The decision brings clarity for supplement companies after a long period of regulatory uncertainty, according to Dr. Jérôme Le Bloch, head of scientific affairs at FoodChain ID and an expert in food ingredient authorization.
“Some authorities, notably Spain, had doubts about the use of D-chiro-inositol before May 1997,” he told NutraIngredients. “For them, it was a novel food, not authorized, so not usable. Indeed, D-chiro-inositol is not present on any list in Europe, this created an uncertainty about its use.
“The update clarifies mainly the status of D-chiro-inositol, which is not novel and so useable in the 27 member states without any problem [and] can be used by food business operators.”
What is inositol and what is it used for?
Inositol is a naturally occurring carbohydrate that is synthesized predominantly in the kidneys. It is also found in small doses in some food sources such as grains and plant fibres.
The crystalline substance has many important functions, including the development of cell membranes and regulating insulin levels. While inositol was once classified as a B vitamin, this has since been disproved due to the body’s ability to produce the substance naturally.
One of the most studied uses of inositol is in the treatment of polycystic ovary syndrome (PCOS). This is due to inositol’s potential ability lower androgen (sex hormone) levels, potentially reducing symptoms such as acne and excessive hair growth.
A recent meta-analysis of 26 randomized controlled trials, which included 1,691 participants, showed that inositol may reduce testosterone and androstenedione levels, increase sex hormone-binding globulin (SHBG) levels and normalize cycle length compared to placebo.
Other studies have investigated whether inositol may be helpful for metabolic and cardiovascular health, with results suggesting that the compound may be able to reduce LDL-cholesterol and blood pressure.
The role of inositol in sleep and mental health has also been investigated, but more research is needed to confirm whether it could be helpful in these areas.
Inositol vs myo-inositol vs D-chiro-inositol
Inositol can be converted into nine different forms, including myo-inositol (the most abundant and well-studied form) and D-chiro-inositol, which the body produces significantly less of and is found in particularly low levels in food sources.
While both forms may improve symptoms of PCOS, research suggests D-chiro-inositol is more likely to reduce luteinizing hormone and free testosterone levels than myo-inositol, and have a more marked action on hyperandrogenism indexes.
Until now, however, it was unclear whether D-chiro-inositol had a history of consumption before May 1997, which led some countries to restrict its use.
A number of National Authorities then sought information regarding the history of its consumption, allowing the European Commission to reach a final verdict on its status as a novel food.
“The change is due to questions raised by Spanish authorities about the use of D-chiro-inositol in supplements,” said Dr. Le Bloch. “The status has been discussed among member states and the commission. Some member states have probably confirmed the use of D-chiro-inositol in EU in supplements before May 1997.”
This decision will allow dietary supplement companies to manufacture and distribute supplements containing D-chiro-inositol across all 27 member states, opening up new opportunities across the European market.