Nanomaterials

Scientific & Regulatory Affairs Services for Nanomaterials

Blue Frog Scientific provides a comprehensive range of services supporting regulatory compliance of nanoforms under the EU REACH Regulation and other regulations within which compliance is implicit.

Nanomaterials present possess novel properties compared to their bulk or ionic counterparts. These create unique opportunities to improve properties or create new technologies. Nanotechnology is known as a Key Enabling Technology (KET).   KETs are seen as crucial to the future goals of the planet; these include pollution reduction, clean water and treatments for key elements in the global burden of disease such as cancer, cardiovascular disease, Alzheimer’s disease and COVID-19.  In fact, one COVID-19 vaccine uses lipid nanocapsules to aid in protection and delivery of their mRNA technology.  

Because the properties of nanoforms are significantly different to other larger forms of the same material,  specific Annexes of the REACH regulation (Commission Regulation (EC) No. 2018/1881 and Commission Regulation (EC) 2020/878). Ongoing research by EU funded projects is working to develop guidance documents and test guidelines (via the OECD)  to support information requirements and assessment procedures for nanoforms.  Representing other key regulations such as plant protection regulation (Commission Regulation (EC) 1107/2008)),  EFSA  continues to work toward a unified approach by issuing and updating  guidance, though no formal changes have yet been made these regulations.

In Europe, we are on the precipice of a movement where all regulations will adapt to formally include nanoform requirements. As such it is essential to remain up to date with the movement of regulatory affairs in the area to ensure continued access to the market for nanoforms and the seamless transition to compliance  as frameworks are updated.

As regulations for nanotechnology is a work-in-progress and subject to significant evolution with time it is essential that registrants of nanomaterials consider the most up-to-date scientific principles when testing and assessing nanoforms beyond that currently detailed in the guidance, to ensure longevity of their dossiers.  Blue Frog Scientific continues to hold a strong position at the interface of academia, industry and regulation; being we are able not only to offer a comprehensive dossier compilation service to our clients, but are also involved in key EU projects such as NanoFASE and GRACIOUS as expert advisers or key stakeholders.

As current approaches to nanomaterials are fluid and subject to change, as such the services we offer are highly specialised, and constantly adapt to new research and implementations within regulatory frameworks. Our team of experts are equipped to tackle any problems.

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