A healthy appetite: how new EU rules have changed the functional food claims landscape

26 April 2013



The transition period for the use of Article 13.1, relating to generic health claims not authorised by the European Commission, ended in December 2012. Now all claims for functional food products must be in line with those authorised for use in the EU claims register. Stefanie Geiser, regulatory affairs manager at EAS Strategic Advice, reports.


Although it is difficult to predict the future impact of the new claims rules for the EU market, the first visible market trends and reactions to the regulation are appearing.

Companies seem to be coping with the regulations by employing a variety of strategies and, by staying within the rules of the rather restrictive-looking claims game, the market is starting to evolve in the search for new marketing concepts and alternatives. In this context, three broad marketing concepts are prevalent.

1. EU-authorised health claims covering vitamins/minerals, fibres and other ingredients

The first example of this is the trend towards emerging mass-market brands of common foods bearing health claims through the addition of vitamins or minerals and/or, for example, their fibre/beta glucan content.

The main idea behind these brands appears to be that messages of simple benefits on brands designed to work well together are key. Their sales success may, however, be dependent on the health status of the targeted consumer. While such functionalised common foods might serve specific consumer niches, average consumers may not be searching for all of the proposed health benefits. There is also a risk that, if health brands start to exaggerate their claimed benefits of various vitamins/minerals and fibres in general, consumers may become sceptical about the truthfulness of approved European Food Safety Authority (EFSA) claims. It remains to be seen, therefore, whether this concept will be successful in the long term.

The second example is a trend towards products such as probiotic dairy goods making use of vitamin/mineral ingredients to continue claiming improved immune health and digestive functions.

Within this concept, the products can bear the same or similar claims as before, but they are now communicated as benefits related to the added ingredients (for example, vitamin C).

While the initial idea of the EU health claims regulation made sense, the result seems to have missed the target for consumers and companies alike. Many firms producing innovative products with ingredients that have very specialised and targeted health benefits have failed in their health claim applications. This is due to tough scientific assessment requirements that some in the sector have argued are more suitable for the assessment of medicines than food.

"Making use of generic health claims as a new concept certainly has its advantages, particularly to manufacturers of mass-market goods."

On the other hand, this regulation has promoted the use of generic claims for common ingredients in common food products. Making use of generic health claims as a new concept certainly has its advantages, particularly to manufacturers of mass-market goods, which can benefit from the investment made by other companies that have submitted claims data. Whether this trend will be beneficial for the consumer in the long run is questionable; label changes for mass-market products with added vitamins/minerals will not necessarily provide consumers with new health benefits or dietary choices. In general, this trend brings no innovation in terms of growing the market with new, specialised healthy products.

The situation is potentially detrimental to companies that in the past invested in a small range of health ingredients. These organisations may need to adapt their strategies by adding further common ingredients, such as vitamins/minerals and fibres, to their products in order to for them to be able to feature certain claims. In addition, the number of new EFSA health claim applications is expected to decrease as companies realise that the marketing advantages are minimal compared with the investment required to meet the tough EFSA substantiation standards for claims that can then be used by all.

2. Making the most of flexibility around enforcement of claims regulation in EU member states

Companies can benefit from those aspects of regulation that are open to interpretation by member states and/or the European Commission. Depending on views expressed in specific nations, there can be a certain level of flexibility when it comes to their enforcement.

Take, for example, the flexibility of the wording of health claims. Member states may be flexible in amending or broadening the wording/expressions of the authorised health claims in the EU Register of health claims. In December 2012, they agreed general principles on the flexibility of wording of authorised health claims and some nations developed more detailed guidelines.

"Future trends for the successful marketing of health products could involve products including simple ingredients with authorised health claims and a preference for more traditional ingredients associated with good quality and naturalness"

Another area open to interpretation is making use of general non-specific health benefit claims. Companies can use product names expressing simplified health effects and other easy, attractive statements as long as these are accompanied by an authorised health claim.

In January of this year, the European Commission clarified the rules related to this in its 'Decision adopting guidelines for the implementation of specific conditions for health claims laid down in Article 10 of the EC claims Regulation 1924/2006'. The guidelines state that the authorised health claim accompanying the general, non-specific health benefit statement should be made next to or following the statement and should relate to the general reference. In the case of broader general health statements - for example, 'for good health' - more claims from the permitted list could be eligible to accompany these.

3. Following other consumer trends not within the scope of the claims regulation

An interesting trend is the use of the term 'natural', which is not within the scope of the EU claims regulation. Generally, the criteria for the permission of this term is not well defined, with the exception of national guidelines or rules in some EU member states.

"Making use of generic health claims as a new concept certainly has its advantages, particularly to manufacturers of mass-market goods."

The use of the term 'natural' for food or food ingredients is in general not harmonised in the EU, except for mineral waters and some flavourings. In addition, the annex to the claims regulation 1924/2006 only provides details on the permission of the following nutrition claim: "'naturally/natural' as a prefix to another permitted nutrition claim is permitted where a food naturally meets the condition(s) laid down in this annex for the use of a nutritional claim (for example, 'naturally sugar free')."

The UK Food Standards Agency guidelines state that 'natural' essentially means that "the product is comprised of natural ingredients"; for example, ingredients produced by nature, not the work of man or interfered with by man (meaning no use of chemicals to change their composition, no technologies including additives and flavourings that are the product of the chemical industry or extracted by chemical processes).

Trends and drivers for 2013-14

Future trends for the successful marketing of health products could involve products including simple ingredients with authorised health claims and a preference for more traditional ingredients associated with good quality and naturalness; for example, including fibres that are related to digestive properties and omega-3 fats associated with heart health.

Ethical matters such as environmental and animal welfare issues, combined with attractive, fresh-looking packaging, could also play a role. While traditional natural ingredients might be preferred, exotic-looking colourful fruits or fibres could also add to attractiveness.

If such ingredients and concepts are then combined with ingredients that in the past have claimed functions that match the 'healthy' or 'natural' product profile, these products could still be successfully sold even without a direct and strong health claim.

Making use of alternative health claim wordings according to EU member state guidelines, and use of general non-specific health benefit claims in combination with the EU-authorised claims, is another potential avenue. Experience from acceptable market practice and national challenges throughout this year will show the way forward for 2014 and beyond.

Probiotic dairy goods now communicate their benefits in relation to the added ingredients


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