The EU has introduced in recent years several pieces of legislation, which mention nanomaterials in their texts but there has been no clear definition of what exactly nanomaterials are.
Over a year ago the European Parliament instructed the Commission to draw up a “comprehensive science-based definition for use in EU legislation.”
Now the Commission has finally come up with one. But it is considered to be so broad by industry that they claim it covers substances that are normally not regarded as being nanomaterials while excluding some of those that are generally seen as being nano.
Environmentalists and NGOs (non-governmental organizations) on the other hand argue that the definition is too narrow and will enable nanomaterials to escape proper testing for their potential hazards.
The coatings sector and its suppliers are angry because under the definition mineral or inorganic pigments and fillers can be categorized as being nanomaterials.
“The definition does not apply to paint formulations,” said Jacques Warnon, technical director for the European trade association for coatings producers (Cepe). “But there is a big concern that it could mean new testing requirements for suppliers of coatings materials, particularly pigment producers and importers, which will ultimately affect coatings companies. The additional costs will be passed on to them.
“Mineral pigments, which have been around for a long time and are not designed to be nanomaterials, are affected because they usually have a certain amount of nanoparticles within them, although these have been shown to be safe,” Warnon said.
The Commission decided that nanomaterials should be defined on the basis of the size of the particles within a material, without any regard to whether they are a hazard or risk. Identification by size would cover not only manufactured nanomaterials but also those that are “natural (and) incidental.”
With respect to what is ‘nanoscale’ the Commission followed the definition applied by the Geneva-based International Organization for Standardization (ISO) of a size range from around one nanometer to 100 nanometers.
The most controversial aspect of the Commission’s definition is its decision to base the threshold for the classifying of a material as a nanomaterial on ‘number size distribution’ or the number of nanoparticles in relation to the total number of particles. The other option was to have a threshold derived from mass or the ratio of weight of nanoparticles to total weight of the material.
Furthermore the Commission chose a threshold of 50 percent nanoparticles for a material to be classified as nano against a one percent cut-off, which it proposed in a draft definition issued last year. This big increase in the threshold has outraged some NGOs but industry has sharply criticized it as well on the grounds that by using numbers rather than weight its scope is too wide.
“The metrics for measuring the number size distribution is the issue,” said a spokesperson for the European Chemical Industry Council, which represents manufacturers of coatings materials and has been favoring a threshold based on nanoparticle weight.
“The methodology for measuring particle numbers needs to be reproducible and consistent but we do not have one which has been validated and agreed,” the source said. “We don’t have the tools to make the definition workable. As a result materials which are being considered non-nano like pigments and fillers are being brought into the definition.”
The Commission acknowledges the absence of a standardized measurement method but argues that this should not be a barrier to a “pragmatic case-by-case approach” to the application of the definition. It has suggested that increasing knowledge about typical concentrations of nanoparticles in particular types of materials could provide a basis for measurement methods. But there is then the problem about how the potential hazards of identified nanomaterials should be assessed.
“We are concerned that new safety tests required specifically for identified nanomaterials will push up costs for materials suppliers to inacceptable levels,” said Warnon. “Producers may decide that since the tests are too expensive materials will have to be withdrawn from the market.”
The Commission’s definition is only a recommendation without legal force with the aim of helping EU and member state authorities in their implementation of legislation. This is particularly the case with REACH, the EU legislation that requires chemical producers and importers to register their substances, including coating materials, with dossiers on their safety profiles.
Legislation like REACH is unlikely to be amended to include the nanomaterials definition. Instead the definition could be applied through changes to guidance documents on the implementation of legislation and the drawing-up of REACH dossiers.
There may then be pressure from politicians and environmentalists for specific information on nanomaterials, whether they are hazardous or not, to be passed down the supply chain.
“We are worried that there may be a requirement for labelling on products to say that they contain nanomaterials,” said Warnon. “We already have individual EU member states making proposals along these lines.”
A key objective behind the Commission’s definition is more harmonization within the EU of regulatory approaches to nanomaterials. But critics of the definition claim that it is so wide in its scope that it will lead to some of the EU’s 27 members states applying their own narrower definitions in preference to the Commission’s one in order to take what they would regard as more effective action to manage perceived risks from nanomaterials.
“Countries will want to take their own measures to control risks,” said Louise Duprez, nanotechnology policy officer at the European Environmental Bureau, a Brussels-based NGO. “This will lead to even more uncertainty for industry and consumers.”
Nonetheless Cepe and other trade associations are pleased that the Commission has finally issued a definition because the absence of one was holding back product and process development.
“It’s good to have a definition, even though we’re not satisfied with it,” said Warnon. “The aim is to apply the same definition across all relevant EU legislation. So companies should at least have the benefit of more stability and consistency in the interpretation of regulations relating to nanomaterials.”