The European Commission has made a critical decision regarding the INTEROX Biocidal Product Family 2, denying its authorisation following unresolved objections about its effectiveness and environmental impact. This decision, encapsulated in Commission Implementing Decision (EU) 2023/2672, is a significant development in the ongoing discourse around biocidal products and their regulation within the EU.
Solvay Chemicals International S.A., the applicant, initially submitted their authorisation request in January 2017. However, France raised substantial objections concerning the efficacy and environmental classification of the product, leading to an extensive review process involving multiple member states.
INTEROX Biocidal Product Family 2, containing hydrogen peroxide concentrations of 35% and 49.9%, was intended for disinfecting drinking water for animals. However, France challenged the product's efficacy, citing non-compliance with the European Chemicals Agency (ECHA) guidelines. Notably, the product failed to meet the required criteria in standard efficacy tests, raising serious questions about its suitability for its intended use.
Furthermore, environmental hazard classification became a contentious issue. While Finland argued for non-classification of environmental hazards, France advocated for a classification as Aquatic Chronic 3 (H412), highlighting potential risks to aquatic life.
After extensive deliberations and an additional opinion sought from the ECHA, it was concluded that the INTEROX family did not convincingly demonstrate efficacy for its intended use, mainly due to deficiencies in the testing methodology. This conclusion, along with the environmental hazard concerns, led to the Commission's decision against authorising the product family under Regulation (EU) No 528/2012.
This outcome underscores the rigorous standards and careful scrutiny applied to biocidal products in the EU, reflecting a strong commitment to both public safety and environmental protection. Member States and companies are reminded of the critical importance of adhering to established guidelines and regulations to ensure the safe and effective use of biocidal products.
