authorised health claims
Five years after the EU health and nutrition claims legislation
was enacted, a draft regulation containing the final list of
permitted ‘general function’ health claims has been approved by the
European Commission and Member States.
The list contains 222 authorised general function health claims.
These are health claims, other than those referring to the
reduction of disease risk or to children’s development and health,
which are based on generally accepted scientific evidence and are
well understood by the average consumer.
Member States had to submit national lists of health claims made
on foods by 31 January 2008. More than 44,000 claims were received.
Taking account of duplications, these were compiled into a
consolidated list of 4,600 claims which then had to undergo a
scientific assessment by the European Food Safety Authority (EFSA).
For approximately 8% of the claims, EFSA concluded that on the
basis of the data submitted a cause and effect relationship had
been established between a food category, a food or one its
constituents and the claimed effect and issued a positive
opinion.
Most of those claims receiving a positive assessment were
included on the final list of authorised claims. However, two such
claims were considered not to comply with other requirements of the
health claims regulation. While a cause and effect relationship was
established for a claim relating to the effect of fats on the
normal absorption of fat soluble vitamins and a claim on the effect
of sodium on the maintenance of normal muscle function, these
claims were not authorised. It was considered that such health
claims would convey a conflicting and confusing message when at the
same time consumers were being advised to reduce their intake of
such nutrients. This would be contrary to one of the general
requirements of the health claims regulation which provides that
nutrition and health claims must not be ambiguous or
misleading.
The draft regulation originally proposed 224 positively assessed
health claims. However, following discussions in early December two
claims – one on fructose and one on glycaemic carbohydrates - were
removed from the list for further consideration.
Those claims that did not receive a favourable scientific
assessment from EFSA will not be included in the list of authorised
claims and thus will no longer be permitted to be used. These
non-authorised claims will, however, be entered in the Union
Register with reasons why they have not been authorised. The
regulation will not apply until six months after it comes into
force in order to give the food industry time to adapt to the fact
that these claims will no longer be permitted.
A number of claims have not yet been finalised either because
additional information or further evaluation is required. In
addition, those substances which are classed as ‘botanicals’, ie
plant or herbal substances, have not yet been scientifically
evaluated by EFSA. All such claims will be listed on the Commission
website and transitional measures will continue to apply for those
claims for which a decision has not yet been taken.
In order to allay concerns that the publication of a list of
authorised health claims may restrict national authorities in their
decisions as to the classification of a substance as a food or a
medicine, an additional recital was added to the draft regulation
to clarify this point. This states that the adoption of a health
claim for a substance does not constitute a marketing authorisation
or classify a substance as a food or for use in food.
The Union Register will contain all the authorised health claims
together with their conditions of use as well as all the rejected
claims ant the reasons for their rejection.
The European Parliament will now have 90 days to scrutinise the
proposal before making its decision.
