Health claims - The battle over wording flexibility heats up!

Gaining a health claim is one thing but gaining one that makes sense to the general public is another. As part of the general conditions of article 13 claims (Art 13(1)ii) a health claim must be ‘well understood by the average consumer’. Claims must also protect the consumer from being misled, and balancing these two issues is causing some difficulties when the Commission is to provide guidance on the flexibility of claim wording.

In a recent meeting between the Commission and Member States (MS) on the 12^th April 2010, the issue of how flexible EFSA approved claim wording could be was discussed. The discussion covered a host of ingredients with health claim approvals including; biotin, calcium and vitamin D, copper, fluoride, iron, and lactase enzyme.

Using biotin as the poster child from this discussion it was clear there are going to be some significant amendments to how claims are interpreted and finally adopted in a consumer friendly manner. One of the approved claims for biotin by EFSA is:

‘Biotin contributes to normal energy-yielding metabolism’

The group discussed whether consumers would understand ‘energy-yielding metabolism and discussed ways of tackling this. One approach would be for MS to amend the wording to make it more consumer-friendly, However, any approved wording will not just stop at the feet of the commission once it provides its final opinion on wording. Any health claim might also be subject to additional changes as a result of translation into other linguistic versions of the Regulation and food business operators (FBOs) making use of the flexibility likely to be permitted to them, despite difficulties this may cause for enforcement. Based on these issues it was agreed that it was best to keep the authorised wording in the Regulation as close as possible to EFSA’s approved wording.

Further discussion about what wording is appropriate for the consumer included EFSA often used ‘normal’ [in EFSA-approved wording of claims] and MS considering if it should be replaced by the word ‘healthy’. Opinions varied and it seemed to depend upon the particular claim in question; therefore it was agreed that ‘normal’ should remain in most cases and that this point could be addressed in guidance. However, it does show that already there are significant issues in relation to MS accepting the clinical nature of EFSA wording.

MS will need to consider how to handle these claims if the consumer is to benefit from the process and also if enforcement will be simplified across the EU or potentially made more difficult. One suggestion was that MS would look at the EFSA opinions and try to suggest more meaningful claims based on the scientific evidence; EFSA would then be asked to verify the new wording.

It was agreed that flexibility of wording would be addressed in future Commission guidance. Whatever the guidance one major concern is that every change in EFSA’s approved claim has the potential to take wording further away from the substantiated meaning of the claim. The fallout could make the process of enforcement and harmonisation of any claims throughout the EU more difficult and complex.