After the passage, in 2002, of Europe-wide regulations for
food supplements, the Alliance for Natural Health has argued
before the European Court of Justice that vitamin and
mineral supplements are innocent - not to be condemned or
worse eradicated by bureaucratic red tape. The court decided
in July 2005, surprisingly disregarding the opinion of its
own Advocate general, who had called for the directive to be
declared illegitimate, commenting that some of its
regulations have a degree of transparency comparable to that
of a black box.
While there are important clarifications in the court's
decision that give hope for the future, many of the crucial
decisions about the destiny of nutritional supplements in
Europe depend on how much precaution will be exercised to
protect us from the supposed hazards of the safest products
that can be found on the market today.
The EU Court, in its decision, cited the "precautionary
principle" as the reason why the restrictive European
supplements law may stand. Looking at the origin of the
principle, which was formulated in the face of toxic
contamination and other threats to our survival, it would
seem somewhat out of place to apply such a rule to - of all
things - food supplements!
Perhaps the EU bureaucracy is still suffering from shell
shock over the outbreak of mad cow disease some years ago
... or perhaps the watering-down of proposed rules to
control toxic chemicals in the face of industry opposition
needs to be balanced by "action" in some other field - the
fact is the court quashed high hopes and confirmed a
monstrous piece of legislation, overriding the voice of
reason provided by its Advocate general.
Bert Schwitters has examined the court's sentence in detail.
He tells us what the decision means for supplements and how
consumers of healthy foods will likely end up ... in
"no-choice-land". Unless, of course ... we find a way to
make reason prevail and make the "risk analysis" that is to
be performed on supplements do its job properly, including
the initial evaluation: "Is there a problem at all?"
To quote Ron Law, risk assessment expert and policy
consultant in New Zealand:
"Consuming natural healthcare products" says Ron Law,
"appears to satisfy both the de minimis level of risk at a
societal level (0.25 deaths per year on average; 1/120 th
the de minimis level) and an individual risk of 0.015 per
million, or 1/67 th of the de minimis risk level, and yet
they have been reclassified via contentious regulation [in
Canada] as a subset of drugs which appear to be some 250,000
times riskier. There appears to be no evidential basis for
such regulation and regulating them in the same mindset as
high risk substances may well produce risks of its own,
especially regarding freedom of choice, and loss of benefits
due to reduced product availability."
Bert Schwitters has put his money where his mouth is. He is
sponsoring a scientific research project, an evaluation of
the available legislative options for ensuring the safety of
nutrients without sending garlic and vitamin C to the
gallows.
- - -
The ‘Framing’ of Food Supplements in the EU
From the frying pan into the fire of ‘Precautionary
Principle’ and ‘Risk Assessment’
by Bert Schwitters
October 12, 2005
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 on 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.
Autobahn country
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.
German science
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.
Tummy aches
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 it, 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.
