MESZ original article · · Date of the parliamentary decision discussed: 7 July 2016.
Scientifically substantiated, yet not authorised: caffeine, EFSA and the 2016 veto
In 2011, the European Food Safety Authority (EFSA) gave a favourable scientific assessment of caffeine's effects on alertness, attention and certain measures of endurance, at specified doses and under specified conditions. In 2016, the European Commission proposed authorising four related claims, but the European Parliament objected to the draft regulation. The case shows that scientific substantiation and authorisation of claims for use on products are separate questions.
What did EFSA conclude?
EFSA's nutrition panel assessed the scientific substantiation of claims relating to caffeine in two opinions published in April 2011. One concerned alertness and attention, and the other concerned physical performance. It reached favourable conclusions for five effects. [1] [2]
| Effect assessed | Dose and target population in EFSA's 2011 opinion | The Commission's 2016 proposal |
|---|---|---|
| Increased alertness | At least 75 mg of caffeine per serving; adults. | Would have authorised the claim, subject to conditions. |
| Improved attention and concentration | At least 75 mg of caffeine per serving; adults. | Would have authorised the claim, subject to conditions. |
| Increased endurance performance | 3 mg of caffeine per kg of body weight, one hour before exercise; adults performing endurance exercise. | Would have authorised the claim, subject to conditions. |
| Increased endurance capacity | 3 mg of caffeine per kg of body weight, one hour before exercise; adults performing endurance exercise. | Would have authorised the claim, subject to conditions. |
| Reduced perceived exertion | 4 mg of caffeine per kg of body weight, one hour before exercise; adults performing endurance exercise. | Would have rejected the claim on safety grounds. |
Endurance performance refers, for example, to the result of a time trial, while endurance capacity refers to sustaining exercise until exhaustion. The two conclusions concern different measurement endpoints. The 75 mg condition applied to the alertness and attention claims, not to the endurance effects. [1] [2]
The assessments concerned caffeine, rather than the complete formulation of a particular energy drink or brand. A 250 ml can of an energy drink with a typical caffeine concentration of 32 mg/100 ml contains 80 mg of caffeine; individual products may differ. This helps put the 75 mg condition in context, but does not, by itself, establish every effect of a particular drink.
Under what conditions would the Commission have authorised four claims?
Draft Regulation D044599/02 would have added to the list of authorised claims in Regulation (EU) No 432/2012. It would have authorised the alertness and concentration claims for servings containing at least 75 mg of caffeine, with a maximum single intake of 200 mg. These claims would not have been permitted on foods intended for children and adolescents. The draft would also have required information about a maximum total daily intake of 400 mg from all sources combined, or 200 mg for pregnant and breastfeeding women. [4]
The two endurance claims would have applied only to foods intended for adults performing endurance exercise. Alongside the dose of 3 mg per kg of body weight and consumption at least one hour before exercise, the draft would have required habitual caffeine consumers to abstain from caffeine beforehand for at least 24 hours for the performance claim and at least 12 hours for the capacity claim. These were the historical conditions of use set out in the draft. [4]
Effects on performance and safety are separate questions
According to EFSA's 2015 safety assessment, single caffeine intakes of up to 200 mg do not raise safety concerns for healthy adults. Total intakes of up to 400 mg of caffeine, spread throughout the day, also do not raise safety concerns for healthy, non-pregnant adults. All sources of caffeine must be counted together. [3]
A study dose adjusted for body weight is not the same as the 200 mg reference value for a single intake: for a 70 kg adult, 3 mg per kg of body weight is 210 mg, and 4 mg per kg is 280 mg. These doses cannot automatically be classified as safe on the basis of the conclusion relating to intakes of up to 200 mg. At the same time, exceeding the reference value does not, by itself, establish harm to health.
The Commission planned to reject the fifth claim, concerning reduced perceived exertion, because it considered that EFSA's safety assessment did not support its authorisation. The minutes of the Standing Committee meeting of 12 April 2016 record this separately. This proposed regulatory decision should be distinguished from the favourable scientific assessment of the effect in 2011. [5]
Why did the European Parliament object?
In its resolution adopted on 7 July 2016, the European Parliament opposed adoption of the draft regulation. This prevented the planned authorisation of the four claims. In addition to protecting children and adolescents, the reasons for the decision included the risk of encouraging excessive sugar and caffeine consumption, the absence of nutrient profiles, and the possibility that the message conveyed to consumers could be misleading. [6]
The Parliament also questioned how increased alertness and concentration could be understood as a claim describing a relationship with health. The resolution therefore brought together several consumer protection and regulatory considerations. The parliamentary objection did not change the scientific conclusions of EFSA's opinions, but a favourable scientific assessment was not, by itself, sufficient for adoption of the draft. [6]
What does this mean today?
The four claims were not authorised through the 2016 draft. However, absence from the authorised list does not automatically mean a complete prohibition on use: pending claims, known as on hold claims, have a separate status. Guidance from the Food Safety Authority of Ireland also mentions caffeine-related claims in this category. Pending claims may be used under specified transitional rules and conditions; the current legal position of a particular claim and product must be checked separately. [7]
EFSA's scientific assessment concerns the evidence for an effect. Authorisation of wording that may be used on a label or in advertising takes additional conditions and consumer protection considerations into account. An accurate account of this case requires an understanding of both levels of decision-making.
Publisher and editor: Magyar Energiaital Szövetség (MESZ), an industry association. This article is an accessible summary of external scientific and official documents. Sources checked: 12 October 2026.
Sources
- EFSA NDA Panel (2011): scientific assessment of claims relating to caffeine, alertness and attention. EFSA Journal, 9(4), 2054. DOI: 10.2903/j.efsa.2011.2054.
- EFSA NDA Panel (2011): scientific assessment of claims relating to caffeine and physical performance. EFSA Journal, 9(4), 2053. DOI: 10.2903/j.efsa.2011.2053.
- EFSA NDA Panel (2015): Scientific Opinion on the safety of caffeine. EFSA Journal, 13(5), 4102. DOI: 10.2903/j.efsa.2015.4102. EFSA summary.
- European Commission (2016): annex to Draft Regulation D044599/02, 8681/16 ADD 1, in the Austrian Parliament's official document repository. The four proposed claims and their conditions of use.
- European Commission: summary of the Standing Committee meeting of 12 April 2016, agenda item B.07. Support for the four claims and the reason for rejecting the fifth.
- European Parliament (2016): Hungarian text of the resolution adopted on 7 July 2016, P8_TA(2016)0319, 2016/2708(RPS).
- Food Safety Authority of Ireland: Permitted Claims, official guidance on authorised and pending claims.