by K&L Gates LLP

How the Food Information for Consumers Regulation (FIC) will change food supplements labelling

Regulation 1169/2011 on the provision of food information to consumers (the FIC Regulation) will be applicable as from December 13, 2014. This is the second of a series of news alerts specifically addressing how those rules will impact foods manufacturers and distributors.

Food supplements are classified by EU law as foodstuffs. As such, the legal provisions that apply to regular food generally apply to food supplements too. This News Alert looks at FIC rules which particularly impact food supplements labels.

Presentation of food supplements’ mandatory particulars

FIC defines mandatory food information as particulars that EU provisions require to be provided to the final consumer. Such information must be marked in a conspicuous place in such a way as to be easily visible, clearly legible and, where appropriate, indelible. The minimum font size (1.2 mm) set out in FIC is new. The presentation of warnings and statements that are mandatory in the label of food supplements (e.g. ‘Do not exceed recommended daily dose’ or ‘Keep out of reach of young children’) must also follow these new provisions.

The names of any allergens on the list of ingredients must be emphasized through a typeset that clearly distinguishes it from the rest of the ingredients - for example, by means of font, style or background colour. The most common solution is to bold the name (or the part of the name) of the ingredient.

Food additives must be designated by the name of that category, followed by their specific name or, if appropriate, E number (e.g. glazing agent - hydroxypropyl methyl cellulose or glazing agent - E 464). The name of the food additive category should always appear as first. The decision whether to use to name or E number is quite important, for instance when the product contains aspartame. If this sweetener is designated in the list of ingredients only by reference to the E number, the additional labelling particular is ‘contains aspartame (a source of phenylalanine)’. Otherwise, if the designation is by the specific name, the additional labelling particular is ‘contains a source of phenylalanine’.

Food supplements placed on the market after December 12, 2014 to which caffeine is added with a physiological purpose should bear in the same field of vision as the name (food supplement) the warning: ‘Contains caffeine. Not recommended for children or pregnant women’. The caffeine content should be expressed per portion as recommended for daily consumption on the labelling.

Mandatory particulars, such as the instructions for use, must be indicated with words and numbers, pictograms or symbols being only an additional means to express such particulars. Food supplements in powder or in other forms which require mixing of the product with water or other liquids should therefore include written instructions and not only depictions.

Nutrition declaration

Food supplements are exempted from the mandatory nutrition declaration. Nevertheless, if provided voluntarily, such information must comply with FIC. This applies to all seven mandatory nutrients: energy, fat, saturates carbohydrate, sugars, protein, and salt. Pursuant to Food Supplements Directive 2002/46/EC, the amount of the nutrients or substances with a nutritional or physiological effect present in the product, have to be declared on the labelling. For consistency, the European Commission advises using the same terminology for food supplements as for other foods. Thus, ‘Reference Intakes’ should replace ‘Recommended Daily Allowance’. As a general rule the nutrition declaration is required for the food as sold, but where appropriate, it can instead also relate to the food as prepared. Most of food supplements bear nutrition and health claims which should refer to the food ready for consumption. Therefore, when it comes to food supplements that bear nutrition and health claims and need preparing before consumption, nutrition labelling relating to the food as prepared might be more convenient for both consumer and producer. On the other hand where there are various preparation options – such as with water, with milk or with juice, such obligation may force a choice of only one option.

For nutrition declaration purposes as well as the declaration of the vitamins and minerals present in food supplements, the names listed in Annex XIII of FIC should be used. For instance, ‘Thiamin’ cannot be replaced with B1 or ‘Folic acid’ with B9.


The indication of the country of origin or of the place of provenance (COOL) is mandatory for certain foodstuffs (e.g. beef, honey, olive oil). It also should be provided whenever its absence is likely to mislead consumers as to the true country of origin or place of provenance of that product. In some cases, producers indicate the origin of a food on a voluntary basis to draw consumers’ attention to the qualities of their product (e.g. ‘Product of USA’, ‘Produced in EU’). Such indications should also comply with harmonised criteria. Moreover, where the country of origin or the place of provenance of a food is given and where it is not the same as that of its primary ingredient (i.e. ingredient that represents more than 50 % or which is usually associated with the name of the food) COOL of the primary ingredient must be indicated as different to that of the food. With regard to food supplements, the origin of plant extract or even of the capsule may have impact on the correct labelling.


FIC applies to food business operators (FBO) at all stages of the food chain, where their activities concern the provision of food information to consumers. The operator under whose name the food is marketed is responsible for the food information. For imported food where FBO does not operate in the EU, the importer may be responsible for the food information. It is mandatory to indicate on the label the name or business name and address of the food business operator responsible for food information. Although, it will be still possible to mention more that one FBO on the label (e.g. ‘produced by… for…’), there should be clear indication which FBO is responsible for food information. Some companies have already been using the statement: ‘food business operator responsible for the food information: … ’.

Labeling, advertising, presentation

It is worth bearing in mind that not only labels are affected by FIC but also information concerning a food and made available to the final consumer by means of a other label accompanying material, or any other means including modern technology tools or verbal communication. This includes also advertising and presentation.
Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers changes the EU’s legal regime on food labelling, advertising and promotion, replacing two EU directives.

As with all regulations, FIC is binding in its entirety and directly applicable in all Member States. This should mean that food information provisions are the same in all EU countries. Member States will continue to be responsible for enforcement of food law, as well as monitoring and verifying the compliance of food business operators.

Next Alert: Transitional measures and the definition of ‘placing on the market’ under FIC


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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