EU article 13 health claims register

222 EU health claims become law; experts predict “tsunami of cheap innovation”

By Shane Starling

- Last updated on GMT

222 EU health claims become law; experts predict “tsunami of cheap innovation”

Related tags Health claims European union

It’s official. Companies have six months – until December – to comply with the controversial European Union article 13, general function health claims register which today won final approval from the European Commission.

When the 6-month transition period of grace expires companies will have 222 positive claims to play with; while more than 1600 proposed health associations will be banned.

The Commission claims the belated publication of the register under the EU nutrition and health claims regulation (NHCR) will usher in a landscape of greater accuracy and certainty in claims, but industry is concerned about the high number of rejections and an innovation-killing uniformity in claim-making.

It is also worried about European Food Safety Authority (EFSA)-approved nutrients being ‘dusted’ into products to win claims on products that may struggle to deliver health benefits.

The full downloadable register of article 13.1, 13.5 and 14 health claims can be found here.

We collated initial reactions:

Cheap innovation

Christiane Alexander, PhD, senior consultant at German consultancy analyze & realize:

“The register of approved 13.1 claims will flood the market place like a tsunami with cheap innovation based on simple formulation changes. But this has no potential for products to differentiate themselves from others based on health claims. The question is whether industry will then recognise that for true innovation they will need the 13.5. or 14 claim route.”

“For certain indications like weight management, gut, brain and joint health this would definitely be necessary, because there are hardly any 13.1 claims available highlighting the specific health message of such products.”

“We expect a second wave of innovation, demanding more thinking about high level substantiation, new clinical trials, in-depth product characterisations as well as higher investments in order to satisfy EFSA.”

Not the end of the process

TC Callis, food supplements technical manager, Proprietary Association of Great Britain (PAGB):

“PAGB welcomes the certainty that the publication of 222 favourable Article 13.1 health claims will provide and are pleased to note that the Commission has confirmed that flexibility of wording for claims is acceptable.”

“Industry has been awaiting this publication for some time and has been reviewing its packaging and advertising to ensure compliance following the end of transition in early December 2012. However, we are aware that this is not the end of the process." 

“There remain a number of outstanding claims that await assessment, and there is always the possibility of new dossiers being submitted for consideration in the future.”

Legal clarity


“FoodDrinkEurope welcomes the publication of this European-wide list as it provides Europe's food and drink industry with the legal clarity required. Consumers can now be confident that all claims on products have been approved for use and are based on solid scientific evidence.

“However, improvements are still needed to the way in which the Health Claims Regulation is applied. FoodDrinkEurope calls on EFSA to improve dialogue with applicants and provide clarity on the information needed to fully substantiate a health claim.”

“Food manufacturers believe that improvements need to be made to the way that the Claims Regulation is applied and look forward to continuing to work together with the Commission and other stakeholders constructively in this respect.


Sebastián Romero Melchor, Food Law Consultants:

“Adoption of the list means the 'sovietisation' of the market, where the majority of the products we’ll see on the supermarket shelves will bear the same claims with slight modifications on the basis of the flexibility principle.”

“A similar development is foreseen in connection with botanicals, as a large number of claims may still be used on the basis of Article 28.5 of the NHCR.”

Science fail

Robert Verkerk PhD, executive & scientific director, Alliance for Natural Health International (ANH-I):

Repeated use of a small cluster of 'me-too' claims will do nothing to inform choice of European consumers. EFSA has indeed congratulated itself time and time again for its high scientific standards. But we challenge them to prove that 15% of the RDA of thiamine, a meagre 165mcg, present in a food or supplement contributes to the normal functioning of the nervous system, psychological or heart function.” 

“Perhaps cracks in EFSA's scientific mantle will only appear when someone has the volition and resources to challenge them in a court. In the meantime it is the European consumer, the very party the European Commission deem to protect with the health claims regulation, that is the key loser.”

Just add fruit

Julian Mellentin, New Nutrition Business:

“Far from health claims disappearing, we will see a massive explosion based on 13.1 claims over the next year, with companies using, for example, the vitamin C immunity claim as the basis for products claiming immunity.”

“This will happen with probiotic products, which can't use any immunity claims. You just need to add enough fruit that is high in vitamin C to deliver 15% of the RDA.”

The end of exaggerated claims

Monique Goyens, director general of the European Consumer Organisation (BEUC):

“The food industry has long used false or exaggerated claims as a means of attracting consumers attention. It’s high time that such misleading and unsubstantiated claims are taken off the market and we welcome todays publication of the list as an important step in this process.”

“For consumers, it means that, by the end of the year, they should be provided with clear and accurate information when choosing what foods to buy and should be able to trust in the claims which appear on food products.”


Cynthia Rousselot, director of European policy, European Federation of Associations of Health Product Manufacturers (EHPM):  

“In light of the pending decision of the European Ombudsman, we believe the publication of the rejected list is premature. Non-authorised claims should be put on hold until this issue is clarified and resolved.”

“This short [6-month transition] timeframe will result in significant costs for SMEs because of required label changes and a lack of time to sell through their stock. An 18-month transition period would be more proportionate. We trust that the national authorities will take into consideration the shelf life of our products when determining the timeframe for their withdrawal from the market.”

Major milestone

John Dalli, health and consumer policy (DGSANCO), the European Commission:

"Today's decision is the culmination of years of work and marks a major milestone in regulating health claims on food. The EU-wide list of permitted health claims will be available on-line and will allow consumers everywhere in the EU to make an informed choice. Non-scientifically backed claims will have to be removed from the market after a short transition period."

New EFSA panel hope

Nigel Baldwin, director, scientific and regulatory consulting, Europe, Intertek Cantox:

“It’s a good a start and leaves a lot left to play for and many opportunities for the future because it will create gaps in the market where well-supported claims can triumph. A new EFSA panel after the summer should freshen things up ready for the next stage of the process. I expect a strong scrutiny on botanicals to be that stage.”

Claims versus efficacy

Cédric Bourges, PhD, founder and managing director, Nutriveris:

“Health claims support communication of products, however efficacy is much stronger to ensure long term sales development.”

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The industry will learn

Posted by Meheut,

This situation have some proximity with the very strict legal environments regarding claims that exist for the spirits beverages industry. In this industry, even if the underlying consumer promise is about own seduction, virility, self attractiveness, trendiness and so on, brands can of course not claim they are standing for that. The industry learnt building a strong and deep marketing and communication approach to build brands based on emotional benefits.

That is probably what the functional food industry will learn, and only the ones who will find ways of attaching emotions (vs rational/Scientifical reasons to believe) to their brands will survive.

A new era for PR (public relations) and strategic brand building is opening

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Bond Pearce - a regulatory perspective

Posted by Matthew Starling, Bond Pearce LLP,

Unfortunately as the EC is not intending to release guidance on the degree of flexibility in permissible wording in health claims before the ban becomes enforceable in 6 months' time, we could see different approaches across Europe by the various regulators as to what they consider is permissible. This has the potential to seriously undermine imports and exports across the EU where a product permitted in one country is not necessarily considered legal in another.
Not only is there the question of translating authorised claims into different languages but proposed rewording of claims so that they are well understood and do not mislead the average consumer, as required under the Regulations, without departing too far from the authorised claim wording could present a real challenge. It's all a matter of interpretation and UK authorities such as the ASA, Food Standards Agency and local trading standard departments may view matters differently in the absence of authoritative guidance by the EU.
In the UK, comprehensive guidance by the Department of Health is available but until EU-wide guidance is produced or case law develops in this area, we are unlikely to see a truly harmonised approach to the rules across the EU and the use of health and nutrition claims in food products will remain an area of uncertainty and corporate risk.

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Provexis' viewpoint

Posted by Stephen Moon,

Following the attempted veto of the EFSA rulings earlier this year, this marks a landmark day in the EFSA story. Although health claims rulings continue to ignite debate within the industry, Provexis believes that the effect they will have will be a positive one. These 222 adopted claims will help to rid the market of invalid and unsubstantiated claims and create opportunities for smaller companies to succeed with new functional ingredients based on rigorous scientific evaluation.

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