Biocidal products and treated articles treated with or incorporating biocidal products
Draft Commission Implementing Decision not approving d-Allethrin as an existing active substance for use in biocidal products of product-type 18 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council; (3 page(s), in English)
This draft Commission Implementing Decision does not approve d-Allethrin as an active substance for use in biocidal products of product-type 18.
According to the opinion of the Agency, biocidal products of product-type 18 containing d-Allethrin cannot be expected to meet the criteria laid down in Article 19(1), points (b)(iii), and (iv), of Regulation (EU) No 528/2012.
In its opinion, the Agency noted that the proposed reference specifications, established on the basis of data provided by one of the applicants, are not in line with the composition of the material that was used for testing to generate the toxicological data provided by the applicants. As a result, on the basis of the data provided in the applications, it could not be established whether the representative biocidal products could fulfil the criteria referred to in Article 19(1), point (b) of Regulation (EU) No 528/2012.
According to the opinion of the Agency, based on the available toxicological data, an unacceptable risk has been identified for the general public due to secondary exposure to genotoxic photometabolites formed after the application of the representative products.
In addition, according to the opinion of the Agency, an unacceptable risk to the environment has been identified for the aquatic compartment (surface water and sediment) and for soil.
In conclusion, no safe use could be identified when considering the risks to human health and the environment for each of the representative biocidal products submitted in the applications.