by: Bert Schwitters
12 October 2005
From the frying pan into the fire of the 'Precautionary Principle and Risk Assessment
In this article, Bert Schwitters, Dutch author and businessman, describes in intimate detail how the EU plans to remove some of the most effective natural products from the market, through the misuse of the Precautionary Principle. He uses his insight to the complex range of scientific and legal issues that have developed following his 25-year sojourn with the European food supplements industry. During the 1980s, Bert helped to lay the foundations for the Dutch Association of Natural Products Manufacturers (NPN). His company, International Nutrition Company (INC), sponsors the HAN Research project, which is reviewing independently the entire framework of EU and international food supplements regulation. INC, dedicated this scientific research project to the Alliance for Natural Health. Bert wrote this article for the Alliance on personal title.
On July 12, 2005, when millions of Europeans happily began their holidays travelling through their frontier-less Europe or “Schengenland”, the European Court of Justice gave its blessing to a European Directive that would, had it applied to travelling, have confined millions of law-abiding, legitimate citizens of some of the Member States to their home country. The Directive, which concerns food supplements, the products you know as nutrients in capsules or tablets, professes to seek a “Schengen” type removal of the archaic national frontiers that have always impeded the free movement of food supplements in Europe, especially from Member States that permitted liberal amounts of essential nutrients in such products, to European states that applied more restrictive regimes. Now that the holidays are over and we have all returned to our day-to-day reality, let’s see what that reality will bring Europeans in terms of vitamins and mineral supplements.
Extra Visa for Baby-food nutrients
In “Schengen” terminology, by approving the framework and effects of the Food Supplement Directive, the European Court of Justice did indeed remove the national frontiers for a relatively small number of predominantly synthetic forms of vitamins and minerals. In fact, the nutrients that were selected for free movement by the makers of the Directive had already been given “Schengen” status years before, be it that they were allowed to cross Europe’s old frontiers only when used as additives in baby-foods. Baby-food and food supplements are entirely different product categories, but the authors of the Food Supplement Directive didn’t mind. With the stroke of a pen they gave the baby-food vitamins and minerals an extra “visa” permitting them to now pass the old national barriers in food supplement form as well. Sounds fine, one would be inclined to think, but by limiting the “Schengenizing” of nutrients to baby-food additives only, all other food supplement nutrients were sent to the guillotine. Thus, the Directive, that came to be known as the Food Supplement Directive, effectively knocked out a considerable number of safe food supplements, even in the countries where they were once legitimately sold. The old system prevented the free movement of safe and legitimate products in Europe. The new system kills many of these safe and legitimate products even in their countries of origin.
How could that happen? Why does a Directive that has harmonization and free movement in its banner produce the contrary?
Directives are Orders
Most Europeans don’t realize that their daily lives are already governed by many thousands of “directives” written by the many thousands of bureaucrats who occupy the many floors of the high rises that mark the legislative horizon of our unelected European Government. Most Europeans never consider the fact that the synonym for “directive” is “an order issued by the government or a military unit.” Every day, invisible, nameless and faceless bureaucrats issue European Orders that influence the details of our daily lives. Indeed, there is supposed to be some token gesture for democracy in the EU law-making process. The European Parliament comprised of over 600 elected Members, must sign off. And so it did, when, on 10 June 2002, it approved the European Food Supplement Order to make arrangements for the free movement of food supplements.
And so, with Organized Industry well on board to make the best of it, the train was set in motion, to criss-cross a frontier-less future. In true Potemkin style, the wagons were clearly marked: FOOD SUPPLEMENTS. And so, officials rushed the Food Supplements Train across European borders to demonstrate their deep respect for the most essential principle on which the Founding Fathers erected the European Union: Free Movement. Where it stopped, there was fanfare and champagne. Yet, it was a façade that hid the fact that although the FOOD SUPPLEMENT wagons should have been filled to the brim with plenty of safe, healthy and legitimately sold food supplements, the train was more or less empty. It was a charade that left a few guessing about what was really going on.
Nutrients are beneficial and life supporting
To put things in perspective, the Food Supplement Directive deals with concentrated sources of nutrients and other dietary compounds that are generally recognized as vital, beneficial, life supporting and safe. That’s why many millions of consumers around the world supplement their daily diet with these nutritional basics which the body itself cannot produce and modern food often lacks. These nutritional elements are essential and you can’t do without them. In their absence, minor, major and life-threatening diseases are bound to occur. It is only in their bountiful presence that we can enjoy a healthy life. That’s why the governments of countries such as the United Kingdom and Holland allowed their citizens unlimited access to these vital compounds by permitting them to be legitimately marketed. However, governments of countries such as Germany are strongly opposed to that kind of nutritional freedom and they installed and seriously enforced restrictive regimes that ruled out certain nutrients and cut off the supply of others at arbitrarily set levels.
Those of you who don’t live in “Autobahn” country may need some explanation. While allowing unlimited speed on their motorways, the German authorities have always appeared to be quite afraid that the population might be overexposed to the nutrients that are seen as healthy, safe and sound in countries such as Holland and the UK. In Germany, influential high ranking scientists and authorities have a tradition of wanting to dispense vitamins by the milligram or microgram, preferably counting them one by one, so as to exclude the risk of exposure. “Hmmm, let’s see, Vitamin C, well, 68, 69, 70 ..... 220mg, 221mg, .... 225mg ...., Mein Gott !, Halt !!! Pull over, here’s the Vitamin Polizei. Here’s your ticket. You took 226 milligrams of vitamin C today. That’s 1 milligram too much.”
The 226th milligram of vitamin C
Fantasy? Read the reports “Verwendung von Vitaminen in Lebensmitteln” and “Verwendung von Mineralstoffen in Lebensmitteln”, published in 2004 and produced under supervision of the head of the German Federal Institute for Risk Assessment, Dr. Rolf Grossklaus. The Germans and their Government have given Grossklaus and his fellow scientists the watchdog task to count their vitamins under the Institute’s motto: “Recognize Risks, Protect Health.” The German authorities, who, as we know, don’t leave much to chance, perceive vitamins and many other nutrients as hazardous and have them on their radar screens that “recognize risk”. With radars bristling, the Institute picked up what they perceived to be hazards of vitamin C. It “recognized” that at 226mg of vitamin C per day, taken in the form of a food supplement, there is 1mg that produces a hazardous beep on the radar screen of risks and that this particular beeping milligram of ascorbic acid may therefore plunge the German population from glowing health into an abyss of scientifically recognized risk and misery.
According to Dr. Grossklaus’ Institute, detecting hazardously beeping milligrams of nutrients is pure science and what’s more, it is this “new” kind of “science” that permitted the Institute to undertake “a comprehensive health assessment of the risks and benefits of vitamins and minerals” ..... Thanks to this assessment,” so say the Germans, ”it is possible, for the first time, to derive maximum levels of these substances for specific food supplements or fortified foods using scientifically based risk assessment.”
According to the German scientists, they “used a uniform, standard procedure when drawing up the proposals on maximum levels of the daily amounts of a vitamin or mineral which can be additionally taken in without any risk to health results ....” In case you missed it, they’re discussing the hazardous 226th, 227th, 228th and so forth milligrams of vitamin C that might inadvertently be beeping in your daily food supplements. Be careful.
Food Supplement Directive used as vehicle
The wise men (and I believe very few women were involved) who put the Food Supplement Directive together used it as a vehicle in which to install the German “Recognize Risks, Protect Health” approach. If there is a recognized risk, we must act. Sounds logical and there’s no point arguing about it, unless, of course, there’s no risk and there’s nothing to recognize. If there’s a bomb threat, we shut the subway. In spite of the fact that nutrients are generally and scientifically recognized as essential to life and health, the Directive’s authors introduced a more German look at what’s essential to life and took great care to frame food supplements in terms as wonderful as “safety” and “risk assessment.” In the hands of those who earn a living at the German Federal Institute for Risk Assessment, risk assessment is capable of providing authorities the tools to stop, restrict, limit and ban nutrients arbitrarily and more or less at will. In this case, the Directive and the provisional measures that were rigged to ban safe and legitimately sold nutrients preceded, if not avoided, a thorough, scientifically rational and unbiased risk assessment. These are exactly the things that are missing with the Directive, which make it fundamentally flawed.
Just for the record, scientific risk assessment didn’t play any role at all in the bureaucratic removal of many food supplements. “Risk assessment” was installed as a way to help set the maximum levels at which the nutrients that survived the Directive may move freely through the Community. In Dr. Grossklaus’ vision, this is to stop the 226th milligram of vitamin C from reaching consumers in the European Union in the form of a food supplement. So, it is not unimportant to take a look at what the German “recognition” of the risks of nutrients is worth, “streetwise”, so to say.
Well, their assessment, like any other, is as flawed as the data they put into, but then it is multiplied by the arbitrarily chosen uncertainty factors they used to reach the calculated outcome. Who am I to call the German method unfit and arbitrary? Well, suit yourself and study the reports of Dr. Grossklaus to make your own judgment. Or, let’s compare the German findings to those presented in an English scientific report titled “Safe Upper Levels for Vitamins and Minerals”. It was produced in 2003 by the Expert Group on Vitamins and Minerals under the direction of Dr. Michael Langman. The British concluded that 1000mg of vitamin C per day is safe for each and every English citizen. The English could not detect studies indicating any adverse effects up to 3000mg per day. Adverse effect in this case means that in the worst case scenario – and only with certain forms the vitamin – some of you might get a tummy ache when taking vitamin C in excess of 3000 mg per day, interestingly, while at the same time deriving considerable benefits which are completely ignored by the ‘risk assessors’.
Limeys and Krauts, who’s wrong, who’s right?
Langman’s English expert group recognized that there’s no cause for alarm whatsoever when people take 3, 4 ... 10 times in excess of that “German” dosage. Langman and Grossklaus are both generally respected and honorable scientists and their institutes are publicly funded by democratically elected governments of Member States of the European Community. Langman and Grossklaus explain in their reports what kind of risk assessment methods they used, and, guess what, their approaches are quite similar. When considering their nicknames, “limeys” and “krauts”, one cannot deny that the British seem to differ from the Germans in terms of nutritional and dietary preferences. So do their health statistics and possibly even their genetics. However, these nutritional differences are irrelevant in relation to nutrient requirements and they are not capable of producing the striking differences between Langman’s and Grossklaus’ recommendations.
When applied in Berlin, risk assessment science produces conclusions that magically fit the German tradition of restricting vitamins as hazardous, while the same science applied in London produces conclusions that wonderfully match the Kingdom’s tradition of a much more fearless approach to the distribution and daily intake of nutrients. There were times when that tradition served a higher purpose than just keeping the population healthy. Wasn’t it by giving them lime that the Brits kept their sailors alive during the intercontinental voyages between the various parts of the Empire ?! Had it been up to Grossklaus, the limeys might have had less of a chance to return home on winds “blowing southerly.”
The elasticity of “scientific” risk assessment.
Scientific risk assessment, why is it so elastic? Why is it not as transparent, European, factual and universal as the word suggests? The reason is simple. Risk assessment not only involves the unbiased collecting and assessment of data, information and research. It also involves risk management and that’s precisely where bias and arbitrary viewpoints strip science from its transparency and universality. It means that Dr. Grossklaus’ 226th milligram of vitamin C is unsafe because he holds the opinion that it is unsafe to let milligram No. 226 roam around freely in Europe. This, however, is not because he has scientifically proven its lack of safety. Also, the fact that Dr. Grossklaus is an honorable scientist doesn’t make all his conclusions and opinions scientific.
Removal of nutrients without assessment
In Article 5, the Food Supplement Directive royally paves the way for Langman, Grossklaus and fellow scientists by introducing the terms “upper safe levels,” “risk assessment” and “generally accepted scientific data” as criteria to determine “maximum amounts of vitamins and minerals present in food supplements.” Sounds fine, but apart from the fact that the risk assessment approach used by both Langman and Grossklaus precludes such incompatible and unworkable results, what’s there to assess when, by way of the “fait accompli” method, you have already effectively removed most of the nutrients from the market before their assessment. There was never an assessment of the alleged risks of the indiscriminately banned nutrients. And what’s more, there wasn’t even an assessment of the public health risks involved in the removal of those safe and legitimately sold nutrients. In addition, food safety regulations were already well in place in all the Member States before the Food Supplement Directive was issued.
So, one might ask, what does all this have to do in a directive that rose from the need to harmonize the European market and provide free movement to legitimate and safe food supplements? Seems a bit out of place, unless, of course, the objective was to install the management tools that could help maintain the status quo by aiming at the very existence of many “law-abiding” nutrients. If you can’t stop them any longer from moving around freely, then you might just as well remove them by introducing and applying precautionary management tools such as “provisional risk management measures.” You turn risk assessment into risk management. And once you manage “by risk” but there’s no assessment of risk and you have no data, you call in the Precautionary Principle. Not as a last, but as a first resort. When free movement results in removal, the principle of free movement may still stand unscathed and revered by all, but consumers are left bare handed because there’s nothing to move around any more!
EFSA and free movement
Understanding how all this worked and works in how the Food Supplement Directive removed food supplements from the European market place, requires going back to an earlier Directive, to the one that installed on 28 January 2002 the European Food Safety Authority, better known under its abbreviated name as EFSA. The EFSA Directive precedes the Food Supplements Directive of 10 June 2002 by only a couple of months. The EFSA Directive also solemnly professes to honour and strive for the principle of free movement of foods and gives EFSA the task of scientifically harmonizing food safety standards throughout the European Community.
“Food law,” so states the EFSA Directive, “shall aim to achieve the free movement in the Community of food ...” Because food supplements fall under the European definition of food, EFSA became the scientific authority that must assist the European Commission to further the free movement of food supplements in the European Community. Wonderful. Put the 2 Directives together and one might think that from there on, all the safe and legitimately sold supplements to which British, Dutch and other consumers always had unlimited access would now become available to the deprived Germans. Sorry, that’s not going to happen. The term “free movement” suggest that there’s something to move. Let’s see what nutrients the Food Supplement Directive left us un-removed.
Risk Assessment lingo
When EFSA speaks of “hazard,” they mean a “biological, chemical or physical agent in, or condition of, food ... with the potential to cause an adverse health effect.” When EFSA speaks of “risk assessment,” they mean a “scientifically based process consisting of four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation.” And when EFSA speaks of “risk,” they mean a “function of the probability of an adverse health effect and the severity of that effect, consequential to the hazard.”
Putting the two Directives together, the Food Supplement Directive tells EFSA to take a look at essential nutrients in terms of hazard, risk and adverse health effects. EFSA must assist the European government by assessing “the potential” of vitamins and other nutrients “to cause an adverse health effect.” No doubt that food can be hazardous when it contains poisons, chemicals, germs or infesting bacteria. Certainly, foods pose hazards when they lack nutrients and other vital compounds required to sustain a healthy life. But putting vitamins, minerals and other safe and life saving compounds in the category of hazards is ripping them out of their natural context and misplacing them in the category of poisons and other ills. It’s like putting a Mozart symphony in the “heavy metal” section. It’s like installing an “Authority” that must assess the potential of Vermeer’s “Milk Maid” painting to cause an adverse effect on the mental health of its admirers. It’s like labelling law-abiding citizens “terrorists” and locking them up until proven innocent.
Alliance for Natural Health
When a “last of the Mohicans” watchdog group called the Alliance for Natural Health challenged in the European Court of Justice as “disproportionate” the fact that the Food Supplement Directive would indiscriminately ban a large number of food supplements, the European Court replied that all was well. The Court asserted that the approach taken by the European Commission was correct and that food supplements could be placed “under orders” by applying a risk assessment principle known in the inner circles of the risk assessment community under the somewhat ominous term: “ex ante.” “Ex ante” is another piece of risk assessment lingo. It means that in the absence of scientific data about something, the public must not be exposed to that something. Applied for example in the field of art, the “ex ante” principle means that as long as a scientifically based process has not shown that Vermeer’s “Milk Maid” does not have an adverse effect on the mental health of all of the museum’s visitors, it shall be removed. In less democratic situations, the “ex ante” principle is generally used as a way to suppress freedom of speech and freedom of movement. Currently, the Chinese government uses the “ex ante” principle to stop Chinese citizens from accessing web-pages that contain words such as “democracy” and “freedom.” Guilty and locked up unless proven innocent, that’s the game of “ex ante risk assessment.” Applied in the field of traditional medicine, it is likely to mean that more than half the world will be without the remedies that have cured their ancestors over millennia.
“Ex ante”, where does it say so?
Although you won’t find the term “ex ante” in the Directives, it’s there all right, when you read between the lines. The “ex ante” approach is presented in the EFSA Directive’s Article 7 as the “Precautionary Principle” that must be applied to assure the “high level of health protection.” The “ex ante” principle is not explicitly found in the Food Supplement Directive, but because food supplements are EFSA’s turf, the Precautionary Principle applies just as well. Here’s the deal presented in Article 7: “In specific circumstances where,” so warns the Directive, ”following an assessment of available information, the possibility of harmful effects on health is identified but scientific uncertainty persists, provisional risk management measures necessary to ensure the high level of health protection chosen in the Community may be adopted, pending further scientific information for a more comprehensive risk assessment.”
“Information” replaces science
In everyday language, this means that under the flag of health protection, measures may be adopted without knowing the outcome of any scientific process. The Precautionary Principle is the club that may hit when “information” becomes available. Must that information be specific and must it relate to a visible, factual, verifiable event? The EFSA Directive doesn’t tell. All they require is that the information alludes to, suggests, perceives or simply evokes a “possibility of harmful effects.” What’s that?, you may ask. “Possible” meaning “capable of happening,” the word “possibility” opens up a field as wide as this universe. Must the source of the “information” be known? Is it mere gossip, disinformation or propaganda? Is it necessary that the supplier of the information declares and explains how he or she obtained or observed the information? Is the observed effect reproducible? The EFSA Directive doesn’t tell and there is no qualification of “information” in the EFSA Directive. As long as the “information” is embedded in and surrounded by “scientific uncertainty,” the Precautionary Principle can hit and remain in force anywhere in the form of “provisional risk management measures.”
The Law of the Land - Scientific Uncertainty
In a world where nothing is absolutely certain, what IS “scientific uncertainty”??? Things can be uncertain, but what if they are “scientifically uncertain”? Might it perhaps mean that scientists have never studied something? But that in itself doesn’t make something uncertain. Might it mean that scientists differ in their opinions concerning whatever they love to differ about? But that doesn’t make something uncertain. Or, might it mean that scientists haven’t yet made up their minds or that they used flawed or different methods to arrive at different or contradictory outcomes. Could it be that we have to endlessly stretch scientific testing to reach the unreachable absolute certainty? Or, might it mean that as long as Grossklaus and Langman have reached some kind of political compromise regarding their significantly different conclusions about the hazards involved in taking vitamin C, there is scientific uncertainty as to who’s right and who’s wrong? Might it also mean that under the Precautionary Principle we might have to settle for the most cautious approach, in other words that of Grossklaus?
The question is; must we then, while the scientists are having their publicly paid disputes, revert to “information” as a kind of overriding super-uncertainty that provides the basis for activating the Precautionary Principle? Does the Precautionary Principle install powers in EFSA and the European Commission that permits them to neglect or waive the work done by its own uncertain scientists, and act upon information and belief instead? When “scientific uncertainty” exists in the halls of EFSA’s own scientific workgroups, can information or belief set the Precautionary Principle in motion and turn it into the law of the land? Yes. All this took place under our very noses with the full consent of the European Court. The Precautionary Principle is now in full force in the field of food and food supplements.
Meteorites and food supplements
Food supplements are increasingly being forced, because of the Precautionary Principle, into an ex-ante risk assessment straightjacket, quite possibly it seems, by applying scientifically flawed risk assessment methods, when they are among the very safest things we are exposed to. Ron Law, a former biochemist and well known New Zealand risk assessment scientist, has shown that in countries like New Zealand or the USA, where food supplements have been used liberally, there are almost no products that pose a risk lower than that caused by ‘natural healthcare and therapeutic products’. In other words, he found this group of products to be much safer than foods, but also less risky than death by bee or wasp stings, lightning or even shark attacks.
In fact, he only found one source of risk that was lower, and that was the risk of being struck by a meteorite. With the negligable risk of these food supplements and natural products being well below the level at which we as a society should begin considering spending huge resources regulating products, shouldn’t we focus on the risks involved in taking medicines, genetically modifed food, and what else is new on the planet ! The hoops the natural products industry is going to be forced to jump through over the coming years are not only unnecessary, but they will undoubtedly result in many casualties and many products falling foul of the system. Unless, of course, we do something about it.
The bear’s liver
“Yes, but”, some of you may think, “haven’t I read somewhere that high doses of vitamins can be dangerous, that vitamin A can kill you !” Oh, sure, long ago, an occasional hunter died when he hungrily devoured the liver of a bear he had shot. The bear’s liver was loaded with vitamin A. And, yes indeed, one can reach levels of toxicity with nutrients, especially with fat-soluble ones such as vitamin A. Toxicity is a matter of dosage and quantity. There is no absolutely toxic substance and there is no absolutely safe one. It’s possible to kill a man with an overdose of water.
But, the risk assessment and Precautionary Principle lingo used in the Food Supplement and the EFSA Directives no longer straightforwardly refers to the “good old” toxicity of substances, as established by way of verifiable and reproducible scientific tests and examinations. Since the days when straightforward and measurable toxicity levels were the rule, the game has been completely changed. Those who manage our lives today work out of the virtual reality of possibilities of probabilities of adverse effects that may exist in the absence of scientific certainty .... The word “probable” has been substituted by the word “possible.” Doesn’t the EFSA Directive give us guidance how to assess the reality and certainty or probability of a perceived risk?
Oh yes, the EFSA Directive tells us that risk assessment shall be “based on the available scientific evidence and undertaken in an independent, objective and transparent manner.” Nevertheless, no such scientific evidence seemed required when the European Commission ruthlessly applied the Precautionary Principle to ban safe and legitimately sold nutrients under the dictates of the “provisional risk assessment measures” laid down in the EFSA Directive. In the wake of this draconian violation of the principle of free movement, no immediate, independent, objective and transparent scientific work was undertaken by EFSA or by the European Commission, to fulfil all the public health duties imposed on them by the Directives.
BAN = removal of legitimate products
If the Food Supplements (FS) Directive does ban a good number of safe and essential vitamins and minerals, how is it then, you may wonder, that you are still able to get all those good old food supplements you used to buy? Are these products now illegitimate? Has the ban been lifted or mitigated? No, the ban has not been lifted, but its blade may not have fallen yet on some of the banned nutrients. Up until August 12, 2005, a so called “derogation procedure” enabled market participants and interested parties to request a national grace period for banned nutrients that were legitimately marketed in any of the Member States before July 2003. Whether the grace period, which definitely ends in December 2009, will eventually be granted will depend on what EFSA has to say about the technical dossier that forms part of the derogation papers. The mere fact that a derogation request was filed is by no means a guarantee that the FS Directive may not, before the ending of the year 2009, deprive you of the legitimately sold products you may have been using for many years. And this is not because all of sudden there’s something wrong with these products. It is not because risk assessment studies had revealed risk. No, it’s only because the European Commission placed nutrients “under orders” by swinging the axe of the Precautionary Principle. What has happened in the field of food supplements shows that the Precautionary Principle is the ultimate and sacrosanct weapon in the hands of those who don’t like to be bothered by good science, sound reason and long standing practices approved by national authorities. Embedded in European Directives, the Precautionary Principle even ties the hands of Judges and Courts.
Entitlement to existence denied
When they decided to not only strip legitimately sold food supplements from their “entitlement to free movement” throughout the European Community, but go a bit further and strip them from what I would call their “entitlement to existence” in the Member States where they were legitimately sold, the authors of the Directive must have figured that an outright ban would be easily branded as disproportionate and confrontational. So, they had to figure out an approach that would withstand public opposition and eventually a legal challenge. They did well. When the Alliance for Natural Health and two UK health trade associations (who joined them in a bid to increase pressure against the European regulators) argued before the European Court that the Directive was disproportionate in that it would remove legitimate and safe products from the shelves in the United Kingdom and elsewhere, the Court took shelter under the umbrella of the Precautionary Principle, stating that: “... the authors of Directive 2002/46 could reasonably take the view that an appropriate way of reconciling the objective of the internal market, on the one hand, with that relating to the protection of human health, on the other, was for entitlement to free movement to be reserved for food supplements containing substances about which, at the time when the directive was adopted, the competent European scientific authorities had available adequate and appropriate scientific data capable of providing them with the basis for a favourable opinion, ...”
The accidental baby-nutrient
This means that food supplements that accidentally contain certain forms of the vitamins and minerals selected for inclusion in baby-foods survived the onslaught of the Food Supplement Directive only because they happened to be in EFSA’s baby-foods dossier. It also means that all other nutrients were indiscriminately banned because EFSA had never evaluated them. It doesn’t mean that these nutrients had never been evaluated at all, it simply means that EFSA never did. Had EFSA ever been asked to evaluate them? Generally no. Had EFSA ever done an exhaustive search of information to form an opinion about the safety of the food supplements that were legitimately sold in many a Member State? No. Had EFSA ever done an assessment of available information? No.
As the European Court stated in its decision, EFSA’s scientists lacked “adequate and appropriate scientific data capable of providing them with the basis for a favourable opinion.” So, EFSA was never in a position of assessing available information because they had no information. It doesn’t mean that the information wasn’t available. It just means that EFSA didn’t have it. Had EFSA ever transparently identified, case by case, supplement by supplement, “the possibility of harmful effects on health” of each and every individual food supplement legitimately sold since many years in England, Holland and elsewhere under the supervision of the relevant national health authorities? No. Was there scientific uncertainty? No. Were there unequivocal and uncontested scientific grounds for the provisional risk management measure that the authors of the Directive used to sweep numerous food supplements off the market? No.
Article 7, please read it again
Yet !!! The European Court boldly filled in the blanks and reorganized history by implying that there had existed specific circumstances that warranted the indiscriminate removal of each and every one of the banned food supplements before or at the time of issuing the Food Supplement. It worded its decision in a way that suggests, but does not show, that all the conditions that must be fulfilled before the European Commission may apply the Precautionary Principle, had in fact been fulfilled. By implying fulfilment, the Court made it possible to retrospectively grant the provisional powers to the authors of the Directive by stating that “by virtue of Article 7” of the EFSA Directive, “..., the Community legislature is entitled to adopt the provisional risk management measures necessary to ensure a high level of health protection and may do so whilst awaiting further scientific information for a more comprehensive risk assessment, ...” That may be true, but let’s see what Article 7 says when you read it from the beginning: “In specific circumstances where, following an assessment of available information, the possibility of harmful effects on health is identified but scientific uncertainty persists, provisional risk management measures necessary to ensure the high level of health protection chosen in the Community may be adopted, pending further scientific information for a more comprehensive risk assessment.”
Reading backwards and deaf ears
So, to remove a product from the market by applying Article 7 of the EFSA Directive, the circumstances must be specific. They must concern a specific case or something and in each individual case an assessment of available information must take place. Only then, when case by case, a possibility of a harmful effect has been clearly described and only when scientific uncertainty persists, may the EC take provisional measures in the interest of public health. However, when you begin reading Article 7 from the end and stop half-way, the “high level of health protection” becomes a rather thin excuse for those who did not comply with the requirement laid down in Article 7’s opening words.
The fact that it was the European Court that read backwards doesn’t make the excuse any better. Had the Directive applied to the free movement of persons, to travelling through the European Union, it would have caused traffic jams, public protest and outrage, especially because there wasn’t any sign of a “clear and present danger” that warranted a provisional measure to keep everybody home. Because the measure hit “some nutrients” that were of interest to “some companies” the case brought by the Alliance for Natural Health widely fell on deaf ears. Even Organized Industry bashed at the Alliance. Still, there was one highly placed European legal official who shared the Alliance’s opinion and for a short while, the Food Supplement Directive was in deep trouble.
Geelhoed declares Directive invalid
Had the Alliance for Natural Health made outlandish claims about the disproportionate nature of the ban? Were they really the fools and strangers some want us to believe they are? Were they making stupid and irresponsible moves that might upset the apple cart to which Organized Industry had also given its blessing? I don’t believe so. Before the European Court makes a decision, it has the case, the surrounding applicable cases and the circumstances evaluated by an Advocate General. As one might expect, an Advocate General at the European Court of Justice is not an inexperienced feather-weight legal amateur and normally the Court places a great deal of confidence in its “AG” and follows his or her Opinion. In the case that was brought by the Alliance for Natural Health to test the validity of the Food Supplements Directive, my fellow Dutch countryman, Advocate General Geelhoed, prepared the Opinion for the Court.
In great detail AG Geelhoed exposed the Food Supplements Directive as a scything and ill-wrought piece that causes enormous prejudice to trade and consumers. Assessing the banning of legitimate food supplements, Geelhoed wrote, “without calling in question the substantive assessment made by the Community legislature, I must conclude that it has seriously failed in its duty to design such a far-reaching measure with all due care.” According to the Advocate General, the “legislative technique applied here,” does not merit such a title. And concerning the procedure offered by the authors of the Directive to industry members who might want to undertake saving a banned nutrient from certain death, “in so far as it (this procedure) may exist and in so far as it may deserve this title,” it has “the transparency of a black box: no provision is made for parties to be heard, no time-limits apply in respect of decision-making; nor, indeed, is there any certainty that a final decision will be taken.”
Geelhoed – Old Hat
With all due respect, I suspect that Advocate General Geelhoed still lives in Pre-Precautionary-Principle times, when “individual interested parties” such as, in this case, responsible companies making, distributing and selling legitimate food supplements, still deserved some basic form of protection against indiscriminate bureaucratic bias and arbitrariness. “In order to ensure,” so admonishes Geelhoed, “that these interests are taken into account in the decision-making process in a manner which is open to judicial scrutiny, the basic legislative act ought for that purpose to provide for the minimal guarantee of an adequate procedure.” Meaning, a procedure that companies should be permitted to follow prior to their products being removed from the market.
Geelhoed found that the procedure proposed in the Directive “... lacks essential guarantees for the protection of the interests of private applicants.” Respecting good old Pre-Precautionary-Principle principles, Geelhoed continues: “the Community legislature in drafting a legislative act may at least be expected to act with such care as to make express provision for minimum conditions of prudent decision-making in that legislative act. The fact that these conditions were not included in Directive 2002/46 is in itself sufficient to conclude that the Community legislature has failed in this respect. The Directive does not comply with essential requirements of legal protection, of legal certainty and of sound administration, which are basic principles of Community law. Thus, lacking appropriate and transparent procedures for its application, the Directive infringes the principle of proportionality. It is, therefore, invalid.” The underlining is mine.
Killing a frog?
Prudent decision-making was not particularly what the authors of the Directive can be accused of. They did not explore the best ways of carefully combining the national procedures for product approval and safety assessment traditionally applied by the competent authorities in the Member States. They did not evaluate how these national procedures could be combined, “approximated” is the technical term, while paying respect to the principles of legal certainty and protection that these procedures had always provided for industry members and consumers alike. Instead, the Community’s law makers solved the problem by putting baby-food nutrients on two Positive Lists (one that identifies the vitamins and minerals and one that identifies the permitted forms of the listed nutrients), a manoeuvre which effectively removed all other nutrients from the European market.
Sure, the banned nutrients were given an initial grace period, so that they could survive until August 2005. And yes, industry was permitted to file requests for “derogation”, so that, until the ending of 2009, these banned nutrients could stay on the market in the Member State where they were already legitimately sold. But that implied that industry had to go way beyond the administrative requirements they had already fulfilled in those Member States where their products had been on the market since long. And then, even if one went through the process of derogation, getting the product on the Positive List is an entirely different matter. Industry members who wanted to go there were left figuring out the best way through what the Advocate General described as a “Black Box.” In the end, it all comes down to applying the “killing the frog” system. Don’t throw it into boiling water, it will jump out. Just slowly raise the temperature until it boils. It helps frogs, or people, adapt to the worst possible outcome: death. In a follow-up article, I will explore how this frog may not only be saved from imminent death, but may be kissed and turn into the prince it was before the European Commission put its spell on it.
Killing a snake
As Geelhoed did point out, the Directive was and is an unworkable piece of legislation. Organized Industry tried to cope and organize things, but failed to take action against the fundamentally flawed “legislative technique” and against the ruthless, inappropriate and improper use of the EFSA Directive’s Article 7. While all involved were doing what they deemed fit, Advocate General Geelhoed tried to shed some light in the procedural darkness of the Food Supplement Directive. Doing so, he overlooked how the Precautionary Principle was lurking in the Black Box’ darkness and how this principle could tear apart his well wrought Opinion that called for the prudent decision making required of EU’s lawmakers.
Had Geelhoed found the Precautionary Principle, he might have been able to dismantle it, if only because there was no circumstance and no reason in the first place to take provisional measures. An old saying has it that when you think you’ve killed a snake you better make sure that it’s dead. Geelhoed found the Directive invalid, but he didn’t make sure it was dead. When the Court looked at it, it still found some activity. It also found the venom for which there is no antidote: The Precautionary Principle. And so, the Court ruled. The snake shall live by virtue of its venom, not by virtue of its benefits. With the help of the European Court, the Community legislature reaped the fruits of the legislative technique that killed the one who tried to kill it. The shrapnel is all over the place and with it came the Black Box’s true label: Pandora.
Organized Industry and Pandora
For reasons about which one can speculate endlessly, Organized Industry took a pragmatic position and it never tried to stab the beast the way the Alliance for Natural Health and Advocate General Geelhoed did. Perhaps they saw the shadows on the wall, perhaps they didn’t. Perhaps they were told that saying “no” was not an option. Perhaps, perhaps, ... Perhaps all the ills contained in Pandora’s box were not perceived as ills for certain players in the food supplement industry. Mass market oriented companies who never planned to offer consumers food supplements containing nutrients other than the ones listed in EFSA’s baby-foods dossier, all of a sudden saw markets opened that had been closed before. Why bother about nutrients they had no intention of selling anyway.
And, realistically speaking, the Directive effectively handled a couple of innovative, progressive and more pioneering competitors who were distracting consumers away from their mass market formulas by offering more sophisticated special formulas containing orthomolecular doses and more sophisticated nutrients that require a bit more work to manufacture or extract, rather than the “run of the mill” ones that have become commonplace in supermarkets and pharmacies around Europe. Who knows. Fact is that most industry members have learned to live with their competitors and with the obsessions of all kinds of authorities and bureaucracies. Most likely they saw the Food Supplements Directive as one of those things “we’ll deal with when it knocks at our door.”
Crawling out of a hole
Consumers and health practitioners face only one problem. Soon, many of the food supplements they used to place their confidence in will not be there anymore. The internet will lead them to American suppliers who will have no problem whatsoever shipping their products across the Atlantic. The European food supplement industry faces three problems. Problem 1 is how to get a removed or new nutrient on the Positive List. Problem 2 concerns the listed nutrients. How does one realistically establish their maximum levels? And, is it necessary to establish such maximum levels? Problem 3 concerns all other substances fit to be presented in the form of food supplements: other nutrients, enzymes, amino acids, phyto-nutrients, unsaturated fatty acids, etcetera. Problem 3 will present itself in 2007, when the European Commission must propose how it wishes to deal with those substances. Looking at what has happened so far, one has to be an optimist not to worry. Problem 2 brings us to making a choice between Grossklaus, Langman or an even better approach. Problem 1 must be faced by the lone ranger who has the guts to enter the Black Box.
There is actually a fourth problem for European industry. It has been effectively removed from a position in which it was capable of competing with American companies in the field of innovative products. It is confronted with a bureaucratic monstrosity that not even the American Food & Drug Administration (FDA) has been capable of producing. And then, last but not least, there is a problem for Europe in general. Its position in the field of health and nutrition has been severely fractured and it remains to be seen what the long term effects will be on public health. Innovation will be more difficult in a legislative environment where the Precautionary Principle can stab one in the back any time to bleed investments and intellectual effort to death.
The HAN Research Project
The major obstacle in the whole process remains the unforeseen abuse of the Precautionary Principle as the somewhat barbaric “technique” that can unfairly upset prudent and appropriate risk management techniques as well as innovative scientific and technological developments. Now that lobbying, reasonable arguments and legal efforts have failed, the only option that remains is to make a scientific evaluation of risk assessment in the field of food supplements. This is why, in June 2005, the Heidelberg Appeal Nederland (HAN) Foundation and the Alliance for Natural Health started a scientific research project to develop “... a straightforward, rational, transparent, and scientifically coherent benchmark methodology to regulate food supplements cost–effectively within a European (or even a global) level–playing field in which assessment and management are explicitly linked.”
The research project will also focus on the problem that, so far, in the field of food supplements, the desire for unconditional safety has been approached by applying inappropriate pharmaco–toxicological assessments used for medicines and toxic substances. “For food supplements,” so write Dr. Jaap Hanekamp and Prof. Aalt Bast, the scientists who will lead the research project, “this won’t do. Risks and benefits need to be evaluated equally within the context of commended normal use ...” The safety of food supplements must be evaluated in terms of risks and benefits rather than in terms of the traditional pharmaco–toxicological approach.
The HAN Research Project will not only evaluate the risks of applying the Precautionary Principle in the field of food supplements, but also whether the continued application of this principle “will eventually shift the locus of market control in the food supplement market in the direction of the pharmaceutical industry and what the effects of such a shift will be on product innovation and research.” After all, in a world of risks, it is best to be precautious.
To be or not to be
In the meantime, there is little consolation for consumers, practitioners, retailers and industry members who may now see many a good supplement go up in bureaucratic smoke. Whether these legitimate products will ever rise again from their ashes remains to be seen. Often, justice delayed is justice denied. Even if the HAN research eventually has an effect, it will be difficult and extremely time consuming and costly to bring the lost supplements back to life.
In the meantime, the Precautionary Principle finds more followers to conveniently attack nutrients. The French government is making an effort to ban the very popular and widely used Co-Q10 phytonutrient. Just out of precaution, so they say. Because the Precautionary Principle is used to stab at the very existence of what’s elemental in life and health, the essential question for food supplements has shifted toward: “To be, or not to be.” Those who fight for the existence of the nutrients that were removed under the false premise of “not existing” have no other option than to “take arms against a sea of troubles,” as the great Shakespeare wrote. Instead of protecting us against the “sea of troubles” that already surround us in every day life, the Precautionary Principle adds oceans of troubles when abused. Now that it has been applied to remove nutrients, the day of reckoning will come. What will be gained in terms of public health, costs, benefits? What will be lost? What do we need to fight for most? The HAN Research Project will tell us.