Warning and instructions for use of foods containing caffeine

Caffeine is used in food as both a flavouring and an ingredient. Where caffeine is present in the food solely as a flavouring, it must be included in the list of ingredients under its own name immediately after the word "flavouring(s)".

For most people, moderate use of caffeine is not considered to pose health risks. Caffeine is obtained from e.g. coffee, tea, energy and cola drinks, and dark chocolate.

The stimulant effect of caffeine is very individual and lasts from a few hours to up to tens of hours depending on the amount of caffeine and a person’s metabolism (EFSA, 2015). Caffeine, even in small doses, can cause people with caffeine sensitivity, pregnant women, and children, to experience heart palpitations and trembling.
The toxic dose of caffeine is 20 mg / kg body weight, for example 1200 mg for an adult weighing 60 kg. A cup (1.25 dl) of filter coffee contains 60 to 135 mg of caffeine.

Article 9 of Regulation (EU) No 1169/2011 of the European Parliament and of the Council (Food Information Regulation) lays down that the packaging shall, where appropriate, include instructions for use, including a warning where appropriate. Annex III to the Food Information Regulation sets out the foods for which the labelling must include one or more additional particulars for caffeine. These are beverages with a high caffeine content or foods with added caffeine  This is why the following foods must have separate warnings for children, pregnant and breast-feeding women. In addition, the products must contain particulars on the caffeine content and the maximum daily consumption of the product.

Children, pregnant and breast-feeding women must also be taken into account when marketing the products. In addition, the Finnish Food Authority recommends that caffeine-sensitive people be included in the previous group.

Beverages (with the exception of those based on coffee or on tea or coffee or tea extract, where the name of which includes the term "coffee" or "tea")

Under point 4 of Annex III to the Food Information Regulation, a beverage intended to be consumed without modification and which contains caffeine, from whatever source, in a proportion in excess of 150 mg/l must be labelled:

  • “High caffeine content (… mg / 100 ml)”.
  • “Not recommended for children or pregnant or breast-feeding women”.
    • Labelling must be in the same visible field as the name of the beverage.
    • Labelling is not required for beverages based on coffee or tea or coffee or tea extract that include the term "coffee" or "tea" in their name.

The Finnish Food Authority considers that under Article 9 of the Food Information Regulation and point 4 of Annex III,  the packaging must, in addition to the above-mentioned labelling of high caffeine content, include the following indication:

  • Maximum daily consumption exactly expressed, for example “Maximum of two cans per day”.  Other similar indications such as “Drink in moderation” are not sufficient.

Foods other than beverages, where caffeine is added with a physiological purpose

Such products may include, for example, confectionery, chewing gum and other similar products.

The packaging must contain the following labelling in the same field of vision as the name of the food:

  • Contains caffeine. “Not recommended for children or pregnant women”. 
  • Caffeine content  ... mg/100 ml or mg/100 g

The Finnish Food Authority considers that the packaging should additionally contain

  • Maximum daily consumption exactly expressed, for example “Maximum of one carton per day”. Other similar labelling such as “Consume in moderation” are not sufficient.

Food supplements

Because food supplements are pills, compresses or capsules sold in small dosage forms, it is possible to consume even a large amount at a time. If, under section 6 of the Decree on Food Supplements (78/2010), the characteristic component is caffeine or an ingredient containing caffeine, caffeine may be considered to be an active substance in the product for the user.

Caffeine is one of the substances listed in Appendix 1 to the List of Medicinal Products (Finnish Medicines Agency Decision 415/2019). This is why the Finnish Food Authority recommends that the operator contact the Finnish Medicines Agency for a possible assessment of the need for classification, especially if the product contains more than 100 mg of caffeine per recommended daily dose. In addition, the Finnish Food Authority recommends that when offering for sale a product as a food supplement, the amount of caffeine, from whatever source, in a single sales package should not exceed 1200 mg, so that non-compliance with the recommended instructions for use does not pose a health hazard to the consumer.

If the characteristic component is caffeine or an ingredient containing caffeine, the following indication must be provided in addition to the mandatory labelling of the food supplement:

  • "Contains caffeine. Not recommended for children or pregnant women” in the same field of vision as the name of the food.

For food supplements, the caffeine content must be expressed per portion as recommended for daily consumption on the labelling.

Page last updated 1/14/2022