1. AGREXIS AG | Schwarzwaldallee 215 | Postfach | CH- 4002 Basel | T +41 61 683 31 47/48 | F +41 61 683 31 49 |
www.agrexis.com
PLANT PROTECTION: DIETARY
SAFETY
Dietary safety assessment is part of the regulatory
requirements to obtain the authorisation of active
substances and formulated plant protection
products within the EU, and to allow the setting of
maximum residue limits (MRLs) in food.
Studies are required to establish the metabolism
pathways in crops and livestock and to identify the
relevant residue. Residue studies are conducted
subsequently: using validated analytical methods,
residues are quantified in edible crop parts, livestock
and their products, processed commodities and in
succeeding crops. The residue data serve to calculate
MRLs and to assess the dietary risk by comparing the
calculated short- and long-term residue intake with
toxicological reference values. Authorisations can
only be granted if the assessment shows that there is
no health risk to the consumer.
Since Regulation (EC) No 1107/2009 came into
force in June 2011, some data requirements for
dietary safety assessment have changed, as
outlined in Regulations (EC) 283/2013 and
284/2013. The EC Guidance document 1607/VI/97
and its appendices (“Lundehn” documents) have
largely been replaced by OECD guidance and test
guidelines.
There are now several new requirements (e.g. on
the nature and quantity of residues in fish, on
residues in honey, and on combined risk
assessment), and the guidelines for some of these
are not yet available or in draft form.
In a constantly changing regulatory landscape, we
strive to be completely up-to-date, working in line
with the latest developments, guidelines, and
format requirements. Our many collective years of
experience in the field of dietary safety help us to
put your data in context and to make sure that we
provide you with the best possible service.
AGREXIS offers
• Data Gap Analysis
o including an estimate of costs and
recommendations for creating a successful
submission package
• Writing of Analytical Methods and Residue
chapters including calculation of MRL/xMRL,
animal dietary burden, and dietary risk
assessment for:
o EU dossiers for existing (AIR) or new active
substances
o Plant Protection Products dossiers (dRRs)
o JMPR/CODEX submissions
o MRL /Import Tolerance applications
• Monitoring of all studies for the analytical and
residue sections
• Post-submission support on all technical issues
relating to dietary safety
For further information please contact us
info@agrexis.com