(5)Norway considers that, based on the efficacy claim and intended use, the product cannot be considered to be a biocidal product, but is rather a veterinary medicinal product by presentation, falling under the scope of Regulation (EU) 2019/6 of the European Parliament and of the Councilnote. According to Norway, applying the product to water to reduce the number of free-living lice in the water, even in the absence of explicit medicinal claims, is to be considered a preventive or curative treatment aimed at preventing or reducing sea lice infestation in salmon – which is a disease in salmon – and not a mere treatment for disinfection of the water in which salmon live. The user will expect the product to treat or prevent sea lice infestation, also in the absence of therapeutic or preventive claims. Norway points out that, as stated in the judgment of the Court of Justice in Case C-319/05note, ‘A product is ‘presented for treating or preventing disease’ […] when it is expressly ‘indicated’ or ‘recommended’ as such, possibly by means of labels, leaflets or oral representation’, or ‘whenever any averagely well-informed consumer gains the impression, which, provided it is definite, may even result from implication, that the product in question should, having regard to its presentation, have the properties in question.’. According to Norway, fish farmers would not incur an expense to reduce levels of free-living stages of crustaceans in general and the only rationale for incurring an expense is an expected reduction of subsequent sea lice infestations. In addition, Norway points out that the product has the same administration route as several veterinary medicinal products authorised against sea lice infestation in salmon. Norway is also of the view that the water where the fish swim does not fall under the definition of animal housing.
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