Safety and efficacy of feed additives consisting of tinctures derived from the roots or leaves and stems of Althaea officinalis L.: Marsh mallow root tincture for use in all animal species and marsh mallow leaf tincture for use in horses and dogs (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of two tinctures obtained from the roots (marsh mallow root tincture) or leaves and stems (marsh mallow leaf tincture) of Althaea officinalis L. when used as sensory additives. The additives are water/ethanol tinctures, with a specified dry matter content of 2%-3% (w/w) (marsh mallow root tincture) and not more than 25% (w/w) (marsh mallow leaf tincture). Marsh mallow root tincture is intended for use in feed or water for drinking for all animal species, while marsh mallow leaf tincture is proposed for use in feed for horses and dogs. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that marsh mallow root tincture is safe at the maximum proposed use level of 250 mg/kg complete feed for all animal species. Marsh mallow leaf tincture is safe at the maximum proposed use level of 1000 mg/kg complete feed for horses and 325 mg/kg complete feed for dogs. No safety concern would arise for the consumer and the environment from the use of marsh mallow tinctures in animal feed. The additives under assessment should be considered as irritant to skin and eyes, and as dermal and respiratory sensitisers. Exposure of users by any route is considered a risk. Since the roots of A. officinalis are recognised to flavour food and their function in feed would be essentially the same as that in food, no further demonstration of efficacy for marsh mallow root tincture was considered necessary. The same conclusions are extended to marsh mallow leaf tincture.