BfR Annual Report 2015

BfR

Annual Report 2015

Hazard identification by IARC and risk assessment

by the BfR

The “hazard identification” conducted by IARC constitutes the first step

in the process of “risk assessment”. The classification of a substance

as a carcinogenic hazard can be an important indication that a certain

level of exposure through a particular job, the environment or through

food, for example, could lead to a higher risk of developing cancer. With

the risk assessment of pesticide residues in foods as conducted by the

Joint FAO/WHO Meeting on Pesticide Residues (JMPR), a safe intake

quantity is established after the degree of risk has been determined.

As the IARC hazard identification can also form an additional basis for

risk assessment in the EU approval process, the BfR recommended

that the European approval process be extended, whereupon the Eu-

ropean Commission postponed the deadline for the submission of the

RAR. Once the IARC monograph was published in July 2015, the BfR

reviewed it and presented its assessment in an addendum to the Re-

newal Assessment Report in September 2015.

Both IARC and BfR assessed the epidemiological studies on glypho-

sate as providing “limited evidence” with regard to the carcinogenic

properties of glyphosate. The assessment of IARC deviates in places

from that of the BfR regarding the industry studies involving animal ex-

periments. This can be explained by, among other things, the fact that

the BfR assessment is based on the original studies of the applicants'

laboratories which conducted them. The IARC assessment, on the

other hand, is not based on the original studies but rather on the pub-

lished evaluations of third parties, such as the American Environmen-

tal Protection Agency (EPA) and Joint FAO/WHO Meeting on Pesticide

Residues (JMPR). The original data of the unpublished manufacturers'

studies were not available to IARC. That is why IARC arrives at some

conclusions in its secondary evaluations which contradict the primary

evaluations of bodies such as EPA and JMPR. The BfR assessed a

much more comprehensive data basis of a total of eleven long-term

studies on rats and mice regarding the carcinogenic properties of

glyphosate using the “weight of evidence” approach recommended in

the European guidelines. This approach is not based solely on a post-

The word hazard is used to describe the properties of

a substance itself. A risk only occurs, however, when

humans come into contact with a hazardous substance.