At a meeting in Brussels on June 6, the heads of European food safety agencies (HoA) unanimously adopted a list of critical substances suitable to be prohibited via initiation of the Article 8 procedure, based on a report from the Working Group on Food Supplements (HoA WG FS) that raised concerns around health and overdosing risks.
The report identified 117 substances that "may pose a health risk due to their potentially dangerous properties" and therefore "should not be used or only used to a limited extent in dietary supplements."
Communicated by the Federal Institute for Risk Assessment (BfR) in Germany, the report outlined the 13 substances most eligible for an Article 8 procedure: black cohosh (Actaea racemosa), coumarin, curcumin, St. John's wort (Hypericum perforatum), maca or Peruvian ginseng (Lepidium meyenii), melaleuca, melatonin, holy basil (Ocimum tenuiflorum), piperine, p-Synephrine, Tribulus terrestri, tryptophan and ashwagandha (Withania somnifera).
The report stated that curcumin, peruvian ginseng, melaleuca, Ocimum tenuiflorum, piperine, Tribulus terrestris and Withania somnifera exhibit (possible) carcinogenic, mutagenic or reprotoxic properties and advised that the European Commission should prioritize these in evaluating these substances.
It listed a further 20 substances which “raise concern based on their hazard characteristics and which (might) exceed normal intake from a balanced and varied diet.” This includes commonly used botanicals such as Carica papaya, Cinnamomum verum and Ginkgo biloba.
"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 (BVL). "The working group is making a significant contribution to this by developing the list of critical substances. 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 cooperation between food safety authorities in Europe."
Ultimately, the European Commission will decide whether these proposals will be implemented.
'Urgent need' to restrict melatonin
Regarding melatonin, based on national risk assessments from France and Norway, the HoA WG FS raised concerns regarding a potential risk to consumers due to general headaches, dizziness, drowsiness and cardiovascular, neurological, digestive and psychological symptoms.
The report noted in many member states (MS), "there is an urgent need to e.g. determine the maximum daily dose of melatonin, or to restrict products aimed at children. However, as melatonin is considered medicinal in several MS, depending on e. g. the daily dose, the topic is highly complex. The HoA WG FS suggests to put further processing and submission of melatonin to the EU COM on hold for now.?
Regarding Tribulus terrestris and ashwagandha, the report noted that the National Institute for Public Health and the Environment (RIVM) is currently working on risk assessments that will be published in 2024. The last report by RIVM on ashwagandha was published in March this year and advised against use of the ingredient, much to the disproval of several experts.
'Careless' and 'biased'
Luca Bucchini, European regulatory expert and managing director at Hylobates Consulting, said that the report reads as the biased opinion of those against food supplements.
"The report is written with a view of encouraging the Commission to ultimately introduce restrictions or complete bans," he told NutraIngredients. There is a long way to such regulations, but it is not reassuring to see bias in efforts such as this. We need high-quality safety assessments of botanicals and other substances from unbiased experts to develop proportionate rules in Europe."
He noted that the report's second list of substances and plants of concern includes everyday herbs, such as basil and cinnamon, in the same column as huperzin, which is banned as a prohibited novel food.
"It will not be easy for impartial scientists and scientific bodies to be heard in this situation, but we really need that type of work to make progress to protect consumers, to understand the plants and have better products," he added. "In short, this report makes it harder to understand the real safety issues and regulate food supplements in the EU, though hopefully the member states and the Commission will correct the issues with the report focusing on the actual problems."
US-based ethnobotanist Chris Kilham, aka the Medicine Hunter, said EU authorities are failing to do basic due diligence in their safety assessments.
"I am blown away by the carelessness and lack of science among EU regulators regarding botanical supplements," he said.
He asserted there were basic checks the authorities should do in assessing the safety of these ingredients, such as reviewing human consumption data from other countries. For example, he asserted: "One could not consume enough curcumin supplements to match the amount of curcumin in the diets of hundreds of millions of Asians."
He questioned if regulators had reviewed Germany's Commission E Monographs, ESCOP (European Scientific Commission monographs on Phytomedicines), the WHO botanical monographs or the peer-reviewed data from systematic reviews, meta-analyses, epidemiological studies and human clinical studies.
He suggested that if they had sought the expertise of people in the industry "whose knowledge of botanicals vastly exceeds their own", they would be presented with an abundance of scientific data on the safety of these ingredients.
"I would assert the regulators who are now taking pot shots at botanicals have done few or none of these things," he said. "We have a significant issue of regulators not at all familiar with botanicals and who don't know the industry has immense peer-reviewed scientific data of real value."
A spokesperson for the German Federal Office of Consumer Protection and Food Safety stated: "All literature considered for the preparation of the report has been listed in this report and in particular addressed in Table 2 and Annex C. Primarily, the risk assessments prepared by the competent national and European authorities were taken into account.
"Furthermore, it was ensured that the risk assessments are up-to-date and of high quality. The primary literature used to prepare the risk assessment is noted in the respective risk assessment.
"The work of the HoA WG FS was not intended to replace the assessment by EFSA. If the COM forwards the substances to EFSA for evaluation, all substances will be scrutinized and evaluated by EFSA anyway and current studies, monographs etc. will be assessed accordingly.
"On the basis of EFSA's opinions, COM can then decide together with the Member States whether the use of a substances should be completely banned, should be restricted or should be put under community scrutiny to be reviewed within further four years."
Article 8
Article 8 authorises the European Commission (EC) to initiate the procedure to prohibit, restrict or put under Union scrutiny a substance that is used in foods, either at the EC's own initiative or at the request of Member States.
While the hope was for member states to find common ground and harmonization, so far this procedure has been used to bring a growing list of botanicals onto the regulatory chopping board.
The European Federation of Associations of Health Products Manufacturers (EHPM) recently called on new EU policy makers not to use the Article 8 procedure as a tool to establish a negative list of botanicals.
“Take risk management decisions that are proportionate to the level of the identified risks, and ensure that the application of the precautionary principle does not have the undesirable effect of limiting consumers’ access to food supplements that can contribute to maintaining or improving their health,” it stated.