FDBusiness.com

The Committee for Medicinal Products for Veterinary Use (CVMP) of the European Medicines Agency (EMA) has recommended the granting of a marketing authorisation in the European Union (EU) for VarroMed (oxalic acid dihydrate/formic acid). This antiparasitic medicine treats the Varroa mite infestation in honey-bee colonies, which is considered to be the most significant parasitic health concern affecting honey bees worldwide.

Honey bees are essential for pollination of crops and wild plants in Europe. The European Commission estimates that pollinators, including honey bees, bumble bees and wild bees, contribute at least Eur22 billion each year to European agriculture and pollinate over 80% of crops and wild plants on the continent.

However, beekeepers around the world have reported losses of honey-bee colonies, which are considered to be caused by a combination of different factors such as habitat loss, climate change, pesticide use, and also diseases affecting bee health. A continued decline of these pollinators could lead to serious biological, agricultural, environmental and economic difficulties.

The main parasite affecting honey bees is the Varroa mite (Varroa destructor), an invasive species from Asia that has affected bee colonies worldwide. The Varroa mite feeds on the circulatory fluid of bees and brood (bee larvae) and can also contribute to the spread of viruses and bacteria.

VarroMed is intended to kill Varroa mites and is a liquid which is trickled onto bees in the hive. It contains as active substance a fixed combination of two organic acids, oxalic acid dihydrate and formic acid. Both substances have been known in veterinary medicine for a long time and are either naturally present in foods or accepted for use in foods. The medicine is not expected to pose a risk to human or animal health or the environment, if used according to the product information.

VarroMed is intended to be used as part of an integrated Varroa control programme, which includes not only treatment with medicines but also non-chemical techniques like queen trapping or drone brood removal. It can be used either as a single-dose treatment during the broodless period (winter treatment) or in the presence of brood (spring or autumn), which will usually require repeated treatments.

The CVMP opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation.