Israel Grants the World’s First Regulatory Approval for Cultivated Beef
On January 17, 2024, the Israeli Ministry of Health (MOH) announced[1] its regulatory approval of the world’s first cultivated beef product produced by the local company – Aleph Farms. This marks another significant regulatory advancement in the cultivated meat sector, following the prior approvals of cultivated chicken products by the authorities in Singapore and the U.S.
Based on the announcement, MOH conducted the evaluation of Aleph Farms’ beef products from cells sourced from cattle under the regulatory framework of “novel food” in Israel. Aleph Farms indicated[2] that they have received the approval in the form of a “No Questions” letter. It is worth noting that Israel operates a website[3] listing food ingredients/foods approved and registered as novel foods. Per our review, it appears that the government has not yet provided additional details regarding the approved cultivated beef (e.g., manufacturing process and product specifications are not made available).
In Israel, there is an application process for novel food, requiring one to submit a list of materials, e.g., safety data, allergens, nutritional composition, etc., demonstrating the safety of the product for human consumption before marketing the product in the country. More details regarding Israel’s novel food process can be found in our prior newsletter – Israel Approves the First Animal-Free Protein for Food Use. In this case, the announcement indicated that the local government reviewed the cultivated beef product and issued the approval after conducting a comprehensive assessment of factors throughout the entire production process, e.g., toxicology, microbiological safety, chemical safety, etc.
Notably, in Israel, obtaining a manufacturers license for a food facility is required for local food production. To this end, MOH established a database listing approved local food facilities, and companies should obtain such a license before the commercial production of their food products in Israel.[4]
From approving the first animal-free protein for food use in early 2023[5] to Aleph Farms’ recent success under the regulatory framework of novel foods, Israel is clearly taking an active and proactive stance in driving the development of alternative proteins in the country. For cultured meat companies seeking to enter the Middle East market, Israel proves to be a viable starting point.
We assist our clients in submitting novel food applications for the approval of their alternative protein foods around the world, as well as strategizing market-entry plans. If you need any assistance or have any questions on the above, please do not hesitate to contact David Ettinger (ettinger@khlaw.com), Jenny Xin Li (li@khlaw.com), or your existing contact at Keller and Heckman LLP.
[1] https://www.gov.il/he/departments/news/17012024-02
[2] https://aleph-farms.com/journals/aleph-farms-granted-worlds-first-regulatory-approval-for-cultivated-beef/
[3] https://www.gov.il/he/Departments/DynamicCollectors/fcs-regulations?skip=0&fcs_regulations_subject=7
[4] https://www.gov.il/he/departments/dynamiccollectors/fcs-manufacturer?skip=0
[5] More details regarding this approval can be found in our newsletter – Israel Approves the First Animal-Free Protein for Food Use, available at: https://www.khlaw.com/insights/israel-approves-first-animal-free-protein-food-use