BfR Annual Report 2015

45 / 112

43
Accompanying discussions on active substance
approval
In June 2015, the media reported on findings of glyphosate in 16 breast
milk samples and described these test results as “very worrying”,
whereupon concerned mothers in particular asked the BfR if breast-
feeding could still be recommended without any reservations. The BfR
expressed scientific doubt about the reliability of the results, since the
ELISA test that had been used is not suitable for the detection of sub-
stances in breast milk and the alleged findings were roughly 200 times
lower than the determination limit that the manufacturer of the test
stated to be reliable. For this reason, the BfR commissioned renowned
European research laboratories to develop two independent analytical
methods with high sensitivity in order to test 114 breast milk samples
from the states of Lower Saxony and Bavaria. Both methods were newly
developed and can precisely determine glyphosate residues in breast
milk from quantities of one nanogram (ng = one billionth of a gram)
per millilitre (mL) (determination limit). This means that these analytical
methods are more than ten times more sensitive than the methods nor-
mally used to analyse plant protection product residues in foods and
75 times more sensitive than the ELISA method (according to the infor-
mation provided by the manufacturer). As anticipated by the BfR on the
basis of the physical-chemical properties of glyphosate, no residues of
the active substance glyphosate contained in plant protection product
were measured above the detection limit in any of the examined breast
milk samples. This confirms the results of the BfR study which conclude
that mothers have no cause for concern and should continue to breast-
feed as before. ||
i More information on glyphosate:
More information from the WHO and JMPR:
Hazard classification of glyphosate
As a consequence of the current discussions, the BfR initiated
a regular examination of the legal classification of the carcinogenic
properties of glyphosate in line with the CLP regulation (Regulation
on Classification, Labelling and Packaging of Substances and
Mixtures) on a European level. Decisions made in compliance with
this regulation are to be used as the only binding legal regulation
for the classification and labelling of substances and mixtures.
As the responsible authority in Germany, the Federal Institute for
Occupational Safety and Health (BAuA) prepared a recommenda-
tion to change the legal classification of glyphosate in consulta-
tion with the other responsible German authorities (UBA, BVL
and BAuA) and submitted it to the European Chemicals Agency
(ECHA). The recommendation for the harmonisation of classifica-
tion and labelling is as follows:
> Serious eye damage Category 1,
H318: “Causes serious eye damage”.
> Specific target organ toxicity with repeated exposure Category 2,
H373: “May cause damage to organs through prolonged
or repeated exposure”.
> Hazard to aquatic environment long-term Category Chronic 2,
H411: “Toxic to aquatic life with long-lasting effects”.
Main Topics 2015 | Glyphosate