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Parabens – Part III (More Info Still!)

Here we are, back again to the parabens.  It may seem like this is a never-ending debate.  But that is fine with me.  Further debate leads to further investigation.  And further investigation may eventually lead us to some solid answers.  I’m a scientist.  I like solid answers, but truth is ever evasive.  As long as everyone is different, there may never be a final answer.

So let’s take a look at the latest information.  It comes to use from the Scientific Committee on Consumer Safety (SCCS) through the European Commission.  It is an independent non-food scientific committee with no financial gain from industry for their work.

The “Opinion on Parabens” paper can be found here: http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_041.pdf

It is some 35 pages long and gets deep into scientific lingo.  So I will try to sort it out for you.

Most parabens are OK.  Methylparaben and Ethylparaben are restricted to 0.40% by weight while Propylparaben and Butylparaben are restricted to 0.19% by weight.  Oh, if more than one paraben is used, they are restricted to .80% by weight in a formula.  Sound good?  Most cosmetic/personal care/personal lubricant formulations do not ever use them at that high of a level.  The most I have ever seen is around 0.40% by weight when using three of the four.

So looks like we are home and dry?  No.  We haven’t really even reached for a warm fluffy towel yet.

The Commission wants more data.  The rat and mouse models (yes, animal testing) do not have enough correlation to a human model.  They are asking for more in vivo human tests.  (In vivo means testing on a live creature, in vitro is testing in a petri dish.)  There are a few other parabens which have not been tested, but no one uses those in and personal care application.

It appears that parabens whether applied subcutaneously or orally rapidly metabolize into PHBA which is found in all plants and is expected to naturally occur in humans.  It is quickly passed through the system through our urine and faeces.  However, intact parabens have been found in the urine and/or serum and seminal plasma.

That is why the SCCS set the above stated limits, because they need more data.  They set the threshold much higher than the Industry’s recommendation.  Enough animal tests, we need to test on humans.  Pretty scary, huh?  Want to be a human test subject?  I would!

Bottom Line Straight from the Report: 

With respect to the safe use of parabens as cosmetic ingredients, concern was expressed as to the potential endocrine modifying effects of parabens of higher chain length including Propylparaben, Butylparaben and related iso compounds. Benzylparaben was also of concern. Based upon the currently available in vitro data and in vivo rodent test results, the SCCS agrees that the estrogenic properties displayed by parabens appear to increase with increasing chain length. Nevertheless, the SCCS stresses that the displayed potency levels remain about 3 to 6 orders of magnitude lower than the potency of the positive controls.

So the jury is still out, but the deliberation is drawing near a close.  We should have more definitive answers in 4-5 more years.  Stay tuned…

Questions?  Love Letters?  Topics?  Nude Pictures?  Send them to me at: drtim@quantumcogitation.com

 

 

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Parabens – Part II

Sparing you any pithy comments, here is an article from Cosmeticsdesign.com which can be found here:

http://www.cosmeticsdesign.com/Formulation-Science/New-data-on-parabens-suggests-no-adverse-hormonal-effect-on-the-body/

New data on parabens suggests no adverse hormonal effect on the body
By Katie Bird, 18-Nov-2009
Related topics: Formulation & Science

The industry awaits the judgement on parabens following the release of further data on skin absorption and the distribution of the chemicals in the body.

Florian Schellauf from industry trade body Colipa presented the findings from a recent study on rats at a conference organised by the Scandinavian Society of Cosmetic Chemists (SCANCOS) in Sweden.

The study was performed at the request of the Scientific Committee on Consumer Safety (SCCS) (formerly the SCCP) for more data on the longer parabens, propyl- and butylparaben, following research that claimed the commonly used preservatives may affect the reproductive and hormonal systems of the body.

According to the study data presented at the SCANCOS conference, in rats, parabens are well absorbed after oral administration but only partially absorbed after dermal exposure.

In addition, the data suggests that the compounds are fully metabolised before they enter the blood stream.

Blood plasma tests highlighted only the presence of a paraben metabolite PHBA (p-hydroxybenzoic acid) and no concentrations of the parabens themselves, regardless of which paraben was used and how it was applied (oral, dermal or subcutaneous).

According to Schellauf, PHBA is not known to have any estrogenic effects and is found widely in plants and human food, so trace exposure in the human organism poses no health risk.

“The study confirms the results of a number of research studies, which concluded from their work that parabens are metabolised rapidly and to a large extent in living organisms and therefore cannot exhibit any adverse effects,” said industry trade body Colipa.

The study will be submitted shortly to the SCCS, which will have to come to a decision on whether this new data means the acceptance of methyl-, ethyl, propyl- and butyl-parabens as preservatives in cosmetics products, should remain unaltered.

According to Maria Lodén founder of Sweden-based consulting firm Eviderm and a member of SCANCOS, a decision from the SCCS can’t come soon enough.

Anti-paraben stance

A number of consumer groups, environmental organisations and some industry members have taken an anti-paraben stance which may not be based on respectable scientific evidence, she said.

For example, the Nordic Swan, an environmental label well known in Denmark and Sweden has said products aiming to gain its label cannot contain parabens. Following the release of this new data and the SCCS’s forthcoming opinion, Lodén believes the Swan label should change their criteria and allow the compounds.

“My interpretation of the current data is that, in addition to methyl- and ethylparaben, also propyl- and butylparaben will represent the safest option for preserving cosmetics in the future,” she said.

“The society anxiously await the final SCCS report on the issue to reduce dissemination of misleading information on parabens,” Lodén added.

Me again –

WOW! It looks like scientists may not have been lying to you!  Of course I blame the Media…

How ‘Bout Them Parabens?

Time to talk about preservatives.  This is a pretty touchy subject with a lot of big guns on both sides of the debate.  Let’s see where we go…

The first thing to mention is that preservatives can be toxic.  Of course they can.  Their sole job is to kill things so that our products stay fresh and usable.  Preservatives kill off nasty microbiological organisms like viruses, bacteria, yeast and mold.  That’s a good thing right?  Otherwise we would only have local cosmetics that have to be kept in the refrigerator and replaced every few days.  No more national brands and a big upswing in the sale of portable coolers.

I mean, how clean are your hands?  Pretty darn clean you think.  You think incorrectly.  One of my favorite show and tell demos when training new chemists is to ask them just like I asked you how clean their hands are.  Then I have them put their thumb on the agar in a micro plate.  (Agar is what we use as food to test for microbial growth.  Give ’em food, a moist warm place to thrive and see if it can survive.)

Two days later, I show them the plates.  And the amount of growth is always amazing.  All kinds of bumps and fuzz of many different colors.  Now we know with great certainty who washes their hands after using the restroom and who doesn’t.  It is truly an eye-opener.

Wash your hands!

Wash your hands!

So if a scientist’s hands which are washed religiously and covered with gloves aren’t clean, how do you think the average person’s hands compare.  Chemistry 101: A real chemist washes their hands before they use the restroom as well as after.

And you think nothing about sticking your finger into your jar of cream after a long day?  Ugh!

OK, so now we know that things are dirty and that preservatives are used to combat all the nasties that can grow on our skin.  So let’s cut to the chase and get to parabens.

parabens

Parabens: A group of preservatives (esters of p-hydroxybenzoic acid) used very commonly in cosmetics, food, pharmaceutical and industrial products.  You can find them on labels listed as: methylparaben, propylparaben, ethylparaben, butylparaben, isopropylparaben or isobutylparaben.  They were first introduced in the 1920’s, hit commercial cosmetic use in the 1930’s, were first listed as GRAS (generally recognized as safe) in 1995 by the US EPA at a combined percentage of 0.8% in cosmetic products.  The average cosmetic concentration of parabens usually runs between 0.20-0.40%.  And as with any material, it is possible to be allergic to parabens.

But in 2004, there was a study by Dr Philippa Darbre at the University of Reading that showed out of twenty breast tumors studied, all of them had parabens in them.  Wow. That set the press in motion and before long many thought that parabens cause breast cancer.  Why would they think that?  Well, it seems that parabens (butylparaben is the most potent of the family) have some oestrogenic activity.  Estrogen is an endocrine distrupor.  Disrupt the endocrine system enough, cancer can grow.  The test was published in the Journal of Applied Toxicology.

So on the one hand, there are a few studies that show a causal link between parabens and breast cancer.  However, those studies bring more questions than answers.  On the other hand the US, EU, Japan, the National Cancer Institute and several respected naturalists do not see any cause for alarm.  The oestrogenic activity of parabens is approximately 100,000 times weaker than a woman’s natural estrogen.

Give the public what it wants.  Several groups have reopened studies on parabens and more work is being. done.  We should probably ban everything that causes cancer, huh?

Did you know that all plants naturally produce p-hydroxybenzoic acid?  They produce parabens to protect themselves against attack by micro-organisms.  Gee, just like we use them in cosmetics and personal lubricants!  And guess what?  Almonds, apples, broccoli, cherry, mango and many, many more have potent oestrogenic activity.  We consume more parabens through organic foods than we get from cosmetics.

Fruit Basket!

How does it end?  Parabens have been used safely for over 50 years.  They are stable, recommended for use with sensitive skin and no link has been conclusively shown between parabens and any cancer or illness.  If the thought of using them makes you uncomfortable, read the labels and buy products with alternative preservative systems.  It does however remind me of an old saying,

“A rumour can run around the world before the truth gets its shoes on.”