Scientific Opinion on the safety and efficacy of inositol as a feed additive for fish, dogs and cats

Abstract

Inositol is an essential micronutrient for salmon, carp, tilapia and shrimps, particularly juveniles. This conclusion is extended to all fish and crustaceans. The requirements differ among species and may be in the range of 250-500 mg/kg complete feed for fish. The use of inositol in feed for fish and crustaceans is considered safe at the recommended levels; setting a maximum content is not considered necessary. Based on the study provided in dogs, it was not possible to (i) demonstrate the essentiality of dietary inositol for dogs and (ii) conclude on the safety of dietary inositol at the recommended use levels of between 500 and 3 000 mg/kg. The FEEDAP Panel is not in the position to conclude on the efficacy and safety of inositol for cats. Supplementing feed for fish and crustaceans will not substantially increase the exposure of the consumer to inositol. Considering dietary exposure and endogenous synthesis of inositol, the additional exposure from fish fed an inositol-supplemented diet is of no concern for consumer safety. Considering the potential inhalation exposure upon handling the additive and the absence of data on inhalation toxicity, the FEEDAP Panel concludes that inhalation exposure from handling inositol could be hazardous. In the absence of data, inositol should be considered as irritant to skin and eyes and as a skin sensitiser. Inositol occurs naturally in the environment, particularly in plants. The use of inositol in fish nutrition is not expected to substantially increase the concentration in the environment. Consequently, the supplementation of fish feed with inositol does not pose a risk to the environment. SUMMARYFollowing a request from the European Commission, the 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 inositol as a nutritional additive to feed and water for drinking for all animal species.Inositol, a carbocyclic polyol, is a sugar-like carbohydrate synthesised by most plants and animals. Inositol contributes to biological processes in almost all tissues, and is a precursor of phosphatidylinositol, an important component of biological membranes and lung surfactant. Inositol plays an important role as the structural basis for a number of secondary messengers in eukaryotic cells (e.g. inositol 1,4,5,-triphosphate).Inositol is an essential micronutrient for salmon, carp, tilapia and shrimps, particularly juveniles. This conclusion is extended to all fish and crustaceans. The requirements differ among species and may be in the range of 250-500 mg/kg complete feed for fish. The use of inositol in feed for fish and crustaceans is considered safe at the recommended levels; setting a maximum content is not considered necessary.Based on the study provided in dogs, it was not possible to (i) demonstrate the essentiality of dietary inositol for dogs and (ii) conclude on the safety of dietary inositol at the recommended use levels of between 500 and 3 000 mg/kg. The FEEDAP Panel is ...

Thermal Cycling Cascade Biocatalysis of myo-Inositol Synthesis from Sucrose

“…In the drug industry, it is a widely used adulterant for numerous drugs, such as semisynthetic taxol, and used to treat cancer, nervous system disorders (e.g., depression), liver cirrhosis, fatty liver, and diabetes . Inositol is also essentially vital for some animals lacking in its synthesis ability, so that it is an important animal feed additive . In addition, inositol is used to make inositol nitrate, which can gelatinize nitrocellulose applied in many modern explosives and solid rocket propellants, next-generation lithium ion batteries, and numerous inositol-derived drugs …”

Safety and efficacy of inositol as nutritional additive for dogs and cats

“…In 2014, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an opinion on inositol when used as nutritional additive (functional group: vitamins, pro-vitamins and chemically well-defined substances having a similar effect) for fish, cats and dogs at the recommended use levels of between 250 and 500 mg/kg feed for fish and 500 and 3,000 mg/kg for cats and dogs (EFSA FEEDAP Panel, 2014). The safety of the additive for fish and crustaceans, consumers, users of the additive (if protective measures recommended in Regulation (EU) No 1249/2014 are used) and the environment was established at that time.…”

“…Inositol (cyclohexanehexol) is a carbocyclic polyol, a sugar alcohol, synthesised by most plants and animals. It exists in nine possible stereoisomers, four of which are physiologically active (EFSA FEEDAP Panel, 2014). Inositol is an essential micronutrient for salmon (Waagbø et al, 1998), carp (Jiang et al, 2009), tilapia (Shiau and Su, 2005) and shrimps (Shiau and Su, 2004), particularly juveniles.…”

“…General information on absorption, distribution, metabolisation and excretion (ADME), as well on the toxicology were described in the previous EFSA opinion on inositol (EFSA FEEDAP Panel, 2014). The ADME properties of inositol did not raise safety concerns (EFSA FEEDAP Panel, 2014). Inositol is an endogenous metabolite that is converted primarily to innocuous cellular compounds and does not have the potential to accumulate.…”

“…The FEEDAP Panel concluded in its previous assessment (EFSA FEEDAP Panel, 2014) that based on the study provided in dogs (Watson et al, 2006), where inositol was supplemented in combination with other nutrients, it was not possible to demonstrate the essentiality of dietary inositol alone for dogs. Similarly, the FEEDAP Panel was not in a position to conclude on the efficacy of inositol for cats.…”