Dietary Supplement Labeling Requirements in the EU: Dos and Don’ts

Imagine taking ingredients you like and just mixing them into a nutritional supplement. You probably wouldn’t be able to get away with it, either from a manufacturing or a legislative point of view. The same applies to labeling. You cannot take any information and put it on the packaging. To save you hours of studying the EU legislation, we summarize the most crucial dietary supplement labeling requirements.

What you need to know about dietary supplement labeling requirements

Supplements are classified as food products in the European Union. Therefore, they are subject to the same general food safety and labeling laws as other food products, such as the Regulation (EU) No 1169/2011. 

The regulation states that you need to provide the mandatory information in a language that is easy to understand for consumers in the country where you sell your product. For instance, if you are a UK-based brand that plans an international expansion to Germany, your label needs to provide information in German language.

It is possible to include the information in several languages, as long as it meets the requirements of the country where the product is sold. 

In the majority of EU countries (except Austria, the Netherlands, Slovenia, and Sweden), food supplement companies are required to inform the relevant national authority to confirm that their product’s composition and labeling adhere to all applicable regulations.

Dos in supplement labeling

Directive 2002/46/EC harmonizes the laws of EU member states regarding food supplements. It lays down, among other things, what must be stated on the label. Ensure you provide the following information: 

• Clearly list the main types of nutrients or ingredients that define the product.
• Indicate the amount of the product suggested for daily consumption.
• Include a warning not to exceed the recommended daily dose.
• Add a statement that supplements should not be used as a substitute for a varied diet.
• Include a reminder that the supplement should be stored out of the reach of young children.
• Include the exact amounts of nutrients or active substances in the product in numbers.
  • These amounts should reflect the portion recommended for daily use, as stated on the label. 
  • Information about vitamins and minerals must also show what percentage they contribute to the recommended daily intake values.

Express nutrient values both numerically and as a percentage of daily intake to help consumers make informed choices.

Don’ts in supplement labeling

Supplement labeling must be clear, truthful, and compliant with EU regulations. Avoiding the following points not only ensures legal compliance but also builds consumer trust and protects your brand’s reputation:

1. Disease prevention, treatment, or cure claims

Supplements cannot be marketed as medicines because as we mentioned in the beginning of this article, the EU law classifies them as foods. Only medical products can be used to treat or prevent a disease.

Therefore, you can’t claim that your dietary supplement can prevent, treat or cure a human disease. Here is also an example:

• If your product portfolio includes collagen, you cannot claim it cures arthritis and eliminates joint pain. The statement implies that the supplement can cure arthritis, which classifies it as a medicinal claim and violates EU regulations.

2. Unauthorized health claims

Unauthorized health claims are strictly prohibited in supplement labeling because they can mislead consumers, violate regulations, and harm both your brand and customer trust. Regulation (EC) No 1924/2006 ensures that health claims are accurate. Here is an example:

• Let’s say, you sell vitamin D. As you likely know, its intake is associated with an improved immune function. However, you cannot declare on the packaging that this vitamin is guaranteed to boost the body’s defenses.

The EU Register of Health Claims provides a list of all approved health and nutrition claims you can legally use on product labels and in marketing messages. It also includes non-authorized claims, making it easier for you to ensure every product is compliant.

• According to the Register you can state the following on your label: ‘Vitamin D contributes to the normal function of the immune system’ as it is an authorized health claim. 

By using only approved and accurate health claims, you can ensure your products are credible and trustworthy.

3. Claims against a balanced diet

Your labels must not suggest or imply that a balanced, varied diet can’t provide enough nutrients on its own. In other words, you can’t mislead consumers into thinking that their regular diet isn’t good enough to meet nutrient needs. Dietary supplements are meant to support, not replace, a healthy diet. 

• If your product portfolio includes protein powder, you cannot claim that it’s the only thing that will support muscle growth. 

Tip: A reliable supplement manufacturer has an overview of the current legislation that is in force and will provide you with mandatory texts for your product labels. Read our blog post to learn more about certificates to look for when selecting your producer. 

Useful links for dietary supplement labeling requirements

In addition to the links to regulations and directives provided in the article, here are some additional resources to help you navigate the EU’s dietary supplement labeling requirements:

1. EU Register of Health Claims: Check the list of authorized and non-authorized health claims for food supplements to confirm which claims you can legally use on your product labels and marketing materials.
2. European Commission: Nutrition claims: This page outlines the conditions under which such claims can be made and provides examples of permitted claims, such as “low fat” or “high fiber”.
3. European Commission: Health claims: This page details the authorization process for health claims and categorizes them into function claims, risk reduction claims, and claims referring to children’s development.
4. Regulation (EU) No 1169/2011 on Food Information to Consumers: Learn about the mandatory labeling information for all food products, including supplements.
5. Directive 2002/46/EC on Food Supplements: Understand the specific rules for labeling dietary supplements, such as the required warnings and daily recommended intake.
6. Regulation (EC) No 1924/2006 on Nutrition and Health Claims: Details the rules for health and nutrition claims made on food products.

Key takeaways

When it comes to dietary supplements in the EU, proper labeling isn’t just about printing eye-catching designs – it’s about following strict regulations to ensure consumer safety and compliance. Supplements are classified as food products, so they must adhere to the same rules as any other food, plus additional requirements specific to supplements.

What you need to know:

• Labels must include all mandatory information, such as nutrient amounts, recommended daily intake, and safety warnings.
• You cannot use unauthorized health claims or imply that supplements can treat or cure diseases.
• Information must be clear, accurate, and in a language understood by consumers in the country where your product is sold.

It’s crucial to know that even if your supplements are manufactured by a private label or contract producer, you are still responsible for ensuring your labels meet EU requirements. Staying compliant not only protects your business but also builds trust with your customers. 

At GreenPharm, we always provide our customers with the mandatory details that need to be included in a label of dietary supplements to ensure compliance of their products at the end of manufacturing process.