培養肉をめぐる米欧の規制動向と今後の課題
Regulatory Trends and Future Issues in the US and the EU Concerning Cultured Meat

立川 雅司
Masashi Tachikawa

日本知財学会誌Vol.19 No.2 p.18-25 (2022-12-20)
Journal of Intellectual Property Association of Japan Vol.19 No.2 p.18-25 (2022-12-20)

＜要旨＞
代替タンパクに対する期待が寄せられるなか，培養肉に関しては，従来の食肉との区別や安全性審査，表示など，様々な規制が関わる可能性がある．本稿ではアメリカとEUにおける培養肉をめぐる規制動向に関して概観し，今後の課題を論じた．アメリカでは2019年にFDAとUSDAとの合意がなされ，「収穫前」をFDA が，「収穫後」をUSDAが所管することとなり，官報で情報提供を求めた．しかし，「肉」としての表示をめぐり多数の反対意見が寄せられたことで，表示ルールの制定にはなお時間がかかる見通しである．EUにおいては，新規食品規則が改訂され培養肉が位置づけられたものの，食品情報規則上は，「肉」として表示することが困難であり，アメリカと同様，表示ルールをめぐって今後の検討が必要である．透明性規則の導入などでEFSAでのリスク評価手続きが改善される動きもみられるものの，EUにおいても培養肉の上市にはなお時間がかかることが予想される．
<Abstract>
While there are high expectations for alternative proteins, cultured meat may be subject to various regulations, such as distinction from conventional meat, risk management, and labeling. This paper reviews the regulatory trends surrounding cultured meat in the US and EU, and discusses future issues. In the US, an agreement　between the FDA and USDA was reached in 2019, with the FDA having jurisdiction over “pre-harvest” and the USDA over“post-harvest.”Both Departments requested public comments in the Federal Register. The establishment of labeling rules is expected to take more time due to the large number of objections received regarding the labeling of　cultured meat as“meat.”In the EU, although the Novel Food Regulation was revised and food from cell culture was included, it is difficult to label it as “meat” under the Food Information Regulations, and, as in the US, there is still a need for further study on labeling rules. Although there are moves to improve the risk assessment procedures at the　EFSA by introducing transparency rules, it is expected that it will take more time before cultured meat can be placed on the market in the EU.

＜キーワード＞
培養肉, 規制, アメリカ, EU
<Keywords>
Cultured meat, Regulation, USA, EU