Difficult job

In a bid to again demonstrate its transparency, the European Food Safety Authority (EFSA) recently opened its doors to 10 observer organisations that were able to witness its deliberations. One of them was Shane Starling, the intrepid Nutraingredients reporter who has previously shown he’s not worried about mincing his words when it comes to EFSA. But with his journalistic eyes trained on the deliberations of EFSA’s nutrition panel, it seems from Mr Starling’s report that nothing untoward occurred. In fact, Mr Starling seemed rather complimentary about the panel’s ability to pull off what was, “A very difficult task, as instructed by EU law makers”.

Given that plenty of natural products industry manufacturers, suppliers, retailers and consumers read the daily Nutraingredients news reports, we felt it important to outline some points that Shane Starling didn’t make.

10 things wrong with EFSA’s evaluation process

For the sake of brevity, here are just 10 points that arise from the apparently exemplary behaviour of EFSA’s nutrition (NDA) panel, as observed at its ‘open’ meeting:

1. The panel was being watched by representatives of Big Food and Big Pharma, namely Merck, Nestlé , Danone and Kemin, along with at least one journalist, and was therefore likely to be on best behaviour
2. The NDA panel wasn’t evaluating either health claims or genetically modified (GM) crops, the two areas that have generated by far the greatest controversy. Instead, the panel was estimating dietary reference values (DRVs) for vitamin C and fluoride. It omitted to even question if fluoride should be regarded as a nutrient, or a poison, because this is not within its remit
3. These DRVs have already been established by other authorities, such as the Institute of Medicine in the USA, and the task is well underway in the Codex Committee for Nutrition and Foods for Special Dietary Uses (CCNFSDU)
4. There is no mechanism for expert members of the EFSA panel to question or debate the validity or implications of what the panel does. Therefore, the panel does not spend any time contemplating how its opinions, even on DRVs, might contribute to reducing – or increasing – the burden of chronic diseases or mental and behavioural disorders
5. The basic requirements of EFSA’s work are established in various EU laws, so that EFSA itself has no capacity to significantly modify its risk, safety or benefit evaluations
6. EFSA uses outmoded risk and benefit assessment models that fail to take into account the systems biology context of human experience, and human interactions with both our internal and external living and non-living environments
7. EFSA’s methodologies for risk and benefit evaluation are based on highly variable data types. For example, when assessing GM crops, EFSA relies heavily on industry-conducted trials, many of which have not been peer reviewed. When evaluating toxicological risks, it relies on published, peer-reviewed data that meet narrowly defined criteria; when these data are perceived as insufficient, large uncertainty factors are used that aim to limit, rather than eliminate, exposure. When health benefits are evaluated for the purpose of authorising health claims, historic data are generally rejected, because they do not meet the narrowly defined criteria. EFSA has therefore become increasingly reliant on industry-sponsored clinical trials, conducted specifically for the purpose of meeting EFSA criteria. If adequate data are not available, EFSA incorrectly presumes, as does the European Commission, that the beneficial effect does not occur. As a result, any claims alluding to this effect are then made illegal by the risk/benefit manager, the European Commission. Enforcement is controlled by each of the 27 Member States, which in turn have varying attitudes to enforcement
8. EFSA is heavily reliant on industry-generated or supplied data. Rarely does it investigate science that has not been placed under its nose by a commercial applicant
9. Nowhere in EFSA’s remit is the authority tasked to evaluate nutritional methods or strategies intended to alleviate the EU’s chronic disease burden, despite good evidence that poor diets and lifestyles are central to the problem
10. No scientific authority has the capacity to influence EFSA, given that, as one of several European institutions, it is deemed the ‘highest authority’ on food safety in the EU. As many of us have found over the years, ‘buck passing’ between EFSA and the European Commission is routine. A common response to criticism by EFSA is that it cannot alter its terms of reference, as these have been handed to it via legislation agreed by the European Commission, European Parliament and Member States. When the Commission is similarly questioned, it defers back to EFSA, saying that only EFSA has the scientific expertise to answer questions about scientific methodology. Frustrating at the very least!

Still on the wrong tracks

And so EFSA continues – still on the wrong tracks – unwilling to remove its blinkers handed to it via poorly thought-through, biased or corrupt EU legislation.

We have no reason to believe that Prof Ambroise Martin is nothing other than a diligent scientist. Having spoken with him, we are convinced of his belief that he and his NDA panel are doing the best job they can within their terms of reference. But what really surprises us is that Prof Martin’s eyebrows were not raised by the 1,719 health claim applications rejected by the NDA panel. Surely, this should call into question the tools being used, rather than a blind acceptance that no evidence exists of a health benefit for the consumer of such nutrients? Even diligent scientists have been known to down tools. But so far, Prof Martin seems intent on holding them as tight as ever.

It’s particularly remarkable that no one within the inner circle of EFSA has thrown up their hands in horror or refused to continue after 95% of plant-derived nutrients were found to have no benefits for human consumers. Especially when the rejections range from the antioxidant effects of polyphenols in berry fruits or resveratrol in grape skins, to all probiotics and essential amino acids.

And what do we do?

The question that we, the public, external scientists and others, would like to ask is this: Should we meekly follow EFSA’s every outpouring and start, for example, thinking of the 8 essential amino acids as of no benefit to human beings – and at least non-essential? Has EFSA the power – or even the expertise – to redefine nutrition in this way?

Reactions to-date would indicate that most people, especially those that value living long, healthy lives, supported by good nutrition and good lifestyle practices, don’t believe much of what EFSA decides. We would urge everyone to maintain this attitude, and carry on selecting those foods and ingredients we know to be healthy or beneficial, in the knowledge that EFSA’s opinions — for the time being — continue to be rarely worth the paper they’re printed on.

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