Establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin (debate) 
President
The next item is the recommendation for second reading by the Committee on the Environment, Public Health and Food Safety on the Council common position for adopting a regulation of the European Parliament and of the Council laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (15079/2/2008 - C6-0005/0009 - (Rapporteur: Avril Doyle).
Avril Doyle
rapporteur. - Mr President, could I start by thanking all my shadow rapporteurs, and indeed the French Presidency for facilitating an early second-reading agreement?
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.
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.
Günter Verheugen
Vice-President of the Commission. - (DE) Mr President, honourable Members, the revision of the legislation on residue limits of pharmacologically active substances in foodstuffs of animal origin is an important initiative for the European Commission. Its aim is to protect consumers against residues of medicinal products in foodstuffs whilst also improving the availability of veterinary medicinal products in the Community. It is also an important component of the Commission's legislative simplification programme.
On 21 October of last year, the Council and Parliament concluded an agreement that is reflected in the present common position. Therefore, we now have a common position of not only the Council and Parliament but also the Commission. I am delighted that the Commission was able to incorporate the amendments from both the European Parliament and the Council, as they retain both the spirit and the substance of the original Commission proposal.
Thus, the Commission expressed its full support for the common position in its communication to the European Parliament of 8 January of this year. The adoption of the common position will now make it possible to bring this dossier to a successful conclusion before the end of this parliamentary term.
Concluding it on the basis of the present common position will enable those involved with food controls and veterinary medicinal products on a daily basis to do a better job in the interests of animal health and consumer protection in the Community. These people have been waiting for the revision of the legislation on residue limits very impatiently for a very long time, and I think they really have waited long enough now, and can all be pleased that a solution has now been found.
I am very much aware of the particular importance of the availability of veterinary medicinal products. Therefore, irrespective of the progress that the present Regulation on residue limits of pharmacologically active substances already represents in this regard, the Commission will present an assessment of the problems entailed in the application of the Directive on veterinary medicinal products in 2010 and, where appropriate, will also present new legislative proposals on this.
I should like to take this opportunity to express my special thanks to the rapporteur, Mrs Doyle, whose truly tireless efforts have enabled us to reach agreement on this important matter. Sincere thanks once again for your excellent work, Mrs Doyle.
Doyle report
The Commission is aware of concerns expressed by citizens, veterinarians, Member States and the animal health industry as regards the directive laying down the rules for the authorisation of veterinary medicinal products, in particular the importance of addressing existing problems linked to the availability of veterinary medicines and the use of medicinal products in species for which they are not authorised and any disproportionate regulatory burden hampering innovation, whilst ensuring a high level of consumer safety with respect to food of animal origin. The Commission points out that positive steps are being taken in this direction such as the simplification of the rules on variations of veterinary medicinal products and this review of the legislation on maximum residue limits in food.
In addition, in order to address the objectives of consumer safety and animal health protection, competitiveness of the veterinary industry including SMEs and reduction of administrative burden, the Commission will present in 2010 an assessment of the problems in the application of the veterinary medicinal products directive with a view to making, where appropriate, legal proposals.
Avril Doyle
rapporteur. - Mr President, I would like just to put on the record that there is one amendment which I cannot support as it would, in fact, create a legal impasse. If you cannot administer a drug under test to animals unless it already has an MRL, then you cannot carry out tests that are necessary to obtain the data to establish MRLs and the withdrawal period in the first place.
I would like to thank the Commissioner for his cooperation in this area and put on the record the urgent need for review of the Veterinary Medicines Directive. In a sense we are using this MRL review as a bit of a 'patch and mend' for a major problem that is under the radar but which we are all very aware of. The availability of an adequate range of veterinary medicines to treat the wide variety of animal species in the European Community has been a growing challenge over the last two decades. During this period, considerable efforts have been made by various stakeholders, including regulators, industry and veterinarians, to address the problems of the availability of medicines.
Despite these efforts, the situation has continued to deteriorate. The lack of authorised medicines poses a real threat to animal health and welfare and the safety of consumers. It also raises significant problems for animal owners, farmers, veterinarians and governments if animals are untreated, or treated with an unauthorised or an unsuitable product - including the risk of zoonotic disease implications from untreated or inappropriately treated animals for the animal owners, consumers and citizens.
There are also financial, legal and trade implications for the various stakeholders involved, whilst the lack of medicines may have negative effects on rural economies and agriculture generally. An example - and a most important point - is the effect on pollination as a consequence of reduced numbers of bee colonies. Bees are a very important Minor Use/Minor Species (MUMS) issue.
However, not only does the current availability problem in the EU have implications across the board for the health and welfare of animals, the security of the Community's food supply and public health, it also undermines the ability of the EU to meet the Lisbon Agenda and to reap the enormous potential for European agriculture and offshore aquaculture to attract research and development in the veterinary pharmaceutical field.
Thank you again to all colleagues and the Commissioner for cooperation on this report.
President
The debate is closed.
The vote will take place tomorrow.
Written statements (Rule 142)
Péter Olajos  
in writing. (HU) We often hear the complaint that the EU tries to regulate everything while at the same time failing to address important questions.
Many of us may think that this report is also of this nature. This would be a mistake, however. For in this case, we are talking about 'foodstuffs' consumed by human beings - this is what we would like to render more secure in the interests of our citizens.
The existing regulations are out of date, and make it problematic for veterinarians to restock their store of medicines. For this reason, appropriate regulation for the distinctive features of this branch is needed.
Nowadays more and more pharmaceutical companies have a division dealing with animal products, which generate considerable revenue. The demand is growing steadily, as animals also fall ill, and now, when food is increasingly valuable, it is worth preventing this.
Yet in recent times, several pieces of information have come to our attention to the effect that certain companies are working on how to 'obtain' more from animals. Rapidly growing chickens, pigs that are fattened to enormous size in a matter of months. All this in done with (medicinal) products which are often harmful to human beings.
This is why every single preparation that is given to animals must be tested, in collaboration with the European Agency for the Evaluation of Medicinal Products (EMEA), to determine whether or not residues of such products that remain in the animals and are later consumed by human beings present any danger.
The testing is paid for by the company. We also need to emphasise the possibility of a fast-track procedure, which reduces the time needed for administration, and it is also important that veterinarians thus have much more rapid access to the medicinal products.
Nothing is more important that human health, and therefore we need to erect a barrier to'animal doping' motivated by monetary gain.
