ATTENZIONE: gli integratori dell'UE sono in grave pericolo
Free choice for supplements could be saved if the European food supplement industry takes action NOW to stop bad science being used for HARMonisation
We’ve become accustomed to a free market where most of us, most of the time, can access the food supplements we need to help keep us healthy, in the forms and amounts we need.
But if the European Commission gets its way and rolls out its full regulatory system for supplements, our freedom of choice will be dramatically restricted in a matter of a few years.
With all the media attention on energy prices, the war in Ukraine, the corona crisis, nitrogen quotas and so on, this threat has been hidden from the public.
If supplements – with their great therapeutic value, safety and cost effectiveness – are banned from the market, it will be difficult to maintain or restore our own health.
How did it all begin?
The attack on food supplements started with the framework European Food Supplements Directive of 2002 which initially limited the forms of allowed vitamins and minerals via a restrictive positive list, and allows the European Commission to harmonise and regulatory limit the maximum permitted levels (MPLs) of vitamins and minerals in supplements.
Thanks to the legal intervention of the ANH (Alliance for Natural Health) and other parties, the different forms of vitamins and minerals have been saved and the ANH has relentlessly petitioned the European Parliament to prevent the Commission from going ahead with its plan using a flawed risk assessment process.
Maximum Permitted Levels (MPLs)
The planned MPLs have not yet been set by the European Commission, which has the power to do so granted under Article 5 of the Food Supplements Directive. The Commission will make this decision based on the scientific opinion of another European institution, the Parma-based European Food Safety Authority (EFSA). The Commission is poised to make a decision in the very near future.
Maximum levels will be set for: iron, folate, manganese, vitamin A, vitamin B6, vitamin D, vitamin E and B-carotene. The EFSA has a history of cherry picking particular, often flawed or irrelevant studies, to justify its very low Tolerable Upper Levels (TULs) for micronutrients, which is among the key determinants of MPLs. On top of that, the EFSA continues to ignore clear scientific evidence of benefits for many people when taking levels above these ridiculously low limits. For example, EFSA has recently moved to halve the previous TUL of vitamin B6 without any new data or signals of risk. See also: https://www.anhinternational.org/news/eu-prepares-for-ban-on-therapeutic-doses-of-b6/
It’s hard to interpret this intention in any other way than a plan to limit freedom of choice and prevent the vitamin’s high dose, therapeutic use.
A new approach by EFSA
In November 2021, the EFSA revised its methodology for establishing TULs. It remains based on a toxicological model developed originally for chemicals in food that have functional but not nutritional value. The methodology aims to completely rule out any risk of micronutrients in any population, however small or reversible the risk, even among those most sensitive to this effect. This makes this kind of methodology completely unsuitable because we have to accept that some foods pose some risks to people, so that others benefit. Such risks are accepted in conventional foods (e.g. gluten-containing grains, dairy, sugars, oxalates, lectins, goitrogens, phytates, tannins, saponins, histamines, salicylates).
EFSA’s new guidance can be found here: ‘The Guidance for establishing and applying tolerable upper intake levels for vitamins and essential minerals’. [https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2022.e20010]
While uncertainty factors (UFs) have long been used to deal with uncertainties caused by lack of data, these have been even more cautionary. For example, young children have now been added as a standard example of a sensitive group, EFSA arguing this is justified because: “foods intended for the general population are also consumed by young children, so young children should be considered as a potentially sensitive consumer group.”
The new methodology has recently been applied to the risk assessment of vitamin B6 With no new data available, the proposed TUL of vitamin B6 has been lowered from 25 mg to a very low 12.5 mg. See also: https://www.anhinternational.org/news/eu-prepares-for-ban-on-therapeutic-doses-of-b6/ To get to this level, one that would be applied to half a billion European citizens in the EU, the EFSA applied a 300-fold uncertainty factor from a study of five beagle dogs published in 1978.
EFSA’s flawed risk assessment approach
Unfortunately, there are a lot of shortcomings to the risk assessment approach of the EFSA.
- The EFSA uses models which are also applied to risk assessments of real toxins like aluminium, lead, cadmium and mercury. The majority of us will admit that vitamins and minerals are not comparable to such hazardous substances. At normal or even therapeutically valuable ranges of consumption, they do no harm and are either essential or beneficial for our health and wellbeing.
- The EFSA approach involves the blanket application of the precautionary principle. However, it is clear from a Commission opinion on the applicability of the precautionary principle, see: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2000:0001:FIN:EN:PDF and case law (e.g. Solgar Vitamin’s France and Others, C-446/08) that such blanket application may lead to disproportionality.
- The EFSA ignores completely the overwhelming evidence of the benefits of supplementing vitamins and minerals and only takes into account the possible risks to the most sensitive or vulnerable populations.
- Although caselaw requires that a proper riskassessment has to be based on the most reliable scientific data available and the most recent results of international research, the Efsa doesn’ t meet that standard. For example: In the Noria case (France) the European Court of Justice (C-672/15), states that restrictions should only be justified “after a comprehensive scientific assessment of the risks for public health, based not on general or hypothetical considerations, but on relevant scientific data.” Regarding its opinion on the proposed new TUL for vitamin B6, the studies used as data sources are outdated, flawed, or irrelevant. There are almost no randomised controlled trial (RCT) studies, which give much more reliable and objective data.
- The EFSA does not take into account that vitamins and minerals appear in different forms and with different effects on our bodies, also in terms of a risk assessment. For example: their scientific opinion about vitamin B6 refers to vitamin B6 in general without specifying which particular form is investigated, which is an incredibly flawed method.
- Despite EFSA’s statutory duty to indicate at which level a substance will be injurious to health and thus be unsafe (see article 14 of the General Food Law) the used methodology works the other way around. The EFSA does not research at which level a substance is unsafe but only makes an estimation on which level the substance is still safe and subsequently concludes that there might be a risk above this level. The EFSA thus fails to meet its legal obligations.
Where are we heading to?
When the EFSA has completed the remit to propose upper levels for the above mentioned 8 vitamins and minerals the European Commission (EC) will create a draft-regulation in which the maximum levels are finally set. Before the regulation can be adopted, the EC has to ask advice from the Committee on Plant, Animals, Food and Feed (PAFF committee). The PAFF Committee is composed of representatives from all EU countries and is presided over by a member of the European Commission. They are all not democratically elected. https://food.ec.europa.eu/horizontal-topics/committees/paff-committees_
In this so-called comitology procedure there is almost no control by the European council or the European parliament. Once the regulation is in place, Member States will no longer have the right to make exceptions or to ignore the restrictions. Supplement companies will have to remove products from their inventory or reduce the levels of affected ingredients. The result will be that before long only food supplements with little or no therapeutic value will be available in Europe. We must avoid this at all costs.
C'è una via d'uscita?
Over the last decade, the ANH has been at the forefront of advocating for the use of assessment models that take into account both risks and benefits. With the help of collaborations with TNO and the University College Roosevelt in The Netherlands, ANH has developed a scientifically valid micronutrient assessment model that takes into account not only the risks but also the benefits of the micronutrients, in their relevant forms. The new, open-source model is called the Micronutrient Risk Benefit (MRB) Model [https://www.anhinternational.org/news/anh-micronutrient-risk-benefit-model-video-released/].
The MRB model stands in sharp contrast to the risk-based models used previously and we believe this model represents our best opportunity to maintain acceptable and effective levels of micronutrients in both food supplements and functional foods.
Our foremost purpose is to ensure that the model is recognised as the most progressive and latest approach to risk/benefit assessment for the determination of MPLs so that other methodologies are not used to unnecessarily and unjustly limit vitamins and minerals in food supplements and functional foods in the EU.
We need your help!
By becoming a member of ANH Europe you can support our activities through your monthly or annual contribution!
Your support will enable us to continue our important work to push back this legislation and to promote the MRB risk-benefit model!
Our ultimate goal is to realise full freedom of choice over our health, lifestyle and use of vitamins and minerals for all European citizens.
We thank you in advance for your much needed support!
President ANH Europe,
Nick van Ruiten, MSc, MBA