This article originally appeared in Food in Canada and is republished with the permission of the publisher.
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 ahead.