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3M Europe, Solvay S.A., and other companies that produce chemicals at the nano-scale would have to provide the European Chemicals Agency more detailed information on their products under a draft European Union regulation.
The EU’s draft regulation seeks more information about the toxicological risks and safe-use data of nano-scale chemicals, which could impose more testing and reporting costs on chemical manufacturers. Until now, there has been no requirement under the EU’s overarching REACH chemicals law to provide nano-specific information separate from data on the same substances at normal scale when chemicals are registered.
The proposed regulation is important because chemical makers currently report “very little nano-specific information,” despite “extensive efforts” to get more data, the European Chemicals Agency said.
A variety of other companies would be required to provide the additional information, said David Carlander, regulatory affairs director of the Nanotechnology Industries Association, which represents companies such as 3M Europe and Solvay.
“If you are a company producing a powder more or less of any kind you would have to check if you are producing a nanoform to understand if you fall under these new provisions,” he told Bloomberg BNA.
For example, companies producing pigments in powder form would be “very much impacted” by the regulation, though “not all pigments are nanomaterials,” Carlander said.
3M Europe declined to comment and Solvay S.A. did not respond to a Bloomberg BNA request for comment.
Once finalized, the draft regulation’s provisions on providing more information on nanomaterials—defined as materials that range in size from 1 nanometer to 100 nanometers—in REACH registration dossiers would take effect Jan. 1, 2020.
Companies would be “very strongly advised” to check and update if necessary their REACH registration dossiers ahead of the requirements taking effect, Carlander said.
The requirements of the draft regulation “might raise compliance costs” but in general the Nanotechnology Industries Association welcomed the draft regulation because it would clarify what the European Chemicals Agency can ask companies to provide in terms of information on nanomaterials, Carlander said.
How much the draft regulation could cost companies is still unclear and the European Chemical Industry Council said it was still evaluating the proposal’s effects.
The draft regulation is “a welcome step” and would “further increase transparency and demonstrate the safety of nanomaterials,” Maria Linkova-Nijs, a spokeswoman for the European Chemical Industry Council, told Bloomberg BNA.
The additional testing and reporting requirements still have to be approved by a regulatory committee. The draft regulation is out for public comment until Nov. 6.
There is a risk the draft regulation could impose requirements on companies to provide information about nanomaterials when the science of nanomaterials is still developing and techniques to derive the required information might not yet be available, Anthony Bochon, a senior associate with law firm Squire Patton Boggs in Brussels, told Bloomberg BNA.
“Certain methodologies don’t exist today. We are still waiting for tools. We are still waiting for protocols. There are a lot of uncertainties,” Bochon said.
Companies that could be affected by the additional information requirements should comment on the draft regulation by the Nov. 6 deadline if they have any particular concerns about their technical ability to provide the nano-specific information, he said.
The delay until 2020 before the draft regulation would take effect would give some time for scientific developments to better characterize and identity the hazards of nanomaterials, Bochon added.
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The draft EU regulation on information on nanomaterials is available at http://bit.ly/2yGmz6x.
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