Nanotechnology

Nanomaterials are considered as substances and their evolving regulation as chemicals has created complex regulatory questions. Our combined understanding of these regulatory requirements and the underlying scientific specificities of defining nanomaterials assist our clients in understanding the regulatory context and establishing compliance with the relevant rules. As the use of nanotechnologies impacts an ever increasing variety of highly regulated consumer products including food ingredients and packaging, cosmetics, medical devices, antimicrobials, pesticides, and drugs, detailed knowledge of these evolving regulatory requirements is also critical to downstream users of nanomaterials. Steptoe supports its clients in their efforts to harvest the possibility of the revolutionary advances and tremendous benefits of these new technologies while safeguarding that the health and environmental impact of nanomaterials are properly understood and controlled. We work to establish a regulatory environment which supports the safety of workers, safety of transport within the industrial chain, safety of final consumers and controls the impact on the environment. While we understand these needs we also engage in discussions with the regulators and industry to devise voluntary schemes that demonstrate compliance without stifling innovation or creating obstacles that inhibit bringing new products to market. 

Our team has developed a wealth of experience in this space in the last two decades:

• We are evaluating the compliance of nanomaterials and nanotechnology-enabled products with the chemical regulatory (REACH and EPA) and other product specific regulatory requirements.
• We support our clients in preparing risk assessments of their applications of nanomaterials and support them against unjustified reporting requirements from authorities; in front of the Board of Appeal of ECHA.
• We prepare submissions to authorities, including the FDA, supporting the safety of certain specific applications of nanomaterials in consumer products (food and food contact materials, cosmetics, food additives, medical devices etc.).
• We are contributing to the development of guidance documents supporting the evolving regulations in the European Union.
• We help companies with voluntary and mandatory reporting requirements and related IP, liability, insurance, and other issues.
• We are supporting product stewardship efforts related to nanotechnologies, including efficient communication strategies to the authorities and in the supply chain.