Philippus
Aureolus Theophrastus Bombastus von Hohenheim was born in 1493 and, perhaps not
surprisingly, changed his name to Paracelsus. Celsus was a Roman physician who
gave the element zinc its name and this pompous Swiss German medic decided to
re-name himself ‘Equal to Celsus’.
He is famous for his dictat: ”Sola dosis facet venum”, which translates from
the Latin into “The dose alone makes the poison”. In other words, everything is
toxic at the right dose and under the right circumstances. Pure Alpine air is
highly toxic if a certain dose is injected intravenously. The exact dose
remains unknown since no such experiment has ever been done but you get my
drift, I hope.
In 2007, a group
of researchers from Southampton University published a paper in the prestigious
medical journal, The Lancet, showing that a cocktail of food additives (6
colours and 1 preservative) caused hyperactivity and reduced cognitive function
in children. The study was well
conducted. It used a placebo (identical in look and taste to the active
cocktail) and it used a cross over design, meaning that each child received the
active cocktail for a week and at another occasion the placebo for a week. They
used two age groups, 3-year olds and a group of 8-9 year olds. The study was
analysed by two important committees of experts, the UK Committee on Toxicology
and the European Food Safety Authority (EFSA). Both gave their approval.
The consequence
of this publication was very serious. The EU introduced a law mandating that a
food containing any one of the 6 colours had to be labeled to state that the
food contains a colour, which “may have an adverse effect on activity and
attention in children”. The
findings were championed by the UK Food Standards Agency (FSA), which pushed
for the ban. However, EFSA held the view that the effects of the food
colourings on children's behaviour were small and the significance for
children's development and education uncertain. The FSA view prevailed within
the EU regulatory process and the ban came into effect.
Without doubt,
this entire affair calls into question the entire approach that the EU and its
agencies to the application of science to risk assessment. Lets just think
about linking evidence to policy. No study has ever been completed in which any
ONE of the 6 colours, on their own,
had any effect on childhood attention deficiency. Now one could respond to that and say that there may only
have been one active colour so lets just label them all. But what about the 7th
additive used, the preservative, benzoic acid. That was excluded from the ban
because it reduces the risk of food poisoning whereas colours are just colours.
Now suppose the active ingredient was benzoic acid? There is a second flaw to
the study, which is relative to the issue of dose as raised by Paracelsus.
According to the authors in the paper, the doses were chosen because they
represented normal exposure of children to food additives in UK children. Thus
they used as their reference intake, the equivalent of three 56g bags of sweets
for the younger children and double that for the older ones. Now 4 x 56 is 224
grams per day and at 4 calories per gram, that translates into almost 900
calories. This would mean that UK 8-9 year olds were deriving about 50% of
their calories from sweets. That would quite simply lead to wholesale
nutritional deficiencies since sweets are just pure sugar with some fat – no
minerals or vitamins. Now, at the time this paper was written, the official UK
data showed that in this age group, the contribution of all sugar confectionary
was just 7%. How could they have got this dose so wrong? Why didn’t the FSA and
EFSA not challenge the dose aspect of the paper?
In Ireland, we
conduct food intake surveys for different age groups and what makes our
approach unique is that we always collect the packaging of all foods consumed.
These are photographed and the ingredients list entered on to a database. So we
set out to ask if among teenagers and children, there was even one eating
occasion among the 118,000 such occasions during the 7-day survey period, when
all 7 additives were consumed. The answer was zero. In other words, no child or
teenager in Ireland ever, even on just one occasion, consumed all 7 additives
at the one time. We then went on to see if the levels of colours used in the
Southampton study were ever achieved in our samples. Even at the top 1% of
consumers of any colour, the intakes came nowhere near the levels used in the
Lancet study.
The ban has come
into force and most food producers have complied well ahead of the build up
period. The public wasn’t screaming for this and the vast majority doesn’t even
know it happened. But it satisfied the worried well who lobby the European
Parliament and it was grist to the mill to their anti science approach to risk
analysis. But some day the development of bad legislation based on bad science
will come back to haunt them.
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