EC to adopt case-by-case assessment of nanomaterials as 2nd regulatory review is announced

Nanotechnology is delivering major advances today and also has the potential to allow ‘game changing’ technological breakthroughs and rekindle economic growth, according to the EC; prompting the second review.

Nanomaterials are diverse in nature and types, ranging from everyday materials that have been used safely for decades to highly sophisticated industrial materials, making it difficult to regulate if all grouped together.

Case-by-case​

There is also an increasing body of information on the hazard properties of nanomaterials, which are difficult to generalize and justify specific risk assessments.

“Nanomaterials require a risk assessment, which should be performed on a case-by-case basis, using pertinent information. Current risk assessment methods are applicable, even if work on particular aspects of risk assessment is still required,”​ says the EC’s communication.

Overall the Commission remains convinced that REACH sets the best possible framework for the risk management of nanomaterials when they occur as substances or mixtures but more specific requirements for nanomaterials within the framework have proven necessary.

It envisages modifications in some of the REACH Annexes and encourages ECHA to further develop guidance for registrations after 2013.

Looking ahead​

In order to improve availability of information on nanomaterials, the Commission will create a web platform with references to all relevant information sources, including registries on a national or sector level, where they exist.

In parallel, it will launch an impact assessment to identify and develop the most adequate means to increase transparency and ensure regulatory oversight, including an in-depth analysis of the data gathering needs for such purpose.

This analysis will include those nanomaterials currently falling outside existing notification, registration or authorization schemes.