European Commission Resolves Dispute Over Procalx Authorisation

Procalx, a product intended for use in aquaculture to combat salmon lice, has been at the centre of a regulatory dispute. Submitted by Seacalx AS for mutual recognition in Latvia, Norway, and the United Kingdom, the product's classification has been debated due to its unique application and effects.

Latvia, acting as the reference Member State, initially supported Procalx's classification as a biocidal product, emphasising its use in disinfecting water environments to combat salmon lice, a common pest in aquaculture. However, Norway raised objections, arguing that Procalx's application and expected outcomes align it more closely with veterinary medicinal products, thereby falling outside the scope of Regulation (EU) No 528/2012.

The Commission's decision, informed by detailed analyses and the European Chemicals Agency’s guidance, concluded that Procalx does not fit the definition of a biocidal product for veterinary hygiene (product-type 3) as per Regulation (EU) No 528/2012. The Commission recognized that while Procalx aims to control copepod crustaceans (salmon lice), this does not align with the standard process of disinfection covered under the regulation.

Furthermore, the active substance in Procalx, calcium oxide, is approved for use in biocidal products of product-type 2 and 3 but not for product-type 18, which covers insecticides and products controlling arthropods. This discrepancy was a significant factor in the Commission's decision.

The Commission's ruling highlights the ongoing challenges in classifying products that straddle the line between biocidal and medicinal applications. This decision sets a precedent for future cases where the purpose and application of a product may blur traditional regulatory boundaries.

The decision, effective immediately, is directed to the Member States and underscores the need for clear and precise regulatory frameworks to guide the authorisation and use of such products in the European Union.