The UK-based aquaculture biotechnology company said that the MRL (Maximum Residue Limit) for Ectosan Vet had been adopted into the Agreement of the European Economic Area (the EEA Agreement) and had today entered Norwegian legislation, completing the regulatory steps required for the commercialisation of Ectosan Vet and CleanTreat in Norway.
Benchmark chief executive Trond Williksen said: “With the granting of the Marketing Authorisation on July 2, the MRL ratified by the European Commission and now in Norwegian legislation, we have completed the regulatory steps required to begin the commercialisation of Ectosan Vet and CleanTreat in Norway.
“We are excited to bring this much needed solution to the salmon industry, driving sustainability through improved animal welfare and yield while protecting the environment.”
Ectosan Vet, previously called BMK08 and before that simply Ecotsan, uses the neonicotinoid imidacloprid as its active ingredient.
It is designed for use in wellboats in conjunction with CleanTreat, a filter system that Benchmark says removes Ectosan residues from treatment water before it is returned to the sea. CleanTreat, which won the Innovation Award at Aqua Nor in Trondheim in 2019, is also said to remove lice egg strings. CleanTreat has previously purified more than 300,000m³ of treatment water during commercial trials of Ectosan Vet in Norway.
Benchmark has been gearing up for a commercial launch of Ectosan Vet in Norway by employing staff for its Bergen branch and commissioning a second CleanTreat system. It announced its first customer agreements for CleanTreat in March.
Ectosan Vet has received the go-ahead in Norway despite a June 9 vote by the European Parliament in favour of Green Party MEP Grace O’Sullivan’s resolution calling for the MRL for imidacloprid in fin fish to be changed to zero.
It is up to the Parliament’s executive division, the European Commission, to decide what to do next. It can choose to reject the vote, accept the proposal as it is, or withdraw the legislation and redraft it. In the interim, the MRL for imidacloprid remains in place. Although Norway is not a member of the EU, its membership of the EEA means it follows the same rules on medicines.
Referring to the vote on July 2, Benchmark stated: “As previously announced, the MRL was ratified as European law through a European Commission Implementing Regulation on 15th April 2021.
“The European Commission’s decision was taken following a rigorous programme of studies confirming the safety of BMK08 (imidacloprid), and a thorough assessment of robust scientific evidence by the European Medicines Agency Committee for Veterinary Medicinal Products, on 9 September 2020.
“Subsequently the Commission recommended on 26 February 2021 that a maximum residue limit in fin fish is established. This recommendation was confirmed on 20 March 2021 by the Commission’s Standing Committee on Veterinary Medicinal Products and adopted by the European Commission on 15 April 2021.”
When it announced that it had been granted marketing authorisation on July 2, Benchmark said the authorisation “does not fully include all anticipated label claims on usage”.
It added: “Benchmark will work closely with its customers as they develop their knowledge on the most effective usage of the product in the field. Benchmark will also continue to develop the optimal product usage in conjunction with NoMA (Norway Medicines Agency) through applications for field trials and variations to the marketing authorisation.”
Benchmark is seeking authorisation for Ectosan Vet one country at a time, beginning with Norway. It has not said which country is next on its list.