The European Commission is being called on to close up 'loopholes' in its nanomaterial regulation by establishing a new stand-alone piece of legislation, to clear up and provide in more detail, information that failed to be provided in its second regulatory review last month.
According to the Center for International Environmental Law (CIEL), ClientEarth and Friends of the Earth Germany (BUND)- the NGOs behind the "nano patch" proposal said to be backed by several EU members: “The loopholes make REACH virtually useless for assessing and regulating nanomaterials."
REACH is responsible for addressing the safety risks of nanomaterials and ensuring that adverse effects from their use are minimised, while also evaluating and validating data submitted, and providing knowledge on the technology.
In 2010, its first communication concluded that; "Knowledge on essential questions such as characterisation of nanomaterials, their hazards,exposure, risk assessment and risk management should be improved."
While a second, published last month similarly announced that: "Important challenges relate primarily to establishing validated methods and instrumentation for detection, characterization, and analysis, completing information on hazards of nanomaterials and developing methods to assess exposure to nanomaterials."
To this, David Azoulay of CIEL told CosmeticsDesign-Europe.com that there is still “no evidence that the knowledge gap around nanomaterials has been filled or that the implementation of these instruments has been adapted to address the risk from nanomaterials.”
And that the current legislation provides “virtually no information whatsoever to regulators, let alone the public, on hazards, uses and risk management measures relating to nanomaterials.”
Thus, Azoulay and his collegues are calling for nanomaterials to be considered distinct from their counterparts above the nanoscale and suggests substantially lower volume thresholds for registration of substances at the nanoscale.
"If this legislation were adopted, it would set common principles for the regulation of nanomaterials and complement existing regulations to make them 'nano fit', particularly REACH, as the cornerstone of EU chemical regulations," he explains.
Azoulay further reveals that various industries have been waiting since 2008 for the Commission to publish its opinion on nanomaterial regulation, and that last month, although meeting its deadline, revealed only minor amendments to REACH annexes.
“If we are serious about addressing the potential risks of nanomaterials, we must close these loopholes, and our proposal suggests how it can be done."
Meanwhile, Vito Buonsante of ClientEarth adds that "Although the Commission admitted the failure of existing legislation to provide data on nanomaterials, it confirmed its reluctance to act to remove the obstacles to the effective protection of EU citizens by refusing to consider the necessary adaptation of the regulation."
Azoulay concludes by telling this publication that the NGOs are awaiting an official response after pitching the idea back in April. "They have declared that they will review the proposal and get in touch with a decision. If they reject the idea, - come 2018 we feel the same issues will still remain and it will be well into 2020 by the time we see any changes."