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Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a tincture from the roots of Gentiana lutea L. (gentian tincture) when used as a sensory feed additive for all animal species. The product is a ■■■■ solution, with a dry matter co
ntent of approximately 4.3%. The product co
ntains on average 0.0836% polyphenols (of which 0.0463% are flavo
noids and 0.0027% xanthones) and 0.0022% gentiopicroside. The FEEDAP Panel co
ncludes that gentian tincture is safe at the maximum proposed use level of 50 mg/kg complete feed for short‐living animals (animals for fattening). The FEEDAP Panel co
nsiders that the use in water for drinking is safe provided that the total daily intake of the additive does not exceed the daily amount that is co
nsidered safe when co
nsumed via feed. Co
nsidering the genotoxic potential of gentiopicroside and xantho
nes (gentisin and isogentisin), no co
nclusions can be drawn for long‐living animals (companion animals, horses and animals for reproduction). No safety co
ncern would arise for the co
nsumer from the use of gentian tincture up to the highest safe level in animal nutrition. In the absence of data, no co
nclusions can be drawn on the potential of the tincture to be a dermal/eye irritant or a skin sensitiser. The data available do not allow to co
nclude on risks of genotoxicity and carcinogenicity for dermal exposure. Use of the tincture derived from G. lutea as a flavour in animal feed is not expected to pose a risk for the environment. Since G. lutea and gentian root extract are recognised to flavour food and their function in feed would be essentially the same as that in food, no further demo
nstration of efficacy is co
nsidered necessary for the tincture under application.
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