Nanomaterials must be assessed on case to case basis - EC
In their second regulatory review on nanomaterials the EC said they are similar to normal chemicals/substances in that some may be toxic and some may not.
The commission said it was currently working on detection, measurement and monitoring methods for nanomaterials and their validation to ensure the proper implementation of the definition.
Approved substances
Silicon dioxide, carbon black and titanium nitride have been authorised for use in plastic food contact materials and further assessments will be made as the case arises.
Current risk assessment methods are applicable, even if work on particular aspects of risk assessment is still required, said the review.
“Detecting nanomaterials in complex matrices such as cosmetics, food, waste, soil, water or sludge is even more challenging. While some monitoring methods exist, these often remain to be validated, which hampers comparability of data,” it said.
The EC admitted there are “certain limitations” in assessment. In particular, these included the need for a case-by-case scientific approach when analysing differences between bulk and various nanoforms of the same chemical substance. But the Commission stressed it is currently possible to perform risk assessments of nanomaterials.
It said applicable legislation must ensure a high level of health, safety and environmental protection but also permit access to innovative products and promote innovation and competitiveness.
The total annual quantity of nanomaterials on the market at the global level is estimated at around 11 million tonnes, with a market value of roughly €20bn, according to the Commission Staff Working Paper (SWP) on Nanomaterial Types and Uses.
In a 2011 scientific opinion, EFSA confirmed that the risk assessment paradigm used for the evaluation of standard food products is also appropriate for nanomaterial applications in the food and feed chain and the need for a case by case approach.
The review follows up the 2008 Commission Communication on regulatory aspects of nanomaterials.
Risk management
The review concluded: “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.
“The Commission envisages modifications in some of the REACH Annexes and encourages ECHA to further develop guidance for registrations after 2013.”
It added it will follow developments and report back to the Parliament, the Council and the European Economic and Social Committee within three years.
