Nanomaterials require assessment on a "case-by-case basis".
The European Commission has confirmed its view that REACH sets the best possible framework for the risk management of nanomaterials when they occur in substances or mixtures. This follows the Commission's Second Regulatory Review of nanomaterials, and the adoption of its Communication on that review on 3 October 2012. However, the Commission has recommended that changes should be made to the existing REACH framework to introduce specific requirements for nanomaterials.
The Commission reported that nanomaterials require risk assessment on a case-by-case basis, as other substances do, as the risks are specific to the particular nanomaterial and its use.
The Commission also noted that specific provisions for nanomaterials have already been introduced for biocides, cosmetics, food additives, food labelling and materials in contact with foodstuffs and that further market surveillance and assessments in these areas is planned or ongoing.
Changes required to REACH
The review noted that a small number of REACH registrations voluntarily included "nanomaterial" as the form of the substance. However, many registrations for substances known to have nanomaterial forms do not mention clearly which forms are covered by the registrations or how the information relates to nanomaterials. Findings such as this have prompted the Commission to recommend changes to REACH to specifically address nanomaterials.
The Commission recommended that modifications to the Annexes of REACH is required and encouraged ECHA to further develop guidance for registrations after 2013.
The Commission concludes that it will continue to follow carefully developments relating to nanomaterials and report back within 3 years. The review also sets out follow up actions including:-
- Setting up a web platform for nanomaterial information with references to all relevant information sources, including registries on a national or sector level.
- Gaining more experience from the evaluation of registrations before ECHA can provide guidance on whether nanomaterials can be treated as the same or distinct from the bulk form of a particular substance.
- Considering to what extent data from one form of a substance can be used to demonstrate the safety of another form which will require assessment on a case by case basis.
- Reviewing the nanomaterial definition in 2014.
As a result of the Commission's conclusion that the current REACH regime sets the best possible framework for regulating nanomaterials we now have an idea of the direction that nanomaterials regulation will take. However the debate continues on a number of issues, including how nanomaterials should be treated within REACH. We anticipate that it will still be some time before we know exactly what changes will be made to REACH to address nanomaterials specifically.
In the meantime, the special characteristics of nanomaterials due to their small particle size means that they are being put to an increasing range of innovative uses from cosmetics to electronics, textiles and food packaging. Products underpinned by nanotechnology are forecast to grow from a global volume of €200 billion in 2009 to €2 trillion by 2015. However, the expansion of the use of these materials and the novel uses to which they are being put to means EU policy makers continue to monitor their use closely.