Lactose is a disaccharide composed of two monosaccharides: D-glucose and D-galactose, linked by a β-1,4-glycosidic bond, and is found mainly in dairy products. It occurs in two isomeric forms: α-lactose and β-lactose, which differ in their chemical and physical properties such as solubility, temperature, pH and crystallization, resulting in different properties when used as an ingredient in food, medicines and other products.
Since lactose powder is white, odorless and with a sweet taste, it has become one of the most widely used excipients in food supplements and pharmaceutical formulations due to its physical and chemical properties such as chemical inertness, stability and non-toxicity, while also being moderately priced. Thus, lactose is used as a diluent or filler in tablets, lozenges, capsules and powders.
Lactose content in food supplements
The lactose content in such products ranges from 100 to 200 mg and usually does not exceed 400 mg per tablet or capsule. However, this amount can have undesirable effects that affect the quality of life and diet of people suffering from lactose intolerance. Lactose intolerance is a clinical condition characterized mainly by gastrointestinal symptoms due to lactose maldigestion and malabsorption. The main treatment for lactose intolerance is to exclude or reduce lactose-containing products from the diet.
Considering that almost 65% of the population is lactose intolerant and the growing awareness of lactose intolerance, the demand for “lactose-free” products is increasing. The food and pharmaceutical industries are therefore using new technologies to develop “lactose-free” products by either extracting lactose, adding lactase enzyme or replacing the lactose with other sugars or sweeteners to meet the needs of people with lactose intolerance.
Regulation and labelling of low- lactose and lactose-free products
Regulations on the values and labeling of lactose-free or low-lactose products are not uniform and vary around the world. EU Regulation 1169/2011 on the provision of food information to consumers includes lactose in the list of substances that trigger allergies or intolerances.
Although there are no harmonized rules in the EU for the use of claims demonstrating the reduction or absence of lactose in foods, generally, lactose content is required to be:
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low-lactose products – less than 1 g/100 g or 100 mL
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lactose-free products – less than 10 mg/100 g or 100 mL