Sodium Borate

Is Sodium Borate (borax) banned in the EU?
According to Annex III it is allowed under certain restrictions.
(http://ec.europa.eu/growth/tools-databases/cosing/index.cfm?fuseaction=search.details_v2&id=31043)
According to Article 15 it is banned (CMR 1B)
What is valid - Article 15 or Annex III?

Comments

  • Interesting.

    Article 15(2) appears to state that SCCS has the right to override a ban on a carcinogen.
    And it seems it does so here:
    http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_027.pdf

    What do you think?
  • BelassiBelassi Member, PCF student
    boric acid is a carcinogen?
    Cosmetic Brand Creation. Concept to name to IMPI search to logo and brand registration. In-house graphic design inc. Pantone specs. Cosmetic label and box design & graphics.
  • Bill_TogeBill_Toge Member, Professional Chemist
    @Belassi it's a category 1B (i.e. proven and serious) reproductive toxin; it's treated in the same way as carcinogens and mutagens
    UK based formulation chemist. Strongest subjects: hair styling, hair bleaches, hair dyes (oxidative and non-oxidative) I know some stuff about: EU regulations, emulsions (O/W and W/O), toothpaste, mouthwash, shampoos, other toiletries
  • @BartJ  
    I interpret the regulation as Article 15.2 can be overruled if enough evidence exist to declare the ingredient safe (or rather the end product safe containing that that ingredient)
    Opinion SCCS/1249/09 clearly states that the sodium borate is safe under the restrictions laid down in Annex III. 
    I have a (small) client in a EU country that has to withdraw their products from the market due to sodium borate (<0,5% in a cream). I believe that is unfair. Moreover LUSH (UK) uses sodium borate as well.
    Annex III has also remained unchanged. IF sodium borate is banned it should be listed in Annex II (at least after a while). Don't know how to help my client. I have Emailed the EU, but no answer so far.
  • johnbjohnb Member, Professional Chemist
    I think Unilever anticipated this balls up some years ago and replaced the sodium borate in Pond's Cold Cream by sodium hydroxide.
    It is still basically a similar product with the alkalinity to neutralise the acids in the beeswax now coming from the NaOH.
    I notice they now include Carbomer in the formula - that's certainly something Galen didn't put in the original.
  • Taking a closer look:

    1. Boric acid becomes a CMR 1B when it's used >5,5% .

    http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:235:0001:0439:en:PDF
    also visible in COSING at the very bottom:
    http://ec.europa.eu/growth/tools-databases/cosing/index.cfm?fuseaction=search.details_v2&id=31043

    2. Contrary to what I said, 15(2) of 1223/2009 requires ALL four conditions to be met for a CMR 1B to get an exception. SCCS opinion being only one of the four.


    If this statement for boric acid(reprotoxic at >5,5%) can be directly extrapolated to sodium borate  then the 15(2) conditions are irrelevant as your client uses <0,5%. 
    [I don't know this, perhaps those four SCCS opinions will give you an answer]

    I think your client is OK but as SAs aren't government officials this will need a court case.
    I think you will need a lawyer+independent safety assessor as expert witness in court to prove it(not taking local national laws into account.)


    I hope I'm correct, you know as well as I do that this is a big maze of regulations. There also that food related regulation that could be of influence but I think proving that they've not reached toxic levels is key.
  • DavidDavid Member
    edited September 2016
    @BartJ good analysis Bart, it appears to me that the EU chemists haven't thought this over very much. Here is another entry in cosing saying it is reprotoxic at>4.5% (not 5.5%). It is all a mess indeed. As a SA and a chemist I definitely still not believe a content of 0.5% sodium borate in a hand cream is a danger to human health but to prove it in court ..well..that's a different story.
  • BelassiBelassi Member, PCF student
    What about soap people who neutralise liquid soap with it? Is that safe?
    Cosmetic Brand Creation. Concept to name to IMPI search to logo and brand registration. In-house graphic design inc. Pantone specs. Cosmetic label and box design & graphics.
  • DavidDavid Member
    edited September 2016
    @Belassi Haven't calculated he amount needed for neutralizing a soap. However, e.g. the CIR Panel concluded that Sodium Borate and Boric Acid, in concentrations =< 5%, are safe in cosmetic products. http://online.personalcarecouncil.org/ctfa-static/online/lists/cir-pdfs/pr215.pdf
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