Legal Updates - Caffeine Health Claims

Product Regulation Law – Refusal of Nutrition and Health Claims - European Food Safety Authority – Caffeine – SmithKline Beecham


The European Food Safety Authority (“EFSA”) recently refused the health claim relating to caffeine and increased alertness submitted by SmithKline Beecham Limited on the basis that it could not be substantiated.



SmithKline Beecham Limited applied for authorisation of a health claim relating to caffeine under Article 13(5) of Regulation (EC) No 1924/2006. The application was based on newly developed scientific data.


Proposed claim: “helps to increase alertness”


The proposed health claim related to “the general adult population” and it was claimed by the applicant that, in order to bear the claim, a product should contain a dose of caffeine of at least 40mg of caffeine per serving.


In reaching its decision the EFSA Panel on Dietetic Products, Nutrition and Allergies (“Panel”) noted:


  • There was a previous favourable assessment of a claim on caffeine for increased alertness in the general adult population, for products containing at least 75mg of caffeine per serving. This was based upon evidence provided by consensus opinions/reports as well as studies;
  • That the present application identified 18 human intervention studies, 15 human studies on bioavailability or mechanistic studies, one pooled analysis and 12 non-human studies.
  • That no conclusion could be drawn from:
    • the human studies on bioavailability;
    • the mechanistic studies; and
    • the non-human studies


for the scientific substantiation of an effect of caffeine on alertness at the proposed condition of use (i.e. at least 40 mg per serving).


The Panel concluded that the “cause and effect relationship had not been established between the consumption of caffeine and increased alertness under the conditions of use proposed by the applicant”.


For any advice on food law, food supplements, labelling and packaging of food or food supplements, label claims, nutrition claims and/or health claims, you may contact us by email Visit or;


© RT COOPERS, 2014. This Briefing Note does not provide a comprehensive or complete statement of the law relating to the issues discussed nor does it constitute legal advice. It is intended only to highlight general issues. Specialist legal advice should always be sought in relation to particular circumstances.




Follow us on Facebook!  







Search Shadow


newsletter Shadow


Testimonial Bottom Shadow

testimonial Shadow Middle

More Testimonials

Testimonial Bottom Shadow