EC looks to implement “controversial" ban of botanical species used in supplements

In the draft regulation​​, officials are considering the restriction of aloe-emodin, emodin, the leaf of Aloe species containing hydroxyanthracene derivatives, danthron and all extracts in which these substances are present.

Also listed for possible restriction include extracts from the rhizome of Rheum palmatum L​ and Rheum officinale Baillon ​root and their hybrids and the extracts from the leaf and fruit of Cassia senna L​.

Other extracts under the spotlight include those from the bark of Rhamnus frangula L., Rhamnus purshiana DC​.

“Considering the severe harmful effects on health associated with the use of aloeemodin, emodin, danthron and aloe extracts containing hydroxyanthracene derivatives in food, and that no daily intake of hydroxyanthracene derivatives that does not give rise to concerns for human health could be set, such substances should be prohibited,”​ the draft states.

Unable to provide advice​

But for Luca Bucchini, the decision, if it goes ahead will be controversial as the plants in question are currently authorised for use in Italy and permitted in traditional herbal medicines.

“There are several reasons for the controversy,”​ he explains. “The first concerns the European Food and Safety Authority’s (EFSA) recent comments that state it, "was unable to provide advice on a daily intake of hydroxyanthracene derivatives that does not give rise to concerns about harmful effects to health" because of concerns about genotoxicity and carcinogenicity.​

“With no safe daily intake set, EFSA has essentially "forced" the Commission to ban plants containing them. ​

“Some object that genotoxic and carcinogens occur in food, such as aflatoxin, and that EFSA uses concepts such as the Margin of Exposure to assess health risks from such contaminants enabling the Commission to set maximum levels. ​

“The argument is that since plants with hydroxyanthracene derivatives are voluntarily used in food, then you can't use the same reasoning as for contaminants.”​

Permitted use in herbal medicines​

Bucchini, managing director of food regulation specialists Hylobates Consulting, goes on to discuss the second and most obvious controversy, which questions the banned plant’s permitted use in traditional herbal medicines.

“Why would it be ok to allow genotoxic plants in traditional herbal medicines (that are sold exactly as food supplements and consumers cannot really tell apart) while banning them in supplements?”​ he asks.

“This is particularly jarring for the BELFRIT countries where the plants have been used in food supplements for a long time (perhaps without sufficient consideration), and traditional medicines are very uncommon (unlike in Germany).” ​

Previously, the European Medicines Agency (EMA) has allowed the plants with indications such as "Not to be used for more than 1 week,” ​where certain incidences allow such medicinal product use for up to two to three times during that week.

However, Bucchini questions why such a statement can't be considered for food supplements or alternatively, why the EMA does not reconsider its position concerning these plants.

“This does not appear proportionate and biased in favour of countries with traditional herbal medicine manufacturers. ​

“While not a big market, such plants used as laxatives were permitted in France (with stringent conditions), Belgium (also with conditions) and Italy.​

“Finally, there will be practical questions as how to certify that emodin and other substances are absent. This will be costly, and with limited time to come up with the data.”​

‘A lack of clarity’​

Feedback​​ is currently open for the draft act with the industry able to give their thoughts between the period of 4 March 2020 - 1 April 2020.

In a comment by Dr Peter Jenkinson, a genetic toxicologist, a lack of clarity in Article 1 of the draft amendment was highlighted.

In addition, Dr Jenkinson points out that EFSA was specifically asked by the EU Commission to provide such advice

However, in its scientific opinion on the safety of hydroxyanthracene derivatives for use in food, the authority failed to deliver such advice and provided no explanation as to why such advice could not be given.

He also pointed out that the draft amendment did not specifically exclude extracts of the leaf of Aloe species that have been processed to remove HAD, such as ‘decolorized’ or ‘purified’ extracts.

“It would seem to be appropriate to include an exclusion for purified extracts because such extracts have been shown to be non-mutagenic, both in vitro and in vivo in all studies except for one,”​ he says.

Bucchini also highlights the effect Covid-19 is having on these decisions arguing that the Commission should allow a longer comment period since Italy and France are affected by the decision and by the Covid-19 virus.

“It will be a challenge for the industry to "save" plants in annex C (rhizome of Rheum palmatum L., Rheum officinale Baillon root extracts and their hybrids, leaf and fruit extracts of Cassia senna L. and extracts from Rhamnus frangula L., Rhamnus purshiana DC.),” ​he adds.

“If there is no convincing data within four years, they will be moved automatically to annex A (banned).”​