Local view for "http://purl.org/linkedpolitics/eu/plenary/2009-04-01-Speech-3-254"
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"en.20090401.20.3-254"2
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"− Mr President, could I start by thanking all my shadow rapporteurs, and indeed the French Presidency for facilitating an early second-reading agreement?
It allowed the extrapolation from a major species to a minor species of the same family, ruminant to ruminant, fish to fish, chicken to other poultry. In 2008, after eight years’ experience, the CVMP issued a new guideline. The Risk Analysis approach for residues of veterinary medicinal products in food of animal origin. This describes a risk-based approach of extrapolation of an MRL for a substance from one or more species to additional species. This guideline allows the extrapolation of MRLs from data on the three major species to all species, provided the MRLs set for the three major species are similar or identical.
The text of this review before us simply provides a legal basis for the current practice of extrapolation in the interests of veterinary medicines availability and animal welfare.
Two amendments specifically target the lack of availability of species-specific medicines for equidae (I must declare an interest) across a range of therapeutic and welfare needs, including the concept of ‘clinical benefit’ and not just the requirement that it is ‘essential’ to have a medicinal product added to the positive list of substance for equidae referred to in the Veterinary Medicines Directive. In clearly defined circumstances, certain products used for equidae will not have to have MRLs but will have to respect a six-month withdrawal period.
Perhaps there is a declaration – may I ask through the Chair – that the Commissioner is going to put on the record: I recall a discussion in relation to this issue some months ago concerning a review of the Veterinary Medicines Directive.
This is a rather technical proposal as it aims to update the existing EU regime, the main purpose of which is to protect public health by limiting the exposure of consumers of food of animal origin to residues of pharmacologically active substances present in veterinary medicines and biocidal products. This is achieved by setting safety thresholds or maximum residue levels (MRLs) for approved substances and by banning substances which are either found to be unsafe or in respect of which a safety profile cannot be scientifically established.
MRLs alone do not protect consumers. Consumers are directly protected by setting an appropriate withdrawal period before slaughter and by having controls in place to monitor it. In practice the withdrawal periods are set using a high safety factor which will reflect the amount of data available at the current stage of product development.
We have reached an agreement on the key issues. First of all, extrapolation of MRLs set for one species to another; secondly, adopting within the EU MRLs set internationally within the Codex Alimentarius; and, thirdly, creating a framework setting MRLs for food imported from third countries.
We managed to clarify the measures which need to be taken when unauthorised substances are found either in EU-produced food or in food imported from third countries, as well as clarifying the basis for reviewing these reference points for action (RPAs): that is, the maximum level established for control purposes for any unauthorised substance in the light of any new data.
The question of setting MRLs for certain biocidal products such as disinfectants used in the animal environment was also agreed on, particularly in regard to the financing aspects of their authorisation and their dossiers.
The establishing of an MRL for a pharmacologically active substance requires an expensive data package of toxicology and metabolism studies. This is too costly for certain less common food species, so-called ‘minor species’, as the market for veterinary medicines for these is small – so-called ‘minor uses’. Setting an MRL is the first step that must be accomplished before an application can be submitted to the regulatory authorities for authorisation of a veterinary medicine for a food-producing species containing a pharmacologically active substance.
So this Minor Use/Minor Species (MUMS) issue is a problem urgently in need of resolution as it creates potential animal welfare and food safety issues. Vets have a duty of care and will always try to treat a sick animal. Under present legislation they are often forced to resort to unlicensed medicines.
The lack of an MRL also prevents authorities from being able to establish a proper withdrawal period for a medicine. The current MRL Regulation does not require MRLs to be set for individual species. The European Medicines Agency’s Committee for Veterinary Medicinal Products (CVMP) sets MRLs for individual species, following an initial cautious approach. In 1997 and following five years’ experience, the CVMP reviewed all the MRLs that had been set and concluded that it was not necessary to set MRLs for individual species as the MRLs for a particular substance are nearly always similar or identical. That same year, the CVMP issued a guideline on the establishment of MRLs for minor species. It defined minor food-producing species as all species except cattle, pigs and poultry, and they included salmonidae."@en1
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