59
cedural coordination would also be important for consid-
ering existing values and proposed values from various
other procedures (biocides, plant protection products,
veterinary medicinal products etc.). The discussion also
covered principles of the assessment of residues and
the need to finalise harmonised guidelines for the as-
sessment of biocide residues.
Hygiene during milking is important. However, residues
from disinfectants can be transferred to milk during
cleaning of the udder and the milking tubes.
What are default maximum residue limits?
These are values which automatically apply when
no specific maximum residue limit (MRL) has been
defined. They are used e. g. in the framework of
plant protection products: scientifically-based spe-
cific MRLs are derived for the individual active
substance(s) contained in the product and apply
to certain foods. If no specific value exists, then
a default maximum residue limit of 0.01 milligrammes
per kilogramme of food (mg/kg) applies. This means
there is a concrete legal provision regarding the resi-
dues allowed in foods for every active substance.
Setting maximum residue limits for biocides
Biocidal products such as pest control products or dis-
infectants are used to combat harmful organisms such
as bacteria, cockroaches or mice. When these agents
are used in animal husbandry or the manufacturing, stor-
ing or processing of food and feed, residues can remain
in the food. The European Biocidal Products Regulation
(Reg. [EU] No. 528/2012) stipulates the setting of maxi-
mum residue limits (MRL) in certain cases. These limits
guarantee safe food, form the basis for food monitoring
and function as trade standards for domestic and im-
ported products.
Key aspects of the exact procedures for setting the maxi-
mum residue limits in the EU were discussed by repre-
sentatives of the European Commission, European and
national authorities and European associations at the
“European Conference on MRL-Setting for Biocides” in
March 2014. As the BfR is involved in various legal pro-
cedures concerning the assessment of plant protection
products and biocides, the Institute organised the event
along with the Directorate-Generals for the Environment
and for Health and Consumers from the European Com-
mission.
The main point of discussion was how biocidal applica-
tions that can lead to relevant residues in food can be
identified as efficiently as possible and for which active
substances the setting of MRLs should be prioritised.
Data suitable for this purpose from national monitoring
programmes and company inspections are scarcely
available in the EU. Computational models could serve
as an alternative here. The use of default maximum
residue limits (see information box) was also discussed.
These could create legal certainty for the monitoring of
many biocidal active substances with minimal effort and
could, if required, be replaced by specific, scientifically
verified values.
The regulatory framework into which the MRLs for bio-
cides could be integrated was also discussed. As cor-
responding values have already been set in other regu-
latory fields, it is important to pay attention not only to
overlaps, but also to synergies. For example, MRLs from
biocidal applications in the presence of livestock are
already regulated together with veterinary medicinal
products in Regulation (EC) No. 470/2009. According
to the majority of conference participants, MRLs of all
other biocidal applications should be regulated as part
of Regulation (EC) No. 396/2005 on residues of active
substances from plant protection products. To achieve
this, the legal texts must be adapted to the specific ap-
plication areas of biocides, for example with regard to
the definition of the food groups concerned. Cross-pro-
Chemicals Safety
