More supplements on the chopping board as Article 8 gains pace

These requests were triggered respectively by Germany, France and Spain who raised concerns on the potential risk for consumers to consume these substances.

Article 8, which dates back to 2006, authorises the European Commission (EC) to initiate the procedure to prohibit, restrict or put under Union scrutiny a substance that is used in foods. 

These procedures can come on the EC's own initiative but in the case of these three substances, each has been brought to the EC's attention via Member States. The EFSA conclusions on these latest assessments are expected by May 2025.

Luca Bucchini, managing director at Hylobates Consulting, says the evidence would suggest these ingredients will almost certainly be restricted, or even banned.

He adds: “The overall lesson for the industry is to make sure that data on the safety of substances used are produced and collected, and to make sure that EFSA and the Commission use the article 8 mechanism in a fair and efficient manner, which has not been the case. We need to get better at understanding and providing evidence on these substances, being proactive whenever possible.”

Fennel​

The German Federal Office of Consumer Protection and Food Safety and the German Federal Risk Institute for Risk Assessment (BfR) have concerns over a potential genotoxic and carcinogenic effect linked to the consumption of fruit preparations from fennel​ by infants and young children, mainly due to the presence of the compound estragole.

According to the French Agency for Food, Environmental and Occupational Health & Safety (ANSES), gastrointestinal disorders, hypoglycemia and hypotension linked to the consumption of food supplements made with plants or plant preparations containing berberine.

And according to the Spanish Agency for Food Safety and Nutrition (AESAN), liver injury has been linked to the consumption of the pericarp of the fruit of Garcinia​ gummigutta (L.) Roxb.​​ containing HCA.

Bucchini points out that there has been a long-running discussion around the safety of Estragole in fennel - in fact, Belgium introduced limits after Van Den Berg et al 2014​ indicated the existence of the issue for children, specifically in herbal teas, and EMA​ recommended to keep it as low as possible.

For this reason, he believes we are very likely to see a restriction of this substance but he is concerned how proportionate the limitation will be.

"Although stakeholders and some scientists resist the idea of limitations, it is very likely to be introduced, and there seems to be scope in variety selection to reduce it.

"I question the decision to use the article 8 mechanism however; many other compounds produced by plants were regulated under contaminant legislation, and the use of the mechanism of article 8 by Germany is of concern because of a history by EFSA and the European Commission to do a better job on contaminants than on article 8.

"There are intricate scientific and legal reasons as well, but I am concerned we will get a maximalist and not proportionate approach. So I think regulating estragole is important, we will have limitations and, given the legal mechanism, they will not be proportionate. EFSA and the Commission have raised questions over the scientific and legal justification of treating food and supplements differently in the case of green tea, and I fear we may have a replay."

Berberine​

Berberine is a chemical found in some plants like European barberry, goldenseal, and tree turmeric and is said to lower cholesterol and triglycerides.

The French Agency for Food, Environmental and Occupational Health & Safety (ANSES) has brought this ingredient to the EC's attention, claiming the consumption of supplements made with plants containing berberine has led to gastrointestinal disorders, hypoglycemia and hypotension.

Bucchini is fairly certain this substance will be restricted, and points out it will be up to the industry to prove its safety.

"Berberine is apparently an unauthorised novel food, which has been used for some time in some Member States. Plants containing berberine are, on the other hand, used legally in several Member States. Such plants are used in the same way as monacolin from red yeast rice in order to maintain healthy cholesterol levels.

"Given the type of effects and the potential for adverse events, restrictions are very likely based on adverse events. EFSA has already shown that, on top of toxicology, adverse events provide useful guidance for providing recommendations for setting at least temporary limitations. Limitations are almost certain, and it will up to the industry to show - with methods used in the food sector, and not in the pharma sector (incidence of adverse events won't matter) - that some levels of berberin are safe."

Hydroxycitric acid (HCA)​

Hydroxycitric acid is a derivative of citric acid extracted from tropical fruits including Garcinia​ gummigutta (L.) Roxb, ​and is found in weight management supplements.

According to the Spanish Agency for Food Safety and Nutrition (AESAN), liver injury has been linked to the consumption of the pericarp of the fruit of Garcinia​ gummigutta (L.) Roxb​​ (G. cambogia​) containing HCA.

Bucchini notes that G. cambogia​, has a history of causing adverse events​ related to the liver and Italy already introduced severe warnings following a string of cases.

He argues a ban of this substance is quite possible.

"Again, the key will be the assessment of the adverse events, and any supporting toxicology. In this case, I also think that limitations or even a ban, within 4 years, are on the cards."

A means to harmonisation

Bucchini points out that with some Member States being more strict than others, Article 8 is veering towards a means for harmonisation.

“It was said that it would not be used to harmonise rules on - say - botanicals or substances in foods but it may end up doing exactly that.

"Countries such as Denmark and Germany are very concerned about some substances which other Member States allow, Overall, I think that article 8 - if properly applied by sound scientific assessments by EFSA and by good rule-making by the Commission - is a good tool. However, the concern is around the two aforementioned ‘if’s’."

B6 cut by half?​

As a result of the Article 8 procedure, the European Food Safety Authority is already recommending lowering the tolerable upper intake level in adults for vitamin B6 from 25 mg to 12 mg/day - a move critiqued by some in the industry as "a slippery slope for free choice and self care"​.

In a draft scientific opinion, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) noted that food supplements were found to contribute up to about 40% of total vitamin B6 intake in children in Denmark. In adults, vitamin B6 supplements contributed more than 50% to total vitamin B6 intake, and up to about 80% of total vitamin B6 intake in adults in Germany (NVS II) and Finland (FINDIET 2017). EFSA also highlighted the high variability in the maximum amounts set by national authorities for addition of vitamin B6 to food supplements.

If agreed, the new ULs will have a significant impact on the limits for vitamin B6 in supplements that the European Commission aims to harmonise across Member States.