7. International regulatory framework provided by Codex and WTO

Characterisation of the currently applied framework

The applicable international framework within the World Trade Organisation (WTO) is provided by the SPS Agreement, which addresses sanitary and phytosanitary measures that may affect international trade. Countries have also the right to implement separate measures, which provide appropriate levels of protection for their own population. Since such measures potentially hinder trade, the SPS agreement encourages international harmonisation of health related food standards. It recognises the Codex Alimentarius as the main source and reference for such harmonisation and correspondingly WTO promotes participation of developing countries in this work.

The SPS agreement also lays down a notification procedure to be followed if a country develops a new measure, which allows other members to comment and to prepare for the implementation of its own measures to meet these requirements.

The Codex Alimentarius Commission has the objective of protecting the health of the consumers and ensuring fair practices in the food trade by developing food standards and other texts related to food safety and quality (i.e. the Codex Alimentarius). With respect to veterinary drugs residues, the Commission recognized that "the occurrence and safety of residues of veterinary drugs in foods of animal origin was of significance to public health and consumer concern". In 1985 it established the Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF), which was tasked to:

• determine priorities for the consideration of residues of veterinary drugs in foods;

• recommend maximum limits of such substances;

• develop codes of practice as may be required;

• consider methods of sampling and analysis for the determination of veterinary drug residues in foods.

MRLs are developed and adopted as Codex MRLs (i.e. international standards) if the risk assessment performed by JECFA results in the establishment of an ADI; and the recommended MRLs are achievable under good veterinary practices (GVPs), and a suitable analytical method is available. The evaluation process depends on the commitment of a sponsor to provide the data and to submit a dossier. Over two decades Codex has adopted MRLs for residues of approximately 50 veterinary drugs.

Codex Alimentarius contains general guidance to member countries on the exchange of information between countries on rejection of imported foods^[3]. This guideline describes many elements that are essential for a rapid and transparent communication between administrations and laboratories if residues are detected in food.

Main problems and gaps

A closer examination of the definitions, guidance texts and procedures developed by the CCRVDF reveals that the Codex Alimentarius does not address residues of substances without an ADI/MRL. In cases where JECFA has decided not to establish an ADI or to propose an MRL (for various reasons), such substances are abandoned and disappear from the adoption procedure. In consequence, the Commission does not consider risk management measures for such substances. Since JECFA has evaluated only less than a third of the active compounds used in food animals, the majority of veterinary drugs used have not been considered and MRLs have not been adopted for their residues by Codex. CCRVDF has not fully complied with its initial mandate to evaluate, as a priority, those veterinary drug residues which pose a significant threat to human health and risk to international trade. In stark contrast to the progress made by national and regional authorities, Codex has adopted comparatively few MRLs for veterinary drugs.

The absence of international standards creates significant trade problems since some member countries may ban, and others may tolerate the use of certain drugs. A ban often involves a zero-tolerance approach, which in practice means that the detection capability of the analytical method applied by the control laboratories of a country determines what levels of residue are tolerated. Debate also arises about what analytical methods should be employed and the residue levels at which a food is considered to be unsafe and should be destroyed. It is noted that these activities often do not involve formal risk consideration steps. Routine arbitration procedures do not exist and their development would be helpful. FAO and WHO shall study the feasibility to develop such procedures and to implement a corresponding system.

A complication exists with substances which have not yet been evaluated by JECFA, or for which JECFA did not have sufficient information to complete the assessment, but which have been approved by national authorities. They have no Codex MRL but many of them are recognised to be safe and are used widely.

It is also recognised that, in some countries, many drugs are used in animal species for which neither JECFA nor national authorities have established MRL as a result of a lack of data.

In summary, the Codex Alimentarius does not contain a comprehensive set of standards that could be implemented by countries to control the use of safe as well as unapproved drugs. In this area Codex has failed to promote harmonisation at an international level which results in a patchwork of national solutions. This failure is the major factor for the issues and problems that were reviewed and analysed by this workshop.

On the other hand, it was noted that guidance from the Codex Alimentarius on the exchange of information between countries on rejections of imported foods (CAC/GL 25), is not considered and implemented by member countries in the case of residues.

The notification procedure of SPS that should be followed if national measures are developed seems to be inadequate and does not assure a consultation and involvement of exporting countries during the development and implementation of new methods. Language problems (documents may not be available in English), insufficient technical information, the short period of 60 days, the lack of capacity and co-ordination to comment in a rapid fashion are issues that weaken the system. New analytical methods are rarely communicated by this route.