Safe Upper Levels: Priority one for the Food Supplements Directive
The European Union's Directive on Food Supplements (2002/46/EC) came into force in July of this year, representing the culmination of some 13 years of negotiation and deliberation and, some claim, putting together a framework which in time could lead to the desirable outcome of a harmonised, pan-European marketplace for supplements.
However, many believe that the greater task lies ahead, because hidden in many of the elements of the new legislation is a need for a staggering amount of scientific and technical information to serve as a basis for the control of these products.
One issue is that the Directive's list of permitted substances does not cover many that are already sold in supplements in the EU. At the moment, companies selling these products are safe because member states can apply to be exempt from complying with the Directive, provided the nutrient was sold in the EU before it came into force (and the sponsor agrees to submit a scientific dossier to support the nutrient's addition to the Directive's positive lists), until 1 August 2005.
By this time, products containing vitamins and minerals also will have to comply with the Directive's requirements on Safe Upper Levels (SULs) of micronutrients and specific label statements and labelling formats, such as allowances for "overages," when higher levels of a nutrient than labelled are used in a product to allow for loss of activity over the course of its shelf life. In addition, all this body of work relates only to the use of vitamins and minerals in supplements, and similar exercises will have to be undertaken in the future as each category of ingredients (for example, amino acids, fatty acids and phytonutrients) is added.
Just thirteen nutrients already have Safe Upper Levels
Of these outstanding issues, the setting of SULs is probably the most pressing. Responsibility for setting these values lies with the European Commission's Scientific Committee on Food (SCF) and, to date, this body has come up with levels for 13 nutrients, a fraction of the total permitted for use in supplements, with the primary problem being a simple lack of scientific data to allow any defensible level to be set. This presents the European Commission with a serious problem, because it is beholden to take the values arrived at by the SCF and then undergo a risk-management exercise to arrive at final SULs to be applied in European law.
"Higher intakes of vitamin B6 could lead to nerve damage, memory problems and loss of balance"
At the end of August, the UK Food Standards Agency's Expert Group on Vitamins and Minerals (EVM) published its own draft report on SULs for a range of nutrients. This body was set up in 1997 in the wake of controversy over the British government's proposal to reduce the permitted level of vitamin B6 in foods and supplements to a maximum of 10mg/day, and tasked to consider the safety of all vitamins and nutrient minerals.
The EVM's draft report covers 34 substances that were assessed in detail and, of these, the EVM has recommended SULs for just nine (vitamin B6 - 10mg/day; beta carotene - 7mg/day; vitamin E - 727mg/day; boron - 5.93mg/day; copper - 5mg/day; nickel - 0.16mg/day; selenium - 0.2mg/day; silicon - 1,500mg/day; and zinc - 25mg/day). Of these, only six have any immediate relevance for the supplements Directive, as three (boron, nickel and silicon) do not feature in the list of permitted minerals.
Reliable data thin on the ground - authorities differ on upper levels
As was the case with the SCF, the EVM project was unable to arrive at SULs for nearly three-quarters of the substances reviewed because of a paucity of reliable scientific data. There is a lack of well-designed, comparative studies of significant size and duration, little consideration of potentially vulnerable populations such as children and the elderly, and, in some cases, only results from animal studies, requiring extrapolation of the data to humans. Despite this, the EVM has come up with guidance, but no SUL, on a further 22 nutrients, including vitamins A, B12, C, D and K, folic acid, iron and calcium.
The EVM's figures are not hugely at odds with those of the SCF, although there are some differences. For example, the SUL for vitamin B6 has been set at 10mg/day by the EVM, which believes that higher intakes could lead to nerve damage, memory problems and loss of balance, while the SCF has set a more generous 25mg/day level and the US Food and Nutrition Board, which has undertaken a similar exercise, favours 100mg/day.
In addition, the EVM has declined to give an SUL for magnesium, while the SCF has set a 'no observed adverse effect level,' or NOAEL, of 250mg/day, based on mild and transient laxative effect at higher levels. The EVM's guidance discounts these gastrointestinal effects and suggests that 400mg/day would not be expected to lead to any significant adverse reactions. This is in concordance with the FNB, which has set an upper level of 350mg/day for this mineral.
Germany, Ireland going it alone?
Since the EVM draft was issued, it has emerged that both Germany and Ireland are setting up their own committees to provide guidance on SULs. However, in terms of European law, the Commission is required to act on the advice of the SCF alone, and there is no obligation to take into account opinions from national committees.
So what does all this mean to the food supplements industry? The answer may well be not too much, at least for the larger companies. Resistance to the directive is being whipped up in the UK, which along with the Netherlands has a very liberal market for food supplements, amid claims that the limits will lead to hundreds of supplements being withdrawn from sale and a significant reformulation effort that could drive many smaller manufacturers into extinction. This view, put forcefully by organisations such as Consumers for Health Choice, is vehemently denied by the Commission which insists that its aim is not to ban supplements, but to ensure those products on the market are safe and encourage manufacturers to conduct safety evaluations of their products.
"The Directive may lead to a liberalisation of the marketplace for food supplements in many countries"
For some, market will become more liberal
One fact that is often ignored in discussion of the implications of the Directive is that, for the vast majority of European consumers, it may actually lead to a liberalisation of the marketplace for food supplements. For instance, the flip-side to the Directive's requirements on positive lists, which many see as a restriction, is that the more restrictive member states must permit vitamins, minerals and supplement products that comply with the Directive to be marketed in their territories from 1 August of next year.
Peter Berry Ottaway, a UK-based consultant in food science and European food law, pointed out to just-food.com that any maximum level of vitamin which is five or more times the EU labelling RDA will actually lead to a whole vista of new product development opportunities for companies servicing upwards of 70% of European consumers. Indeed, the SULs arrived at by the SCF are likely to be more generous than the current situation in many countries, notably Germany, France, Italy, Spain and Ireland, where maximum levels are set at between one- and three-times the recommended daily allowance.
Moreover, a large proportion of the food supplement market in Europe consists of multivitamin products designed to deliver a large number of nutrients at or near the RDA, for example, products such as Whitehall-Robbins Healthcare's Centrum. In terms of volumes, products aiming to deliver high levels of nutrients are still largely niche brands, although of course there are exceptions, for instance Roche's Berocca, which delivers various substances, notably vitamins B complex and C, at high multiples of the RDA. Berry Ottaway believes that, providing adequate SULs are set for certain key nutrients such as vitamins C and E, most companies should not be too worried about the rest.
The EVM is welcoming comments on its consultation document, which visitors can view by clicking here, and will be presenting the final document to the FSA early next year.
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