By James J. Gormley

The European Food Supplement Directive (EFSD) is in place. Codex guidelines relating to vitamin and minerals have been adopted. WTO trade agreements are in place. The FAO/WHO Nutrient Risk Assessment workshop has come out with a model to help Codex and possibly the European Food Safety Agency (EFSA) use risk assessment to set potentially restrictive dosage levels.

With the Supplements Directive now in force, this is causing problems for some US companies in several ways:

The approved list leaves off hundreds of critical nutrients, so formulation choice and consumer access are greatly hindered;

• non-EU companies which file dossiers in EU countries and obtain approval are not always able to go to market since EU companies are awaiting final EFSA opinions;
• some US companies which sell into the EU are already pre-emptively dumbing down certain supplements in anticipation of restrictive European dosage levels.

Therefore, American consumers are already being impacted by restricted access here in the US since companies that also sell their US products into Europe are reducing potencies of certain ingredients across the board: for the US and EU markets.

Europe: Members Only?

The EFSD created a list of allowed ingredients and forms of ingredients (initially only applying to vitamins and minerals) for food supplements. All nutrients not on Annex I (ingredients) or Annex II (ingredient forms) of “the positive list” were restricted EU-wide as of August 1, 2005.

The immediate effect of the Directive was a ban on approximately 300 of the 420 or so forms of vitamins and minerals present in around 5,000 products then sold on the UK market, for example. The ban had similar effect on products in such countries as Sweden, the Netherlands, Ireland and others, which had been robust markets for food supplements.

The main exception was for companies submitted detailed safety dossiers for each vitamin or mineral-based ingredient form via recognized, competent authorities, typically member state’s food safety ministries, such as the UK’s Food Standards Agency (FSA) by July 12, 2005, a very expensive process, indeed. Member states which agreed to grant derogation (approval for continued sale until December 31, 2009) forwarded many hundreds of derogation requests on the Parma, Italy-based European Food Safety Authority (EFSA), requesting that these ingredients be added to the approved list.

In the case of the UK’s FSA, 375 dossiers were forwarded on EFSA, and that’s only via the UK—-the Netherlands and other countries were used to submit flotillas of requests for derogation and safety dossiers.

One of the problems with this process is that those ingredients which have been granted derogation by various EU member states are effectively in a state of commercial and regulatory limbo until the end of 2009 since international marketers and manufacturers are often hesitant to formulate, or reformulate, using an ingredient form that has derogation until 2009 but which has not yet been added to the positive list by the EFSA since there is the risk, some point out, that the particular ingredient may have to be removed from products if not added by EFSA by December 31st, 2009.

“Another question to ask is why the ‘EU Directive’ allows each member to set its own requirements for the importation and sales of dietary supplements,” said Philip Pittsford, international sales manager for Bloomingdale, IL-based NOW Foods. “Give us a true Directive, one establishing the criteria for entry into any one of the 27 EU member states. Set the safe upper levels (SULs) and then let us decide whether we should pursue the reformulations that may be necessary to enter the market.”

Herbals Directive

The EU Herbals Directive (Traditional Herbal Medicinal Products Directive) was published in the Official Journal of the European Union on April 30, 2004.  Under this directive, EU member states were required to take necessary measures to comply with the directive by October 30, 2005 (EU Herbals Directive, Art. 2.1). In this regard, the UK published Statutory Instrument 2005 No. 2750, “The Medicines (Traditional Herbal Medicine Products for Human Use) Regulation 2005.”

The Herbals Directive is supposed to establish higher levels of safety and quality for traditional herbal remedies and improve public confidence in the products. Although the Herbals Directive was to have been written into the national laws of all member states by October 30, 2005, most member states allow a transitional phase that will let companies “adapt” to the new regs until April 2011.

The EU Herbals Directive also requires the European Commission to submit a report to the European Parliament and to the European Council concerning application of the directive, including an assessment on the possible extension of traditional use regulation to other categories of medicinal products (EU Herbals Directive, Art. 16i), a report that is due April 30, 2007.

According to attorney James Turner of Washington, DC-based Swankin & Turner and chair of DC-based grassroots group, Citizens for Health: “Citizens has sought and received initial legal counsel on this EU Herbals Directive and been told by Richard Cunningham, who’s considered a dean of international lawyers in Washington, that the EU Herbals Directive is in direct violation of the standards of the World Trade Organization and is ripe for challenge.”

“In fact, Citizens for Health urges the members of the supplement industry, their trade associations and all other individuals and organizations supporting the consumer right to access to dietary supplements to join in exploring the development of a legal challenge to the EU Herbal and Supplement directives,” Turner added.

“Already companies are informing Citizens for Health that they will have to restrict the development and sale of supplements worldwide because of the EU directives,” said Turner. “It is just too costly, they say, to make different products for different countries; friends of consumer access to supplements need to organize a global campaign to bring the EU directives into line with DSHEA,” rather than harmonizing the other way around.

According to Turner, “The US Dietary Supplement Health and Education Act should be the international standard for trade in dietary supplements (vitamins, minerals, amino acids and herbs).”

“Citizens for Health views the European Union directives on supplements and herbs as contrary to this position,” he added. “Dietary supplements, for example, are very different from the industrial chemicals (food additives, color additives, pesticide residues, and animal drugs) added to the food supply.”

Said Turner: “While Citizens for Health strongly supports and urges that strict regulation such as prior approval, safety and efficacy testing and the precautionary principle be applied to the industrial chemicals added to foods, it strongly objects to applying such industrial regulations to agriculturally derived food based dietary supplements.”

“The two European Union Directives one on Herbs and one on Supplements act against this fundamental approach to regulation and in so doing, deprive consumers of the choices to which they are entitled, expose consumers to unnecessary heath problems and irresponsibly run up the cost of healthcare wherever their reach is effective,” Turner added.

Pay to Play? There have been some statements suggesting that EFSA will make companies pay hefty fees (in the tens of thousands of euros and more) for reviewing dossiers submitted under EU legislation for health claims, supplements, herbals and novel foods.

This has been roundly condemned by industry and consumer groups who say small and medium companies won’t be able to comply and will be forced out of the market, resulting in less consumer choice and less innovation.

Restricted Potencies

In addition, the potency of food supplements on the positive list will also be limited, as the EFSD stipulates these nutrients will be subject to maximum permitted amounts, maximum upper safe levels. In summary, the EFSD will ban high potency, bioavailable vitamins and minerals, regardless of the fact that they have been on sale in EU Member States as food for many years.

Although initially the EFSD will apply only to vitamins and minerals, it requires the EU Commission to make proposals for a similar directive for all other “nutrients or substances with a nutritional or physiological effect,” such as herbs, etc. In this way, the EFSD provides a legislative model for all food supplements mandating a narrow list of allowed nutrients with low potency and limited efficacy.

In November 2006, European market stakeholders met in Brussels to discuss the setting of maximum vitamin and mineral levels, with the potential establishment of a two-tier system that would allow EU countries to keep high-dose products on the market provided they carry warning labels.

The month previous, October, saw the adoption of the controversial health and nutrition claims regulation, set to go into effect by June 2007. Member states must submit their lists to the Commission by early 2008. In the meantime, in the summer of 2006 fortified food regulations were adopted, regulations that will also require the establishment of maximum upper levels for vitamins and minerals.

“I have my opinions as to the reason for the delay in issuing the SULs, a delay which makes it difficult to be too proactive in the reformulation of many of our products,“ added NOW’s Pittsford.

“While we have redone some formulas we are in a holding pattern on many more due to a lack of information,” Pittsford noted. “One begins to wonder whether this is being done on purpose to keep US products out of the market. Give us the SULs and let us put our product in the market. The plan for the Herbals Directive may be the same: to delay a final decision is to keep US manufacturers out of the market in any serious way. Keeping us off balance keeps us from trying to make a big push into the market.”

According to Mark A. LeDoux, JD, CEO and chairman of the board of San Marcos, CA-based Natural Alternatives International: “I do think that there remains a bias in Europe to foster internal consumption at the expense of imported goods. While the UK and the Netherlands have historically been champions of higher potency goods and advocates for allowing the consumers to make their own decisions about intake, these two countries are in the minority of the new Europe. The jury is still out on how the Food Supplement Directive will play out—and as inexorable as is the passage of time will be the generation of further enabling regulations for the ‘harmonization of the European marketplace.’ “

“At present many different maximum levels of vitamins and minerals used in food supplements and other foods are set across the EU,” said Efi Leontopoulou, scientific & regulatory affairs manager for Belgium-based European Advisory Services (EAS).

“It makes product formulation and selling a huge problem,” Leontopoulou added. “2007 is the year when the European Commission will put forward proposals to harmonize maximum levels; not only is this likely to be one of the most controversial issues ever addressed in the EU, but it will also have global implications as other countries wrestling with the same issues look to Europe for guidance.”

Nutrition Labeling, Health Claims

As if there were not enough areas of contention between European regulators, consumer advocates and industry, nutrition labeling of prepackaged food products (governed by Council Directive 90/496/EC and a subsequent amendment from 2003) has created another schism, in this case between consumer and health nongovernmental organizations (NGOs), who favor mandatory nutrition labeling, and the food industry, which has been pushing for a voluntary approach.

In January 2007, some of the UK’s largest food makers launched a multimillion euro campaign to promote guidance daily allowance (GDA) labeling of energy, fats, carbohydrates and proteins in addition to traditional labeling information. Meanwhile, the UK’s Children’s Food Campaign said that these labels would be hard for 62 percent of people to understand.

Some industry observers have suggested that serious compromise is needed.

Regulations concerning health and nutrition claims have also been a key, embattled zone pitting eager manufacturers against conservative regulators. What made the whole tete-a-tete especially farcical this past January 2007 was the fact that the EU mistakenly published the wrong version of the regulation. Corrected shortly therafter, the approved regulation contains provisions for derogations related to nutrient profiles, accelerated procedures and claims relating to children’s development and health.

“The EU has recently adopted a single scheme for making food claims across the 27 markets,” said Leontopoulou. “There will be a single list of those claims that are permitted for all foods, including food supplements and functional foods. If the claim you want to make for your ingredient or product is on that list it would, in future, be possible to use it across all countries, which is a real advantage over having to deal with all the individual national systems. However, the downside is that if your claim is not listed it will be very difficult to get approval to use it. Time is fast running out for the industry to get the list right.

Codex

“Codex Alimentarius” is Latin for food law. The Codex Alimentarius Commission (CAC) is one of the international standard-setting bodies recognized by both the North American Free Trade Agreement (NAFTA) and the World Trade Organization (WTO) for establishing global food standards.

The US has been involved in Codex since 1962, but historically Codex standards were not regarded as safety standards, nor were they accepted as safety standards by FDA (21 CFR § 130.6). According to Public Citizen, recent international trade agreements have caused a radical change in the nature of Codex standards.

The Uruguay Round of the General Agreement on Tariffs and Trade (GATT) changed the nature of Codex standards by “designating Codex as the international body establishing presumptively trade-legitimate food safety standards.”

Under the Uruguay Round’s Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement), regulatory requirements that differ from Codex standards may be challenged as trade barriers, although this is more likely to play out as high-potency US products being restricted in or “dumbed down” for Europe rather than the other way around.

Codex & Risk Assessment

Codex’ parent bodies, the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) recently published the results of a nutrient risk assessment project that was kicked off by a workshop in May 2005. The stated goal of the initiative was to “define a scientifically-based and internationally applicable approach for nutrient risk assessment.”

In comments submitted to this project, Washington, DC-based Citizens for Health questioned the underlying assumptions of talking about supplements within the context of hazard/risk assessment.

Although Codex guidelines, in general, have been dismissed by some, the various guidance documents are recognized and referenced as expert, international advice and reference points. In addition, if Codex’ guidance is adopted by EFSA or other legislative and regulatory bodies, then guidelines can carry the force of law very quickly.

One such area is food additives. “Codex has very high influence in those countries” which are considering the revision or establishment of legislation relating to food additives, said David Pineda Ereño of IADSA.

Codex & Additive Levels

Industry and consumer groups do not always see eye to eye, of course. Case in point the recent push by the International Alliance of Dietary Supplement Associations (IADSA) to restore or raise approved levels for additives such as erythrosine—also called FD&C Red 3, a cherry-pink/red synthetic coal tar dye that was banned by the US FDA for many uses in 1990.

IADSA also pushed for (and won) higher allowable levels for BHA, BHT and carnauba wax. In addition to an existing petition to ban BHA, concerns have also been raised about the use of BHT in food products. The compound has been reportedly banned for use in food in Japan, Romania, Sweden and Australia and the US has barred it from being used in infant foods. In addition, some food producers have voluntarily eliminated it from their products, including McDonald’s as of 1986.

According to the International Association of Color Manufacturers, Red No. 3 is widely used in industry and hard to replace. It makes a very close match for primary red, which is important in creating color blends. It doesn’t bleed, so drug companies use it to color pills with discernible shades for identification.

Regardless, what certain sectors of industry are pushing for here may be, in principle, to prevent what may be considered by multinationals to be intrusive and restrictive meddling.

This also highlights, however, one of the main differences between consumer health protection and commercial or industry freedoms—where consumer groups would want restrictive policies on potentially carcinogenic or possibly unhealthful substances, industry (from the pesticide giants of agribusiness to some international industry groups) are not yet willing to side with consumers on these kinds of issues.

The flipside is a question of self-definition: Does the natural products industry really want to be remembered as the champion of synthetic, potentially carcinogenic chemicals?

London Calling?

So there you have it. Brand marketers, ingredient makers and finished product manufacturers either selling into Europe or considering it: forewarned is forearmed. You will be facing a bewildering array of conflicting directives, differing interpretations of the directives, in addition to a restrictive, innovation-stifling and high-potency-unfriendly regulatory and political environment.

Perhaps only by truly and actively listening to, and collaborating with, international consumer health groups will industry ultimately receive the respect it deserves abroad: from EU consumers, regulators and legislators. And perhaps only by constructively supporting the responsible core of the dietary supplement industry will consumer groups be able to open this dialogue and enable this partnership.

If not, London may very well just put us on hold. NIE

For More Information:

• European Advisory Services, 32 2 2181470
• Natural Alternatives International, (800) 848-2646
• NOW Foods, (888) 669-3663