Formaldehyde releasers at risk in EU

PhilGeisPhilGeis Member, Professional formulator
EU's SCCS has proposed reduction of the free formaldehyde level (from formaldehyde releaser preservatives) requiring "contains formaldehyde" labeling from current 500 ppm to 10 ppm.  I can't address safety concerns that compelled but do know 10 ppm level is useless as preservative, obsoleting formaldehyde releasers for those who can't live with that unhappy label, 

Comments

  • PerryPerry Administrator, Professional Chemist
    Wow, that's a significant development!
  • PerryPerry Administrator, Professional Chemist
    @PhilGeis - I was just looking up Glydant 2000.  The Lonza datasheet claims it has 0.09% free formaldehyde.  Even if you use 1% of the ingredient you would be below the 10 ppm level (9 ppm) right?  Am I missing something?

  • PhilGeisPhilGeis Member, Professional formulator
    edited May 12
    Think the raw material - not in finished product.  Don't remember if  2000 was unique but experience with Glydant at 2000-25000 ppm was 100-200 free.  As efficacy of releasers is based on the released formaldehyde,  10 ppm is not an effective level for the stuff.  Not aware that the parent molecule per se has efficacy. 

    So doesn't seem reasonable - but would sure be good if true.
  • chemicalmattchemicalmatt Member, Professional Chemist
    A nefarious portent out of E.U. to be sure. Our 3V Sigma Abiol and Abiol Forte have zero free CH2O, but just heat them a wee bit in solution (e.g. compounder adds above 50C) and there will be way more than 10ppm in the product. How will the regulators measure this is my concern. Meanwhile, trends being what they are, we've virtually stopped marketing efforts for Abiol (imidazolidinyl urea), which was once the most widely used preservative in our biz here in the USA. 
  • PhilGeisPhilGeis Member, Professional formulator
    Right chemicalmatt -  Germall 115 loss is a sad reality - by any name.
  • PerryPerry Administrator, Professional Chemist
    Ah, so when you buy it, it may be low free formaldehyde but when you use it you release enough to get you over the 10 ppm level
  • PhilGeisPhilGeis Member, Professional formulator
    Think so - 10 ppm is pretty low, about the low end of what you find in fruit.
     https://www.cfs.gov.hk/english/whatsnew/whatsnew_fa/files/formaldehyde.pdf
  • PharmaPharma Member, Pharmacist
    ...How will the regulators measure this is my concern... 
    From my understanding: They usually won't and if someone does, 10 ppm shouldn't be an issue with modern technology. It's up to the manufacturer to guarantee levels below the limit. However, sorry if my brain is toast right now and I'm babbling nonesense, said guarantee is neither obtained by relying on data which show what maximum % of free formaldehyde could be formed nor by actually measuring it but by mathematical calculation what could theoretically be formed = full hypothetical decomposition. IIRC this is already the case. Then again, I don't trust my memory, not tonight...
    Me, personally (=irrationally), I think it's good to lable the amount of formaldehyde and to lower the current declaration limit. Although formaldehyde is a CMR category 1B compound (Presumed human carcinogen, mutagen or reproductive toxicant based on animal studies) which usually results in a ban in cosmetics, formaldehyde and related ingredients are still allowe with restrictions. It's not a ban but just a declaration and formaldehyd releasers will still be okay below already defined %.
    Does this decrease/increase product safety? For some yes, for others no... depends on the definition of who's safe and safe from what.
  • PhilGeisPhilGeis Member, Professional formulator
    edited May 12
    It's just too useful at 10 ppm.
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