There are many different ways for you to sell your cosmetic products in Europe: via the web, in a shop, local markets, via a distributor, …
Whichever solution(s) you decide to go with, you will need to follow a few steps to get all the paperwork related to your products up to scratch before you can go ahead and sell them. I’m not talking about taxes, but about the safety related documents required by law in Europe. You can talk to your accountant about taxes. 😊
Even if you produce your creams, soaps, etc yourself in your lab at home, or have them produced by another laboratory, you still need to follow these rules. You, or your company, are the “Responsible Person” of your cosmetic products. Your name (or your company’s name) will need to be found on all the documents related to each product (CPSR, PIF, labels, CPNP registration, etc).
What’s great about being in Europe, is that once you have your documents, you can go ahead and sell all over Europe.
Here are the 12 steps you need to follow to be able to sell your cosmetic products in Europe.
1. Develop your formula / recipe
You have made THE perfect face cream and you want to sell it.
It is important to determine if it will be possible to upscale it once orders come flying in. It isn’t because you are able to make the perfect emulsion (or whatever other form of product you are developing) at a 200ml volume, that you will be able to make it work out the same way when you try making 2 litres, or even 10 litres. Test it! Scale up step by step.
If it doesn’t work, think about adapting your formula, because once your safety report is done with the said formula, you are stuck with it (unless you request for a modification to your safety report).
Is your lab equipment adapted? Are your suppliers able to supply enough of your ingredients, or will you have to find another who is able to sell you larger volumes? How are you going to fill 200 tubes of that cream before it becomes too thick – it may be easy when you only have 15 to do, but 200…are you going to be able to cope with the equipment you have?
Think about all these things before launching your products on the market because you really don’t want to be a victim of your success.
2. Test the characteristics of your product
To be able to sell your products, you need to be able to guarantee the quality of your products. This means that when you are in the development phase (when you are having fun inventing that perfect recipe and getting everyone to try this, that and the other) you need to identify the characteristics of your product.
When you produce lots that you will sell, you will to verify these characteristics to ensure that your product is exactly as it should be. If yes, you can go ahead and sell the new lot. If not, you can’t go ahead and sell that lot since it does not comply to the specifications.
These characteristics will also be useful for testing the stability of the product over the long term (and help you determine the shelf life).
If your product contains water, you will need to verify the pH. A very low pH (so an acidic formula) could be detrimental to the skin. A pH that is too high may not be adequate for the preservative that you want to add.
Check your products color, odor, texture (liquid, solid, gel….), density, does it separate or stay in phase?
In other words, know what your product looks and feels like so that you can make the same thing time and time again.
You need to be able to test these parameters when you are testing the shelf life of the product (before you start selling the product) but also after each lot production.
You can probably measure most of these parameters yourself or have them tested by a professional lab.
3. Testing the long term stability of your product
Whilst you are developing your product, you need to think about your products shelf life: in other words, should it have an expiry date and how should you calculate it, or should it have a PAO (Period after opening) pot and how many months are acceptable for the PAO?
This is determined by the stability tests which you can do yourself or out contract to a professional lab.
You need to evaluate the characteristics of your product and how they evolve over time. Your product needs to stay the same for its shelf life.
If you have a couple of years ahead of you, you can keep a few pots/tubes of your product in a storage space (where you will be storing your products for sale in the future) and every few months check its characteristics.
The following table can give you an idea of what to do:
|stays in phase ?
T means time: T=0 means the day of the production, T=3M is 3 months after the production, and so on.
If you are in a bit of a hurry to sell your products, you can test the long-term stability in an accelerated fashion. Its not always ideal, but it is a compromise in most situations. You can do it yourself or have it tested by a laboratory that specializes in such tests.
For this you will need to incubate your product in an incubator (like one for reptile eggs) at 40 degrees Celsius for 3 months. Two or three tubes/pots for testing after 1 month, same for after 2 months and same for after 3 months.
If your product is stable (i.e. all the characteristics remain the same after 1 month at 40 degrees Celsius your product is stable for 1-year real time. If it is stable for 3 months at 40 degrees Celsius, it is in theory stable for up to 3 years (36 months).
I also think it is a good idea to test the stability for the product in the freezer by doing 3 freeze/thaw cycles, then checking if it is still in phase, if it changes in any way, etc. This is important if you ship your products by mail, since they may end up in the freezing cold plane cargo, and if not stable, your product may arrive looking and feeling rather strange, and your client won’t be happy!
4. Challenge test (microbial test)
If your product contains water (or honey or hydrosols or aloe vera, etc), you will need to add a preservative to the final product. Without a preservative, bugs may contaminate your product and potentially contaminate your client. Don’t even think about not including any in your water-based product, since the risk is really not worth it. Honey preserves itself on its own, but once it is diluted with other ingredients, it just becomes a source of sugar (food) for bacteria! Plus, the toxicologist (me!) who will be doing the safety evaluation will want to see challenge test data and that all the criteria have been passed. Without a preservative your product will not be safe and will not be acceptable for sale.
To verify that the preservative you have used is efficient at its job, you will need to have a challenge test done. This is impossible to do at home. You will need to have this tested in a lab where they do cosmetic challenge tests. The challenge test checks to see if the preservative kills bacteria, moulds and fungus that are injected into the product (in real life they come from your lab, the storage area, the client’s hands, etc).
If your product contains vegetable oils and essential oils (ie no water), then you don’t need a preservative. And you won’t need to do a challenge test since it is not relevant. What you will need instead is an antioxidant (such as vitamin E) which will stop the oxidation process of the oils and stop them from going rancid (the vegetable oils anyway).
SAF soaps are also an exception for needing preservatives since the water that is added during the production process mostly evaporates before the product is sold.
If you are not certain as to whether you need a preservative, ask me!
5. Détermining the expiry date or the PAO of your product
Ah the big question! Do I put an expiry date or the little pot with 6M?
This will be determined by the results of your stability test and the challenge test.
If your product is stable for less than 30 months, then you will need to write an expiry date on the product packaging.
If your product is stable for more than 30 months, then you can use the little open pot, which signifies that the product is stable for more than 30 months and that once the pot/tube is opened the product remains stable for 6 months. (Or 3 months if 3M is noted, 12 months if 12M is noted, and so forth). This is the PAO (period after opening) rule.
A few examples:
- A face cream with preservative is sold in a pot where the user will dip his/her finger into the pot to get the cream out. This type of product has a high risk of contamination since bugs may come in contact with the cream every time the cream comes in contact with the finger. The stability test shows that it is stable for more than 36 months. For this cream, it would be best to put a PAO of 3 months (3M).
- A natural cream with preservative, with stability of more than 30 months, that is sold in an airless pump could have a PAO of 6 months, or even 12 months.
- If you cream changes color or separates after 24 months, and doesn’t really look the same after 30 months, then best go with an expiry date.
If in doubt, ask me.
6. Quality control
Once you have determined the characteristics of your product, it will be important to verify them after each production (i.e. each lot). This is your quality control.
Your product needs to meet each of these characteristics after the production, and if yes, then it is “acceptable” for sale. It is does not meet the specifications (i.e. these criteria – for example it is black instead of being yellow, too liquidy, etc), analyse it and see what is wrong with it. Did you add the wrong ingredient, not enough of an ingredient, not mix it well, etc etc? Your clients are not going to be happy with a product that isn’t the same as it was before.
You can only sell that lot if you are certain of the quality of your product. If your lot does not pass the quality control tests, then you have to start again by making another lot. (But check to see where you went wrong with this lot to avoid repeating the mistake).
This kind of thing happens frequently in pharmaceutical labs, so don’t stress. It is a part of the process.
Each lot (i.e. each time you make that product) must have its lot number, its production file and its file for the quality control. The quality control is important to ensure that each lot your produce remains stable over time. Keep a tube of the product for each time point where you will be checking the quality after production (eg after 12 months, 24 months and 36 months)
In case of a problem with a lot, for instance your client says that the cream has turned black a few weeks after she opened it, then you can go back to your quality control samples (for that particular lot) and the quality control file and check if this has also happened when under your storage. It can help prove that your product is ok, and that the client may have mishandled it, or that your lot does indeed have a problem.
7. Good Manufacturing Practices (GMP)
Super important ! Good manufacturing practice is key to working well. It is there to protect you during the production, to ensure the quality and traceability of your ingredients and the final product.
You need to have a GMP document outlining how you work. This is valid for a small lab (where you produce only a few products) and a large lab where you produce hundreds of liters.
Keep your products clean and keep yourself safe.
8. Allegations/ claims
Your soap works super well at removing blackheads on teenagers’ noses. Your cream hydrates the skin.
These are allegations or actions related to your product. You need to prove that your product does exactly that.
If you can’t prove it, then don’t say it.
Also think about avoiding medical terms like “repair”, “inflammation”, “scarring”, “pain”, “migraine”, and so on. Your product is a cosmetic product, not a medication. If you want to use medical terms, then go ahead and do phase I to III clinical trials which will cost you a couple of million euros.
9. Safety assessment / Report (CPSR)
Before you can even think about selling your product you need to follow a few rules.
The first of these is to have your product’s formula (recipe) and its ingredients evaluated by a European toxicologist. The toxicologist will write the CPSR (Cosmetic Product Safety Report) for you. This report needs to be written and signed by a toxicologist (like me…).
The safety report evaluates the composition of your product and confirms that each ingredient is at a concentration which is safe for the consumer, that the product is stable, and that it will be free of microorganisms. The report will also provide you with a list of the ingredients in their INCI form, in the correct order for the packaging, as well as the allergens that need to be listed. The report will also provide with the safety warnings that you need to include on the packaging, the PAO as well as the target populations (for example adults, children babies, etc.) who are or are not allowed to use the product.
This report contains confidential information (your formula) so only show it to the competent authorities. To reassure your clients that you have had a safety evaluation done, you can show them the first page of the safety report that I provide you with. It is a little bit like a certificate for the product confirming that it has been evaluated for its safety.
Once you have your safety assessment, you can go ahead and finalize the PIF (see action 10), the labelling, notify the product on the CPNP portal and go ahead and sell it in Europe. (yeah finally!!)
10. Product information file (PIF)
The second rule is to create a Product Information File which outlines several aspects of your product.
You can do the majority of the PIF yourself and keep it up to date, or you can get me to write it for you.
You can include all the information in one file or keep them separately. They can be paper versions or electronic. Keep on file called the PIF which outlines where all the relevant information can be found so that in case you have the authorities asking you for it, you have everything you need at hand.
All the information in the PIF must be kept at the same address as that of the responsible person.
Since this document contains confidential information, only show it to the competent authorities.
The PIF is made up of 5 parts:
- Product description
The name of the product, its properties, photo of the packaging, EAN code, CPNP code… anything that is useful in helping describe and identify the product.
- The safety assessment (CPSR)
This report will be provided to you by the toxicologist who wrote the report. In your pif file you should list the safety assessment number, when it was done, the toxicologist’s name and contact details and the overall conclusions on the product’s safety.
Here you need to include the formula and a detailed step by step production protocol (how you make your product).
You should also include the list of lots produced, production dates, etc. and the quality control performed.
- Efficacy data
If you are making claims on the efficacy of your product (e.g. removes wrinkles) this is were you can detail the data, you have proving that your product actually does that.
- Animal experimentation
In Europe, it is formally forbidden to perform any experiments on animals to evaluate your cosmetic product. This is the rule for all companies, even if they say that they are cruelty free. This section is a little redundant, but just note that you haven’t done any experiments (unless you have before the law came into play).
11. Packaging and labels
Your packaging and product labels need to include the legally required information.
The following website shows you what you need on your labels.
Keep in mind that you packaging/label needs to be in the national language(s) of the country where you will be selling your products. You can use several languages if for instance you are selling online or in several countries.
12. CPNP – Cosmetic portal
This is the last step and, in a sense, the most important step since the CPNP portal provides details of your product to the European Union and all the national poison centers. You can do this yourself or I can do it for you. The CPNP formula is online and easy to fill out via an account which you need to create for you company. The CPNP portal has a step by step tutorial online which will guide you:
Ok so there you have it. With all this information, you have what you need to prepare everything to sell those fabulous products. Have fun and contact me if you want me to do your safety assessments or need help.