Which regulatory approvals are required in Canada for selling meat from cloned animals or their offspring?
This fact-check may be outdated. Consider refreshing it to get the most current information.
Executive summary
Canada’s food regulators historically treated meat from somatic cell nuclear transfer (SCNT) cloned cattle and swine — and their offspring — as “novel foods” requiring a pre-market safety assessment under Health Canada’s Novel Foods framework, but recent policy work by Health Canada and the Canadian Food Inspection Agency (CFIA) proposed removing cloned cattle and swine (and their offspring) from that definition, which would eliminate mandatory pre-market reviews and labeling for those species if implemented [1] [2]. Until any formal change is finalized, Health Canada says foods from cloned cattle and swine remain subject to the novel food assessment and there are currently no approved cloned-food products on the Canadian market [1] [3].
1. Which approval is currently required: the Novel Foods pre-market safety assessment
Since the early 2000s, foods derived from cloned animals were handled as novel foods, meaning producers had to submit detailed safety information and undergo a pre-market safety assessment to legally sell such foods in Canada — a position Health Canada reaffirmed while it reviewed the scientific literature on SCNT clones and their offspring [1] [4]. Health Canada’s public consultation materials state explicitly that, until the policy is updated, cloned-cattle and -swine-derived foods will continue to be subject to the novel food assessment, and that no cloned-derived foods have yet been approved for sale [1].
2. What the proposed policy change would remove — and what that would mean in practice
Documents and reporting indicate Health Canada, working with CFIA and Agriculture and Agri-Food Canada, produced a scientific opinion concluding foods from cloned cattle and swine and their progeny are compositionally equivalent and do not present greater risks than conventional foods; the agencies therefore proposed excluding those animals from the novel-food definition, which would remove the requirement for mandatory pre-market safety assessments and would allow such meat to be sold without special labeling or ministerial approval for those species [5] [2] [4]. Multiple industry and media accounts interpret that regulatory shift to mean beef and pork from cloned animals — and their offspring — could enter the Canadian food supply without review or disclosure if the change is finalized [6] [7].
3. Parallel environmental/organism rules still apply: CEPA and new-substance notifications
Even as the food-framework stance shifts, SCNT animal clones and their offspring are classified under the Canadian Environmental Protection Act (CEPA) as “new” living organisms, which triggers obligations under the New Substances Notification Regulations and other CEPA-related assessment processes for import or manufacture of such organisms — a regulatory track separate from the Novel Foods framework and noted in Health Canada and CFIA materials [1] [4]. Thus, regulatory oversight is not monolithic: food-safety pre-market review and environmental/new‑organism notifications sit in different statutes and can both affect commercialization pathways [1] [4].
4. The current status: pause, consultation and market reality
Following public pushback and stakeholder feedback, Health Canada announced a pause or extended consultation on the proposed update, noting it will consider science-based comments before taking a final decision and reiterating that no cloned-food products are currently approved for sale in Canada [8] [1] [3]. Several producers and advocacy groups — notably duBreton — have publicly urged voluntary labeling and called for clearer engagement with consumers, while Health Canada and CFIA argue the science supports equivalence for cattle and swine [2] [5] [8].
5. Practical takeaway and outstanding limits in reporting
Practically, the required approvals today remain the Novel Foods pre-market safety assessment for cloned cattle and swine products, plus any CEPA/new‑substance notifications for clones as organisms, but those food-review requirements are the subject of a proposed policy change that would remove them for cattle and swine if finalized; Health Canada has paused to gather further input and warns there are currently no approved cloned-foods in the market [1] [4] [8]. Reporting shows clear disagreements: government scientists and some industry sources point to scientific equivalence as the rationale for deregulation, while organic producers and public-interest groups frame the move as a transparency and consumer‑trust problem — and the sources do not provide independent verification of long-term population-level or multi‑generation impacts, an evidence gap Health Canada says it considered in its scientific review but which critics highlight as unresolved [5] [9] [4].