Five years after it was first brought forward (July 2003) the Nutrition and Health Claims Regulation is finally being implemented.What started out as a wheeze to enable a few major manufacturers under pretext of consumer protection to overcome local advertising rules and make strong claims to help market their wares has led to an avalanche of claims being submitted for authorisation: a staggering 43,000. Not quite what regulators had in mind.
The principle behind the regulation seems sound, but the process of authorisation is magnificently bureaucratic. Manufacturers must obtain advance authorisation for proposed health claims, compiling detailed dossiers citing scientific evidence. The Commission then passes dossiers to the European Food Safety Authority (EFSA) for assessment.
When a sound principle collides with 27 different cultural approaches to regulation, is over-complicated by a Commission which cannot resist meddling in detail, and a European Food Safety Authority ambitious to grow its budget, the outcome is rather different. 43,000 proposed claims have been submitted, distilled to 1,500 "relationships", and a whole industry is involved in compiling extensive dossiers to support claims which are often the stuff of basic nutritional text books and common sense.
For many Member States the Regulation was not really necessary, as they had tight advertising rules, food safety and consumer protection rules, backed up by strict prohibitions on medicinal claims.
In those countries it may prove a Trojan Horse to permit more claims than anticipated by hoodwinked officials. In others, the volume of claims submitted swamped regulators now lost in the deluge of paperwork associated with draft lists and demands for supporting evidence.
EFSA is also now rumoured to be asking manufacturers to submit copies of all the reference papers they cite in their dossiers, leading either to massive copyright fees, or widespread intellectual property infringement - and all for claims which are essentially generic rather than product specific.
Once EFSA has accepted the final list of proposed claims, its team of tax-payer-funded scientists will begin to assess them. The Commission should adopt the list of permitted claims by January 2010 at the latest.
But the Regulation also provides for the introduction of "nutrient profiles" by January 2009. Their purpose is to avoid nutrition or health claims which could mislead consumers as to the overall quality of a food product when trying to make healthy choices in the context of a balanced diet - defining acceptable limits on salt, fat and calorie content.
Yet this regulation being a "horizontal" measure, applies across all specialist food categories as well as normal foods.
So, unless specifically exempt, such products as PARNUTS foods (foods for particular nutritional purposes) are also covered.
PARNUTS foods are defined legislatively as not resembling normal foodstuffs, and being specially formulated for a defined group with particular nutritional needs (foods for infants, diabetics, slimmers, seriously incapacitated patients, sportsmen) which may actually require them to be high in sugar, or fat, or salt.
For example, salt is crucial to the effectiveness of post-exercise rehydration products, energy bars might reasonably be expected to be high in calories, and cod-liver-oil supplements might contain a high proportion of fat (though an insignificant amount in terms of the overall diet).
The law of unintended consequences (or muddled Commission thinking) means that a legally compliant product, formulated to meet a demonstrable need, and conferring a real benefit, could be prohibited from making the very claim for which a manufacturer had spent thousands of Euros compiling a dossier under the Claims Regulation.
Cost, chaos, mountainous bureaucracy, and endless frustration for all manufacturers involved. Kafka would have loved it!
FIHN Chris Whitehouse is md of The Whitehouse Consultancy, which advises clients how best to identify, approach and influence key decision-makers in Brussels and the UK government.
Contact him at: firstname.lastname@example.org