1

陈君石 Junshi Chen, M.D.

Institute of Nutrition and Food Safety, Chinese Center for Disease Control and Prevention,

Beijing, China

The application of risk assessment in food safety control in

mainland China

Risk Analysis Framework

Risk Assessment

• Science based

Risk Management• Policy based

Risk Communication

• Inter active exchange of information and

opinions concerning risks

FAO/WHO encourages member countries to develop national food control measures based on risk assessment, in order to assure proper protection level to consumers and facilitate fair trade.

This is particularly important for developing countries, because it is clearly stated in the SPS Agreement that: SPS measures should be based on risk assessment techniques developed by relevant international organizations.

Importance of risk assessment

As scientific basis for food standard development;

For setting up priorities in food inspection and control;

For evaluating the success of various food safety control measures; and

Important sources of information for risk communication.

Basic components of risk assessment

Hazard identification

Hazard characterization

Exposure assessment

Risk characterization

It is not necessary for each country to conduct own risk characterization.

However, it is necessary to conduct exposure assessment by each individual country, because exposure to food chemicals varies from country to country.

2

In mainland China, risk assessment of food chemicals has been applied in developing national food safety standards (e.g. heavy metals, pesticides residues, food additives, etc.) and assessing emerging chemical hazards in food (e.g. choloropropanols, acrylamide, dioxins etc.).

Examples of exposure assessment

Food additives

Dioxins

Choloropropanols - 3-MCPD

Acrylamide

Food additives

Dietary exposure of 10 common food additives was assessed using probabilistic model

Data – (1) food consumption data of 3-6, 7-15 and 20-50 year-old group from 2002 National Nutrition and Health Survey, N= 47,439. (2) maximum use level and national monitoring data of food additives.

Dietary intakes of each additive was compared with JECFA ADI.

Exposure assessment of saccharin– based on maximum use level（male, mg/kg bw/day）

Exp

osur

e(m

g/kg

bw

/day

)

0

0.5

1

1.5

2

2.5

3

mean P 95 P 97.5

3-6 yr.

7-15 yr.

20-50 yr.

ADI 5 mg/kg bw/day

Exposure assessment of saccharin– based on average detected level

（male, mg/kg bw/day）

Exp

osur

e(m

g/kg

bw

/day

)

0

0.1

0.2

0.3

0.4

mean P 95 P 97.5

3-6 yr.

7-15 yr.

20-50 yr.

ADI 5 mg/kg bw/day

Exposure assessment of saccharin– based on P97.5 detected level（male, mg/kg bw/day）

Exp

osur

e(m

g/kg

bw

/day

) ADI 5 mg/kg bw/day

0

0.3

0.6

0.9

1.2

1.5

1.8

2.1

mean P 95 P 97.5

3-6 yr.

7-15 yr.

20-50 yr.

3

Exposure assessment of sodium benzoate– based on maximum use level（male, mg/kg bw/day）

Exp

osur

e(m

g/kg

bw

/day

)

0

1

2

3

4

mean P 95 P 97.5

3-6 yr.

7-15 yr.

20-50 yr.

ADI 5 mg/kg bw/day

Exposure assessment of sodium benzoate– based on average detected level

（male, mg/kg bw/day）

Exp

osur

e(m

g/kg

bw

/day

)

0

0.5

1

1.5

2

2.5

mean P 95 P 97.5

3-6 yr.

7-15 yr.

20-50 yr.

ADI 5 mg/kg bw/day

Exposure assessment of sodium benzoate– based on P97.5 detected level（male, mg/kg bw/day）

Exp

osur

e(m

g/kg

bw

/day

) ADI 5 mg/kg bw/day

0123456789

10

mean P 95 P 97.5

3-6 yr.

7-15 yr.

20-50 yr.

Study sites of Total Diet Study in China (2000)Study sites of Total Diet Study in China (2000)

South 2South 2

North 1North 1 North 2North 2

South 1South 1

Levels of PCDD/Fs and Dioxin-like PCBs in Chinese food (pg WHO-TEQ/g)

South 2South 1North 2North 1

PCBsPCDD/FsPCBsPCDD/FsPCBsPCDD/FsPCBsPCDD/Fs

0.010.0440.010.0410.0080.0230.0120.026Milk

0.090.1380.160.2760.170.1010.240.183Fish

0.040.0660.070.1230.040.0620.050.211Meat

0.070.1180.070.0540.040.0310.050.089Egg

Dioxins

0

0.05

0.1

0.15

0.2

0.25

0.3

0.35

0.4

0.45

Egg Meat Fish Milk Egg Meat Fish Milk Egg Meat Fish Milk Egg Meat Fish Milk

PCBsPCDD/Fs

North 1 North 2 South 1 South 2

Levels of PCDD/Fs and Dioxin-like PCBs in Chinese food (pg WHO-TEQ/g)

4

Dietary intakes of PCDD/Fs and Dioxin–like PCBs and contribution from each food group

(pg WHO-TEQ/person*/day)

8.11[37.6%]

0.21

3.94

1.92

2.04

PCBs

21.93[38.4%]

0.88

6.89

10.21

3.95

PCBs

3.88[42.8%]

0.55

1.55

1.02

0.76

PCBs

13.3[34.8%]

0.73

3.24

6.84

2.49

PCBs

South 2South 1North 2North 1

sumPCDD/F

ssumPCDD/FssumPCDD/Fssum

PCDD/

Fs

0.80(3.7% )

0.593.28

(5.7%)2.4

2.13(23.5%)

1.582.31(6%)

1.58Milk

21.613.45[62.4%]57.135.17

[61.6%]9.065.18[57.2%]38.1924.89

[65.2%] Total

10.43(48.4%)

6.4919.01

(33.3%)12.12

3.95(43.6%)

2.416.91

(44.3%)13.67Fish

4.86(22.5%)

2.9427.82

(48.7%)17.61

1.63(18%)

0.6112.06

(31.6%)5.22Meat

5.47(25.4%)

3.436.99

(12.2%)3.04

1.35(14.9%)

0.596.91

(18.1%)4.42Egg

* Adult male

0

10

20

30

40

50

60

Egg Meat Fish Milk Total Egg Meat Fish Milk Total Egg Meat Fish Milk Total Egg Meat Fish Milk Total

PCBs

PCDD/Fs

Dietary intakes of PCDD/Fs and Dioxin-like PCBs in China (pg WHO-TEQ/person/day)

North 1 North 2 South 1 South 2

0

0.5

1

1.5

2

2.5

3

3.5

North1 North2 South1 South2 Japan U.S. Holland Finland Spain Belgium

PCBsPCDD/Fs

Comparison of dietary intakes of PCDD/Fs and Dioxin-like PCBs between countries

(pg TEQ/kg bw/day)

Concentrations of 3-MCPD in foods from 2000 China TDS (µg/kg)

0.0NDNDNDNDAlcohol

0.0NDNDNDNDBeverages

0.0NDNDNDNDSugar

2.35.7NDND3.6Milk

48.416.738.412810.6Aquatic foods

16.8ND42.324.7NDEgg

36.830.074.534.58.3Meat

1.14.5NDNDNDFruits

16.410.122.923.78.7Vegetables33.440.48.618.066.4Legumes

12.84.05.242.0NDPotatoes

3.46.63.3ND3.7Cereals

Average North 2North 1South 2South 1Food

choloropropanols

Comparison on dietary intakes of 3-MCPD among countries

% PMTDIRegion

741.48Holland

10.5%～40.50.21~0.81Australia

14.0%～16.40.29～0.34China average

12.9%～13.50.27～0.27North 2

16.4%～18.40.35～0.39North 1

15.1%～20.10.32～0.42South 2

10.2%～12.30.21～0.26South 1

µg/kg bw/day Study in Beijing

Subjects – 15-55 years-old, N=315

Food items – fried potato products, fried wheat flour sticks, instant noodle, traditional Chinese snacks, biscuits, pastries and breads, coffee (instant) and chocolate. N=150.

Acrylamide

5

12511811197214374Complimentary foods

999876ND6Infant formula, milk

373737361015ND10Infant formula, rice

536.0486.6437.3338.6153.5189.8238Chocolate

396.0390.2384.4372.995.0164.3478Coffee

191.0148.0104.953.220.032.6ND15.0Cakes, breads

1569.01385.71202.4835.8183.0367.4ND13Biscuits

734.0543.4433.2321.448.0111.7ND50Chinese snacks

145.0118.792.4856.36.524.3ND14Instant noodles

197.0186.5176155.063.579.1138Fried wheat sticks

5269.03435.43015.21743.8409.5751.7ND50Fried potato

Max.P97.5P95P90P50MeanMin.NFood

Concentrations of acrylamide in foods, µg/kg Dietary intakes of acrylamide(µg/kg bw/day)

Food consumption(g/d)

Contamination level (µg/kg)

6.745.452.770.201.14P97.5

5.684.582.330.160.97P95

3.833.071.570.110.66P90

0.800.620.340.020.15P50

1.611.260.660.050.29Mean

P97.5P95P90P50Mean

Contribution of various types of food to total dietary exposure of acrylamide (%)

64.862.964.856.262.3Cereal （2~5）6.16.57.314.69.5Chocolate3.33.85.36.05.5Coffee5.54.53.20.83.6Cakes, breads26.126.727.126.127.7Biscuits24.222.724.616.219.9Chinese snacks4.64.23.71.93.7Instant noodles4.44.86.211.27.4Fried wheat sticks25.926.722.623.322.6Fried potato

P97.5P95P90P50meanFood

MOE calculation based on JECFA approach (carcinogenicity)

1,034 (general population) 0.29*

186 (high consumers) 1.61**

MOEDietary intakes

(μg /kg bw/day )

* Mean concentration x Mean consumption ** Mean concentration x P 97.5 consumption

Study sites of Total Diet Study in China (2000)Study sites of Total Diet Study in China (2000)

South 2South 2

North 1North 1 North 2North 2

South 1South 1

Composite food samples:

Cereal

Legume

Nuts

Tuber

Meat & poultry

Egg

Sea food

Dairy

Vegetable

Fruit

Sugar

Beverage

Alcohol drinks

Water

6

Acrylamide content of food in 2000 TDS(µg/kg)

0.00.75.60.015.00.01.80.00.016.46.71.6

Average

(lower

limit)

ND0.65.1ND25.9ND3.4NDND15.46.2NDNorth 2

ND0.54.5ND19.3ND1.5NDND23.614.12.1North 1

ND1.287.0ND8.3NDNDNDND18.03.23.9South 2

ND0.525.8ND6.4NDNDNDND8.63.2NDSouth 1

Beve-

ragesAlcoholSugarFruitsVeg.Milk

Aquatic

foodsEggMeatTubersLegumeCerealRegion

Vegetables, tubers, cereals and

legumes accounted for 78% of

total acrylamide intake.

Exposure assessment and MOE calculation

2,1430.14China, average

1,5790.19North 2

1,5000.20North 1

2,7270.11South 2

5,0000.06South 1

MOEExposure

(µg/kg bw/day)Region

Comparison of China and JECFA evaluation

—2,143—0.14TDS

1861,0341.610.29Beijing

China

7530041JECFA

High consumer

General population

High consumer

General population

MOEAA intake (μg /kg bw/day )

SummaryThe application of risk assessment in food safety control in mainland China has just started. It is necessary to follow the international practice to conduct national RA and learned experience from developed countries.

Provisions on risk assessment should be specified in the national food legislation and independent expert risk RA bodies need to be established.