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Research and Development
Johnson & Johnson Guidelines: Responsible Use of Nanotechnology

Background

Nanotechnology is an emerging field of science that involves the manipulation of matter at the molecular or atomic level, between 1 and 100 nanometers. A nanometer equals one billionth of a meter, a size so small it is not visible to the human eye without a microscope. Nanotechnologies encompass an extremely broad range of technologies, from well understood micronized materials used in consumer sunscreen applications, to coatings that change the behavior of substrates, to buckyballs/nano tubes, and to nanomilled pharmaceuticals. Many questions about nanotechnology remain unanswered. As research brings more clarity, and in consideration of risks and benefits, Johnson & Johnson has set forth the following Guidelines for Responsible Use of Nanotechnology. These standards provide a general framework for Johnson & Johnson Operating Companies to use in parallel with relevant international, national and local laws.


Johnson & Johnson Guidelines for Responsible Use of Nanotechnology

The Johnson & Johnson Family of Companies has robust product stewardship programs and a rigorous, data-based approach for risk assessment and selection of ingredients and materials. All ingredients and their individual safety data (i.e. environmental effects, human health, physical and chemical properties), as well as data from external scientific authorities, are reviewed by medical doctors, toxicologists or other experts prior to use in a product. Processes used in research, development and manufacture of a product also undergo technical review by industrial hygiene and process safety experts. With respect to responsible use of nanotechnology, each Johnson & Johnson Operating Company should:

  1. Ensure that the responsibility for guiding and managing involvement with nanotechnologies resides with an appropriate governing body.
  2. Seek input from key stakeholders and evaluate these inputs in development or use of products using nanotechnologies.
  3. Identify and minimize sources of risk for workers handling products using nanotechnologies, at all stages in the discovery/research and production processes or in industrial use, to ensure high standards of occupational and environmental health and safety.
  4. Carry out thorough risk assessments and minimize any potential human health, safety and environmental risks relating to its products using nanotechnologies.
  5. Consider and respond to any social and ethical implications and impacts in the development or sale of products using nanotechnologies.
  6. Adopt responsible practice in the sales and marketing of products using nanotechnologies.
  7. Consider the sustainability of nanomaterials.
  8. Engage with suppliers and/or business partners to assure there are no conflicts with these guidelines.


Defining Nanomaterial

There is no universally accepted definition of nanotechnology or nanomaterials. Johnson & Johnson uses the following definition that is consistent with but not identical to definitions adopted by regulatory authorities in North America and the EU.

Nanomaterials are intentionally manufactured, solid, insoluble particulate substances either in powder form, as dispersions or as aerosols on the order of 1 to 100 nm (i) which contain, when measured by standardized and recognized methods, at least 10 wt.-% of nano-objects, or (ii) which have, when measured by appropriate methods, a volume specific surface area larger than 6 x 1/100 nm (60 m2/cm3).

The term “nanoscale phenomena” references the properties of the product, material, substance, ingredient, device, system or structure which are attributable to its size and enable scientists to utilize the unique chemical or physical properties that naturally occur at that scale.

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References

Auffan, M. et al. 2009. ‘Towards a definition of inorganic nanoparticles from an environmental, health and safety perspective,’ Nature Nanotechnology 4: 634-641.

Bergeson, L.L. 2008. Nano Opportunities & Risks. Environmental Claims J. 20: 144-159.

Berube, D.M. 2008. Rhetorical gamesmanship in the nano debates. J. Nanoparticle Research.

BIAC Nanotechnology Committee, ‘Responsible Development of Nanotechnology: Turning Vision into Reality,’ February 2013.

Commission of the European Communities, ‘Commission recommendation on a code of conduct for responsible nanosciences and nanotechnologies research,’ 2008.

Commission of the European Communities, ‘Commission recommendations on the definition of a nanomaterial,’ 2011.

Commonwealth of Australia Consolidated Acts, ‘Industrial Chemicals (Notification and Assessment) Act,’ 1989.

Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Science (OPS) Manual of Policies and Procedures (MAPP), Reporting Format for Nanotechnology-Related Information in CMC Review, 2010.

Food and Drug Administration (FDA), ‘Considering Whether and FDA-Regulated Product Involves the Application of Nanotechnology,’ Draft Guidance 2011.

Health Canada, Policy Statement on Health Canada’s Working Definition for Nanomaterials, October 2011.

OECD WPMN Publication Number 25: ‘Guidance Manual for the Testing of Manufactured Nanomaterials: OECD Sponsorship Programme: First Revision’ (ENV/JM/MONO(2009)20/REV, 2nd June, 2010)

United States, Memorandum for the Heads of Executive Departments and Agencies, ‘Principles for Regulation and Oversight of Emerging Technologies,’ 2011.

United States, Memorandum for the Heads of Executive Departments and Agencies, ‘Policy Principles for the U.S. Decision-Making Concerning the Regulation and Oversight of Applications of nanotechnology and Nanomaterials,’ 2011.

“VCI position on the definition of the term ‘nanomaterial’ for use in regulations laying down provisions on substances;” German Chemical Industries Association (Verband der Chemischen Industrie) (February 2010).

Last Updated: April 2017 | Download the PDF