Keto Claims in the European Union: Rules and Regulations on Products

April 14, 2022 251 views

At first glance, the European Union might not seem like an area of the world with culinary traditions and cultures that would be open to radically reducing carbohydrate intake. The pizzas and pasta of Italy, wine and bread of France, and other similar high carbohydrate culinary staples of several European countries generally account for a moderate to high intake of carbs on a daily basis. However, as the industrialized food system has slowly begun to overtake more traditional cuisines, many European consumers find their diets overrun by the excessive added sugars and highly refined carbs that characterize the industrialized, globalized, and extremely processed food diet. Given this reality, more and more consumers across the European Union are beginning to look for low-carb food alternatives for a healthier diet, and brands are looking to create products to cater to them. However, they are left wondering what the rules and regulations are for keto claims on products in the European Union (EU).

This trend toward the rising popularity of low-carb diets is most evident in the growing popularity of the Keto Diet across different regions of the European Union. According to Fi Global Insights, “Google searches for ‘Keto’ reached an all-time high in the US in January 2019. But in Europe, interest has lagged, peaking as early as June and July 2019 (France and Spain) and as late as January and April 2021 (the UK and Italy).” Fior Market, for example, expects the global Keto diet market to reach a value of $17.8 billion by 2026, growing at a compound annual growth rate of 7.1 percent from US$10.3 billion in 2018. Much of that expected growth will be driven by increasing demand by European consumers.

The increasing approval of the Keto diet by European consumers, however, doesn’t mean that the EU authorities are similarly on board with low-carb nutritional paradigms. In fact, the European Commission has extensive food labeling legislation in place that strictly regulates health and nutrition claims on food products sold within the EU countries. Though the relevant regulations do not specifically mention the Keto diet, there are several possible implications for health food brands looking for ways to specifically market their products to people who are either following the Keto diet or are interested in reducing their overall carbohydrate intake. Below, we briefly explain some of the pertinent rules and regulations affecting low-carb and Keto claims on products within the European Union.

Who Regulates Keto Claims on Food Products within the EU?

Within the EU, the European Commission is the EU’s politically independent executive arm. For countries within the EU, the European Commission has the responsibility for drawing up proposals related to new European legislation. For example, in the areas of food safety, regulations, and labeling requirements, the European Commission is involved in various legislative actions, including:

Assuring effective control systems for food items sold within the EU. The Commission also strictly evaluates compliance with the EU standards related to food safety and quality, animal health, animal welfare, animal nutrition, and plant health sectors.
Managing international relations with non-EU countries and international organizations concerning food safety, animal health, animal welfare, animal nutrition, and plant health;
Overseeing relations with the European Food Safety Authority (EFSA) to ensure science-based risk management for food products.

Similarly, the European Food Safety Authority (EFSA) provides independent scientific advice on food-related risks. EFSA issues advice on existing and emerging food risks. This advice informs European laws, rules, and policymaking – and so helps protect consumers from risks in the food chain.

Strictly Regulated Health and Nutrition Claims

The European Union generally has more severe and progressive food labeling regulations than the United States and Canada. For example, since 2015, the EU has implemented strict protocols that allow for the traceability of genetically modified organisms (GMOs) in food products. According to the Commission, “traceability also makes the labeling of all GMOs and GM food/feed products possible. It allows for close monitoring of potential effects on the environment and on health. Where necessary it can allow the withdrawal of products if an unexpected risk to human health or to the environment is detected.”

In the United States, by comparison, it wasn’t until earlier this year (2022) that food manufacturers, importers, and retailers had to begin to comply with the new national labeling standard for food products that have been genetically modified in a way that isn’t possible through natural growth.

In the specific case of health and nutrition claims (under which most Keto claims fall), the European Union certainly has rigorous and thorough legislation in place. We will look at the specific regulations for both health, nutrition, and Keto claims in the European Union, and briefly outline how these regulations impact food brands looking to market Keto or low-carb products within the European Union.

Nutrition Claims on Food Products in the European Union

Both the European Commission and the EFSA strictly regulate any nutrition claim that can or cannot be made on a given food product. A nutrition claim is defined as any claim that states, suggests, or implies that a food has particular beneficial nutritional properties due to its energy or calorific values, or the nutrients and other substances it contains, contains in reduced or increased proportions, or does not contain. Thus, claiming that a food product has zero carbs or reduced carbs would be an example of a nutrition claim in the EU, and would thus be subject to the following regulation.

The European Commission has a strictly delimited list of permitted nutrition claims for food products sold within EU member countries. Those permitted nutrition claims include:

Low energy: the food product must not contain more than 40 kcal (170 kJ)/100 g for solids or more than 20 kcal (80 kJ)/100 ml for liquids.
Energy-reduced: the food product´s energy value must be reduced by at least 30 percent.
Energy-Free: the food product must not contain more than 4 kcal (17 kJ)/100 ml.
Low Fat: the product must contain no more than 3 g of fat per 100 g for solids or 1.5 g of fat per 100 ml for liquids.
Fat-Free: the food product must contain no more than 0.5 g of fat per 100 g or 100 ml.
Low Saturated Fat: the food product does not exceed 1.5 g per 100 g for solids or 0.75 g/100 ml for liquids.
Saturated Fat-Free: the sum of saturated fat and trans-fatty acids does not exceed 0.1 g of saturated fat per 100 g or 100 ml.
Low-Sugar: the food product must contain no more than 5 g of sugars per 100 g for solids or 2.5 g of sugars per 100 ml for liquids.
Sugar-Free: the food product must contain no more than 0.5 g of sugars per 100 g or 100 ml.
No Added Sugars: the food product must not contain any added mono- or disaccharides or any other food used for its sweetening properties.
Low-Sodium Salt: A claim that a food is low in sodium/salt, and any claim likely to have the same meaning for the consumer, may only be made where the product contains no more than 0,12 g of sodium, or the equivalent value for salt, per 100 g or per 100 ml. For waters, other than natural mineral waters falling within the scope of Directive 80/777/EEC, this value should not exceed 2 mg of sodium per 100 ml.
Source of Fibre: the food product contains at least 3 g of fiber per 100 g or at least 1.5 g of fiber per 100 kcal.
Source of Protein: At least 12 percent of the energy value of the food is provided by protein.
High-Protein: At least 20 percent of the energy value of the food is provided by protein.

Though the legislation does not specifically mention carbohydrates or low-carb claims, the permitted nutrition claims by the EU also mention the following:

Reduced [Name of the Nutrient]: A claim stating that the content in one or more nutrients has been reduced, and any claim likely to have the same meaning for the consumer, may only be made where the reduction in content is at least 30% compared to a similar product, except for micronutrients, where a 10% difference in the reference values as set in Directive 90/496/EEC.

Following this explanation, “low-carb” claims, or “reduced carb” claims should be able to be made when the reduction in the carb content of a specific food is at least 30 percent when compared to a similar product. Cauliflower pizza dough, for example, might be eligible to make this claim when compared to regular pizza dough.

Many Keto and low carb food brands may also wish to market and advertise the healthy fat content of their food products. The European Commission also has stipulations that regulate claims for food products that claim to be:

A Source of Omega-3 Fatty Acids: the food product must contain at least 0.3 g alpha-linolenic acid per 100g and per 100kcal, or at least 40mg of the sum of eicosapentaenoic acid and docosahexaenoic acid per 100g and per 100kcal.
A Source of High Omega-3 Fatty Acids: the food product contains at least 0.6 g alpha-linolenic acid per 100 g and per 100 kcal, or at least 80 mg of the sum of eicosapentaenoic acid and docosahexaenoic acid per 100 g and per 100 kcal.
A Source OF High Monounsaturated Fat: At least 45 percent of the fatty acids present in the product derive from monounsaturated fat under the condition that monounsaturated fat provides more than 20 percent of the energy of the product.
A Source of High Polyunsaturated Fat: At least 45 percent of the fatty acids present in the product derive from polyunsaturated fat under the condition that polyunsaturated fat provides more than 20 percent of the energy of the product.
A Source of High Unsaturated Fat: At least 70 percent of the fatty acids present in the product derive from unsaturated fat under the condition that unsaturated fat provides more than 20 percent of the energy of the product.

Health Claims on Food Products in the European Union

The European Commission and EFSA also regulate health claims on food products, which they define as any statement about a relationship between food and health. According to the Commission´s website, they “authorize different health claims provided they are based on scientific evidence and can be easily understood by consumers. The European Food Safety Authority (EFSA) is responsible for evaluating the scientific evidence supporting health claims.”

In general, however, health claims on food products are prohibited unless the European Commission has allowed them in the so-called “Union list” in accordance with Regulation (EC) No 1924/2006 on nutrition and health claims made on foods. A complete list and explanation of the authorized claims are published in Commission Regulation (EU) No 432/2012 of 16 May 2012. You can find this list of permitted health claims made on foods here.

Among the health claims on food products as they pertain to Keto or low-carb foods, there is no mention of the word Keto or low-carb diets. In fact, in relation to carbohydrates, the list of authorized food claims states that “carbohydrates contribute to the maintenance of normal brain function. In order to bear the claim, the information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 130 g of carbohydrates from all sources.” Health claims related to carbohydrates can also be made when a certain food is targeted toward adults who have performed highly intensive and/or long-lasting physical exercise leading to muscle fatigue and the depletion of glycogen stores in skeletal muscle.

Weight loss health claims for food products are also strictly regulated. However, the regulations only mention/allow weight loss health claims for food products that have energy-reduced diets (reduced caloric consumption.

The Final Word on Rules and Regulations of Keto Claims in the European Union

None of the legislation or regulation set forth by the European Commission or the European Food Safety Authority specifically mentions the word Keto or low-carb diets. However, as we mentioned above, no health claim can be made on food products except those approved by the Commission. Low-carb claims or other Keto-related health claims are thus not permitted as a health claim. One possible “loophole” might be found in the permitted nutrition claims where regulations allow for reduced nutrient claims wherein reduction in nutrient content is at least 30% compared to a similar product.

As the Keto diet and other low-carb diets continue to gain in popularity across the European Union, there may be more specific legislation related to low carb claims. For example, a 2015 EFSA study involved preparatory work for the evaluation of the essential composition of total diet replacement products for weight control. The study reported on different types of low-calorie diets, including ketogenic and nonketogenic diets. This study concluded that “a very-low-calorie ketogenic diet as compared to a very low-calorie nonketogenic diet resulted in higher concentrations of ketone bodies. In one study mild acidosis was reported in the ketogenic diet group. In addition, in three studies, very low-calorie nonketogenic diets showed to be superior to ketogenic diets in protein sparing during a period of 4 weeks.”

This type of study by one of the bodies governing food labeling requirements and regulation in the EU goes to show that there may very well be increased regulation regarding Keto claims for food products in the near future.