Chloramphenicol

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Changed on: 20.07.2021

Monitoring foodstuffs for chloramphenicol residues

Ban on the use of chloramphenicol

Chloramphenicol is a broad-spectrum antibiotic with a very high potential bacteriostatic action that is used in veterinary and human medicine. Due to massive side-effects its use in human medicine is very restricted nowadays. The use of chloramphenicol in animals intended for food production has been prohibited in the EU since 1994 via its inclusion in Annex IV (list of pharmacologically active substances for which no maximum limits can be set) to Regulation (EEC) 2377/90. This ban was superseded by Regulation (EU) No 37/2010 (Table 2), which repeals the annexes of the above-mentioned regulation. The ban is based on the suspicion that chloramphenicol can cause aplastic anaemia in humans (reduction / cessation of blood cell production by the bone marrow) as well as indications of possible embryonic/foetal toxicity and reproduction toxicity.

As chloramphenicol residues in any concentration can constitute a risk to consumer health, foodstuffs of animal origin are closely monitored.

In the interests of preventative consumer protection there exists within the scope of the National Residue Control Plan (NRKP) a comprehensive inspection plan for monitoring domestic foodstuffs for improper use of chloramphenicol.

Furthermore, samples are tested within the scope of official foodstuff-monitoring activity and in cases of suspected contamination. Special attention is given to monitoring products from countries outside the EU (e.g. aquaculture products from South-East Asia, honey from China, etc.).

Non-EU countries importing products into the EU must guarantee that the efficacy of their residue monitoring measures is at least equivalent to those per residue monitoring directive 96/23/EC. However, since the use of chloramphenicol is permitted in many countries outside the EU and since it is used due to its high potential impact and low price, non-EU country products in the EU market are subject to intensive monitoring.

Matrices tested/examined

  • Blood
  • Animal tissue (meat, liver, kidney)
  • Aquaculture (fish, prawns, mussels)
  • Milk
  • Eggs
  • Honey

Examination strategy and testing procedures

For the purpose of safeguarding health - in order to guarantee sufficiently sensitive analyses - an MRPL (minimum required performance limit) of 3 µg/kg was set for chloramphenicol by Commission Decision 2003/181/EC. This limit is a minimum performance limit and not a maximum limit, i.e. the analytical methods applied must be able to detect at least 3 µg/kg. Results lower than 3 µg/kg are, as long as they are backed up by a confirmation method, also rated as positive.

For the sake of quick and cost-effective testing, a two-step procedure is generally used:

Screening

Screening methods are designed for rapid sample throughput. In accordance with Commission Decision 2002/657/EC, the rate of false negative results must not exceed 5%. An immunochemical ELISA test is used for this purpose.

Confirmation analysis

This step is used to confirm and quantify non-negative screening results.
In accordance with Commission Decision 2002/657/EC, a mass spectrometric method is required for the confirmation of banned substances. The method used includes a liquid/liquid extraction for sample purification. This is followed by liquid chromatographic separation with mass spectrometric detection (LC/MS-MS).

 

Legal basis

  • Commission Regulation (EU) No. 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin (OJ EU No. L 15 of 20/1/2010).
  • Council Directive 96/23/EC of 12 August 1996 on measures to monitor certain substances and residues thereof in live animals and animal products (OJ No. L 125 of 23/5/1996).
  • Commission Decision 2003/181/EC of 13 March 2003 regarding the setting of minimum required performance limits (MRPLs) for certain residues in food of animal origin (OJ No. L 71 of 15/03/2003).
  • Commission Decision 2002/657/EC of 12 August 2002 implementing Council Directive 96/23/EC concerning the performance of analytical methods and the interpretation of results (OJ No. L 221 of 17/8/2002).

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