The new „General Scientific Guidance on Health Claim Application“, for the first time, summarizes various guidance documents and Opinions on a number of common issues encountered by health claim applicants. It helps improve the transparency of necessary product characterization, characterization of the claimed physiological effect, and the evidence required to substantiate health claims.

The new guidance provides especially:

  • A comprehensive summary of the legal framework for the authorization of health claims in the EU (including who does what when), including administrative and procedural aspects governing the life cycle of a claim application
  • Guidance on the main application steps, the scientific requirements for applicants and the workflow during the evaluation, which is graphically supported by flow schemes
  • An explicit differentiation between the principles applied to the evaluation of health claims based on the essentiality of nutrients (article 13.1) and those applied to other claims (articles 13.5 and 14)
  • A compendium of molecular methods and technologies validated and suitable for the characterization of microorganisms (bacteria, yeast) that shall be the object of a health claim
  • Considerations and suggestions concerning the validation (validity and reliability, ability to obtain consistent results) of questionnaires (which are generally considered to be rather subjective and thus generally not preferred over the use of objective measures) and their use as outcome parameters for claim substantiation

From a&r’s perspective, the most important information for applicants concerns the guidance on using questionnaires, which emphasizes that they are only appropriate if the population in which the questionnaire has been validated is representative of the study population, and if the setting in which the questionnaire has been validated is representative of the setting of the study in which it is to be used.

Most notably, validation of the questionnaires cannot be performed in the same trial in which the questionnaire is being used to show a cause effect relationship between a food constituent and a health benefit. Thus, only pre-validated questionnaires can be used. Also, any modification of an existing validated questionnaire, such as translation into another language, modification, or leaving out any items requires re-validation.

This updated guidance is very welcome, as it helps clarify a substantial amount of uncertainty surrounding the health claim application process.