[{"_1":2,"_123":-5,"_124":-5},"loaderData",{"_3":4,"_28":29,"_30":31},"root",{"_5":6,"_7":-5,"_8":9},"locale","id","session","ENV",{"_10":11,"_12":13,"_14":15,"_16":17,"_18":19,"_20":21,"_22":23,"_24":25,"_26":27},"APP_ENV","production","APP_URL","https://veritask.ai","GA_MEASUREMENT_ID","G-X1BV3QBZEM","META_PIXEL_ID","4698743733686194","TIKTOK_PIXEL_IDS","D8A3HTBC77U9J3L243V0","CLARITY_PROJECT_ID","wn9rn7xb4l","AMPLITUDE_API_KEY","74a0c7cc1509a379d3647ec140dd375","MIDTRANS_CLIENT_KEY","Mid-client-hwjEU5pmwAKVMbIA","MIDTRANS_SNAP_URL","https://app.midtrans.com/snap/snap.js","routes/$locale",{"_5":6},"routes/$locale.search-engine.regulation.$regulationId",{"_32":33,"_34":35},"regulationId","b38b98e3-0f76-4594-a14f-3ea907939b70","regulationData",{"_36":33,"_37":38,"_119":120,"_121":122},"regulation_id","overview",{"_39":40,"_41":42,"_43":44,"_45":46,"_47":48,"_49":50,"_51":52,"_53":54,"_59":60,"_61":62,"_66":67,"_71":72,"_73":74,"_75":76,"_77":78,"_79":-5,"_80":81,"_82":83,"_84":-5,"_85":86,"_87":88,"_89":83,"_90":91,"_92":93,"_100":101,"_102":103,"_104":105,"_106":107,"_108":109,"_110":111,"_112":113,"_114":115,"_116":-5,"_117":118},"title","Peraturan Badan Pengawas Obat dan Makanan Nomor 17 Tahun 2019 tentang Persyaratan Mutu Suplemen Kesehatan","short_title","Peraturan Badan Pengawas Obat dan Makanan Nomor 17 Tahun 2019","number","17","year","2019","published_date","2023-07-25","effective_date","2019-07-29","status_id","89192b77-602e-484c-89df-4fd3166b732a","status",{"_6":52,"_55":56,"_57":58},"name","Tidak Berlaku","description","Peraturan yang sudah tidak berlaku karena dicabut, diubah, atau habis masa berlakunya","type_id","6f5779f5-e2ea-448d-8bb0-b22517233239","type",{"_6":60,"_55":63,"_64":65},"Peraturan Badan Pengawas Obat dan Makanan","short_name","Peraturan BPOM","subjects",[68],{"_6":69,"_55":70,"_57":-5},"10e70ff8-158d-4e9e-849e-554938c706d9","Pelayanan Kesehatan","tags",[],"location","Badan Pengawas Obat dan Makanan","place_of_enactment","Jakarta","theme","Persyaratan Mutu Suplemen Kesehatan","subject_matter","abstract","\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n


2019
Peraturan Badan Pengawas Obat dan Makanan NO. 17, BN 2019 (820); 35 hlm
Peraturan Badan Pengawas Obat dan Makanan TENTANG Persyaratan Mutu Suplemen Kesehatan
ABSTRAK:	\n \n \n
CATATAN:	\n \n Peraturan Badan Pengawas Obat dan Makanan ini mulai berlaku pada tanggal 29 Juli 2019. \n \n

","regulatory_relationship","(-)","scope_and_parties","policy_content","

Peraturan Badan Pengawas Obat dan Makanan ini mengatur persyaratan mutu suplemen kesehatan untuk melindungi masyarakat dari peredaran produk yang tidak memenuhi standar. Latar belakangnya adalah perlunya standar baku mutu yang harus diterapkan dalam pembuatan suplemen kesehatan.

\n\n

Ketentuan substansial mencakup:

\n\n

Persyaratan mutu yang harus diterapkan sebelum dan selama suplemen kesehatan beredar.
Kewajiban Pelaku Usaha untuk menjamin suplemen kesehatan yang dibuat, diimpor, dan/atau diedarkan memenuhi persyaratan mutu.
Persyaratan mutu meliputi Bahan Suplemen Kesehatan (Bahan Aktif dan Bahan Tambahan) dan Produk Jadi (sediaan oral seperti serbuk, efervesen, tablet/kaplet, kapsul, dan cairan oral).
Bahan Aktif harus mempertimbangkan aspek keamanan dan rasionalitas, dapat berasal dari bahan alam (isolat, fraksi, ekstrak).
Pelarut ekstraksi selain air harus memenuhi batas residu pelarut.
Bahan Tambahan yang diizinkan meliputi pengawet, pemanis, pewarna, antioksidan, perisa, dengan batasan penggunaan yang jelas.
Produk Jadi harus memenuhi parameter uji seperti organoleptik, kadar air, disintegrasi/waktu hancur, disolusi, keseragaman bobot, cemaran mikroba, cemaran logam berat, dll.
Pengujian laboratorium harus dilakukan oleh laboratorium terakreditasi atau laboratorium industri bersertifikat Cara Pembuatan yang Baik.
Dalam hal persyaratan mutu belum diatur, Pelaku Usaha harus mengajukan permohonan pengkajian kepada Kepala Badan.

\n","transitional_provisions","1. Pelaku Usaha di bidang Suplemen Kesehatan yang telah mendapatkan izin edar sebelum berlakunya Peraturan Badan ini wajib menyesuaikan dengan ketentuan dalam Peraturan Badan ini paling lama 2 (dua) tahun terhitung sejak Peraturan Badan ini diundangkan.","sanctions","revokes",[],"revoked_by",[94],{"_95":96,"_97":98,"_36":99},"text","Peraturan BPOM No. 24 Tahun 2023 tentang Persyaratan Keamanan dan Mutu Suplemen Kesehatan","link","https://peraturan.bpk.go.id/Details/284992/peraturan-bpom-no-24-tahun-2023","aaf5a8a8-c169-442e-bf40-9c44d84f09a1","partially_revokes",[],"partially_revoked_by",[],"amends",[],"amended_by",[],"partially_amends",[],"partially_amended_by",[],"establishes",[],"established_by",[],"constitutional_review","is_verified",false,"english_excerpt","\n

REGULATION OF THE FOOD AND DRUG MONITORING AGENCY
NUMBER 17 OF 2019
ON
QUALITY REQUIREMENTS FOR HEALTH SUPPLEMENTS

WITH THE BLESSINGS OF GOD ALMIGHTY

HEAD OF THE FOOD AND DRUG MONITORING AGENCY,

\n\n \n \n \n \n \n \n

Considering / Whereas:

that to protect the public from the circulation of
health supplements that do not comply with
quality requirements, it is necessary to regulate the requirements
quality for health supplements;
that the quality requirements for health supplements
as referred to in letter a are
quality standard that must be applied in
manufacturing health supplements;
that based on the considerations as
referred to in letters a and b, it is necessary to stipulate
Regulation of the Food and Drug Supervisory Agency on
Quality Requirements for Health Supplements;

Bearing in Mind / Having Regard to:

Presidential Regulation Number 80 of 2017 on the

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