Chemical name: Phenol, 5-chloro-2-(2,4-dichlorophenoxy)- 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: All uses of triclosan in biocidal products of product type 1, human hygiene biocidal products. 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: Triclosan is not included in the list of approved active substances under regulation (EU) No 528/2012. Therefore, as governed by Article 89(2)(b) it is prohibited to place on the market as of 17 February 2017 and to use as of 17 August 2017 biocidal products of product-type 1, human hygiene biocidal products, containing triclosan. The reasons for the final regulatory action were relevant to: Environment Summary of known hazards and risks to the environment: A consumption-based approach was considered for the environmental risk evaluation: the use as antimicrobial hand soaps (restricted to surgical operations). The exemplary soap is a model formulation which contains 0.7% Triclosan by weight and the number of disinfection events/day is 4. For the surface water, realistic worst-case assumptions are used (a predicted no effect concentration (PNEC) for Triclosan of 0.05 g a.s./L, derived from data consisting of long-term no observed effect concentrations (NOECs) for the three trophic levels). The PEC/PNEC relation for surface water is 6.4, indicating a risk for surface water due to the evaluated use of Triclosan. Non-compartment specific effects relevant to the food chain (secondary poisoning): Based on the NOECbirds obtained from feeding studies with birds, the PNECoral of 1.67 mg a.s./kg food was derived. Because birds are more sensitive predators than mammals, the PNEC of birds is used in the risk characterisation. To assess the risk for fish eating birds, the PNECoral, mammals is compared with the PECoral, predator (27.8 at pH 6). As the PECpredator is higher than the PNECoral (16.6), a risk from non-compartment specific exposure relevant to the food chain due to the proposed use of Triclosan is identified. However, the wide range of bioconcentration factor (BCF) values in fish raises some uncertainty regarding the actual bioaccumulation potential of triclosan. This PEC value is based on a BCF of 8700 which is the highest value identified (pH = 6). The BCF varies strongly with the pH of the media and decrease at higher pH values; however these values are considered as representing a realistic worst case. Furthermore, it should be noted that an assessment factor of 3000 has been used for the PNECoral (birds) as no chronic data was available; therefore this value also represent a realistic worst case situations. Furthermore, there are several other factors that might influence the effects on fish eating predators due to bioaccumulation via the food chain. The depuration half-life in fish is short (1-2 days) and Triclosan is excreted in fish via the bile as inactive glucuronides. However, during the review process it was concluded that the PEC/PNEC ratio for secondary poisoning was 16.6 and a risk was identified. Therefore based on the consumption-based approach, a risk is identified for both surface water and for the non-compartment specific effects relevant to the food chain (secondary poisoning). Based on the specific evaluated use no possibilities for any risk mitigation measures seem to be realistic. Expected effect of the final regulatory action in relation to the environment: Reduction of risk for the environment from the use of biocidal products containing triclosan. Date of entry into force of the final regulatory action: 17/02/2016 |