When it comes to labeling requirements for food and dietary supplements in the European Union (EU), you must pay close attention to detail. The EU has established strict regulations to ensure that consumers receive accurate and transparent information on the products they consume. In this blog, we shall delve into the essential aspects of the EU’s labeling requirements for food and dietary supplements, including the rules and regulations that govern the product claims and information.

Understanding the Foundation of EU’s Labeling Requirements for Food and Dietary Supplements

  • Directive 2002/46/EC and Regulation (EU) No. 1169/2011: The foundation of EU’s labeling requirements for food and dietary supplements can be traced back to the following two (02) key documents:
    • Directive 2002/46/EC on Food Supplements.
    • EU Food Information Regulation No. 1169/2011.

The above documents outline the mandatory labeling requirements that responsible operators within the EU must adhere to.

  • Steering Clear of Disease-related Claims: One of the most critical aspects of EU labeling regulations is that it prohibits claims suggesting that a product can prevent, treat, or cure a disease. This prohibition ensures that consumers are not misled by extravagant and false promises of health and well-being, which in turn promotes transparency and honesty in product marketing. Moreover, all health claims on food and dietary supplements must be approved by the European Commission (EC) and should always be accompanied by a statement emphasizing the foremost importance of a varied, balanced diet and a healthy lifestyle.

Understanding Dietary Supplements

Dietary supplements play a significant role in the lives of consumers, serving as concentrated sources of essential nutrients and substances that come with specific physiological effects. They are designed to address nutritional deficiencies in the human body, support physiological functions, and ensure that individuals receive an adequate amount of all the vital nutrients.

Crucial Information for Pre-packed Foods

For pre-packed foods, the EU mandates specific labeling requirements that include:

  • Name of the food.
  • Ingredient list (including additives).
  • Allergen information.
  • Quantity of certain ingredients.
  • Date marking (best before date/use by date).
  • Country of origin.
  • Name and address of the EU-based FBO or importer.
  • Net quantity.
  • Special storage conditions and/or conditions of use.
  • Instructions for Use (IFU), if required.
  • Alcohol level for beverages (if higher than 1.2%).
  • Nutrition declaration.

Labeling Information for Dietary Supplements

When it comes to dietary supplements, the EU’s N°1169/2011 (INCO) Regulation specifies the following mandatory labeling elements:

  • Trade name.
  • Ingredient list (including allergens).
  • Net quantity.
  • Date of minimum durability or use by date.
  • Special storage and/or use conditions and an indication to store the product away from the reach of young children.
  • Name/business name and address of the EU-based FBO.
  • Recommended daily dosage of the product with a warning to not exceed it.
  • The amount of the substances with nutritional or physiological purpose per daily dose.
  • A statement emphasizing that dietary supplements should not be used as a substitute for a varied, balanced diet.

Additional Warnings on Food and Dietary Supplement Labels

Depending on the ingredients contained in a dietary supplement, responsible operators may have to provide additional warnings in compliance with EU legislation. Some key ingredients in dietary supplements that necessitate additional warnings are caffeine, plant extracts, sweeteners, phytosterols, phytostanols, or even other nutritional substances with physiological effects.

To conclude, the EU’s labeling requirements for food and dietary supplements are highly regulated and are aimed at ensuring that consumers receive accurate and transparent product information. The two (02) key regulations that FBOs must comply with are Directive 2002/46/EC and Regulation (EU) No. 1169/2011. Additionally, they must be compliant with the national requirements of each member state. Staying informed about the latest EU regulations and requirements for food and dietary supplements will help you seamlessly navigate the complex Regulatory landscape and uphold consumer safety and trust.

Consult Freyr for expert guidance on EU labeling regulations!


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