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  1. ZAT ADITIF MAKANAN — CODEX PresentasiMikrobiologiAnalitik

  2. FOOD ADDITIVES Food and Drug Administration (United States)

  3. What Is a Food Additive? • any substance added to food. • used in the production, processing, treatment, packaging, transportation or storage of food. • Direct food additives added to a food for a specific purpose in that food • xanthan gum  used in salad dressings, chocolate milk, bakery fillings, puddings and others add texture identified on the ingredient label of foods. • Indirect food additives become part of the food intrace amounts due to its packaging, storage or other handling Food packaging manufacturers must prove to the FDA that all materials coming in contact with food are safe before they are permitted for use in such a manner.

  4. When evaluating the safety of a substance and whether it should be approved, FDA considers: 1) the composition and properties of the substance, 2) the amount that would typically be consumed, 3) immediate and long-term health effects, and 4) various safety factors.

  5. If an additive is approved FDA issues regulations that may include the types of foods in which it can be used, the maximum amounts to be used, and how it should be identified on food labels. • If new evidence suggests that a product already in use may be unsafe federal authorities may prohibit its use or conduct further studies to determine if the use can still be considered safe.

  6. groups of ingredients Under the Food Additives Amendment: • GROUP I (Prior-sanctioned substances ) • substances that FDA or USDA had determined safe for use in food prior to the 1958 amendment • Ex. sodium nitrite and potassium nitrite used to preserve luncheon meats. • GROUP II (GRAS (generally recognized as safeingredients) • those that are generally recognized by experts as safe, based on their extensive history of use in food before 1958 or based on published scientific evidence. • Among the several hundred GRAS substances are salt, sugar, spices, vitamins and monosodium glutamate (MSG). Manufacturers may also request that FDA review the industry's determination of GRAS Status.

  7. Codex General Standard vs. FDA US • Codex allows the use of cyclamates artificial sweetener to birth defects, the impairment of the function of testes, and the enhancement of the carcinogenic effect of cancer-causing chemicals. have been banned in the U.S. since 1970. • cyclamates in carbonated soft drinks and other foods that could result in the consumption of large amounts of a food additive that the FDA has previously found to be unsafe. • Codex permits the use of alitame (artificial sweetener)The FDA has not approved the use of this additive, and the addition of this unapproved substance in a wide range of foodstuffs could raise serious public health concerns. •  Codex permit the use of additives used in the U.S. at levels or in specific foods that have not been approved The FDA restricting the types of foods in which the additive can be used, and by limiting the additive’s purpose for which it may be used. • The Codex General Standard allow for the use of additives in specific foods and in quantities that are not permitted in the U.S. • In 1986, the use of sulfites , because of the incidence of severe allergic reactions, was not Generally Recognized as Safe (GRAS) and changed its regulations to restrict the use of these additivesFDA’s regulations bar the use of sulfites on meats, in contrast, the General Standard for Food Additives allows the use of sulfiting agents on fresh meat, poultry. • In 1970, nitrate could be converted to nitrite which, when combined with secondary amines, forms cancer-causing nitrosaminesThe U.S. banned nitrates from most processed meats.The proposed General Standard for Food Additives, however, allows their use in a far greater number of foods than is permitted in the U.S., including cheese and alcoholic beverages.

  8. Actual News (December 31, 2009) • Common foods, herbs, nutrients, amino acids, homeopathic and other natural remedies  called drugsPotencies would be limited prescriptions would be required for their use, some would be banned altogether. • In contrast, about 300 dangerous food additives will be allowed (including aspartame, BHA, BHT, potassium bromate, and tartrazine). (Lendman, 2010)

  9. Regulasi Food Additive

  10. SCF / EFSA • Peran : • Menjamin bahan pengawet lolos uji sebelum dipatenkan oleh EU • Mereview food additive berdasarkan informasi scientific • Re-evaluasi sistematik seluruh Food Additive yang sudah resmi di EU • Standar evaluasi : • Menguji level Food Additive terhadap hewan dan manusia (toksisitas )  NOAEL (no-observed-adverse-effect)  ADI (Acceptable Daily Intake)

  11. ADI (Acceptable Daily Intake) • Mengestimasi level food additive yang dapat diterima tubuh berdasarkan berat badan (tanpa resiko) • Yang menentukan : SCF  diaprove oleh European Comittee Directives (member states)  EFSA (publish opini)  E-number

  12. Authorization

  13. Ringkasan Dokumen • Tidak lebih dari 15 halaman • Part I : Data Administratif 1. Nama dari petitioner (perusahaan, organisasi, dll), alamat dan telefon 2. Nama pabrik yang menghasilkan substansinya berikut kerangannya 3. Nama dari orang yang bertanggung jawab pada dosis 4. Tanggal submit dokumen 5. Tabel yang tercantum dalam dokumen

  14. Part II : Data Teknis 1. Identity of substance 2. Microbiological characteristics 3. Proposed chemical and microbiological specifications 4. Manufacturing process 5. Methods of analysis in food 6. Reaction and fate in food 7. Case of need and proposed uses 8. Exposure 9. Additives produced by microbiological processes 10. Additives produced from genetically modified organisms 11. Information on national authorisations

  15. Part III : Data Toxixitas 1. General framework for the toxicological evaluation of food additives 2. Study protocols 3. Toxicological section of the dossier • 3.1 Core studies • 3.2 Other studies 4. Data reporting 5. Review of results and conclusions Part IV : Referensi • APPENDIX I Flowchart proses penilaian dari SCF dalam dosis tertentu Food Additive • APPENDIX II Kriteria umum penggunaan Food Additives

  16. Peraturan untuk Food Additive • Framework Directive (89/107/EEC) • Berisi kriteria penilaian secara general dan teknis : • Directive 94/35/EC Pemanis • Directive 94/36/EC Pewarna • Directive 95/2/EC  additives selainpemanis dan pewarna • Ketiga tujuan ini menyimpulkan additive mana yang aman dan level maksimum nya dalam makanan

  17. Food Additives Approved by the EU

  18. Food Additive yang digunakan di EROPA • Antioxidan • Tocopherols (E 306-309), BHA (butylated hydroxyanisole or E 320 • Preservatives • Nitrates and nitrites (sodium and potassium salts) (E 249-252) – digunakan sebagai pengawet pada proses pembuatan HAM dan daging lain  mencegah C. Botulinum yang patogen • Pewarna • Penyedap • acesulfam K (E 950), aspartame (E 951) and saccharin (E 954)  130-200 kali, 200 kali and 300-500 kali lebih manisdari gula dan kalori nya 0.


  20. Pewarnamakanan Pigmen/substrat yang mewarnaimakanan, obat-obatan, kosmetikatautubuhmanusia atraktif, menarik, berselera, daninformatif mengontrol agar pewarnamakanandapatdigunakandenganamandansesuai

  21. Klasifikasipewarnamakanan Straight colors : tidakdicampur/direaksikansecarakimiadengansubstrat lain. Contoh : FD&C Blue No. 1 or Blue 1. Lakes : mereaksikanstraight colordenganpresipitandansubstrat. Contoh : Blue 1 Lake. Mixtures : pencampuransatudenganpewarnalainnyatanpareaksikimia. Contoh : food inks.

  22. Informasi yang dibutuhkan • Identitaspewarnamakanan • Propertifisika, kimia, danbiologis • Spesifikasikimia • Deskripsiprosesmanufaktur • Stabilitas data • Batasanpenggunaan • Labeling • Toleransidanlimitasi

  23. Informasi yang dibutuhkan (2) • Metodeanalitikuntukspesifikasikimia • Metodeanalitikdeterminasipewarnamakananpadaproduk • Identifikasidandeterminasisubstansi yang terbentukpadaprodukkarenapenggunaanpewarnamakanan • Pembelajarankeselamatan • Estimasikemungkinanpendedahan • Regulasi yang diajukan • Pengecualian yang diajukandaribeberapasertifikasi • Perkiraanpencemaranlingkungan

  24. PewarnaMakanandi Indonesia • Penggunaanpewarnamakanandi Indonesia diaturdalam SK MenteriKesehatan RI No. 235/MenKes/Per/VI/79 dandirevisimelalui SK MenteriKesehatan RI No. 722/MenKes/Per/VI/88 mengenaibahantambahanmakanan. • Warnaberartibahan yang dapatmeningkatkanpewarnaanpadamakanan (pasalI)

  25. BahanTambahanMakanandiizinkandenganpemakaianmaksimumterlimitdalammakanantertentuBahanTambahanMakanandiizinkandenganpemakaianmaksimumterlimitdalammakanantertentu

  26. BahanTambahanMakananselaindari yang ditetapkandapatdigunakansebagaibahantambahanmakanansetelahmendapatpersetujuansebelumnyadariDirekturJenderalPengawasanObatdanMakananberdasarkanevaluasi

  27. Tanda khusus

  28. Eropa • Zataditifmakanan yang telahdisetujuipenggunaannyadinegara-negaraUniEropadiberikode yang bernama “E numbers” • Safety assessment danpersetujuandilakukanoleh European Food Safety Authority (EFSA) • Nomor yang diberikanpadazataditifmengikutinomorpada International Numbering System (INS) dari Codex Alimentarius, namundiberiawalan E- • Tidaksemuazataditif yang disetujuioleh Codex Alimentariusdisetujuioleh EFSA

  29. Level maksimalbergantungpadajenismakanan yang diberiaditif.


  31. Pengertian dan tujuan • Zat aditif pengawet: bahan tambahan pangan yang dapat mencegah atau menghambat fermentasi, pengasaman atau penguraian dan perusakan lainnya terhadap pangan yang disebabkan oleh mikroorganisme. • Tujuan penambahan zat pengawet makanan: • Agar mutu dan kestabilan makanan tetap terjaga. • Agar makanan lebih tahan lama disimpan.

  32. Zat pengawet • Alami • Garam dapur, bawang putih, asam cuka. • Buatan/sintetis • Natrim benzoat dan asam benzoat, natrium nitrit, asam propionat, asam sorbat.

  33. Data pengaturanbahanpengawetdariCodex Alimetarius Commission (CAC), USA (CFR), Australia dan New Zealand (FSANZ) tercatat 58 jenisbahanpengawet yang dapatdigunakandalamprodukpangan. • Indonesia : PeraturanMenteriKesehatan No. 722 tahun 1988 26 jenisbahanpengawetdanbatasmaksimumpenggunaanbahanpengawetuntukmasing – masingjenis / bahanmakanan.

  34. Pengawet yang diizinkan berdasarkan Permenkes No.722/1988

  35. Contohpengawet yang tidakdiizinkan

  36. Permenkes No. 722/MENKES/PER/IX/1988 tentangBahanTambahanMakanandiubahdenganPerMenKesNomor. 1168/MENKES/PER/X/1999 • Peraturantersebutmenyebutkanbahwabahankimiatertentudiijinkanuntukdipergunakan, misalnyaAsamAskorbat (Ascorbic Acid) untukjenisbahanmakanantepungdenganbatasmaksimumpenggunaan 200mg/kg.

  37. ContohJumlahmaksimumpengawet yang dianjurkan • K-sorbat 0,05 – 0,3 % (diaplikasikanlangsung) dan 10 – 20 % (disemprotkanpadapermukaanmakanan). • Asambenzoat1000 ppmatau 1 gram per kg bahan • Nitrit produkakhirdagingproses adalah200 ppm.

  38. Pengaruhbeberapabahanpengawetterhadapkesehatan

  39. AlternatifPengawetPangan

  40. ContohZatPengawet: DIMETIL DIKARBONAT • Dimetildicarbonate (DMDC)  pengawetmakanan, sterilisasiminumandanmakanan (ex: wine, jus buah, produk obat2an, beer, dll) • lebihbaikdaridietildikarbonatlebihaktifmenghambatmikroba, solubilitas yang tinggipadacairan.

  41. Terdaftarpada codex General Standard for Food Additives (GSFA) dan European union (EU) sebagaifood additive • Dalamstandar international :

  42. Pada Negara Lain • Australia & new zealandmengajukanamandemen food additive menjadi processing aid; ketidakcocokandalamterjemahanantar food additive danpembuatanobat • EU diizinkanoleh EU directive 95/2/EC, sebagai: food additive, minumanberasa non-alkohol; alcohol-free wine; liquid-tea concentrate padabatas 250mg/L. residu DMDC tidakterdeteksi • US  FDA mengijinkan DMDC sebagaipengawetmakanan; mencegahpertumbuhan yeast pd wine; menghambat yeast dlm wine bebasalkoholsertaalkoholrendahdengankadarpenambahan 200 mg/L • Indonesia  mengikutistandarinternasionaldari Codex Alimentarius


  44. Pemanis buatan • Merupakan susbtansi untuk memberikan rasa manis ke makanan atau sebagai pemanis ‘table-top’. • Pemanis ‘Table-top’  produk yang mengandung pemanis yang diizinkan dan ditujukan untuk penjualan (gula alternatif) • Labelling Pemanis ‘Table-top’ : • ‘[Name of sweetener(s)]-based table-top sweetener’ • Jika mengandung polyol /aspartane : • untukpolyols – ‘excessive consumption may induce laxative effects’ • Untuk aspartame – ‘contains a source of phenylalanine’

  45. Directive 94/35/EC • Tujuan dibuat pemanis buatan : i) makanan rendah energi (kalori) ii) makanan anti karies iii)Makanan tanpa gulauntuk penderita diabetes (diaetic product)

  46. Contoh : • Pemanis buatan : • Aspartane • Tidak toxic • Tidak Karsinogenik • ADI = 40 mg/kg berat badan

  47. Persyaratan • Directive 88/388/EC and Directive 91/71/EEC : • Nama penyedap harus tercantum di komposisi makanan pada label • "natural flavoring" hanya jika substansinya diekstraksi dari sayuran atau hewani • Penyedap yang dijual  labelling tambahan yaitu : • daya tahan minimum • Kondisi penyimpanan dan pemakaian • Identifikasi substansi lain yang terdapat dalam penyedap