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Volume 16 // Number 2 // Article 5
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For the Approval Process of GMOs: The Japanese Case
Georg-August-Universität Göttingen, Germany
Technische Universität München, Freising, Germany
This article reviews the approval process of genetically modified organisms (GMOs) in Japan. The purpose of this review is to explain the Japanese safety approval procedures for food, feed, and imported GMOs and place it in an international context through a comparison with the United States and the European Union (EU). While the regulatory regime in the United States and EU is often discussed, little is understood about the Japanese regulations. However, Japan plays an important role in terms of biotechnological development as well as international trade through agricultural and food imports. Therefore, this article tries to fill the gap in the existing literature. Within Japanese regulations, GMOs are first tested following the Cartagena Protocol on Biosafety. In a second and final step, compliance with the national laws as well as food and feed safety is assessed. We also summarize the processes used in identity preservation and labeling of approved GMOs. The last section of the article reveals the pragmatic nature of Japanese GMO regulations as compared to the EU and the United States.
Key words: GMOs, policies, regulations, Japan.
Introduction

Today the world faces the challenge of increasing agricultural production to meet the growing demands for food and plant-based fuels in an environmentally sustainable manner. The world’s population is currently increasing and is projected to grow even further in the future. Studies suggest that the increasing population will require current food production to double by 2050 (Food and Agricultural Organization of the United Nations [FAO], 2009). In addition, producing fuel from agricultural commodities is becoming more important, and there is an on-going debate of food versus fuel (Edgerton, 2009). Many fear that the production of agricultural commodities cannot keep up with the increasing demand from the food as well as the fuel sectors (Cassman & Liska, 2007). However, some studies suggest that it is possible to supply enough agricultural commodities to meet the needs for both food and fuel if a significant increase in yield is achieved (Slade, 2012).

In the past, yield increases have been driven through increasing inputs such as land and fertilizer (Ruttan, 2002). However, most fertile land is already under cultivation (Ramankutty, Foley, & Olejniczak, 2002). Therefore, the possibility to achieve production increases from using more land for agricultural production is limited. Also, further increases in input use such as fertilizer and pesticides generate concerns over the environmental impacts (Cassman & Liska, 2007).

Since the beginning of the 20th Century, the improvement of agricultural production technology has been the major driving force for increases in productivity. Conventional breeding has increased production quantities by selecting varieties with higher yields and higher resistance towards pests and diseases (Khush, 1995; Rosegrant & Cline, 2003). Currently, the technology of genetic modification (GM) is thought to have a strong potential to achieve further increases in agricultural productivity without increasing negative environmental impacts. Many current GM varieties are tolerant towards agricultural chemicals that are generally used. As a result, producers are able to apply others that are more efficient and therefore reduce the overall production inputs as well as costs (Persley, 2000; Phipps & Park, 2002; Qaim & Zilberman, 2003; Wesseler, Scatasta, & Fall, 2011).

However, despite its potential, the application of biotechnology has always been controversial (FAO, 2001). As a result, public aversion towards genetically modified organisms (GMOs) is reflected in GMO-related policies throughout the world (Lynch & Vogel, 2001). This article summarizes the GMO approval process in Japan. Little is understood about the Japanese regulations related to GMOs compared to the European Union (EU) and the United States. However, Japan plays an important role in development of biotechnology (Organisation for Economic Co-operation and Development [OECD], 2013; Science Council of Japan, 2010). Moreover, imported agricultural goods have a large share in the domestic market (Ministry of Agriculture, Forestry, and Fisheries [MAFF], 2007a). Therefore, understanding the GMO regulations in Japan is important. This article begins by providing an overview of GMO approval for food, feed, and imports in Japan, as well as currently approved GMOs. Then, the identity preserved handling (IP handling) process and labeling of GMOs is explained. The article then lays out a comparison between the Japanese GMO approval process and the process in the EU and the United States, followed by a summary and conclusion.

GMO Approval Process in Japan

General Overview

By 2013, Japan has approved eight GM food and feed crops for human consumption and animal feeding purposes (Council of Biotechnology Information Japan, 2013; MAFF, 2013; MHLW, 2013). These are soybeans, sugar beet, corn, canola, cotton, alfalfa, potatoes, and papaya. All GMOs have been tested through approval processes under three national laws and the implementation of an international treaty, namely the Food Safety Basic Act (FSBA); the Food Sanitation Act (FSA); the Animal Feed Sanitation Act (AFSA, officially known as the Act on Safety Assurance and Quality Improvement of Feeds); and the Cartagena Protocol on Biosafety (Council of Biotechnology Information Japan, 2013; MAFF, 2007b). As described in Figure 1, all organisms are first tested at controlled experimental fields in terms of their impacts on biodiversity, following the Cartagena Protocol, under the supervision of the Ministry of Education, Sports, Science, and Technology (MEXT), the MAFF, and the Ministry of the Environment (MOE). Then, products for human consumption are assessed according to the FSA and the FSBA, while animal feed crops are studied following the AFSA as well as the FSBA (Council of Biotechnology Information Japan, n.d.; MAFF, 2007b).

Figure 1. Safety approval process regarding GMOs in Japan.
Source: Council of Biotechnology Information Japan (n.d.), MAFF (2007b)

Step 1: The Cartagena Protocol

The goal of the Cartagena Protocol is to ensure safety in terms of biodiversity conservation and human health when transporting and utilizing living modified organisms (LMOs) across borders (Ministry of Foreign Affairs of Japan, 2012). Although the Cartagena Protocol refers to LMOs, we will use the term GMOs for consistency. Based on the Cartagena Protocol, first all GMOs have to be proven safe for the local environment. Under the Japanese approval process, all GM food, processing aids, and food additives are subject to a safety assessment. It generally takes about a year for all organisms to go through the entire approval process. The Ministry of Health, Labour, and Welfare (MHLW) is the main entity in charge of the GMO approval procedure for human consumption, while MAFF is responsible for impacts on the environment, approval of feed crops, and labeling of GMOs (Gruère, 2006).

Under the Cartagena Protocol, all GMOs subjected to an assessment are first categorized into two groups—those for Type 1 use and those for Type 2 use (MAFF, n.d.a). Type 1 use is defined as an open usage of GMOs, i.e., under conditions that may influence the local environment. Type 2 use involves a closed environment where impacts of GMOs are contained. Such applications are relevant in the case of an experimental field or isolated greenhouse (MOE, n.d.).

Type 1 Usage

In order to have GMOs approved by the Cartagena Protocol for Type 1 usage, applicants of GMOs have to submit a “Biological Diversity Risk Assessment Report” to corresponding ministries (MOE, n.d.). The report must be based on research conducted through literature review and laboratory experiments (MOE, n.d.). The ministries will request more information from the applicants if there are possible adverse effects or a lack of information on biological safety. If no adverse effect is observed, they will consult the public and the applications will be further assessed according to the FSA or AFSA, depending on their purposes. Ministries that receive applications include MAFF, MHLW, MOE, and MEXT. In the case of Type 1 usage, MOE is always involved, as the main concern of the assessment is the environmental impacts of the GMOs in question. Figure 2 illustrates the procedure of assessment of GMOs for Type 1 usage.

Figure 2. Approval process of GMOs (agricultural plants and tree species) for Type 1 usage under the Cartagena Protocol.

Corresponding ministries: MAFF, MOE

Source: MAFF (n.d.c); University of Tokyo, School of Science (n.d.)

After GMOs are approved for Type 1 usage, the Cartagena Protocol further requires appropriate monitoring and handling of the GMOs. As shown in Figure 3, importers or developers of approved GMOs are requested to continue obtaining information from field usage, which is to be submitted to the MAFF and the MOE. Independent administrative institutions (IAIs) conduct inspections following requests from both ministries. The purpose of such inspections is to ensure that the approved GMOs are produced and handled according to the regulations, to keep records through official documents, and to conduct scientific tests concerning the DNA structure. Different research units are in charge within the ministries depending on the purposes and types of usage of each GMO.

Figure 3. Proper handling of GMOs approved for Type 1 usage.
Corresponding ministries: MAFF, MOE
Source: MAFF (n.d.c)

Type 2 Usage

For Type 2 usage, applicants must comply with the procedure to avoid GMOs’ diffusion into the local environment. In some cases, corresponding ministries have already defined specific procedures to be undertaken. If this is the case, applicants can follow the already-existent procedures. If the standard has not been set, each application must be submitted to the appropriate ministries for approval. Such institutions include the MAFF, the MHLW, the MEXT, and the National Tax Agency (MAFF, 2007c; MOE, n.d.). Table 1 presents ministries in charge and Figure 4 graphically represents the approval process of GMOs for Type 2 usage.

Table 1. Corresponding ministries in charge for Type 2 approval.
Ministries in charge Type 2 uses by category
Ministry of Agriculture, Forestry, & Fisheries Improvements to crops in equipment, development of live vaccines for animals
Ministry of Health, Labour, & Welfare Viruses for gene therapy
Ministry of Education, Culture, Sports, Science, & Technology Uses in the experiments of gene recombination in universities
Use in research and development activities
Ministry of Economy, Trade, & Industry Uses in the process of production of industrial enzymes
National Tax Agency Yeast used in the production of alcoholic beverages
Source: Ministry of the Environment (n.d.), Japan Biosafety Clearing House (2004)

Figure 4. Approval process of GMOs (agricultural plants and tree species) for Type 2 usage under the Cartagena Protocol.
Source: MAFF (n.d.c); University of Tokyo, School of Science (n.d.)

Summary on the Cartagena Protocol

In summary, the Cartagena Protocol requires assessment of each GMO whose environmental safety has not been tested yet. Individuals or institutions interested in utilizing specific GMOs in Japan must apply to the ministries concerned. They must file either a biological report to investigate the GMO’s impact on the local environmental safety or a request to define safety instructions to be followed when handling such organisms. For Type 1 usage, after approving the environmental safety of GMOs, applicants and government entities will discuss the results of field experiments to ensure the safety obtained from actual observations. The GMOs will be assessed finally by the national laws only when proven to be safe in the local environment, complying with the Cartagena Protocol (MAFF, n.d.a). Generally speaking, applicants are developers of GM seeds and predominantly large international corporations. Such corporations include Monsanto Japan Co., DuPont, Bayer Crop Science, and Dow Chemical Japan Ltd. (MAFF, 2013).

Step 2: Food or Feed Safety Assessment

After GMOs are proven to be safe under the Cartagena Protocol, they are further investigated, following the FSBA, the FSA, and the AFSA. Food items are assessed by the FSBA and the FSA, both of which are monitored by the MHLW; feed items are studied based on the FSBA of the MHLW as well as the AFSA of the MAFF.

Food Safety Assessment

The MHLW requires each applicant to request food safety approval by genetic event. Then, the MHLW will submit the request to the Food Safety Commission of Japan (FSC) within the Cabinet Office (CAO) of Japan, which will consult a group of scientists for investigation. The general public will be informed about the newly-considered GMOs and can give feedback to the FSC. If the Minister of the MHLW approves the GMO’s safety, it has completed the food-safety approval process. Finally, the public will be notified of the decision (MHLW, 2012). This approval process was made mandatory by the MHLW in 2001 (FSC, 2004). Figure 5 graphically illustrates the approval process of food GMOs by the MHLW.

Figure 5. Approval of food item GMOs by the MHLW.
Source: MHLW (2012)

There are two laws that play a role in food-safety approval, i.e., the FSA and the FSBA. The FSBA emphasizes food safety for consumers (Ministry of Internal Affairs and Communications, 2011), whereas the FSA is concerned with preventing sanitation hazards caused from consuming food (Ministry of Internal Affairs and Communications, 2009). After the safety assessment is done within the CAO, the MHLW Minister will make the final decision, referring to the FSA as well as the FSBA (Honda, 2010).

Feed Safety Assessment

Approval of feed GMOs is done by the MAFF. As described in Figure 6, the MAFF undertakes an assessment of feed safety within the ministry for each application. The assessment is carried out under the AFSA, which ensures feed safety and quality (Ministry of Internal Affairs and Communications, 2007). The act is concerned with feed produced domestically as well as imported. It also aims to promote improvement of feed quality and to stabilize the supply of high-quality feed (Ministry of Internal Affairs and Communications, 2007). The MAFF also requires all GM feed items to go through the FSC within the CAO as in the case of food GMOs. The purpose is to investigate the impacts from GM feed on human health. Unlike in the case of food GMOs, this food-safety investigation addresses the safety of food products derived from animals fed with GMOs. This assessment is done following the FSBA (Honda, 2010). The public has the opportunity to express its opinions before feed GMOs are officially released (MAFF, n.d.c).

Figure 6. Approval of GM feed items by the MAFF.
Source: MAFF (n.d.c)

Approval of GMOs for Imports

Before importing GMOs, importers have to obtain approval for Type 1 usage in the Cartagena Protocol (Japan Biosafety Clearing House, n.d.). When importing GMOs, the MHLW conducts random inspections of GMOs at ports of entry. This has been in place since April 2001 to detect non-approved GMOs (MHLW, 2012). The MHLW has a 0% tolerance on GMOs that are not approved abroad. In other words, no import will be made unless exporting countries have certified their GM products’ safety through their own regulatory mechanisms (Gruère, 2006). The procedure of inspection is presented in Figure 7.

Figure 7. Procedure of quarantine on imported GM food items.
Source: MHLW (2012), Kamada (2011)

“Order inspection” in the figure is what importers must comply with when they intend to import GM food items that may not satisfy the safety standards set by the Japanese regulations. In this case, the importers have to evaluate the organisms at registered inspection institutions at their own cost. “Monitoring inspection” occurs when the government proposes a guideline to conduct regular inspections in order to understand the current hygienic situation involving imported food items.

As of March 2012 (MHLW, 2012), examples of GM items currently subject to inspections are rice (63Bt, NNBt, CpTI, LLRICE601), papaya (PRSV-YK), canola (RT73 B. rapa), and flaxseed (FP967). Since 2001, detected unapproved GMO items include 2 maize, 0 soybeans, 31 rice, 2 flaxseed, and 3 papaya events (MHLW, 2012).

Time and Costs of GMO Approval

A study done by CropLife International summarizes the results of a survey asking major biotechnology companies for the time duration and costs of plant biotechnology research and development (R&D) activities (Phillips McDougall, 2011). Questionnaires were sent to six major companies, namely BASF Corporation, Bayer CropScience, Dow AgroSciences, DuPont/Pioneer Hi-Bred, Monsanto, and Syngenta AG. Although there are no statistics available specifically for Japan, the aforementioned six corporations are the major players in approving GM traits in Japan. Therefore, the observations described in this section can be considered as an appropriate approximation for the situation in Japan.

The key findings in the article suggest that the average dollar amount that surveyed companies spent on discovery, development, and approval of a new GM trait was a total of $136 million between 2008 and 2012. Out of the total costs, the R&D activities consisted of the highest share: 51% or $69.9 million, followed by approval process (26% or $35.1 million) and gene discovery (23% or $31.0 million). Table 2 summarizes incurred costs organized by categories of different activities.

Table 2. Incurred costs by companies from discovery to authorization of a plant biotechnology trait.
Category Costs ($ millions)
Discovery Early discovery 17.6
Late discovery 13.4
Total cost 31.0
Construct optimization 28.3
Commercial event production & selection 13.6
Introgression breeding & wide-area testing 28.0
Regulatory science 17.9
Registration & regulatory affairs 17.2
Total 136.0
Source: Phillips McDougall (2011)

On average, the time duration for registration and regulatory affairs is 5.5 years as of 2011, while it was approximately 3.7 years prior to 2002. Table 3 shows the average duration of each activity undertaken by companies. The total time taken from discovery to commercialization has increased since 2002. When combining the regulatory science phase and the registration and regulatory affairs phase, the time involving regulatory processes is the longest phase that companies go through in all periods.

Table 3. Duration of each activity stage in the plant biotechnology trait R&D process (months).
Category Event sold before 2002 Event introduced between 2008-2012 Required to complete each stage in 2011
Duration % share Duration % share Duration % share
Early discovery 38.0 16.4% 33.9 14.5% 25.8 9.6%
Late discovery 17.3 7.4% 20.0 8.5% 20.9 7.8%
Construct optimization 18.0 7.7% 27.0 11.5% 32.8 12.2%
Commercial event production & selection 24.0 10.3% 30.0 12.8% 34.0 12.7%
Introgression breeding & wide-area testing 40.0 17.2% 37.2 15.9% 42.0 15.7%
Regulatory science 50.5 21.7% 37.2 15.9% 47.0 17.5%
Registration & regulatory affairs 44.5 19.2% 48.8 20.8% 65.5 24.4%
Total 232.3 234.1 268.0
Source: Phillips McDougall (2011).

The average time length of discovery projects is 13.1 years. It ranges from 11.7 years for canola to 16.3 years for soybeans, with corn (12.0 years) and cotton (12.7 years) in between. This excludes the duration of applying for regulatory approval.

Currently Approved GMOs

By April 2013, of the total of 166 approved events, 11 GM crops have been approved for Type 1 and Type 2 usage, following the Cartagena Protocol (MAFF, 2013). In order to identify the GMOs approved for Type 1 usage, this study uses the records published by both the MAFF and the MHLW. The list of all genetic events approved for food and/or feed can be found in the Appendix. It is organized based on commodities, which are potatoes, soybeans, canola, sugar beet, maize, cotton, alfalfa, and papaya. Besides these eight food and/or feed commodities, several flower species are also approved for Type 1 usage. In addition, rice and a number of other flowers have been approved for Type 2 usage (MAFF, 2013).

Each commodity is further arranged according to the features of the GMOs. The table contains information on the applicants as well as the first date of approval. The date refers to the year that each trait was approved as a food and/or feed item.

Identity Preservation

Identity Preserved Handling

Identity preserved (IP) handling of GMOs is enforced for imported GMOs (MAFF, n.d.b). In 2001, the Japan Food Industry Center (JAFIC) and the MAFF jointly published a logistics manual for IP handling of GM soybeans, maize, and potatoes. With the approval of GM papayas, the JAFIC published guidelines for IP handling of papayas in 2011. IP handling is necessary, as GM products need to be segregated and labeled properly by law. The regulations involving labeling will be revisited more thoroughly in the next section.

IP handling is defined as “the management method where any involved entities ensure careful handling to segregate GM and non-GM agricultural products through providing official statements at each stage involving production, transportation, and processing of GM and non-GM agricultural products” (JAFIC, 2001, p. 5). For all four crops, the IP handling process starts from farms in an exporting country until the products reach the final manufacturing entities or consumers in Japan. Although there are slight differences across commodities, the IP handling procedures for all crops in question are rather alike. The standard procedure of IP handling is presented in Figure 8. Since the first exporter of GM soybeans, maize, potatoes, and papaya to Japan was North America, manuals were originally written specifically for imported GM and non-GM goods from the United States and Canada (MAFF, n.d.b). Now, the same IP handling procedure is imposed on other exporting nations if both GM and non-GM products are produced within the same country (JAFIC, 2001).

Figure 8. IP handling in segregating GM soybeans, maize, potatoes, and papayas.
: official documents required
Source: Japan Food Industry Center (2001, 2011), MAFF (n.d.b, 2002)

For all GMOs, raw materials are first collected from individual farms by collectors and/or local processors. Then, products are transferred to exporters through shipping entities. When they reach Japan, importers distribute the products to processors or wholesalers. Finally, the products will be received by food manufacturers to reach consumers. At every step except for the first, it is required to ensure that the IP handling procedure is followed by providing official documents (JAFIC, 2001). In the figure, the “D” indicates the necessity to provide certifying documents. The documents should ensure safe and careful handling of GMOs, such as appropriate maintenance and cleaning of storing, as well as logistic facilities.

Labeling GMOs in Japan

All GM food products as well as their derivatives are subject to mandatory labeling under the Japanese regulations. Table 4 shows all product types subject to mandatory labeling. Labeling regulation has been in place since April 2001 under the Law on Standardization and Proper Labeling of Agricultural and Forestry Products introduced by the Japanese Agricultural Standards (JAS; Consumer Affairs Agency, Government of Japan, 2011). Under the Japanese labeling regulation, there are three types of GMO labels. Products can be labeled as “genetically modified,” “genetically modified organisms not segregated,” or “not genetically modified.” The first two labeling options are mandatory if GMOs are included in the final products while the last option is voluntary.

Table 4. Processed food items subject to mandatory labeling (as of August 2011).
Raw materials: soybeans, maize, potato, canola, cotton, alfalfa, sugar beet, papaya; Processed food (33 food items)
No. Ingredients Processed food
1 Soybean Tofu and fried tofu
2 Tofu-derived food items
3 Fermented soybeans
4 Soy milk
5 Miso paste
6 Boiled soybeans
7 Canned and bottled boiled soybeans
8 Soybean powder
9 Fried soybeans
10 Food items derived from 1-9
11 Food items derived from soybeans
12 Food items derived from soybean powder
13 Food items derived from soybean protein
14 Edamame beans Food items derived from edamame beans
15 Soybean sprouts Food items derived from soybean sprouts
16 Maize Corn snacks
17 Corn starch
18 Pop corn
19 Frozen corn
20 Canned and bottled corn
21 Food items derived from corn flower
22 Food items derived from grinded corn (except for cornflakes)
23 Food items derived from corn
24 Food items derived from 16-20
25 Potato Potato snacks
26 Dried potato
27 Frozen potato
28 Potato starch
29 Food items derived from 25-28
30 Food items derived from potato
31 Alfalfa Food items derived from alfalfa
32 Sugar beet Food items derived from sugar beet
33 Papaya Food items derived from papaya
Source: Consumer Affairs Agency, Government of Japan (2011)

The labeling regulations in Japan focus on the final products. Unlike in the case of the EU, traceability is not enforced. Therefore, only when the final products contain the same DNA characteristics as the raw material, they need to be labeled as GM. In contrast, it is not necessary to label products if the end products do not preserve the DNA characteristics of the original crops. Vegetable oils and soy sauce are examples because their DNA characteristics are altered through processing.

Furthermore, the regulations allow a 5% impurity with respect to the total weight of final products when GMOs are accidentally mixed in with non-GM products. Moreover, labeling is only necessary for the top three ingredients. In other words, the products can still be labeled as “non-GM” if the content of GMOs in the top three ingredients is less than 5% of the total weight.

In the case of GM crops whose genetic and nutritional characteristics largely differ from their conventional counterparts, final products need to be labeled to identify how they differs from the conventional products (e.g., “genetically modified to contain higher level of oleic acid in soybeans”; Consumer Affairs Agency, Government of Japan, 2011).

Voluntary labeling of non-GM food items can be found on processed foods. If GMOs are segregated in the supply chain, products can be labeled as “not genetically modified” or sold without labels (Consumer Affairs Agency, Government of Japan, 2011). This applies to the food crops currently approved for human consumption (soybean, maize, potato, canola, cotton, alfalfa, sugar beet, and papaya). Food items for which GM counterparts do not exist cannot be labeled as non-GM. For instance, apples cannot be labeled as non-GM since there is no GM apple available in the market. When labeling as “non-GM,” producers need to clearly specify which ingredients the statement refers to (e.g., “potatoes [not genetically modified]”).

In general, the nature of GMO labeling regulations has driven GM products out of the market, failing to provide consumer choices (Gruère & Rao, 2007). Due to the fear of losing market share, companies tend to avoid producing GMO-derived products that require labelling. As a result, it is rare to find products at the retail level that are labelled GM. However, because traceability is not enforced and 5% impurity is allowed, consumers do get GMO-derived products without labels. Highly processed food items, such as soy oil and soy sauce, are examples of such products.

GMO-related regulations on labeling in Japan are looser than those in the EU but more stringent than those in the United States, Canada, and many other large exporters of GMOs. While the EU nations require traceability as well as labeling of derived and non-derived products, regulations in the United States, Canada, and Argentina only have voluntary labeling if the GM products do not demonstrate any difference in the final products, i.e., they are substantially equivalent (Gruère, 2006). As mentioned above, Japan imports large amounts of agricultural products from many of the leading producers of GM products. While it is certain that Japan imports GM crops, the final products are not labeled as such because the imported products are largely used for animal feeds as well as processed foods that do not preserve the DNA characteristics of the raw materials.

Regional Comparison

This section presents a regional comparison in the number of GMOs approved and the year of GMO approval between Japan, the EU, and the United States. As seen in the labeling regime, Japan’s regulations for GMOs are often described as more stringent than in the United States but looser than in the EU. One way to observe this is to compare the years when the same GM events were approved in each region. Another is to look at the number of approved events over time.

A comparison was made using the GMO Compass from MAFF (2013) for Japan; GMO Compass (2013) for the EU; and US Department of Agriculture, Animal and Plant Health Inspection Service (APHIS) for the United States (2013). In the case of Japan, the approval year is defined as the year the GMO was approved as safe following the food-safety assessment. The reason for this is that both food and feed GMOs have to pass the food-safety assessment to be officially released. Therefore, this date can be considered as the final assessment date of GMOs. For the EU, the date when the European Commission’s decision was made is utilized, while the Federal Register (FR) ruling and determination date was used for the United States.

Table 5 summarizes all GMOs accepted in each region. Blanks mean that the GMOs have not been accepted or approval has not been explicitly reported. Generally speaking, GMOs are approved first in the United States, followed by Japan and then the EU. For instance, the canola event T45 was approved in 1998 in the United States, 2001 in Japan, and finally 2009 in the EU. Similarly, the maize event NK603 was approved in 2000 in the United States, 2001 in Japan, and 2005 in the EU. Assuming applications for approval have been submitted at the same point in time at least for the EU and Japan, this supports the expectation that the Japanese regulatory regime lies between the EU and the United States. Further analysis has to consider the submission date, which is difficult to obtain in the case of Japan.

Table 5. Comparison of GMO approval processes in Japan, the European Union, and the United States.
Crop Genetic event Japan EU US
Soybeans 260-05 2001
40-3-2 2001 1994
A2704-12 2002 2008
A5547-127 2002
CV127 2012
DP-305423-1 2010 2010
DP-305423-1*40-3-2 2012
DP-356043-5 2009 2008
G94-1, G94-19, G168 1997
MON87701 2011 2011
MON87701*MON89788 2011
MON87705 2012 2011
MON89788 2007 2008 2007
W62, W98, A2704-12, A2704-21, A5547-35 1996
Canola CDC Triffid 1999
GT200 2003
GT73 2005
MS1 2002
MS1RF1 2001
MS1RF2 2001
MS8 2001
MS8RF3 2001 2007 1999
MS8*RF3*RT73 2011 1994
pCGN3828-212/86-18 & 23
RF3 2001
RT73 2001 1999
RT200 2001 1998
T45 2001 2009
Topas19/2 2001
WESTAR-Oxy-235 2001
Sugar beet GTSB77 1998
H7-1 2003 2007 2012
T120-7 1999 1998
Maize 1507 2002 2006 2001
176 1995
3272 2010 2011
1507*DAS-59122-7 2005 2010
1507*DAS-59122-7*MON810*NK603 2011
1507*59122*MON810*NK603*MIR604 2012
1507*MIR604*NK603 2011
1507*MON810*NK603 2011
1507*MON810*MIR162*NK603 2013
1507*NK603 2004 2007
3272*Bt11*MIR604*GA21 2010
5307 2013
6275 2004
676, 678, 680 1998
98140 2009
B16 1995
Bt11 2001 2004 1996
Bt11*DAS-59122-7*MIR604*1507*GA21 2011
Bt11*GA21 2007 2010
Bt11*MIR162*1507*GA21 2010
Bt11*MIR162*MIR604*GA21 2010
Bt11*MIR604 2007
Bt11*MIR604*GA21 2007
Bt11*MIR162*GA21 2010
CBH-351 1998
DAS40278 2012 2005
DAS-59122-7 2005 2007
DAS-59122-7*1507*NK603 2005 2010
DAS-59122-7*NK603 2005 2009
DBT418 2001 1997
DLL25 2001
DP-098140-6 2009
DP-32138-1 2011
Event 176 2003 1995
GA21 2001 2008 1997
GA21*MON810 2003
HCEM485 2013
LY038 2007 2006
LY038*MON810 2007
MIR162 2010 2010
MIR162*GA21 (sweet corn) 2011
MIR604 2007 2009 2007
MIR604*GA21 2007
MON80100 1995
MON87427 2013
MON87460 2011 2011
MON87460*MON89034*MON88017 2011
MON87460*MON89034*NK603 2011
MON87460*NK603 2011
MON802 1997
MON810 2001
MON810*MON863 2004 2010
MON863 2002 2006 2002
MON863*MON810*NK603 2004 2010
MON863*NK603 2003 2010
MON87460 2011
MON88017 2005 2009 2005
MON88017*MON810 2005 2010
MON89034 2007 2009 2008
MON89034*1507*DAS-59122-7*MON88017 2008
MON89034*1507*MON88017*DAS-59122-7*DAS40278 2013
MON89034*1507*NK603 2010
MON89034*1507*NK603*DAS40278 2013
MON89034*MON88017 2008
MON89034*NK603 2008 2010
MS3 1996
MS6 1999
NK603 2001 2005 2000
NK603*DAS40278 2013
NK603*MON810 2003 2007
NK603*T25 2009
T14 2001 1995
T25 2001 1995
T25*MON810 2003
TC6275 2007 2004
Cotton 531 2001 1995
757 2001 1995
1076 1995
1445 2005 1995
15985 2002 2002
1445*531 2003
15985*1445 2003
1698 1995
19-51a 1996
281*3006 2005
281*3006*1445 2006
281*3006*MON88913 2006
281-24-236 2004
3006-210-23 2004
BXN 1994
COT102 2012 2005
COT67B 2012 2011
Events 31807 & 31808 1997
GHB614 2010 2009
GHB614*LLCotton25 2010
LLCotton25 2004 2008 2003
LLCotton25*15985 2006
MON88913 2005 2004
MON88913 (Pima cotton) 2010
MON88913*15985 2005
T304-40XGHB119 2012 2011
Alfalfa J101 2005 2005
J101*J163 2005
J163 2005 2005
Papaya 55-1 2011 1996
63-1 1996
X17-2 2009
Potatoes BT6, BT10, BT12, BT16, BT17, BT18, BT23 1995
EH92-527-1 2010
EH92-527-1 2010
RBMT15-101, SEMT15-02, SEMT15-15 1999
RBMT21-129 & RBMT21-350 1998
RBMT22-82 2000
SBT02-5 & -7, ABBT04-6 & -27, -30, -31, -36 1996
Rice LLRICE06, LLRICE62 1999
LLRICE601 2006
Source: MAFF (2013), GMO Compass (2013), USDA APHIS (2013)

Figure 9 illustrates the evolution of the number of GMO events accepted in each region over time. Among the three regions under discussion, the United States is the first country that started approving GMOs. Japan followed with its first approval in 1999 and Europe’s first approval after the quasi moratorium was in 2004. As of 2013, the United States, Japan, and the EU have approved a total of 106, 58, and 18 events, respectively. The United States has a relatively stable growth of GMO approvals, while Japan observed a significant increase between 1999 and 2001. Note that this comparison was made only on single events or non-stacked traits. This is because Japan and the EU present explicit approval in the sources utilized but the United States does not. Therefore, all the stacked events are excluded from the comparison for this study.

Figure 9. Number of GMO approvals in Japan, the European Union, and the United States.

Although explaining the causes of such regional difference in duration of GMO approval is beyond the scope of this study, Table 6 may provide some useful insights. It presents the dates when a GM event was submitted for approval and when it was accepted in each region. For Japan, we use the date when each event was authorized for protected field experiments as the date of application submission since the application date is not provided by the ministries. Generally speaking, Japan takes approximately 2 years between application submission and approval, while the EU takes 2 to 4 years and the United States goes through the process relatively faster.

Table 6. Comparison of time length between application approval and acceptance.
Japan EU US
Applied* Accepted Applied Accepted Applied Accepted
MON89788 May 2, 2006 Jan 31, 2008 Nov 10, 2006 Dec 4, 2008 June 27, 2006 July 3, 2007
H7-1 May 25, 2005 April 24, 2007 Nov 26, 2004 Oct 24, 2007 July 29, 2010 July 20, 2012
MIR604 May 25, 2005 Aug 23, 2007 Feb 18, 2005 Nov 30, 2009 Aug 2, 2006 March 16, 2007
MON89034 May 2, 2006 Jan 31, 2008 Jan 2007 Oct 30, 2009 Oct 24, 2006 July 24, 2008
* approved for protected field experiments
Source: MAFF (2013), GMO Compass (2013), USDA APHIS (2013)

Conclusions

This article summarized the GMO approval process in Japan. It gave an overview of the assessment based on the Cartagena Protocol as well as national regulations that are in place to ensure safe utilization and commercialization of the GMOs. The labeling regime and the IP handling process were also discussed. Finally, an international comparison was made on different GMO approval processes in Japan, the EU, and the United States.

Japan’s regulatory regime is often described as less stringent than that in the EU, but is stricter than in North America. However, there was only limited information available about the Japanese regulatory framework to evaluate GMOs. This article contributes to the literature by providing a detailed description of the Japanese regulations as well as evidence for the claims about the strength of its regulation.

Another contribution of this article is the international comparison of GMO approvals. This study revealed that Japan generally approves GMOs after the United States and before the EU. Also, the trend of the number of approved GMOs suggests that the United States and Japan have approved the same number of GMOs since 1994 while the EU approval has been less than half that amount. This study provided empirical observations that the Japanese GMO regulations are, in fact, stricter than in the United States but looser than in the EU.

Japan has responded to the GM technology in a cautious manner and intended to provide both GM and non-GM options in its domestic market. However, this attempt has not been successful, as GMOs are generally used for highly-processed food or feed, thus avoiding the legal responsibility to label the products as GM. The approval process complies with international as well as national laws to ensure safety from utilization of GMOs through consumption, production, and logistics. As the portion of agricultural land devoted to production of GMOs increases throughout the world, Japan may face challenges in securing enough non-GM agricultural products to meet the demand. In summary, Japan’s policies involving GMOs are likely to become more and more important in the future.

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Appendix. GMO compass in Japan.
Commodity Trait Genetic event Applicant First approval
Potatoes Insect tolerant BT-6 Monsanto Japan 2011
Insect tolerant, virus tolerant RBMT15-101 Monsanto Japan 2003
RBMT21-129 Monsanto Japan 2001
RBMT21-350 Monsanto Japan 2001
RBMT22-82 Monsanto Japan 2001
SEMT15-02 Monsanto Japan 2003
SEMT15-15 Monsanto Japan 2003
Insect tolerant SPBT02-5 Monsanto Japan 2001
Soybeans High-oleic acid 260-05 DuPont 2001
High-oleic acid, acetolactate synthase resistance, herbicide tolerant 305423*40-3-2 DuPont 2010
Herbicide tolerant 40-3-2 Monsanto Japan 2001
A2704-12 Bayer CropScience (Germany) 2002
A5547-127 Bayer CropScience (Germany) 2002
BPS-CV127-9 BASF Japan 2012
CV127 BASF Japan 2012
High-oleic acid, acetolactate synthase resistance DP-305423-1 DuPont 2010
Herbicide tolerant, acetolactate synthase resistance DP-356043-5 DuPont 2009
Insect tolerant MON87701 Monsanto Japan 2011
Insect tolerant, herbicide tolerant MON87701*MON89788 Monsanto Japan 2011
Low saturated fat, high-oleic acid, herbicide tolerant MON87705 Monsanto Japan 2012
Herbicide tolerant MON89788 Monsanto Japan 2007
Canola Herbicide tolerant HCN10 Bayer CropScience (Germany) 2001
HCN92 Bayer CropScience (Germany) 2001
Herbicide tolerant, male sterility, fertility restorer MS1RF1 Bayer CropScience (Germany) 2001
MS1RF2 Bayer CropScience (Germany) 2001
MS8 Bayer CropScience (Germany) 2001
MS8*RF3*RT73 Bayer CropScience (Germany) 2010
Herbicide tolerant, male sterility MS8*RT73 Bayer CropScience (Germany) 2011
Herbicide tolerant, male sterility, fertility restorer MS8RF3 Bayer CropScience (Germany) 2001
Herbicide tolerant PGS1 Bayer CropScience (Germany) 2001
PGS2 Bayer CropScience (Germany) 2001
PHY14 Bayer CropScience (Germany) 2001
PHY23 Bayer CropScience (Germany) 2001
PHY35 Bayer CropScience (Germany) 2001
PHY36 Bayer CropScience (Germany) 2001
Herbicide tolerant, fertility restorer RF3 Bayer CropScience (Germany) 2001
RF3*RT73 Bayer CropScience (Germany) 2011
Herbicide tolerant RT200 Monsanto Japan 2001
RT73 Monsanto Japan 2001
T45 Bayer CropScience (Germany) 2001
Topas19/2 Bayer CropScience (Germany) 2001
WESTAR-Oxy-235 Bayer CropScience (Germany) 2001
Sugar beet Herbicide tolerant 77 Monsanto Japan 2003
Herbicide tolerant H7-1 Monsanto Japan 2003
Herbicide tolerant T120-7 Bayer CropScience (Germany) 1999
Maize Insect tolerant, herbicide tolerant 1507 DuPont 2002
Heat-tolerant alpha amylase 3272 Syngenta Seeds AG (Switzerland) 2010
Insect tolerant, herbicide tolerant 1507*DAS-59122-7 DuPont 2005
1507*DAS-59122-7*MON810 DuPont 2011
1507*DAS-59122-7*MON88017 Dow Chemical Japan Ltd., Monsanto Japan 2008
1507*GA21 Syngenta Seeds AG (Switzerland) 2010
1507*MIR604*NK603 DuPont 2011
1507*MON810 DuPont 2011
1507*MON810*NK603 DuPont 2009
1507*MON88017 Dow Chemical Japan Ltd., Monsanto Japan 2008
Insect tolerant, herbicide tolerant 1507*NK603 DuPont 2003
1507*5307 Syngenta Japan Co. 2013
1507*5307*GA21 Syngenta Japan Co. 2013
1507*59122*MON810*NK603*MIR604 DuPont 2012
1507*DAS40278 Dow Chemical Japan Ltd. 2013
1507*DAS-59122-7*DAS40278 Dow Chemical Japan Ltd. 2013
1507*DAS-59122-7*MON810*MIR604 DuPont 2012
1507*DAS-59122-7*MON810*NK603 DuPont 2009
1507*DAS-59122-7*MON810*NK603*MIR604 DuPont 2012
1507*DAS-59122-7*NK603*MIR604 DuPont 2012
1507*MIR162*NK603 DuPont 2013
1507*MON810*MIR162 DuPont 2013
1507*MON810*MIR162*NK603 DuPont 2013
1507*MON810*MIR604 DuPont 2012
1507*MON810*NK603*MIR604 DuPont 2012
1507*MON88017*DAS40278 Dow Chemical Japan Ltd. 2013
1507*MON88017*DAS-59122-7*DAS40278 Dow Chemical Japan Ltd. 2013
1507*NK603*DAS40278 Dow Chemical Japan Ltd. 2013
Heat-tolerant alpha amylase, insect tolerant, herbicide tolerant 3272*Bt11 Syngenta Seeds AG (Switzerland) 2010
3272*Bt11*GA21 Syngenta Seeds AG (Switzerland) 2010
3272*Bt11*MIR604 Syngenta Seeds AG (Switzerland) 2010
3272*Bt11*MIR604*GA21 Syngenta Seeds AG (Switzerland) 2010
Heat-tolerant alpha amylase, insect tolerant 3272*GA21 Syngenta Seeds AG (Switzerland) 2010
3272*MIR604 Syngenta Seeds AG (Switzerland) 2010
Heat-tolerant alpha amylase, insect tolerant, herbicide tolerant 3272*MIR604*GA21 Syngenta Seeds AG (Switzerland) 2010
Insect tolerant, herbicide tolerant 5307*GA21 Syngenta Japan Co. 2013
Bt11 Syngenta Seeds AG (Switzerland) 2001
Bt11 (sweet corn) Syngenta Seeds AG (Switzerland) 2001
Bt11*1507 Syngenta Seeds AG (Switzerland) 2010
Bt11*1507*GA21 Syngenta Seeds AG (Switzerland) 2010
Insect tolerant, herbicide tolerant Bt11*DAS-59122-7*1507 Syngenta Japan Co. 2011
Bt11*DAS-59122-7*1507*GA21 Syngenta Japan Co. 2011
Bt11*DAS-59122-7*GA21 Syngenta Japan Co. 2011
Bt11*DAS-59122-7*MIR604*1507 Syngenta Japan Co. 2011
Bt11*DAS-59122-7*MIR604*GA21 Syngenta Japan Co. 2011
Bt11*DAS-59122-7*MIR604 Syngenta Japan Co. 2011
Bt11*GA21 Syngenta Seeds AG (Switzerland) 2007
Bt11*MIR162 Syngenta Seeds AG (Switzerland) 2010
Bt11*MIR162*1507 Syngenta Seeds AG (Switzerland) 2010
Bt11*MIR162*1507*GA21 Syngenta Seeds AG (Switzerland) 2010
Bt11*MIR162*MIR604 Syngenta Seeds AG (Switzerland) 2010
Bt11*MIR162*MIR604*GA21 Syngenta Seeds AG (Switzerland) 2010
Bt11*MIR604 Syngenta Seeds AG (Switzerland) 2007
Bt11*MIR604*1507 Syngenta Japan Co. 2011
Bt11*MIR604*1507*GA21 Syngenta Japan Co. 2011
Bt11*MIR604*GA21 Syngenta Seeds AG (Switzerland) 2007
Bt11*1507*5307 Syngenta Japan Co. 2013
Bt11*1507*5307*GA21 Syngenta Japan Co. 2013
Bt11*5307 Syngenta Japan Co. 2013
Bt11*5307*GA21 Syngenta Japan Co. 2013
Bt11*DAS-59122-7 Syngenta Japan Co. 2011
Bt11*DAS-59122-7*MIR604*1507*GA21 Syngenta Japan Co. 2010
Bt11*GA21 (sweet corn) Syngenta Japan Co. 2012
Bt11*MIR162 (sweet corn) Syngenta Japan Co. 2012
Bt11*MIR162*1507*5307 Syngenta Japan Co. 2013
Bt11*MIR162*1507*5307*GA21 Syngenta Japan Co. 2013
Bt11*MIR162*5307 Syngenta Japan Co. 2013
Bt11*MIR162*GA21 Syngenta Seeds AG (Switzerland) 2010
Bt11*MIR162*GA21 (sweet corn) Syngenta Japan Co. 2012
Bt11*MIR162*MIR604*1507 Syngenta Japan Co. 2013
Insect tolerant, herbicide tolerant Bt11*MIR162*MIR604*1507*5307 Syngenta Japan Co. 2013
Bt11*MIR162*MIR604*1507*5307*GA21 Syngenta Japan Co. 2013
Bt11*MIR162*MIR604*1507*GA21 Syngenta Japan Co. 2013
Bt11*MIR162*MIR604*5307 Syngenta Japan Co. 2013
Bt11*MIR162*MIR604*5307*GA21 Syngenta Japan Co. 2013
Bt11*MIR604*1507*5307 Syngenta Japan Co. 2013
Bt11*MIR604*1507*5307*GA21 Syngenta Japan Co. 2013
Bt11*MIR604*5307 Syngenta Japan Co. 2013
Bt11*MIR604*5307*GA21 Syngenta Japan Co. 2013
Herbicide tolerant DAS40278 Dow Chemical Japan Ltd. 2012
Insect tolerant, herbicide tolerant DAS-59122-7 DuPont 2005
DAS-59122-7*MON810*NK603 DuPont 2011
DAS-59122-7*1507*GA21 Syngenta Japan Co. 2011
DAS-59122-7*1507*NK603 DuPont 2005
DAS-59122-7*GA21 Syngenta Japan Co. 2011
Insect tolerant, herbicide tolerant DAS-59122-7*MIR604*1507 Syngenta Japan Co. 2011
DAS-59122-7*MIR604*1507*GA21 Syngenta Japan Co. 2011
DAS-59122-7*MIR604*GA21 Syngenta Japan Co. 2011
DAS-59122-7*MON810 DuPont 2011
DAS-59122-7*MON88017 Dow Chemical Japan Ltd., Monsanto Japan 2008
DAS-59122-7*NK603 DuPont 2005
DAS-59122-7*DAS40278 Dow Chemical Japan Ltd. 2013
DAS-59122-7*MIR604 Syngenta Japan Co. 2011
DAS-59122-7*MON810*MIR604 DuPont 2012
DAS-59122-7*MON810*NK603*MIR604 DuPont 2012
DAS-59122-7*NK603*MIR604 DuPont 2012
DBT418 Monsanto Japan 2001
Herbicide tolerant DLL25 Monsanto Japan 2001
Insect tolerant, herbicide tolerant Event 176 Syngenta Seeds AG (Switzerland) 2001
Herbicide tolerant GA21 Monsanto Japan 2001
Herbicide tolerant GA21 (sweet corn) Syngenta Japan Co. 2012
Insect tolerant, herbicide tolerant GA21*MON810 Monsanto Japan 2001
High-lysine LY038 Monsanto Japan 2007
High-lysine, herbicide tolerant LY038*MON810 Monsanto Japan 2007
Insect tolerant MIR162 Syngenta Seeds AG (Switzerland) 2010
MIR162 (sweet corn) Syngenta Japan Co. 2012
Insect tolerant, herbicide tolerant MIR162*1507 Syngenta Seeds AG (Switzerland) 2010
MIR162*1507*GA21 Syngenta Seeds AG (Switzerland) 2010
MIR162*GA21 Syngenta Seeds AG (Switzerland) 2010
Insect tolerant MIR162*MIR604 Syngenta Seeds AG (Switzerland) 2010
Insect tolerant, herbicide tolerant MIR162*MIR604*GA21 Syngenta Seeds AG (Switzerland) 2010
MIR162*1507*5307 Syngenta Japan Co. 2013
MIR162*1507*5307*GA21 Syngenta Japan Co. 2013
Insect tolerant MIR162*5307 Syngenta Japan Co. 2013
Insect tolerant, herbicide tolerant MIR162*5307*GA21 Syngenta Japan Co. 2013
MIR162*GA21 (sweet corn) Syngenta Japan Co. 2011
MIR162*MIR604*1507 Syngenta Japan Co. 2013
MIR162*MIR604*1507*5307 Syngenta Japan Co. 2013
MIR162*MIR604*1507*5307*GA21 Syngenta Japan Co. 2013
MIR162*MIR604*5307*GA21 Syngenta Japan Co. 2013
MIR162*NK603 DuPont 2013
Insect tolerant MIR604 Syngenta Seeds AG (Switzerland) 2007
Insect tolerant, herbicide tolerant MIR604*1507 Syngenta Japan Co. 2011
MIR604*1507*GA21 Syngenta Japan Co. 2011
MIR604*GA21 Syngenta Seeds AG (Switzerland) 2007
Drought tolerant, herbicide tolerant MIR604*NK603 DuPont 2011
Insect tolerant, herbicide tolerant MIR604*1507*5307 Syngenta Japan Co. 2013
MIR604*1507*5307*GA21 Syngenta Japan Co. 2013
Insect tolerant MIR604*5307 Syngenta Japan Co. 2013
Insect tolerant, herbicide tolerant MIR604*5307*GA21 Syngenta Japan Co. 2013
Insect tolerant, herbicide tolerant MIR604*GA21 Syngenta Seeds AG (Switzerland) 2007
Insect tolerant MON810 Monsanto Japan 2001
MON810*MON863 Monsanto Japan 2004
MON810*MIR162 DuPont 2013
Insect tolerant, herbicide tolerant MON810*MIR162*NK603 DuPont 2013
MON810*MIR604 DuPont 2012
MON810*NK603*MIR604 DuPont 2012
Insect tolerant MON863 Monsanto Japan 2002
Insect tolerant, herbicide tolerant MON863*MON810*NK603 Monsanto Japan 2004
MON863*NK603 Monsanto Japan 2003
Herbicide tolerant, male sterility MON87427 Monsanto Japan 2013
Herbicide tolerant MON87427 Dow Chemical Japan Ltd. 2013
Drought tolerant MON87460 Monsanto Japan 2011
Drought tolerant, insect tolerant, herbicide tolerant MON87460*MON88017 Monsanto Japan 2011
Drought tolerant, insect tolerant MON87460*MON89034 Monsanto Japan 2011
Drought tolerant, insect tolerant, herbicide tolerant MON87460*MON89034*MON88017 Monsanto Japan 2011
MON87460*MON89034*NK603 Monsanto Japan 2011
Drought tolerant, herbicide tolerant MON87460*NK603 Monsanto Japan 2011
Insect tolerant, herbicide tolerant MON88017 Monsanto Japan 2005
MON88017*MON810 Monsanto Japan 2005
MON88017*DAS-59122-7*DAS40278 Dow Chemical Japan Ltd. 2013
Insect tolerant MON89034 Monsanto Japan 2007
Insect tolerant, herbicide tolerant MON89034*1507 Dow Chemical Japan Ltd., Monsanto Japan 2008
MON89034*1507*DAS-59122-7*MON88017 Dow Chemical Japan Ltd., Monsanto Japan 2008
MON89034*1507*MON88017 Dow Chemical Japan Ltd., Monsanto Japan 2008
MON89034*1507*NK603 Dow Chemical Japan Ltd., Monsanto Japan 2010
MON89034*DAS-59122-7*MON88017 Dow Chemical Japan Ltd., Monsanto Japan 2008
MON89034*MON88017 Monsanto Japan 2007
MON89034*NK603 Monsanto Japan 2007
MON89034*1507*DAS40278 Dow Chemical Japan Ltd. 2013
Insect tolerant, herbicide tolerant MON89034*1507*DAS-59-122-7 Dow Chemical Japan Ltd., Monsanto Japan 2008
MON89034*1507*DAS-59122-7*DAS40278 Dow Chemical Japan Ltd. 2013
MON89034*1507*MON88017*DAS40278 Dow Chemical Japan Ltd. 2013
MON89034*1507*MON88017*DAS-59122-7*DAS40278 Dow Chemical Japan Ltd. 2013
MON89034*1507*NK603 Dow Chemical Japan Ltd. 2010
MON89034*1507*NK603*DAS40278 Dow Chemical Japan Ltd. 2013
MON89034*DAS40278 Dow Chemical Japan Ltd. 2013
MON89034*DAS-59122-7 Dow Chemical Japan Ltd., Monsanto Japan 2008
MON89034*DAS-59122-7*DAS40278 Dow Chemical Japan Ltd. 2013
MON89034*MON88017*DAS40278 Dow Chemical Japan Ltd. 2013
MON89034*MON88017*DAS-59122-7*DAS40278 Dow Chemical Japan Ltd. 2013
MON89034*NK603*DAS40278 Dow Chemical Japan Ltd. 2013
Herbicide tolerant NK603 Monsanto Japan 2001
Insect tolerant, herbicide tolerant NK603*MON810 Monsanto Japan 2002
Herbicide tolerant NK603*T25 Monsanto Japan 2009
NK603*DAS40278 Dow Chemical Japan Ltd. 2013
T14 Bayer CropScience (Germany) 2001
T25 Bayer CropScience (Germany) 2001
Insect tolerant, herbicide tolerant T25*MON810 DuPont 2001
TC6275 Dow Chemical Japan Ltd. 2007
Cotton Insect tolerant, herbicide tolerant 281 Dow Chemical Japan Ltd. 2005
Insect tolerant 531 Monsanto Japan 2001
757 Monsanto Japan 2001
Herbicide tolerant 1445 Monsanto Japan 2001
Insect tolerant, herbicide tolerant 3006 Dow Chemical Japan Ltd. 2005
Insect tolerant 15985 Monsanto Japan 2002
Insect tolerant, herbicide tolerant 1445*531 Monsanto Japan 2003
Insect tolerant 15985 (Pima cotton) Monsanto Japan 2010
Insect tolerant, herbicide tolerant 15985*1445 Monsanto Japan 2003
281*3006 Dow Chemical Japan Ltd. 2005
Insect tolerant, herbicide tolerant 281*3006*1445 Dow Chemical Japan Ltd. 2006
281*3006*MON88913 Dow Chemical Japan Ltd. 2006
Herbicide tolerant BXN cotton 10211 Stoneville Pedigreed Seed (USA) 2001
BXN cotton 10215 Stoneville Pedigreed Seed (USA) 2001
BXN cotton 10222 Stoneville Pedigreed Seed (USA) 2001
Insect tolerant COT102 Syngenta Japan Co. 2012
COT67B Syngenta Japan Co. 2012
Insect tolerant, herbicide tolerant GHB119 Bayer CropScience (Germany) 2012
Herbicide tolerant GHB614 Bayer CropScience (Germany) 2010
Insect tolerant, herbicide tolerant GHB614*15985 Bayer CropScience (Germany) 2010
Herbicide tolerant GHB614*LLCotton25 Bayer CropScience (Germany) 2010
Insect tolerant, herbicide tolerant GHB614*LLCotton25*15985 Bayer CropScience (Germany) 2010
Herbicide tolerant LLCotton25 Bayer CropScience (Germany) 2004
Insect tolerant, herbicide tolerant LLCotton25*15985 Bayer CropScience (Germany) 2006
Herbicide tolerant MON88913 Monsanto Japan 2005
MON88913 (Pima cotton) Monsanto Japan 2010
Insect tolerant, herbicide tolerant MON88913*15985 Monsanto Japan 2005
Alfalfa Herbicide tolerant J101 Monsanto Japan 2005
J163 Monsanto Japan 2005
J101*J163 Monsanto Japan 2005
Papaya Virus tolerant 55-1 Hawaii Papaya Industry Association 2011
Source: MAFF (2013), MHLW (2013)


Suggested citation: Ebata, A., Punt, M., & Wesseler, J. (2013). For the approval process of GMOs: The Japanese case. AgBioForum, 16(2), 140-160. Available on the World Wide Web: http://www.agbioforum.org.
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