ID 1101 - Kofeina

PL: Kofeina
EN: Caffeine
Pdf: caffeine

Oświadczenie (4)

Oświadczenie (2)

1. Charakterystyka żywności / składnika

The foods/food constituents that are the subject of the health claims are Coffea arabica L. (coffee) and other Coffea spp., Paullinia cupana Kunth (guarana) and caffeine.
Caffeine is a natural compound present in coffee beans and tea leaves. Other sources include the kola nut, yerba mate, guarana berries and Yaupon Holly. Caffeine is a well characterised substance which can be measured by established methods.
The food/food constituent which is the subject of ID 1101 is “Coffea arabica L. and other spp”. Coffee contains a wide range of compounds including caffeine and other purine derivatives, polyphenolic compounds such as the degradation product caffeic acid, and specific diterpenes such as kahweol and cafestol. No information was provided on the concentration of such compounds in coffee, but these compounds will likely depend on the coffee variety, on the roasting of the beans and, in relation to human consumption, on the brewing process, such as the use of coffee filters. The Panel notes that “caffeine” has been specified as the “active” food constituent that is responsible for the claimed effects considered in this opinion, but the Panel also notes that coffee contains a wide and variable range of compounds, including caffeine.
The food constituents which are the subjects of IDs 2063, 2103 and 2375 are “guarana”, “Paullinia cupana (Common Name: guarana)” and “guarana seed; (Paulina cupana fruit)”. The varieties Paullinia cupana Kunth and Paullinia cupana var. sorbilis (Mart.) Ducke are native to the Amazon basin. Guarana is derived from both wild and cultivated plants. The seeds typically contain: caffeine 2.5-5 %, tannins 16 %, saponins, theophylline and theobromine (small quantities) (Carlini, 2003; Houghton, 1995; Scholey and Haskell, 2008). The Panel notes that “caffeine” has been specified as the “active” food constituent which is responsible for the claimed effects considered in this opinion, but the Panel also notes that guarana contains a wide and variable range of compounds, including caffeine.
The Panel considers that, whereas the foods/food constituents Coffea arabica L. and Paullinia cupana Kunth are not sufficiently characterised in relation to the claimed effects evaluated in this opinion, the food constituent caffeine is sufficiently characterised.

2.3. Zwiększenie czujności (ID 736, 1101, 1187, 1485, 1491, 2063, 2103)

The claimed effects are “cognitive and mental performance”, “mental and physical stimulant effect”, “mental state and performance”, “mental performance (where mental performance stands for those aspects of brain and nerve functions which determine aspects like concentration, learning, memory and reasoning, as well as resistance to stress)”, “mental performance and cognitive function (enhances mental alertness during intense muscular activity)”, and “mental performance”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings and the clarifications provided by Member States, the Panel assumes that the claimed effects refer to alertness. Alertness may relate to either a cognitive (i.e. behavioural) or an affective (i.e. subjective self-rating) construct. Cognitive alertness refers to a state of enhanced arousal and readiness to receive and process information and respond. Alertness is a well defined construct and can be measured by validated psychometric cognitive tests.
The Panel considers that increased alertness might be a beneficial physiological effect.

3.3. Zwiększenie czujności (ID 736, 1101, 1187, 1485, 1491, 2063, 2103)

A number of the references provided addressed endpoints other than the claimed effect, including mood, lipid or carbohydrate metabolism, metabolic rate, physical performance and cardiovascular endpoints, or investigated substances other than caffeine, or caffeine in combination with other substances, or the effect of caffeine withdrawal rather than the effect of caffeine on subjects under normal conditions of use. A meta-analysis (Riby, 2004) addressed the effects of glucose, and a systematic review (Hoyland et al., 2008) reported on macronutrients but not caffeine, which is the
subject of the claim. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
Two double-blind, placebo-controlled intervention trials assessed the effect of a commercial standardised guarana extract (containing approximately 12 % caffeine) on measures of alertness (Haskell et al., 2007; Kennedy et al., 2004). The Panel notes that the placebo (capsule containing no guarana extract) used in these two studies did not control for substances other than caffeine. The Panel considers that no conclusions can be drawn from these studies for the scientific substantiation of the claim.
A total of 19 randomised, double-blind, placebo-controlled intervention studies assessed the effects of caffeine on reaction time (RT), a measure of alertness as a cognitive construct. The cognitive tests used to measure RTs can be classified into simple reaction time tasks (nine studies), choice reaction time tasks (six studies) and other vigilance tasks measuring speed of reactions (e.g. rapid information processing tasks, visual or auditory vigilance tasks; 10 studies). These studies differed with respect to their design (cross-over, parallel), their sample size (11 to 120 subjects), the baseline characteristics of participants (age range 18-57 years; usual coffee consumption from 0 to 7 cups/day), the doses of caffeine administered (range 12.5 mg to 500 mg in drinks/capsules) and the time between caffeine administration and RT testing (range 20 min to 8 hours). The majority of studies used cross-over designs with relatively small sample sizes (15-25 subjects), involved young regular caffeine consumers (males and females, 18-30 years) who were on caffeine withdrawal for at least 12 hours, and administered caffeine doses ranging from 100 to 300 mg in a single dose, 45-90 min before RT testing.
Of the nine trials which assessed the effect of caffeine on simple reaction time tasks, six reported a significant reduction in RTs following caffeine consumption (dose range 12.5 mg to 320 mg) (Brice and Smith, 2002; Haskell et al., 2005; Robelin and Rogers, 1998; Smit and Rogers, 2000; Smith et al., 1992; 1993), while three studies found no effect (dose range 32 mg to 320 mg) (Hewlett and Smith, 2007; Hogervorst et al., 1999; Lieberman et al., 1987). A significant effect of caffeine on simple reaction time tasks was observed regardless of whether subjects were on caffeine withdrawal (4 trials) (Haskell et al., 2005; Robelin and Rogers, 1998; Smit and Rogers, 2000; Smith et al., 1993) or not (2 trials) (Brice and Smith, 2002; Smith et al., 1992). Most of these studies were conducted in rested subjects. One study which investigated the effect of caffeine on simple reaction time tasks during the day and at night (rested or sleep deprived subjects) reported a significant effect of caffeine in both conditions (Smith et al., 1993). The Panel notes that six of the nine studies which assessed the effects of caffeine consumption on simple RT tests showed a significant reduction in RT following caffeine consumption.
Three studies showed a significant decrease in RTs on choice-reaction time tasks after caffeine consumption (dose range 32 mg to 300 mg) (Lieberman et al., 1987; Lorist et al., 1994a; van Duinen et al., 2005). Lieberman et al. (2002) reported significantly decreased RTs on one choice-reaction time task after caffeine consumption at 200 mg and 300 mg, but not at 100 mg. One study observed a significant effect of caffeine after exercise, but not before (dose range 150 mg to 320 mg) (Hogervorst et al., 1999). One study found no effect (dose of 1 mg caffeine per kg body weight) (Hewlett and Smith, 2007). The Panel notes that five of the six studies which assessed the effects of caffeine consumption on choice-reaction time tasks showed a significant reduction in RT following caffeine consumption.
Of the 10 trials which reported the effect of caffeine on speed of reactions using other vigilance tasks, eight showed a significant decrease in RTs following caffeine consumption (dose range 75 mg to 500 mg), whereas two studies found no effect (dose range 12.5 mg to 250 mg) (Ruijter et al., 2000c; Smit and Rogers, 2000). Again, a significant effect of caffeine on RTs was observed regardless of whether subjects were caffeine deprived (4 trials) (Fine et al., 1994; Hasenfratz and Bättig, 1994;
Rosenthal et al., 1991; Smith et al., 1990) or not (4 trials) (Frewer and Lader, 1991; Lieberman et al., 2002; Smith et al., 1992; Warburton, 1995). Most of these studies were conducted in rested subjects. Two studies tested the effect of caffeine under stress conditions (sleep deprivation and/or exercise), and found a significant effect of caffeine on RTs for visual or auditory vigilance tasks (Lieberman et al., 2002; Rosenthal et al., 1991). The Panel notes that 8 of the 10 studies which assessed the effects of caffeine on other vigilance tasks showed a significant reduction in RT following caffeine consumption.
The Panel notes that the vast majority of the studies which investigated the effects of caffeine consumption on RTs using simple and choice RT tests, and other vigilance tasks, showed a reduction in RTs following caffeine consumption. The Panel also notes that the evidence provided by consensus opinions/reports (ANZFA, 2000; IoM, 2001) shows that there is good consensus on the role of caffeine in increasing speed of reaction time, and in the maintenance of speed of reactions/increased alertness, particularly in low arousal situations (e.g. sleep deprivation and fatigue).
Overall, 12 of the studies provided assessed the effects of different caffeine doses on RTs (Frewer and Lader, 1991; Hasenfratz and Bättig, 1994; Haskell et al., 2005; Hewlett and Smith, 2007; Hogervorst et al., 1999; Lieberman et al., 1987; 2002; Robelin and Rogers, 1998; Rosenthal et al., 1991; Smit and Rogers, 2000; Smith et al., 1993; Warburton, 1995). Two studies investigated dose-response effects. Using doses of 100 mg, 200 mg and 300 mg, Lieberman et al. (2002) found a dose-related effect of caffeine on RTs in a visual vigilance test (no effect on RTs in a 4-choice RT test). Warburton (1995) reported a dose-related effect of 75 mg and 150 mg caffeine in RTs on a rapid visual information processing task. The results from the other studies are heterogeneous (in some studies the effect appeared to increase with increasing caffeine doses, whereas in others the decrease in RTs appeared unrelated to the caffeine dose used). This heterogeneity suggests that the effective dose of caffeine may vary from individual to individual, and may depend on many factors (IoM, 2001). Although some effects have been observed at very low caffeine doses (<75 mg), results were inconsistent (Hewlett and Smith, 2007; Lieberman et al., 1987; Smit and Rogers, 2000). The majority of significant results were obtained when subjects consumed caffeine doses in the range of 75-500 mg. This finding is consistent with consensus opinions reporting on caffeine doses in the range of 100-400 mg (IoM, 2001) and of 60-600 mg (ANZFA, 2000) which have consistently demonstrated reductions in reaction time and enhanced speed of reaction in vigilance tests.
In weighing the evidence, the Panel took into account that the evidence provided by consensus opinions/reports, and by the majority of the studies submitted for the scientific substantiation of the claim, showed that there was good consensus on the role of caffeine in increasing alertness measured as speed of reaction times in healthy individuals of both sexes, at doses of at least 75 mg.
The Panel concludes that a cause and effect relationship has been established between the consumption of caffeine and increased alertness.

4.1. Zwiększenie czujności (ID 736, 1101, 1187, 1485, 1491, 2063, 2103)

The Panel considers that the following wording reflects the scientific evidence: “Caffeine helps to increase alertness”.

5. Warunki i możliwe ograniczenia stosowania oświadczenia

The Panel considers that, in order to bear the claim, a product should contain at least 75 mg caffeine per serving. The target population is the general adult population.
For children, consumption of a dose of 5 mg/kg body weight could result in transient behavioural changes, such as increased arousal, irritability, nervousness or anxiety (SCF, 1999). In relation to pregnancy and lactation, moderation of caffeine intake, from whatever source, is advisable. A European Commission Directive lays down rules for the labelling of foodstuffs containing caffeine (Directive 2002/67/EC6).

Warunki i możliwe ograniczenia stosowania oświadczenia

Seeds, On the average 15 g of dried seeds a day