Agriculture Reference
In-Depth Information
specific analytical test - increasingly, MS, coupled to
either liquid chromatography (LC) or gas chromatogra-
phy (GC), is used. All veterinary drug residue testing
laboratories in the member states must be accredited to
ISO 17025, must perform satisfactorily in proficiency
testing schemes and are subject to regular audits by the
European Commission's FVO to ensure the quality of
their analytical work. There is no mandatory require-
ment for third country laboratories to be accredited to
ISO 17025. However, without such accreditation, it
is difficult to ensure equivalence. Similarly, there is
no mandatory requirement for third countries to follow
the same validation guidelines as member states. How-
ever, methods must be validated; otherwise, equivalence
cannot be demonstrated.
tives. Neither is a sampling level set in Commission
Regulation (EC) No. 136/2004 (2004), laying down the
procedures to be followed by EU BIPs.
Frequency of sampling of imports from
third countries
All consignments containing food of animal origin must
be subjected to a documentation check and to a physical
check, which may include an examination for the pres-
ence of unacceptable residue levels (Annex IIIc of Council
Directive 97/78/EC (1998)). Member states are obliged to
inform the European Commission each year of the results
of residue checks carried out on animals and animal
products imported from third countries. There is no stip-
ulated frequency of such import checks. A Commission
recommendation on veterinary checks on animal prod-
ucts or products of animal origin entering the European
Community from third countries (VI/2062/94) suggested
that at least 1% of consignments be checked for residues
(chapter VII, 4 b). However this document was never
formally adopted by the Commission.
CC
α
and CC
β
The performance characteristics CCα and CCβ were
introduced to control the performance of analytical
methods. In effect, CCα takes the measurement uncer-
tainty associated with an analytical method into account
at the level of interest. CCβ has no regulatory function.
For MRL substances, CCα is the drug residue concen-
tration in a sample where there is 95% certainty that the
true concentration is above the MRL. At concentrations
below CCα, the sample is compliant. At concentra-
tions equal to or greater than CCα, the sample is non-
compliant, with a statistical certainty of at least 95%.
For banned substances, CCα is the drug residue
concentration in a sample where there is 99% certainty
that the sample is non-compliant (i.e. that the drug is
present in the sample). At concentrations below CCα,
the sample is compliant. At concentrations equal to or
greater than CCα, the sample is non-compliant, with a
statistical certainty of at least 99%.
Further details concerning analytical methods are to
be found later in this chapter under technical aspects.
Interpretation of non-compliant results
Imported consignments that contain residues of licensed
veterinary medicinal products in excess of EU MRLs
may not be legally placed on the EU market and will be
rejected. Imported consignments that contain residues
of any of the illegal drugs at a concentration in excess of
the MRPL (where set) may not legally be placed on the
EU market and will be rejected or destroyed at the dis-
cretion of the member state. Where no MRPL has been
set, the consignment will be rejected when the confirmed
concentration exceeds CCα. It should be noted that
interpretations and actions in different EU member
states may vary in this case, too - as action is at the dis-
cretion of the member states.
The Rapid Alert System for Food
and Feed (RASFF)
Legal basis and description of the RASFF
Regulation (EC) No. 178/2002 of the European
Parliament and of the Council (2002) laid down the gen-
eral principles and requirements of food law, established
the EFSA and laid down procedures in matters of food
safety. It also established the EU RASFF. The purpose of
the RASFF is to provide the control authorities with an
effective tool for exchange of information on measures
taken to ensure food safety. Weekly summaries of notifi-
cations made under the RASFF are published on the
Internet. These are available at http://ec.europa.eu/food/
food/rapidalert/index_en.htm. It deals with issues
relating to unsafe animal feedingstuffs or unsafe food
Sampling of imported food
Legal basis for sampling of imports from third
countries
In addition to reviewing the residue monitoring plans
and results from third countries by means of a desk
evaluation and by FVO audit, compliance with the
guarantees offered by third country plans submitted by
third countries may be verified by means of veterinary
checks at EU Border Inspection Posts (BIPs). The system
of veterinary checks on animals and animal products is
set out in Council Directive 91/496/EC (1991) (animals)
and in Council Directive 97/78/EC (1998) (animal prod-
ucts). There is no statutory minimum (or maximum)
level and frequency of sampling set out in these direc-
