What is a nanomaterial?
The European Commission defines a nanomaterial as “a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm - 100 nm.”
Nanomaterials are divided into three groups according to their structure:
Nanoparticles and fullerenes
Nanotubes and nanofibers
This definition was issued by a recommendation from 2011. A revision was announced for 2014-2015, but has not been published so far.
Nanomaterials in cosmetics: what are the consequences?
What does the EU Cosmetics Regulation says?
Article 2 of Cosmetics Regulation 1223/2009 defines a nanomaterial as: “an insoluble or biopersistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm”
The Cosmetics Regulation as opposed to the European Commission definition does not take into account natural nanoparticles. Nevertheless, nanoemulsion and nanopigments are considered as nano-ingredients.
To place cosmetics products containing nanomaterials on the European market you should meet the following requirements:
- Appropriate Safety Assessment
- Compliant Labeling, i.e. nano information in the ingredient listing
- CPNP (Cosmetic Products Notification Portal) notification 6 months prior to market access
1- How to assess the safety of cosmetic nanomaterials?
The difficulty of nanomaterial testing
Due to their high surface/ volume ratio, nanomaterials possess physicochemical properties which are difficult to assess on humans. Currently, there is no standardized test method, and the necessary tests to assess the toxicity of nanoparticules require a higher degree of detail than the ones asked for REACH registration.
Identifying nanomaterial risk
All the relevant toxicological effects must be considered to assess the safety of a cosmetic ingredient and then apply it to the nano-ingredient. The usual in vivo and in vitro methods can be used. Nevertheless, it must be kept in mind that no in vitro method has been approved regarding nanomaterials.
It’s important to assess all the toxic consequences of nanomaterials present in cosmetics, especially in case of inhalation, ingestion and skin application. All the possible routes of nanoparticles into the human body must be considered as well as the potential risks due to an accumulation.
However, only a few molecular models in silico are currently available for tests.
The SCCS’ opinion
The European Scientific Committee on Consumer Safety (SCCS) regularly advises on the risks for health and safety. If there are any doubts regarding the safety of a nanomaterial the European Commission will follow the opinion of the SCCS. It’s firmly recommended to follow their opinion concerning nanomaterials.
The SCCS has published a guide to ensure cosmetic nanomaterial safety
The European Commission’s catalog
The European Commission has planned the establishment of a public catalog which includes all cosmetic nanomaterials already used in products and placed on the EU market. It has also planned to update this catalog regularly. However, if the publication of the catalog was scheduled for the 11th January 2014, it’s still a project in 2016. In addition, the focus of the catalog will be more oriented towards nanotechnology in cosmetics, a much wider subject than the initial one.
2- Cosmetic labeling requirements for nanomaterials (Article 19)
Since 11th July 2013, the European Cosmetics Regulation No. 1223/2009 that has come into forcedefines the rules concerning labeling, and also the particularity of labeling nanomaterials in article 19: “All ingredients present in the form of nanomaterials shall be clearly indicated in the list of ingredients. The names of such ingredients shall be followed by the word ‘nano’ in brackets [nano]”
3- The CPNP notification (Article 16)
Cosmetic products containing nanomaterials should be notified 6 months before being placed on EU market. Exception is made if they were already placed on the market by the same Responsible Person before the 11th January 2013.
To proceed with the notification the Responsible Person should use the Cosmetic Products Notification Portal (CPNP). The CPNP is a “free of charge online notification system created for the implementation of Regulation (EC) No 1223/2009 on cosmetics products. When a product has been notified in the CPNP, there is no need for any further notification at national level within the EU”.
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 Regulation 1223/2009.
Content of CPNP notification
Article 16 of the Cosmetics Regulation defines the scope of nanomaterials in cosmetics: “For every cosmetic product that contains nanomaterials, a high level of protection of human health shall be ensured”
The following requirements must be met:
- The identification of the nanomaterial including its chemical name (IUPAC) and other descriptors as specified in point 2 of the Preamble to Annexes II to VI
- The specification of the nanomaterial including size of particles, physical and chemical properties
- An estimate of the quantity of nanomaterial contained in the cosmetic products intended to be placed on the market per year
- The toxicological profile of the nanomaterial
- The safety data of the nanomaterial relating to the category of cosmetic product, in which it is used
- The reasonably foreseeable exposure conditions
The word [nano] must be specifically added in the Annex provided for this purpose.
Discover our European Cosmetics Regulation services
Please do not hesitate to contact us: [email protected], if you have any questions about cosmetic compliance or if you’re looking for specific services. EcoMundo acts as Responsible Person for Europe and can provide the following services:
- Regulation 1223/2009 services
- EU cosmetic compliance
- Responsible Person for Europe
- Formula review
- Claim review
- Cosmetic labeling services
- PIF creation
- Safety Assessment
- CPNP notification services
- Cosmetic certification for Europe
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