How does Lush UK get away with it?

We have a GMP certified (and regularly inspected) cosmetics production facility in Malaysia. We jump through the hoops for exports to the EU where standards are high. But check out the Lush UK factory tour video below. They seem to break every GMP rule in the book.

Any insights into how this can be? I'm perplexed, they even have outsiders wandering around the production areas. And not one hair net in sight.



Dr. Mike Thair
Cofounder & Chief Formulator
Indochine Natural

Comments

  • At that level of production I would already have automated the weighing.
    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.
  • I think the fact that it’s handmade is a part of their marketing story.
  • I'm sorry, but WTF??? Are you kidding me, why are they still in the market with this? 
  • SibechSibech Member, Professional Chemist
    While I don’t necessarily agree with the clothing, lack of hairnets and face masks not to mention raw materials literally standing on the floor.

    I am unsure of how this video indicate multiple breaches of ISO 22716:1007(E)? 
    Dabbling Formulator — Qualified Cosmetic Safety Assessor — experienced in claim substantiation & EU regulatory affairs.
  • PerryPerry Administrator, Professional Chemist
    Perhaps they change things up when the inspectors come.
  • Perhaps it is because of marketing soaps as natural?

    Human saliva is naturally occurring
    mucus = natural
    sneeze and cough fluids = natural
    hair = natural
    dead skin cells = natural
    sweat = natural
    floor microbes = natural

    Sorry, I couldn't resist  :D
  • @Gunther ? ewwww! I try and tell everyone that natural is NOT always better! ??
  • If I ever start my skincare line my slogan will be ‘Proudly with Silicones and Parabebs’ ?
  • SibechSibech Member, Professional Chemist
    @Gunther  :D 

    Luckily for their customers most of the products shown are of low microbial risk.

    @ngarayeva001 good luck with the re-education of consumers, for some reason interest groups are deemed more trustworthy than “big beauty”
    Dabbling Formulator — Qualified Cosmetic Safety Assessor — experienced in claim substantiation & EU regulatory affairs.
  • mikethairmikethair Member
    edited September 2018
    In reality, if you check Lush ingredients they are not so "natural" (whatever that means).

    @Perry that would require a massive reconstruction for a visit by inspectors. I doubt it very much.

    @Sibech not sure if I agree with you. Some of what I observe would require a microbial regime

    So, from my side as the owner of a GMP cosmetics facility, still non the wiser. As @em88 says "WTF??? Are you kidding me, why are they still in the market with this? "   My thoughts exactly. Even without any microbial risks, this place would never be accepted under any GMP regime.

    Mark Constantine, the Lush founder, was originally making stuff for Anita Roddick (The Body Shop). After some time, the Body Shop then paid £11 million for the rights of Mark Constantine's recipes. So this guy has been around for a while and knows the cosmetics business. 
    Dr. Mike Thair
    Cofounder & Chief Formulator
    Indochine Natural
  • SibechSibech Member, Professional Chemist
    @mikethair I Don’t spend most of my time in the production I do troubleshooting with them, pilot plant scale ups, formulating and regulatory stuff.

    I am certain that you are right about them being more than subpar, but please enlighten me;
    Besides dressing.
    Lack of cleaning (or easy access to doing so based).
    raw material storage
    And Allowing non-trained personnel in the production facility (which is also extremely cluttered and likely hazardous.)

    Can you assert as being against GMP from that video?

    As for how they get away:
    it it might just be regulators rarely doing a GMP audit but who knows?

    Dabbling Formulator — Qualified Cosmetic Safety Assessor — experienced in claim substantiation & EU regulatory affairs.
  • ngarayeva001ngarayeva001 Member
    edited September 2018
    I analysed their ingredients and agree with @mikethair they are not so "natural". They use parabens, SLES and PEGs. Their marketing claim is that their cosmetics is "Fresh and handmade". My guess is that uneducated consumers think that "handmade" and  "natural" (whatever it means) is the same. I actually think it's a good trick.
  • SibechSibech Member, Professional Chemist
    @ngarayeva001 who needs “natural” anyway? - it’s performance inferior, it demonizes safe synthetics and arguably less safe as extracts are rarely well defined or toxicologically studied

    if anything good is to be made about the “fresh and handmade” claim it is that using a “value added” claim from positives instead of the regular “without toxic chemical XYZ and chemicals all together” (even though they might did that as well)
    Dabbling Formulator — Qualified Cosmetic Safety Assessor — experienced in claim substantiation & EU regulatory affairs.
  • @Sibech, I agree with you but as you correctly pointed out, it is almost impossible to re-educate consumers. Most people don't know that parabens are preservatives but they "know for sure" that it is bad. And it's actually not surprising. Every time I google an ingredient the second or third link is "Why xx is bad for you" followed by a chemophobic article written by some dilettant.
  • @Sibech without going too far into GMP requirements you have already identified a few critical issues.

    Addition areas are, in my opinion, layout and design of production area to minimise the risk of cross contamination and errors during all aspects of manufacture, filling and packaging. 

    The weighing of starting materials should be carried out in a separate purpose designed weighing area.

    The list goes on....
    Dr. Mike Thair
    Cofounder & Chief Formulator
    Indochine Natural
  • SibechSibech Member, Professional Chemist
    @mikethair thank you for the examples!

    Maybe I missed that part but what in the video showed weighing of raw materials right next to production (/not in a separate area)?

    To be the devils advocate even though I agree;
    What defines appropriate clothing and protective garments for avoiding contamination of the products?

    Premise design should be based on the type of product, existing conditions, cleaning and sanitizing measures used.
    Why does this not qualify the flat tables for bath bombs?

    Technically the ISO requires only sufficient space And separated or defined areas (Again I agree there is not sufficient space, but isn’t that subjective?)
    Dabbling Formulator — Qualified Cosmetic Safety Assessor — experienced in claim substantiation & EU regulatory affairs.
  • MicroformulationMicroformulation Member, Professional Chemist
    @Sibech cGMP encompasses a great deal and while in many cases it is still unfortunately not mandatory, it is crucial. I saw numerous issues as well.

    For a quick overview of the FDA's cGMP Checklist, which the WILL go through during a site inspection, here is a link.  https://www.fda.gov/cosmetics/guidanceregulation/guidancedocuments/ucm2005190.htm

    markfuller@microformulation.com Microformulation.com Microformulation Cosmetic Consulting provides Custom Formulations for both large Commercial accounts as well as smaller entrepreneurs. We can provide Naturally compliant Formulations under the NSF, NPA, Whole Foods and USDA Organic Certifications. BS.Pharm Albany College of Pharmacy, Union University.
  • WTF??? I guess this is some sort of DIY tour like in chocolate factories, I doubt the production is as amateur as it shows, but still I wouldn't show a rusty and filthy shelf with pride. 

    I guess deep pockets and good contacts get you this far.
  • SibechSibech Member, Professional Chemist
    edited September 2018
    @Microformulation Thank you for providing a link, it seems to be an abbreviated version of the ISO 22716:2007 with the addition of a definition of adulteration for the US.
    The EU is a bit odd on the GMP for cosmetics. You must produce under GMP, however, it technically does not have to follow ISO 22716:2007. In addition, you do not need certification as long as the product is produced following GMP guidelines (local regulations may apply and it is just EASIER to follow ISO 22716:2007 as an inspector may question your choice of GMP standard). However, how often an inspection occurs may vary from country to country.

    After watching the video, the first time I re-read the ISO 22716:2007(E) and watched the video again to spot new errors. Now I just went over the FDA list as well and rewatched the video, yet again (she is getting too many views from me I tell you).

    With numerous GMP issues please assist me in completing the list of currently 7 apparent issues in the spoiler (to reduce post length):

    • Openable windows (with/without proper screening - I cannot discern that from the footage).
    • Lacking hairnets and facemasks for powder handling.
    • Seeming lack of cleaning (or easy access to doing so based) & shelves in "Poor repair".
    • Raw materials stored poorly - for instance on the floor.
    • Allowing non-trained personnel in the production facility
    @mikethair mentioned
    • Poor flow of production allowing for cross contamination and errors.
    • Lacking separate/designated weighing area for raw materials
    Dabbling Formulator — Qualified Cosmetic Safety Assessor — experienced in claim substantiation & EU regulatory affairs.
  • ngarayeva001ngarayeva001 Member
    edited September 2018
    They put avocado in their products. A fruit not an extract. Is it even possible to preserve it effectively? https://youtu.be/BCoyvPp1IQ8
  • SibechSibech Member, Professional Chemist
    @ngarayeva001 Something tells me they add a small amount which is negligible in the formula. Regardless they have to prove microbial stability to legally sell it on the European market so I can only assume yes (that, or they disregard the rules and sell illegal products - who knows)
    Dabbling Formulator — Qualified Cosmetic Safety Assessor — experienced in claim substantiation & EU regulatory affairs.
  • @Sibech I'd say the lack of fire extinguishers is the most important thing I noticed. (by the size there should be at least 3 or 4 visible and inspectors would still bitch about it) Or at least they are not signaled, which is another thing an inspector will bitch about.

    The flammable stuff piled on the floor deserves a chapter on its own.
  • I bet the staff get RSI from making all those bath bombs by hand.
    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.
  • MicroformulationMicroformulation Member, Professional Chemist
    @Sibech I think if you walked through that checklist in order at the facility, you would get the full picture. cGMP covers a lot of ground and a lot of proper documentation.
    markfuller@microformulation.com Microformulation.com Microformulation Cosmetic Consulting provides Custom Formulations for both large Commercial accounts as well as smaller entrepreneurs. We can provide Naturally compliant Formulations under the NSF, NPA, Whole Foods and USDA Organic Certifications. BS.Pharm Albany College of Pharmacy, Union University.
  • SibechSibech Member, Professional Chemist
    @Microformulation the thing is, I did walk over it (Not only did I go over the FDA shortlist but the actual ISO standard) and since most of them are documentation, which obviously is not shown, or subjective/vaguely worded, I am at a loss as for what else could be wrong.

    I am even doubtful as for if the separate/defined RawMat weighing area is an issue as it is hardly shown in the video.

    But by the sound of it everyone else commenting knows all GMP requirements well enough to mention numerous issues, so it appears logical to ask for help.
    Dabbling Formulator — Qualified Cosmetic Safety Assessor — experienced in claim substantiation & EU regulatory affairs.
  • SibechSibech Member, Professional Chemist
    @DAS but are fire extinguishers a GMP issue or an HSE issue?

    @belassi I bet you are right about that!
    Dabbling Formulator — Qualified Cosmetic Safety Assessor — experienced in claim substantiation & EU regulatory affairs.
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