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Glydant™ Plus™ Liquid / free formaldehyde
EU regulation:
Finished products containing DMDMH must be labeled with the
warning “contains formaldehyde” if the (free) formaldehyde concentration
exceeds 0.05%.How do I know this value is not exceeded in my formulation? -
12 Replies
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firstly, “contains formaldehyde” is only required on products containing formaldehyde itself, i.e. not formaldehyde donors, and even then it’s only required if it’s included for non-preservative purposes; see Annex III/13
Annex V/5, which covers its use as a preservative, does not specify any labelling requirement, and nor do any of the entries for formaldehyde donors in Annex V
secondly, any product containing DMDM hydantoin that’s not formulated at an extremely acidic or alkaline pH, or stored at temperatures over about 50°C, will have a negligible concentration of free formaldehyde; it only releases formaldehyde when microorganisms try to digest it
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Thanks Bill_Toge, but regarding Annex V - I think you are wrong:
Annex V says (at the bottom):All finished products containing formaldehyde or substances in this Annex and which release formaldehyde must be labelled with the warning ‘contains formaldehyde’ where the concentration of formaldehyde in the finished product
exceeds 0,05 %secondly I agree - however a negligible concentration is unfortunately not defined and doesn’t mean < 0,05% ! -
in which case I’d suggest you refer this matter to your safety assessor and see what their view is, since they’ll ultimately be the ones who sign your product(s) off as safe and determine whether or not they go to market in their current state
for what it’s worth, none of the safety assessors I’ve dealt with have ever recommended adding this warning, not even the ones working to corporate policies and limits which went went well over and above the ones prescribed by the regulations
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In the first instance I would be doing an analysis on “free” formaldehyde in your formulation using the colourimetric acetyl acetone method.( Refer Japanese Law 112) You will need a Visible spectrophotometer for this analysis or send the sample out to a registered laboratory to do the work. A level of 0.05% is 500 ppm and this method will readily detect down to 1 ppm .
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You may all be correct with your answers, but the bottom line is that “formaldehyde donors” like Paraben” are not liked by the general public. I would try and stop using them. I don’t think it is worth trying to fight it anymore. There really are quite a few products out there, that preserve well, at least until the next bombshell hits us!!!
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Parabens is not a formaldehyde donor.
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I’m not sure the general public knows what parabens are. There is a small segment of the population who cares and lots of cosmetic marketers seem to but whenever I’ve done an informal poll of people, and I ask what they think of parabens, almost no one knows what they are.
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Also, the small segment of the population who do care about parabens tend to be very heavily concentrated in the segment of people who want “all-natural” products.
So, if you’re not marketing a “natural” or an “all-natural” product, and if your marketing department doesn’t care about having a “paraben-free” claim, there’s really no reason not to use parabens. All of the scientific evidence behind the paraben scare has been pretty thoroughly debunked/discredited. -
exactly Bobzchemist& Perry it is not a natural product - which brings me back to the actual question - do I need a warning? one says most safety assessors don’t care another says I should measure… maybe not so easy to answer - that is why I put it under “advanced” -anyway thank you for the input
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The language in the regulation is not unambiguous. You need to measure and if your product contains higher than the minimum concentration of free formaldehyde, then you need to put the warning. -
sorry Belassi, my english is from UK. What i was saying is that “formaldehyde donors” ,and preservative like parabens are not liked by the general public. I do hope that all the people here know that parabens are not formaldehyde donors. Sorry if what i wrote gave anyone else the idea that i was suggesting that. best regards edwardgaunt@gmail.com
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thanks MarkBroussard, I believe so too…
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