Making claims for Europe -the health claims directive

The UK's Joint Health Claims Initiative has been making news with a new health claim for soya protein in foods. This week Novis's Lindsey Partos takes a closer look at health claims and discuss the EU's draft proposal to regulate health claims with Jean Feord, nutrition regulatory affairs manager of Netherlands-based research organisation TNO Nutrition and Food Research.

The UK's Joint Health Claims Initiative recently passed a new health claim for soya protein in foods. While this will no doubt have a significant impact for soyfoods producers in the UK, it is restricted to this country alone, preventing manufacturers from seeing the same success for their products once exported elsewhere.

And perhaps more significantly, it is a voluntary system, backed by the industry rather than national law.

However the work of the JHCI cannot be ignored and some might argue that it played a role, alongside other European nations' health claims standards, in bringing this year's Draft Proposal for regulation of the European Parliament and of the Council on nutrition, functional and health claims made on food (SANCO/1832/2002) into fruition.

The proposal, which is still open for comment, is "a huge step for the industry", according to Jean Feord, nutrition regulatory affairs manager of Dutch organisation TNO Nutrition and Food Research, in a recent interview.

"Health claims are undoubtedly linked to the success of a product. The world of ingredients is quite small and everyone is coming up with the same ideas so a health claim gives a real competitive edge."

The European proposal provides a distinction between 'disease prevention' and 'significant reduction of a major disease risk factor' and permits both 'enhanced function claims' and 'reduction of disease risk factor claims'.

Feord confirmed that individual health claims bodies, set up on a national basis, have acted as a precursor to the draft proposal. "The countries that have claims definitely initiated it. A year ago the EU published a paper on 'Nutrients and Functional claims' which covered nutrients, and terms such as 'light' etc and functional claims. But it stayed away from the health arena. So the industry reacted - they said it didn't go far enough, suggesting that if we couldn't define the bottom line things would get worse."

"Now, a year later, we actually have a draft proposal which will go through. This is a huge step for the industry. After all, Europe was splitting up over this issue."Sweden was the first to initiate standards for health claims and launched its Swedish Food Industry Code of Practice in 1996, soon followed by Britain's Joint Health Claims Initiative (JHCI) in 1997. Finland and the Netherlands also developed guidelines for making health claims, in 1998, and Belgium followed in 1999. They all vary considerably in their definitions of claims, and where they can be used. Meanwhile other EU Member States are "very restrictive".

"In the EU, Sweden was the first country to introduce health claims and it has always been a big advocate of natural and health products. However it became increasingly obvious that there was a need for a body in each country," explained Feord.

"The function was to examine substantial data connected with health claims. Companies placing products on the market all too often were pulled up by the medicine controls agency for being borderline," she said.

The claims did however fill a vital role. "In general they give the industry a structure in which to work. It gives validation of what you are doing, that the claims you are making are valid," commented Feord. "In food legislation they legislate for everything apart from health claims. To have an expert group review them is a support to companies."

She does not, on the other hand, deny the limitations of the current version of health claims. "These health claims schemes don't offer any legal protection. The primary idea is to support data given by the companies and to stay out of the medical claims arena.

"And don't forget that the claims are restrictive. The disadvantage is that in some countries health claims work but in others they are different so you have to change the packaging across the markets - it is a real inhibition to a free market."

To measure the impact the claims directive will have, we have only to look at those countries who have, until now, been without health claims of any sort. "These countries are excluded from many of the health products that have appeared on the market. And they are also faced with the issue of how to market a product without a claim."

There is also of course a need on another level - to protect consumers. "It is all very well telling consumers they can lower their cholesterol but they need extra information on why this is good ie linking the benefit to their heart health. And this is why the protection is there. We need a balance between informing the consumers and misleading them. For many countries it is difficult to strike the balance."

"It is essential that claims are carefully controlled. As seen by much consumer research, many consumers don't have good understanding of nutrition," added Feord.

However implementing the directive across the European community will be far from straightforward, especially for those countries with no previous standards in place. Yet Feord takes a positive approach.

"It's possible that these countries may have a bigger problem with the directive but then the Danes are currently the head of the EU and they are going to push it through quickly - despite having very restrictive laws themselves. At the end of the day, this is the only way to make it a binding legislation."

Feord does have some additional reservations. "They will need a great deal of manpower to enforce the legislation and do the policing work, but then this is the same with all legislation," she argued, noting that the nutrient side of the legislation will cover those often controversial terms such as 'low salt' and other misleading terms.

She continued that the health claims are not a foolproof measure. "In the US there are still a huge number of rogue claims, for example from companies making marketing claims on the Internet. These probably come from companies who are unaware of the legislation, not the kind we see at HiE for example, but nevertheless the industry has to commit to complying with it."

Then there is the 'all-encompassing' medicines directive, unchanged since 1965. Some countries have stayed very close to the original directive within their national legislation. "The terminology must be reviewed," stressed Feord, as even with European-wide health claims, products will not benefit if a nation's medicines legislation does not permit them to be classed as a food.

Future challenges for the Directive will also include the development of standard tools and biomarkers for disease risk reduction. Feord pointed out that PASSCLAIM, or Process for the Assessment of Scientific Support for Claims on Foods, carried out by an EC Concerted Action Programme on Health, Food and Nutrition, has gone some way to prepare for this.

"This is the scientific side of the legislation which will soon be published in a report. It has developed tools, or standard methods, to identify disease risk reduction claims."

She added that the committee, organised by ILSI (International Life Sciences Institute) focused on main areas such as bone health, but as more ingredients develop, the research methods will have to evolve too.

"I trust them to do a good job - the knowledge in food and health there is enormous. And it is not a static process, but rather a moving target."

Whatever her reservations, it is hard to dampen enthusiasm for a directive which will change so much, and in EU terms, has evolved into a draft proposal relatively quickly. As Feord puts it: "It is an enormous piece of legislation."

Dominique Patton