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New EU Cosmetics Regulations – A Quick Guide for Busy Formulators

This is a guest post by UK cosmetic chemist Colin Sanders. You can read more from Colin on his excellent blog at Colins Beauty Pages.

The latest iteration of the EU cosmetic regulations come into force in July 2013, and they are a pretty major upgrade with lots of new provisions and innovations that will affect everyone in the business of supplying cosmetics and personal care into the European market. If you are doing so, you really should know all about them by now, but here is a quick whistle stop tour if you are just starting or if you don’t operate in Europe but are curious.

EU cosmetic regulations

There are 6 main new areas.

Claims – it is now necessary to have data on file to support any claims you make for the product. This has been an implied requirement for some time via other bits of consumer legislation but it has now been codified into the actual cosmetic regulations. One eye catching provision is that it is now illegal to make claims that denigrate safe and legal ingredients. This sounds a bit like somebody somewhere is working out their pet peeve. In theory this outlaws claims like ‘paraben free’, though I dare say ways will be found round this one soon enough.

Nanoparticles – nanoparticles as defined by the EU will now need to be specified as such on the label. The format will distinguish a nano particle with the suffix ‘nano’, so Titanium Dioxide becomes Titanium Dioxide nano.

Cosmetic GMP – cosmetics will now have to be produced under controlled conditions, i.e., pretty much how they already are but it is now mandatory.

Notification – all products and their individual raw materials will have to be disclosed on a database covering the whole EU. This is to provide information for poison centres for them to use in the event of dealing with an adverse event where the ingredients of the cosmetics the victim is using might be relevant. (If any toxicologists reading this can give an example of how this might be useful I would love to hear it.)

Safety Assessments – currently the safety of cosmetic products have to be assessed prior to release by a ‘suitably qualified’ person. The new regulations specify that the qualifications should be in toxicology and that the assessment should follow a particular protocol.

Adverse Event Reporting – all adverse reactions now need to be reported directly to the authorities in the country in which the reaction occurs. The intention is that the data thus generated will be made public.

Regulation implications

Overall these changes represent a significant tightening of the regulations governing the manufacture, promotion and sale of cosmetics. I am planning to allocate an hour a day to the work needed to get ready for it, and I imagine that it will create about 2 hours a month extra work per formulation to keep compliant once it is in force. This isn’t too much of a burden for a large company or even for a medium sized one, but I think it might be onerous for smaller ones and start ups.

There are some clear advantages to the user. The adverse event reporting is long overdue and will give us all a better idea of what is causing problems and issues. The notification system is going to be expensive both for companies providing the data and for the general public who will pick up the tab for maintaining the database. Whether it is worth it or not is a matter of opinion. It seems to me a huge investment of resources for very little return, but I am open to being corrected on that if it turns out that lives are saved by the rapid availability of detailed cosmetic formulation information.

The requirement for cosmetic GMP is probably neutral. There are poorly produced and controlled cosmetics around. But whether the companies who make them will take any notice of this regulation is a good question. The companies that will comply with the new regulations are probably doing it already. I am particularly unimpressed by the tightening of the rules about safety assessments. It is good news if you are a toxicologist in want of employment, but it doesn’t seem to me that by being more prescriptive it makes things any safer. The phrase suitably qualified seemed to me to a good description, because it allowed for different levels of assessment for different products. I would say that just about anyone is suitably qualified to assess the safety of a bar of soap for example. On the other hand, a really advanced skin innovation using a lot of materials that don’t have a track history of use really ought to be assessed by somebody who understands that specific technology. Getting in a toxicologist off the street and following a set format doesn’t sound like the way to determine whether it should be released to me.

But however I feel about it, it is coming. It is such a large and widely ranging piece of legislation that I dare say most people will be able to find bits they like and bits they hate.

Don’t miss the podcast episode that featured a discussion with Colin Sanders!

{ 12 comments… add one }

  • mark arlott 09/16/2013, 2:29 pm

    can anyone tell me if face paints are included in these new regulations??????????

    • Perry Romanowski 09/16/2013, 2:31 pm

      I’m not sure but I would think so.

  • Davina Pinn 05/29/2013, 6:11 am

    Hi,
    I’m a small maker of a few skincare products. I found your website when I searched google for how detailed the address needs to be that we put on our labels. Is a postcode enough? I don’t have much room left there!
    Meanwhile I finally found a good company to do my safety assessments. Affordable and helpful. oxfordbiosciences.com
    Any info on the label address thing is very much appreciated!
    Thanks, Davina

    • Perry Romanowski 06/03/2013, 10:13 am

      That depends on where you are selling your products. In the US, you have to follow FDA labeling rules. That means putting the company name, city and state on it.

  • Harold Collier 05/15/2013, 10:29 am

    Are industrial hand cleansers invoved in these regulations, they are not on open sale to general public, thanks?

  • michelle 03/11/2013, 10:12 am

    Please can someone give me a name of a company who can help me do ALL of this as I have no idea where to even start.I have a semi-permanent mascara product.I would be very happy if I had some help here.thanks michelle

    • Bozec Francis 05/29/2013, 7:25 pm

      Hello,

      I’m Francis and I would like to introduce you to EcoMundo, a French-based company specialized in cosmetic compliance.

      EcoMundo can manage cosmetic compliance for Europe: we offer Responsible Person services including Safety Assessment, Notification, etc.

      Please let me know how I can assist your company comply with European Cosmetic Regulation.

  • Trevor Cash 02/26/2013, 6:13 am

    Help!!!! We are one of the smaller companies that you have so rightly pointed out that are finding this onerous. Based in London, we are selling a wide range of simple, mainly novelty cosmetics, ie Lip Balms as well as nail polish etc. None with any particular earth shattering benefit claims.

    However, we need to ensure that we are fully compliant going forward and would love to employ someone, possibly part time or on a short term contract, even though we are always introducing new products, so it could be longer term

    Would be very grateful to be introduced to anyone on your data base that could be interested to help us pull this all together.

    Many thanks

  • Henrik 01/24/2013, 10:05 am

    Thanks for this great article colins. One question that is in my mind: should the manufacturing site have a GMP certificate ? I mean anyone could say they are GMP. GMP certificate is not a requirement here in Canada.

  • Richard Rolls 11/26/2012, 7:54 am

    Good & concise update from Colin. For today’s Cosmetic Formulator, compliance is critical and we are challenged every day in finding ways to innovate and ‘do R&D’ whilst meeting the ever changing demands of compliance.

  • lily 07/19/2012, 10:26 am

    I have to say that I am totally lost. As a newcomer to the production of face creams and body creams I am realising just how difficult it is to comply.
    I am becoming discouraged and confused . I wonder if there is a source of information that make things easier to understand. I have had a lot of input from various testing ‘companies’. I can’t quite establish if they are independent agencies . I would really like to contact a laboratory directly… Can you help

    Thanks ..Lily

    • Lorraine 05/02/2013, 7:37 am

      Hi Lily,

      I’m in the same boat perhaps we should swap our knowledge. I would also like to start up by myself but me oh my it’s difficult to find the necessary info-can I do it myself in my home, do I need a small lab, and now extra compliance…..There really is not allot of incentive for cottage industry is there….

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