Chemical name: Esbiothrin Final regulatory action has been taken for the category: Pesticide Final regulatory action: The chemical is Banned Use or uses prohibited by the final regulatory action: Applications as a biocidal product for product-type 18 (insecticides, acaricides and products to control other arthropods). No other uses of esbiothrin are authorised in the European Union. Not relevant Use or uses that remain allowed: Not relevant Pesticide use or uses that remain allowed: Not relevant The final regulatory action was based on a risk or hazard evaluation: Yes Summary of the final regulatory action: Esbiothrin has not been approved as an active substance for use in biocidal products for product-type 18 (Insecticides, acaricides and products to control other arthropods) in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (BPR). No other uses of esbiothrin as an active substance in biocidal products are approved in the EU. As a result, it is prohibited to place on the market or use biocidal products containing esbiothrin. The reasons for the final regulatory action were relevant to: Human health Summary of known hazards and risks to human health: According to Regulation (EC) No 1272/2008 (CLP Regulation) esbiothrin has a harmonized classification for Acute Tox. 4 (H302, harmful if swallowed and H332, harmful if inhaled). Based on the available data and information used for the assessment of human health in context of Regulation (EU) 528/2012 and Regulation (EC) 1272/2008 esbiothrin is also considered as being toxic if swallowed (Acute Tox. 3). Furthermore, it is considered to cause damage to the skin through prolonged or repeated exposure (STOT-RE 2) and to the nervous system after oral and inhalation exposure (STOT-SE 1). Esbiothrin is considered suspected of damaging the unborn child (Repr. 2). A proposal for harmonised classification for these hazard classes has been submitted under the Regulation (EC) 1272/2008, but the final proposal is pending. Mutagenicity of photometabolites: Mutagenicity in bacteria was observed following light exposure to substances of the allethrin series. This mutagenic finding is attributed to the formation of reactive photometabolites. Based on this finding the photometabolites epoxide and allethronyl glyoxylate monohydrate are considered as mutagenic. Based on the mutagenicity of photometabolites a TTC (Threshold of Toxicological Concern) approach applying a value of 2.5 x 10-6 mg/kg bw/day was used for the risk assessment of the photometabolites. Furthermore, it is concluded that esbiothrin is converted in real-life exposure conditions by sunlight to these genotoxic photodegradation products in a yield of approximately 0.5 % (50 % exposure and 1 % formation rate). It is considered that the available data do not show that glass shields inhibit the photodegradation and that no further refinement is applicable. In particular, for exposure to genotoxic photodegradation products a non-acceptable human health risk was identified even after refinement of the exposure assessment. Further options for reduction taken into consideration (reduction factor for closed windows decreasing the fraction of UV light; total exclusion of sun light and UV light) are considered not realistic for non-professional users. In conclusion, the risks for human health due to secondary exposure to the generated photometabolites are considered as not acceptable and cannot be mitigated. Overall, no safe use could be identified during the evaluation.Expected effect of the final regulatory action in relation to human health: Reduction of risk for human health from the use of biocidal products containing esbiothrin. Summary of known hazards and risks to the environment: Not relevant Expected effect of the final regulatory action in relation to the environment: Not relevant Date of entry into force of the final regulatory action: 18/02/2021 |