The EU Has Banned Over 1000 Chemicals; The FDA Has Only Banned 9

Internet Distortion Alert, Number 329

It seems to me that, a year or two back, someone looked at the EU Cosmetics Directive and spotted Annex II (“List of substances which must not form part of the composition of cosmetic products” ) and noted that there were over 1,000 substances on this “banned” list – there are currently 1,371. You can see them all by following this link to the Consolidated version of Cosmetics Directive 76/768/EEC

As there are 163 pages in the full document, I will be helpful and tell you that Annex II begins on p. 18! (Be warned, this Annex ends on p.65!)

The person who first noticed this then drew the comparison between the “over 1,000 chemicals” on Annex II and the 9 chemicals banned in cosmetics by the FDA, and this interesting piece of information started to be spread around the internet as “proof” that the FDA did not care about regulating cosmetics. If that person actually looked at the list, they either did not understand what they were reading, or they chose to ignore it, and decided that there was some great ammunition against the FDA here.

The simple reality is that the vast majority of the banned substances have never been used in cosmetics. Should some adventurous formulator decide that the skull of a bovine animal is a must-have ingredient, they will be disappointed, as this is banned under Item 419 (which refers to the EU TSE regulations, but DOES include skulls of bovine animals!).

Other curious entries include:

203 – warfarin (cosmetics for rats?)

268 – picric acid (highly explosive, perhaps a useful exfoliator!)

280 – thalidomide (?!!!)

293 – radioactive substances (in a cream to bring that rosy glow to your cheeks?)

323 – vaccines, toxins and serums (at least the regulator knows how to use the word “toxin”!)

416 – cells, tissues or products of human origin (shame – I wanted to develop a range of products for cannibals!)

762 – asbestos (would have been useful in sunscreens)

763 – PETROLEUM (official – you can’t use petroleum in cosmetics in the EU!)

1016 – ziram (one of many agricultural pesticides on the list – would have been useful if you wanted to smear skin cream on vegetables)

Playing the numbers game, the following are interesting:

There is a large group (items 467 – 610, so 144 of the total) that are various types of tail gas / alkanes / fuel gases / hydrocarbons, all of which are only banned if they contain more than 0.1% butadiene, and so, in effect, these are not banned if they DON’T contain butadiene – it is basically only butadiene that is banned – remove 144 from the total!

Similarly, various extracts, residual oils and distillates (petroleum) (items 764 – 865, so 102 of the total) are banned only if they contain more than 3% DMSO – remove another 102 from the total.

Items 1212 – 1233 and 1244 – 1369 are all substances banned for use in hair dyes – a fairly narrow niche within cosmetics; my point being that none of these substances would be considered for general usage, so this further skews the total.

So, the bottom line here is that numbers themselves don’t really tell the whole story.

But what really mystifies me is that the people who proclaim that the FDA don’t regulate cosmetics AT ALL and that cosmetics companies can put ANY ingredient in their products are often the very same people who state that the EU has banned over 1000 chemicals, when the FDA has only banned 9. Forgive me if my logic is faulty here, but I cannot match the two claims – how can the same organisation NOT regulate cosmetics at all, but ban 9 ingredients from cosmetics?

I am not defending the FDA per se, nor am I saying that I think that cosmetics are necessarily well-regulated in the USA – I happen to believe that the USA would probably benefit from a regulation broadly in line with that of the EU – but I AM saying that the claim highlighted in the title of this article is a major distortion of the reality of the situation, and is gross misrepresentation.

Finally, I have to confess that I have never actually seen any list specifying these 9 substances that are banned by the FDA – there may actually be more, or even fewer – does anyone know if this list exists?

  • http://www.sterlingminerals.com/ Katherine

    Thanks so much Dene for clarifying the numbers and setting the record straight.

    However just a small tidbit from Estelle Hayes article on Chemicals In Your Cosmetics:

    “In a recent Congressional hearing the head of the FDA’s Center for Food Safety and Applied Nutrition, Stephen Sundlof, waved the white flag when he said, “The law as it is currently written allows virtually anything to be incorporated into a cosmetic.” This lack of oversight means that consumers actually know very little about what makes up their make-up. And there is little rigor to the enforcement of existing policies: only nine out of tens of thousands of chemicals have been banned in the U.S., compared to 11,000 so far in the E.U.. Even more alarming is the fact that only 11 percent of ingredients used by Americans in personal care products have even been reviewed for safety — by anyone.”

    You’ll notice that she has suggested that 11,000 chemicals have been banned in the EU. Now this may be a typo, but this article unfortunately has been recycled multiple times by others, hence another vehicle of incorrect reporting which will now become the perpetual truth somehow just because it is on the internet now written by someone who lacks any scientific knowledge whatsoever.

    At the very least this woman should have rechecked her sources and information before arbitrarily writing with emotive language and totally skewing the actual numbers. Frustrating to be sure!

  • Anonymous

    thanks for putting this in perspective Dene. Here is a link to 51 ingredients banned by the cosmetic ingredient review: http://www.cir-safety.org/staff_files/CIR%20Zero%20Use%20Ingredients%201-7-2011.pdf and here is the list of 11 now substances banned by the FDA http://www.cir-safety.org/staff_files/prohibitedrestrictedbyFDA%20revised%201-7-2011.pdf
    I’m sure you are aware that the Huffington Post says there are 11,000 banned substances in the EU and you are saying just 1,000. Hmm, I wonder which one of you has got that fact correct?? :-)

  • Siobhan

    Hi Dene! Yes, the list exists, and the number is 8, not 9—though there are 3 “restricted” substances as well. You can find the list here: http://www.fda.gov/Cosmetics/ProductandIngredientSafety/SelectedCosmeticIngredients/ucm127406.htm

    • Dene62

      Thanks, Siobhan (and also to Cindy) for the links to the lists. It is interesting to note that 4 of the items on the list actually refer to groups of ingredients, so even the “9 banned ingredients” – or 8 – is not correct!

      • Siobhan

        True story! Still not very many, however. Agree with some of what you say here.

        • Dene62

          And I agree that it is not very many! But part of the main thrust of my article is that the numbers are not the real story. The FDA reserve the power to ban any cosmetic ingredient if it is proven to be unsafe for the intended use. That makes much more sense to me than the EU drawing up a ridiculously long list of items that no-one would ever consider putting into a cosmetic product. There must be tens of thousands of other substances that would never be used and that would be harmful. Why are some included and others not?
          The other main point I am trying to make is that this disparity is not a reason to claim that cosmetics in the USA are less safe (I am based in the UK, incidentally, so I am not trying to defend anything other than from a reasonably altruistic position!)

          • Philippe Papadimitriou

            If there is a negative list, it should list all banned + inappropriate substances. The name of Annex II list being “List of Substances Prohibited in Cosmetic Products” (or similar – see Dene’s differing name at the beginning of his article), how can it be restricted to components that could only likely be used as ingredients of cosmetic products? A negative list lists everything “negatively admitted” and that is the reason for it to look so full compared to what we see in the US.
            A “List of Banned Substances” would not be as numerous, but would also not be as effective probably.
            Regrettable, but logical.

            Besides, most regulations are made as to avoid overlaps. Take REACH for example. This regulation was created to be enforced where nothing was already present. The Cosmetic Directive (and its amendments) comes first when REACH deals with cosmetic products in the EU. REACH fills the gap when there is one (and there are/were some).

            Same for regulations in Switzerland. There is a decree on cosmetics, but it is part of a decree on “usual objects” (considering all material that go in contact with humans – jewelry, toys, candles, etc. to quote a few examples). What is not expressly written in the cosmetic decree -but is present on the usual objects decree- is to be followed nonetheless.

            The Annex II may not list all banned or inappropriate subtances, because these may be mentionned elsewhere (see IFRA regulations for example – the IFRA had banned Musk Xylene in June 2009 and the European Commission followed recently: http://personalcaretruth.com/2011/02/ifra-press-release-eu-regulation-follows-fragrance-industry’s-voluntary-global-ban/). I doubt the overall count to reach 11’000, but there are more prohibited substances than in this Annex II alone in Europe.

            In the end, I doubt there are so many substances missing, Dene (according to your comment “Why are some included and others not?”). For sure, there are tens of thousands of other substances that would never be used, but they surely are not (demonstrated as) harmful via the usual routes of exposure of cosmetics. If demonstration is made, the Annex II list is then completed. Examples: in 2003, #423 to 451 were added; in 2005, #1133 to 1136 were added following the work of groups on plants safety.

            For the persons still thinking plants are the panacea, have a eye on the series of interesting books “Council of Europe, Plants in cosmetics” (3 volumes available) where more bans or restrictions might also come from once.

            PS: I do not care about figures in Europe, US, Japan, Korea or the IFRA code of practice imposes: SAFETY IS PARAMOUNT.
            I deplore figures are taken out of context for more scare tactics.

  • Rich Summers

    A lot of the items not permitted in cosmetics as per Annex II are actually Pharmaceutical actives, all of which aren’t listed, as the list would have to be updated on a daily basis. They are of course mostly excluded any way by the sheer definition of a cosmetic and are then regarded under the various medicines directives/regulations.

    I get quite disturbed by people using these kinds of statistics as evidence that the industry is trying to poison people. We aren’t. Honestly. I would love to know what is on this mythical 11,000 chemical list, Agent Orange ? DDT ? “Fire” ?

    • Philippe Papadimitriou

      Fire! Ha-ha-ha! :)

      The absence of all pharmacological substances is a silent one. It is, as you mention it yourself, a direct consequence of the EU definition of cosmetics (but also of the FDA definition!).
      It could well be that this additional figure was somehow counted to get to this 11’000 value.

      Great addition, Rich!

      • Rich Summers

        :-) My cynism is too much sometimes…

        I do think that as you posted in the comment further down this thread that the number of “banned” chemicals is pretty much listing everything that isn’t used. Which is not really very relevant to most of these arguments, in my humble opinion, and I like the efforts that people ar starting to make to try to correct the wrongness and irrelevancy of these slightly ridiculous arguments.

        I would like to know if someone has actually sat down and counted all these chemicals, because if they have then I would like to know who it was so that we can all write to them to suggest that they get more of a life !!!

        • Philippe Papadimitriou

          I would correct you by saying some people confuse the “banned” and the “inappropriate” lists.

          There is no one banned list in the EU.
          There is one such banned list in the US.
          Let’s compare what is comparable.

          It’s not only about getting a life (even if this one hypothetical person definitely should get one).

  • NYCWorkingMom

    No disrespect intended: who is your employer?

    • Dene62

      Likewise – no disrespect intended, but I don’t understand the relevance of your question. How would it impact on the facts I have presented if I was unemployed compared to, say, working for Avon, or the PCPC? My article states clear facts, with links to the original information sources, and gives several genuine examples in support of my point. What would change the veracity of the article – you either choose to believe it, or not (although simply following the links provided would demonstrate the accuracy of my work), although I fail to understand how anyone could not accept that the claim that I am exposing is based on a distortion of the information available, taking it out of context. My background is publicly available (under the “About Experts” tab at the top of the home page on this site), and you can Google my name to find out my entire employment history if that will satisfy your curiosity, but I would genuinely appreciate you explaining what difference you think this makes to your interpretation of the article!

      • Dene62

        As I have received no response to my questions from NYCWorkingMom, I can only assume that her question was an attempt at an ad hominem dismissal of my article – and one that failed!

  • Angela

    No well researched words of wisdom to post but this just really made me laugh!

  • Andrew

    I bet if you, reader, knew exactly why each of these 1,371 chemicals was banned in the EU, you would conclude that the FDA should ban more than 9 of them. Just a hunch.

    • Dene62

      Andrew, whilst I am pleased that you have taken the time to read my article, I fear that you have missed the point. The vast majority of those substances listed in the EU Annex have NEVER been used, and would NEVER even be considered for use in cosmetics – so what is the point of including most of them? It would, theoretically, be possible to add several hundreds of thousands of other substances to that list but, again, none of them would ever be considered for use in cosmetics and their inclusion is, therefore, entirely pointless. I refer you back to my example of picric acid – a powerful explosive – there is no possible justification for using this as a cosmetic ingredient as it would perform no useful function (other than the possibility of clearing out residual product from the container as it explodes, thereby reducing waste!), so why is it included in the list? Inclusion in the EU list is no reflection on the toxicity of any specific substance because, as my friend Richard pointed out in an earlier comment, some of the items are pharmaceutical actives, and are included because cosmetics cannot usually contain pharmcologically active substances. As far as I can see, the FDA list bans only those substances that have previously been used in cosmetics, with the possible exception of the bovine derivatives (banned as part of the hysteria over BSE).

      • dylbert

        “Picric acid was used in a number of herbal burn treatments – worryingly most of the recipes called for it to be heated too!”

        Chemicals are funny like that. Science folk like using them for different things. Just because they have a primary function that has nothing to do with cosmetics, doesn’t mean they can’t also have a cosmetic function.

        • Chris

          Thank you. This guy is a self-misinformed joke.

        • Dene Godfrey

          Thank you, Dylbert for your constructive correction. I am always happy to be corrected if I get something wrong. I have never claimed to know everything about cosmetics, and my original comment about picric acid and the other ingredients were mainly intended to make the article faintly amusing and slightly less dry. I often make the same point about ingredients having other uses, especially when people seek to question the use of propylene glycol in cosmetics “because it is also antifreeze”.

        • http://www.sterlingminerals.com/ Katherine

          I actually have been hard pressed to find this ever being used in a cosmetic since herbal burn treatments or other skin treatments using this ingredient for the most part have been under physicians care or physician prescription, including stocking it at pharmacies. This therefore would not be considered a cosmetic but either an OTC or an FDA controlled substance as a pharmaceutical drug. Therefore, it is not a cosmetic, but a drug and the two are mutually exclusive.

          I think Dene’s point still stands in the face of the fact that it is not an ingredient used in cosmetics, since a burn ointment does not fall in this category. Thanks for pointing out the slight discrepancy, however if you can show me when and if this ingredient was ever used in a cosmetic, then the article about the EU vs FDA still remains true and accurate.

  • http://colinsbeautypages.co.uk/ Colin

    I don’t think your hunch would be right Andrew. I have the EU regulations printed out and often refer to them.  I have written notes and annotations on bits that are important and highlights to draw my attention to bits I refer to often.  I have hardly ever looked at the banned list.  The last time was simply to confirm how many there are.  I am afraid that legislators around the world are not scientists and often bring in regulations that aren’t particularly useful.  The EU’s list is frankly pointless other than to give Dene the opportunity to write an amusing post.  (I refer you to California for the worst examples of misguided legislation.)  

    • http://www.facebook.com/eddie.farrow.12 Eddie Farrow

      Actually, there are extensive reports with studies online accessible outlining greatly the assessments on a lot of substances. I know. I trudged through enough of them. the EU has an extensive scientific community to consult before bringing in bans.

  • http://www.facebook.com/profile.php?id=1180039101 Jill Herendeen

    http://www.fda.gov/Cosmetics/ProductandIngredientSafety/SelectedCosmeticIngredients/ucm127406.htm
    I decided maybe you have a point, maybe there ISN’T a list of the 9 things the FDA has banned from cosmetics; so I googled it, and found the above, and golly, it sort of looks like a list of 9 things banned by the FDA for use in cosmetics.  Interestingly, ‘products containing mad cow disease’ is one of them…possibly what the EU was thinking of when it included “bovine skull” on its list?

    • http://colinsbeautypages.co.uk/ Colin

      I am not sure I am reading the article the same way as you are Jill.  I think the author does indeed confirm that the FDA have a list of 9 substances prohibited in cosmetics.  They have quite a few other regulations as well.

    • Dene62

      Jill, I doubt that the EU was thinking of BSE when “bovine skull” was included on the list, as there are far more bovine parts that would constitute a far greater risk (if indeed there is any at all). It doesn’t make sense to only prohibit bovine skull and not specify other body parts in this context.

      • Chris

        It sounds like you are insinuating that the people who decided to ban these things were either stupid or banning random things to appear safer than the FDA. For that, sir, you sound like a shoe-less child raised in the woods, never having seen a book, who enjoys oversimplifying things he doesn’t understand so he feels like he does. You have not done near enough research.

        • Dene Godfrey

          It was not my intention to insinuate either point that you have made; if you chose to employ such a totally negative interpretation of my words, that is your prerogative. The main point of the article was to highlight that the difference in numbers of banned substances between the EU and the FDA is nowhere near as dramatic as it sounds when only taking the two numbers without any futher information. My use of a little light humour in highlighting a few curious items in the EU list seems to have passed you by. Picric acid IS a curious ingredient to be used in cosmetics. I was not defining WHY I found certain items curious; just that (in my opinion), they were so.
          Your comment is rude, for all its faux politeness (“sir”!), and I find it disappointing when people offer such rudeness when hiding behind pseudonyms. I always give my full name in forums, whether I am being rude or not (and I am occasionally rude, and can easily sound just as pompous as you, when I so wish – but at least people know who it is that is being rude to them!).
          I feel that I did sufficient research in order to make the point I wanted to make. If you wish to offer slightly more constructive criticism, or even add to the body of knowledge in this forum, I would welcome such a move.

  • Jim

    Some of those “curious” items aren’t nearly as surprising as you say.

    Radioactive substances saw widespread use in cosmetics following the discovery that they glowed in the dark; you allude to it but there really were lipsticks to make your lips glow.

    Petroleum and other hydrocarbons are also not surprising. Vaseline of course is petroleum jelly – although contains no petroleum funnily enough.

    Asbestos has been found in talc and associated products.

    Thalidomide is a pretty obvious addition in light of its affect on pregnant women.

    Warfarin is an anti-coagulant prescribed for deep-vein thrombosis amongst other things (although its use in cosmetics I can’t decipher…).

    Picric acid was used in a number of herbal burn treatments – worryingly most of the recipes called for it to be heated too!

    Did you even bother to look up these ingredients’ role in cosmetics?