Regulatory Compliance

How to create a compliant supplement label for Europe?

The 3 regulations to follow to create a compliant food supplement label for the European market

The labeling of a food supplement is highly regulated. The mandatory labeling information is listed in Directive 2002/46/EC. As it is also a foodstuff, the mandatory information laid down in the Regulation on Consumer Information applies. Finally, depending on the composition and the communication, other labeling information may be required.

#1: The INCO Regulation

Regulation (EU) No. 1169/2011 on Consumer Information, also known as the “INCO Regulation”, sets out the rules for food labeling. It has been in force since December 13, 2014.

According to Article 7, food information must not mislead the consumer. It must be accurate, clear and easily understandable. Food business operators are responsible for the presence, accuracy, compliance, changes and communication of this information.

This Regulation sets out mandatory information to be provided on food packaging (Articles 9 and 10) as well as voluntary information.

The mandatory information, including for food supplements, to be included on a label according to these articles of the INCO Regulation are the following:

  • Trade name
  • List of ingredients including allergens and quantity of certain ingredients
  • Net quantity
  • Date of minimum durability or use-by date
  • Special conditions for storage and/or use
  • Name or business name and address (EU) of the food business operator
  • Instructions for use, if their absence would make it difficult to use the food properly
  • Nutrition declaration (food supplements not concerned)
  • Only for the products concerned: alcoholic strength by volume for beverages containing more than 1.2 degrees of alcohol by volume
  • Only for the products concerned or under certain conditions: country of origin or place of provenance

#2: The Food Supplement Directive

Directive 2002/46/EC on food supplements lists the mandatory labeling information specific to food supplements:

  • Trade Name: “Food Supplement
  • The names of the categories of nutrients or substances that characterize the product or an indication of the nature of these nutrients or substances.
  • The recommended daily amount of the product + a warning not to exceed the recommended daily amount.
  • Statement that food supplements should not be used as a substitute for a varied diet
  • Warning that the products must be kept out of the reach of young children
  • Mandatory nutrition declaration: Amounts of nutrients or substances with a nutritional or physiological effect expressed in numerical form:
  • Per recommended daily amount of product
  • For vitamins and minerals: also expressed as a percentage of the nutrient reference values/reference intakes as defined in INCO Regulation (EU) No 1169/2011.

#3: The Health Claims Regulation

In the case of health claims, according to Regulation (EC) No 1924/2006 on nutrition and health claims made on foods, the label of the food supplement must also include

A statement about the importance of a varied and balanced diet and a healthy lifestyle.
The use of certain claims may also require additional labeling.

Depending on the ingredients present in the food supplement, additional warnings may be required under European legislation. This is a case by case analysis depending on the ingredients present in the food supplement.

Examples :

  • Food supplement with caffeine or with a plant extract rich in caffeine
  • Food supplement with sweeteners
  • Food supplement with phytosterols or phytostanols
  • Food supplement with nanomaterials
  • Food supplements with red yeast rice (publication of the final text expected in May 2022)
  • Food supplements with novel foods

In addition, at the national level, many lists of plants or substances specify conditions of use and mandatory warnings depending on the ingredients present in the food supplement.

Specifically, for a food supplement, the information to be included on a label is the information provided by :

  • Regulation 1169/2011 on Consumer Information
  • Directive 2002/46/EC on food supplements
  • Regulation 1924/2006 on nutrition and health claims
  • Other regulations on a case-by-case basis depending on the product

What are the risks of improper labeling?

For France, in case of non-conformity of labeling or claims, the French Consumer Code indicates the following sanctions:

  • The maximum possible fine is 1500 euros per non-conforming product on the market (in the case of a ticket, a 5th class fine); note that this decision must be taken by a criminal court and is quite lengthy.
  • In order to sanction companies more quickly, the inspectors prefer to use administrative orders to comply within a certain period of time and/or an administrative fine (with lower costs: up to a total of 15,000 euros for food).

In short, these sanctions can range from a simple warning or an order to comply within a specified time, with or without an administrative fine, to a fine (longer criminal proceedings). The consequences of non-compliance are assessed by inspectors on a case-by-case basis.

Note that the risk is higher for therapeutic claims: If the product can be mistaken for a medicine or is considered to be a medicine by function, the risk is the sale of a medicine without authorization.

The penalties for marketing a medicinal product without the necessary authorization are five years’ imprisonment and a fine of 375,000 euros.

Our solutions for creating a compliant label

For 10 years, we have been performing the audits and notifications required before selling products to the European market. We rely on our in-house tools Supplements R&D Insight and Supplements Compliance.

Stay up to date with our newsletter

This field is for validation purposes and should be left unchanged.

Interesting articles

Product Development

Food & Beverage Emulsifiers Associated with Risk of Diabetes

Regulatory Compliance

Migration Modelling Challenges

Regulatory Compliance

Streamline Regulatory Compliance with Advanced Analysis Tools

Regulatory Compliance

Streamlining Regulatory Compliance

Food Safety

State Food and Color Additive Bans: Unpacking the Impact on Your Products

Regulatory Compliance

Quality of food supplements – Europe