Nanomaterials are increasingly used in industrial production, especially cosmetic products. Some regulations are specific to the use of nanomaterials in cosmetic products that we suggest you discover in the article below.
What does the European Cosmetics Regulation say?
Article 2 of the Cosmetic Regulation No. 1223/2009 defines nanomaterial as a “an insoluble or bio-persistent material, manufactured intentionally and characterized by one or more external dimensions, or an internal structure, on a scale of 1 to 100 nanometers.”
It is interesting to note that cosmetic regulations differ slightly from the broad definition given by the European Commission. In fact, it does not take into account nanoparticles of natural origin. Nanoemulsions and nanopigments are also considered to be nano-ingredients.
The requirements imposed on companies marketing cosmetic products focus on 3 aspects:
- security assessment
- the conformity of the labelling, i.e. the mention [nano] in the list of ingredients
- the CPNP (Cosmetic Products Notification Portal) notification to be made 6 months before marketing
How to assess the safety of cosmetic nanomaterials?
The difficulty of testing nanomaterials
Because of their high surface area/volume ratio, nanomaterials have physicochemical properties poorly or poorly evaluated in humans. There is currently no standardized test method, and the tests required to assess the toxicity of nanoparticles require greater precision than those required for REACH registration.
Identifying the risks associated with nanomaterials
All toxicological effects relevant to assess the safety of a cosmetic ingredient should be considered and applied to the nano-ingredient. The usual in vivo and in vitro methods can be used. However, it should be remembered that to date, none of the in vitro methods have been validated for nanomaterials.
It is very important to assess the toxic consequences of the nanomaterial present in the cosmetic product, especially in case ofinhalation, ofingestion And ofcutaneous application. All possible routes of nanoparticles in the human body must be considered, as well as the risks caused by their potential accumulation.
However, only a few in silico molecular models are currently available for testing.
The opinion of the SCCS
The European Scientific Committee for Consumer Safety regularly issues opinions on health and safety risks. If there are doubts about the safety of a nanomaterial, the European Commission will comply with its opinion. It is therefore recommended to follow their work on nanomaterials.
The CSSC has published A guide (in English) in order to ensure the safety of cosmetic nanomaterials.
The European Commission catalog
The European Commission has planned to set up a public catalog that lists cosmetic nanomaterials used in products already placed on the market. It is planned to update this catalog regularly.
It was supposed to be published no later than January 11, 2014; it was still not online in 2016. In addition, it would focus on the use of nanotechnology in cosmetics, a more global theme than the “catalog of all nanomaterials used in cosmetic products placed on the market” planned previously.
Cosmetic labelling requirements for nanomaterials (article 19)
Since July 11, 2013, the European Cosmetic Regulation No. 1223/2009 establishes in its article 19 that the presence of nanomaterial must appear in the composition of cosmetic products. The name of the nano-ingredient must be followed by the mention [nano] between square brackets on the labelling of the cosmetic product.
A. CPNP notification (article 16)
Contrary to normal, cosmetic products containing nanomaterials must be declared on the CPNP portal, 6 months before being put on the market (except for products already placed on the market by the Responsible Person before 11 January 2013). As a reminder, there is no minimum delay for cosmetic products that do not contain ingredients at the nanoscale.
To make this notification, the Responsible person CNCP Portal (Cosmetic Products Notification Portal). The CNCP is a free online notification system created for the application of the EC cosmetic regulation No. 1223/2009. When a product has been notified on the CNCP, there is no need to make another notification at the national level for EU member countries.
This regulation does not apply to cosmetic products containing nanomaterials belonging to Annexes III (restricted substances), IV (dyes), V (preservatives) and VI (UV filters) of the European cosmetic regulation.
Content of the CPNP notification
Article 16 of of the Cosmetic Regulation defines the scope of nanomaterials in cosmetics “For any cosmetic product containing nanomaterials, a high level of human health protection is guaranteed.”
The information requested is as follows:
- The identification of the nanomaterial, including its IUPAC name, and the other classifications specified in point 2 of the Preamble to Annexes II to VI
- The specification of the nanomaterial, including particle size and physicochemical properties
- An estimate of the quantity of nanomaterial contained in cosmetic products intended to be placed on the market each year
- The toxicological profile of the nanomaterial
- Data relating to the safety of the nanomaterial, linked to the category of cosmetic product in which it is used
- Reasonably foreseeable exposure conditions
In addition, the mention [nano] must be added specifically in the annex provided for this purpose.
Nanomaterials are increasingly used in industrial production, especially cosmetic products. Some regulations are specific to the use of nanomaterials in cosmetic products that we suggest you discover in the article below.
What does the European Cosmetics Regulation say?
Article 2 of the Cosmetic Regulation No. 1223/2009 defines nanomaterial as a “an insoluble or bio-persistent material, manufactured intentionally and characterized by one or more external dimensions, or an internal structure, on a scale of 1 to 100 nanometers.”
It is interesting to note that cosmetic regulations differ slightly from the broad definition given by the European Commission. In fact, it does not take into account nanoparticles of natural origin. Nanoemulsions and nanopigments are also considered to be nano-ingredients.
The requirements imposed on companies marketing cosmetic products focus on 3 aspects:
- security assessment
- the conformity of the labelling, i.e. the mention [nano] in the list of ingredients
- the CPNP (Cosmetic Products Notification Portal) notification to be made 6 months before marketing
How to assess the safety of cosmetic nanomaterials?
The difficulty of testing nanomaterials
Because of their high surface area/volume ratio, nanomaterials have physicochemical properties poorly or poorly evaluated in humans. There is currently no standardized test method, and the tests required to assess the toxicity of nanoparticles require greater precision than those required for REACH registration.
Identifying the risks associated with nanomaterials
All toxicological effects relevant to assess the safety of a cosmetic ingredient should be considered and applied to the nano-ingredient. The usual in vivo and in vitro methods can be used. However, it should be remembered that to date, none of the in vitro methods have been validated for nanomaterials.
It is very important to assess the toxic consequences of the nanomaterial present in the cosmetic product, especially in case ofinhalation, ofingestion And ofcutaneous application. All possible routes of nanoparticles in the human body must be considered, as well as the risks caused by their potential accumulation.
However, only a few in silico molecular models are currently available for testing.
The opinion of the SCCS
The European Scientific Committee for Consumer Safety regularly issues opinions on health and safety risks. If there are doubts about the safety of a nanomaterial, the European Commission will comply with its opinion. It is therefore recommended to follow their work on nanomaterials.
The CSSC has published A guide (in English) in order to ensure the safety of cosmetic nanomaterials.
The European Commission catalog
The European Commission has planned to set up a public catalog that lists cosmetic nanomaterials used in products already placed on the market. It is planned to update this catalog regularly.
It was supposed to be published no later than January 11, 2014; it was still not online in 2016. In addition, it would focus on the use of nanotechnology in cosmetics, a more global theme than the “catalog of all nanomaterials used in cosmetic products placed on the market” planned previously.
Cosmetic labelling requirements for nanomaterials (article 19)
Since July 11, 2013, the European Cosmetic Regulation No. 1223/2009 establishes in its article 19 that the presence of nanomaterial must appear in the composition of cosmetic products. The name of the nano-ingredient must be followed by the mention [nano] between square brackets on the labelling of the cosmetic product.
A. CPNP notification (article 16)
Contrary to normal, cosmetic products containing nanomaterials must be declared on the CPNP portal, 6 months before being put on the market (except for products already placed on the market by the Responsible Person before 11 January 2013). As a reminder, there is no minimum delay for cosmetic products that do not contain ingredients at the nanoscale.
To make this notification, the Responsible person CNCP Portal (Cosmetic Products Notification Portal). The CNCP is a free online notification system created for the application of the EC cosmetic regulation No. 1223/2009. When a product has been notified on the CNCP, there is no need to make another notification at the national level for EU member countries.
This regulation does not apply to cosmetic products containing nanomaterials belonging to Annexes III (restricted substances), IV (dyes), V (preservatives) and VI (UV filters) of the European cosmetic regulation.
Content of the CPNP notification
Article 16 of of the Cosmetic Regulation defines the scope of nanomaterials in cosmetics “For any cosmetic product containing nanomaterials, a high level of human health protection is guaranteed.”
The information requested is as follows:
- The identification of the nanomaterial, including its IUPAC name, and the other classifications specified in point 2 of the Preamble to Annexes II to VI
- The specification of the nanomaterial, including particle size and physicochemical properties
- An estimate of the quantity of nanomaterial contained in cosmetic products intended to be placed on the market each year
- The toxicological profile of the nanomaterial
- Data relating to the safety of the nanomaterial, linked to the category of cosmetic product in which it is used
- Reasonably foreseeable exposure conditions
In addition, the mention [nano] must be added specifically in the annex provided for this purpose.
