Regulatory Open Forum

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  • 1.  Global Ingredients

    Posted 23-Mar-2017 21:38
    Hello Everyone ,
    I am looking for some guidance. I work for a company in the US that manufactures skin care and sun care products We are currently looking to market our products internationally and are working towards maki sure all the ingredients in our products are globally acceptable. I am working on a global strategy plan on how to make this happen. Does anyone know if there is a list of acceptable and unacceptable ingredients for these products globally. I would appreciate any suggestions and or ideas. Thank you.

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    Olufunke Bundo (Olu)
    Audit/Regulatory Specialist
    Swiss-American CDMO
    Carrollton, Texas
    USA
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  • 2.  RE: Global Ingredients

    Posted 24-Mar-2017 08:24
    Hi Olufunke.

    The answer to your question is the ever-popular "it depends".  In many jurisdictions there might be lists of allowed preservatives, colorants, sunscreens, etc. (see for example the Annexes to the EU Cosmetic Regulation) that will specify when, how, how much, etc. of a particular ingredient is allowed.  Also in the EU there is another annex to the regulation that has ingredients that are not allowed or that are otherwise restricted.  I don't know how well these annexes match other jurisdictions but I do know that "generally" there are really 2 jurisdiction templates - the US (usually followed by countries with strong relationships in the past with the US like Canada) and the EU (usually followed by most of the rest of the world including Latin America and Asia).  While this is NOT intended to sound like if you follow one of these you are OK for these additional jurisdictions (even when the template is the same the lists may or may not be!) what it does show is that most of the world "thinks" similarly to one or the other of these two models.  So if I were starting to do this, my first thought would be to look to the EU.  Note - if you are looking at China - ALL BETS ARE OFF - there are lots of nuances to Chinese regulation that must be looked at to determine compliance and I probably could write my PhD dissertation on that topic if I were so inclined to obtain my PhD!

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    Victor Mencarelli
    Director - Regulatory Affairs
    Hain Celestial Group
    United States
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  • 3.  RE: Global Ingredients

    Posted 24-Mar-2017 18:22
    I would suggest you may visit the below website of International Pharmaceutical Excipient Council. It has mainly four region including America, China, Japan and Europe. As we have in US Inactive Ingredient Database (IID), rest area must have similar database with different names. That might help you.

    IPEC Federation





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    Gaurang Bhavsar
    Edison NJ
    United States
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