... and a continuing focus on carbon nanotubes, nano-Silver, and TiO₂

 

Mandatory reporting is all the rage:
The US EPA is working on an elaborate mandatory data collection and data development regulation, which is expected to be launched later this year (or early in 2011) (together with a revised definition of ‘molecular identity’), while

France is currently developing a compulsory reporting scheme on nanomaterials (according to Art.73 Grenelle law 2), which is expected to be launched in 2010, and

in Norway, the Pollution Control Authority (SFT) has announced plans to establish a mandatory reporting scheme of the use of nanomaterials in chemical products.

In Australia, a tiered mandatory reporting scheme and mandatory notification and assessment scheme have been suggested as part of the ‘Proposal for Regulatory Reform of Industrial Nanomaterials’, while

in Canada, we are still waiting for the publication of the ‘Data Survey on Nanomaterials’, which Environment Canada and Health Canada had initially announced for September 2008.

On the European level, mandatory reporting schemes and inventories of nanotech-enabled products find significant support amongst many stakeholder (and expert) groups, but it’s not always clear which one of the two is being requested. The European Commission ‘has not made up its mind on how precisely to get the information needed’, but it has ‘no plans to introduce a reporting scheme additional to REACH requirements. [...] any efforts to gather information on nanomaterials should consider the internal market and should ideally be aligned and coordinated.’ (Note: cf. the mandatory reporting scheme prepared by France.)

 

Regulations & Legislations have been proposed:
Of the above list, Australia’s jurisdiction is the first one to have proposed detailed changes of the legislation, in order to create a broad nano-specific regulatory cover, while other governments have started to review existing application-specific regulations (predominantly chemicals regulations) with regard to their applicability to nanomaterials in the relevant products:

In 2009, Europe set the precedence of passing the first product-specific regulation (i.e. European Cosmetics Regulation) to specify particular safety requirements on nanomaterials contents, including the notification and labelling of nanomaterials in cosmetic products.

A similar set of nano-specific requirements has been drafted into the European Novel Foods Regulation, which is awaiting its 2^nd Reading in Parliament; NOTE: there is a strong push to demand the ‘nano’-label to be placed on the front of the food container, effectively making it a warning-label.

Europe is furthermore in the process with reviewing both the European Biocides Directive (98/8/EC), as well as the European RoHS – and WEEE-Directives, for which the explicit inclusion of ‘nanomaterials’ is also foreseen by the European Parliament.

Following the European Parliament’s ‘own initiative report’ (April 2009), demanding Community legislation on labelling, notification, and ‘no data – no market’-principles to be created and enforced on products containing nanomaterials, the United States is now experiencing the introduction of the ‘Nanotechnology Safety Act of 2010’ into US Senate.

 

Risk Assessment is getting specific and 'applied':
Meanwhile, there is a strong drive to move the generic nanomaterials Risk Assessment exercises conducted during the last years (and invariably resulting in the recommendation of case-by-case approaches) towards focussed application-specific studies with (potential) regulatory relevance. We saw the first example of this during the 2^nd half of 2009:

• The OECD Working Party on Manufactured Nanomaterials (WPMN) (Steering Group 6 on ‘Co-Operation on Risk Assessment’) and the Society for Risk Analysis (SRA) held a workshop on Risk Assessment in a Regulatory Context (16^th – 18^th September 2009, Washington D.C., US), during which specific RA case studies of nano-TiO₂, carbon nanotubes, and nano-silver.
• The annual ‘Nano Safety for Success’-workshop held by European Commission DG SANCO was organised around industry case studies products containing nano-TiO₂, carbon nanotubes, and nano-silver.

Within the European Union, the drive for optimisation of risk assessment approaches towards the requirements and information of risk managers has been enforced in a new mandate of the European Commission’s scientific committees.

 

2010 will be a very important year for the future of nanotechnologies; the Nanotechnology Industries Association is linked in to represent the industries in all of the above and many more activities and initiative. 

We are looking forward to working with you on securing the continuing advancement of nanotechnologies.

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