Why Does Hydroquinone Keep Getting Banned in the EU in Concentrations Above 1%?

Skin Care
why does hydroquinone keep getting banned in the EU

I’m going to get all Carrie Bradshaw on you for a minute and talk about men. (Don’t worry, this has a point). A few years back, I dated a man who was smart, funny, and attractive. He wasn’t the love of my life, but we got along.

But my friends and family really didn’t like the guy. Even my friends who aren’t the type to judge or criticize would offer upon asking, “Well, as long as you are happy, that’s all that matters.” Ouch.

It didn’t last — he went this way, I went that, but I often wondered, Was he really that bad? What did they see that I didn’t?

It’s the same way with hydroquinone.

Since 1982, hydroquinone has been FDA-approved for the treatment of freckles, melasma, and general brown patching. Worldwide, hydroquinone is still the most commonly used bleaching agent. People who love hydroquinone absolutely love it, because it works. I’ve personally been a supporter of it for a long time. (Am I just too willing to give a rave review to men and products?!)

Yet the EU has banned hydroquinone in concentrations greater than 1%, and there is a growing number of people online who want to see this ingredient banned, once and for all. So I’m going to break down the facts — what is good about it, what is not-so-good about it — and let you decide.

Hydroquinone Is Effective Because It Works In Two Different Ways

How Hydroquinone works futurederm

Most skin lighteners work by inhibiting an enzyme, tyrosinase, which is necessarily for pigment (melanin) production within the skin. Hydroquinone also works in part by inhibiting the activity of tyrosinase.

However, unlike skin lighteners like kojic acid, mulberry extract, and peptides, hydroquinone also works by increasing the cytotoxicity of melanocytes (melanin-producing cells). Essentially, this means that hydroquinone can kill melanin-producing cells within the skin.

Because of the drastic difference in effects I’ve seen in people using hydroquinone-based products, I believe that cytotoxicity is greater than tyrosinase inhibition when it comes to fighting hyperpigmentation and lightening the skin in general.

The Concentration of Hydroquinone Matters When You Have Dark Skin

If you are of South Asian/Indian, Middle Eastern, Hispanic, or African descent, you may want to avoid using hydroquinone without the supervision of a physician. Though very rare (1 in 100,000 cases), according to the American Journal of Clinical Dermatology, use of hydroquinone in concentrations of 2% or greater can cause a condition known as exogenous ochronosis. This is a reflexive darkening of the skin — exactly the converse of what you want when using hydroquinone! It is worsened with sun exposure. As such, those with darker skin may wish to take extra precautions in avoiding products with excessive sun exposure when using hydroquinone products.

Yet, 1 in 100,000 isn’t significantly high enough to say all dark-skinned individuals should avoid hydroquinone. According to Dr. Susan C. Taylor, M.D., a Philadelphia-based dermatologist who has literally written the book on darker skin, ”The maximum levels of hydroquinone currently allowed (2 percent for over the counter, 4 percent for prescription) aren’t dangerous. At worst, it might cause redness or irritation, but only if your skin is sensitive or allergic to the medication.”

Some Risky Formulations Contain Mercury

The biggest risk of hydroquinone use appears to be the fact that some formulations contain trace amounts of mercury, though these formulations found to contain mercury were produced only in Mexico, Africa, and the Middle East (Boston Globe, 2003). Mercury poisoning is associated with damage to the brain, kidneys, and eyes (Pediatric Clinics of North America, 2007), and unlike many other ingredients that are reported on the internet to be toxic, mercury actually is toxic in very low, realistic doses to be found in skin care creams.

Therefore, if you are using a skin care treatment with hydroquinone, take caution that it is not produced in Mexico, Africa, or the Middle East, just to be on the safe side.

Hydroquinone May Even Prevent Cancer

And in a 2006 review in the Journal of the American Academy of Dermatology, Dr. Jacob Levitt, M.D. reports that topical applications of hydroquinone in standard product concentrations are not carcinogenic to humans. According to Dr. Levitt, use of hydroquinone in murine (mouse) studies led to an actual decrease in murine hepatocellular carcinomas (cancerous liver tumors) but an increase in hepatic adenomas (benign liver tumors), suggesting protective effects of hydroquinone.

Dr. Levitt further reports that murine renal (kidney) tumors caused by use of hydroquinone do not appear relevant to humans after decades of widespread use, and murine leukemia has not been reproducible and would not be expected from small topical doses in humans as well. As such, it seems that topically applied treatments with hydroquinone are safe, as Dr. David J. Goldberg, a clinical professor of dermatology at the Mount Sinai School of Medicine reports, “Over 100 scientific articles confirm it is a safe topical for humans; no independent studies prove the opposite.”

In General, So Long as They Are Mercury-Free, Over-the-Counter Products with Hydroquinone are Safe and Effective

The risks of hydroquinone (see above) appear to be minimal. To be on the safe side, I advise using hydroquinone for no longer than 4 weeks, and then cycling off for 4 weeks. It is great to start using again come fall.

Overall, is hydroquinone safe and effective?

Unlike with boyfriends, it’s not good to listen to the opinions of others about hydroquinone. It works, and it is safe and effective, so long as the formulation is sourced in the U.S. or Europe, and you avoid the sun during its use. Based on the scientific literature, hydroquinone seems to be both safe and effective at this time. Talk to your dermatologist if you are interested in a prescription-strength hydroquinone treatment. . If you are using any type of products with hydroquinone, use a sunscreen daily, and try to avoid the sun for best results, and if you are using hydroquinone, follow doctor’s orders and do not use for longer than eight weeks.

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  • Nicki Zevola

    Hi there @MaSkintologist,

    The CIR is definitely a well-respected panel and authority on which ingredients are safe.

    I will direct you here: http://online.personalcarecouncil.org/ctfa-static/online/lists/cir-pdfs/TR647r.pdf

    From an overview of the situation, it seems that the CIR approves hydroquinone for use under 1% because:
    1.) 2% or greater caused conjunctivitis of the eye of guinea pigs;
    2.) More importantly, 2% or greater also mild irritation and dermatitis in 4/10 subjects tested. A small sample size, but enough to heed caution at 2% or greater.

    As far as I can tell, the CIR is “playing it safe” in recommending 1% or less. The rationale seems to be to avoid dermatitis, irritation, and potential eye contact that are potential with higher concentrations.

    The CIR, like most other dermatologists, scientists, and experts who review this information independently, seem also to come to the conclusion that there is no evidence to support hydroquinone causes cancer or significant (> 1/100,000) risk of ochronosis. Again, I do not want to speak on their behalf, but from my quick analysis of this, it seems this is the case.

    Hope this helps,

  • First, THANK YOU very much for your effort and taking the time out of your surely busy schedule to write up this blog! I really appreciate you! I love reading educational articles on your blog! 🙂

    Now, although I indubitably concur with you on this issue and as insightful as this article is, it doesn’t exactly answer original question. Please don’t take this the wrong way, Nicki! >_<

    The Cosmetic Ingredient Review Expert Panel has, since 1986 to the present, been persistently opposed the use of hydroquinone ≥ 1%. In their latest 2014 unpublished report, I quote:

    "The CIR Expert Panel concluded that hydroquinone is safe at concentrations of ≤ 1% for cosmetic formulations designed for discontinuous, brief use followed by rinsing from the skin and hair. Hydroquinone is safe for use in nail adhesives and as a polymerization inhibitor in artificial nail coatings that are cured by UV light when photo – protective materials (e.g., gloves, sunscreen) for the skin are used in professional settings; these products are unsafe for the new in – home use. Hydroquinone is unsafe for use in other leave – on cosmetic products. This conclusion supersedes the earlier conclusion issued by the Expert Panel in 2010"

    Once again, this “conclusion” is echoed since their first report in 1986 in the International Journal of Toxicology.

    So, obviously I’m perplexed by this. I support the use of hydroquinone and I've been using it personally for several years now without any adverse skin reactions. But, I’m no authority figure. I am not a licensed toxicologist, cosmetic chemist, or dermatologist, so my understanding and opinions ultimately rely on other ‘experts’. The CIR is a respected panel, right? They published their research opinion in a reputable academic journal and they’ve been persistently clear in their conclusion on the safety of hydroquinone. Yet, many dermatologists and plastic surgeons (and you, too, Nicki) still say hydroquinone is safe. Do you see my confusion? Ha-ha! I’m just disturbed as to why there’s no authoritative and unanimous consensus on this, yet (wishful thinking, I guess). Where is the disconnect between the CIR and the other many dermatologists/plastic surgeons? Is the CIR bias? Is it political? Could the CIR have overlooked the studies you've mentioned here? Perhaps, this is beyond your scope of expertise, but I was wondering if you can try to answer it. 🙂


    http://ijt.sagepub.com/content/5/3/123.abstract (1986)
    http://ijt.sagepub.com/content/13/3/167.abstract (1994)
    http://ijt.sagepub.com/content/29/6_suppl/274S.short (2010)

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