Manushvi Chadha, BPharm, RA Cert
Regulatory Affairs Associate, dicentra Inc.

Nanomaterials are engineered molecules whose defining characteristic is their size – they range from 1-100 nanometers where each nano is about the size of 3-5 atoms across. For the last few years, the use of nanotechnology has been used in the formulation of dietary supplements, cosmetics and other products with the aim of increasing absorption and efficacy of active ingredients.

The concern regarding nanomaterials stems from the fact that the particles are specifically designed to exploit their small size and consequently, their large surface area when aggregated. This causes much faster absorption in the body and can lead to uncommon risks because we are yet to learn how nanomaterials interact with human biological systems. Such materials may behave in a way completely different from bulk materials.

Regulatory bodies worldwide have taken notice of this fact and have been considering ways to deal with the challenges created by nanomaterials. There have been recent developments where regulators have formally defined the term ‘nanomaterials’. However, there is still ongoing work in regard to regulations.

Canada

Health Canada released its Policy Statement on Health Canada’s Working Definition for Nanomaterial on October 11, 2011. There was a consultation period of just over a year where comments from stakeholders were invited and have been implemented in drafting the policy.

In it, ‘Nanomaterial’ has been defined as:

Health Canada considers any manufactured substance or product and any component material, ingredient, device, or structure to be nanomaterial if:

It is at or within the nanoscale in at least one external dimension, or has internal or surface structure at the nanoscale, or;

It is smaller or larger than the nanoscale in all dimensions and exhibits one or more nanoscale properties/phenomena.

where

The term “nanoscale” means 1 to 100 nanometres, inclusive;

The term “nanoscale properties/phenomena” means properties which are attributable to size and their effects; these properties are distinguishable from the chemical or physical properties of individual atoms, individual molecules and bulk material; and,

The term “manufactured” includes engineering processes and the control of matter.

Health Canada had also added a rider saying that the definition is subject to change in case of any new research or developments in this field. They recognize that the “state of science around nanomaterials is evolving” and have pledged a flexible approach and have informed that guidance documents specific to regulatory program areas will be developed.

In their evaluation of nanomaterials, Health Canada requests the following:

• Intended use, function and purpose of the nanomaterial, and information regarding any end product in which it will be used;
• Manufacturing methods;
• Characteristics, and physical chemical properties of the nanomaterial such as:
  • composition,
  • identity,
  • purity,
  • morphology,
  • structural integrity,
  • catalytic or photo-catalytic activity,
  • particle size/size distribution,
  • electrical/mechanical/optical properties,
  • surface-to-volume ratio,
  • chemical reactivity,
  • surface area/chemistry/charge/structure/shape,
  • water solubility/dispersibility,
  • agglomeration/aggregation (or other properties), and
  • descriptions of the methods used to assign these determinations;
• Toxicological, eco-toxicological, metabolism and environmental fate data that may be both generic and specific to the nanomaterial if applicable; and,
• Risk assessment and risk management strategies, if considered or implemented.

EU

It is interesting to note that the European Commission also came out with their definition of a nanomaterial on the 18^th of October, 2011, which reads as follows:

A natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm – 100 nm.

In specific cases and where warranted by concerns for the environment, health, safety or competitiveness the number size distribution threshold of 50 % may be replaced by a threshold between 1 and 50 %.

By derogation from the above, fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm should be considered as nanomaterials.

USA

The FDA has put out a draft guidance document regarding nanotechnology as well. However, currently, they have not come up with a precise definition.

It will be interesting to watch the evolution of this nascent field of science and how regulators handle the creation of guidelines for health-based nanomaterials. However, it appears that it will be difficult to classify all nanomaterials under the same category as there is no guarantee that all nanomaterials will act and react in the same way. From another perspective, they are a door to the future and should trigger a lot of new ideas.

For further information on scientific and regulatory affairs please contact our experts at dicentra.

dicentra provides regulatory and scientific solutions for accelerated business growth. We specialize in the areas of natural health products, dietary supplements, foods, beverages, cosmetics and OTCs. We can be reached at 1-866-647-3279 or at dicentra.com
References:

1. Policy Statement on Health Canada’s Working Definition for Nanomaterial http://www.hc-sc.gc.ca/sr-sr/pubs/nano/pol-eng.php
2. What is a “nanomaterial”? European Commission breaks new ground with a common definition http://europa.eu/rapid/pressReleasesAction.do?reference=IP/11/1202&format=HTML&aged=0&language=en&guiLanguage=en
3. Draft Guidance: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/ucm257926.htm