regulatory perspectives on gm food in indonesia

Current Regulatory Perspectives on GM Food

in Indonesia

Roy SparringaDeputy for Food Safety and Hazardous Substance Control

National Agency for Drugs and Food ControlThe Republic of Indonesia

ILSI SEA Region SILSI SEA Region SILSI SEA Region SILSI SEA Region Seminar on “Science and Regulatory Perspectives on

Stacked Events in Genetically Modified Crops” Jakarta, 22 – 23 September 2010

PRESENTATION AGENDAPRESENTATION AGENDA

Global situation and its regulatory perspectives

Policy on GMF in Indonesia

Conclusion and Recommendation

GMF Control in Indonesia

GLOBAL SITUATION AND ITS REGULATORY

PERSPECTIVES

CURRENT SITUATION ON GMOCURRENT SITUATION ON GMO

–– The global The global hectaragehectarage of GMOs has continued to grow of GMOs has continued to grow in 2009 and reached 134 million hectares in 2009 and reached 134 million hectares

–– Since 1996 the mean yearSince 1996 the mean year--toto--year growth is 7% equal year growth is 7% equal to 9 million hectaresto 9 million hectares

–– 25 countries planted GMOs in 2009 25 countries planted GMOs in 2009 –– 10 in Central 10 in Central and South Americaand South America

Source: James, C. 2009. Global Status of Commercialized Biotech/GM Crops: 2009. ISAAA

FUTURE PREDICTION ON GMOFUTURE PREDICTION ON GMO

•• Today around 30 commercial GM events are cultivated Today around 30 commercial GM events are cultivated worldwide, by 2015 the prediction is that there will be worldwide, by 2015 the prediction is that there will be over 120over 120

•• Moreover, individual GM events can easily be Moreover, individual GM events can easily be combined (‘stacked’) by conventional crosscombined (‘stacked’) by conventional cross--breedingbreeding

•• Apart from the current main traits , new commercial Apart from the current main traits , new commercial traits covering crop composition and traits covering crop composition and abioticabiotic stress stress tolerance will become availabletolerance will become available

Source: Office for Official Publications of the European Communities. 2009. The global pipeline of new GM crops: implications of asynchronous approval for international trade

in Indonesia

PERSPECTIVES

in Indonesia

PERSPECTIVES

in Indonesia

PERSPECTIVES

in Indonesia

PERSPECTIVES

in Indonesia

PERSPECTIVES

GLOBAL LEGAL SITUATIONS ON GMF GLOBAL LEGAL SITUATIONS ON GMF

•• GMF do not obtain simultaneously approved in GMF do not obtain simultaneously approved in everywhereeverywhere

•• Different countries show different legal situation, with Different countries show different legal situation, with different authorisation procedures different authorisation procedures

•• This asynchronous approval has an economic impact This asynchronous approval has an economic impact on international trade and may cause rejections of on international trade and may cause rejections of importsimports

•• In the EU such incidents have already disrupted trade In the EU such incidents have already disrupted trade and economic problemsand economic problems

•• Because of the differing regulations in each country, Because of the differing regulations in each country, the detection requirements for the GMO testing can the detection requirements for the GMO testing can be quite differentbe quite different

Trend in Food Science & Technology 18 (2007), 101-109

STACKED EVENT STACKED EVENT (1)(1)

!! Stacked event is GM Crops obtained through Stacked event is GM Crops obtained through conventional cross breeding (De conventional cross breeding (De SchrijverSchrijver et al. 2007).et al. 2007).

!! According to current regulatory practice within the EU, According to current regulatory practice within the EU, stacked events are considered as stacked events are considered as newGMOsnewGMOs: prior to : prior to marketing they need regulatory approval, including an marketing they need regulatory approval, including an assessment of their safety, similar to single events. In assessment of their safety, similar to single events. In other nations, like the United States, this may not be other nations, like the United States, this may not be obligatory (e.g. obligatory (e.g. KuiperKuiper, , KleterKleter, , NotebornNoteborn, & , & KokKok, 2001)., 2001).

!! Although stacked event products are entering global Although stacked event products are entering global markets with increasing frequency, existing international markets with increasing frequency, existing international approaches and data requirements for assessing their approaches and data requirements for assessing their safety are varied and are often nonsafety are varied and are often non--prescriptive .prescriptive .

!! Many countries have yet to decide how they will evaluate Many countries have yet to decide how they will evaluate such products, and an overall lack of harmonization such products, and an overall lack of harmonization indicates that several questions indicates that several questions -- if and how the safety of if and how the safety of these products can best be assessed these products can best be assessed -- remain remain outstanding. outstanding.

!! The scientific criteria for safety assessment are needed.The scientific criteria for safety assessment are needed.!! Capacity on risk assessment and regulatory measures in Capacity on risk assessment and regulatory measures in

dealing with GM crops / food containing stacked trait dealing with GM crops / food containing stacked trait genes are needed.genes are needed.

WHY WE NEED TO INCREASE FOOD PRODUCTIVITY?

• Population growth• Food, feed and fuel colliding to

compete for agricultural comodities• Increasing food demand including

protein• Shrinking land base

FOOD SECURITY PERSPECTIVES

Food Safety Included

POLICY ON GMF IN INDONESIA

Genetically Modified Food (GMF)is a food derived from Genetic Engineering Products that

include fresh food, processed food, food additives and other materials used for food production.

(Head of NADFC Regulation NNumberumber : HK.00.05.23.3541 : HK.00.05.23.3541 YearYear of of 2008 2008 onon Guidelines Guidelines For Food Safety Assessment of Genetically Modified Food)For Food Safety Assessment of Genetically Modified Food)

Definition

Genetically Modified Food Policy in IndonesiaGenetically Modified Food Policy in Indonesia

Pre-market biosafety assessment on GMF

(Act No 7/1996)

Import ProductImport

ProductLocal

Product

If GMO is declared safe as food and marketed in retail package, it must be

labelled according on GR No. 69/1999 on Food Labelling and Advertisement (Article

35) based on threshold level.

GR No. 21/2005 (Article 25)

Authority Minister and Head of Non Departmental Government Institution controlling and monitoring GE that marketed in Indonesia according to legislation and regulations.

LEGAL ASPECTS OF GMF IN INDONESIALEGAL ASPECTS OF GMF IN INDONESIA

1.1. ActAct ofof TheThe RepublicRepublic ofof IndonesiaIndonesia NumberNumber 77 ofof 19961996 onon FoodFood;;2.2. ActAct ofof TheThe RepublicRepublic ofof IndonesiaIndonesia NumberNumber 2121 ofof 20042004 onon

RatificationRatification ofof CartagenaCartagena ProtocolProtocol onon BiosafetyBiosafety;;3.3. GovernmentGovernment RegulationRegulation ofof TheThe RepublicRepublic ofof IndonesiaIndonesia

NumberNumber 6969 YearYear ofof 19991999 onon FoodFood LabelingLabeling AndAndAdvertisementAdvertisement;;

4.4. GovernmentGovernment RegulationRegulation NumberNumber 2828 YearYear ofof 20042004 onon FoodFoodSafety,Safety, QualityQuality andand NutritionNutrition;;

5.5. GovernmentGovernment RegulationRegulation ofof TheThe RepublicRepublic ofof IndonesiaIndonesiaNumberNumber 2121 YearYear ofof 20052005 onon BiosafetyBiosafety ofof GeneticallyGenetically ModifiedModifiedOrganismOrganism;;

6.6. PresidentialPresidential RegulationRegulation NumberNumber 3939 YearYear ofof 20102010 onon BiosafetyBiosafetyCommissionCommission ofof GeneticallyGenetically ModifiedModified OrganismOrganism;;

7. Head of NADFC Regulation NNumberumber :: HKHK..0000..0505..2323..35413541 YearYearofof 20082008 onon GuidelinesGuidelines ForFor FoodFood SafetySafety AssessmentAssessment ofofGeneticallyGenetically ModifiedModified FoodFood..

Definition

(Act No 7/1996)

ProductLocal

Product

Definition

(Act No 7/1996)

ProductLocal

Product

Definition

(Act No 7/1996)

ProductLocal

Product

Definition

(Act No 7/1996)

ProductLocal

Product

Definition

(Act No 7/1996)

ProductLocal

Product

Article 13(1) Any person who produces food or uses raw material, food

additives and or other processing aid material in the production or process of food, which is derived from genetic engineering process, the safety of the food for human health shall be assessed before being distributed.

(2) The Government establish the requirements and the principles of research, development and the use of genetic engineering method in the food production activity or process and establish the requirements for the testing of food which is produced from the genetic engineering process.

Act of The Republic of Indonesia Number 7 Act of The Republic of Indonesia Number 7 Year of 1996 on FoodYear of 1996 on Food

Article 35(1) Label of food derived from genetic engineering process

must be declared as “GENETICALLY MODIFIED FOOD”.(2) In case of food derived from genetic engineering

process as specified in paragraph (1) constitutes the material used in a food product, it is enough to declare information of the genetically engineered food only for that specific material.

(3) Beside the statement mentioned in paragraph (1), specific genetic engineering logo can be added.

Government Regulation of The Republic of Indonesia Government Regulation of The Republic of Indonesia Number 69 Year of 1999 on Food Labeling And AdvertisementNumber 69 Year of 1999 on Food Labeling And Advertisement

Article 14(1) Any person who produces food or uses raw materials, food

additives and/or any other processing aid in the activity or process of producing food obtained from genetically engineered process, the safety of such food shall be assessed prior to distribution.

(2) The assessment of the safety of such genetically engineered food as contemplated in paragraph (1) shall include:

Government Regulation Number 28 Year of 2004 on Food Government Regulation Number 28 Year of 2004 on Food Safety, Quality and NutritionSafety, Quality and Nutrition

a. its genetic information, among others the general description of the genetically engineered food product, the host description and its use as food;

b. its donor organism description;c. its genetic modification description;d. its genetic modification characterization; ande. its information on the safety of the food, among others its

substantial equivalence, nutrition value alteration, allergenicity and toxicity.

Continued…Continued…Government Regulation Number 28 Year of 2004 on Food Safety, Government Regulation Number 28 Year of 2004 on Food Safety, Quality and NutritionQuality and Nutrition

(3) The assessment of such a genetically engineered food product as contemplated in paragraph (1) shall be conducted by the committee that deals with the food safety of genetically engineered products.

(4) The requirements and procedures for the genetically engineered food product safety assessment as contemplated in paragraph (3) shall be set forth by the committee that deals with the genetically engineered products.

(5) The Head of the Agency shall determine the raw materials, the food additives and/or any other processing aid that are obtained from any genetically modifying process and declared safe as food, complying with the recommendation of the committee that deals with the food safety of genetically engineered food.

Article 14

Article 5

Type of GMO:

a. GM Animal, raw and processed products from animal;

b. GM Fish, raw and processed products from fish;

c. GM Plant, raw and processed products from plant; and

d. GM Microorganism, raw and processed products frommicroorganism.

Government Regulation of The Republic of Indonesia Number 21 Year of 2005 on Biosafety of Genetically

Modified Organism,

Continued…Continued…GRGR No 21 No 21 Year ofYear of 20052005

ArticleArticle 66((33)) BasicBasic InformationInformation asas aa guidanceguidance forfor thethe compliancecompliance ofof foodfood

andand feedfeed safetysafety requirementrequirement asas mentionedmentioned inin ((11)) shallshallincludeinclude::a.a. GeneticGenetic engineeredengineered methodmethod shouldshould followfollow thethe standardstandard

procedureprocedure whichwhich isis scientificallyscientifically soundsound;;b.b. NutrientNutrient contentcontent ofof GMGM FoodFood shouldshould bebe substantiallysubstantially

equivalentequivalent withwith nonnon GMGM FoodFood;;c.c. TheThe contentcontent ofof poisonouspoisonous substances,substances, antianti--nutrientnutrient andand

allergenicallergenic inin thethe GMGM foodfood shouldshould bebe substantiallysubstantiallyequivalentequivalent withwith nonnon GMGM FoodFood;;

d.d. TheThe contentcontent ofof carbohydrate,carbohydrate, protein,protein, ash,ash, lipid,lipid, fiber,fiber,aminoamino acid,acid, fattyfatty acid,acid, mineral,mineral, andand vitaminvitamin shouldshould bebesubstantiallysubstantially equivalentequivalent withwith nonnon GMGM FoodFood;;

e.e. TheThe proteinprotein encodedencoded byby thethe transferredtransferred genegene isis notnotallergenicallergenic;;

f.f. MethodMethod ofof destructiondestruction appliedapplied whenwhen unexpectedunexpected resultresultoccursoccurs..

Article 14

Article 5

Type of GMO:

Modified Organism,

Article 14

Article 5

Type of GMO:

Modified Organism,

Article 14

Article 5

Type of GMO:

Modified Organism,

Article 14

Article 5

Type of GMO:

Modified Organism,

Article 14

Article 5

Type of GMO:

Modified Organism,

a. Certificate of free trade from the country of origin; and

b. Assessment and risk management document from the authorizedinstitution where the assessment was conducted.

IMPORTED GE Product

GRGR No 21 No 21 Year ofYear of 20052005 Article 13

1) Any person who import similar GMO for the first time must submitthe application to the authorized Minister or Head of NonDepartmental Government Institution.

2) The application to import the GMO must be completed withthe supporting documents which explain the environmental safety,food and/or feed safety requirements as mentioned in article 6.

3) In compliance with the provision as mentioned in (2), importingthe GE product must also be completed with :

Continued….Continued….GRGR No 21 No 21 Year ofYear of 20052005 Article 13

4. Following the acceptance of the application as mentioned in (1),the authorized Minister or Head of Non Departmental GovernmentInstitution :a. Check the requested document and requirement as intended in(2) and (3),b. Announce to the applicant the requested document andrequirement which need to be complied according to theexisting regulation on the importing GMO no later than 15(fifteen) days after acceptance of the application.

5. Regarding the document and requirement as intended in article 2and 3 being completed the authorized Minister or Head of NonDepartmental Government Institution request therecommendation of environmental safety from the Minister .

6. The authorized Minister or Head of Non Departmental GovernmentInstitution must forward their decision based on the biosafetyrecommendation given by Minister or Head of BiosafetyCommittee.

7. Provision on the requirement and procedure of importing GMO isfurther regulated by the authorized Minister or Head of NonDepartmental Government Institution.

I. Preface

II. Food Safety Type and Requirement of GM Food

III. Food Safety Assessment Procedure and Scheme of GM Food

IV. Food Safety Assessment of GM Food

V. Marketing Decision for GM Food

VI. Closing

Head of NADFC Decree Number : HK.00.05.23.3541 Year of 2008 on Food Safety Assessment Guideline for Genetically Modified Food

(3) Assignment letter from Biosafety Commission to Bio-safety Technical Team (time limit : 14 days)

(4) Assessment Report from Bio-safety Technical Team(time limit : 7 days)

Bio-safety CommissionFood Safety Assessment

Deputy of Food Safety and Hazardous Substance Control, NADFC

Head of NADFC

Applicant

(1) Acceptance of Application document

(2) Assignment letter from Head of NADFC to Bio-safety Commision (time limit : 14 days)

(8) Letter of Approval/ Refusal

(7) Bio-safety recommendation to Head of NADFC (time limit : 14 days)

Bio-safety Technical TeamFood Safety Assessment Technical Team Director of Food Product Standardization

(time limit : 56 days)

(9) Regular Reports

Bio-safety Clearing HouseAdministrator : Ministry of Environment

(public comments for 60 days)

(6) Report to Biosafety Commission(time limit : 7 days)

(5) Letter to Bio-safety Clearing House for public comments

Food Safety Assessment SchemeFood Safety Assessment Scheme

Chapter IVFood Safety Assessment of GM Food

Genetic InformationGenetic Information

1. General Description2. Host Description and its used as food3. Donor Organism Description4. Genetically Modification Description5. Genetically Modification Characterization

Food Safety InformationFood Safety Information

1. Substantially Equivalent2. Change in Nutrient Content 3. Alergenicity4. Toxicity5. Other consideration

APPLICATION FOR BIOSAFETY APPLICATION FOR BIOSAFETY APPLICATION FOR BIOSAFETY APPLICATION FOR BIOSAFETY APPLICATION FOR BIOSAFETY APPLICATION FOR BIOSAFETY APPLICATION FOR BIOSAFETY APPLICATION FOR BIOSAFETY ASSESSMENT OF GM FOODASSESSMENT OF GM FOODASSESSMENT OF GM FOODASSESSMENT OF GM FOODASSESSMENT OF GM FOODASSESSMENT OF GM FOODASSESSMENT OF GM FOODASSESSMENT OF GM FOOD

No Commodity Event Proponent Status

1 Corn MON 89034 PT. Branita SandhiniDone in Clearing House, waiting for Bio-safetyCommission meeting

2 Corn NK 603 PT. Branita SandhiniDone in Clearing House, waiting for Bio-safetyCommission meeting

3 Corn Bt 11PT. Syngenta Indonesia

Initial assessment by Peer reviewer of Bio-safety Technical Team

4 Corn GA 21PT. Syngenta Indonesia

Assessment underway by Food Safety and Bio-safety Technical Team

5 Corn MIR 604PT. Syngenta Indonesia

Assessment underway by Bio-safety Technical Team

7 Sugar cane6 event (N11-1T to N11-6T)

PT. Perkebunan Nusantara XI

8 Corn event 3272PT. Syngenta Indonesia

Not yet

9 Soybean GTS 40-3-2 PT. Branita SandhiniAssessment done by Bio-safety Technical Team, waiting for Clearing House

10 Soybean MON 89788 PT. Branita SandhiniAssessment done by Bio-safety Technical Team, waiting for Clearing House

IMPORTED GE Product

I. Preface

VI. Closing

Head of NADFC

Applicant

(9) Regular Reports

Not yet

IMPORTED GE Product

I. Preface

VI. Closing

Head of NADFC

Applicant

(9) Regular Reports

Not yet

IMPORTED GE Product

I. Preface

VI. Closing

Head of NADFC

Applicant

(9) Regular Reports

Not yet

IMPORTED GE Product

I. Preface

VI. Closing

Head of NADFC

Applicant

(9) Regular Reports

Not yet

IMPORTED GE Product

I. Preface

VI. Closing

Head of NADFC

Applicant

(9) Regular Reports

Not yet

GMF CONTROL IN INDONESIA

Agriculture Production

Post harvest Fresh Food

Ready to For further consume process

Processed Food

Processing

A. PRE-MARKET EVALUATION(Government Regulation Number 28 Year of 2004 on Food Safety, Quality Government Regulation Number 28 Year of 2004 on Food Safety, Quality and Nutritionand Nutrition)

• None of GM processed food gets approval by NADFC at the moment, becausethe assessment process by the Biosafety Commission is underway.

• Processed food containing soybean, corn, potato, and tomato, applicant musthave “Self Statement Letter” which state that the food “not contain GMO”accompanied by CoA that show negative result of GM gene.

All processed food in retail package must have marketingcertification letter from NADFC, exempt for food produced bysmall industry/in house production.

Ministry of Agriculture NADFC

B. POST-MARKET EVALUATION(Government Regulation Number 28 Year of 2004 on Food Safety, Government Regulation Number 28 Year of 2004 on Food Safety, Quality and Nutrition)Quality and Nutrition)

PROCESSED FOOD

DISTRIBUTION CONSUMER

NADFC controls food safety, quality and nutrition by periodicallysampling, and or laboratory analysis and follow up the result.

RETAILERPRODUCER

NADFC do the inspection if there is a law violations in the field of food processing.

If violation occur according to laboratory analysis and inspection, they will get administrative sanctions (GR 28/2004, Art. 47 (2)), an investigation shall be launched by investigators based on the prevailing legislation If any criminal suspects occur (GR 28/2004, Art. 49). 3333

GM Food LabelGM Food Label

All processed food in retail package :

1. Must have marketing certificationletter from NADFC

2. Must be labelled on and or in foodpackage

GM Food LabelGM Food Label3535

GM Food Label in IndonesiaGM Food Label in Indonesia

!! GM Food must be labelledGM Food must be labelled!! Requirement to be labelledRequirement to be labelled

threshold levelthreshold levelthreshold levelthreshold levelthreshold levelthreshold levelthreshold levelthreshold levelDraft proposed : 5% for each commodityDraft proposed : 5% for each commodityDraft proposed : 5% for each commodityDraft proposed : 5% for each commodityDraft proposed : 5% for each commodityDraft proposed : 5% for each commodityDraft proposed : 5% for each commodityDraft proposed : 5% for each commodity

Processed Food

Processing

PROCESSED FOOD

RETAILERPRODUCER

Processed Food

Processing

PROCESSED FOOD

RETAILERPRODUCER

Processed Food

Processing

PROCESSED FOOD

RETAILERPRODUCER

Processed Food

Processing

PROCESSED FOOD

RETAILERPRODUCER

Processed Food

Processing

PROCESSED FOOD

RETAILERPRODUCER

CONCLUSION AND RECOMMENDATION

CONCLUSION AND RECOMMENDATIONCONCLUSION AND RECOMMENDATION

• The regulatory framework of Genetically Modified Food (GMF) in Indonesia is available and to be implemented effectively.

• One of strategic issues on GMF is the risk assessment of GM stacked events obtained from crosses between GM events.

• Although stacked event products are entering global markets with increasing frequency, existing international approaches and data requirements for assessing their safety are varied and are often non-prescriptive.

• Thus the scientific criteria for safety assessment of GM stacked events are needed, together with the improvement of capacity on risk assessment and regulatory measures in dealing with GM crops / food containing stacked trait genes.

ROY SPARRINGANational Agency for Drug and Food Control

Jalan Percetakan Negara No. 23, Jakarta 10560Tel: +62 21 4253857

E mail [email protected], [email protected]

Further information please contact Directorate for Food Product Standardization

National Agency for Drug and Food Control, The Republic of IndonesiaJalan Percetakan Negara No. 23, Jakarta 10560

Phone: +62 21 42875584, Fax: +62 21 42875780 Email: [email protected]

Phone +62 21 4253857; E mail: [email protected], [email protected]

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