By the ANH-Intl Team

KEY POINTS

1. The amending Regulation that will mandate a list 222 authorised, ‘general function’ health claims into European law, implicit in the Nutrition and Health Claims Regulation (No 1924/2006), will likely be passed to the European Parliament for its consideration on 5th December
2. The European Parliament will then commence a three-month period of scrutiny after which it would have to veto the proposed Regulation if the list is not to become law in 2012
3. If passed into law, this Community list of authorised general function claims will represent the only allowed ‘general function’ health claims to be issued in writing, or even verbally, on any commercial food or natural health product (other than those that have not yet completed evaluation)
4. The list is astonishingly short, being comprised of just 222 claims based on only 70 foods or food ingredients. These were derived from a long list of some 44,000 claims, that was later culled to 2,758. This means that around 92% of claims evaluated have been rejected
5. ANH-Intl asserts that to make the list law would be disproportionate and would cause the Regulation to fail in its original key objective to avoid misleading the consumer
6. ANH-Intl has long argued that the reason for such a high rejection rate is linked to the application of inappropriate scientific methodologies used in the evaluation process
7. ANH-Intl calls on European citizens to encourage their MEP to block the Regulation that would otherwise make the list of claims the only allowed general function health claims for commercial products, other than those for which evaluation has yet to be completed
8. References to official information about the Nutrition and Health Claims Regulation, including European Commission and UK Department of Health guidance, are given at the end of this feature

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On 5th December, a European Commission committee will likely put forward to the European Parliament a proposal for an EU-wide Regulation that will establish a list of authorised ‘general function’ health claims, under Article 13.1 of the EU’s Nutrition and Health Claims Regulation. If green-lighted by the Parliament, six months after its passage into law, all general function health claims for commercial food and food supplement products that are not authorised will be banned across all 27 EU Member States. We say that this will amount to an infringement of freedom of commercial speech, given the fact that the 222 health claims on the list are limited to just 70 foods or food ingredients. The only exceptions to the ban will be those claims that have not yet completed evaluation by the Parma-based European Food Safety Authority (EFSA) and the European Commission, such as those for botanical substances and probiotics.

The 222 proposed, authorised health claims originate from a list of 44,000 health claims that were submitted by the various EU Member States back in 2008. These were consolidated by the European Commission into a single list of some 4,637 claims, the biggest drop in number arising because all claims not supported by human evidence were discounted. Guidance to stakeholders indicating that claims without human evidence would be rejected was not given and this represented a clear movement of the ‘goal posts’ after the 44,000 claims had been received. After around 1500 claims for botanicals and probiotics were largely rejected, pressure from industry forced the European Food Safety Authority (EFSA) to re-evaluate these claims, a process which is still ongoing. This left a shortlist of some 2,758 claims, of which only 222, around 8%, made it through to the draft list.

Referring to the draft list of claims, Robert Verkerk PhD, ANH-Intl’s executive director, said; “Rejected claims will be banned if the Regulation mandating the Community list goes through in its present form. It would be madness to turn something as half-baked as this into law, and all eyes will be on the European Parliament during its 3-month scrutiny period that’ll likely run from December through to March 2012.”

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What’s on the list

As indicated above, the majority of plant-based ingredients have yet to complete evaluation given the industry forced re-evaluation by EFSA. With this in mind, it is odd to find a smattering of botanicals on the draft list. These include the ‘natural statin’, red yeast rice, with a claim for maintenance of normal blood cholesterol, beta glucans from oats and barley, polyphenols in olive oil for protection of blood lipids from oxidative stress, and walnuts for improvement of elasticity of blood vessels.

Claims that are likely to assist the large food corporations are also represented, including, for example, claims for synthetic and natural sugar replacers, sugar-free chewing gum with and without carbamide, guar gum, glucomannan and a variety of forms of fibre.

Surprise turnouts in the final draft list are melatonin — with claims for relief of jet leg and helping sleep, and fluoride — for maintenance of tooth mineralisation. Melatonin’s inclusion is a surprise because the pineal gland-originating hormone is considered a medicine in many EU Member States or can only be sold by pharmacies or provided by prescription. Fluoride’s inclusion is less of surprise considering EFSA’s previous manipulation of the science on the toothpaste ingredient, sodium monofluorophosphate. The benefits of fluoride in tooth mineralisation are debatable scientifically and related to very specific exposures in young children. Too much fluoride, and the reverse occurs, with dental fluorosis, the mottling of teeth, being the result. Such a condition, the result of excess fluoride intake, afflicts a third of children in fluoridated areas of Ireland (where 75% of the population reside).

Walnuts have made it on to the draft list with an allowed health claim for improvement of elasticity of blood vessels

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What’s not on the list

ANH-Intl asserts that it is the absence, rather than the presence, of claims on the draft list that is the greatest concern. This is because claims not authorised will not be able to be made in any commercial communications once the list is mandated, except while ‘transitional measures’ continue to apply during the time the claim is under review.

Aside from a massive range of plant-based foods and plant-derived ingredients that await re-evaluation by the EU authorities, omissions from the draft list will likely be of great concern to consumers and natural product manufacturers and suppliers alike. While vitamins and minerals are generally well represented, the absence of any claims for either boron or silicon, both minerals being permitted by the Food Supplements Directive (2002/46/EC), is astonishing. As is the omission of sulphur, either from the claims list or the list of permitted minerals in food supplements.

Even more astonishing, however, is the absence of any of the nine essential amino acids. These are regarded as ‘essential’ because they must be ingested and cannot be made by the body. They include lysine, methionine, tryptophan and tyrosine. Omitted as well are a further 13 semi-essential or non-essential amino acids for which additional intakes yield numerous demonstrated benefits, these including arginine, cysteine, glycine, lysine and proline. These amino acids are all allowed in foods within the EU, being present on a positive list for a framework directive for specialised and dietetic food products (PARNUTS).

There are numerous other natural ingredients that are devoid of authorised claims, these being widely used, on account of their benefits, by millions of EU consumers who choose to self-care. They include:

• Alpha lipoic acid, as a multi-functional antioxidant that is invaluable for pre-diabetics and diabetics or those with neuropathy (including nerve pain)
• Various forms of carnitine, widely used for cardiovascular support, especially among very active people
• Co-enzyme Q10, one of the most important supplements used in supporting cardiovascular health, and one that is depleted, and therefore particularly beneficial when taken supplementally, in those taking statin drugs
• Glucosamine and chondroitin, the two most commonly used ingredients for those looking for joint support
• Glutamine, used particularly by sportspeople for helping to increase muscle mass
• Ribonucleotides, added to infant formulae and taken by immune compromised adults to help support the immune system and support healthy gut function

Carnitine offers cardiovascular support, especially among very active people, but is not on the draft list

Apart from missing ingredients, there are also key functions omitted in their entirety on the draft claims list. This includes any claim to aid detoxification in the body. Detoxification support is one of the most important elements in maintaining good health, and one that is the starting point for many naturopathic regimes. The scientific evidence in the peer review literature for natural ingredients supporting detoxification pathways, particularly in the liver, is abundant. Given this wealth of supporting data, there appears to be no good, scientific reason why any reference to this key process has been omitted from the claims list.

All of these ingredients and applications are supported by strong scientific evidence, given, for example, high ratings for the strength of scientific evidence in the independent Natural Standard database.

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Why have so many health claims been rejected by EFSA?

There are many reasons why EFSA’s the rejection rate for general function health claims has been so high, but the single most important one relates to the specific form of scientific substantiation employed by EFSA in its evaluation of claims. The Nutrition and Health Claims Regulation itself defines a health claim as “any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health”, requiring that the relationship is supported by “generally accepted scientific data”. However, in its interpretation of this, EFSA requires that an unequivocal causal relationship between consumption and the claimed effect has been demonstrated beyond reasonable doubt. This level of scientific certainty is simply not possible in the greater part of the field of nutritional science. The sheer complexity of human physiological and metabolic interactions with our food, genetic variations between individuals, variability in the chemical composition of foods, along with the relatively low investment in research, mean nutritional science is far from being black and white.

Making matters worse, since the Nutrition and Health Claims Regulation exists within the realm of food law and not medicines law, EFSA has seen fit to require only human studies on healthy populations to substantiate beneficial relationships. Of this, only clinical (intervention) studies are accepted in their own right, with observational and epidemiological studies only being allowed as supporting data. Animal studies or biochemical evidence are also of little value in the EFSA evaluation process.

This system of evaluation, based largely on a pharmaceutical model for proof of efficacy, is the very system that was used in EFSA’s initial evaluation of some 1500 health claims concerning botanicals. The result was a staggering 97% rejection rate. This for foods from plants that are the primary foods of human beings! It beggars belief that the ‘experts’ employed by EFSA seem to continue on the same track, seemingly in ignorance of the fact that nutritional science is a rapidly growing and dynamic discipline that doesn’t fare well in the black and white space of European regulation. To have an extremely high threshold for scientific substantiation, whereby a health relationship has to have been proven in healthy people via clinical trials, is a very tall order. Even the relationships between table salt intake and hypertension risk, or the lowering of cancer and heart disease risk through the consumption of more fruit and vegetables, aren’t proven in this way. These relationships are demonstrated through epidemiological and observational studies, not clinical ones. An enormous number of studies have also been undertaken on unhealthy populations because those who have had an interest in funding the studies have often been moved to demonstrate the importance of particular foods or nutrients in correcting pre-existing health conditions. All of these studies are, however, out of bounds from the EFSA evaluation process.

The relationship between table salt intake and hypertension risk wasn't proven in healthy people via clinical trials

There are other reasons for EFSA’s stunning rejection rate as well, such as the fact that some studies do not sufficiently characterise the food or nutrient, in the eyes of EFSA. The bottom line is that there is something seriously amiss with the process being followed. One obvious indication of the faultiness of EFSA’s process comes from the ample evidence of clinical efficacy from case reports and clinical experience among nutritionists and related practitioners. But again, such clinical experience is off limits to EFSA.

At the ANH, we firmly believe that the only system for authorising health claims that could adequately take into account the broad range of evidence for the beneficial effects of foods and food ingredients on health, would be a graded one. This would be able to account for the different types of evidence. Such a graded system would, we believe, be greatly preferable and more reflective of the state of nutritional science than the existing binary system being used by the European Commission which either allows or disallows claims. We prefer a simple categorisation system for positive claims, involving just three grades, based largely on clinical studies (Grade A), epidemiological and observational studies (Grade B) and biochemical or molecular evidence (Grade C). This is not about allowing inclusion of weak science, but rather science that is of varying direct relevance to the target population. But more on this another time….

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Where to from here?

The Nutrition and Health Claims Regulation (No 1924/2006) came into force in 2007 primarily as a means of ensuring consumers were not subjected to false or misleading claims by the food and natural products industry. Firstly, to allow some claims, such as those relating to vitamins and minerals, while not yet deciding the fate of thousands of other claims relating particularly to botanicals and probiotics, is grossly disproportionate. If the approach were to be changed for botanicals, would this be fair on those claims that are among the 92% that have been rejected thus far?

The Regulation never envisaged issuing Community lists for general function claims in this kind of step-wise fashion, and few Members of the European Parliament who voted in support of the Regulation in 2006 felt that the claim attrition rate would be so high.

Irish MEP, Marian Harkin, stated: “We all have a problem with cowboys in the food industry who make outlandish claims that are not supported by science – and this is why I, and the majority of other MEPs, supported the Regulation when we voted for it in 2006. But I’m now very concerned about just how few claims have gone through."

"For many consumers trying to ensure their families eat as healthily as possible, it would be very confusing if these were the only ones allowed", continued Ms Harkin. "They’ll see the same few claims repeated over and over again on some foods, but so many others will be claim free. It’s difficult to accept that among the thousands of known beneficial food ingredients, nutritional science supports the use of only 70! The Parliament will have to think very carefully about how it acts when it comes to voting on this general function health claims list because the implications are so far-reaching.”

Dr Verkerk added: “There are other problems to consider with mandating such a small list into law, that could have wide-ranging effects on public health. Major commercial food manufacturers and suppliers will inevitably be encouraged to focus on foods and ingredients that are subject to authorised claims. This will further reduce the diversity of the food supply. Dietary simplification, caused by the industrialisation and globalisation of the food supply, is already recognised as a major contributing factor to the epidemic of chronic diseases like heart disease, cancer, diabetes, obesity and osteoporosis, that now present the major burden on healthcare systems around the world. This European law will make it even worse.”

Next month, ANH-Intl will be providing a detailed review of the draft claims list, along with an analysis of the implications and possible solutions, to MEPs in Brussels. ANH-Intl considers that a decision to veto the Regulation accompanying the health claims list will be in the public interest and wants to encourage European citizens to write to their MEP if they feel strongly about the issue. Intervention by the European Parliament is the only remaining action that will stop the list becoming law. The Parliament’s power of veto was only granted in 2006, and since that time there have only been two occasions when MEPs have successfully blocked the passage of a legislative proposal from the European Commission and Council. The most recent related to the Parliament’s blocking of a proposal to legitimise the inclusion of meat glue (thrombin) in meat products. The veto in May 2010 was carried by just a single vote.

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Call to action – for the attention of all adults resident in the European Union

When it comes to legislation the affects the food we eat, there has rarely been a more important time to use what’s left of the democratic process. In this situation, it’s too late to do anything at the national parliament level. The only people who can change this is a majority in the current 736 MEP-strong European Parliament. Getting a majority to block the law is a very tall order and will need every concerned European citizen to play their part.

Now’s the time to start writing. Now’s also the time to pass this article on to as many people as you know within the EU. Forward it by email it, share it via your social networks and talk to people about it. This is about creating a political groundswell among the grassroots and all it takes is for very large numbers of people to engage with this for a few minutes. Why not trade your next work break in for a little time spent networking this message and writing your letter or email to your MEP?

European citizens should write to their MEP and ask them to support a resolution to block the passage of the Article 13.1 health claims list into European law.

Find your MEP.

It is best to write by letter or email in your own words, but below are some of the key arguments that you may wish to use:

• The draft list of authorised general function health claims is very limited, comprising just 222 health claims relating to just 70 foods or ingredients
• These claims were taken from a list of 2,758 evaluated by the European Food Safety Authority (EFSA) and so represent just 8% of claims evaluated
• Evaluation of other claims, such as those on botanicals and probiotics, has yet to be completed and it would be disproportionate to apply a ban on rejected claims and not on others that might be rejected in the future
• There has been no adequate impact assessment on how authorising so few claims, while banning so many that were used in the past, will affect consumer decision-making and ultimately public health

There is also a significant risk that mandating such a narrow list of claims will distort the commercial food supply, encouraging food producers to focus more on foods and ingredients for which authorised claims have been allowed. This will narrow the range of foods available and could have serious long-term health consequences on the population.

We strongly encourage anyone and everyone over the age of 18 who lives within the EU to take the time to write to your MEP. Hoping sufficient others will do it is simply too great a risk, given that this decision will set a lasting precedent. If the European Parliament fails to block this half-baked list of authorised claims, it will not only impact all of us next year, it will also greatly affect future generations who will not have had the same privilege as us, growing up in an environment where scientific information about our food could be more openly communicated.

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Further information:

Download draft annex of authorised general function health claims.

Download draft text of Regulation seeking to mandate Community list of authorised general function health claims into EU law

Download Nutrition and Health Claims Regulation (EC) No 1924/2006 (consolidated version)

Download European Commission guidance on implementation of the Nutrition and Health Claims Regulation

Download UK Department of Health updated guidance on implementation of the Nutrition and Health Claims Regulation (updated November 2011)

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