健康被害の報告義務化　品質管理基準導入も―機能性食品見直し方針・政府

　政府は３１日、小林製薬の紅麹（べにこうじ）製品を巡る健康被害問題を受け、機能性表示食品制度の見直し方針を関係閣僚会議でまとめた。事業者に対する健康被害情報の報告義務化や、品質管理基準の導入などが柱。消費者庁と厚生労働省は今後、食品表示法、食品衛生法に関連する省令などの改正を進める。
　機能性表示食品制度では、事業者が安全性や機能性の科学的根拠などを国に届け出ることで、企業の責任として機能性を表示して販売できる。特定保健用食品（トクホ）と異なり国の審査は不要なため、安全性などの根拠が不明確との指摘が出ていた。
　見直し方針では、健康被害の拡大防止のため、重篤度に応じて何日以内に報告するかなど明確なルールを設け、速やかな被害報告を義務付ける。違反すると機能性表示をできなくさせたり、営業禁止などの行政処分を出したりできるようにする。（2024/05/31-19:13）

The Japanese government compiled Friday a plan to overhaul the system allowing foods to be labeled as having specific functions on health, following a string of health issues caused by Kobayashi Pharmaceutical Co.'s dietary supplements containing "beni koji" red yeast rice.
   Key measures in the review of the foods with function claims system include obliging businesses to report health problems caused by such foods and introducing for them quality management standards currently required for drugs.
   The Consumer Affairs Agency and the health ministry plan to revise related ordinances and other regulations.
   Under the current system, companies can market foods with function claims at their own responsibility by indicating such features after submitting scientific evidence on the safety and functionality of the products to the central government. Unlike the system for foods for specified health uses, it does not require a government screening, leading to concerns about product safety being raised.
   The overhaul plan, adopted at the day's meeting of related cabinet ministers, will make it mandatory for companies to report health issues related to foods with function claims to authorities promptly under relevant ordinances and regulations to prevent them from spreading. Currently, businesses are urged to do this under related guidelines.