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Safety and efficacy of a feed additive consisting of titanium dioxide for all animal species (Kronos International, Inc.)

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Legal notice: Relevant information or parts of this scientific output have been blackened in accordance with the confidentiality requests formulated by the applicant pending a decision thereon by the European Commission. The full output has been shared with the European Commission, EU Member States and the applicant. The blackening will be subjected to review once the decision on the confidentiality requests is adopted by the European Commission.

Abstract

Following a request from the European Commission, the EFSA was asked to deliver a scientific opinion on the safety and efficacy of titanium dioxide (TiO2) for all animal species. TiO2 is applied to be used as a sensory additive (functional group: colourants; i) substances that add or restore colour in feedingstuffs). The specification for TiO2 used as feed additive meets the specifications of TiO2 used as food additive. The EFSA Panel on Food Additive and Flavourings (FAF) concluded that TiO2 (E171) can no longer be considered as safe when used as a food additive. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) endorses this conclusion and considers that it also applies to TiO2 as a feed additive for all animal species. TiO2 is absorbed to a low extent; however, particles of TiO2 can accumulate in the body due to their long half‐life. The genotoxicity of TiO2 particles cannot be ruled out raising potential concerns on the safety of the additive for the target species (especially for long‐living animals and reproductive animals), consumers and user. Considering this fact and the absence of specific data related to its use as a feed additive, the Panel cannot conclude on the safety of TiO2 for the target species, consumers and environment. In the absence of studies with the additive under assessment, the Panel cannot conclude on the assessment of the effects of the additive on eyes and skin. TiO2 is potentially carcinogenic to workers if inhaled. The concern for genotoxicity of TiO2 particles cannot be ruled out, this should be considered as an additional potential concern to users handling the additive. TiO2 is efficacious in colouring the food for cats and dogs at a minimum content of 1%.