Chloramphenicol is a broad-spectrum antibiotic with very high bacteriostatic action potential that has been used in veterinary and human medicine. Due to massive side effects, its use in human medicine is now severely restricted. Since 1994, chlorampenicol has been banned in the EU for use in food-producing animals. The ban is based on the suspicion that chloramphenicol can cause aplastic anemia (reduction/cessation of blood cell production by the bone marrow) in humans, as well as evidence of possible embryo/fetotoxicity and reproductive toxicity.
Situation in Austria
For the control of domestic foodstuffs for misuse of chloramphenicol, there is a comprehensive testing program within the framework of the National Residue Control Plan(NRKP) in the sense of preventive consumer protection.
Furthermore, samples are examined within the framework of actions of the official food control as well as in cases of suspicion. Special attention is paid to the control of products from countries outside the EU (e.g. aquaculture products from the Southeast Asian region, honey from China, etc.).
Third countries importing products into the EU must guarantee that their residue control measures are at least equivalent in effect to the legal requirements of the European Uniun. However, since in many countries outside the EU the use of chloramphenicol is allowed and practiced because of its high efficacy potential and low price, third country products are intensively controlled.
In total, about 3,500 samples in various animal matrices are tested for chloramphenicol per year in the Department of Veterinary Medicinal Products, Hormones and Contaminants of the Institute for Food Safety Vienna.
- Animal tissues (mainly muscle)
- Aquaculture (fish, shrimp, mussels)
Analytical strategy and methods
For the purpose of uniformity in analytical performance and interpretation of results across the EU, an RPA (reference point for action) of 0.15 µg/kg has been set for chloramphenicol (CommissionRegulation (EU) 2019/1871 ). This means that, firstly, the detection limits of the laboratories must be below the RPA and, secondly, results above the RPA must be judged as positive ("non-compliant"). Foods with chloramphenicol concentrations below the RPA are marketable, but the cause of the residues is being investigated.
In the Department of Veterinary Drugs, Hormones and Contaminants of the Institute of Food Safety Vienna, we analyze chloramphenicol in food of animal origin and are also the National Reference Laboratory for these studies.
Regular participation in international interlaboratory comparisons and in workshops of the EU Reference Laboratory(EURL) in Fougères (France), which is responsible for antibiotics, ensure the quality of the results and constant further development of the analytical methods to the latest state of the art and research.
In the interest of rapid and cost-effective screening, a two-step approach is generally used:
- Screening Screening methods are designed for rapid sample throughput, with a maximum false negative rate of 5% according to Commission Implementing Regulation (EU) 2021/808. Immunochemical methods (Beadyplex, Infiniplex, ELISA) are used for this purpose depending on the matrix.
- Confirmatory analysis This step is used for confirmation and quantification in case of non-negative screening results. According to Commission Implementing Regulation (EU) 2021/808, a mass spectrometric method is required for the confirmation of prohibited substances. The method used involves liquid/liquid extraction for sample cleanup followed by liquid chromatographic separation with mass spectrometric detection(LC-MSMS).
COMMISSION REGULATION (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification with regard to maximum residue limits in food of animal origin(OJ EU No L 15, 20.1.2010).
COMMISSION REGULATION (EU) 2019/1871 of 7 November 2019 concerning reference points for action on non-authorized pharmacologically active substances present in food of animal origin and repealing Decision 2005/34/EC.
DELEGATED COMMISSION REGULATION (EU) 2022/1644 of 7 July 2022 supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council as regards specific requirements for the performance of official controls on the use of pharmacologically active substances authorised as veterinary medicinal products or as feed additives and on prohibited or unauthorised pharmacologically active substances and their residues
COMMISSION IMPLEMENTING REGULATION (EU) 2022/1646 of 23 September 2022 laying down uniform practical arrangements for the performance of official controls on the use of pharmacologically active substances authorized as veterinary medicinal products or feed additives and on prohibited or unauthorized pharmacologically active substances and their residues, on the specific content of multi-annual national control plans and on specific arrangements for drawing them up
COMMISSION IMPLEMENTING REGULATION(EU) 2021/808 of 22 March 2021 concerning performance criteria for methods of analysis for residues of pharmacologically active substances in food-producing animals and the interpretation of results and methods to be used for taking samples and repealing Decisions 2002/657/EC and 98/179/EC
Last updated: 30.05.2023