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permitted raw materials
Hello,
i am formulating in Australia to export to USA. I would like the final product to pass through US requirements without issue. Is there a definitive ‘allowed ingredients’ list that i can reference. FDA seems to have a few restricted/prohibited lists, but no positive list. TSCA seems more industrial than cosmetic. Do i rely on suppliers telling me “it is OK, trust me”???
Where can i check that i am not formulating with something unlisted (as opposed to banned) that may impact on my importing into US.
many thanks for any input, rodb. -
4 Replies
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In the US, there are only 11 or 12 banned ingredients in cosmetics. You can find that list here.
https://www.fda.gov/cosmetics/cosmetics-laws-regulations/prohibited-restricted-ingredients-cosmeticsBut the most important thing is colorants. The FDA allows only colorants on the linked list. Don’t use anything else to color your products.
https://www.fda.gov/cosmetics/cosmetic-ingredient-names/color-additives-permitted-use-cosmetics -
If you are making a US cosmetic (see definition https://www.fda.gov/cosmetics/cosmetics-laws-regulations/it-cosmetic-drug-or-both-or-it-soap), the requirements are to use safe ingredients and to avoid making certain drug claims. As far as proving safety, you can go about this by doing things like:
-getting PET/AET testing performed on your finished product
-having HRIPT testing performed on your finished product to see if there are any reactions/skin sensitization
-getting an SDS generated on your finished product, or at least having an SDS for each componentI’d understand ‘unlisted’ ingredients to mean things with no INCI name. If you are using something in that situation you may still have a work around (https://www.fda.gov/cosmetics/cosmetics-labeling-regulations/cosmetics-labeling-guide). Otherwise just stick to avoiding the list perry provided and be careful with claims.
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Not sure what types of products you are formulating but also be aware of VOC regulations in California.
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many thanks for the feedback. It seems a fairly open situation.
regards, rodb
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