Last year the European commission ruled that RNA can be administered to bees and that the risk to humans was so small that no maximum residue limit (MRL) would be required.

* * *

On 27 May 2013 the European Commission adopted a Regulation establishing maximum residue limits for double stranded ribonucleic acid homologous to viral ribonucleic acid coding for part of the coat protein and part of the intergenic region of the Israel Acute Paralysis Virus in honey, valid throughout the European Union. These maximum residue limits were based on the favourable opinion and the assessment report adopted by the Committee for Medicinal Products for Veterinary Use.

3.5. Conclusions and recommendation for the establishment of maximum residue limits

Having considered that [among other things, edited by PLB for brevity]

• there is no inherent risk associated with oral ingestion of nucleic acids in general;

• the sequence of IAPV-specific dsRNA has been found by bioinformatic analysis to have no 100% sequence homologies greater than 20 base pairs to human genes;

• as a result of the size and polar nature of RNA molecules, cell penetration is most likely very limited;

• lAPV-specific dsRNA are naturally occurring substances in bees and also honey as a result of IAPV infection;

• the establishment of a maximum residue limit for double stranded ribonucleic acid (dsRNA) homologous to coat protein (CP) and intergenic region (IR) of the Israel Acute Paralysis Virus (IAPV) in bees is not necessary for the protection of human health;

the Committee recommends the inclusion of dsRNA homologous to viral RNA coding for part of the coat protein and part of the intergenic region of the IAPV in table 1 of the Annex to Regulation (EU) No. 37/2010 as follows:

Bees, Honey, No MRL required

23 July 2013
EMA/CVMP/430890/2013
Committee for Medicinal Products for Veterinary Use

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