Health Claims
Communication on the health effects and benefits of botanical food supplements is essential for the consumer to understand the product's purpose in relation to a particular aspect of health maintenance, health optimisation or disease risk and how to use it. Under the new EU Nutrition and Health Claims Regulation (Regulation EC No, 1924/2006) which is applicable to all foodstuffs, such communication, whether on pack or in brochures or websites, is considered to be “health claims” and therefore must be in conformity with the new rules. This comprehensive regulatory framework for foods and botanical food supplements aims to ensure a high level of protection for consumers and prohibit the use of information that would mislead the purchaser.
The regulatory structure for the use of health claims
The Nutrition and Health Claims Regulation made on foods has tightened food legislation by introducing a process for the pre-approval of health claims made on European food products. It recognises several different categories of health claims, including:
- nutrition claims
- 'generic' or well-established health claims (maintenance/health optimisation claims)
- reduction of disease risk claims
- based on and substantiated by generally accepted scientific data
- well understood by the average consumer.
Approved ‘generic’ health claims will be included in a Community list of permitted health claims bsed on the decision of the European Commission following the opinion of the European Food Safety Authority (EFSA) on the health claims collected bt the 27 Member States. This
is foreseen by January 2010.
new health claims, reduction of disease risk claims and
claims referring to children’s development and health are subject to apriory authorisation procedures. Applications
for such health claims must be evaluated by the European Food Safety
Authority (EFSA) and approved by the European Commission before they
can be used on a food product. This means that for each claim a
full dossier of data with the name of the food or food component and, for
botanicals, the plant part used, the relationship between the botanical
and its contribution to health (the 'health relationship), the
conditions of use, the nature of the substantiating evidence, the
relevant references, and an example of the desired claim wording, must
be submitted to EFSA. If EFSA's opinion is positive - that the evidence
submitted substantiates the claim – the European Commission will give
the final approval for the claim to be used.Such claims will then be included in the Community list of permitted claims, together with all the necessary conditions for the use of these claims.
In addition, for reduction of disease risk claims the labelling or, if no such labelling exists, the presentation or advertising shall also bear a statement indicating that the disease to which the claim is referring has multiple risk factors and that altering one of these risk factors may or may not have a beneficial effect.