BfR Annual Report 2015

Chemicals Safety

Food Safety Authority (EFSA) was commissioned to draw

up a technical guidance document for the assessment

of exposure levels of users, workers, local residents and

bystanders. A working group in which BfR experts also

played a lead role then assessed all existing models in

terms of their quality and the availability of the underlying

data. The idea behind the guidance document is to iden-

tify the most suitable model for the exposure scenario in

question, to define basic principles for exposure assess-

ment and to stipulate relevant standard parameters.

Following a public consultation phase, the guidance

document was adopted in May 2015 by the Standing

Committee on Plants, Animals, Food and Feed. The Com-

mittee also stipulated that the document applies to all

approval applications for plant protection products from

1 January 2016 onwards.

The EFSA guidance document introduces many funda-

mentally new rules, including the use of two new expo-

sure models. The AOEM (agricultural operator exposure

model) developed at the BfR uses statistical methods for

the first time in order to identify parameters that influence

exposure and to model the measurement data. In addi-

tion, the EFSA guidance document incorporates further

relevant exposure pathways and application scenarios

for bystanders and local residents. The guidance docu-

ment is an important milestone for the harmonised risk

assessment of plant protection products in Europe.

The EFSA guidance document is available at:

The prerequisite for the authorisation of plant protection products in Germany is a comprehensive assessment of the

health risks by the BfR.