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Consultation phase
The Federal Office of Consumer Protection and Food Safety (BVL) con-
veyed the application for the renewal of approval of glyphosate to the
BfR, JKI and UBA in August 2012. The applicant is the Glyphosate Task
Force (GTF), which comprises 26 firms. In line with legal provisions for
the approval process, the applicants must submit comprehensive data
which prove that the active substances can be used safely. To this end,
the applicants must also conduct literature research and report on the
status of studies. In addition to the GTF documentation, the BVL pro-
vided the BfR with additional documentation which had been submitted
by third parties for review. In line with these legal provisions, the active
substance glyphosate was then tested for its suitability for continued
use in plant protection products in compliance with legal stipulations
by the German authorities.
The BVL handed over the entire assessment report to EFSA at the end
of 2013. EFSA then invited the applicants, the other EU Member States
and the general public to comment on the report at the beginning of
2014. In this way, all interested persons, organisations, associations
and other interest groups were able to participate in the process. The
submitted comments, 350 of which concerned the health assessment,
were validated by rapporteur Germany with the involvement of the BfR
and worked into a new version of the Renewal Assessment Report
(RAR) in which the staff reviewed more than 250 experimental studies
with animals which the applicants had submitted and evaluated more
than 1,000 sources. Unresolved assessment issues and questions
raised in the comments were discussed at a meeting of experts organ-
ised by EFSA in February 2015 with the participation of all 28 member
states. Rapporteur Germany, with the involvement of the BfR, incorpo-
rated all of the results of the scientific discussion into the final version
of the RAR of April 2015.
At almost the same time that the EFSA Renewal Assessment Report was
completed, the International Agency for Research on Cancer (IARC),
an institute of the World Health Organisation (WHO) which evaluates
epidemiological studies on cancer all over the world to investigate the
causes of cancer and also prepares prevention strategies, announced
in a booklet published in March 2015 that they had assessed the ac-
tive substance glyphosate as “probably carcinogenic to humans” along
with the active substances contained in other pesticides. The IARC did
not present a complete assessment at this point in time.
BfR staff reviewed over 250 new experi-
mental studies with animals that had been
submitted by applicants and assessed
more than 1,000 sources from published
scientific literature.
Main Topics 2015
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Glyphosate