Pertemuan 14 Risk Assestment For Food Additives - translate.ppt

bahan tambahan pangan

1. KAJIAN
KEAMANAN
BAHAN
TAMBAHAN
PANGAN

2. SUB TOPIK
•Prinsip penilaian/assesment keamanan
bahan tambahan pangan
•Menjelajahi penilaian risiko yang terkait
dengan keamanan bahan tambahan
makanan

3. FOOD ADDITIVES
•Suatu zat yang karena tujuan
penggunaannya dapat menjadi komponen
makanan, atau sebaliknya dapat
mempengaruhi karakteristik makanan.
•– Termasuk zat yang dimaksudkan untuk
digunakan dalam memproduksi, membuat,
memproses, menyiapkan, mengolah,
mengemas, mengangkut, atau menyimpan
makanan.

4. •Market of Food Additives
–∼3000 additives
–∼1800 flavoring agents
–Texturing agents used in highest quantity
–Soft drinks are biggest market

5. Food Additives Numbering
Systems
•E System
–Developed by the European Economic
Community (EEC)
–Number and description
–e.g. “E123 Amaranth, Color – Red”
•Bahan Tambahan Pangan dianggap aman
dan diizinkan antar negara
•Nutrient additives not included

6. Food Additives Numbering System
•International Numbering System (INS)
•Developed by Alimentarius
–CCFAC (Commission Committee on Food
Additives and Contaminants)
–Broader than E system
–e.g. “491 Sorbitan Monostearate; Emulsifiers
and
•Tidak menyiratkan persetujuan toksikologi
•INS largely E w/o E in number
•27 functional classes

7. Food Additives classification by FDA
(The Federal Food, Drug, and Cosmetic Act;1958)
•Prior-sanctioned substances (Zat-zat yang
disetujui sebelumnya)
•GRAS additives (Generally-Recognized-
As Safe = Umumnya diakui aman)
•Direct additives (food additives)
•Indirect additives contaminant.

8. Food Additives classification by FDA:
Exempt Chemicals (1997 changes)
•Prior-sanctioned substances
–Prior sanctioned - approved by FDA/USDA prior
1958 (1938-1958)
–e.g. sodium nitrite, etc
•GRAS additives (Generally-recognized-as-
safe)
–From scientific studies or wide usage
–Salt, vitamins, etc
–GRAS – qualified experts determined safe
–May not be FDA decision (GRAS)
–Company can self-proclaim (GRAS)

10. GRAS Ingredients
(1997 changes)
•Not food additives
•Dikecualikan untuk izin pra-pasar tetapi
harus didukung oleh data keamanan
•Dikecualikan dari Klausul Delaney
•GRAS list in CFR is not inclusive (but not
in Codex)

11. GRAS Ingredients: 1997
Changes
•Tidak semua petisi GRAS akan ditinjau
secara ketat
•Company will submit intention to list as
GRAS
•FDA may or not review
•Speeds process and better directs
resources

12. •Basically GRAS is substance(s) that added in
food but it not classified as food additives
•Sebagian besar zat GRAS tidak memiliki
batasan kuantitatif untuk digunakan, meskipun
penggunaannya harus sesuai dengan praktik
pembuatan yang baik (CPPBP)
•Some GRAS substances, such as sodium
benzoate, do have a quantitative limit for use in
foods.

13. GRAS timeline
•GRAS timeline

14. GRAS Examples
•Caffeine, GRAS since 1960
•Simplesse, GRAS in 1990
•Menhaden fish oil, GRAS in 1989
•Chymosin from recombinant DNA, GRAS in
1990

16. Regulated Food Additives by FDA
(1997 changes)
•Direct food additives
•Certified color additives
–Prefix of FD&C
–Every batch must be FDA certified
–Aromatic amines, aromatic azos
•Exempt color additives
–Usually naturally occurring (dried algae, beet powder, grape skin
extract, fruit juice, caramel, etc.)
–Lack precise chemical identity
–Fade readily lack intensity and uniformity readily, – Higher levels
required
–Used less (except caramel)
•Unintentional additives

17. Regulated Food Additives by FDA
•Unintentional additives
–Packaging materials (BHA/BHT, polymers,
metals)
–Processing chemicals (PAH from cooking,
solvents from extractions)
–Environmental (natural and anthropogenic,
Pb, Hg, pesticide, fumigants

18. FDA’S CONCEPT OF ‘SAFETY’
•Reasonable Certainty of No Harm(risk
analysis concept)
•“a reasonable certainty in the minds of
competent scientists that the substance is
not harmful under the intended conditions
of use” (21 CFR 170.3(i))

19. FDA’S CONCEPT OF ‘SAFETY’
•Reasonable Certainty of No Harm (risk
analysis concept)
•The Delaney Clause (‘zero-cancerrisk’), in
year 1960’:
•That no additive shall be deemed to be safe if it is
found to induce cancer when ingested by man or
animal, or if it is found, after tests which are
appropriate for evaluation of the safety of food
additives, to induce cancer in man or
animal…………………..

20. The Delaney Clause
•The statement has led to the cancellation of
about 8 different additives in the group of
(1963):
–A veterinary drug
–A veterinary feed additives
–A flavoring agent
–Saccharin
–Indirect additives from packing materials
–Several color additives

21. Direct and indirect food additive petitions received by the
FDA (Oct 1, 1989 to March 31, 1995)

22. •Kerangka Risk Analysis

23. Kajian Risiko
(Risk Assessment) BTP

24. PERIJINAN BTP: tahap identifikasi dan
karakterisasi bahaya
•INFORMASI YANG HARUS DIMILIKI
•1. Identitas dan sifat-sifat senyawa ybs
•2. Rencana aplikasinya dan perkiraan
konsumsinya (intake)
•3. Stabilitas selama pengolahan dan penyimpanan
•4. Metode analisis dari:
•Hasil samping (impurities)
•Hasil degradasi
•5. Studi keamanan

25. IDENTITAS DAN SIFAT BTP
• Nama kimia, nama trivial, IUPAC, CAS-No.
• Struktur kimia, rumus kimia, BM
• Komposisi, kemurnian, senyawa impurities
• Sifat fisik: titik leleh, BJ, rotasi optis, dll
• Prosedur sintesis:
•?????? Bahan baku
•?????? Pelarut, katalis
•?????? Kondisi sintesis
•?????? kemurnian
• Stabilitas: pengolahan & penyimpanan

26. Kemurnian
•o-toluen sulfonamida (OTS)
–Impurity dari sakarin
–Terbentuk pada proses tertentu
–Diduga menginduksi tumor
–Limit dalam produk 0.0025%
–Penelitian terakhir mengeliminir dugaan tersebut
•5-bensil-3,6-diokso-2-piperazin asam
asetat
–Produk siklisasi aspartam
–Limit dalam produk 1.5%

27. METODE ANALISIS
•Sifat fisik dan kimia BTP
•Menentukan jumlahnya dalam pangan
•Menentukan jumlah senyawa impurities
•Menentukan jumlah senyawa hasil degradasinya
•Bersifat mudah
–Dapat dilakukan di semua laboratorium
–Dapat dilakukan oleh teknisi bukan ahli)
•Bersifat spesifik dan akurat
•Penting untuk law enforcement
–Menentukan jumlahnya dalam pangan
–Menentukan konsumsinya oleh masyarakat

28. STUDI KEAMANAN
•Aspek yang paling menentukan
•Bagi produsen BTP yang paling lama dan membutuhkan
biaya
•Aspek yang diteliti:
•Uji toksisitas
•Uji karsinogenisitas
•Uji genotoksisitas
•Uji mutagenisitas
•Uji teratogenisitas
•Uji farmakokinetik
•Menggunakan hewan percobaan
•Metodologi sangat menentukan

29. PENETAPAN NILAI ADI
•Menentukan dosis konsumsi maksimal yang tidak
menyebabkan efek negatif terhadap hewan percobaan
–NOAEL (no observable adverse effect level)
–NOEL (no observable effect level)
–Jumlah yang dikonsumsi dalam mg/kg berat badan/hari
•Data digunakan untuk menentukan ADI
–Jumlah BTP (mg/kg) yang dapat dikonsumsi oleh seseorang
setiap hari, selama hidupnya, tanpa resiko menimbulkan efek
negatif terhadap kesehatan
–ADI = 1/100 x NOAEL
–100 = faktor keamanan, ekstrapolasi hewan percobaan ke
manusia (uncertainty factor)

30. RENCANA APLIKASI DAN INTAKE: tahap
studi paparan dan karakterisasi resiko
•Jenis makanan, tergantung sifat fisik & kimia
–Aspartam
•Jumlah yang ditambahkan
–Jumlah impurities yang terkonsumsi
–BTP tetap dapat berfungsi selama shelf-life produk
tsb.
•Perkiraan intake (konsumsi)
–Average consumer vs high consumer
–Digunakan untuk menghitung EDI (estimated daily
intake)
–dan ADI (acceptable daily intake)

31. RENCANA APLIKASI DAN INTAKE
•EDI (estimated daily intake)
•amount of food consumed daily) x concentration of additive in food)
•EDI = concentration (C) x intake (I)
•Sum of all sources of additive in food and non food
•Unique number for each direct additive
•The sum of EDIs for an additive from all sources cannot
exceed the RfD/ADI
•Reference Dose (RfD)
•An estimate (with uncertainty spanning perhaps an order of magnitude) of a
daily oral exposure to the human population (including sensitive subgroups)
that is likely to be without an appreciable risk of deleterious effects during
lifetime)
•Can be derived from NOAEL or benchmark dose

32. Concentration in Food:
direct additives
Estimating consumption
•Level of additive in food category
•Daily intake of each food category
containing additive
•Distribution of intakes in population groups
•Exposure from non-food sources

33. Concentration in Food:
direct additives
•Determined by manufacturer
•Assume highest level allowable
•Assume processor uses GMP and does
not abuse levels

34. •PROTAP CODEX
•• Step 1 : usulan dikaji oleh Executive Committee
•• Step 2 : penyusunan draft
•• Step 3 : Permintaan tanggapan kepada negara
anggota & organisasi internasional terkait
•• Step 4 : pembahasan komentar
•• Step 5 : persetujuan draft oleh Komisi
•• Step 6&7 : draft yang telah disetujui diedarkan kembali
•kepada negara anggota
•• Step 8 : adopsi & publikasi

35. TERIMA KASIH - BTP
Seveline