Proposal To Restrict Use Of Popular Supplement Ingredients In EU 'Highly Problematic'
Executive Summary
FoodChain ID’s head of scientific affairs Jérôme Le Bloch discusses a proposal put to the European Commission by national food regulators to restrict on safety grounds the use of popular substances such as curcumin, melatonin and St John’s wort in supplements.
Popular food supplement ingredients including melatonin and curcumin and have been recommended for a safety assessment which could lead to their use being restricted or banned outright across the EU.
A working group of the heads of European food safety agencies (HoA) has drawn up a list of 13 substances – other than vitamins and minerals – with a nutritional or physiological effect added to supplements which it says should be prioritized by the European Commission for a review under Article 8 of Regulation (EC) No 1925/2006. Annex III of this Regulation lists substances which are known or suspected to have adverse effects on health and outlines restrictions on their use.
Substances Prioritized For Article 8
Actaea racemose, Coumarin in plant preparations, Curcumin in Curcuma spp.-preparations, Hypericum perforatum, Lepidium meyenii, Melaleuca spp.-essential oils, Melatonin, Ocimum tenuiflorum, Piperine, p-Synephrine in Citrus spp.-preparations, Tribulus terrestris, Tryptophan, and Withania somnifera.
According to the HoA working group’s report, the 13 substances – listed in sidebar – are eligible for an Article 8 procedure as they are considered to pose a risk to consumers and their intake through supplements greatly exceeds normal intake from a balanced diet.
The working group identified in total 117 substances which it says based on existing risk assessments should be prohibited or restricted in supplements.
Of these, 65 were assumed to be “novel,” with the group recommending assessment by the Commission under the Novel Foods Regulation.
Jérôme Le Bloch
As for the remaining 49 substances, the group says 13 should be prioritized by the Commission for Article 8 as they pose the greatest risk to consumers, with some exhibiting possible carcinogenic, mutagenic or reprotoxic properties.
With manufacturers now facing a nervous wait to see how the Commission responds to the working group's recommendations, market expert Jérôme Le Bloch tells HBW Insight that the HoA report represents the latest move by the regulatory authorities to increase their oversight of Europe’s supplements industry.
Le Bloch – who is head of scientific affairs at consultancy FoodChain ID – takes issue with many aspects of the report, questioning the working group’s motivations and methods in drawing up the unsafe substances list.
He also offers his advice to those companies marketing supplements containing substances listed in the report and suggests where industry needs to improve when it comes to assessing the safety of the ingredients in their products.
However, this process is biased, as:
1) The safety evaluation is performed by national competent authorities, but does not include up-to-date scientific data. Some reports were published more than 10 years go, and even 20 years ago for one report on Griffonia simplicifolia. The decision is based therefore on part of the available data.
2) The reading of the HoA report clearly shows that the initial idea was to request Article 8 review for these substances, before assessing their safety.
The justification presented for each substance – in Annex C of the report – is questionable for some ingredients, but there are not enough details in the document. As the HoA position is based on the work performed by national authorities, we need to evaluate each single report.
*Editor’s note: The DACH list was established by Germany, Austria, and Switzerland with the objective to provide all parties involved in the trade of goods with a decision guidance for the assessment of substances regarding their use as food or food ingredients.
If some ingredients are added to Part A or Part B there is no possibility to provide additional data. Food business operators (FBOs) just need to follow the new requirements. If ingredients are added to Part C, FBOs can provide new data. In this case, I strongly recommend providing a full characterization of the ingredient with the safety report.
The recent EFSA opinion on the safety of plant preparations containing hydroxyanthracene derivatives (HADs) listed in Part C is a perfect example. The 14 studies evaluated showed a lack of any genotoxicity effects but were rejected due to insufficient characterization of the tested extracts. EFSA based its opinion on a single extract, in which compounds with potential safety concerns have been identified. The final decision was a risk of HADs, despite the data provided by FBOs. So, to be included in the EFSA opinion of a substance under scrutiny in Part C, a full characterization of the ingredient is mandatory.
EFSA opinions and evaluations are also examples of the current position of the authorities. Novel food approvals are limited, and EFSA requirements are now so high that applications need years to be authorized, after a significant investment in terms of analyzes and studies. Clearly, the regulatory changes and upcoming regulations will strongly affect the supplement market.
I strongly recommend FBOs provide data and studies to EFSA when given the opportunity through public consultations. If these analyzes and studies are pertinent, this can affect positively the authorities’ evaluation. Of course, if there is no request from the authorities, it’s useless to provide data.