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Instructions for use of foodstuffs containing caffeine

Caffeine is used in foodstuffs both as a flavouring substance and as an ingredient. The moderate consumption of caffeine is unlikely to present any health risks for most people.

The stimulatory effect of caffeine is very individual, lasting from a few hours to dozens of hours depending on the amount of caffeine and the person’s metabolism. (Poison Information Centre 2006). Caffeine, even in small doses, may cause heart palpitation and trembling in people sensitive to caffeine, pregnant women and children.

A toxic dose of caffeine is 20 mg/kg; i.e. 1200 mg for an adult weighing 60 kg. The therapeutic treatment dose for adults and those over 15 years of age is about 300 mg/day (Poison Information Centre 2006).

The EU Scientific Committee on Foods, in its opinion on so-called energy drinks is-sued on January 21, 1999, states that the proportion of caffeine from energy drinks in comparison with the total consumption of caffeine is unlikely to be harmful to adults, apart from pregnant women, as it is assumed that energy drinks replace other caffeine sources. However, for children daily additional exposure may cause temporary behav-ioural changes such as restlessness and nervousness. The Committee states that pregnant women must be advised to reduce their caffeine consumption.

The Finnish Food Safety Authority Evira considers that the labelling according to Di-rective 2002/67/EC (implemented in Finland by the Decree on the labelling of food-stuffs 1084/2004, issued by the Ministry of Trade and Industry) is not sufficient to pro-tect the most sensitive consumers. Section 6 of the Decree on the labelling of food-stuffs states that the packaging must have warning labelling when necessary. For this reason, Evira considers that the following foodstuffs must have separate warnings for pregnant women, children and consumers sensitive to caffeine. The products must also have information about the maximum daily intake.

Marketing of the products must take into account children, pregnant women and peo-ple sensitive to caffeine.

DRINKS

According to Directive 2002/67/EC (Section 21 of the Decree on the labelling of food-stuffs) a drink that contains more than 150 mg/l of caffeine from any source must have the following text:

“High caffeine content (….mg/100ml)”

  • The marking must be next to the name of the drink
  • The marking is not required for coffee and tea based drinks, nor for drinks made from coffee or tea extract that have the term “coffee” or “tea” in their name.

Refering to Section 6 of the Decree on the labelling of foodstuffs Evira considers that in addition to the relating to high caffeine content, the package must also have the fol-lowing labelling:

  •  “Not recommended for children, pregnant women or people sensitive to caffeine”
  • The maximum amount to be used daily expressed precisely, for example, “a maximum of two cans per day”. Other equivalent markings such as “to be consumed in reasonable amounts” are inadequate.

CONFECTIONERY, CHEWING GUMS, CHOCOLATE BARS AND OTHER SIMILAR PRODUCTS

Because confectionery, chocolate bars and other similar products are foodstuffs con-sumed especially by children, Evira considers that the following labelling must be on the package of products that contain caffeine.

  • ”Not recommended for children, pregnant women or people sensitive to caffeine”
  • The maximum amount to be used daily has to be expressed precisely, for example, “a maximum of one box per day”. Other equivalent labels such as “to be consumed in reasonable amounts” are inadequate.

FOOD SUPPLEMENTS

Because food supplements are pills, tablets or capsules sold in small dosage form, it is possible to consume a large amount of them at one time. If caffeine or an ingredient containing caffeine is a characteristic substance as referred to in Article 8 in Directive 2002/46/EC (implemented in Finland by the Decree on food supplements, 571/2003), the caffeine in a product can be considered a substance affecting the user.

Caffeine is one of the substances mentioned in Annex 1 of the medicinal products list (decision of the National Agency for Medicines on the medicinal products list 1024/2003). Because of this, Evira recommends that the operator shall contact the National Agency for Medicines concerning the possible assessment of the need for classification, especially if a product contains more caffeine than the 100mg/recommended daily dosage. Evira also recommends that when a product is sold as a food supplement, the amount of caffeine from any source in a single sales package should not exceed 1200 mg, so that failure to observe the recommended in-structions for use will not harm the consumer’s health.

Evira considers that if caffeine or an ingredient that contains caffeine is a characteris-tic substance in a product, in addition to the compulsory labelling for food supple-ments the following text must also be included:

  • “Not recommended for children, pregnant women or people sensitive to caffeine”

As the Directive on food supplements requires labelling of the recommended daily dosage, labelling of the maximum daily intake is not required separately as in the other foodstuff groups mentioned previously.


 








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