As one veteran European food lawyer puts it, the 2006 European nutrition and health claims regulation is a “long story”.
While the present regulation first hit the tables of European Commissioners and member states in the early part of this decade, the ideas of improved consumer information about the potential health benefits of foods and food supplements and trade liberalisation that informed it, go back about 20 years before that.
It was 1979 that a labelling directive first proposed the idea of a negative list of prohibited disease reduction claims, a proposal that never made it into the legislature, but which influenced a lot of thinking in the area.
A sound idea
There were further attempts to introduce a negative list system, but nothing eventuated until 1989 when the idea for a positive list was first tabled. European Union scientists would assess health claims submitted by companies or groups, some about specific products, some about generic foods like fruits and vegetables or nutrients like calcium, vitamin D or particular herbs.
A centralised list would be compiled of claims that could prove their veracity. Those claims could be employed across the Union’s 27-member states (although in 1989 there was only 15). Consumers benefit because they know if a claim is being made it has been proven in a scientific manner.
Industry benefits because of the certainty of the list and the fact the same claims are available for use throughout the Union.
At the time of its adoption just before Christmas in 2006, Markos Kyprianou, the European Commissioner for Health and Consumer Protection, said: "The health and nutrition claims regulation will allow EU consumers to be fully aware of what they are eating. They can no longer be duped by false or confusing assertions on food labels. Under the new rules, if a food claims to offer some added benefit, then it will have to be true."
An apparent win-win situation. The fact that idea took near-on 20 years to pass into the rulebook, with more than 600 amendments to the draft that became the current law, points to a far more complicated situation.
Those complications are playing out in the present as the European Food Safety Authority (EFSA) gets down to the business of passing opinion on about 4000 nutrition and health claims, turning in mostly negative opinions to about 60 claims so far.
The fact aspects of the regulation such as nutrient profiling, the source of many of the amendments, remains unresolved highlights further difficulties.
Nigel Baldwin, the senior scientific and regulatory consultant and EU manager at Cantox Health Sciences International, says the regulation is too open to interpretation, with too many parties involved, leading to a rule that was hard to understand and inordinately long in implementation.
“There needs to be a streamlining but it doesn’t look like that is likely to happen,” he said. ‘The fact it is more than a year since the first positive opinion on plant sterols was given by EFSA and it still hasn’t made it into the rule book is testament to that.”
The likes of the European Federation of Associations of Health Product Manufacturers (EHPM) and the European Responsible Nutrition Alliance (ERNA), have voiced similar concerns about the manner of the regulation’s implementation.
EHPM regulatory affairs director, Lorène Courrège, told NutraIngredients.com this morning. “We feel the approach being taken by EFSA is too demanding and it was warping the good intentions of the legislation.”
The veteran lawyer referenced above, whose work in the area means he prefers to remain unnamed, calls the regulation “total chaos”.
The main gripe from industry is this openness to interpretation which has led to food companies struggling to get their scientific house in order because it has not been clear just what the order is. How much evidence is enough? Should the same standards apply for all claims?
These questions continue to vex industry and there are some that are airing the possibility of challenging the legality of the rule in a court of law. This call is likely to grow in strength if a good proportion of a batch of about 1000 generic health claim opinions due for publication by the end of this month are negative.
At that point, the regulation’s true impact, some 30 years after it was first mooted, is likely to come into clear focus.