Scientific substantiation of health claims – what’s cooking?Posted: November 12, 2013
Lately, we have seen a number of positive EFSA opinions for various health claims. What do these claims relate to? Who are the applicants for such claims? What type of evidence was relied on? And again: what different types of claims exist and what are the proceedings for requesting such claims? This is to provide you with a recap on the role of evidence in requesting a health claim and what is yet to come.
Types of health claims
- General function claims (article 13) of which 222 were approved and published pursuant to Regulation 432/2012;
- General function claims based on newly developed scientific evidence (article 13.5);
- Disease risk reduction claims (article 14);
- Claims regarding children’s health and development (article 14).
This blog post focuses on article 13.5 and article 14-claims that need to go through a case-by-case authorisation procedure.
Any company wanting to use an article 13.5 or article 14 health claim, should file an application with its national competent authority. For the Netherlands, this is the Netherlands Food and Consumer Product Safety Authority (Nederlandse Voedsel- en Warenautoriteit, NVvA). The national authorities mainly function as a box office and will swiftly forward the application to EFSA. As a very minimum, the application should contain, according to article 15.3 of the Health Claim Regulation:
- the name of the applicant;
- the nutrient or other substance for which the health claim is to be made;
- a proposal for the wording of the proposed health claim as well as its conditions of use;
- a copy of the studies that have been made with respect to the health claim;
- if appropriate, a request for protection of proprietary data;
- a summary of the application.
EFSA subsequently informs the Commission and the other Member States and makes the summary available to the public.
Within five months upon receipt of a valid application (“stop the clock” requests for additional information excluded), EFSA shall render an opinion on the requested health claim. Basically, this comes down to evaluate whether there is a cause and effect relationship between the intake of a particular nutrient and the claimed effect. This evaluation is done by EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA Panel). Questions addressed in every evaluation of the NDA Panel are the following:
- Is the food sufficiently characterized? NB When the claim regards a food constituent, it should be measurable by established methods.
- Who is the target population (e.g. general population, infants, children from birth to the age of three years)?
- Is the claimed effect a beneficial physiological effect?
- What is the evidence relied on (e.g. interventional human study, observational human study, in vitro studies, animal studies)?
- Do the studies contain evidence on the food that is the subject of the claim?
- Can a cause and effect relationship be established between the food product under evaluation and the alleged health effect?
Recent claims evaluated
Recently, Specialised Nutrition Europe, a trade association representing the interests of the specialized nutrition industry, filed two article 14 applications for claims regarding the contribution of vitamin B5 (panthogenic acid) and vitamin B2 (riboflavin) to a normal energy yielding metabolism. Furthermore, the French company Aptonia, active in the field of body care for athletes, filed an article 13.5 application for a claim regarding the consumption of glycaemic carbohydrates and recovery of normal muscle function after strenous exercise. Another article 13.5 application was filed by Vivatech, a French consultancy company being part of the Viva Sante Group, for a claim regarding the consumption of hydroxyanthracene derivatives and an improvement of the bowel function. EFSA rendered a positive opinion regarding all these applications. The same did not apply to four article 13.5 applications made by Italsur s.r.l., an Italian company producing frozen vegetable products, for claims regarding the contribution of a combination of vegetables, such as Tuscan black cabbage and tri-coloured Swiss chard, and the protection of blood lipids from oxidative damage, as well as a normal blood cholesterol concentration.
Evidence required unclear
The Health Claim Regulation is not specific on what types of studies are required for scientific substantiation of health claims. As a result, the nature of those studies varies considerably. This is exactly the reason why EFSA organizes, on 20 November 2013, a technical meeting on the reporting of human studies submitted for the scientific substantiation of health claims. EFSA considered that consistent reporting in a harmonized and standard way would benefit both EFSA and its stakeholders.
Evaluation of evidence submitted
Anyhow, the evidence submitted by Italsur in view of the benefits of its frozen vegetable products was considered not substantial enough. Apart from a number of published human studies, who did not refer to the subject of the claim, it consisted of open label single-arm interventions regarding 38 or 49 health volunteers, who were given 300 gr. of the product at stake on a daily basis during 14 days. EFSA considered that on the basis of the data presented, a cause and effect relationship could not be established. Quite to the contrary, the evidence submitted by Specialized Nutrition Europe was evaluated to be satisfactory. This organization had first of all submitted literature studies, which showed a positive effect of vitamin B2 on the mitochondrial function. Furthermore, it relied on consensus opinions dating back to 1998, from which the well established role of riboflavin in energy yielding metabolism was deduced. As a consequence, the claim “Riboflavin contributes to a normal energy yielding metabolism” received a positive advice with respect to the target group, being infants and young children up to the age of 3. Of course it helped that a claim on pantothenic acid and normal energy yielding metabolism in the general population was already assessed with a favorable outcome.
Grant of application for health claim
Once EFSA’s opinion is available, EFSA will forward this to the Commission, the Member States and the applicant and it will also be published. The applicant and the members of public may then make comments to the Commission within 30 days from such publication. In making its decision for granting an application for a health claim, the Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health. Within two months upon receipt of the EFSA opinion, the Commission will send to the Standing Committee a draft decision of permitted health claims. After a decision on the application has been made, the Commission shall without delay inform the applicant and the details will be published in the Official Journal. Health claims authorized in accordance with this procedure may in principle be used by any food operator, unless any restrictions of use apply in view of data protection under article 21 of the Health Claim Regulation.
In order to scientifically support a health claim, substantial evidence is required. This does not necessarily require newly generated evidence. In some cases, EFSA agreed to rely on a combination of literature studies and consensus documents. However, if one initiates studies to substantiate a health claim, the scope thereof should be sufficiently broad. Guidance on what was NOT considered sufficient can be taken from the above. Also, new guidance is to be expected further to the EFSA technical meeting to be held on 20 November 2013. Stay tuned to be updated!