Agriculture Reference
In-Depth Information
5
Withdrawal periods under the 'cascade'
EU medicine legislation (Directive 2001/82) allows for
the use of some medicines outside of their authorisa-
tion where there is no authorised medicine available
to treat a particular disease or condition in an animal.
This is known as the cascade. This process is subject to
a number of restrictions. One of these is a set of blan-
ket minima for the withdrawal periods that must be
applied to such 'off-label' administrations. Another
change allows the Commission to modify these with-
drawal periods or establish other withdrawal periods
(article 30.2 (a)). This will be done in accordance with
the procedure referred to in article 89(2) of Directive
2001/82.
since the requirement for MRLs came into force,
partly driven by the cost of providing the necessary
data, more than 100 pharmacologically active sub-
stances are no longer authorised for food-producing
species. This effect was not foreseen or intended when
the previous legislation relating to the setting of MRLs
was adopted. The guidelines for carrying out
extrapolation have already been established. The
Commission's proposal would make the potential for
extrapolation to be a compulsory part of the overall
scientific assessment of an application. This work
would be carried out by independent assessors. It
would not automatically require companies to pro-
vide additional data.
3
Biocides
In future, the MRL procedure for veterinary medi-
cines will also be used to set MRLs for some biocides
used in animal husbandry (such as disinfectants). The
Commission is doing this because the previous EU
law (article 10 of the Biocides Directive 98/8/EC)
required MRLs to be set where 'relevant' for some in
biocides. That directive did not establish the proce-
dure for setting MRLs, and the Commission saw the
current proposal as an opportunity to address this.
Pharmaceutical companies would not be required to
pay any extra fee for the work of assessing existing
products for MRLs. However, if a new active ingredi-
ent comes forward for assessment, the company will
have to pay the costs of the MRL assessment.
4
Medicines for horses
The new regulation gives extra flexibility regarding
the availability of veterinary medicinal products for
horses, which are categorised as food-producing ani-
mals in EU legislation. Some leeway for substances to
treat horses has already been provided through
Council Regulation 1950/2006. This established a list
of substances for horses which are considered
essen-
tial
, but for which there is no MRL. Although MRLs
were not set, the substances were reviewed by the
EMEA, and a minimum 6-month withdrawal period
was introduced. This is to ensure that consumers are
not exposed to unacceptable residues. The European
Parliament has proposed to widen the criteria by
which substances can be added to the list. As well as
substances which are considered 'essential for the
treatment of equidae, the new regulation would add
substances 'which bring added clinical benefit com-
pared to other treatment options available for equidae.
Again, the EMEA would be involved in assessing the
substances that would be subject to a minimum
6-month withdrawal period. These two measures are
again to ensure consumers are not exposed to unac-
ceptable residues.
Hormones and ß-Agonists
Under the terms of Council Directive 96/22/EC, as
amended by Directives 2003/74/EC (2005) and 2008/97/
EC (2008) of the European Parliament and of the
Council, the possession and use in food-producing ani-
mals of substances having a hormonal or ß-agonistic
action are forbidden within the EU. This legislation:
1
Forbids the import into the EU of any food of animal
origin from any country that allows the use of stil-
benes and their derivatives or thyrostatic drugs in any
animal food-producing species.
2
Requires the establishment of a split system for the
import into the EU of food of animal origin from any
country that allows the use of hormones or ß-agonists
in food-producing animals. Food imported into the
EU must have been produced without the use of hor-
mones or ß-agonists at any time in their lives. There
are limited exceptions to this rule. These exceptions
are listed in articles 4, 5, 5a and 7 of the Directive.
These exceptions relate to the use of certain products
for clinical reasons and do not allow the administra-
tion of these compounds, under any circumstances,
for the purposes of growth promotion.
3
Requires checks to be made on imports from third
countries (i.e. non-members of the EU) to ensure
compliance.
Prohibited compounds
Table 2 of Commission Regulation (EU) No. 37/2010
(2010) contains a list of compounds whose use in food-
producing animals is prohibited within the EU. Their
use is forbidden because no acceptable daily intake for
their residues could be set and because residues of the
substances concerned, at whatever limit, in foodstuffs of
animal origin constitute a hazard to the health of the con-
sumer. The compounds listed in Table 2 are
Aristolochia
spp., chloramphenicol, chloroform, chlorpromazine,
