Nanotechnology & Product Development
N a n o t e c h n o l o g y (the study of particles less than 100 nanometers in their greatest dimension) is an emerging field which is changing the regulatory landscape for the food, beverage and dietary supplement industry. While many see this new science showing promise and potential in many applications and products, it’s a science whose safe use and regulatory compliance must be fully understood before integrating into your product line.
Nanotechnology provides changes to the physical characteristics of substances and offers new possibilities that were once not possible for reasons including:
- Solubility or emulsification
- Absorption and bioavailability difficulties
- Ability to maintain controlled release into the medium or upon delivery
The changes in physical properties of substances at the nano-level, enabling these new applications, may come with a price however, as nanoparticles have a reputation for producing unforeseen toxic effects. These effects are often based on the increased ability of the nanoparticle to cross biological membranes because of their small size. Because much of the safety of currently approved substances is based on their limited ability to traverse biological membranes (such as the blood-brain barrier, placental barrier or even penetrating the gut wall), the ability of nanoparticles to easily gain entry to these normally protected areas may produce hitherto unseen toxic effects. For example, there are published data on carbon nanotubules entering the brain and liposomes selectively coalescing with mitochondria resulting in subsequent detrimental effects. Also, with such ease of penetration to entry into cells, simple excretion of nano-particles may present a problem. There are studies describing how macrophages, liver and kidney cells may become engorged with nano-particles, resulting in cell or organ failure. The bottom line is that we cannot have it both ways, we must accept the fact that the desirable changes in physical properties of substances often also results in different interactions with biological systems, not all of which are desirable.
While continuing research continues to reveal new and exciting applications of nano-sized materials, regulatory agencies have been approaching the subject of approvals of nanoparticles with great caution, as the result of the uncertainties resulting from their interaction with biological systems. Understandably, the regulatory agencies do not equate approval of non-nanoparticle substances as being readily extended to nanoparticle use of the same substance.
Burdock Group is prepared to help you make the right decisions regarding safety testing and eventual regulatory approval of your nanotechnological product. We provide complete risk assessment and solutions by assessing the safety of clients’ nanotechnology-enabled products through toxicity evaluations and offer strategies for meeting safety and regulatory requirements, shortening the time to market.
Nanotechnology Services Include:
- Regulatory Monitoring and Compliance
- Initial Nanosafety Assessment
- Toxicology Testing
- Risk Assessments
- R&D Support
- Post Regulatory Support
We have the knowledge, the experience and the network. Contact us today for your free initial consultation.