EU opinion on Phenoxyethanol - Margin of Safety

Hi
I was reading about the EU "Opinion on Phenoxyethanol" and the conclusions states that the Margin Of Safety for use in childrens products is about 50. Considering that the maximum usage for Phenoxyethanol is 1%, does this mean that for childrens products the maximum usage is 0.5%?
I understand how MoS is calculated, I'm just not sure how to apply the figure to usage amounts.
Thanks!

Comments

  • BelassiBelassi Member, PCF student
    Margin Of Safety for use in childrens products is about 50
    50 what? 50%? 50 ppm? 50 times?
    Cosmetic Brand Creation. Concept to name to IMPI search to logo and brand registration. In-house graphic design inc. Pantone specs. Cosmetic label and box design & graphics.
  • even with this opinion, today it is very difficult to sell cosmetics with phenoxyethanol in Europe, especially in country like France
  • PerryPerry Administrator, Professional Chemist
    @jeremien - what are formulators using instead?

  • Bill_TogeBill_Toge Member, Professional Chemist
    edited March 2018
    this is the full text of the opinion in question; the MoS calculations are on page 72 and 73

    the conclusion is on page 83:

    1. Does SCCS consider Phenoxyethanol safe for use as a preservative with a maximum concentration of 1.0 %, taking into account the information provided?
    The SCCS considers phenoxyethanol safe for use as a preservative with a maximum concentration of 1.0%, taking into account the information provided.

    2. The SCCS is asked, when making the assessment, to take into account the specific age groups who might be particularly susceptible to the effects of Phenoxyethanol used as preservatives in cosmetic products.
    The toxicokinetics default factor of 4.0 can be reduced to 1.0 yielding a minimum Margin of Safety (MoS) of 25 instead of 100 for the safety assessment of 2-phenoxyethanol.  Therefore, the MoS of about 50 for children also covers this specific age group who might be higher exposed to 2-phenoxyethanol than adults.

    UK based formulation chemist. Strongest subjects: hair styling, hair bleaches, hair dyes (oxidative and non-oxidative) I know some stuff about: EU regulations, emulsions (O/W and W/O), toothpaste, mouthwash, shampoos, other toiletries
  • @Perry
     good question :) you try different combination of preservatives and after checking that it doesn't affect the physchem properties of the product, you try to pass the Challenge ... i guess that all the comsetic industry have the same problem today... time and money consuming, and as far as i know, there is not a unique solution that work for all formulations.

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