1
Current 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
11
PRESENTATION AGENDAPRESENTATION AGENDA
Global situation and its regulatory perspectives
Policy on GMF in Indonesia
Conclusion and Recommendation
GMF Control in Indonesia
22
11
GLOBAL SITUATION AND ITS REGULATORY
PERSPECTIVES
33
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
44
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
55 66
1
Current 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
11
PRESENTATION AGENDAPRESENTATION AGENDA
Global situation and its regulatory perspectives
Policy on GMF in Indonesia
Conclusion and Recommendation
GMF Control in Indonesia
22
11
GLOBAL SITUATION AND ITS REGULATORY
PERSPECTIVES
33
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
44
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
55 66
1
Current 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
11
PRESENTATION AGENDAPRESENTATION AGENDA
Global situation and its regulatory perspectives
Policy on GMF in Indonesia
Conclusion and Recommendation
GMF Control in Indonesia
22
11
GLOBAL SITUATION AND ITS REGULATORY
PERSPECTIVES
33
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
44
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
55 66
1
Current 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
11
PRESENTATION AGENDAPRESENTATION AGENDA
Global situation and its regulatory perspectives
Policy on GMF in Indonesia
Conclusion and Recommendation
GMF Control in Indonesia
22
11
GLOBAL SITUATION AND ITS REGULATORY
PERSPECTIVES
33
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
44
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
55 66
1
Current 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
11
PRESENTATION AGENDAPRESENTATION AGENDA
Global situation and its regulatory perspectives
Policy on GMF in Indonesia
Conclusion and Recommendation
GMF Control in Indonesia
22
11
GLOBAL SITUATION AND ITS REGULATORY
PERSPECTIVES
33
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
44
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
55 66
1
Current 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
11
PRESENTATION AGENDAPRESENTATION AGENDA
Global situation and its regulatory perspectives
Policy on GMF in Indonesia
Conclusion and Recommendation
GMF Control in Indonesia
22
11
GLOBAL SITUATION AND ITS REGULATORY
PERSPECTIVES
33
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
44
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
55 66
2
77 88
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
99
Trend in Food Science & Technology 18 (2007), 101-109
1010
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 .
1111
!! 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.
1212
STACKED EVENT STACKED EVENT (2)(2)
2
77 88
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
99
Trend in Food Science & Technology 18 (2007), 101-109
1010
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 .
1111
!! 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.
1212
STACKED EVENT STACKED EVENT (2)(2)
2
77 88
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
99
Trend in Food Science & Technology 18 (2007), 101-109
1010
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 .
1111
!! 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.
1212
STACKED EVENT STACKED EVENT (2)(2)
2
77 88
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
99
Trend in Food Science & Technology 18 (2007), 101-109
1010
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 .
1111
!! 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.
1212
STACKED EVENT STACKED EVENT (2)(2)
2
77 88
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
99
Trend in Food Science & Technology 18 (2007), 101-109
1010
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 .
1111
!! 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.
1212
STACKED EVENT STACKED EVENT (2)(2)
2
77 88
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
99
Trend in Food Science & Technology 18 (2007), 101-109
1010
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 .
1111
!! 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.
1212
STACKED EVENT STACKED EVENT (2)(2)
3
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
1313
FOOD SECURITY PERSPECTIVES
1414
Food Safety Included
22
POLICY ON GMF IN INDONESIA
1515
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)
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
1616
Genetically Modified Food Policy in IndonesiaGenetically Modified Food Policy in Indonesia
Pre-market biosafety assessment on GMF
(Act No 7/1996)
Import ProductImport
ProductLocal
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.
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.
1717
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..
1818
3
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
1313
FOOD SECURITY PERSPECTIVES
1414
Food Safety Included
22
POLICY ON GMF IN INDONESIA
1515
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)
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
1616
Genetically Modified Food Policy in IndonesiaGenetically Modified Food Policy in Indonesia
Pre-market biosafety assessment on GMF
(Act No 7/1996)
Import ProductImport
ProductLocal
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.
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.
1717
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..
1818
3
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
1313
FOOD SECURITY PERSPECTIVES
1414
Food Safety Included
22
POLICY ON GMF IN INDONESIA
1515
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)
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
1616
Genetically Modified Food Policy in IndonesiaGenetically Modified Food Policy in Indonesia
Pre-market biosafety assessment on GMF
(Act No 7/1996)
Import ProductImport
ProductLocal
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.
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.
1717
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..
1818
3
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
1313
FOOD SECURITY PERSPECTIVES
1414
Food Safety Included
22
POLICY ON GMF IN INDONESIA
1515
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)
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
1616
Genetically Modified Food Policy in IndonesiaGenetically Modified Food Policy in Indonesia
Pre-market biosafety assessment on GMF
(Act No 7/1996)
Import ProductImport
ProductLocal
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.
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.
1717
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..
1818
3
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
1313
FOOD SECURITY PERSPECTIVES
1414
Food Safety Included
22
POLICY ON GMF IN INDONESIA
1515
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)
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
1616
Genetically Modified Food Policy in IndonesiaGenetically Modified Food Policy in Indonesia
Pre-market biosafety assessment on GMF
(Act No 7/1996)
Import ProductImport
ProductLocal
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.
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.
1717
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..
1818
3
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
1313
FOOD SECURITY PERSPECTIVES
1414
Food Safety Included
22
POLICY ON GMF IN INDONESIA
1515
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)
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
1616
Genetically Modified Food Policy in IndonesiaGenetically Modified Food Policy in Indonesia
Pre-market biosafety assessment on GMF
(Act No 7/1996)
Import ProductImport
ProductLocal
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.
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.
1717
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..
1818
4
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
1919
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
2020
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.
2121
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
2222
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,
2323
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..
2424
4
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
1919
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
2020
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.
2121
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
2222
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,
2323
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..
2424
4
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
1919
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
2020
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.
2121
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
2222
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,
2323
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..
2424
4
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
1919
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
2020
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.
2121
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
2222
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,
2323
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..
2424
4
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
1919
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
2020
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.
2121
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
2222
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,
2323
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..
2424
4
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
1919
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
2020
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.
2121
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
2222
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,
2323
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..
2424
5
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 :
2525
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.
2626
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
2727
(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
(time limit : 15 days)
Food Safety Assessment SchemeFood Safety Assessment Scheme
2828
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
2929
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
6 Corn MIR 162PT. Syngenta Indonesia
Assessment underway by Bio-safety Technical Team
7 Sugar cane6 event (N11-1T to N11-6T)
PT. Perkebunan Nusantara XI
Initial assessment by Peer reviewer of Bio-safety Technical Team
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
3030
5
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 :
2525
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.
2626
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
2727
(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
(time limit : 15 days)
Food Safety Assessment SchemeFood Safety Assessment Scheme
2828
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
2929
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
6 Corn MIR 162PT. Syngenta Indonesia
Assessment underway by Bio-safety Technical Team
7 Sugar cane6 event (N11-1T to N11-6T)
PT. Perkebunan Nusantara XI
Initial assessment by Peer reviewer of Bio-safety Technical Team
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
3030
5
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 :
2525
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.
2626
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
2727
(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
(time limit : 15 days)
Food Safety Assessment SchemeFood Safety Assessment Scheme
2828
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
2929
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
6 Corn MIR 162PT. Syngenta Indonesia
Assessment underway by Bio-safety Technical Team
7 Sugar cane6 event (N11-1T to N11-6T)
PT. Perkebunan Nusantara XI
Initial assessment by Peer reviewer of Bio-safety Technical Team
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
3030
5
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 :
2525
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.
2626
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
2727
(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
(time limit : 15 days)
Food Safety Assessment SchemeFood Safety Assessment Scheme
2828
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
2929
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
6 Corn MIR 162PT. Syngenta Indonesia
Assessment underway by Bio-safety Technical Team
7 Sugar cane6 event (N11-1T to N11-6T)
PT. Perkebunan Nusantara XI
Initial assessment by Peer reviewer of Bio-safety Technical Team
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
3030
5
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 :
2525
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.
2626
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
2727
(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
(time limit : 15 days)
Food Safety Assessment SchemeFood Safety Assessment Scheme
2828
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
2929
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
6 Corn MIR 162PT. Syngenta Indonesia
Assessment underway by Bio-safety Technical Team
7 Sugar cane6 event (N11-1T to N11-6T)
PT. Perkebunan Nusantara XI
Initial assessment by Peer reviewer of Bio-safety Technical Team
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
3030
5
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 :
2525
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.
2626
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
2727
(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
(time limit : 15 days)
Food Safety Assessment SchemeFood Safety Assessment Scheme
2828
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
2929
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
6 Corn MIR 162PT. Syngenta Indonesia
Assessment underway by Bio-safety Technical Team
7 Sugar cane6 event (N11-1T to N11-6T)
PT. Perkebunan Nusantara XI
Initial assessment by Peer reviewer of Bio-safety Technical Team
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
3030
6
33
GMF CONTROL IN INDONESIA
3131
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.
• 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
3232
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
3636
6
33
GMF CONTROL IN INDONESIA
3131
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.
• 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
3232
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
3636
6
33
GMF CONTROL IN INDONESIA
3131
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.
• 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
3232
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
3636
6
33
GMF CONTROL IN INDONESIA
3131
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.
• 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
3232
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
3636
6
33
GMF CONTROL IN INDONESIA
3131
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.
• 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
3232
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
3636
6
33
GMF CONTROL IN INDONESIA
3131
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.
• 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
3232
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
3636
7
44
CONCLUSION AND RECOMMENDATION
3737
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.
3838
ROY SPARRINGANational Agency for Drug and Food Control
Jalan Percetakan Negara No. 23, Jakarta 10560Tel: +62 21 4253857
E mail [email protected], [email protected]
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]
National Agency for Drug and Food Control, The Republic of IndonesiaJalan Percetakan Negara No. 23, Jakarta 10560
Phone +62 21 4253857; E mail: [email protected], [email protected]
3939
7
44
CONCLUSION AND RECOMMENDATION
3737
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.
3838
ROY SPARRINGANational Agency for Drug and Food Control
Jalan Percetakan Negara No. 23, Jakarta 10560Tel: +62 21 4253857
E mail [email protected], [email protected]
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]
National Agency for Drug and Food Control, The Republic of IndonesiaJalan Percetakan Negara No. 23, Jakarta 10560
Phone +62 21 4253857; E mail: [email protected], [email protected]
3939
7
44
CONCLUSION AND RECOMMENDATION
3737
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.
3838
ROY SPARRINGANational Agency for Drug and Food Control
Jalan Percetakan Negara No. 23, Jakarta 10560Tel: +62 21 4253857
E mail [email protected], [email protected]
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]
National Agency for Drug and Food Control, The Republic of IndonesiaJalan Percetakan Negara No. 23, Jakarta 10560
Phone +62 21 4253857; E mail: [email protected], [email protected]
3939
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