TABLE 4.
Regulatory prebiotic definitions worldwide1
| Regulatory body | Prebiotic regulatory status or definition |
|---|---|
| FDA2 | “Complementary and alternative medicine products” are subject to FDA regulation. Prebiotics are included in the “biologically-based” group of foods, under the Center for Complementary and Integrative Health (a subset of NIH), using the 1995 definition. Manufacturers can also self-affirm GRAS status for products labeled as prebiotics (19). |
| EFSA2 | FAO definition, “a nonviable food component that confers a health benefit on the host associated with modulation of the microbiota” (5, 20) |
| Health Canada | The phrase “prebiotic” is only allowed for products that satisfy the requirement for an approved health claim. The phrase “prebiotic” on labels is regulated as an implied health claim (Canada Food Inspection Agency). |
| Japan (FOSHU) | “Prebiotic” not used, but rather “foods to modify gastrointestinal conditions.”3 |
| Costa Rica (RTCA) | A prebiotic substance must: be preferred by ≥1 species of beneficial bacteria in the large intestine or colon, be resistant to gastric acids, be fermentable by intestinal microflora, be resistant to endogenous enzymatic hydrolysis, stimulate selectively the growth and/or activity of those bacteria that are associated with health and wellness.4 |
| Colombia | A prebiotic substance must: be a preferred substance by ≥1 species of beneficial bacteria in the large intestine or colon, be resistant to gastric acids, be fermentable by the intestinal microflora, be resistant to endogenous enzymatic hydrolysis, have the ability to produce changes in the lumen of the large intestine or in the host organism showing health benefits, selectively stimulate the growth and/or activity of those bacteria that are associated with health and wellness.4 |
1
EFSA, European Food Safety Authority; FOSHU, food for specified health uses; GRAS, generally recognized as safe; RTCA, Reglamento Tecnico Centroamericano.
2
Neither FDA or EFSA has their own definition of prebiotics.
3
Accepted foods/ingredients include: oligosaccharides, lactose, bifidobacteria, lactic acid bacteria, ingestible dextrin, polydextrol, guar gum, psyllium seed coat, etc.
4
The amount of food to be consumed to obtain the beneficial effect should be reasonable in the context of the daily diet.