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?


Dene Godfrey has been involved with preservatives for cosmetics since 1981, from both technical and commercial angles and has a degree in chemistry. Dene worked for one of the largest manufacturers of parabens from 1992 – 2002, and currently works for a UK company involved in the distribution of ingredients for cosmetics, health care and food. The Boots Company, 1973 – 92, Dene spent 11 years working with bronopol, although he was also involved in the initial development of Myavert C, now known as Biovert – a well-known “non-preservative”. Latterly was responsible (as Technical Manager) for the operation of the Formulation Laboratory and the Microbiology Laboratory. As Technical Manager when at Nipa Laboratories, Dene was responsible for development and sales of new preservative products, mainly into personal care. Developed the Nipaguard range of preservatives and co-patented a preservative system based on phenoxyethanol and IPBC. In 2002, Dene founded MGS MicroPure (as Technical & Sales Director) to compete with the giants of preservation, establishing the Paratexin brand name in the UK and several other markets (EU/ global). MGS MicroPure ceased trading in 2005. Since 2005, Dene has been employed by a major UK distributor of personal care ingredients, with his focus primarily on preservation systems. Dene’s articles are based solely on his personal opinions, observations and research, and are not intended to represent any official position of the part of his employer. Dene obtained a BSc (Hons) in Chemistry from the Open University in 1996. He also obtained the Professional Certificate in Management from the Open University in 1997. He has been an active member of the UK Society of Cosmetic Scientists since 1992, and has served 4 terms on the SCS Council, and is involved with the SCS Social Committee from 1993 to date; from 2004 – 7 as Social Secretary. Dene has presented papers at many SCS meetings and was President of the SCS (2009/10)

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