Scaremongers Science

Cosmetic Safety Assessments

cosmetic safety assessmentsSince the nineties the European Union’s cosmetic legislation has required that all cosmetic and personal care products placed on the market should be assessed for safety by a suitably qualified person.  I am not sure what the exact thinking behind this was. As cosmetics had not been particularly unsafe before that, the intention must have been simply to reassure consumers.  But as almost nobody outside the industry knows about the existence of these assessments, I have a feeling that the general public has not been particularly reassured.  Given how much work and effort goes into them this really is a bit of a shame.   So I thought I’d do a blog post to help spread this knowledge a little.

The original legislation was vague in the extreme.  I remember that at the time I simply prepared a boilerplate statement stating that the products from the lab I was managing were safe.  That was enough to meet the letter of the law at the time.   Subsequent amendments to the legislation have been steadily more prescriptive and there is now quite a bit of detail about how these assessments should be performed and who should perform them.  The requirements for the safety assessment have an annex to themselves with over two pages of detail about what the report needs to contain.

We all want the products we use to be safe,  so it is quite a good idea to require somebody who knows what they are doing to check this out prior to launch.  Although there are some very detailed restrictions on a wide range of chemicals, it is no easy matter to come up with legislation that covers every possible thing that somebody somewhere might want to do.  Take for example something like menthol.  In a foot soak it is ideal.  Put it in an eye serum and you will have people’s eyes watering.  That is the sort of common sense thing that any assessor  who knows what he is doing will pick up.  But it would be pretty hard to legislate for every similar eventuality.

But the thing that seems to bother the public most is the safety of the chemicals used in the individual formulations.  If you aren’t familiar with chemistry an ingredient list is a bit mystifying and it might well be a bit alarming if you aren’t sure what all those chemical names mean.

This is something that a safety assessment ought to be able to put people’s minds at rest about.  In reality cosmetics are very safe, certainly when you compare them to other things we come into contact with on a daily basis.  If you overuse alcohol – you risk liver cirrhosis.  Smoking tobacco risks lung cancer.  The worse that can happen with overdoing your use of beauty products is you risk looking a bit of a tart.  I can’t help you with that, but I can assure you that all the ingredients you use  have undergone a separate toxicological assessment.  Whatever else they do for you, your cosmetics are not going to harm your health.

The nub of the safety assessment is the margin of safety calculation on the individual ingredients.  This isn’t too hard to understand at all, though it is usually presented with so much jargon that only a toxicologist or somebody who has studied a related subject will be able to follow it.  All you do is you feed your ingredient to animals and work out the lowest dose that does them any harm.  You then calculate the equivalent amount that you would need to administer to a human – taking into account their different body weight.  Apply a safety margin of 100 times, and you have your margin of safety.  Actually doing all that is actually quite a lot of work and requires a fair amount of skill, but the principle behind it is pretty straight forward.

To illustrate it lets have a look at Pantene Pro V.  This was used by the Campaign for Safe Cosmetics and the Story of Stuff project in a video back in 2010.   The basic premise of the video was Pantene was full of dangerous stuff which was illustrated by lots of skull and cross bone symbols.  They also claimed that they had got a scientist to help them understand it.  The scientist wasn’t named, we just saw a cartoon of him.  It looked a bit like my friend Terry.  But it can’t have actually been him because Terry knows how to carry out a margin of safety calculation.  In fact, not just Terry, any scientist knowledgeable enough about toxicology to do so would have told the campaigners that they had nothing to worry about.  So we are still in the dark about who this mysterious figure was.safety assessement scientist

Joking aside, the business of knowing who actually said something is one that is taken seriously by people who are concerned about safety.  The most important body when it comes to cosmetic safety in Europe is the Scientific Committee on Consumer Safety.  This is a committee of scientists, mainly medics and academics,  appointed by the EU to advise them on matters of safety relating to cosmetic products.

The membership of this group varies over time, but whenever they issue a report all the experts who have contributed to it are listed so you can find out who they are and what their qualifications are.   They also cite all the references they use at the end.  Most of these are published scientific papers that have named authors.  Most of the papers are from recognised journals that have editors, again people you can identify, who take the trouble of getting other experts to review the papers before they publish them.  This means that all the information that they base their decisions on has been past a lot of well informed people.  It also means that if you have the inclination you can examine their reasoning and make your own decision on whether it makes sense.

In the United States there is a similar body called the Cosmetic Ingredient Review Panel who adopt much the same approach and who again can be personally identified.  I personally place more trust in a system like this than I do in a Youtube video’s cartoon character.  Getting safety advice from anonymous people online seems distinctly risky to me – especially ones who appear to be not so much scientific experts as drawings.

Another problem I have with the use of graphics to talk about safety is that if you put pictures all over the video with skulls and crossbones and things like that you are short-circuiting your logic and replacing it with emotion. It is almost a way of making making yourself more stupid.  Emotions are fine things in their place, but they don’t enable you to exercise good judgement.  Would you rather be operated on by somebody who is being calm and logical or somebody who was getting carried away with the excitement of the moment?safety assessment risks

So back to my safety assessment of Pantene.  I don’t actually know the formulation for this product but I have been formulating shampoos long enough to have a pretty good guess.

This is my rough guess based on looking at the ingredients list.

 

Ammonium Laureth Sulfate 7
Ammonium Lauryl Sulfate 8
Ammonium Xylenesulfonate 1
Cetyl Alcohol 2
Citric Acid 0.5
Cocamide MEA 3
Dimethicone 1
Disodium EDTA 0.1
Glyceryl Stearate 2
Panthenol 0.2
Panthenyl Ethyl Ether 0.2
Parfum 0.2
PEG-7M 1
Polyquaternium-10 0.5
Sodium Benzoate 0.2
Sodium Chloride 1
Sodium Citrate 1

So, as I am a suitably qualified person I will have a go at assessing the safety of this formulation.

Let’s look at the margin of safety calculations first.  The rules allow you to skip this if you have a sufficient justification.  This sounds like a loophole, but there are some pretty good reasons for why a margin of safety calculation isn’t always necessary.   The most common is simply that the ingredient is already generally regarded as safe.  In the US this designation is actually a legal one and the FDA, the food and drug administration, actually maintains a list of materials that it categorises as GRAS.  The capital letters are a sign that it is official.

pantene pro V

For example on our list above is Sodium Chloride or common salt has GRAS status.  We all know that it is safe and wouldn’t worry about applying a 1% salt solution to our skins so there is very little point in sacrificing animals and wasting lab time to prove what we know already.  Other ingredients on the list fall into the same category even if they aren’t as well known.

Safety Assessments GRAS status

 

Here are the margins of safety for  the ingredients in Pantene where it makes sense to calculate them.

Ammonium Lauryl Sulfate 2,100
Ammonium Xylenesulfonate 71.400
Cocamide MEA 16,000
PEG-7M 100,000
Sodium Benzoate 43,750

Just to be clear what these numbers mean, what the margin of safety here tells you is that the lowest concentration of ammonium lauryl sulfate that can be shown to have a harmful effect is 2,100 times higher than the level in this shampoo.  These calculations are done in the most conservative way possible. If there are two different figures for the level which causes a harmful effect available, the worst case one is chosen.  The assumptions made about use levels are always on the generous side.  The body weight assumed is 60Kg for an adult – which in my case gives a 50% extra margin of safety on top of the calculated one.  (One advantage of being overweight is that it gives you more body mass to cope with any toxins you ingest.)

The margin of safety calculation is just one aspect of the safety assessment.  The person carrying them out will look at all the data available to come to a judgement.  He or she will record all the sources of those data so that if challenged the assessment can be justified. Anything relevant to safety is considered.

One of the ingredients that the Story of Cosmetics video picked up on was disodium EDTA.  This was talked about as if it was very dangerous chemical indeed. Is that it’s nothing of the kind, far from it.  It is in fact used to counteract the effect of toxins by doctors.  If it was indeed dangerous the assessor would not be prepared put his name to the report.  And all the ingredients will have been assessed in this way.

When  the report is completed it is signed and dated and filed in the product information file.  It can be referred to for years to come and the author is held responsible for its contents.

These safety assessments are a legal requirement in the European Union. Although they are not required in the United States, a great many companies still use them anyway. They are a useful format for proving that you have formulated your product according to sound principles and that will stand you in good stead if you run into any trouble later.

So you can see that the safety of cosmetics is far from a hit and miss affair. Every product Europe and most products in the United States Will been carefully assessed by a qualified person who puts a name to a document to sign them off once a done so. This is I hope a reassuring fact.

If the people behind the Story of Cosmetics video are reading this I hope they are reassured as well. It is a shame that they couldn’t find somebody a bit more knowledgeable to advise them before they started.  It would’ve saved a lot of people a lot of stress and worry.  My only regret is that I don’t have the wherewithal to come up with a lot of  entertaining comic figures to illustrate this blog post.

Photo credit: atomicShed via photopin cc

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