New EU Cosmetics Regulations – A Quick Guide for Busy Formulators
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.
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!
More about the author: From the UK, Colin Sanders has been a formulator of cosmetic and topical pharmaceuticals for 27 years. Read more from this author