The following article was first published in the December 2010 issue of the European Product Liability Review and on the International Law Office website.
Nanomaterials are defined by the French Agency for Environmental and Occupational Health Safety (Afsset) as materials "composed of elementary structures of which at least one of the dimensions is typically, but not exclusively, between 1 and 100 nanometres"69.
As highlighted in our September 2008 edition70, nano-sized structures are not new. They were simply not assessable before due to difficulties in measuring them. The knowledge of their use in products for the general public is therefore quite recent and keeps on increasing. The Afsset, in its report of 17 March 2010, identified nanomaterials in a number of everyday life products such as "sun protection cream, textiles, foodstuffs, transport" in "sectors as diverse as building, automotive, packaging, chemical, environmental, energy and health"71.
This reality was revealed together with the fear that nanotechnologies may be at the origin of asbestos-like illnesses in the future and warnings that both workers and consumers should be protected from them. This explains why nanomaterials are today the central focus of abundant research projects all around the world. Professor Bengt Fadeel, Vice chairman at the institute of environmental medicine at Karolinska Institutet72 and coordinator of the project NANOMMUNE created by the European Commission to study the hazardous effects of engineered materials on the immune system, hence warned that "when you shrink material down to nanoscale, you change their properties and we still don't really understand which properties are hazardous"73. France makes no exception to this concern. The Afsset, which carried out a national level research on nanomaterials this year, indeed considers this field as being "the booming area of scientific and technical research"74.
The cosmetics industry is known as one of the industries using the highest level of nanomaterials as they offer innovative solutions to manufacturers and producers. Consequently, the Regulation 1223/2009 on cosmetic products (hereafter "the Regulation"), scheduled to enter into force on 11 July 2013, explicitly and specifically regulates the use of nanomaterials and acknowledges the existing uncertainties regarding their hazardous properties. Even more, this Regulation provides for an earlier entry into force for the provisions on nanotechnologies, i.e. on 11 January 2013.
Nanomaterials, which are said to be surrounding all of us, should therefore be considered by manufacturers and suppliers from the cosmetics industry, as a factor which will increase risk liability in the near future, especially in France where Afsset has decided to monitor their use very closely.
NEW SPECIFIC NOTIFICATION AND LABELLING OBLIGATIONS
In order to ensure traceability and transparency regarding the use of nanotechnologies in cosmetic products, the Regulation creates a distinct set of obligations, specific to nanomaterials75.
Pursuant to Article 16-3, the "responsible person"76 shall notify the Commission six months prior to placing on the market a product containing nanomaterials. Willing to prevent manufacturers from placing on the market numerous products before the entry into force of the Regulation, the latter further states that products that are placed on the market before the entry into force of the Regulation should fulfil the notification requirement between 11 January 2013 and 11 July 201377.
- The notification to the Commission shall be made by electronic means and should contain, "at least": 78
- "the identification of the nanomaterial, including its chemical name (IUPAC) and other descriptors (...)";
- "the specification of the nanomaterial including size of particles, physical and chemical properties";
- "an estimate of the quantity of nanomaterial contained in 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, as used in such product";
- "the reasonably foreseeable exposure conditions".79
Identification, assessments and tests will therefore be required in order to ascertain the data necessary to conform to the notification requirements. Manufacturers and producers will have to plan ahead in order not to have their manufacturing and selling process blocked for a number of months because of a lack of notification in due time.
Additionally, Article 19 establishes new labelling requirements for products containing nanomaterials. "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".80 Current practices of labelling will therefore have to also be reviewed in order to comply with the provisions of the Regulation.
The availability of the information on the boom of the industrial use of nanomaterials being quite recent, their effects on human health are yet to be assessed. Along these lines, Professor Bengt Fadeel asserted that "there are great many studies on cells and animals suggesting that nanomaterials can have damaging effects on the health and the environment".81
The Regulation acknowledges these potential risks, as Recital 30 recognises the fact that the current information on the risks associated to nanomaterials is "inadequate". In addition, Article 16-1 provides that "for every cosmetic that contains nanomaterials, a high level of protection of human health shall be ensured".
Based on these potential and yet uncertain risks for human health, the Regulation has built a flexible scheme that will be adjusted according to the findings of ongoing and future scientific research. In effect, the current definition of nanomaterials is provisional and the list of allowed nanomaterials is deemed to change.
Provisional definition of nanomaterial
Nanomaterials are currently defined by the Regulation as being "an insoluble or biopersistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on a scale from 1 to 100 nm".82
As previously mentioned, this definition will be subject to changes. Indeed, Recital 29 addresses the necessity to establish a definition of nanomaterials at an international level and adds that "should such an agreement be reached, the definition of nanomaterials in this Regulation should be adapted accordingly".
In addition, Article 2-3 states that the definition of nanomaterials will be adapted by the Commission, "in view of the various definitions of nanomaterials published by different bodies and the constant technological and scientific development in the field of nanotechnologies, the Commission shall adjust and adapt point (k) of paragraph 1 to technical and scientific progress and to definitions subsequently agreed at international level".83
Finally, the Commission will publish by 11 January 2014 a catalogue of all nanomaterials used in cosmetic products placed on the market. This catalogue will be public and regularly updated afterwards.84
Flexible list of authorised nanomaterials
The provisions allowing the use of nanomaterials may be adapted based on the progress of the understanding about the possible hazards of nanomaterials. Article 16-11 provides that "the Commission shall regularly review the provisions of this Regulation concerning nanomaterials in the light of scientific progress and shall, where necessary, propose suitable amendments to those provisions". The first review is scheduled to be undertaken by 11 July 2018,85 i.e. only five years after the entry into force of the Regulation.
Moreover, if the Commission has concerns regarding the safety of a nanomaterial, it must, "without delay" request the Scientific Committee for Consumer Safety (SCCS)86 to give its opinion on the safety of such nanomaterial. This information shall be made public by the Commission. If the SCCS considers that "any necessary data is lacking", it will have to request the responsible person to provide the data necessary for the inquiry "within an explicitly stated reasonable time", with no extension possible. The SCCS should deliver a final public opinion within six months .87
Based on the result of this inquiry, the Commission will have the power to amend the list of prohibited and restricted products in order to include a nanomaterial if there is a "potential risk to human health, including where there is insufficient data".88 The precautionary principle finds an important application here and creates great uncertainties for manufacturers and suppliers as some ingredients may be suddenly prohibited from being used when they were, at first, allowed.
It is recommended that companies start adapting their chain of production and supply as well as their contracts with their sub-contractors in order to take into account the new obligations as well as the uncertainties originating from the Regulation concerning nanomaterials. When doing so, manufacturers should bear in mind the fact that research is likely to force them to find new ingredients within a short time scale as some nanomaterials may be prohibited when they were first allowed.
This reality is also true outside the scope of the cosmetic industry as highlighted by the Afsset which identified 246 products on the French market within the census that was carried out which contain nanomaterials. Indeed, while the effects of nanomaterials on human health are yet to be ascertained, some risks are already being studied very seriously. For example, Professor Bengt Fadeel asserted that "there are serious fears that carbon nanotubes might have the same harmful properties as asbestos fibres".89
Nanomaterials being presented as the "future asbestos", the potential discovery of their hazardous properties, whether used in the cosmetics field or any other industry, may increase the liability of manufacturers and producers not only towards consumers, but also towards their employees who are in contact with nanomaterials and even perhaps towards the populations living nearby manufacturing plants. We may indeed see former employees suing their employers, claiming their liability based on the negligent exposure to a hazardous substance or for gross negligence should they develop an occupational illness. Serious questions should therefore be raised today about notably the insurance coverage of such risks. Indeed, for instance in France, it is very rare to find companies which are covered for asbestos-related risks, leading most of them into great financial difficulties. Another approach may be preferable for nanotechnologies. Manufacturers, producers and suppliers should start focusing on such questions.