Home Cosmetic Science Talk Formulating Advanced Questions EC Cosmetics Regulation Article 15

  • em88

    Member
    June 20, 2019 at 7:33 am

    So anyone has any experience with EC Regulation 1223/2009 on cosmetics?

  • Sibech

    Member
    June 20, 2019 at 9:39 am

    Article 15 is not as such about restricted substances but is about the ban and exemptions to this ban of CMR chemicals (Carcinogenic, Mutagenic and toxic to Reproduction).

    Basically, it tells you that compounds that are classified as CMR compounds according to the REACH chemical legislation are prohibited.

    If they are approved by the SCCS as safe for category 2 compounds they can still be used. If they are category 1A or 1B they need to have additional criterions included for the safe and legal use.

    To have the SCCS develop an opinion, then the EU commission need to request (mandate) a such opinion.

    There are diverging opinions on how the legal text should be read, and a few EU countries consider the ban in effect from the moment a compound is harmonized in the EU as a CMR compound. The EU commission however considers it to be understood as needing to be banned (placed on Annex II) within 15 months of the CMR registration and after this point only would be banned.

  • em88

    Member
    June 20, 2019 at 11:02 am

    Thank you for the clarification,
    So if a substance does not have a  SCCS  opinion and is included in 1B, it can’t be used in cosmetics?

  • Sibech

    Member
    June 20, 2019 at 2:24 pm

    Not legally in the EU, no.
    but remember the category 1 compounds also need the additional criteria you mentioned in your first post.

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