BfR Annual Report 2015

BfR

Annual Report 2015

Guidance for the safe use of plant protection

products

Plant protection products must not have any harmful ef-

fects on human health. The same plant protection product

can have different effects in different doses, depending

on the amount of the product to which a person is ex-

posed. The exposure pathway also plays a role – wheth-

er the substance is inhaled or absorbed via the skin, for

example. This is why the approval of plant protection

products in Germany is conditional on a comprehensive

assessment of health risks by the BfR. After a toxicologi-

cally defined health-related limit level has been set (this

is called an AOEL – acceptable operator exposure level),

this risk assessment serves to determine a safe expo-

sure level for the active substance based on direct use of

the plant protection product. Above all users of the plant

protection product can be exposed, but so can workers

performing other tasks in the treated cultures, as well

as non-involved bystanders and local residents. If the

health risk resulting from proper use of the substance is

too high, protective clothing must be worn, for example,

or safety distances must be complied with when using

the substance. If risk reduction measures of this kind are

not sufficient to exclude damaging effects to health, the

plant protection product may not be approved.

In order to determine the health risk for the various groups

who might be affected due to the use of plant protection

products, the BfR first estimates their exposure levels and

compares them to the AOEL. As no specifically deter-

mined data are generally available for the plant protec-

tion product in question, models are used that are based

on measurement data for comparable applications. Until

recently, different models and outdated concepts were

still being used in Europe for the assessment of plant

protection products. In accordance with the EU regu-

lation on plant protection products, one member state

performs the assessment of a plant protection product

for all requested applications for one zone of the EU on

behalf of the other states. To improve and harmonise the

exposure assessment in all member states, the European

The working area of chemical and pesticide safety affects many areas of consumer and user health

protection. In Germany, the BfR is one of the central institutions for health-related substance evaluations.

Multiple departments within the BfR, such as the departments for exposure, chemical and product safety,

and pesticide safety, deal with this issue.

Chemicals Safety

The EFSA guidance document is an important milestone

for the harmonised risk assessment of plant protection

products in Europe.