There is a concept in the software business called the minimum viable product. This is the barebones of an application that does just enough to enable it to get onto the market so the concept can be tested. This is an interesting idea in the fast moving world of information technology where change is so fast that nobody knows what is going to work until it has been tried out.
Could that idea work in cosmetics? After all it is another area where things move very quickly. Fashions in some cosmetic sectors change even faster than technology does.
So what is the bare minimum you need to do to comply with the Cosmetic Regulations?
It does vary a little bit. If you have a non aqueous product then things a lot easier. As soon as you involve enough water to support microbial growth then things got a lot more difficult.
Let’s look at the easier case first.
Get Hold Of A Formulation
The first thing you need is a formulation. This is normally something that takes some time in the lab to come up with, and sometimes quite a lot of time. But there are plenty of formulations out there in the public domain. They are published in books and on websites, or available from raw material suppliers. You can hunt through these to find one that matches your needs. Most formulators have lists of these on hand. If you don’t know enough to find one yourself there will be somebody you can find who does.
EU regulations refer to stability, but not in any detail. You have to address the issue but there is no set protocol you have to follow. The bare minimum could simply be to place a sample somewhere and make a note of the date, then examine it every two weeks. This isn’t the best way to do it scientifically, and you would normally be much better advised to do a lot more – but it is enough to get you started. In the long run on most projects it will save you time and trouble to get a proper stability study carried out by people who know what they are looking for and I recommend doing so – but it isn’t an actual legal necessity.
Make It Correctly – Cosmetic GMP
The next problem is getting it made. If you don’t have the capability to make it yourself, you need to find a manufacturer who works to the principles of cosmetic GMP. This should be straight forward. It is a legal requirement so any company whose business is making cosmetics should comply with this. There are lots of things you need to consider when selecting your contract manufacturer, but this is the only one that is mandatory.
Legally Compliant Label
You have to make sure you label is legally compliant. You will need to assign either a shelf life or a period after opening duration. You don’t have much to go on at this stage so judge conservatively.
You need an accurate ingredient list. This is a little tedious but shouldn’t take too long. You aren’t making any claims so you don’t need to check you have any supporting data. Just remember that you product name can be construed as a claim. Make sure your quantity declaration meets the stipulated size of the characters.
You now have nearly everything you need for your PIF – your Product Information File. The last thing you need is a safety assessment. Your safety assessor should pick up if there is anything else you have missed out. You are now ready to roll.
Make Sure It Passes the PET Test
If you have to use an aqueous formulation, you will have to give serious thought to preservation. This is an issue which simply cannot be skimped on. The standard for this is the challenge test, of which there are official versions all around the world. (They are sometimes called preservative efficacy tests, PET tests, or microbial loading tests or just straight micro tests.) They are all much the same so it doesn’t matter too much which one you use – but which one to use is the only thing you can afford to be casual about.
The challenge test takes 4 weeks of lab time and you can add a week either end of that if like most companies you don’t have your own micro lab and you have to contract it out. This is a big chunk of time on the project. If time is what you are short of the best approach is to send in a set of formulation variations to make sure at least one of them passes. If your scarce resource is cash think carefully about what to test in the first place and pore over the results to learn as much as you can from them. For example, you might choose to do a stability study first and do the micro testing on aged samples.
Notify on the CPNP Portal and Launch!
You can now organise your production – following the principles of cosmetic GMP – and launch your product. Your last hurdle before shipping the products to customers is to notify the product on the CPNP, or Cosmetic Product Notification Portal. This is a tedious and frustrating business, but shouldn’t take an enormous amount of time. It doesn’t require the payment of any kind of fee, and there is no approval as part of the process. You just tell the database what you are doing, give some details and upload your artwork. (See this video for how to upload to the CPNP portal.)
For a non-aqueous product you can probably get everything done in a couple of months. If you need to address preservation you can get through it all in about twice that. Of course, this project plan allows no time for consumer evaluation, claim substantiation or even simply optimising the formulation to make it a good product. But if just you want to get on the market, these are all the steps you actually need.