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PLEASE HELP!! Does anyone know the usage % for these materials?
Hi all of you awesome formulators!
Does anyone know where to find the usage % limits for these ingredients? Or what they are? The ingredients im trying to find the limits for are,
1.Arbutin
2. Glycolic acid …..and
3. Blue 4?
The EU, US, AUS and Japan usage limits if possible?
Ive tried cosIng for EU
The Fda website for US
NICNAS and TGA for AUS
No idea where to look for JP.
Ive been looking for months and still havent found the right place yet? A point in the right direction or knowledge of the limits would be so awesome and deeply appreciated.
Thank you!!
Bec
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6 Replies
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The US has no regulatory usage limits at all for Arbutin, Glycolic Acid or D&C Blue #4 in cosmetics. It is solely up to the manufacturer to prove that the products sold are safe.
http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm106626.htm
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Keeping in mind, of course, that you need to be really, really careful about what you say that your product does in order to avoid the FDA designating your product as an unapproved new drug.
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What kind of product are you looking to make?
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in the EU, there is no legal limit on arbutin, but two recent SCCS opinions have found alpha-arbutin safe up to 2% (in face creams) and 0.5% (in body lotions); and beta-arbutin safe up to 7% in face creams
beyond these levels the margin of safety is unknown; fore this reason, many safety assessors are likely to reject a product if it contains a higher level
opinion on alpha-arbutin
opinion on beta-arbutinthere is no legal limit on glycolic acid, but the current opinion recommends maximum 4% and a pH of at least 3.8, with appropriate warnings on the pack
D&C Blue 4 (FD&C Blue 1) would be declared as “CI 42090”, and this is covered by Annex IV/63
hope this helps!
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Why are you looking for limit ceilings? It would be of more use to look at typical usage rates.
Glycolic acid technically doesn’t have a limit, but there is lots of guidance (Cosmetic Ingredient Review) that limits non-Professional products (those not administered by a practitioner in a practice setting) to less than or equal to 10% and a pH greater or equal to 3.5 pH. I have had a regulatory person point out that this information is well disseminated and if an adverse reaction occurred with a product not in compliance, an attorney could have a field day.
There is some variance here from Bill’s numbers. Here is my reference.
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Thank you all so much.
Hi Bobzchemist.. thanks for the US info and yip ill keep that in mind if ever i formulate with these ingredients and make sure to be mindful of claims my wording might imply.
Hey Perry.. im at the tail end of a cosmetic chemistry diploma. This is a question in the last workbook. Its been a struggle completing this course. After enrolling 2 years ago i stumbled on yours and love the way it seems presented. The course im doing is all over the place and not as clear as your delivery seems to be but yea not formulating with the ingredients yet. I will enrol in your course in the future because i feel like based on the concise way you present information, that it will cement the knowledge ive gained from this one.. looking forward to it
Hey Bill_Toge.. yea all that info definately helped! Thanks for the links aswell awesome! thank you.
Hi Microformulation… yea i share the same perspective. It seems more useful to know the usage range aye but i suppose can also see the benefit of knowing the legal requirements, being these type of ingredients. Im finishing up a course ive been battling with. This is one of the questions in it.Cool thanks heaps. I will state those things mentioned and follow the links shared.
Much appreciated
Bec
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