contamination of maleic anhydride modified starch...

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2014/SCSC/WKSP1/011

Contamination of Maleic Anhydride Modified Starch in Food

Submitted by: Chinese Taipei

Workshop on Improved Food Inspection Capacity Building Based on Risk Analysis

Seoul, Korea21-23 May 2014

藥求安全藥求安全食在安心食在安心

衛生福利部食品藥物管理署Food and Drug Administration, Ministry of Health and Welfare

藥求安全藥求安全食在安心食在安心

http://www.fda.gov.tw/

Baoren Jiang, DVMBaoren Jiang, DVM

Taiwan Food and Drug Taiwan Food and Drug Administration Administration May 23, 2014May 23, 2014

1

藥求安全食在安心

OutlineOutlinelBasic InformationlActions TakenlAmendment of the Act l Information Transparent and Consumer

ProtectionlConclusions

歡迎至本署網站查詢更多資訊http://www.fda.gov.tw/

lBasic InformationlActions TakenlAmendment of the Act l Information Transparent and Consumer

ProtectionlConclusions

2

藥求安全食在安心

Basic InformationBasic Information

歡迎至本署網站查詢更多資訊http://www.fda.gov.tw/

3

Modified Modified Starch for Starch for FFood Useood Usev Modified starch is a starch treated with chemicals to

modify its physical characteristics, such as viscosity, texture, and stability.

v In Taiwan, modified starch for food use, is classified as food additive-pasting agent to increase the viscosity. 21 modified starches were approved by FDA as food additives.

v Food additive shall be registered and receive a permit from FDA.

v Modified starch is a starch treated with chemicals to modify its physical characteristics, such as viscosity, texture, and stability.

v In Taiwan, modified starch for food use, is classified as food additive-pasting agent to increase the viscosity. 21 modified starches were approved by FDA as food additives.

v Food additive shall be registered and receive a permit from FDA.

4

Starch＋

Maleic Anhydride Modified StarchMaleic Anhydride Modified Starch

chemical synthesis

Maleic anhydride modified starch1.not approved as food additive2.currently its metabolic

mechanism in animal and human is not clearly understood

Maleic Anhydride Modified Starch

Maleic Anhydride

＋ Maleic anhydride modified starch1.not approved as food additive2.currently its metabolic

mechanism in animal and human is not clearly understood

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Maleic AnhydrideMaleic Anhydride

SynonymsSynonymscis-butenedioic anhydride

BackgroundBackground

UsagesUsagesUsagesUsagesv an ingredient to manufacture trans-butenedioic

acid, tartaric acid, malic acid, and resinv used in food packaging materials, and is an

indirect food additive approved by the US FDA and EU EFSA; may exist in trace amount in legal food additives such as malic acid and trans-butenedioic acid

6

Maleic AcidMaleic Acid

SynonymsSynonymscis-butenedioic acid

Possible sources in foodPossible sources in food

BackgroundBackground

Possible sources in foodPossible sources in foodv transformed from malic acid and trans-butenedioic acid

in fermentation or produced via maillard reaction during high temperature baking

v migrating into foods from packaging materials with legally adding maleic acid

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Toxicity Maleic acid Maleic anhydrideacute toxicity Low (LD50 708 mg/Kg, Rat) Low (LD50 400 mg/Kg, Rat)

reproductive anddevelopmental toxicity, genotoxicity,carcinogenicity

none none

nephrotoxicity v Kidney damage was observed in dog with a single dose of 9 mg/kg maleic acid.

v In the same study, no nephrotoxicity was observed in rat, mice and monkey,at doses of 117, 191, and 29 mg/kg maleic acid, respectively. It indicates animals of different species show different sensitivity.

v US EPA reported that no kidney damage was observed in a dose of 100 mg/kg maleic anhydride every day for 2 years in rat.

v Similarly, no kidney damagewas observed in a dose of 60 mg/kg maleic anhydride every day for 90 days in dog.

Safety of Maleic Safety of Maleic Acid/Maleic AnhydrideAcid/Maleic Anhydride

v Kidney damage was observed in dog with a single dose of 9 mg/kg maleic acid.

v In the same study, no nephrotoxicity was observed in rat, mice and monkey,at doses of 117, 191, and 29 mg/kg maleic acid, respectively. It indicates animals of different species show different sensitivity.

v US EPA reported that no kidney damage was observed in a dose of 100 mg/kg maleic anhydride every day for 2 years in rat.

v Similarly, no kidney damagewas observed in a dose of 60 mg/kg maleic anhydride every day for 90 days in dog.

Based on EFSA’s information, a TDI (tolerable daily intake) of 0.5 mg/kg is set for maleic acid

TDITDI

8

Risk Assessment of Maleic AcidRisk Assessment of Maleic Acidv TDI (Tolerable Daily Intake) 0.5 mg/kg for a 60 kg adult

0.5 mg/kg × 60 kg = 30 mg/dayv Risk Assessment：

v Assume tapioca balls contain 400 mg/kg maleic acid. More than 75 g tapioca balls (250 tapioca balls) would be consumed every day over a long period of time to exceed the TDI.

v 30 mg/day ÷ 400 mg/kg = 75 g/day

v TDI (Tolerable Daily Intake) 0.5 mg/kg for a 60 kg adult0.5 mg/kg × 60 kg = 30 mg/day

v Risk Assessment：v Assume tapioca balls contain 400 mg/kg maleic acid.

More than 75 g tapioca balls (250 tapioca balls) would be consumed every day over a long period of time to exceed the TDI.

v 30 mg/day ÷ 400 mg/kg = 75 g/day

It is postulated that maleic anhydride modified starch may be metabolized and transform to maleic acid and absorbed completely after injection.

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Actions TakenActions TakenActions TakenActions Taken

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Sequential steps一二三四五六日

2月

1 2 34 5 6 7 8 9 10

11 12 13 14 15 16 1718 19 20 21 22 23 2425 26 27 28

3月

1 2 34 5 6 7 8 9 10

11 12 13 14 15 16 1718 19 20 21 22 23 2425 26 27 28 29 30 31

4月

1 2 3 4 5 6 78 9 10 11 12 13 14

Step 1: Latent period 2/4~3/15

Step 2: Tracing back and pre-investigation 3/18~5/13

Step 3: News release 5/10~5/13

Step 4: Enforce inspection national wide 5/14~

4月

8 9 10 11 12 13 1415 16 17 18 19 20 2122 23 24 25 26 27 2829 30

5月

1 2 3 4 56 7 8 9 10 11 12

13 14 15 16 17 18 1920 21 22 23 24 25 2627 28 29 30 31

6月

1 23 4 5 6 7 8 9

10 11 12 13 14 15 16

Step 1: Latent period 2/4~3/15

Step 2: Tracing back and pre-investigation 3/18~5/13

Step 3: News release 5/10~5/13

Step 4: Enforce inspection national wide 5/14~

11

Latent period 2/4~3/15

n Whistle blower：in Feb, 2013, TFDA was informed that manufacturers use unapproved maleic anhydride to make food chewy (QQ).

n Relevant information was collected and testing method was developed immediately.

一二三四五六日

2月

1 2 34 5 6 7 8 9 10

11 12 13 14 15 16 1718 19 20 21 22 23 2425 26 27 28

3月

1 2 34 5 6 7 8 9 10

11 12 13 14 15 16 1718 19 20 21 22 23 2425 26 27 28 29 30 311 2 3 4 5 6 78 9 10 11 12 13 14

n Whistle blower：in Feb, 2013, TFDA was informed that manufacturers use unapproved maleic anhydride to make food chewy (QQ).

n Relevant information was collected and testing method was developed immediately.

4月

8 9 10 11 12 13 1415 16 17 18 19 20 2122 23 24 25 26 27 2829 30

5月

1 2 3 4 56 7 8 9 10 11 12

13 14 15 16 17 18 1920 21 22 23 24 25 2627 28 29 30 31

6月

1 23 4 5 6 7 8 9

10 11 12 13 14 15 1612

Tracing back and pre-investigation 3/18~5/13n Development of testing method

n Sampling starch products in market：74 samples including relevant starches and starch based products such as sweet potato balls, tapioca balls, taro balls, etc. were tested and 5 of them were maleic acid positive

n Tracing back：tracking and tracing the source and distribution of products and ingredients involved; recalls, and taking products off the shelves


2月

1 2 34 5 6 7 8 9 10

11 12 13 14 15 16 1718 19 20 21 22 23 2425 26 27 28

3月

1 2 34 5 6 7 8 9 10

11 12 13 14 15 16 1718 19 20 21 22 23 2425 26 27 28 29 30 311 2 3 4 5 6 78 9 10 11 12 13 14

n Development of testing method

n Sampling starch products in market：74 samples including relevant starches and starch based products such as sweet potato balls, tapioca balls, taro balls, etc. were tested and 5 of them were maleic acid positive

n Tracing back：tracking and tracing the source and distribution of products and ingredients involved; recalls, and taking products off the shelves

4月

8 9 10 11 12 13 1415 16 17 18 19 20 2122 23 24 25 26 27 2829 30

5月

1 2 3 4 56 7 8 9 10 11 12

13 14 15 16 17 18 1920 21 22 23 24 25 2627 28 29 30 31

6月

1 23 4 5 6 7 8 9

10 11 12 13 14 15 1613

News release 5/10~5/13

n May 13, 2013：TFDA released news about this incident and published all relevant information. Calling for starch related producers should self control, avoid using unapproved modified starch.


2月

1 2 34 5 6 7 8 9 10

11 12 13 14 15 16 1718 19 20 21 22 23 2425 26 27 28

3月

1 2 34 5 6 7 8 9 10

11 12 13 14 15 16 1718 19 20 21 22 23 2425 26 27 28 29 30 311 2 3 4 5 6 7

10 11 12 13 14

n May 13, 2013：TFDA released news about this incident and published all relevant information. Calling for starch related producers should self control, avoid using unapproved modified starch.

4月

1 2 3 4 5 6 78 9 10 11 12 13 14

15 16 17 18 19 20 2122 23 24 25 26 27 2829 30

5月

1 2 3 4 56 7 8 9 10 11 12

13 14 15 16 17 18 1920 21 22 23 24 25 2627 28 29 30 31

6月

1 23 4 5 6 7 8 9

10 11 12 13 14 15 16 14

Enforce inspection national wide5/14n complete the investigation, recall, seal,

and destroy the illegal products

n enforce the overall inspection to starch factories and additives relevant companies

n Start of 0527 Food Safety Project :ü relevant food manufacturers shall provide the

affidavit or certificate to the sellers to ensure the safety


2月

1 2 34 5 6 7 8 9 10

11 12 13 14 15 16 1718 19 20 21 22 23 2425 26 27 28

3月

1 2 34 5 6 7 8 9 10

11 12 13 14 15 16 1718 19 20 21 22 23 2425 26 27 28 29 30 311 2 3 4 5 6 78 9 10 11 12 13 14

n complete the investigation, recall, seal, and destroy the illegal products

n enforce the overall inspection to starch factories and additives relevant companies

n Start of 0527 Food Safety Project :ü relevant food manufacturers shall provide the

affidavit or certificate to the sellers to ensure the safety

4月

8 9 10 11 12 13 1415 16 17 18 19 20 2122 23 24 25 26 27 2829 30

5月

1 2 3 4 56 7 8 9 10 11 12

13 14 15 16 17 18 1920 21 22 23 24 25 2627 28 29 30 31

6月

1 23 4 5 6 7 8 9

10 11 12 13 14 15 1615

0527 Food Safety Project0527 Food Safety Projectv Health authorities complete the investigations, recall and

seal the non-compliant products and destroy the product within 1 week

v All manufacturers of starch based products shall provide Affidavit or Certificate to the sellers

v Health authorities start the overall inspection from June 1v Speed up amendment of the Act Governing Food

Sanitationv Cooperation among governmental Agencies: chemical

management, food exporting, and public communications

v Health authorities complete the investigations, recall and seal the non-compliant products and destroy the product within 1 week

v All manufacturers of starch based products shall provide Affidavit or Certificate to the sellers

v Health authorities start the overall inspection from June 1v Speed up amendment of the Act Governing Food

Sanitationv Cooperation among governmental Agencies: chemical

management, food exporting, and public communications

16

0527 Food Safety Project0527 Food Safety ProjectInspection of Affidavit or Certificate ProvidedInspection of Affidavit or Certificate Provided

starting from June 1starting from June 1

17 17

0527 Food Safety Project0527 Food Safety ProjectSafe Food Logo is Designed and Distributed Safe Food Logo is Designed and Distributed

by Local Health Bureausby Local Health Bureaus

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Asking staff in operation line, in particular for recipe, raw material coming in record

Package

Audit in place

Asking staff in operation line, in particular for recipe, raw material coming in record

Food Additives

Operation area

19

Relevant starch manufacturers involvedn Until June 30, 2013, testing 3094 samples.n Test results: 249 positive to MC (79 products, 170

ingredients)p chemical sellers involved: 4p starch manufacturers involved: 9p starch importer involved: 1p starch dealers involved:71p products involved: 11

n Until June 30, 2013, testing 3094 samples.n Test results: 249 positive to MC (79 products, 170

ingredients)p chemical sellers involved: 4p starch manufacturers involved: 9p starch importer involved: 1p starch dealers involved:71p products involved: 11

20

Maleic Acid positive rate

34.5%

53.8%

31.9%40.0%

50.0%

60.0%

Until June 30, 2013, testing 3094 samples, 249 cases were positive to MC

34.5%31.9%

13.7%

8.3% 5.7% 5.3%1.1% 0.0

0.0%

10.0%

20.0%

30.0%

40.0%

4/16~4/25 4/26~5/6 5/7~5/13 5/14~5/20 5/21~5/27 5/28~6/3 6/4~6/10 6/11~6/17 6/18~6/30

29 13 47 415 723 1364 393 94 16

檢

出

率(

%)

抽樣日期

檢驗件數

製表日期：102年7月22日(一) 21

starch manufacturers involved

27 27 27 27 27 27

3743 45 45 45

48 50 52

6671 71 71 71 71

30

40

50

60

70

80

家

數

Producer (9)

Dealer (71)

8 8 8 8 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 914

17 1923

27 27 27 27 27 27

0

10

20

30

統計日期

統計日期：102年7月22日

22

Recalls of Maleic Acid Positive Food Products Recalls of Maleic Acid Positive Food Products and Ingredientsand Ingredients

By June 3, 2013, 392 tons of products and ingredients were recalled.

166.40

140.00 160.00 180.00 公噸tons

5/27 6/1enhance enforcement

39.95

111.45

74.13

0.00 20.00 40.00 60.00 80.00

100.00 120.00 140.00

5/14~5/21 5/22~5/26 5/27~5/31 6/1~6/3統計日期

新增回收封存量趨勢圖

date

23

Amendment of Amendment of Act Governing Food SanitationAct Governing Food Sanitation


24


v The statutory bill passed by the legislative Yuan on May 31, 2013

v The statutory bill passed by the legislative Yuan on May 31, 2013

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Main Points of the Amendment Main Points of the Amendment (1/2)(1/2)

v Strengthen domestic food businesses managementvStipulate food businesses taking responsibilities of self

management vMandate specific food business to register before doing

businessvEstablish food tracing and tracking systemvAdditional mandatory labeling Items

v Strengthen domestic food businesses managementvStipulate food businesses taking responsibilities of self

management vMandate specific food business to register before doing

businessvEstablish food tracing and tracking systemvAdditional mandatory labeling Items

26

Main Points of the Amendment Main Points of the Amendment (2/2)(2/2)v Impose heavier penalties

v Impose heavier fines (up to 15 million NT dollars); v For adulteration, counterfeiting, using unapproved

additives or causing death, the people will be put in jail for 3 years.

vConsumer protectionv Consumer damage compensate, whistleblower protection

or penalty reduction to whistleblower

v Impose heavier penaltiesv Impose heavier fines (up to 15 million NT dollars); v For adulteration, counterfeiting, using unapproved

additives or causing death, the people will be put in jail for 3 years.

vConsumer protectionv Consumer damage compensate, whistleblower protection

or penalty reduction to whistleblower

27

Information Transparent and Information Transparent and Consumer ProtectionConsumer Protection

Information Transparent and Information Transparent and Consumer ProtectionConsumer Protection

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Information Transparent & Consumer ProtectionInformation Transparent & Consumer Protectionv Set up a section of Maleic Anhydride Modified Starch on

the websites of TFDA v TFDA has set up Consumer Hotline at 02-27878200v 26 hospitals of DOH provide related medical

consultations; if one consumes food products with modified starches and has any health concern, physicians can help in outpatient referral if needed

v Set up a section of Maleic Anhydride Modified Starch on the websites of TFDA

v TFDA has set up Consumer Hotline at 02-27878200v 26 hospitals of DOH provide related medical

consultations; if one consumes food products with modified starches and has any health concern, physicians can help in outpatient referral if needed

29

藥求安全食在安心ConclusionsConclusions

Source has been controlled and the inspection has completed. The DOH ensure food safety and the reputation for foods in Taiwan.

歡迎至本署網站查詢更多資訊 http://www.fda.gov.tw/

Source has been controlled and the inspection has completed. The DOH ensure food safety and the reputation for foods in Taiwan.

30

THANK YOU FOR YOUR ATTENTIONTHANK YOU FOR YOUR ATTENTION

歡迎至本署網站查詢更多資訊 http://www.fda.gov.tw/ 31

歡迎至本署網站查詢更多資訊歡迎至本署網站查詢更多資訊 http://www.fda.gov.tw/http://www.fda.gov.tw/

安門安門

安全安全

安通安通安產安產

安定安定

歡迎至本署網站查詢更多資訊歡迎至本署網站查詢更多資訊 http://www.fda.gov.tw/http://www.fda.gov.tw/

安門安門

安全安全

安通安通安產安產

安定安定

安通安通安產安產安通安通安產安產

32

contamination of maleic anhydride modified starch...

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