This article originally appeared in Food in
Canada and is republished with the permission of the
3D printing is the new buzz technology being used to replicate
human tissues, fighter jet parts, and human prosthetics. The
technology is also showing excellent potential in the food industry
to create personalized foods that meet specific dietary needs for
the elderly, individuals with digestive disorders and
gastro-intestinal disease, and athletes. It can also be used to
streamline food production and offer customizable dietary solutions
at lower costs. At this point, the entire Food Guide can be created
by pushing a button, including edible meat, cheese, fruit, and
vegetable. While this technology holds great promise, is the
Canadian food regulatory system prepared for the ethical and legal
implications associated with 3D printing?
The regulatory framework for 3D printed medical devices is more
advanced and several devices have already been approved by the US
FDA. In May 2016, the US FDA released Draft Technical Guidance on
“Additive Manufactured Devices”, which is synonymous
with 3D printing to help manufacturers understand and comment on
the government’s position with respect to testing and device
characterization requirements. This Draft Technical Guidance
touches on several elements that may also be applicable to foods,
including software formatting, labelling, starting material
composition and recycling, process validation, cleaning, and
sterilization. While the 3D printed food legal framework is still
in its infancy, it is important for innovative food companies to
take a broader look at what type of regulatory barriers already
exist for new technologies and ingredients in Canada and how they
may be applied to 3D technology.
Broadly speaking, a novel food application will more than likely
be required for foods or ingredients made using 3D technology. A
“novel food” is defined in the Food & Drug
Regulations as a substance that does not have a history of
safe use; has been manufactured, prepared, preserved, or packaged
by a process that has not been previously applied to that food, and
causes the food to undergo a major change; or genetically modified.
Since 3D printing is innovative and does not have a history of safe
use, pre-market approval by Health Canada should be considered
prior to advertising or selling in Canada. Novel food applications
typically require safety and efficacy evidence that explore dietary
exposures, nutrient content, toxicology, chemical, microbiological,
and allergenicity considerations. Although Health Canada is making
efforts to improve the novel food assessment process, the timelines
for approval can vary from six months to two years (or longer). If
you are planning to use 3D technology in your business, it is
important to remember this significant regulatory hurdle.
New food additives may also be required for 3D printers due to
challenges associated with the shelf life and adhesion. A food
additive is any chemical substance that is non-nutritive and is
added during preparation or storage and either becomes a part of
the food or affects its characteristics for the purpose of
achieving a particular technical effect. New food additives also
require pre-market safety and efficacy approval by Health Canada
and can follow similar approval timelines as novel foods.
Food companies should also consider the need for good
manufacturing practices (“GMPs”)
for the unique nature of 3D printing, especially for the highly
regulated sectors of fruit, vegetable, fish, dairy, and meat. GMPs
will become even more important when the Safe Food For
Canadians Act is fully in force and preventative control plans
are mandated for all foods.
From the consumer perspective, will they want to know that their
food has been created using 3D technology? Will there be a similar
push for 3D technology labels as there is for GMO?
Only time will tell how Canada will regulate these 3D printed
foods. While companies may wish to stay ahead of the curve, it is
prudent to be mindful of the regulatory barriers, including food
safety requirements, marketing authorizations, labelling, and
intellectual property issues, prior to printing full steam
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
To print this article, all you need is to be registered on Mondaq.com.
Click to Login as an existing user or Register so you can print this article.
The prospect of an internal investigation raises many thorny issues. This presentation will canvass some of the potential triggering events, and discuss how to structure an investigation, retain forensic assistance and manage the inevitable ethical issues that will arise.
From the boardroom to the shop floor, effective organizations recognize the value of having a diverse workplace. This presentation will explore effective strategies to promote diversity, defeat bias and encourage a broader community outlook.
Staying local but going global presents its challenges. Gowling WLG lawyers offer an international roundtable on doing business in the U.K., France, Germany, China and Russia. This three-hour session will videoconference in lawyers from around the world to discuss business and intellectual property hurdles.
Effective September 1, 2016, the Disposition of Surplus Real Property Regulation to the Ontario Education Act was amended with the intention to reduce barriers to the formation of health and community hubs in Ontario.
This appeal relates to two generic drug submissions for two different products: exemestane and infliximab. Both submissions cross-referenced the submission of another generic company that had received a Notice of Compliance.
Two recent decisions from the Supreme Court of Canada directly affect Quebec's farm businesses by confirming La Financière Agricole du Québec's discretion in the administration of the farm income stabilization program...
On October 6, 2016, the Ontario Legislature reintroduced the Patients First Act, 2016 as Bill 41. Bill 41 is very similar to its predecessor, Bill 210, which was introduced in June 2016, but makes some important changes to the previous bill.
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).