Lactose-free Claims

Information about claiming something as lactose-free.

What is lactose?

Lactose is a naturally occurring sugar present in milk. Lactose is a disaccharide made up of glucose and galactose units.

Common products that contain lactose include milk, milk or dairy based products such as cheese, yoghurt and butter, and processed foods which contain milk (e.g., cereals, baked foods like bread, cakes and pastry, sauces).
What is lactose intolerance?

Lactose is broken down in the small intestine into glucose and galactose by the enzyme lactase (also known as β-galactosidase). Glucose and galactose are then readily absorbed by the body.

Lactose intolerance occurs due to a decreased ability to digest lactose resulting from the absence or a low level of the enzyme lactase. Lactose intolerance can cause a range of symptoms including diarrhoea, abdominal pain, flatulence, or bloating which can occur after eating foods containing lactose.

Lactose intolerance can be managed by consuming a diet with reduced lactose content or lactose-free foods. It is important to note that the tolerance level for lactose varies between individuals who suffer from lactose intolerance.
Is lactose an allergen?

No. Lactose is not an allergen. Lactose intolerance is not the same as a milk allergy. A milk allergy is defined as an atypical immune-mediated response to certain milk proteins. Signs and symptoms of milk allergy include wheezing, vomiting, hives and digestive problems. Milk allergy can also cause anaphylaxis — a severe, life-threatening reaction.

However, lactose is present in products containing milk. As per the Annex II of Regulation (EU) No. 1169/2011¹, on the provision of food information to consumers, milk is one of the 14 EU priority allergens which must be declared and emphasised on food labels when present in foods.

Foods which have a lactose-free claim may not be suitable for those with a milk allergy as the product could still contain the allergenic milk proteins.

¹ REGULATION (EU) No 1169/2011 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004
How is lactose-free milk produced?

In industrial settings, there are three ways to remove lactose from milk: lactose hydrolysis, chromatographic separation, and membrane filtration.

Lactose hydrolysis means the breakdown of lactose into its two components, glucose, and galactose through the addition of a commercial lactase to milk either pre- or post- heat treatment. The use of the enzyme lactase is the most common method to obtain lactose-free milk. This results in a ‘sweeter’ milk with larger quantities of glucose and galactose.

Chromatographic and membrane filtration methods involve the physical separation of lactose from milk. These methods do not increase the levels of glucose and galactose; however, the total removal of lactose is not possible, and the small amount of residual lactose is usually hydrolysed with lactase.
Are there any authorised nutrition or health claims for lactose-free?

Nutrition and health claims are regulated under Regulation (EU) No 1924/2006², on nutrition and health claims made on foods, and there is currently no EU legislation on the use of lactose-free nutrition or health claims for general foods.

The use of the term lactose-free on or about a food is a voluntary declaration which is controlled under Regulation (EU) No 1169/20111, however specific rules on lactose-free labelling have not yet been developed. An exception to this is Article 9.2 of Regulation (EU) 2016/1273 which allows for the statement “lactose-free” to be used on infant formula and follow-on formula.

² REGULATION (EC) No 1924/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 December 2006 on nutrition and health claims made on foods
When can I use the statement lactose-free?

Lactose containing products can be treated with the enzyme lactase which can result in a small residue of lactose – in the order of <0.01 g/100 mL.

While the food information for consumers Regulation (EU) No 1169/2011 applies, there is no specific legislation regarding lactose-free claims for general food. However, it is reasonable to expect that the same lactose residue allowed for in Article 9.2 of Regulation (EU) 2016/1273 on Infant and Follow-on formula would apply to general foods.

This regulation states, inter alia.

“The statement lactose free may be used for infant formula and follow-on formula provided that the lactose content in the product is not greater than 2,5 mg/100 kJ (10 mg/100 kcal).”
Are there additional labelling requirements of lactose-free products?

Given that lactose-free products made using the enzyme lactase result in the presence of large quantities of galactose, the FSAI recommends that such products carry a warning “not suitable for people with galactosaemia”. This is much the same as the requirement in Article 9.2 of Regulation (EU) 2016/127³ which also states, inter alia:

“The statement ‘lactose free’ may be used for infant formula and follow-on formula provided that the lactose content in the product is not greater than 2,5 mg/100 kJ (10 mg/100 kcal).

When the statement ‘lactose free’ is used for infant formula and follow-on formula manufactured from protein sources other than soya protein isolates, it shall be accompanied by the statement ‘not suitable for infants with galactosaemia’, which shall be indicated with the same font size and prominence as the statement ‘lactose free’ and in close proximity to it.”

While it is mandatory for infant/follow-on formula to include a warning for example, “not suitable for infants with galactosaemia” this is not the case for food intended to be used by the general population. Hence, from a safety point of view, the FSAI strongly recommends that this additional information is included on the label of galactose containing products using the lactose-free claim.

³ COMMISSION DELEGATED REGULATION (EU) 2016/127 of 25 September 2015 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for infant formula and follow-on formula and as regards requirements on information relating to infant and young child feeding
What is Galactosaemia?

Galactosaemia is an inherited disorder of galactose metabolism which is due to an enzyme deficiency. The main source of galactose in the diet is lactose. If untreated, galactosaemia presents in the first week of life with life-threatening illness after lactose is introduced.
How common is Galactosaemia?

Ireland has the highest prevalence of galactosaemia within the EU. According to EFSA, there is a high prevalence of galactosemia amongst Irish Travellers (1 in 500 births) and this is also present in the general population (1 in 30,000). For this reason, in Ireland, there is a national screening programme for galactosemia for all new-born babies.
Are lactose-free dairy products suitable for people with galactosaemia?

Lactose-free dairy products are generally made by treating milk with a commercial enzyme lactase. This breaks up the lactose into glucose and galactose. This way, the lactose is removed, allowing those with an intolerance to lactose to consume the food. In galactosaemic individuals, however, galactose is the substance of concern and these lactose-free products with increased levels of galactose would therefore not be suitable for consumption.
What does the FSAI recommend in terms of labelling for those with galactosaemia?

Patients with galactosemia are always advised to have a lactose free diet but this is complicated as these foods can still have high level of galactose. The correct labelling of products which are lactose free is therefore critically important for the dietary management of those with galactosaemia as stated in the above section “Are there additional labelling requirements of lactose-free products?"