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  • EU Registration Question

    Posted by DavidW on July 31, 2014 at 3:10 pm

    When registering a cosmetic skin product for importation into the EU does anyone know if exact amount of each ingredient is necessary to give them?  Or is it good enough to provide my customer with a range to report?

    DavidW replied 9 years, 11 months ago 3 Members · 3 Replies
  • 3 Replies
  • LianePamuspusan

    Member
    August 12, 2014 at 9:02 am

    From my experience, it mostly depends on their RP’s requirements. However, the safety report guidelines states:


    “The complete product composition is to be specified, stating the name and identity (qualitative) of each raw
    material (including chemical name, INCI, CAS, Einecs/ELINCS, where possible), and the amount of each raw
    material, stating the weight percentage (quantitative). Ranges should not be used, unless this can be justified (e.g. viscosity or pH adjusters). If concentration ranges are unavoidable, toxicological considerations and calculations should be based on the highest concentration figure. It may also be useful to indicate the supplier(s) of the raw materials”
  • Bill_Toge

    Member
    August 12, 2014 at 5:10 pm

    if they just want to register the product on the Cosmetic Product Notification Portal, then ranges will be sufficient, though there are certain prescribed ranges you have to use (0.1-1%, 1-2.5% etc.)

    though as @LianePamuspusan said, if you want to get it safety assessed in accordance with Annex I of the cosmetics regulations, the vast majority of assessors will want the exact formula

    the finished safety report is held by the Responsible Person and is not uploaded onto the Portal; the only third party who’d need to see it would be a member state’s competent authorities (e.g. the Trading Standards Institute in the UK), who’d need to see the report if they were addressing specific safety or regulatory concerns that had been raised about the product

  • DavidW

    Member
    August 15, 2014 at 10:30 am

    Thank you both.

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