EFSA’s FEEDAP Panel has just published an opinion on the safety of ractopamine, a growth promoter used in animal feed in some countries outside the EU.
Ractopamine is a drug belonging to the ‘β-agonist’ category which is banned from use in food producing animals in the EU by EC Directive 96/22/EC, with some exceptions for therapeutic purposes. In certain countries outside the EU its regular use is allowed in feed for pigs and cattle, to accelerate weight gain, improve feed efficiency and increase the leanness of carcasses. The EU ban on the substance applies to meat produced in the EU and imported from third countries.
The international body charged with recommending maximum residues of veterinary drugs in foods – the Committee for Residues of Veterinary Drugs in Foods of the Codex Alimentarius Commission – has proposed maximum residue levels based on a risk assessment carried out by the Joint FAO/WHO Expert Committee on Food Additives (JECFA). The European Commission, which represents the Community in international organisations, asked EFSA to review the JECFA risk assessment and other scientific information regarding the safety of ractopamine. The Panel also considered other relevant issues, particularly safety for the target species and product quality.
EFSA’s FEEDAP Panel found weaknesses in the data underlying the JECFA assessment which would undermine any proposal for a maximum residue level for ractopamine. The Panel found that the study on cardiovascular effects in humans cannot be taken as a basis to derive an Acceptable Daily Intake (ADI) of 0-1 micrograms per kilogramme of body weight per day as proposed by JECFA. EFSA consulted the Community Reference Laboratory responsible for beta-agonists and the European Medicines Agency (EMEA) and included the results of this process in its final opinion. Notably, the Committee for Medicinal Products for Veterinary Use of the EMEA fully supported the safety evaluation of ractopamine made by the FEEDAP Panel.