EU - Low levels of Chloramphenicol detected in Vitamin A and D3
Two EU rapid notifications (one alert and one information) are currently active, reporting the detection of low but detectable amounts of chloramphenicol in some Vitamin A and D3 products. These products, which are sourced from two different producers in China, have been placed on the EU market by two EU operators. The products have been distributed to several EU countries, and were subject to information and recalls by the concerned companies.
According to the EU law, such residues of pharmacologically active substances are regulated through the outlet of the feed chain, i.e. by setting limits in the foodstuff of animal origin. In the case of chloramphenicol, the law (Regulation EU 37/2010) provides that the substance is simply prohibited.
As far as the upstream part of the chain is concerned, Chloramphenicol is neither authorized as a feed additive nor as a veterinary medicine and cannot be present in compound feed, premixtures and feed additives. Chloramphenicol is not a typical and/or expected case of contamination in feed additives.
There is no obvious route of contamination related to such products and the source of the detected contamination is not known at this stage.
From information available, the detected amounts are low and they are measurable in the concerned vitamin A/D3 products only. Due to the low incorporation rate of these products, the levels in feed and animal by-products will be far below the limits of quantitation (LOQs). Indeed, we haven’t got any information that the detected amounts would be of any safety concern for the feed chain.
However, FEFANA, the EU Association of Specialty Feed Ingredients and their Mixtures, underlines that such incidents should not occur and that the quality aspect shoud be well monitored.
From this perspective, the alert and recall process can be very much seen as a precautionary measure.
FEFANA welcomes this and understands that the concerned companies acknowledged the approach: a previously unidentified potential risk or route of contamination was identified and both the authorities and concerned companies take the conservative measures to analyze the situation. The
relevance and extent of risk management measures should then be assessed at the light of this analysis. The EU Vitamin industry is closely watching this case and is available to the authorities for any further required action.