Nutrition and health claims regulation: will Article 13.5 help food businesses?


14 February 2013

Today EFSA has given unfavorable opinions on a new batch of applications for approval of health claims under the Nutrition and Health Claims Regulation.  These applications were made under Article 13. 5, which is the route for claims based on new science.  A number of industry players thought that Article 13.5 might provide salvation for those stymied by the widespread rejection of claims submitted for the “generic list” under Article 13.1.

It was hoped that Article 13.5 would give food businesses “another go” at winning approval – by submitting a more persuasive case which “characterised” the ingredient precisely enough to satisfy EFSA and which contained additional scientific evidence for the health effect.

The overall trend of this latest batch of  EFSA opinions shows that the first lesson has been learnt: the substances submitted for approval have been sufficiently “characterised”, that is to say precisely identified.  However the scientific studies presented have still been found to be wanting – typically EFSA has reported that the scientific evidence presented was not sufficient to conclude that the claimed effect was true.  EFSA opinions are criticised on the basis that the Authority is applying scientific standards more appropriate to the approval of new medicines.  If so, the situation comes down to this: does one accept the proposition that because this is only about food, it does not matter if the consumer is persuaded to spend money on something to achieve a health benefit that has not yet been proved to be true, but might be true?

The NHCR was plainly intended to give the answer to this question, “Yes, it does matter – such claims should not be permitted.” Recital 14 to the Regulation gives as one of the purposes of the law the following:

(14) There is a wide variety of claims currently used in the labelling and advertising of foods in some Member States relating to substances that have not been shown to be beneficial or for which at present there is not sufficient scientific agreement. It is necessary to ensure that the substances for which a claim is made have been shown to have a beneficial nutritional or physiological effect.

Perhaps food businesses should now consider taking the approach that was adopted in the USA – of challenging the law as an unnecessary restriction on freedom of speech, because it does not permit claims to be made on the lines that “There is some evidence, but it is not yet fully proved, to suggest that this ingredient helps with the following aspect of health……”

For further information, please contact:

Owen Warnock
Partner
Tel: +44 1223 224282
OwenWarnock@eversheds.com
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Owen Warnock
Owen Warnock, Partner
e: OwenWarnock@eversheds.com
t: +44 1223 22 4282
m: +44 785 089 4177