Honey is defined in Council Directive 2001/110/EC. EU Maximum Residue Limits (MRLs) in honey are listed in Regulation (EU) No 37/2010 for residues of pharmacologically active substances in honey (e.g. tau-fluvalinate and amitraz) and in Regulation (EC) No 396/2005 for residues of pesticides.
Residues of pharmacologically active substances
In the European Union, veterinary medicinal products intended for use in food producing animals have to be scientifically evaluated according to human food safety requirements (Regulation (EC) No 470/2009). Products that have not been assessed as safe according to these requirements can neither be authorised nor used otherwise for food production animals. For those substances for which it has been considered necessary maximum residue limits (MRLs) have been established. There are no EU MRLs for antimicrobial/antibiotic medicines in honey and therefore these veterinary medicinal products are not authorised for the treatment of honey bees in the EU. However, it is certainly the case that antimicrobial drugs are authorised for the treatment of honey bees in many third countries.
This situation may potentially raise some problems with imports of honey into the EU. In the absence of EU MRLs, the presence of any detectable residues in honey imported into the EU would mean that those consignments can not legally be placed on the market in the EU. Therefore it is important that analytical methods used in third countries' residue control plans are as sensitive and reliable as possible in order to provide assurances that honey exported from third countries to the EU will comply with EU rules.
EU rules on setting of MRLs for pharmacologically active substances have been updated by Regulation (EC) No 470/2009. This legislation has, for the first time, introduced a mechanism for the extrapolation of MRLs from one species/food commodity to another. In addition the legislation elaborates the principles by which the European Commission can establish so-called "Reference Points for Action" (RPAs) for residues of pharmacologically active substances for which MRLs have not been (nor can not be) established. It is important to stress that RPAs are NOT MRLs. RPAs are residue concentrations which are technically feasible to detect by food control laboratories. In the event that the RPA is exceeded, the Member State is obliged to reject the consignment as it can not be legally placed on the EU market (see Article 23 of Regulation (EC) No 470/2009).
If a food control laboratory in an EU Member State unequivocally confirms and quantifies the presence of a substance at a concentration below the RPA (where an RPA has been established) in an imported consignment (i.e. the decision limit CCα as defined in Article 6 of Commission Decision 2002/657/EC has been exceeded), the Member State competent authority is obliged to permit the consignment to be placed on the market, however, it is also obliged to follow certain administrative procedures including, in some circumstances, informing the Commission services.
The RPA concept is not new – it has been described in Commission Decision 2005/34/EC and to date RPAs have been established in honey for substances such as chloramphenicol and nitrofurans. It is important to stress that in the absence of either MRLs or RPAs for many residues of pharmacologically active substances in honey, the finding of any confirmed residue concentration in honey shall result in the rejection of the consignment.
Pesticide residues may be taken up by honey bees during the collection of nectar and/or pollen when plant protection products are used while the treated crops are flowering. EU-MRLs are therefore set, in order to protect the consumers and to make trade possible in products containing residues. EU MRLs for pesticide residues are set in the framework of Regulation (EC) No 396/2005.