By Rob Verkerk PhD

Founder, executive and scientific director

 

The European Food Safety Authority (EFSA) in Parma, Italy – the ‘highest authority’ on food in the EU – has recently issued a gamut of opinions on so-called novel foods and on health claims. Here we provide a summary analysis (see Table 1 below) and propose there is little in the way of relaxation in its approach.

In fact, we’re concerned that a pattern is emerging that ultimately isn’t at all good for natural health or for the smaller businesses that have been the main natural product innovators and suppliers up until recently.

See below our evaluation of recent EFSA opinions.

Table 1: ANH-Intl commentary on EFSA opinions on novel foods and health claims published in 2017

Legislative area

Ingredient/

food

Main findings

EFSA decision/

date and

Link to full EFSA opinion

ANH-Intl comment

Novel Food

Alginate-

konjac-xanthan polysaccharide complex (PGX)

Insufficient evidence of safety in chronic exposure

Negative,
8 May 2017
4776

PGX (PolyGlycopleX®) has patents in various countries including Canada, Australia, China and Russia and is taken with meals to reduce appetite and promote a feeling of fullness (satiety) for weight loss support. Considering alginates and xanthan gum are approved in the EU as food additives, that konjac glucomannan has an authorised health claim, and PGX has a long history of use, the additional data threshold and safety margin required by EFSA is unreasonable especially when there are so few products recognised in the EU to help support weight loss – and that obesity was a major policy driver - for EU health claims legislation.

Health Claim (Article 13.5, emerging science)

Curcumin / normal functioning of joints

Insufficient evidence to establish cause and effect relationship

Negative,
8 May 2017
4774

The claim sought by Finnish company Suomen Terveysravinto Oy was ‘normal functioning of joints by reducing the biomarkers of inflammation’. EFSA considered that no conclusions could be drawn from the 15 human intervention studies with osteoarthritis or rheumatoid arthritis patients and from one study in obese subjects on serum cytokines. Therefore EFSA considered the additional pharmacokinetic, animal and in vitro studies were of no value.

Health Claim (Article 14.1, disease risk reduction)

Condensyl®, opuntia fruit dry extract ( incl. N-acetyl cysteine, zinc, nicotinamide, vitamins B2, B6, B12 and E and folic acid) / male fertility

Insufficient evidence to establish a cause and effect relationship

Negative,
5 May 2017
4775

Laboratoire Nurilia in France submitted extensive data to support a claim for its opuntia extract in reducing sperm DNA damage, which is a major risk factor in male subfertility and infertility. Despite 4 human intervention (clinical) trials with men with clinical infertility, EFSA did not agree that there was sufficient evidence to prove a causal link between consumption of the opuntia extract and reduction of DNA sperm damage.

Novel Food

Hydroxytyorosl

The novel food is safe under the proposed uses and use levels

Positive,
10 March 2017
4728

This novel food authorisation opens the door to one of the main, identified bioactive components in unrefined, cold-pressed olive oils being added to margarine and vegetable oils, consumption of both being associated with dysregulated blood lipids and increased inflammation and disease risk.

Health Claim (Article 13.5, emerging science)

Stablor® (amino acid-based drink) / decrease in visceral fat while preserving lean mass

Insufficient evidence to establish a cause and effect relationship

Negative,
28 Feb 2017
4723

Of the 4 human studies (2 published, 2 unpublished) submitted to support the application, 3 were dismissed as they were uncontrolled. In the other, EFSA disagreed with the applicant’s conclusions of results which depended on different methods of analysis.

Novel Food

Tolerase® G, proline-specific oligopeptidase produced from a genetically-modified (GM) self clone strain of Aspergillus niger

The Panel concludes the novel food, is safe for the intended use at the intended use level.

Positive,
15 Feb 2017
4681

Sourced from a GM fungus, Tolerase-G sold through DSM, one of the world’s largest nutraceutical ingredient suppliers, helps break down gluten. It is specifically intended to digest ‘hidden’ gluten for those requiring a gluten-free diet. The authorisation is positive in approving enzymes as foods, but opens the door to wider use of undeclared GMOs to produce foods and food ingredients. Most consumers interested in such products are likely to not be supportive of GM technology, or would at least wish to have the GM origin of the product declared.

Novel Food

Lavitol®: taxifolin (dihydroquercetin)-rich extract from Dahurian Larch (Larix gmelinii)

The novel food is considered to be safe

Positive,
14 Feb 2017
4682

This authorisation opens the door in the EU to the Dahurian larch-derived dihydroquercetin products based on Lavitol®, produced by Russian specialists, Ametis JSC. This ends a 7-year backwards-and-forwards journey for the company between EU and national authorities, with the UK considering the ingredient safe a year after its initial application in 2010. However, gaining an authorised Article 13.5 health claim for the ingredient requires a whole new journey for the company and will be very much more difficult to achieve.

Health Claim (Article 14.1, disease risk reduction)

‘Nutrimune®’ (fermented milk) / immune defence against pathogens in the gastrointestinal (GI) tract and upper respiratory tract (URT)

Insufficient evidence to establish a cause and effect relationship

Negative,
30 Jan 2017
4679

One human intervention study on immune defence against pathogens in the GI tract and the URT, whilst the results from one animal study could support an effect on defence against pathogens in the GI tract. EFSA considered there were inconsistencies in the reporting of the process and criteria used for the diagnosis of URTI in the human intervention study, and as the results of this study have not been replicated, and no evidence was provided for a plausible mechanism by which ‘Nutrimune®’ could exert the claimed effect in vivo in humans

Health Claim (Article 14.1, disease risk reduction)

Vitamin C

A cause and effect relationship has been established

Positive,
27 Jan 2017
4685

Vitamin C is acknowledged as an antioxidant and this authorisation opens the door for more claims to support the effectiveness of Vitamin C use in the human population.

Conclusions

Trends emerging from our analysis are as follows:

  • It’s still extremely difficult to successfully have an emerging science or ‘new function’ (Article 13.5) health claim approved, with only four such claims being authorised on the EU Register, namely non-digestible carbohydrates, “Non-fermentable” carbohydrates, carbohydrates, sugar beet fibre, and 108 having received negative opinions from EFSA

  • There is a trend in novel food authorisations for patented or trade marked ingredients being authorised, the beneficiaries of which are large corporations with the financial capacity to pay for new, bespoke studies intended to meet the requirements set by the EU. This approach discriminates against small-to-medium-sized enterprises (SMEs) which have historically been the main innovators in the natural health sector

  • The high level of rejection of health claims by companies that have invested heavily to undertake studies that meet EFSA guidelines for scientific substantiation of health claims acts as a demotivator to other companies who might have otherwise invested in research

  • There is a trend in authorisations of novel foods and health claims that will accelerate the development of highly processed, so-called functional foods in the marketplace, that benefit Big Food, and are at odds with the general principles of healthy eating linked to consuming less processed, whole foods prepared in the home (e.g. as suggested by ANH-Intl Food4Health guidelines)

  • Novel food authorisations for ingredients made with GMOs will likely increase (e.g. Tolerase® G; Table 1) , without the consumer being made aware of the GM origin of the food or ingredient.

 

Call for reform and action

Since its inception 15 years ago, EFSA has increasingly cemented its approach, which is a specific interpretation of the legal remit handed to it by the EU’s executive body, the European Commission.

We have long-argued that the approach is not fit-for-purpose, and it is important that EU citizens make their MEPs aware of the urgent need for reform. We hope to soon have an eAdvocacy system up-and-running that will allow our supporters to readily communicate their concerns to their MEPs – watch this space! If you can’t wait, you may wish to meet up with, write to or email your MEP. Find your MEP here.

With the UK exiting the EU, there is a real opportunity for a more rational approach to substantiating health claims and authorising novel foods. At ANH-Intl, we’re working on both the UK and EU fronts to ensure the best possible outcomes for natural health and all citizens of Europe, both sides of the English Channel.

There is fundamental work to be done to achieve all of this, including, as relayed at Natural Organic Products Europe in London last month, disbanding the ‘artificial contract between food and medicine'.