Maximum Residue Limits (MRLs) for residues of veterinary drugs
Veterinary drugs are used to cure and prevent diseases in animals, including animals used for food production. Veterinary drugs are given to animals via feed or drinking water, or by injection. The use of veterinary drugs may result in residues of these drugs in animal products like milk, eggs and meat.
A lot of countries have established legal limits for residues of veterinary drugs in food.
According to the Agreement on the Application of Sanitary and Phytosanitary Measures (SPM) and Agreement on Technical Barriers to Trade food safety standards for veterinary drug residues established by the Codex Alimentarius Commission are the reference points in international trade. Thus far, Codex established MRLs for about 50 veterinary drugs. Once accepted member states of Codex are expected to implement these MRLs in national (or community) law. Deviations from Codex MRLs are possible but have to be substantiated with scientific proof of risk.
MRLs for residues of veterinary drugs in the European Union (EU)
Maximum residue levels (MRLs) for residues of veterinary drugs are set at the EU level. Only substances for which MRLs are established are allowed to be authorized for use in food producing animals by EU member states, and then only for those species for which MRLs are established.
The European Medicines Agency (EMEA) evaluates all applications for MRLs. The summaries of these scientific risk evaluations are published at the EMEA website (http://www.emea.europa.eu/ under ‘veterinary medicines’). The evaluation procedure is laid out in Council Regulation (EC) 2377/90 of 26 June 1990.
The consolidated version of this Regulation contains in its annexes all the MRLs for residues of veterinary drugs established thus far in the EU. This version can be found as a pdf-file at the Eur-lex website, http://eur-lex.europa.eu/nl/index.htm . To obtain the consolidated version click on ‘simple search’ then on ‘consolidated text’, and enter the year (1990) and the number (2377).
Missing species in the list of MRLs of EC/2377/90
MRLs are established only for those food producing animals for which an authorization is wanted. For instance, in the annexes of Regulation (EC) 2377/90 MRLs can be found for residues of abamectin in target tissues of bovine and ovine, but not in milk, poultry, swine or any other product of other food producing animals. This means that a) veterinary drugs containing abamectin can not be authorized for use in for example swine in any member state of the EU and b) residues of abamectin should be absent (‘zero tolerance’) in tissues of swine.
Missing substances in the list of MRLs of EC/2377/90
If a substance that can be used as a veterinary drug is not listed in the annexes I, II or III of Regulation (EC) 2377/90 this means that a) veterinary drugs containing this substance can not be authorized for use in any member state of the EU and b) residues of this substance should be absent (‘zero tolerance’) in tissues/products of all food producing animals.
Substances explicitly forbidden to use as veterinary drugs
Annex IV of Council Regulation (EC) 2377/90 contains a list of substances for which no MRLs are set because they were considered to be too dangerous as regards to their potential effect on human health. For example nitrofurans, chloramphenicol and dimetridazol are included in this Annex IV list. This means that these substances are forbidden to be used in food producing animals in the EU, and residues of these substances should be absent in food products derived from all food producing animals. Furthermore Council Directive 96/22/EC prohibits the use of thyrostatic substances, stilbenes, stilbene derivatives and their salts and esters, oestradiol 17 βand beta-agonists in food producing animals.
Action limits for forbidden or not listed substances
For some substances that are not allowed to be used in food producing animals ‘action limits’ were set for the control by official laboratories. These substances are:
- chloramphenicol (Commission Decision 2003/181/EC)
- nitrofuran metabolites (Commission Decision 2003/181/EC)
- medroxyprogresterone (Commission Decision 2003/181/EC)
- malachite green (Commision Decision 2004/25/EC).
Updated on 18-03-2009