• Formulating

  limit of Benzyl alcohol

  Posted by amitvedakar on May 31, 2018 at 5:32 am

  can use Benzyl alcohol more than 1% in cream/Cosmetic product?

  Is there any limit?

  Gunther replied 5 years, 11 months ago 4 Members · 6 Replies
• 6 Replies

• 

  em88

  Member

  May 31, 2018 at 12:47 pm

  According to handbook of pharmaceutical excipients, up to 3% as preservative.
  I have seen formulations with 2% several times 

• 

  OldPerry

  Member

  May 31, 2018 at 1:10 pm

  See the CIR report.  https://online.personalcarecouncil.org/ctfa-static/online/lists/cir-pdfs/pr323.pdf  The EU restricts preservative use to 1%. (unless they changed since 1995.  The report also says it is safe for use up to 5% in many applications.

• 

  Gunther

  Member

  June 1, 2018 at 12:17 am

  @Perry if you use several preservatives in one product,
  is that 1% upper limit per preservative, or 1% total preservatives added?

• 

  OldPerry

  Member

  June 1, 2018 at 1:57 am

  @Gunther - EU regs are not my specialty so I don’t know for sure. The way I read it is that the limit of Benzyl Alcohol for preservation purposes is 1% of itself. 

• 

  amitvedakar

  Member

  June 1, 2018 at 9:14 am

  It is true as a preservative limit is 1% in pharma in india.

  But as @em88 & @perry 3% can be used as solvent    

  Link shows more than 3% make irritation.

  https://toxnet.nlm.nih.gov/cgi-bin/sis/search/a?dbs+hsdb:@term+@DOCNO+46.

• 

  Gunther

  Member

  June 1, 2018 at 3:53 pm

  …Benzyl alcohol has been found to be irritating to the skin at levels 3% or greater. Patch test with 0.65% benzyl alcohol did not produce irritation of the skin…
  https://toxnet.nlm.nih.gov/cgi-bin/sis/search/a?dbs+hsdb:@term+@DOCNO+46

  While that was patch testing, where the occlusion with adhesive tape causes more irritation that normal topical use,
  it’s best to limit BA below 0.65%
  You can use BA along other preservatives, like Potassium sorbate, or Sodium Benzoate.

Log In to Reply