What will EFSA’s caffeine opinion mean for product formulation?
Raising the point at an EFSA stakeholder meeting in Brussels last week, Dr Mark Tallon, managing director of consultancy firm Legal Foods, said whether EFSA swayed towards an absolute (200 mg) or relative (per kg body weight) caffeine limit could have big ramifications for product formulation.
EFSA’s opinion stated “single doses of caffeine up to 200 mg, corresponding to about 3 mg/kg body weight for a 70-kg adult” were unlikely to cause health problems such as changes in blood pressure, hydration status or reduced perceived exertion or effort during exercise.
Some observers at the meeting said this body weight relating to the ultimate 200 mg limit was quite small, particularly considering populations such as sportspeople.
Commenting on this point after the event, Tallon told NutraIngredients a safety limit by body weight would allow consumers to ensure they used the product in a way that delivered the health claim benefit on endurance performance and capacity - as approved by EFSA but not yet approved by member states.
However, he said: “If a 200 mg per serving limit is imposed any consumer with a body weight over 66 kg would not consume the 3 mg/kg (67 kg x 3 mg = 201 mg thereby exceeding the 200 mg threshold) dose specified as conditions of use according to the EFSA approved claim.”
He said this 200 mg limit would equate to a ‘condition of use’ that may result in some food businesses “misleading” consumers that have a bodyweight over 66 kg and mean a “de facto ban” for over 80% of adult males and 30% of females in the EU who exceeded this body weight. According to the 2010 UK Office of National Statistics (ONS) survey, the average male in the UK weighs 83.6 kg while the average female weighs 70.2 kg.
He said this could also see firms increasing the size of sports products in order to legally target heavier sportspeople like rugby players.
Health claim history
Five health claims for caffeine have been stalled since EFSA’s approval due to member state concerns on what message this would send to consumers. The first claim related to sports nutrition stated ‘caffeine contributes to a reduction in the rated perceived exertion/effort during [endurance] exercise' and required a dose of 4 mg per kg body weight (therefore 280mg for a 70 kg person).
Two other claims stated ‘caffeine contributes to an increase in endurance capacity' and 'caffeine contributes to an increase in endurance performance' for dosages of 3 mg per kg body weight (therefore 210 mg for a 70 kg person).
Tallon said while the opinion did not impact EFSA’s decision on the cause and effect relationship established in the approved claims, it could add to debates on safety.
“These debates/negotiations could therefore result in prolonged 'on-hold' status for caffeine as a performance enhancer and a delay to its addition to the register of approved claims.”
He said it was important that EFSA took into account that the caffeine and performance health claims were not targeting an unhealthy population.
“It seems clear that for healthy individuals there is no risk of caffeine consumption during exercise at a dose of 3 mg/kg body weight. So why not use that data for the population the claims on caffeine and performance are intended for i.e. a healthy population?”
The risk assessment would be finalised after the consultation deadline of 15th March, for which Legal Foods would be submitting its comments.
