The Precautionary Principle: All Style and No Substance?

In this article, I will examine the highly-vaunted “Precautionary Principle” (PP) so often invoked in discussions on the safety of cosmetics. The basis of this principal seems to be that, if there is any doubt over the safety of a substance, it should be banned – period. If this is not the actual basis of the principal, it is certainly the basis on which it is being evoked in the discussions in which I have been involved. I believe that there are several issues with this type of thinking, and some important questions should be raised:

1)      What are the causes of the doubts over the safety?

  • Are the doubts raised as a result of sound scientific studies?
  • Are they due to misinterpretation of sound scientific studies?
  • Are the studies that form the basis for concern sound in the first place?

2)      Who actually doubts the safety – scientists or lobby groups?

  • Do the lobby groups have sufficient evidence for doubt – to the extent that a ban could be justified?
  • Do the scientists have any vested interest in sowing the seeds of doubt (i.e. gaining funding for more work on the substance in question)?

3)      Has the relationship between the hazard identified and the potential human exposure been fully assessed?

  • Does the Precautionary Principle allow for any type of risk assessment?

These are all important considerations, because it is very difficult to know where to draw the line in terms of assessing a substance as being “dangerous”, or “unsafe”. What may be unsafe in one application may be perfectly safe in another. It is becoming something of a cliché, but water can be a dangerous substance – there are many documented cases of long-distance athletes dying from drinking excessive quantities.

Should we invoke the PP in the case of water? Clearly, the answer is “no”, but where should the line be drawn? How much anecdotal evidence should be required before a substance should be banned in the absence of firm scientific evidence? Salt (sodium chloride) has clearly been shown to be linked to high blood pressure, yet low doses are essential to survival. Who makes the decision on the risk/benefit calculation?

In 1996, the legendary toxicologist, Professor Bruce Ames (as in the Ames Test for mutagenicity) made the following statement:

Of the 1000 natural chemicals in a cup of coffee, 28 have been tested for carcinogenicity [in rodents] and 19 of them came out positive.

At least 19 carcinogens (possibly more have been identified in the subsequent 16 years since that statement was made) would appear to present a very strong case for invoking The Precautionary Principle, but I am not aware of any of the lobby groups calling for coffee to be banned.

A study conducted by the University of Heidelberg in Germany and the University of Milan indicates that just one alcoholic drink per day can increase a woman’s risk of developing breast cancer by 5%. Those women who are heavy drinkers, consuming three or more drinks each day, increase their risk of the disease by up to 50%. It is believed that alcohol affects oestrogen levels, which can trigger certain forms of breast cancer. Although the link between alcohol and breast cancer is already known, until now it has been unclear whether there was an increased risk with low levels of consumption or a ‘safe’ threshold, below which there was no effect on breast cancer. The full findings are published in the journal Alcohol and Alcoholism. The link between alcohol consumption and breast cancer is well-established and yet, again, the groups who take such a keen interest in consumer health are not calling for alcohol to be banned.

From The Ecologist:

Dangerous dining?
But the most controversial part of the soya debate is that surrounding its impact on human health. The main reason for concern is the isoflavones, a type of phyto-oestrogen, present in significant quantities in soya. According to Kate Arthur, a spokesperson for the British Dietetic Association (BDA), the issue is that these phyto-oestrogens are often confused with human oestrogen. ‘There have been studies done on soya isoflavones, or plant oestrogens, and fertility but all those studies have been on animals or in test tubes,’ she explains. ‘All the human data out there suggests that soya is safe to consume.’  Dr Kaayla Daniel, nutritionist and author of The Whole Soy Story is more concerned. ‘Thousands of studies link soy to malnutrition, digestive distress, thyroid problems, cognitive decline, reproductive disorders, immune system breakdown, even heart disease and cancer,’ she argues. ‘Possible benefits are far outweighed by proven risks.’ The Vegan Society’s Amanda Baker says that soya needs to be looked at in a more level-headed way. ‘What we do know is that soya is a good source of protein and including a moderate amount of soya protein can help to reduce cholesterol levels,’ she comments. ‘Really, other claims both positive and negative are almost entirely controversial – they’re not proven.’

In 2003, the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment released a report identifying three groups of people who, evidence suggested, were potentially at risk. These were infants fed on soy-based formula, people with hypothyroidism and women with breast cancer. With babies, the fear is that the high levels of isoflavones may affect development. The BDA says soya is fine from the age of six months but before that, breast milk is best. Arthur also says soya is a good option for those avoiding dairy as it contains amino acids and is often fortified with things like calcium and vitamin D. The Department of Health agrees but says breast milk it better up to a year old and that people should speak to their GP about alternatives.

For the full article, see ‘The dark side of soya: how one super crop lost its way

The fact that there is controversy over soy suggests that human consumption should be banned, according to the Precautionary Principle.

On a lighter note, there is surely an argument to ban babies – their breath contains measurable levels of formaldehyde – a known carcinogen: ‘Toxic Baby Alert

So the question seems to be:

“Why are some materials a target for the Precautionary Principle, whereas others (coffee, alcohol, soy, babies) appear to be immune from attack”?

This is totally inconsistent, especially when the link to dangers are much stronger (for alcohol especially) than for many of the cosmetic ingredients under attack.

The real issue seems to be one of bias. If something is a “chemical” (i.e. a synthetic substance) then it is acceptable to invoke the Precautionary Principle, but if the material occurs “naturally” (coffee, soy, etc.), then the PP doesn’t matter. The basic problem appears to be an attack of chemophobia – it’s as simple as that! The Precautionary Principle is a weapon used/misused to promote the agenda of those who believe all/most synthetic chemicals are bad. It should be ignored and decisions on the banning of ANY substance should be taken on the basis of sound science; not on the ill-informed speculation of those with an agenda who neither consider nor understand the science.

  • CapnPegleg

    Food =/= cosmetics

    Cost-benefit certainly applies here, no?

    • Dene62

      I have to confess that I have never seen “=/=” before, and I don’t understand what it is supposed to represent. However, I can respond to your cost/benefit question! I don’t see what the cost – benefit calculation has in connection with the Precautionary Principle. If a substance is proven to be unsafe under normal (or potential) conditions of use, then it should be banned. Cost is irrelevant, safety is paramount. If, however, there is no real proof of a measurable risk, then no action should be taken, other than further studies to elucidate the risk to human health. A cost – benefit calculation based on an unproven risk is a waste of time. The fatal flaw in the PP is that no actual proof is required – only the often-hair-brained theory of some well-intentioned(?) but intellectually ill-equipped lobby group. (I mean intellectually ill-equipped in scientific terms, not in general terms, although this may be the case for some active members of these lobby groups!)

      I hope this is an acceptable response to your point.

  • Rodolfo Baraldini

    Thanks for having examined the subject. I hope to deepen your analysis, also involving others in the discussion. The risk-benefit ratio in the cosmetic is between a health risk and aesthetic benefit . The low (ethical?) value of the aesthetic benefits seems to amplify the risks. Probably for the same reason (the low value of ethical aesthetic benefits)  in cosmetics rules, Europe has accelerated the process for the banning of animal testing. If you think that an animal test is helpfull to discover a drug that will save the life of millions of people, you continue to test.  If you keep it serves to find a cream that erase a wrinkle you ban it. Unfortunately, by politicians and environmentalists, the precautionary principle is interpreted and used inappropriately. I see campaigns and lobbies that make ridiculous claims by appealing to the principle of precaution. If it is considered as a risk management strategy,  the principle of precaution has its own logic unassailable, especially if applied by considering the limits of scientific knowledge in the face of extreme danger and serious damages.If we assess the risk with the usual parameters of risk management (probability of damage, extent of damage, detectability of risk) in 99% of cases in which it has invoked the precautionary principle about the safety of cosmetics, for me , said it was nonsense.

    But we must admit that the other party, the cosmetics industry, has profited for years on a basis equally unscientific. Promising miracles, with ingredients that are not effective and sometimes not sufficiently tested for safety. It is less scientific to think that some specific parabens could be dangerous when used in cosmetics to give to children under 3 years or less scientific applying a shampoo with vitamins to eliminate split ends in your hair?

    • Dene62

      Excellent points, Rodolfo. I agree with your observations about the cosmetics industry, but let’s not forget that the scientists put excellent products together, and the marketing team get hold of it and it’s out of the hands of the scientists. The products may be scientific (in many respects), but that doesn’t matter to the customer. What matters to the customer is the dream that the industry sells in those bottles. I am appalled at some of the more outrageous claims made for certain products but, frankly, anyone taking them literally is being a little naive. This is different to safety, however.

      I wish you had not used parabens as an example, but I must now emphasise that there is no scientific basis for concern over their use in products on young children.

  • Bill Troy

    I believe that one commenter was trying to suggest that, as regards “risk/benefit”, food and cosmetics are not the same.  Well, can humans live without food?  No, so this of course leads to the conclusion that we can live without cosmetics.  Shall we all become Luddites and turn the clock back to the 16th century?  Throw away our cellphones, computers, automobiles, etc!  Ridiculous.  The extremists who have blocked the acceptance of genetically modified foods are directly responsible for the continued starvation in third world regions.  This is the same group who embrace the Precautionary Principle and who promote the flawed concept of zero risk.  Do they never drive a car?  Fly in a plane?  I know of no study or statistic that proves that use of a cosmetic will kill you, but there are plenty of the same that demonstrate unequivocally that some of us who rides in cars/planes will most definitely die as a result.  The ‘public interest group’ movement began as being well intentioned (who doesn’t want to save a whale?), but these have all become businesses with budgets and staffs that must be paid, and they have become self-perpetuating entities who must continue the invention of issues to be solved (by them).  Yes, sound science is one approach to answer these criticisms, but forceful public dialogue is also needed to engage these critics at their own level, which is not scientific.  Thanks to this site for doing its part!

    • Dene62


      I totally agree on every point you made. It is been observed many times that the logical step to take if you are worried about cosmetic ingredients is to avoid using cosmetics altogether – they are not essential, but this is a different argument to the one describing the logic/effectiveness of the PP. You are absolutely right in your assessment of the modus operandum of the “public interest groups”, and there are several posts here on PCT that delve into the machinations of the EWG in particular. They DO need to keep up the scary stories to continue to justify their existance but, sadly, too many people believe their hype and (amazingly) some suggest that it is wrong to criticise them because they are trying to do good things!

  • Rodolfo_Baraldini

    I purposely used the example of parabens as “decisions to be madewithout scientific certainty”. In fact ,my question was: what is less scientific?
     I read some article of yours and I’ve been following, during the lastyears,   the scientific discussion on the safety of parabens and Ihave cited the parabens under the light of the recent european rulesabout cosmetic for infants.
    For an ironic formulator, perhaps the question of the absence ofscientificity of unsustainable alarmist  vs. pseudoscientific cosmetic claims can be posed in another way:Would you eliminate parabens from a cosmetic formula based on soy isoflavones, hops, kigelia sold claiming that grow breasts?
    The discussion about the precautionary principle could proceed only if we stop to divulgate the ridicolous interpretation that Precautionary Principle means Zero Risk.
    Your reference to the Luddites forces me to consider, probably with very different conclusions from yours and those of Dene, that, while ignorance and absurdity of such matters of opinion by groups like the EWG, the final effect was a great advance in the regulatory approach and in cosmetic formulations.
    More innovation. The fearmongers have forced regulatory bodies to work overtime for updating the regulations and the Guidelines, in the same way the industry and formulators have been forced to  more transparency and drastic renovations. The previous situation governed by the concept of “safe as used” and “we have always used this ingredient, why change?” was, for me, worse than the current one.

    • Dene62

      My apologies – I tend to get a little defensive when parabens are mentioned (although I am getting this tendency under control better these days!). I totally agree with your observation about the interpretation of Precautinary Principle meaning Zero Risk – I wish I had included that in the article!