Agriculture Reference
In-Depth Information
13
Controls on veterinary drug residues
in the European Union
Glenn Kennedy
Legal framework
Policy and legislation within the European Union (EU)
lies within the remit of the Health and Consumer
Protection Directorate General of the European
Commission. These officials are responsible for the
development and implementation of EU legislation on
food and feed. In the specific area of veterinary medici-
nal products, they oversee and approve the monitoring
plans submitted by EU member states and third coun-
tries and evaluate the results of those plans. They also
implement the Rapid Alert System for Food and Feed
(RASFF), described later. The Food and Veterinary
Office (FVO), part of the Health and Consumer
Protection Directorate General, is responsible for the
verification of the implementation of national and com-
munity legislation on residues in the member states and
for the inspection of laboratories to ensure compliance
with the required standards. In addition, the FVO carries
out missions in third countries to ensure that the guar-
antees offered by their legislation, residue monitoring
plans and laboratories are at least equivalent to those in
the EU. Within the EU, the primary legislation relating
to veterinary drug residue analysis is Commission
Decision 96/23/EC (1996). This chapter describes the
implementation of this legislation in EU member states.
It should be noted that the European Commission is in
the process of revising this legislation, but it is likely that
the principles described will remain the same.
veterinary medicinal compounds is large - encompassing
antibiotics, parasiticides, sedatives, tranquillisers, anti-
inflammatory agents, etc. While the list of compounds
included in this category is long, it is discrete. Each
compound and each formulation have a unique and
individual marketing authorisation. The basic principles
established by the EU for the establishment of maximum
residue limits (MRLs) are set out in Regulation (EC) No.
470/2009 of the European Parliament and of the Council
(2009). This has introduced a number of significant
changes to previous legislation. These include:
1
Adoption of Codex MRLs without further assessment
Before a veterinary medicine for use in a food-
producing species is authorised in the EU, its active
ingredient must be assessed for safety. This will usu-
ally mean an MRL is set. However, the EU is not the
only body that sets MRLs. The Codex Alimentarius of
the Food and Agriculture Organisation (FAO) is an
international body that sets standards for food.
The EU is a member as are individual member states.
All are able to assess the scientific data for substances
as they pass through the Codex system. The situation
was that where Codex set an MRL, a further scientific
assessment by the European Medicines Evaluation
Agency (EMEA) had to be carried out before it could
be included in EU legislation. The new regulation
makes provision for
future
MRLs passed by the Codex
Alimentarius Commission to be adopted by the EU
without a further risk assessment, where the EU agrees
the science.
2
Extrapolation
The majority of the first MRLs were set for 'all food-
producing animals. Subsequently, setting MRLs for
specific species has become more common. Also,
Licensed veterinary medicines
All pharmacologically active compounds that are admin-
istered to food-producing animals must have been
evaluated for their quality, safety and efficacy as part
of the registration process. The number of licensed
