The EU's health claim conundrum: The capsizing of consumer protection?

As disappointed as many are with the European Food Safety Authority’s (EFSA) assessments of health claims, few dispute the EU nutrition and health claim (NCHR) regulation’s original aims: Give consumers, “the necessary information to make choices in full knowledge of the facts”,​ thanks to a “scientific assessment of the highest possible standard”.​

Another stated aim: “Create equal conditions of competition for the food industry.”​

All well and good, but is NHCR implementation becoming the next barrier to the regulation’s aims?

Take claim wording. Condensing complicated science into a sentence is a tough job, and a quick read of authorised health claims suggests experts have not been always so successful in making the science understandable, and relevant. In any case, once the experts have agreed, approved health claims are turned into law, with a suggested wording.

What matters for businesses is that they can then modify the authorised wording to comprehensible wording they actually use on product packages – as long as the essential claim remains the same.

This is known as flexibility. Surely businesses can hire smart marketers and clever scientists to do better than the legalese of, “vitamin B12 contributes to normal energy-yielding metabolism”​ while keeping with the science approved by EFSA.

Flexibility fixing?​

Of course, there is a legitimate concern that, thanks to flexibility, businesses go too far and enter the realm of illegality.

Would it be fair to say we all need more of the vitamins with approved health claims, when the evidence suggests most Europeans already have adequate intakes?

It is obvious that marketers should not be allowed to turn a humble “copper contributes to the normal function of the immune system” into a miracle immunity boosting, can’t-live-without health claim, when, as EFSA duly noted, the evidence does not suggest that inadequate intake of copper leading to impaired function of the immune system occurs in the general EU population.

Explaining health claims in keeping with the science is not easy.

Concerns, however, are easily exaggerated. In this case, several regulators – actually those from most member states – came to the conclusion that since it was too difficult for food inspectors to evaluate different wordings, it was better to produce guidance which would minimise flexibility.

For example, in Italy the background science EFSA cites in its opinions to contextualise and make health claims relevant is severely frowned upon, practically prohibited.

“Vitamin B6 contributes to normal homocysteine metabolism,”​ for example, is all the full knowledge consumers need to make up their minds, and explaining what homocysteine is and does would be totally inappropriate.

Also, the term “normal”​ as opposed to “important for”,​ “healthy” ​– which EFSA copied from textbooks – is given a very special standing; there are several other similar principles. Some have even argued that all products should have the same identical texts if they have health claims.

Regulation run out of control?​

The impression is that regulators have lost sight of the original goal of the regulation – to give consumers the necessary facts so they have full knowledge of the science – and overestimated their abilities to understand science. 

Some may claim that final wordings provide all the necessary facts and all the science consumers need to know. Nutrition scientists with EFSA and EC expert working groups, with stakeholder input, have after all haggled long enough to arrive at a perfect gold standard wording.

It is against that hard fought gold standard – not the science itself but the health-food relationship validated by EFSA – that any alternative wording should be judged. Yet, it is hard to accept that the authorised wording is more important than the actual scientific evidence, and that businesses can’t be better at explaining the science in a way that consumers understand it.

Social sciences can help, and it has not even started to be tapped at a sufficient level. While EFSA, as dictated by its mandate, made a Herculean effort on nutrition science when assessing claims, social sciences – those that deal at the consumers’ end of the equation – have not been involved to a comparable extent.

The EC has funded projects on this topic, such as the food labelling impact project Clymbol​. There are others that have a social science component like the botanicals project called PlantLIBRA​. Yet, social scientists have provided little or no input on the wording of health claims written into regulations (and it shows). Nor have they been asked much about flexibility guidance and the concepts underpinning it.

Surprisingly, there is no approved experimental protocol to show that consumers understand two wordings of the same health claim similarly – though this is the NHCR yardstick.

And what about the other aim of the NHCR? Creating equal conditions of competition for the food industry? Here, enforcement is key, and we are not seeing a uniform approach across Europe.

The UK Advertising Standards Authority (ASA) ultra-strict and didactic adjudications, because of their accessibility and clever reading of the flexibility guidance, have caught the attention of stakeholders across Europe. In fact, ASA seems determined to change marketing practices in the UK with its NHCR interpretations that are proving increasingly controversial​.

Trade group actions​

Other countries – though not all – seem far more relaxed. Member states may have different enforcement priorities, say novel foods over health claims, or vice-versa, but one wonders whether cross-border e-commerce in food has put an end to enforcement niches that don’t impair equal competition.

Trade associations have a role here, as they can put forward codes of practices with detailed practical examples which members across Europe can follow to ensure a level playing field. Authorities also need to work together; sometimes, priorities are the result of genuine policy differences; often they are the result of lack of awareness, discussion, or peer-review.

It is perhaps true that national experts have determined that “normal”​ was a key concept, very different from “healthy” ​or “important for”​ in the UK, whereas in other member states “healthy”​ would be an appropriate word for the same ‘normal’ concept. Workshops and joint trainings involving national authorities may help harmonise enforcement more than you may expect.

Court actions?​

Finally is there also a role for the courts? The strict guidelines enforced by UK’s ASA and undersigned by several Member States would seem to go further than EU law, and it would not be entirely surprising if national courts, and perhaps even the European Court of Justice (ECJ) in Luxembourg, were to disagree with the authorities.

The complexity intrinsic to the NHCR can’t be avoided. At the same time, we should not be afraid to go back to the original aims, and wonder whether the implementation of the NHCR needs appraisal.

Too little flexibility may make inspectors’ lives easier but does not provide consumers with facts and full knowledge.

There are three easy improvements.

• Better and recognised ‘consumer science’ methods to establish – experimentally – that consumers do get the EFSA-validated scientific facts rights.
• Ask social scientists to help regulators when writing wordings, when devising ways to check compliance, and on what concepts are really important – so that the existing guidance documents can be replaced.
• For the single market to function, trade bodies need to help businesses across Europe with codes of practice, and national authorities need to work together so that equal conditions of competition are effectively in place.

But what momentum exists for a genuine review is difficult to assess and it seems the NHCR ship will remain for now adrift in a sea of consumer and industry confusion.

Luca Bucchini PhD, MPH, is the managing director of Italian-based Hylobates Consulting.​​