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Lampiran 1. Pedoman evaluasi dan verifikasi prebiotik menurut FAO (2007) Karakteristik komponen sumber, asal, kemurnian, komposisi kimia, struktur Karakteristik fungsional uji in vitro/uji hewan Formulasi produk, pembawa, konsentrasi dan jumlah
Pengujian pada manusia secara acak, buta ganda, dikontrol (RCT) dengan ukuran sample dan outcome utama yang diinginkan utk pengujian bila produk bermanfaat. Bukti minimum dari korelasi antara pengukuran outcome fisiologi dengan modulasi mikrobiota pada tempat tertentu
Evaluasi keamanan In vitro dan/atau hewan, dan/atau fase I study pada manusia bila bukan GRAS atau sejenis
Lebih disukai studi RCT independent kedua untuk mengkonfirmasi hasil
Prebiotik
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Lampiran 2. List status substansi GRAS terkait prebiotik dan probiotik di Amerika Serikat GRN No. 171 118
49 44 42
Substansi Lactobacillus acidophilus, Lactobacillus lactis, and Pediococcus acidilactici Inulin
Bifidobacterium lactis strain Bb12 and Streptococcus thermophilus strain Th4 Fructooligosaccharide Milk-derived lactoferrin
GRN No. 241 240
239
236 235 233 231 189
Substansi
Ket
High-selenium yeast
Ditunda
Corn, cane, or beet sugar cultured with Lactobacillus paracasei subsp. paracasei, Bacillus coagulans and Propionibacterium freudenreichii subsp. Shermanii Yeast beta-glucan
Ditunda
Galactooligosaccharides Lactoferrin (human) dari beras Galactooligosaccharides and polydextrose Lactobacillus casei, subsp. rhamnosus GG Lactoferrin (human) purified from bovine milk
Ditunda Ditunda Ditunda Ditunda Ditunda Ditunda
Sumber : FDA/Center for Food Safety & Applied Nutrition (http://www.cfsan.fda.gov/~rdb/opagras.html) pmg/emw/jmf/hrw 11 Maret, 2008
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Lampiran 3. Komponen/ingredient fungsional FOSHU terkait prebiotik dan probiotik Kategori Penggunaan Kesehatan Khusus (SPECIFIED Health Uses Category) Kesehatan Saluran Pencernaan (Gastrointestinal Health)
Katagori Komponen Fungsional (Functional Component Category) Oligosaccharides/Pre biotic
Serat Pangan (Dietary Fiber)
Bakteri Asam Laktat (Lactic acid Bacteria/Probiotics)
Komponen Fungsional untuk Produk FOSHU (Functional Component for FOSHU Products) 1) Fructo Oligosaccharides 2) Galacto Oligosaccharides 3) Soybean Oligosaccharides 4) Isomaltulose/Palatinose Oligosaccharides 5) Lactosucrose 6) Xylo Oligosaccharides 7) Lactulose 8) Raffinose/Beet oligos 1) Polydextrose 2) Indigestible Dextrin 3) Guar Gum Galactomannose 4) Psyllium Husks 5) Wheat Bran 6) Kanten/Plant Jelly Fiber 7) Lowmolecule Alginic Acid Sodium 8) Beer Yeast/Brewers’Yeast Fiber 9) Agar Fiber 10) Wheat Husks Fiber 11) Soluble C 1) Lactobacillus GG 2) Lactobacillus delbrueckii subsp. 3) Bulgaricus 2038 4) Streptococcus saliviarious subsp. Thermophilus 1131 5) Lactobacillu s delbrueckii subsp. Bulgaricus 2038 6) Bifidobacteria 7) Acidophilus SBT2062 8) Bifidobacterium Longum SBT2928 9) Bifibobacterium Longum BB536 10) L. Casein Shirota B. 11) Breve Shirota 12) Propini Bacterium 13) Casein Bacterium NY1301
Sumber (Japan Ministry of Health, Labour and Welfare http://www.mhlw.go.jp/english/topics/food safety/fhc/02.html).
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Lampiran 4. Data produk pangan mengandung komponen prebiotik inulin, FOS, dan GOS yang terdaftar di Badan POM dari rentang tahun 20022007 No
Kategori pangan
1 Produk-produk Susu Susu dan analognya Susu Kental
2 Kembang Gula/permen dan coklat
3 Produk pangan untuk keperluan gizi khusus
4 Minuman tidak termasuk produk susu
Jenis Pangan
Susu Susu UHT Susu Kental Manis Susu Bubuk Bebas Lemak
Jenis Prebiotik Jml FOS Inulin FOS GOS 2 2 4 4 8
4 4 8
1 Kembang Gula Makanan pencuci mulut
1 11
11 3
Formula bayi Formula lanjutan Makanan bayi dan anak dalam masa pertumbuhan
Formula bayi Formula lanjutan MP ASI (makanan pelengkap)
Susu pertumbuhan Makanan diet Makanan diet rendah khusus untuk laktosa keperluan kesehatan termasuk untuk bayi dan anak-anak Makanan diet Makanan diet khusus untuk pelangsing pelangsing dan penurun berat badan Makanan diet Pangan untuk ibu contohnya hamil dan menyusui suplemen pangan untuk diet Minuman bebasis air perisa tidak Nata de coco dalam berkarbonat minuman Serbuk minuman Air minum berkarbonasi Sari Buah dan Sari Buah sayuran Jumlah
2 8 40 2
1 2 2 10
2 10 3
53 2
11
11
4
4
2 2 7
7 1
1 1 107
1 16
3
126
