Winiati P. Rahayu dan Khusnul Khotimah JEJARING INTELIJEN PANGAN NASIONAL PUSAT RISET OBAT DAN MAKANAN BADAN POM RI

REGULASI DAN HARMONISASI METODE ANALISIS MIKOTOKSIN BAHAYA BIOLOGIS

BAHAYA KIMIA

AMANKAN PANGAN dan BEBASKAN PRODUK dari BAHAN BERBAHAYA BAHAYA FISIK

BEBAS BAHAYA

Winiati P. Rahayu ([email protected]) dan Khusnul Khotimah JEJARING INTELIJEN PANGAN NASIONAL PUSAT RISET OBAT DAN MAKANAN BADAN POM RI Disampaikan pada Focus Group Discussion AFLATOKSIN FORUM INDONESIA V Jogyakarta 21 Desember 2010

TOPIK BAHASAN TOPIK BAHASAN • PENDAHULUAN • KAJIAN RISIKO MIKOTOKSIN SEBAGAI DASAR REGULASI • REGULASI MIKOTOKSIN • HARMONISASI STANDARD KEAMANAN PANGAN • PENGEMBANGAN METODE ANALISIS MIKOTOKSIN

Stress pada tanaman Kerusakan oleh hama

PENDAHULUAN

Jumlah air dalam tanah Temperatur lingkungan tinggi Defisiensi nutrisi pada tanah

Iklim tropis I d Indonesia i

Pangan rentan pertumbuhan jamur

MIKOTOKSIN SNI 7385 7385, 2009

Aflatoksin

Fumonisin

Metode Analisis Mikotoksin

DON

Ok Okratoksin k i

Patulin

MIKOTOKSIN Mikotoksin adalah senyawa organik beracun hasil metabolisme dari kapang (SNI 7385:2009).

Mycotoxin y Marine /algae toxin Animal toxin

Bacterial toxin

Plant toxin

COMMON MYCOTOXIN, COMMODITY AFFECTED AND HEALTH EFFECTS Mycotoxin

Commodity

Fungal Source (s)

Toxicity Effects

Aflatoxin B1,B2

Maize, peanuts, and many other commodities

Aspergillus flavus

Aflatoxin B1, & naturally occuring mixtures of aflatoxins, identified as potent human carcinogens by IARC, Adverse effects in various animals, animals especially chickens

Deoxynivalenol (DON)

Wheat, maize, barley

Fusarium graminearum, F.crookwellense, F.culmorum

Human toxicoses India, China, Japan, and Korea. Toxic to animals, especially pigs

Fumonisin B1

Maize

Fusarium moniliforme

Suspected by IARC as human carcinogen. Toxic to pigs and poultry. Cause of equine eucoencephalomalancia (ELEM), (ELEM) a fatal diseases of horses, neural tube defects, esophagal cancer

Ochratoxin A

Barley, wheat Barley and many other commodities

Aspergillus ochraceus

Suspected by IARC as human carcinogen. carcinogen Carcinogenic in laboratory animals and pigs

Patulin

Apple

A.clavatus, P.expansum, P.patulum, P..aspergillus, P. byssochlamys

Immunotoxic, neurotoxic

KAJIAN RISIKO MIKOTOKSIN SEBAGAI DASAR REGULASI

What is our concern

CHEMICAL RISK ASSESSMENT Toxicological g reference ARfD, NOEL, LOEL, ADI, PTDI, PTWI etc.

HAZARD IDENTIFICATION

HAZARD CHARACTERIZATION

How much, much how often, what is the level, who is the consumer

EXPOSURE ASSESSMENT

RISK CHARACTERIZATION

Compare the daily intake (exposure) with the toxicological reference. Exceeding the reference is a risk for human health

Strengthening ASEAN Risk Assessment Capability to Support F d safety Food f t Measures M CHEMICAL RISK ASSESSMENT CASE STUDY

AFLATOXINS IN PEANUTS AND OTHER FOODS Technical coordinator: FSANZ Australia

Prepared by ASEAN countries 2007

Supported by: ASEAN-Australia Development p Cooperation Program Stream

0.3 cancers/year per 100,000 100 000 population l ti per ng aflatoxin/kg bw per day Uncertainty range 0 05 to 0 0.05 0.5 5

HBsAg g-

HBsAg g+

POTENCY VALUES 0.01 cancers/year per 100,000 100 000 population per ng aflatoxin/kg bw per day Uncertainty range 0.002 to 0.03

Dietary exposure asessment on aflatoxin B1 in Indonesia* Food Type

Aflatoxin concentration (µg/kg)

Food consump tion (kg/day)

Estimated mean dietary exposure of Aflatoxin (µg/day)

Peanut

5.83

0.0026

0.0150

Peanut sauce

25 5 25.5

0 0016 0.0016

0 0413 0.0413

Total Dietary Exposure (µg/day)

0.0563

Total Dietary Exposure (µg/kg bw /day

0.0009

Source: Ambarwati (2007) in ASEAN-Australia Development Cooperation Program Stream *Food consumption data from Susenas 2004 (BPS, 2005); Average body weight 60 kg

Dietary intake of aflatoxin B1 in Indonesia* From peanut and peanut sauce

Food Consumption 2007

Food Type

Aflatoxin concentration (µg/kg)

Food consump p tion (kg/day)

Estimated mean dietary y exposure p of Aflatoxin (µg/day)

Peanuts

5.83

0.0033

0.0192

Peanut sauce

25.5

0.0067

0.1696

Total Dietary Exposure (µg/day)

0 1887 0.1887

Total Dietary Exposure (µg/kg bw /day

0.0032

*Sparringa (2008) based on food consumption data 2007; average body weight 60kg; 50 g peanuts in each portion of pecel/gadogado/ketoprak

Risk Characterization of Peanut and Peanut sauce (gado-gado, (gado gado, pecel and ketoprak)* ketoprak) • 0.27 cancers/year/100,000 population (Hepatitis B) • 0.009 cancers/year/100,000 population (Non Hepatitis B) For Hepatitis B population: 0.3 x 3.2 = 0.96 cancers per year per 100,000 population per ng aflatoxin per kg bw per day For Non-Hepatitis B population: 0.01 x 3.2 = 0.032 cancers per year per 100,000 population per ng aflatoxin per kg bw per day


Estimated cancer/year due to peanut and peanut sauce consumption consumption* HBsAg prevalence in Indonesia 10% (3.4 – 20.3%) It assumes that 10% of the population carries the Hepatitis B virus Potency: 0.01 x 90% + 0.3 x 10% = 0.039 cancers per year/100.000 people per ng aflatoxin B1/kg body weight per day 3.2 ng/kg bw per day x 0.039 cancers/year per 100.000 population per ng aflatoxin/kg bw per day = 0.1248 cancers/year per 100,000 people Estimated cancers/year in Indonesia: 222.192.000 people/100.000 people x 0.1248 = 227 persons


Country

Estimated cancer number due to aflatoxin exposure (cancer/year/100,000 population) Hepatitis p Bp population p

Non-hepatitis p Bp population p

Brunei Darussalam

0.03 – mean exposure


C b di Cambodia

0 18 mean exposure 0.18–

0 006 – mean exposure 0.006

Indonesia



Lao PDR

Not available

Not available

Malaysia



Myanmar



Phillipines*



Singapore

0.0264 – mean exposure 0.0798– high exposure

0.0009 – mean exposure 0.0027 – high exposure

Thailand**



Vietnam



AFLATOXIN CONTROL: Risk based approach • ON FARM

• PREHARVEST

•

HARVEST

• POST-HARVEST

• •

CONSUMPTION

•

Think about consequence, exposure and probability Aflatoxin control should be food chain approach Considering risk factors for aflatoxin production (e.g. temperature, moisture, humidity) for management strategies throughout the food chain Standard setting should be achievable Think a priority Need awareness raising to build a commitment Strengthening a partnership

Risk Assessment Organisations 1. World Health Organisation (WHO) – International Programme on Chemical Safety (IPMS) - 2001 Evaluation of Trichothecenes ((DON,, T-2 etc)) 2. European Food Safety Authority (EFSA) 3. US Food and Drug g Administration ((FDA)) 4. Council for Agricultural Science and Technology (CAST) - Jan 2003 Evaluation of Mycotoxins

REGULASI

Asia/Oceania: mycotoxins regulated in food PHO AGA FUMB1

mycoto oxins

FUMB1/2 ZEN T-2 DON PAT OTA AFM1 AFB1 AFT

0

5

10 number of countries

Hans van Egmond, 2010 RIKILT

15

20

AFLATOKSIN (SNI 7385:2009) No.

Jenis Pangan

Jenis

Batas Max. (ppb)

Regulasi Internasional

1

Susu dan minuman berbasis susu

M1

05 0.5

• 24 negara mengatur 0 0.5 5 ppb (termasuk CAC 2003) • 34 negara mengatur 0.05 ppb

2

Susu fermentasi & produk susu hasil hidrolisa enzim renin (tawar)

M1

0.5

3

Susu kental & analognya (tawar)

M1

0.5

4

Krim (tawar) dan sejenisnya

M1

0.5

5

Susu bubuk & krim bubuk dan bubuk analog (tawar)

M1

5

• Argentina, Brazil, Mauritius, Paraguay, Taiwan, Uruguay, Venezuela 5 ppb • Bulgaria 0.4 ppb Iran Maroko, Maroko Turki, Turki Ukraina 0.5 0 5 ppb • Iran, • Syria 0.05 ppb

6

Keju & keju analog

M1

0.5

• Argentina, Brazil, Mauritius, Paraguay, Taiwan, Uruguay, Venezuela 5 ppb • Bulgaria 0.4 ppb • Iran, Maroko, Turki, Ukraina 0.5 ppb • Syria 0.05 ppb

7

Makanan pencuci mulut berbahan dasar susu (misal: puding, puding yogurt berperisa atau yogurt dengan buah)

M1

0.5

• 24 negara mengatur 0.5 ppb (termasuk CAC 2003) • 34 negara mengatur 0 0.05 05 ppb

8

Whey & produk whey kecuali keju whey

M1

0.5

AFLATOKSIN (SNI 7385:2009) No.

Jenis Pangan

Jenis

Batas Max. (ppb)

9

Kacang tanah & produk olahan

B1

15

• • • • •

Total

20

• Malaysia 35 ppb • 14 negara mengatur 20 ppb • 10 negara mengatur 15 ppb (termasuk CAC 2003, Australia) • Yordania, Y d i S Srilanka il k 30 ppb b

B1

15

• • • •

Total

20

• Malaysia, Kosta Rika 35 ppb

10

Jagung dan produk olahan

Regulasi Internasional 15 negara mengatur 15 ppb 4 negara mengatur 10 ppb Yordania 15 ppb Cina & Hongkong 20 ppb Data penelitian di Jabotabek (1990) 17% sampel mengandung 3.0-60 ppb aflatoksin B1

27 negara mengatur 5 ppb Mesir 10 ppb Cina 20 ppb Yordania 15 ppb

DON (SNI 7385:2009) No.

Jenis Pangan

Jenis

Batas Max. (ppb)

Regulasi internasional

1

Gandum

-

1750

• Kanada 2000 ppb • Ukraina 500 ppb • EU 2005 : 1750 ppb

2

Jagung

-

1750

• Bulgaria Bulgaria, Cina, Cina Iran 1000 ppb • Ceko 2000 ppb • Data penelitian pada jagung komersial di Jawa Tengan (1998) : 12% sampel positif mengandung DON rata-rata 29.5 ppb

3

Produk olahan jagung sebagai bahan baku

-

1000

• Regulasi EU 2005 : 750 ppb

4

Produkolahan terigu sebagai bahan baku

-

1000

• Kanada 1200 ppb (untuk terigu) • Regulasi EU 2005 : 750 ppb

5

Produk olahan terigu siap konsumsi (pastri, roti, biskuit, snack)

-

500

• • • •

6

Pasta & mie serta produk sejenisnya

-

750

• Regulasi EU 2005 : 750 ppb produk ini perlu pengolahan lebih lanjut

7

MP-ASI MP ASI berbasis terigu

-

200

• • • •

Regulasi EU 2005 & Ukraina : 500 ppb Jepang 1100 ppb Cina, Iran, Ukraina, USA, Uruguay : 1000 ppb Armenia, Belarus, Estonia, Moldova, Rusia : 700 ppb b

Regulasi EU 2005 & Ukraina 200 ppb Kanada 600 ppb Belarusia tidak mengizinkan Harus lebih rendah dari kategori pangan lainnya karena dikonsumsi oleh balita

FUMONISIN (SNI 7385:2009) No.

Jenis Pangan

Jenis

Batas Max. (ppb)


1

Jagung

-

2000

• • • • •

Kuba 1000 ppb (FB1) USA 2000-4000 ppb (FB1+FB2+FB3) Iran Swiss Iran, Swiss, Bulgaria 1000 ppb (FB1+FB2) EU 2005 : 2000 ppb (FB1+FB2) Data penelitian (2000) pada jagung di Jawa Timur menunjukkan 100% positif mengandung fumonisin rata-rata 514.25 ppb; di Bandung 73% mengandung fumonisin rata-rata 11540 ppb; di Cianjur 100% mengandung fumonisin rata-rata 28380 ppb; di Bogor 100% mengandung fumonisin ratarata 3540 ppb

2

Produk olahan jagung sebagai b ib bahan h b baku k

-

2000

• Regulasi EU 2005 (FB1 + FB2) 1000 ppb • Perancis P i 1000 1000-3000 3000 ppb b (FB1) • USA 2000-4000 ppb (FB1+FB2+FB3)

3

Produk olahan jagung siap konsumsi (corn flakes, popcorn, corn chips)

-

1000

• • • • •

Kuba 1000 ppb (FB1) Iran Swiss Iran, Swiss, Bulgaria 1000 ppb (FB1 + FB2) Regulasi EU 2005 : 400 pb (FB1+FB2) Perancis 1000-3000 ppb (FB1) USA 2000-4000 ppb (FB1+FB2+FB3)

OKRATOKSIN A (SNI 7385:2009) No.

Jenis Pangan

Jenis

Batas Max. (ppb)


1

Serealia (padi, jagung, sorgum, gandum)

-

5

• Eropa, Turki, Slovenia, spanyol, swedia, Portugal, Polandia, Norwegia, Belanda, Liechtenstein, Lithuania, Luxembourg, Italia, Islandia, Irlandia, Hungaria, Finlandia, Perancis, Jerman, Yunani, Denmark, Bulgaria, Belgia, Austria (24 negara yang mengatur okratoksin pada serealia sebagai bahan baku sebesar 5 ppb) • Data penelitian tahun 2000 pada jagung menunjukkan 60.6% positif mengandung okratoksin rata-rata 68.41 ppb

2

Produk olahan serealia sebagai bahan baku

-

5

• Eropa, Turki, Slovenia, spanyol, swedia, Portugal, Polandia, Norwegia, Belanda, Liechtenstein Lithuania Liechtenstein, Lithuania, Luxembourg Luxembourg, Italia Italia, Islandia, Irlandia, Hungaria, Finlandia, Perancis, Jerman, Yunani, Denmark, Bulgaria, Belgia, Austria (24 negara yang mengatur okratoksin pada serealia sebagai bahan baku sebesar 5 ppb)

3

Produk olahan serealia siap konsumsi

-

3

• EU 2005, Turki, Slovenia, Spanyol, Swedia, Portugal, Polandia, Norwegia, Belanda, Liechtenstein, Lithuania, Luxembourg, Italia, Islandia Irlandia Islandia, Irlandia, Hungaria, Hungaria Finlandia Finlandia, Perancis Perancis, Jerman, Yunani, Denmark, Ceko, Bulgaria, Belgia, Austria (25 negara dari 33 negara yang mengatur okratoksin pada produk serealia sebagai bahan baku siap konsumsi)

OKRATOKSIN A (SNI 7385:2009) No.

Jenis Pangan

Jenis

Batas Max. (ppb)


4

MP-ASI berbasis serealia

-

0.5

• Regulasi EU 2005, Italia, Swiss, 0.5 ppb • Ceko, Iran, Slovakia 1 ppb • Rumania 5 ppb

5

Rempah-rempah

-

20

• Swiss 20 ppb, Bulgaria 10 ppb

6

Buah anggur kering termasuk kismis

-

10

• EU 2005, Turki, Swedia, Spanyol, Slovenia, g , Polandia,, Norwegia, g , Belanda,, Portugal, Luxembourg, Lithuania, Liechtenstein, Italia, Irlandia, Iran, Islandia, Hungaria, Yunani, Jerman, Perancis, Finlandia, Denmark, Belgia, Austria 10 ppb (24 negara dari 26 negara yang e ga u o okratoksin a o s pada bua buah kering) e g) mengatur

7

Sari buah anggur

-

2

• Regulasi EU 2005 2 ppb, Bulgaria 3 ppb, Italia 50 ppb

8

Kopi sangrai termasuk kopi bubuk

-

5

• Regulasi Eu 2005 & Kuba 5 ppb, Bulgaria & Italia 4 ppb, Yunani 20 ppb, Hungaria 10 ppb, Singapura 2.5 ppb, Uruguay 50 ppb

9

Kopi instan

-

10

• Regulasi EU 2005 10 ppb

10

Bir

-

0.2

• Italia, Bulgaria 0.2 ppb

PATULIN (SNI 7385:2009) No.

Jenis Pangan

Jenis

Batas Max. (ppb)


1

Buah apel segar

-

50

• Singapura 50 ppb

2

Buah apel dalam kaleng

-

50

• Ukraina, Slovakia, Singapura, rusia, Hungaria, E t i Kuba, Estonia, K b B Belarus l (8 negara yang mengatur patulin pada buah apel dalam kaleng sebesar 50 ppb )

3

Puree apel

-

25

• Eropa, UK, Swedia, Spanyol, Slovenia, Portugal, Norwegia, Belanda, Luxembourg, Liechtenstein, Italia, Irlandia, Islandia, Yunani, Jerman, Perancis, Finlandia, Denmark, Belgia, Austria (20 negara yang mengatur patulin pada puree p sebesar 25 pp ppb)) apel

4

Sari buah apel

-

50

5

Nektar apel

-

50

• Codex, Eropa, Uruguay, USA, UK, Turki, Swiss, Spanyol, swedia, Slovenia, Singapura, Serbia & Montenegro, Rusia, Rumania,Portugal Polandia, N Norwegia, i b belanda, l d M Maroko, k M Moldova, ld Luxembourg, Liechtenstein, Latvia, Korea, Jepang, Italia, Israel, Irlandia, Iran, Islandia, Yunani, Jerman, perancis, Finlandia, denmark, Kuba, Kroasia, Cina, bulgaria, Belgia, Austria : 50 ppb b (41 negara d darii 44 negara yang mengatur patulin pada sari buah dan nektar apel)

PATULIN (SNI 7385:2009) No.

Jenis Pangan

Jenis

Batas Max. (ppb)


6

MP-ASI berbasis apel

-

10

• Eropa, UK, Swedia, Spanyol, Slovenia, Portugal, Norwegia, Belanda, Luxembourg, Liechtenstein, Italia, Irlandia, Islandia, Yunani, Jerman, Perancis Finlandia Perancis, Finlandia, Denmark Denmark, Belgia Belgia, Austria (20 negara dari 21 negara yang mengatur patulin pada MP-ASI berbasis apel sebesar 10 ppb)

7

Minuman beralkohol berbasis apel

-

50

• Eropa, UK, Swedia, Spanyol, Slovenia, Portugal, Norwegia, Belanda, Luxembourg, Liechtenstein, Italia Irlandia, Italia, Irlandia Islandia, Islandia Yunani, Yunani Jerman Jerman, Perancis, Finlandia, Denmark, Belgia, Austria (20 negara yang mengatur patulin pada pada minuman beralkohol berbasis apel 50 ppb)

HARMONISASI STANDARD KEAMANAN PANGAN

7 th ASEAN Food Safety y Standards Harmonization Workshop, May, 2008, Malaysia Results: Countryy members agreed g to add contaminants in their harmonization targets for next meeting in 2009. - Heavy metals : tin, lead, mercury, arsenic (organic/inorganic), cadmium - Mycotoxins: Aflatoxins (B/G, M1), ochratoxin - Process contaminants: 3-MCPD

8th ASEAN Food Safety Standards Harmonization Workshop, September 20 – October 1, 2009, Indonesia Results: For the 8th installment in this series of annual workshops, food regulatory representatives from the ASEAN countries provided updates on the regulatory status in their respective countries, focusing on colorings sweeteners colorings, sweeteners, preservatives and other additives additives. In addition, emerging issues related to contaminants, eg. melamine, the threshold of toxicological concept and microbial standards were also discussed. discussed Next .. 9 th ASEAN Food Safety Standards Harmonization Workshop, January 11-12, 2011, Singapore

PENGEMBANGAN METODE ANALISIS MIKOTOKSIN

Analytical methods for mycotoxins

Solid Phase Extraction (SPE) Immunoaffinityy Column (IAC)

Routine methods

GC, HPLC, ELISA

ANALYTICAL METHODS

Rapid/Emerging methods

LFD, dipsticks, FPIA, NIR, LC-MS/MS ...

Reference methods/Official methods

AOAC International, CEN

Angelo Visconti , 2010 Institute of Sciences of Food Production (ISPA) National Research Council of Italy (CNR)

Development of a Protocol for Increasing Risk Assessment and Analysis of Mycotoxin in Foods in Climate Change Context

PROM, Badan POM RI & WHO Project (2009) : review pengembangan protokol analisis mikotoksin sesuai SNI Harmonisasi antar: 1. UGM 2 IPB 2. 3. BBalitvet 4. Pusat Pengujian Obat dan Makanan Nasional (PPOMN) 5 Pusat 5. P t Riset Ri t Obat Ob t dan d Makanan M k (PROM)

Development of a Protocol for Increasing Risk Assessment and Analysis of Mycotoxin in Foods in Climate Change Context REKOMENDASI JENIS MIKOTOKSIN

METODE ANALISA YANG DIREKOMENDASIKAN

Aflatoksin

Menggunakan HPLC pada kacang tanah (PPOMN) Menggunakan HPLC pada lada (PPOMN) Menggunakan SPE-HPLC pada jagung (Balitvet)

Okratoksin A

Menggunakan HPLC pada kakao bubuk (Puslit Kopi Kakao) Menggunakan IAC-HPLC pada kakao bubuk (Puslit Kopi Kakao) Menggunakan HPLC pada jagung & sereal (BBalitvet)

Deoksinivalenol (DON)

Menggunakan IAC-HPLC detektor UV (UGM)

Fumonisin

Menggunakan HPLC pada jagung & sereal (Bbalitvet)

Patulin

Menggunakan HPLC pada jus apel (AOAC, 1995.10) Menggunakan HPLC pada jus apel & pure (AOAC 2000.02)

METODE ANALISA MIKOTOKSIN YANG TELAH DAN AKAN DIKEMBANGKAN BADAN POM RI JENIS MIKOTOKSIN Aflatoksin

METODE ANALISA Menggunakan HPLC pada kacang tanah (PPOMN) Menggunakan HPLC pada lada (PPOMN)

Okratoksin A

Menggunakan HPLC pada kakao bubuk (PPOMN)

Deoksinivalenol (DON)

Menggunakan IAC-HPLC pada jagung (PPOMN)

M Menggunakan k IAC-HPLC IAC HPLC pada d sereall (PROM) next..... t Fumonisin

Menggunakan IAC-HPLC detektor FL pada jagung (PROM)

Patulin

Menggunakan HPLC pada jus apel (AOAC, 1995.10)

REFERENCE 9 SELAMAT (www.selamat.net) 9 MoniQa M iQ ((www.moniqa.org) i ) 9 RASFF (www.ec.europa.eu/food/food/rapidalert/index_en.htm) 9 EFSA (www.efsa.europa.eu) 9 MycoRed (www.mycored.eu)

Tanjung Kelayang Beach, Belitung Island

TERIMA KASIH TERIMA KASIH Matur M t kesuwun

Contact information: Wi i ti P. Winiati P Rahayu R h Kepala Pusat Riset Obat dan Makanan-Badan POM RI Jl.Percetakan Negara No.23, Jakarta Pusat 10560 Telp./fax. 021-42887351, Email: [email protected]

Winiati P. Rahayu dan Khusnul Khotimah JEJARING INTELIJEN PANGAN NASIONAL PUSAT RISET OBAT DAN MAKANAN BADAN POM RI

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