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Regulatory Aspects for the Drugs and Chemicals Used in Food-Producing Animals Chapter | 7 113

VetBooks.ir TABLE 7.4 Minimum Required Performance Limits (MRPLs) Established for Several Antimicrobials MRPL

Matrixes
Substance and/or Metabolite
Chloramphenicol Meat, eggs, milk, urine, aquaculture 0.3 μg/mL
products and honey
Nitrofuran metabolites: furazolidone, furaltadone, nitrofurantoine, Poultry meat, aquaculture products 1 μg/mL for all
nitrofurazone

Recently, maximum tolerances for the presence of the Decision 2002/657/EC (EC, 2002b), and established
active substances contained in coccidiostats have been MRPLs for different antimicrobials (see Table 7.4) where
established in food of animal origin and in feed stuffs results of analytical tests on products: (1) are at or above
(Commission Regulation (EC) No. 124/2009 (EC, 2009b); the MRPLs, the consignment concerned shall be consid-
Commission Directive 2009/8/EC (EC, 2009b)). The occur- ered noncompliant with community legislation and (2) are
rence of unavoidable carryover and/or cross-contamination below the MRPLs, the products will not be prohibited
of coccidiostats in nontarget feed, even below maximum from entering the food chain.
levels established, may result in the presence of residues of On the other hand, according to Article 1 of the
coccidiostats in food products of animal origin (i.e., in feed Regulation (EC) No. 470/2009 (EC, 2009a), the “refer-
for which the use of coccidiostats or histomonostats are not ence point for action” is defined as the level of a residue
authorized, such as feed intended for animal species or cat- of a pharmacologically active substance established for
egories not provided for in the additive authorization). The control reasons in the case of certain substances for which
maximum levels were set out for the coccidiostats lasalocid an MRL has not been laid down. The MRPL corresponds
sodium, narasin, salinomycin sodium, monensin sodium, to the average limit above which the detection of a sub-
semduramicin, maduramicin, robenidine, decoquinate, and stance or its residues can be construed as methodologi-
halofuginone. However, other antimicrobials used as pre- cally meaningful. Regulation (EC) No. 470/2009 (EC,
mixes for medicated feed stuffs have not yet been evalu- 2009c) states that the setting of reference points for action
ated for this purpose. should in no way serve as a pretext for condoning the ille-
gal use of prohibited or nonauthorized substances to treat
food-producing animals. Therefore, any residues of those
Minimum Required Performance Limits and
substances in food of animal origin should be considered
Reference Point for Action undesirable. Regulation (EC) No. 470/2009 (EC, 2009c)
highlighted that the reference points for action shall be
With the minimum required performance limits (MRPLs),
reviewed regularly in light of new scientific data relating
the European Commission has proposed a temporary mea-
to food safety and the outcome of investigations, analyti-
sure to address urgent problems related to prohibited or
cal tests, and technological progress. In conclusion, the
authorized substances in the EU, in particular in relation to
EU would demand from its trading partners prohibition of
third country trade. Commission Decision 2002/657/EC
the use of substances banned in the EU or to establish
introduced MRPLs intended to ensure harmonized imple-
split systems and ask third countries to provide respective
mentation of Directive 96/23/EC (EC, 1997) for substances
for which no permitted limits have been established. guarantees. As a consequence, detection of prohibited
substances below the MRPL would still be documented
MRPLs is defined as the minimum content of an analyte in
and reported.
a sample, which at least has to be detected and confirmed.
In contrast to MRLs for substances that may be used in
food-producing animals in the EU, the MRPLs would be
control tools based on expert advice on feasibility of con- PESTICIDE SUBSTANCES/RESIDUES
trols, and other legitimate factor in risk analysis. FROM CONSUMPTION OF STOCKFEED
Consignments containing residues above the MRPLs would TREATED WITH AGRICULTURAL
be rejected. If guarantees are provided, they may be CHEMICALS
returned to the sender.
The MRPLs laid down in Annex II to Commission The use of agricultural chemicals can result in residues in
Decision 2002/657/EC (EC, 2002b) are used as “reference crops and pastures that are subsequently consumed by
points for action” irrespective of the matrix tested. The animals and therefore pose a risk to these animals due to
Commission Decision 2003/181/EC (EC, 2003) amended a single or at most a few days of exposure. Residues of