By Deborah Cross

In a concerted effort to help clean up the food and beverage ingredients market, and increase the level of scientific credibility behind products, the European Food Safety Authority (EFSA) introduced the Nutrition & Health Claims legislation on 20th December 2006. The main objective of the Nutrition & Health Claims legislation is to increase the degree of protection provided to consumers, while also harmonising the rules for the use of claims for health and nutrition on consumer products. The information on consumer food products in the EU is therefore destined to become more clearly worded and transparent, helping consumers to choose optimally at point of sale. From the perspective of companies, the regulation aims to protect innovation in food ingredients, and promote fair competition within the marketplace.

Individual company submissions for consideration for the award of health claims for ingredients under this regulation (EC 1924/2006) had the final deadline in July 2007, and the EFSA is considering and evaluating claim submissions throughout the period from July 2007 to the final deadline of 31st January 2010. For this evaluation process, around 3000 dossiers have been submitted to be evaluated for their potential to carry health and nutrition claims. These claim submissions, or dossiers, are being evaluated by the Panel on Dietetic Products, Nutrition and Allergies (NDA), within the EFSA.

According to the regulation, a 'Health claim' refers to any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health. Under this regulation, there are different types of health claims, as explained below. Nutrition claims are statements that suggest that a food has particular beneficial nutritional properties due to the nutrients it does or does not contain. Some examples of nutrition claims are 'low in fat', 'high in fibre' or 'no added sugar'.

If a claim contains factual information only, such as "contains bilberry" or "contains lycopene", then this is the basis of a nutrition claim. However, if a claim contains information relating to the ingredient providing a benefit to health, then it becomes a health claim. For example, "contains probiotic bacteria", or "contains prebiotic fibres", are examples of health claims, as well as "contains antioxidants", which allude to the presence of an antioxidant effect or pre/probiotic effect.

In October 2008, the EFSA finished the first stage of its pre-screening process, which distinguished those original claims which could be evaluated, and those dossier submissions which needed more information to be submitted before they could reach the next stage of the evaluation process. Rejection of these dossiers included those containing claims which were vague, not properly described, or where the conditions of use have not been spelled out, or those with an unclear scope or health relationship.

In February 2009, the EFSA is currently considering a global list of 4,185 claims, including those that have been submitted originally and have not since been modified, those submitted and extra information provided, new claims submitted in November 2008 which have also passed pre-screening, and finally also new claims submitted in December 2008 which have not yet passed pre-screening stage and require further information to be provided by the EFSA Technical Panel.

Requirements for Claims

Foods must be healthy overall if they are to be able to carry a nutrition or health claim, and the EFSA is also considering a nutrient profiling approach, which is still being agreed and will be published later in 2009. Following a list of criteria for various nutrients, such as sodium and amount of sugars, a nutrition claim will be allowed if a food exceeds one of these criteria. For a company to make a nutrition claim on its product, the specific claim must be listed in the annex of nutrition claims in the regulations. However, a food which is to carry a health claim must meet all of the criteria. A list of permitted health claims will be available from January 2010.

Several types of claims will not be permitted, including:

• Medicinal claims regarding the prevention, treatment or cure of diseases
• Claims on alcoholic beverages (containing more than 1.2 per cent alcohol)
• Claims suggesting that health could be affected by not consuming the food
• Claims quantifying the rate or extent of weight loss
• Claims referencing recommendations made by doctors and health professionals

The claim evaluation process for article 13 and article 14 claims dictates that companies must submit dossiers to their relevant nutritional authority in the country. The regulatory authority will then send the dossier to the EFSA's Panel for consideration. After acceptance, successful claims using new data produced by the company concerned will be protected for a period of 5 years.

To date, over the claim evaluation process, the panel has adopted a hard line policy on the submitted claims from companies within the food and beverage industry, favouring a "gold standard" science approach from ingredients manufacturers. Consequentially, an initial flood of rejections by the EFSA has caused consternation in the market, and presents a significant challenge to companies. Since 2007, several companies have also withdrawn their submitted claims even before evaluation, as a precaution to avoid outright rejection. Such companies have withdrawn their claim submissions in order to go and compile a more comprehensive collection of research trial evidence or re-writing the claim submission, with the view of re-submitting the dossier at a later date. With the necessity of establishing a claim legally in the European Health and Nutrition market, potential rejections by the Panel have negative consequences and present a large challenge to companies. These include:

• The shock to companies of having claims rejected
• Potential future loss of revenue or income through bad publicity as a result of claim rejection
• Not being able to make the same ingredient claims as their market competitors

The General Food Law Section of the Standing Committee on the Food Chain and Animal Health (SCFCAH), composed of representatives from the 27 EU member states, has evaluated EFSA's initial opinions regarding 21 submitted dossiers, and has agreed with the findings of EFSA. This means that final opinions regarding 21 submitted claims are soon to be made legal, with 14 negative and 7 positive opinions. These claims relate primarily to article 14 submissions for children's health and disease. One successful claimant in the market so far is Unilever, regarding its plant sterol submission claim to lower cholesterol and reduce the risk of developing coronary heart disease. The potential for companies to make claims such as this one will strongly increase their future market activities in Europe.

The legislation contains a number of potential classifications, but the two most important and relevant to the functional food ingredients market are:

• Article 14 claims (disease reduction and children's health claims)
• Article 13 claims (include generic nutrition and health claims)
• Article 13 claims are health claims describing or referring to roles of a nutrient or other substance in growth, development and the functions of the body, or physiological and behavioural functions, or slimming, weight control, an increased sensation of satiety or the reduction in available energy from the diet (requirements separate from those in Directive 96/8/EC).

As such, Article 13 claims are "function claims". Other classifications include comparative claims (Article 9 claims, which are nutrition claims), based on foods in the same category, which allow a product to state either 'reduced', 'energy reduced', 'light' or 'increased', in connection with particular nutrients.

Ingredient Claims are being rejected by the European Union Panel on several criteria, including:

• Failure to demonstrate causality between consumption of specific nutrients or foods and their intended benefits to health
• Lack of strength of the submitted trial evidence in dossiers
• Requests for more details, or other missing information
• The presence of enough scientific evidence of the health claims in a particular area already
• Quality of scientific studies

In the case of Unilever dossier submitted for alpha-linolenic acid (ALA) and linoleic acid (LA), concerning the healthy growth and development in children, the Panel decided that the science supporting the dossier was sound, but that supplementation in the diet was not needed. In relation to the quality of the various scientific studies used to support ingredient claims, claims have been rejected based on factors including; the small population numbers used in the study, lack of scientific significance in the studies, failures to demonstrate that the benefit was caused by the ingredient, and the use of tolerance studies which are not representative of administering the same supplement to a healthy individual. Tolerance studies may use 10 times the quantity of an ingredient for establishment of an effect at any dose, but do not represent the quantities required by or given to a healthy individual. Studies may also use immuno-compromised patients, rather than generally healthy individuals, in order to maximise the potential effect of the supplement, which is not considered representative of the target market.

Article 13.5 and Article 14 claims in particular have raised a number of concerns with the participating companies. The EFSA applies relatively similar evaluation process criteria to evaluate Article 13 claims as well as Article 14 claims, in terms of substance characterisation, observational and intervention trials. This is despite the fact that the article 13 claims are generic claims, while the article 14 claims are specifically related to disease reduction and children's health, which are very specific areas. Currently, industry groups are lobbying the EFSA to determine and establish separate criteria for their evaluation of Article 13 and Article 14 claims. The information provided by EFSA and the Panel has so far been unclear, which has led the French company Danone to pull 3 claims relating to its probiotic yoghurt products until the Panel has successfully provided more information on the procedures necessary. Although Danone is confident regarding the science backing the claims it has made under Article 13.5 and Article 14, it will re-submit these same claims in June 2009, possibly with changes to the wording but not the trials used in the submissions. Other companies have also withdrawn dossiers pending further information from EFSA, including; Nestle, Unilever, Valio, the Irish Dairy Council and Association of the Food Industries for Particular Nutritional Uses of the European Union (IDACE; France). In total, around 10 claims originally submitted for Article 14 have been withdrawn, as companies adopt a prudent and cautious approach to the new Regulation submission process.

To date, in April 2009, no claims submitted under Article 13.5 have successfully been approved by EFSA. Industry groups and companies are still learning about the process and its requirements. EFSA has been criticised for not engaging in sufficient dialogue with the industry, which it hopes to remedy by holding a Health Claims summit in its headquarters in Parma, Italy in June 2009, and preparing a "frequently asked questions" (FAQ) document. Some industry trade groups intend to build a dialogue with the EFSA, with the view that some elements of Regulation 1924/2006 are potentially challengeable in court, as regards the potential loss of earnings to companies if a large number of Article 13.1 claims are rejected within the next few weeks. These trade groups feel that the Regulation places an excessive burden on the availability of clinical, human and intervention trials, which do not reflect the original intention of the Regulation. However, these bodies have indicated that taking EFSA to court is a last ditch strategy, being both costly and time-consuming, after the damage has already occurred from having claims rejected that are already in use commercially.

Another issue in the evaluation process is the consistency of the Panel's decisions, where, for example, the EFSA's NDA panel approved 2 omega-3 eye health claims for Mead Johnson Nutritionals, but simultaneously rejected 3 claims for infant brain health also submitted by the company. Furthermore, if a number of studies are made in the dossier provided by a company, the Panel may decide that only a small proportion of studies are relevant to the submission. For example, the claim submitted by Merck for DHA originally contained 48 scientific trials as supporting evidence, but the Panel concluded that only a small fraction of these were relevant, at least partially due to some of the reasons mentioned previously.

The Health and Nutrition Claims legislation remains an ongoing process, which has thrown up much controversy so far. To date, the process has resulted in a great deal of confusion, and it is clear that companies involved in the process are not clear of the boundaries and the requirements involved. EFSA has recognised the difficulties and issues faced by the companies regarding the preparation of dossiers, and aims to provide guidance and support for Article 13.5 and Article 14 claim submissions. Hopefully, the proposed Brussels summit and FAQ publication from the EFSA will help to clear away some of the confusion in the coming months, but the seriousness of the matter and the lengthy time and cost commitment involved on the part of the companies will clearly affect the degree of innovation in the market until companies have received increased granularity on what they are required to do. Clearly, many issues are still to be resolved, but the NDA panel remain confident that they are on target to publish the list of approved claims after Jan 31st, 2010.