Lactose-free production of foodstuffs
In the supermarket you can find many products that are lactose-free. There is no European standard for this claim, only for infant formula. National guidelines do apply in some Member States. These are not equal.
What is in the law?
The claim lactose-free is only regulated by law for infant formula. In the Delegated Regulation (EU) 2016/127 a standard of 10 mg lactose per 100 kcal has been established. This standard is intended to protect babies with galactosemia. No requirements have yet been set in European legislation for the claim to be lactose-free in regular products. Some Member States have laid down national requirements for lactose-free products.
Germany has had national regulations for lactose-free dairy products for some time now regulations. For these products, such as lactose-free milk and cheese, a limit of 1000 ppm has been set. No official limit has been set for other products.
In Italy, 1000 ppm (=0,1g/100g or ml) is the general standard.
In Finland, Sweden, Spain and Norway, a limit of 100 ppm lactose applies. This standard was also proposed in the draft Regulation on nutrition and health claims made on foodstuffs of 2005, but was ultimately not included.
There is no Dutch regulation. For the Netherlands, the NVWA uses a maximum of 10 mg lactose per 100 grams/ml product (100 ppm) as a guideline value for the claim “lactose-free”. And for the claim "low lactose" the standard of a maximum of 1000 mg lactose per 100 grams/ml product. The Dutch Food and Consumer Product Safety Authority (NVWA) has laid down in the 'Handbook Nutrition and health claims' .
Difference between lactose intolerance and galactosemia
Galactosemia is a rare but serious metabolic disease. Galactose is released in the intestines during the breakdown of lactose (milk sugar). Lactose is split into glucose and galactose. Galactosemia causes serious liver problems because this galactose cannot be broken down in the liver. Nowadays this metabolic disease can be diagnosed by the heel prick, but in the past children died from this disease. For this group of people, a very strict standard is of vital importance; they must follow a lactose- and galactose-free diet for life.
People with lactose intolerance do not get any complaints from galactose. They lack the enzyme lactase, which prevents lactose from being broken down. The undigested lactose is broken down by the intestinal bacteria. This is accompanied by the production of gases and causes intestinal complaints, such as abdominal pain, flatulence and diarrhoea.
Infant formula standard not suitable for regular products
The Belgian government (Federal Public Service Public Health, Safety of the Food Chain and Environment) uses it point of view that in the absence of general provisions regarding the claim lactose-free, the standard for infant formula must be applied to all foods. This has led to reactions from, among others, the Federation of the Belgian Food Industry (Fevia). They indicate that this is not practically applicable. Infant formula has a fixed caloric intake. It is the only source of nutrition for infants. This does not apply to regular products. Introducing the limit of 10 mg lactose/100 kcal means that low energy products (such as drinks with sweeteners) will have an unmeasurable and unnecessarily low limit. At the same time, products with a high caloric value, such as chocolate (582 kcal/100 grams), would have a too flexible limit (582 ppm) due to the application of this standard. This does not provide protection for consumers with galactosemia.
The table shows that a product, such as a drink with a sweetener, should contain a maximum of 0,2 ppm lactose when applying the lactose-free standard for infant formula. This can be calculated with the following formula:
Energy (kcal/100 g) x standard lactose-free (=10 mg/100 kcal) x 10 (from 100 g to 1 kilo) = maximum concentration of lactose (ppm or mg/kg)
Table: Energy values and calculated maximum lactose content (ppm) when applying the standard for infant formula
| Product | Energy (kcal/100 g) |
Converted max. concentration of lactose |
| Drink with sweetener | 0,2 | 0,2 |
| Low-fat yogurt | 50 | 50 |
| Greek yoghurt | 120 | 120 |
| Cheese | 365 | 365 |
| Chocolate | 582 | 582 |
To determine whether the standard is met, analysis for lactose should be analysed in combination with the nutritional value and then converted. This does not provide clarity for manufacturers. An absolute standard in ppm is preferred, both for the manufacturer and for enforcement.
Communication on the label
Some lactose-free products use the terms '0% lactose' or 'zero lactose'. This suggests a zero limit. Lactose-free dairy products always leave a residual amount of lactose in the product. That is why it is better, also in line with gluten-free, to only use the claim 'lactose-free'. In addition, stating the limit used (100 ppm or 0,01g/100g) is useful or even mandatory under German law.
However, only a standard for the claim lactose-free to protect people with galactosemia is not enough. Dairy products can be made lactose-free, for example by adding the enzyme lactase. Lactose is converted into glucose and galactose. Enzymatically lactose-free milk, regardless of the standard for lactose, contains a lot of galactose and is dangerous for people with galactosemia. There is therefore no need for a stricter standard for the claim lactose-free, but a warning if galactose is present. This is also prescribed in Regulation (EU) 2016/127: 'not suitable for infants/persons with galactosemia'.
In addition, the group of consumers with a milk allergy is always at risk when drinking lactose-free dairy products. Lactose (milk sugar) is no longer present, but milk protein is.
This is also the reason why the Code of Practice from SimplyOK additional labelling conditions require the use of the lactose-free claim, namely:
- Not suitable for people with a milk allergy, if the products are prepared from milk.
- Not suitable for people with galactosemia, with lactose-free dairy products due to an enzymatic treatment.
Analysis and VITAL
Lactose does not cause an allergic reaction, but an intolerance. No reference doses have therefore been drawn up for lactose, such as for milkprotein. It therefore does not appear in the VITAL risk assessment.
Rapid tests can be used to check surfaces after cleaning. If cross-contact with milk ingredients occurs, both lactose and milk protein will usually be present. Rapid tests for milk can therefore be used for line checks (e.g. release after cleaning). If no milk protein is present, logically no lactose is present either. Only if pure lactose is used as an ingredient, as is the case with food supplement manufacturers, are these milk rapid tests pointless. Then a specific lactose rapid test (ask us for more information) or laboratory analysis.
In product analysis - when a lactose-free claim is used - a specific lactose analysis will have to be used instead of a milk protein analysis.
To watch the laboratory analysis of lactose many different methods are available, each with its own measurement range and detection limit. Depending on the product composition, the correct method must be chosen. The enzymatic lactose analysis often used in the past can cause problems in the presence of other sugars. This gives, for example, false positive results in the presence of galactose (in lactose-free dairy products) or products with a lot of glucose or GOS. An adapted enzymatic method is available for lactose-free dairy products. It regularly turns out that laboratories still carry out the wrong method, resulting in too high amounts.
However, it is better to opt for non-enzymatic methods, such as HPLC-MS or HPAEC-PAD.
The NEN standards committee 'Milk and dairy products' is contributing to the development of an international standard for the analysis of lactose. As long as there is no recognized standard, attention must be paid to choosing the right method. We offer a laboratory service with which we support you in choosing the right method.
Want to know more or need help?
Please touch with contact us, we are happy to help!