Cosmetic kits are considered as borderline products between CLP regulation and Cosmetic Regulation. The European Commission has clarified the status in their guideline named �Manual of the working group on cosmetic products (sub-group on borderline products) on the scope of application of the cosmetics regulation (EC) No 1223/2009 (ART. 2(1)(A))�
For the question: �Are cosmetic kits cosmetics products?� they made a difference between two major kit types.
1- Cosmetic kits, which are considered as cosmetic products:
If the kit components need to be mixed on clear instructions, the product is considered as a cosmetic product and the EU Regulation 1223/2009 applies. In this case, you should follow the usual EU cosmetic compliance process.
In this particular case, the CLP regulation will not be applicable because of an exception for finished cosmetic products. Nevertheless, if the consumer needs to add any ingredients, which are not in the kit (e.g. water) to make the cosmetic product then the Safety Assessor needs to take it into account when he assesses the safety of the cosmetic product. As all cosmetic products in Europe, the product must be notified on the CPNP by the Responsible Person.
2- Cosmetic kits which are not considered as cosmetic products.
If the cosmetic kit does not contain any clear instructions with a set recipe to make a finished product, then the components of the kit are not a cosmetic product but raw materials. Therefore, the CLP Regulation applies, and the product must be compliant.
How to comply with the EU Cosmetic Regulation No.1223/2009 when your kit is a cosmetic product?
We provide comprehensive documentation on our blog. Don�t hesitate to read more about cosmetic compliance.
The process is the same for a cosmetic kit and a ready-to-use product.
The EU Cosmetic Regulation 1223/2009 came into force in 2013 and concerns 31 European countries (28 countries of the EU + Norway + Iceland + Lichtenstein).
The regulation is based on five main principles:
- Safety of Raw Materials and Ingredients
- Good Manufacturing Practices
- Monitoring the cosmetic market
- Animal testing
- Proof of efficacy of the cosmetic product
You are affected if you are:
- A brand / private label
- A distributor
- A manufacturer or supplier (only in certain cases)
- An importer
What should you do to comply?
Here is a non-exhaustive list of regulatory obligations:
- Designate a Responsible Person (RP)
- Prepare a Product Information file (PIF) including a Safety Assessment
- Respect Good Manufacturing Practices (GMP) for cosmetics
- Comply with Labeling and Packaging requirements
- Ensure notification via the Cosmetic Products Notification Portal (CPNP)
Before planning to sell your cosmetics, be sure you will be able to go through the process:
- Assess the data gap with your manufacturer
- List the product(s) you want to export to Europe
- Budget your compliance (including testing, consultancy fees, RP fees, etc.)
- Designate your Responsible Person
- Collect data from the manufacturer
- Anticipate reformulations and labeling updates
What testing will you need to provide?
For all cosmetics placed on the EU market, tests are mandatory. When it comes to commercializing a DIY kit, we recommend performing the tests listed below:
These tests need to be done by the manufacturer, not the consumer!
Stability test for the cosmetic kit (mandatory):
The main objective of the stability test is to verify the microbiological environment is stable. The appearance and the smell of the product must not change during at least a month.
Differents parameters are monitored:
- Organoleptic characteristics (apparence, smell...)
- Chemical (pH, viscosity,...)
There's no unique standard to carry out a stability test. Nevertheless, a lot of laboratories will use the same standards. Two types of testing are usually performed: tests in real condition and tests in accelerated conditions.
-Test in real condition are carried out at room temperature for about 3 years during which the selected parameters are monitored.
-Test in accelerated condition are done in extreme conditions (high temperature, humidity,etc.) in order to accelerate the aging of the formula and thus observe variations more quickly
The stability test will allow to measure the DOMD which is a key requirement in European compliance.
Challenge test for the cosmetic kit (mandatory):
If the DIY cosmetic kit preparation needs water to be added or contains hydrosols the challenge test is mandatory.
The main objective of the challenge test is to verify the preservative system for at least 1 month at room temperature. We recommend conducting the challenge test in accordance with ISO standard (ISO 11930) or with the European pharmaceutical standards. You can also use other standards such as USP 51 as long as you add a measure at Day 7.
If the product is anhydrous, it can be exempted from challenge testing, see ISO 29261 to learn more about exemptions.
NB: We highly recommend that you provide an appropriate packaging with your kit for the finished product e.g. airless pump to reduce the risk of microbiological development.
Use of the kit (recommended):
This test allows you to verify if the instructions on the kit are clear so that a beginner can make the recipe without difficulty. You can set up a panel who will follow the recipe individually without any help or prerequisites. If the panel encounters any difficulty, you may have to review the instructions.
You�re making your own cosmetics. Are you concerned by the EU Regulation 1223/2009?
Yes, you may be! As you may know the legal principles �Ignorance of law excuses no one�.
If you are making your own cosmetics for yourself only, then you�re not concerned by the Regulation. But from the moment you give the product to a member of your family, friends or colleagues, you should comply with the Regulation (see above) and become the Responsible Person with all the obligations the role implies.
Also, if you want to sell your products even a small quantity, you should be compliant with the Cosmetic Regulation: all products sold in the European Union must comply with the regulation.
Discover our European Cosmetics Regulation services
Cosmetic kits are considered as borderline products between CLP regulation and Cosmetic Regulation. The European Commission has clarified the status in their guideline named �Manual of the working group on cosmetic products (sub-group on borderline products) on the scope of application of the cosmetics regulation (EC) No 1223/2009 (ART. 2(1)(A))�
For the question: �Are cosmetic kits cosmetics products?� they made a difference between two major kit types.
1- Cosmetic kits, which are considered as cosmetic products:
If the kit components need to be mixed on clear instructions, the product is considered as a cosmetic product and the EU Regulation 1223/2009 applies. In this case, you should follow the usual EU cosmetic compliance process.
In this particular case, the CLP regulation will not be applicable because of an exception for finished cosmetic products. Nevertheless, if the consumer needs to add any ingredients, which are not in the kit (e.g. water) to make the cosmetic product then the Safety Assessor needs to take it into account when he assesses the safety of the cosmetic product. As all cosmetic products in Europe, the product must be notified on the CPNP by the Responsible Person.
2- Cosmetic kits which are not considered as cosmetic products.
If the cosmetic kit does not contain any clear instructions with a set recipe to make a finished product, then the components of the kit are not a cosmetic product but raw materials. Therefore, the CLP Regulation applies, and the product must be compliant.
How to comply with the EU Cosmetic Regulation No.1223/2009 when your kit is a cosmetic product?
We provide comprehensive documentation on our blog. Don�t hesitate to read more about cosmetic compliance.
The process is the same for a cosmetic kit and a ready-to-use product.
The EU Cosmetic Regulation 1223/2009 came into force in 2013 and concerns 31 European countries (28 countries of the EU + Norway + Iceland + Lichtenstein).
The regulation is based on five main principles:
- Safety of Raw Materials and Ingredients
- Good Manufacturing Practices
- Monitoring the cosmetic market
- Animal testing
- Proof of efficacy of the cosmetic product
You are affected if you are:
- A brand / private label
- A distributor
- A manufacturer or supplier (only in certain cases)
- An importer
What should you do to comply?
Here is a non-exhaustive list of regulatory obligations:
- Designate a Responsible Person (RP)
- Prepare a Product Information file (PIF) including a Safety Assessment
- Respect Good Manufacturing Practices (GMP) for cosmetics
- Comply with Labeling and Packaging requirements
- Ensure notification via the Cosmetic Products Notification Portal (CPNP)
Before planning to sell your cosmetics, be sure you will be able to go through the process:
- Assess the data gap with your manufacturer
- List the product(s) you want to export to Europe
- Budget your compliance (including testing, consultancy fees, RP fees, etc.)
- Designate your Responsible Person
- Collect data from the manufacturer
- Anticipate reformulations and labeling updates
What testing will you need to provide?
For all cosmetics placed on the EU market, tests are mandatory. When it comes to commercializing a DIY kit, we recommend performing the tests listed below:
These tests need to be done by the manufacturer, not the consumer!
Stability test for the cosmetic kit (mandatory):
The main objective of the stability test is to verify the microbiological environment is stable. The appearance and the smell of the product must not change during at least a month.
Differents parameters are monitored:
- Organoleptic characteristics (apparence, smell...)
- Chemical (pH, viscosity,...)
There's no unique standard to carry out a stability test. Nevertheless, a lot of laboratories will use the same standards. Two types of testing are usually performed: tests in real condition and tests in accelerated conditions.
-Test in real condition are carried out at room temperature for about 3 years during which the selected parameters are monitored.
-Test in accelerated condition are done in extreme conditions (high temperature, humidity,etc.) in order to accelerate the aging of the formula and thus observe variations more quickly
The stability test will allow to measure the DOMD which is a key requirement in European compliance.
Challenge test for the cosmetic kit (mandatory):
If the DIY cosmetic kit preparation needs water to be added or contains hydrosols the challenge test is mandatory.
The main objective of the challenge test is to verify the preservative system for at least 1 month at room temperature. We recommend conducting the challenge test in accordance with ISO standard (ISO 11930) or with the European pharmaceutical standards. You can also use other standards such as USP 51 as long as you add a measure at Day 7.
If the product is anhydrous, it can be exempted from challenge testing, see ISO 29261 to learn more about exemptions.
NB: We highly recommend that you provide an appropriate packaging with your kit for the finished product e.g. airless pump to reduce the risk of microbiological development.
Use of the kit (recommended):
This test allows you to verify if the instructions on the kit are clear so that a beginner can make the recipe without difficulty. You can set up a panel who will follow the recipe individually without any help or prerequisites. If the panel encounters any difficulty, you may have to review the instructions.
You�re making your own cosmetics. Are you concerned by the EU Regulation 1223/2009?
Yes, you may be! As you may know the legal principles �Ignorance of law excuses no one�.
If you are making your own cosmetics for yourself only, then you�re not concerned by the Regulation. But from the moment you give the product to a member of your family, friends or colleagues, you should comply with the Regulation (see above) and become the Responsible Person with all the obligations the role implies.
Also, if you want to sell your products even a small quantity, you should be compliant with the Cosmetic Regulation: all products sold in the European Union must comply with the regulation.
Discover our European Cosmetics Regulation services
