Agriculture Reference
In-Depth Information
member states in 2002 and 2003 when it was discovered
that a significant proportion of food (mainly poultry and
aquaculture products from South and Southeast Asia
and South America) contained residues of the com-
pounds listed in table 2 of Commission Regulation (EC)
No. 37/2010 (2010) - most notably the nitrofurans and
chloramphenicol. Thus, consignments were declared as
being 'compliant' or 'non-compliant' on the basis of the
limits of detection applied in the various testing labora-
tories. However, the limits varied considerably between
laboratories leading to pressure being brought to bear on
the European Commission by third countries who
wanted a minimum standard to be adopted - to allow for
harmonisation between member states.
The Commission agreed that the 'minimum required
performance limit' (MRPL) should be used as the refer-
ence point for action (RPA) when dealing with illegal
veterinary drugs (Commission Decision 2005/34/EC,
2005). Prior to this decision, the MRPL had been
intended as an internal quality control tool for laborato-
ries in EU member states. However, with the adoption of
this decision, its purpose changed radically. If the con-
centration of an illegal drug detected in a sample or
imported consignment exceeded the MRPL, then severe
enforcement action would follow. If the concentration
was between the limit of detection (CCα) and the MRPL,
the sample or imported consignment would still be
regarded as non-compliant - but it would be allowed
into the food chain. Depending on the frequency of any
such findings, more severe enforcement action might be
considered necessary.
However, the number of compounds covered by
MRPLs is comparatively small. To date, they have been
established only for chloramphenicol (0.3 µg/kg), the
nitrofuran metabolites (1.0 µg/kg), medroxyprogester-
one acetate (5.0 µg/kg) and malachite (and leucomala-
chite) green (2.0 µg/kg, sum of both compounds). Under
Regulation (EC) No. 470/2009 of the European
Parliament and of the Council, a procedure for setting
'RPAs' for substances that are not authorised for use in
the EU has been introduced. RPAs may be set in any
matrix (irrespective of whether it is 'food' or not). If a
sample is found to contain residues at or above any RPA
that may be set, the food is deemed non-compliant with
community legislation and should not be placed on the
market. If residues below the RPA are found, the cause
should be investigated to identify any illegal action and
apply appropriate penalties. The legislation allows mem-
ber states to refer substances to the European Food Safety
Authority (EFSA) for its opinion. It is anticipated that
existing MRPLs will become RPAs.
For those compounds not covered by an established
RPA/MRPL, a non-compliant result remains as was the
colchicine, dapsone, dimetridazole, metronidazole,
nitrofurans and ronidazole. Residues of these com-
pounds must not be present in food imported into the
EU from third countries. However, third countries may
authorise the use of these compounds in their domestic
production. They may also authorise their use in animals
(farm and aquaculture) destined for the EU market -
providing that residues are not present.
Unauthorised and unlicensed compounds
There are also a small number of compounds which may
not be used in food-producing animals within the EU.
Notably, these include malachite green (never evaluated
as a veterinary medicinal product - as a consequence, no
safety data are available), phenylbutazone (licensed for
use only in horses, but not in horses that may be slaugh-
tered as food), carbadox and olaquindox (formerly
licensed in the EU but which lost their marketing author-
isations because of concerns over the safety of these
materials - particularly to farmers and feed mill
employees).
Regulatory limits: MRLs, MRPLs and RPAs
Licensed veterinary medicines
Part of the approval process, referred previously, nor-
mally involves the establishment of an MRL for each
drug in each species in which its use is licensed in a range
of edible tissues. These MRLs are listed in table 1 of
Commission Regulation (EU) No. 37/2010 (2010).
One complication exists in relation to specified feed
additives (alternatively known as zootechnical feed addi-
tives). Under separate legislation dealing with animal
feedingstuffs (Regulation (EC) No 1831/2003 of the
European Parliament and of the Council, 2003) and for
historical reasons, a range of pharmacologically active
compounds - coccidiostats and histomonostats - have
been approved for incorporation into animal feeding-
stuffs and for feeding to food-producing animals with-
out the need for the establishment of MRLs. This
anomaly is being addressed and MRLs are progressively
being introduced for the coccidiostats (currently, there
are no licensed histomonostats in the EU).
Illegal drugs
For illegal drugs, a different situation applies. The use of
these compounds is forbidden in the production of food
of animal origin. Therefore, residues are unacceptable, as
their presence indicates that an illegal treatment has
occurred. The consequence of this is that a “zero toler-
ance” approach to the presence of residues may seem to
be a logical way of evaluating residues. Any amount is an
offence. This was the approach that was adopted by EU
