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August 2003 Update                Diverging views on the EU Directives

Manufacturers, suppliers, retailers, practitioners and consumers in Europe have received a very wide range of sometimes conflicting messages about the likely impact of the EU legislation (see Box 1 for summary). Information filtering across the Atlantic is even more inconsistent. With so much confusion, many companies are doing nothing.

Box 1: Summary of key EU Directives

The reality is that a clutch of EU legislation is making its way through the EU law-making pipeline covering the full spectrum of dietary supplements, including herbal products, so-called ‘borderline products’, fortified foods, sports nutrition. In addition new EU regulations on health claims have recently been proposed and these are more or less identical to those just proposed in the US. For many it is the combined effect of all the EU laws that is of greatest concern. 

Fortunately, only one directive has so far been passed in to EU law and EU member country legislation, this being the Food Supplements Directive. There is therefore still considerable scope to amend and shape the other legislation, assuming European and international interests get behind the appropriate campaigns.

One of the reasons the Food Supplements Directive managed to scrape through the European Parliament is that major international and European trade associations advised their member companies that the directive was going to be generally beneficial for the industry and they should plan ahead to comply with it. In contrast, it has been consumer, retailer and practitioner groups, especially in the UK, Sweden and Ireland, that have consistently claimed that the legislation could be catastrophic for particular sectors.

Since the directive’s passage in to EU law, many of the leading companies and associations with interests in the innovative sector of the European dietary supplement industry have come together under the umbrella of the pan-European and international Alliance for Natural Health (www.alliance-natural-health.org).

A detailed look at the legislation suggests that the primary reason for discrepancies in view over the Food Supplement Directive’s impact is the difference in impact of the legislation on different sectors of the industry. Innovator suppliers and those who are dependent on their products will inevitably be hardest hit. Companies manufacturing or selling relatively low-dose, synthetic vitamins and inorganic minerals will actually be set to gain considerably from the legislation, benefiting from the single market conditions across the 15 EU member countries (soon to be enlarged to 25) set by the directive, its primary intended purpose.

But, for others, the loss of many food-state vitamins (e.g. mixed tocopherols, tocotrienols, natural carotenoids, methylcobalamin (a form of B12), a range of minerals such as sulphur, boron, vanadium, silicon and many chelated or plant-derived forms is of great concern. Since the Food Supplements Directive is incremental in its effects, with even the bans on nutrient forms not coming in to force until 1 August 2005, many detractors argue that future effects could cumulatively have catastrophic impacts on innovators, independent retailers and practitioners.

Food Supplements Directive: key concerns

In summary there are four primary concerns about the Food Supplements Directive. These are:

1. Limited range of nutrient forms allowed on the ‘positive list’ (Annex I & II of FSD). The UK Food Standard Agency has determined that there are at least 270 ingredients (nutrient forms) that are presently used in the UK that are not included on the positive list. The National Association of Health Stores has in fact determined that this is an understatement, the real figure being in excess of 300 ingredients. These ‘missing’ ingredients are included in some 5000 products just on the UK market. The Irish Association of Health Stores has determined that around 85% of vitamin/mineral products in Irish health stores contain one or more missing nutrient form and would require reformulation to comply with the directive. One of the greatest concerns of the Alliance for Natural Health (the leading pan-European group working to positively shape the legislation) is that many of the missing forms are food-forms that are more bio-available (and generally safer) than the synthetic or inorganic forms included on the positive list.

2. Difficulties and costs in submission of dossiers (Article 4.6) to allow derogated use of off-list nutrient forms. The key issue here is that most supplement companies are in fact formulation companies who buy in products from a limited number of raw ingredient manufacturers or producers. If these manufacturers choose not to put in dossiers, then the formulation company would not be able to use it. However, if one manufacturer submits (and has approved) a particular dossier, any formulator can use that ingredient (at least until 31 December 2009). Costs for dossiers vary greatly according to the amount and nature of existing data: but estimates vary from €20,000 to over €300,000, depending on the ingredient. In addition, because the time frames are limited (12 July 2005), there may not be sufficient time to generate all the data for some ingredients.

3. Reductions in Maximum Permitted Levels via unnecessarily low Upper Safe Levels (USLs), being developed by the SCF/EFSA without a procedure that allows open consultation with outside scientists or other experts. The Alliance for Natural Health Expert Committee has determined that some of the science being used by the SCF is flawed[1] and it appears that it is being used in order to justify very low maximum levels of nutrients in food supplements (the consequence of this is that higher levels will still be regarded as drugs and can therefore only be administered by doctors as is currently the protocol in many of the countries with less permissive legislative regimes) (Article 5).

4. Future restrictions on nutrients other than vitamins and minerals as of 2007, such as amino acids, fatty aids, phytonutrients, enzymes, fibre, probiotics, etc. These restrictions could be brought in via a positive list system (Recitals 6 & 8, Article 4.8).

It seems that the intended purpose of the FSD is to protect the simplest, low-dose, food supplements, of the type typically sold in European supermarkets and pharmacies. The more specialist forms, particularly those using food-form nutrients will only be able to remain on the market after August 2005 if dossiers for their ingredients are submitted and accepted, with all the contingent difficulties.

For many companies there is simply not enough time to conduct the necessary safety studies, given that there has never been any incentive or reason to do this work for a large proportion of the food-form nutrients. For others the task is too expensive. Take for example, selenomethionine, the most common form of selenium found in foods and well known as a very important antioxidant mineral: this form of selenium was rejected by the European Food Safety Authority (EFSA, formerly the Scientific Committee on Food [SCF]) in 1999 because long-term safety studies had not been conducted. Instead, EFSA has allowed use of two inorganic forms of selenium (sodium selenate and sodium selenite) that are both more toxic and less beneficial as antioxidants. For many consumers this is very confusing, as they hear on one hand that we should increase our consumption of Brazil nuts which contain high doses of selenomethionine, yet the EU Commission does not approve on its positive list use of this safe form of selenium simply because the studies are not available. Are food manufacturers being asked to provide safety data on natural products? Who for, example, has been required to prove via clinical trials that fruits and vegetables are safe?

Legal challenge of the Food Supplements Directive

The ANH is working with its scientific Expert Committee, outhouse lawyers, public affairs and media specialists to either annul or positively shape key EU legislation set to otherwise severely impact the innovative supplement industry and its beneficiaries. Although there is plenty that can still be achieved by effective lobbying on the amendments to the Pharmaceuticals Directive and the Traditional Herbal Medicinal Products Directive, and ANH is hard at work on this, options are far fewer for the Food Supplements Directive.

There is still some room to influence the maximum permitted levels and positive lists for nutrient groups other than vitamins and minerals, but the directive has already passed into European law and gets its full teeth once the directive is implemented fully in EU member states 2 years after its transposition in to their laws, in August 2005.

So, on behalf of innovators and practitioners, the ANH is proposing to challenge the validity of this directive later this year, and is working on this case with its out-house lawyers who are among the most experienced European lawyers in the EU.

Challenging the directive would make no sense unless there were reasonable grounds and probabilities of success. The ANH has retained the only legal team to ever have overturned an EU Directive – and after a detailed examination of the FSD, this team has given the ANH a green light to proceed (www.alliance-natural-health.org; see Latest News, 8 August 2003). The case is being built on a number of grounds, but of particular importance are EU constitutional grounds which suggest that there is a real chance of annulling the directive.

In addition, it appears that the effects of the directive can be challenged on grounds of proportionality, based on the fact that that it will impact on certain sectors of the industry, notably those associated with innovative products, in a disproportionate manner. The challenge must be mounted by the end of September of this year, so there is a huge amount of work still to be done. Legal, scientific and commercial experts are hard at work on the case already, since as a Judicial Review, the case needs to be built with solid foundations before it is submitted. Interestingly, if the directive is annulled, all national laws reliant on the directive are likely to be invalid.

Dr Robert Verkerk, Executive Director of the ANH, said, “the case will allow the real science of nutrients to be showcased to the Commission, to the Parliament and to the public generally. People will understand that supplementation of a good diet with high quality nutrients is a valid and effective way towards optimum health. There is no scientific rationale for accepting synthetic vitamins and a limited range of inorganic mineral forms while rejecting the plethora of naturally occurring vitamins and minerals. Winning the case will pave the way to a very bright future for the industry. We are not suggesting that there should be no directive at all, but the existing directive needs to be replaced with a re-worked version that allows for high quality, effective supplements across the whole of Europe. It’s about harmonising to good standards, not bad ones.”

It is now time for all manufacturers, suppliers, retailers and practitioners who believe their businesses are at risk to join the ANH campaign – and support the legal challenge. Contact Henrietta Lee, the ANH Campaign Manager on info@alliance-natural-health.org or phone + 44 1252 371 275 to find out how you can join the campaign and be part of the ANH’s rapidly expanding Support Base (see www.alliance-natural-health.org). Support is needed NOW as the timescales for the legal action are very tight.

The other Directives

The two key EU directives that will regulate basic supplements will be the FSD (but only those containing ingredients on the positive list or for which dossiers have been approved) and the amended pharmaceutical directive (PD) (Directive 2001/83/EC), of which the traditional herbal medicinal products directive (THMPD) is a part. So if a product is not able to be controlled under the FSD, it will default to the PD. If it falls under the PD, it will either require a full drug license (with the very substantial data requirements and costs required for drug approvals) or, if appropriate, botanically-based products can be classified as ‘medicinal herbs’ and benefit from a ‘fast-track’ licensing scheme. This ‘fast-track’ THMPD procedure requires that the applicant can demonstrate 30 years safe, traditional use is used in lieu of safety data (the major component of data required for market authorization as a drug).

The THMPD is passing through the European regulatory process now and one particularly contentious issue is the requirement in the EU Commission’s proposed legislation for 15 years EU use, out of the total 30 years traditional use. The Alliance for Natural Health, along with several other organisations have tabled amendments and are campaigning to allow 30 years demonstrated safe use form anywhere in the world. They argue that limiting non-EU use will prevent interesting and beneficial herbs discovered in parts of the world with very strong herbal cultures (e.g. China, India, South East Asia, South Africa, South America) from being brought in to Europe and it will therefore strongly impact future innovation. The legislation would essentially have the effect of freeze-framing the industry in the early 1990s.

In addition to this, further directives are being prepared by the EU Commission on sports nutrition and fortified foods, and draft Health Claims Regulations were tabled in Brussels in July of this year.

Conclusion

The US dietary supplement industry has flourished in the face of what must be regarded relatively as very liberal laws. There are clearly steps being taken by the FDA and others to alter this, but it seems the industry together with its huge consumer support base has so far defended itself very well against unnecessarily restrictive legislation. The current US campaigns against Durbin’s Bill S722 is a good example of how a diverse range of interested parties can work together.

The US industry is without question the world leader in this field, and there is growing evidence that nutrients in dietary supplements may be used very successfully in the prevention or even treatment of diseases.

Owing to the trends towards global harmonization, and in particular increased pressure towards trans-Atlantic harmonization, the EU Directives have a direct influence on the shape of future US laws. In addition to this, many US companies have substantial and growing markets in Europe, which will, following enlargement in two years time, have a population of some 450 million people.

The Alliance for Natural Health developed initially as a diverse range of largely European interests who were not against legislation per se, but were concerned about legislation that would potentially kill off innovation in the future. It has now developed an increasingly strong support base across Europe as well as in the US. The joint international committee of the NNFA and AHPA in July unanimously put forward a motion that supported the ANH’s legal action against the Food Supplements Directive. Some have gone as far as suggesting that the EU Directives are an even bigger threat to the US industry than the original proposal for DSHEA which was positively amended in 1994 following huge protests in Congress.

Time is of the essence – and every company or individual with interests in the future of the dietary supplement industry, both in Europe and the US, should now very seriously consider whether they want to accept the Food Supplements Directive, or be part of the potentially ground-breaking challenge that could pave the way to a very bright future for the industry.