MIC and usage rate of formalin in this shampoo at pH 4-5

I have decided to use DMDM hydantoin as preservative in my shampoo.

I have to import it from china and MOQ is 50kg. On the other has Formalin is available locally and $1/kg with no MOQ. So that always makes me think if i can use formalin instead of DMDM hydantoin in shampoo.

The ingredients are: filtered water, SLES, SLS, CAPB, APG, Amodimethicone emulsion, cationic guar, NACL, EDTA 0.2%, citric acid, fragrance.
pH 4-5. Currently the pH is 4.1.

Here are my questions.

a. What percentage of formalin would be a good starting point to preserve this shampoo at this pH?

b. What is the MIC or MBC of formalin for following organisms?

1. Pseudomonas aeruginosa
2. Escherichia coli
3. Burkholderia cepacia
4. Staphylococcus aureus
5. Aspergillus niger
6. Candida albicans

Comments

  • PhilGeisPhilGeis Member, Professional formulator
    Formaldehyde reactivity may limited its stability.  Formaldehyde releasers can maintain an effective level through consumer use.
    To your question - 100-500 ppm should be effective for bacteria, fungi can be more challenging.
  • @Abdullah Formaldehyde (which is the main constituent of formalin) is prohibited in cosmetics: https://ec.europa.eu/growth/tools-databases/cosing/index.cfm?fuseaction=search.details_v2&id=97916
  • @ketchito is it banned in US too?

    This is the cir report conclusion from 2012


  • @PhilGeis 500 ppm formalin, or formaldehyde which equals 1351 ppm of formalin? 
  • @Abdullah The CIR report you mentioned focuses mainly on the use of formaldehyde in nail-hardening and hair smoothing products. Also, it seems to be outdated (it was published in 2013) since it mentions that Formaldehyde is approved for use in Europe (the ban in Europe started in 2019). I believe this will be ammended anytime by the FDA (unfortunately, the agency has some limitations compared to its european counterpart, plus, they were very busy with pandemic related affairs).
  • PhilGeisPhilGeis Member, Professional formulator
    Banning formaldehyde and lower free formaldehyde in preservation is typical EU bureaucratic excess.  This misguided ban merely increases micro risk by eliminating some of the few generally effective preservatives.

    FDA typically doesn't chase useless efforts in this context.  Covid is prob irrelevant - cosmetics are under CFSAN not CDER,  
    It does address the higher levels in some products -https://www.fda.gov/cosmetics/cosmetic-products/hair-smoothing-products-release-formaldehyde-when-heated .     AND
    https://www.fda.gov/cosmetics/cosmetic-products/nail-care-products
  • PhilGeisPhilGeis Member, Professional formulator
    Abdullah said:
    @PhilGeis 500 ppm formalin, or formaldehyde which equals 1351 ppm of formalin? 
    Formalin ~37% with a little methanol.   But formaldehyde releasers are so much better in stability, safety in manufacturing and avoiding chemophobic hysteria
  • @PhilGeis I agree that formaldehyde in solution has a different behavior and inherent risk compared to the gas. Actually, the mixture formaldehyde-MIT/MCIT-EDTA is the best system I've ever tried.

    In my experience visiting some plants here in Latin America, I found that both the person who weights the ingredients and the manufacturer were constantly exposed to some amounts of formaldehyde gas when manipulating large amounts of formalin (not that the ingredient itself is to blame for this), and since we have well performing and safer alternatives (formaldehyde-releasers), and especially in places where there's low survailance over manufacturing sites and practices, wouldn't the decission from Europe especifically about formaldehyde make some sense?
  • PhilGeisPhilGeis Member, Professional formulator
    ketchito said:

    In my experience visiting some plants here in Latin America, I found that both the person who weights the ingredients and the manufacturer were constantly exposed to some amounts of formaldehyde gas when manipulating large amounts of formalin (not that the ingredient itself is to blame for this), and since we have well performing and safer alternatives (formaldehyde-releasers), and especially in places where there's low survailance over manufacturing sites and practices, wouldn't the decission from Europe especifically about formaldehyde make some sense?
     I am aware of the broader use of formaldehyde (formalin) in Latin America - not sure some could even make clean products without it.  But 'm not with you on this.   Manufacturing risks are established by many ingredients and practices - caustics, HCl, heat, ozone, unprotected belts, pinch points, inappropriate tank entry, failed lock out, etc.  Failure in worker safety should be addressed by PPE, safety procedures, etc. 
    Banning formaldehyde Europe fixes none of that.   We sure do not have "safer alternatives" than releasers as preservatives.

  • ketchito said:
    @PhilGeis I agree that formaldehyde in solution has a different behavior and inherent risk compared to the gas. Actually, the mixture formaldehyde-MIT/MCIT-EDTA is the best system I've ever tried.
    what was the percentage of these ingredients in this mixture and the usage rate?

    @k@ketchito
  • PhilGeis said:
    Abdullah said:
    @PhilGeis 500 ppm formalin, or formaldehyde which equals 1351 ppm of formalin? 
    Formalin ~37% with a little methanol.   But formaldehyde releasers are so much better in stability, safety in manufacturing and avoiding chemophobic hysteria
    Thanks
  • PhilGeisPhilGeis Member, Professional formulator
    Think enzymes are the greatest manufacturing risk I've seen 
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