EC Cosmetics Regulation Article 15


I was browsing Cosmetic ingredient database and I came across to this article 15 about restricted substances, which is found in the annexes section article 15
Than I kept searching more regarding article 15 and I found 
Page 50 (pdf page 9) says that for substances classified in 1B:
1 B may be used in exceptional cases in cosmetic products when the following requirements are met:
• Food safety requirements pursuant to Regulation 178/2002 must be met.
• Analysis of the alternatives: no suitable replacement substances available.
• Use for a specific application with known exposure.
• Assessment by the Scientific Committee for Consumer Safety (SCCS) of the European Commission: safe bearing in mind total exposure from other sources and vulnerable groups in the population.
• If appropriate special labelling in order to prevent misuse.
• Re-evaluation by SCCS: every five years to the extent that no safety concerns have been raised.

So has anyone experience with this kind of procedure? 


  • em88em88 Member
    So anyone has any experience with EC Regulation 1223/2009 on cosmetics?
  • SibechSibech Member, Professional Chemist
    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.
    Dabbling Formulator — Qualified Cosmetic Safety Assessor — experienced in claim substantiation & EU regulatory affairs.
  • em88em88 Member
    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?

  • SibechSibech Member, Professional Chemist
    Not legally in the EU, no.
    but remember the category 1 compounds also need the additional criteria you mentioned in your first post.
    Dabbling Formulator — Qualified Cosmetic Safety Assessor — experienced in claim substantiation & EU regulatory affairs.
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