Benchmark said it marked an important step towards the launch of its novel lice treatment BMK08 – which contains imidacloprid – in the second quarter of next year.
In a statement today, Benchmark said: “On 10 September 2020 the Committee for Medicinal Products for Veterinary Use (CVMP), a committee of the European Medicine Agency, adopted an opinion recommending the inclusion of BMK08’s active pharmaceutical ingredient in fin fish as an allowed substance regarding maximum residue limits in foodstuffs of animal origin (the MRL opinion).
“The MRL opinion is an important step towards the launch of BMK08 together with the Company’s water purification system CleanTreat in Q2 CY 2021. The MRL opinion is without prejudice to the European Commission’s decision and ratification into EU law, which represents the next milestone for BMK08 together with CleanTreat, and is a condition for obtaining Marketing Authorisation (MA) in Norway.”
Significant stepping stone
Benchmark chief executive Trond Williksen said: “The MRL opinion is a significant stepping stone towards the launch of our novel sea lice treatment BMK08, together with CleanTreat which purifies the treatment water.
“The positive opinion of the European Medicine Agency’s experts in medicine safety is a critical step in a 10-year data collection and assessment process which ensures that the medicine is safe to use and safe for consumers.
“I congratulate our teams for getting us to this point and we look forward to making further progress towards a launch in Q2 CY 2021.”
BMK08, previously known as Ectosan, is designed for use in wellboats in conjunction with CleanTreat, which Benchmark says removes all traces of imidacloprid from treatment water.
The CleanTreat system is also capable of removing other treatment chemicals, along with lice and egg strings.
The BMK08/CleanTreat combination has undergone extensive commercial trials in Norway, which is the first country where Benchmark is seeking permission for full scale commercial use.
In March salmon farmer Mowi Scotland made initial enquiries with regulators about carrying out field trials of the system at its Ardnish site at Loch Ailort.
No threat to bees
As of 1999 imidacloprid was the most widely used insecticide in the world.
Its use in terrestrial farming was banned by the European Union in April 2018 along with the use of two other neonicotinoids after the European Food Safety Authority reported that the substances posed a serious danger to bees, although no such threat would apply to its use in a closed system in fish farming.
Benchmark has previously pointed out that BMK08 was developed under the strict veterinary medicinal products guidelines of the European Union (Directive 2001/82 as amended).