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EC Cosmetics Regulation Article 15
Greetings,
I was browsing Cosmetic ingredient database and I came across to this article 15 about restricted substances, which is found in the annexes section http://ec.europa.eu/growth/tools-databases/cosing/index.cfm?fuseaction=ref_data.annexes_v2 article 15 http://ec.europa.eu/growth/tools-databases/cosing/index.cfm?fuseaction=search.results&annex_v2=Article%2015&search
Than I kept searching more regarding article 15 and I found https://www.ikw.org/fileadmin/ikw/downloads/Schoenheitspflege/SP_Kosmetikrichtlinie-en_01.pdf
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?
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4 Replies
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So anyone has any experience with EC Regulation 1223/2009 on cosmetics?
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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.
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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? -
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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