for the

approval of active substances and authorisation of plant protection

products takes these circumstances into account by taking a separate

look at the mixture toxicity. In this context, the BfR also recommended

on the basis of its own research that, as has already been the case in

Germany for some time, certain co-formulants (tallow amines) should

no longer be approved in other European countries as well.

A distinction between effects caused by the active substance and observations with plant protection products containing

glyphosate is not only necessary where users are concerned but also non-involved third parties, including children.

Main Topics 2015

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Glyphosate