EHPM raises concerns over EU report flagging botanicals as possible health risks

The report, produced by the Heads of Food Safety Agencies (HoA) Working Group on Food Supplements, identified a total of 117 substances that should not be used in food supplements or should only be used to a limited extent due to their “possible hazardous properties which may lead to human health risks”.

Of the 117 substances identified, 13 ingredients have been prioritised by the working group based on their risks for human health that require a legally binding regulation.

Besides curcumin, St John’s wort (Hypericum perforatum), and ashwagandha (Withania somnifera), the list also includes coumarin in plant preparations; tea tree (Melaleuca) essential oils; melatonin; tryptophan; black cohosh (Actaea racemosa), and the black pepper alkaloid piperine.

Other ingredients prioritised in the report included p-synefin in citrus preparations; Peruvian ginseng or maca (Lepidium meyenii); holy basil or tulsi (Ocimum tenuiflorum); and the tribulus (Tribulus terrestris) plant.

“Making food supplements safer is an important component of our daily work to protect the health of citizens in Europe,” said Friedel Cramer, president of the Federal Office for Consumer Protection and Food Safety. “By drawing up the list of critical substances, the working group is making a significant contribution to this.

“I would like to thank all members of the working group for their constructive work. For me, it is a successful example of the valuable and practical co-operation between food safety authorities in Europe.”

Existing nutrivigilance systems are ‘valuable tools’ to guarantee safety of food supplements

The working group, which comprises representatives from 26 European countries, as well as members of the European Commission’s Directorate-General for Health and Food Safety and the European Food Safety Authority (EFSA), said the European Commission should now support EFSA in evaluating the substances.

Should EFSA support the working group’s conclusions, legislative action can be taken by the EU Commission. For the remaining substances, the report advised further regulatory measures.

Industry concern over the report’s findings centres on the current strict EU rules, which ensure a high level of safety and quality are in place to protect consumers.

The European Federation of Health Products Manufacturers (EHPM) pointed out that the food supplements industry is already required to collect data to address safety concerns.

“Existing national notification systems and nutrivigilance systems are valuable tools to further guarantee the safety of food supplements marked in the EU,” said Livia Menichetti, director-general of the EHPM.

“The EHPM supports its members by providing tools and resources to further enhance safety and quality, advocating for compliance to regulations and adherence to best practices, and representing industry interests in regulatory discussions.”

EHPM: Food safety agencies ‘overstepping’ their remit

Regarding the report, the EHPM identified the potentially misleading use of Article 8 of Regulation 1925/2006 and the working group’s intention to use this regulation for the listed substances.

“Article 8 of Regulation (EC) No 1925/2006 needs to be applied when a safety risk arises and not for an arbitrary classification purpose,” explained Menichetti.

“EHPM is concerned about the fact that the European Heads of Food Safety Agencies’ (HoA) approach may lead to a misleading use of the Art. 8 procedure for classification purposes, which could set a concerning legal precedent.”

The EHPM also flagged an “overstepping” of food safety agencies’ remit, which the industry group said “encroached upon risk management responsibilities reserved for the European Commission and member states”.

Menichetti said: “Food safety agencies are tasked with conducting risk assessments, not risk management. The latter falls under the remit of the European Commission after a risk assessment is conducted by EFSA or member states’ safety agencies.

“If food safety agencies are directly influencing risk management decisions, it could undermine the regulatory process and encroach upon the responsibilities of the appropriate authorities.”

EHPM highlighted the need for clear separation between risk assessment (by EFSA and national food safety agencies) and risk management (by EU bodies and member states).

In an Instagram post, Chris Kilham, an author, educator, and researcher of plant-based medicines, said: “HoA, knowing absolutely nothing at all about maca, wants to restrict or ban it.

“Companies in the European botanical industry will be well advised to take this situation seriously. People in the botanical industry are the botanical experts.

“We have the deep knowledge, the science, the field experience, the manufacturing expertise, and most of the most valuable studies on botanicals.”