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AgVetLink: Number 52, October 2005

Codex Working Group on veterinary drugs without current ADIs and MRLs

The Working Group of the Codex Committee on Veterinary Drugs in Foods (CCRVDF) has been charged with coming up with recommendations on how to deal with veterinary compounds for which there is no current Acceptable Daily Intake (ADI) and hence no current Codex Maximum Residue Level (MRL). The issue that the Working Group is trying to resolve arises from the rules associated with international MRL setting. The Joint Expert Committee on Food Additives (JECFA) provides the CCRVDF with advice on the ADIs and MRLs that can be adopted, but is required to recommend ADIs only when the toxicology data package is up to current standard requirements.

Many veterinary drugs (particularly older drugs that no longer have data protection) do not have modern data packages, and because they are essentially ‘orphan’ drugs, do not have any sponsor willing to update their packages. JECFA is thus obliged to withdraw the ADI for these drugs because the data package does not meet modern standards; this then requires the CCRVDF to withdraw the Codex MRLs. Thus, even though there are no concerns regarding the risk arising from residues of these drugs in foods, there are few Codex MRLs set for them and so no residue is acceptable in international trade and a non-tariff barrier is effectively set up.

The countries most affected by this scenario are the third world countries that cannot afford the newer chemistry that is available to developed countries and the barrier to their exports does not allow them to develop economically as they should. Countries such as New Zealand are also affected because perfectly useful, cheaper veterinary drugs cannot be used for fear of causing disruptions in our produce trade.

New Zealand (amongst other countries) has been a strong advocate for JECFA to develop another parameter (to sit alongside ADIs) that establishes the dietary intake that does not represent a risk to consumers, and that enables Codex to recommend acceptable levels of residues in foods in international trade. John Reeve, Principal Advisor (Toxicology), therefore joined the Working Group that met on 15 September in Brussels to finalise a paper for the consideration of the 16th CCRVDF (that will meet in May 2006). The recommendations are expected to become available for consultation before the end of 2005.