Food supplements are products used both to improve the well-being of the body and support the common diet. Their intended use is strongly related to the properties of the herbal or other components that constitute a concentrated source of substances (such as amino acids, vitamins, minerals, fatty acids, fibers, etc.) capable of producing a nutritional and/or physiological effect. In other words, the formulation makes a food supplement suitable for the satisfaction of specific needs related to the body’s physiological conditions. From the point of view of the legislative framework, supplements fall into the macro-category of food and must contain on the label certain information for the consumer, established by specific European directives. For these reasons, the labeling of a food supplement is subject to great attention from the consumer and the presentation of the finished product must meet specific requirements. The labeling of food supplements is regulated by Directive 2002/46/EC, implemented in Italy by Legislative Decree No. 169 of 21 May 2004, and must satisfy the following requirements:

• The definition of ‘food supplement’;
• The allowed vitamin and mineral substances;
• The labeling requirements applicable to all supplements;

With the European Regulation 1169/2011 that came into force on 13 December 2014, some labeling rules were added.

1. Information visibility:
   • Positioning of wording;
   • Readability of wording;
   • Minimum height of wording;

2. The loyalty of information:
   • Truthfulness;
   • Distinctive value;
   • Clearness and easiness of understanding;

For the positioning of the labeling, the “single field of vision” rule applies, i.e. the sales designation and the indication of quantity must be placed in the same field of vision. This means that it must not be necessary to turn or rotate the packaging to simultaneously see these two pieces of information. The field of vision is the choice of the operator; it does not necessarily have to be the main field of vision, it can also be one side, the back, or the bottom. Information that is clearly accessible to the consumer must be legible, and this legibility is determined by several elements:

• The size of the font
• The line spacing;
• The thickness;
• The type of color;
• The proportion between the width and height of the letters;
• The surface of the material;
• The contrast between text and background;

The key point is certainly the authenticity of the information on the label. All the characteristics attributed to a food, such as its nature, identity, properties, composition, quantity, shelf life, origin, method of manufacture or production, must be truthful and demonstrable. They must not suggest that food has a distinctive value compared to others. And they must always be accurate, clear, and easily understood by the consumer. According to Directive 2002/46/EC, it is compulsory to label the name (Food supplement or Dietary supplement) accompanied by a description of the supplement and the nutritional or physiological function attributed to the product. The formulation of the list of ingredients follows the general rules of EU Regulation 1169/2011, according to which the definition of an ingredient (including flavors, additives, and enzymes) must always be included, except adjuvants and additives that are used to dissolve or dilute an ingredient without changing its function.

• A special topic is one of the allergens.

  An allergen is a substance that is usually harmless to most people but can produce allergic reactions in others (“atopic” people). The presence of an allergen invalidates any exception: it must always be declared on the label! The name of the substance considered an allergen shall be highlighted in a clearly distinguishable font from the other ingredients listed, such as size, style, or color of the background. As always, there are some exceptions, which are listed in Annex II of EU Regulation 1169/2011. According to the regulation, allergens are usually considered substances intentionally introduced into food, but sometimes there could be cross-contamination to finish the product accidentally. In this case, it is good practice to follow up the list with statements advising the consumer of the presence of a possible allergenic substance, if it is not already declared in the ingredients, see below:

  «It may contain traces of milk and soya«

Other mandatory indications according to Regulation 2002/46/EC are:

• »Do not exceed the recommended doses»
• » Food Supplements should not be used as a substitute for a varied diet and a healthy lifestyle»
• » Keep out of reach of children under three years old»

Other warnings may be required depending on the type of substances used if they would interfere with the intake of medicines or are not recommended during pregnancy or breastfeeding. It is also important to mention a new aspect, regulated in September 2020, regarding waste management.

According to Decree 116/2020, each part of the packaging (cap, bag, bottle) must be identified with:

• The material family
  • For example cap (metal)
• The codification of the specific material
  • For example ALU41
• The disposal instructions
• The warning to check the regulations of the local municipality

Who is responsible for the information on the label?

EU regulations leave a lot of freedom to individual member states to define permitted substances, possible labeling, and the way in which they are notified and marketed. In the European Union, common labeling rules apply to all member states. Each member state can then introduce national rules which, unless imposed by special health requirements, must not affect the sale of food from other EU countries, as there is free circulation of goods. In non-EU countries, there may be common rules with the EU, as is the case with European Economic Area (EEA) countries such as Norway or Lichtenstein, or different regulations. Therefore, when we work with our customers, we send them our graphics, which can obviously be adapted according to their regulatory requirements. Let’s take a few practical examples:

Conclusion

The safety of food supplements at the European level is always under the direct responsibility of those who produce, import, and distribute these types of products. These parties are responsible for ensuring that food supplements are safe for the consumer and comply with regulations. EU countries have the right to request a notification every time a supplement is placed on their territory, in order to monitor the product and control it.  The discussion that led to the EU Regulation 1169/2011 lasted several years, consulting and assessing the needs of all the social partners involved. The main reasons that led to this new legislation are:

1. The need to achieve common legislation at European level, applied in all Member States.
2. Simplifying and harmonizing the regulatory structure
3. The needs of manufacturers
4. The necessity to increase consumer protection and information

In conclusion, never forget to be aware of and examine the legislation and/or guidelines before marketing food supplements in EU and Extra EU countries.

References:

1. Directive 2002/46/EC
2. Legislative Decree n. 169/2004
3. Regulation 1169/2011/EC
4. Merieux NutriSciences, Webinar 2021, Integratori Alimentari
5. http://www.salute.gov.it
6. https://eur-lex.europa.eu/homepage.html