Food Safety Focus ( 103rd Issue, February 2015 ) – Food Safety Platform

Evaluation of Health Claims on Formula Products and Foods for Infants and Young Children

Reported by Ms. Melissa LIU, Scientific Officer,
Risk Assessment Section,
Centre for Food Safety

Apart from nutrition claims introduced in the last issue, health claims are also commonly found on formulae and foods for infants and young children.

Health Claim

"Health claim" is any representation which states, suggests or implies that a relationship exists between a food or a constituent of that food and health. The Codex Alimentarius Commission (Codex) opines that health claims shall not be permitted for formulae and foods for infants and young children except where specifically provided for in relevant Codex standards or national legislation. Health claims on these products are allowed in some countries. For example, "DHA (docosahexaenoic acid) intake contributes to the normal visual development of infants up to 12 months of age" can appear on follow-up formulae for infants below 12 months in the European Union (EU) when the product contains at least 0.3% of the total fatty acids as DHA. Nevertheless, the presence of health claims may not necessarily indicate the superiority of the concerned products over their counterparts. Breastmilk also contains DHA and is always the best choice for infants and young children.

Evaluation of Health Claims

False, misleading and inappropriate use of health claims can cause harm to health. As such, it is important to ensure health claims are scientifically substantiated before they are allowed on formulae and foods for infants and young children. The evaluation is often based on reports of scientific studies and other relevant information collected by the industry.

1. Basic Criteria

   Codex has developed recommendations on scientific substantiation of health claims to assist competent national authorities in their evaluation of health claims to determine their acceptability for use by the industry.

   Some health claims are based on research findings from animal studies or in the laboratory environment. There is no guarantee that similar health effect will appear on human. In addition, poorly-designed studies may lead to false positive result, i.e. a result that indicates an effect is present when it is in fact not. As such, Codex recommends that health claims should primarily be based on evidence provided by well-designed human intervention studies.

   Moreover, different studies regarding the same substance and same health effect may result in different conclusions. To ensure the veracity and consistency of the claimed health effect, Codex considers it necessary to identify and review the totality of evidence, including evidence that contradicts or supports the claimed effect, and evidence that is unclear or ambiguous. Also, to substantiate a claim, the evidence based on human studies should demonstrate a consistent association between the concerned substance and the claimed health effect, with little or no evidence to the contrary.

2. Considerations

   In considering whether a claimed relationship is substantiated, Codex recommends to look into a number of factors. For example, the scientific studies in concern should be addressing the relationship between the food or food constituent and the health effect. The study design and the statistical analysis conducted should be appropriate. Besides, taking into account the totality of the available scientific data and by weighting of evidence, the systematic review should demonstrate the extent to which (i) the claimed effect of the substance involved is beneficial for human health, (ii) a cause and effect relationship is established between consumption of the substance involved and the claimed effect in humans, (iii) the quantity of the substance and pattern of consumption required to obtain the claimed effect could reasonably be achieved as part of a balanced diet, and (iv) the study group is representative of the target population for which the claim is intended.

3. Professional Support

   Evaluation of health claim is a complicated task requiring expertise on various scientific aspects. As such, in overseas jurisdictions, the exercise is often performed by a group of highly qualified scientific experts with relevant professional training and experience in different fields such as human medicine, human nutrition, epidemiology and toxicology.

   To further explain the health claim evaluation mechanism, the approach adopted in the EU will be discussed.