1. Overview of Genetically Modified Crops in Japan

In Japan, many research and development activities are being conducted to utilize modern biotechnology in plant breeding.

The Ministry of Agriculture, Forestry and Fisheries (MAFF) established guidelines in 1989 to ensure the environmental safety of Genetically Modified Organisms (GMOs).The guidelines provide petitioners of GMOs with instructions to conduct the assessment of potential risk of GMOs to the environment. MAFF then evaluates and approve, if appropriate, the results of the assessment. The first approval was granted to a variety of virus-resistant GM tomato developed in Japan as an experimental model. Since then, the environmental risk assessments of approximately 64 applications have been confirmed: some of them are developed by the Japanese companies or governmental institutes and others by foreign companies. MAFF established another guidelines in 1996 for evaluation and approval of feed safety.

In addition, a safety assessment system for food application of GMOs based on guidelines started in 1996 to protect human health under the authority of the Ministry of Health and Welfare (MHW; currently Ministry of Health, Labour and Welfare (MHLW)). The guidelines were converted into a legally binding regulation in April 2001. Thereafter, it has been prohibited to sell and import GMOs whose safety has not been assessed for human consumption.

As of July 2002, 43 applications and 32 applications have been approved for use as food and feed respectively. All of them were developed by foreign companies.

Along with the environmental safety, the approval of the food or feed safety of GM products enabled their commercialization in Japan.

Japan is the biggest food importer in the world. As such Japan imports a large amount of cereal grains and soybean from countries such as the United States and Canada for direct use as feed or for processing into foods. While GM crops may be produced separately from non-GM counterparts in these countries, these crops are generally distributed without segregation process. For this reason, a significant part of the imports into Japan of corn, soybean and other crops for which GM varieties have been developed may contain both GM and non-GM varieties unless special measures were taken to avoid commingling. It is assumed that there is an increase in foods and feeds containing GMOs on the Japanese market proportionate to the enlarged production of GM crops in major exporting countries.

On the other hand, there is no commercial cultivation of GM crop at present in Japan.

In April 2001, mandatory GM food labelling requirements were introduced for certain types of processed food.

MAFF endeavoured to obtain public understanding on biotechnology, because Japanese consumers' concern is still generally strong in particular about the safety of GM foods. However, the StarLink case occurred in 2000 and other problems concerning commingling of unapproved GM varieties raised further confusion and concern through the public in Japan.

2.Research and Development of GMOs for Agriculture and Food Production

In Japan many research institutes, universities and private companies have been conducting research and development on the use of genetic engineering in the area of agriculture and food production for years. For instance, MAFF launched a national research project for rice genome sequencing in 1993. Currently the project is continuing in cooperation with eleven economies.

MAFF is conducting various other research projects to make use of modern biotechnology to develop the following new varieties of crops, in particular, rice which is the staple food in Japan.

Genetic engineering research on livestock and fish is also being conducted in Japan, but transgenic livestock and fish have not resulted in commercialization.

Since the public is becoming more nervous and negative to GM foods, Japanese companies tend to reduce, suspend or withdraw their research plans in the area of developing GM crops for food use.

3. Safety Regulation of GMOs for Agricultural or Food/Feed Application

Genetically modified plants should be tested on a step-by-step basis. Tests have been carried out according to a law or guidelines established by different competent authorities.

3.1 Assessment and Management of Potential Environmental Risk

3.1.1 Current Scheme for the Environmental Safety

Environmental risk assessment should be conducted by the breeder through conducting field trials in accordance with the MAFF Guidelines for the Application. The Guidelines give guidance for two-step safety assessments. First, it is examined whether a release of the GM crop under test into an isolated field can be allowed, and if it is affirmative, an isolated field test is conducted and various data are collected. Then, a final risk assessment is done on the basis of these data in order to decide whether the release into an open field can be permitted. The objective of the assessment is to assure that the genetically modified crop under test does not present adverse effect on the environment.

All imported genetically modified crops should be tested in an isolated field with respect to their effects on the environment in Japan if they are to be put on the Japanese market in a self-reproducible form independently of whether there is the intention to cultivate them in Japan.

At present, 36 transgenic plants were approved for cultivation in Japan and other 28 were approved for importation into Japan, respectively.

3.1.2 Cartagena Protocol on Biosafety

Japanese government highly evaluates the significance of the Cartagena Protocol on Biosafety adopted in 2000. The Government is currently considering a new scheme necessary for implementing it, toward ratifying the Protocol as soon as possible.

Intensive discussion is ongoing at several committees and councils of relevant ministries, of which members were appointed from various stakeholders including scientists, biotechnology companies, traders, food industry, consumer groups, mass media, lawyers and so on.

It is expected that they provide constructive suggestions on principles and fundamental framework for establishing the new scheme to implement the Protocol properly, taking into consideration related broad matters including scientific arguments, experiences under the current guidelines, relevant international frameworks, consumers' concerns, the actual situation of production, trade, distribution, manufacture and consumption, feasibility and costs of the implementation, implication on the safety, civil society and trade, consistency with other similar regulations and so on.

3.2 Assessment and Management of Potential Food Risk

MHW decided in May 2000 that safety assessment of such foods and food additives should be legally imposed. One of the reasons is that such foods and food additives are developed and subsequently used. It was expected that such foods and food additives would circulate globally and new types of foods would be developed in the future. Therefore, a mandatory system for assessing safety of such foods and food additives at pre-market stage was felt necessary to avoid the distribution of any GM food that has not gone through safety assessment. The legal system under the Food Sanitation Law entered into force in April 1, 2001.

43 foods and 10 food additives derived from modern biotechnology have been evaluated in accordance with the Standards for Safety Assessment by the Pharmaceutical Affairs and Food Sanitation Council and have been confirmed individually by MHLW so far.

3.3 Assessment and Management of Potential Feed Risk

Feed safety of 32 transgenic crops was confirmed so far in Japan. When the use of genetically modified crops as feed was intended, concerned companies/persons are requested to supply necessary information in accordance with the MAFF Guidelines for Feed Safety Assessment.

The objectives of the Guidelines are to establish basic requirements for safety
assessment of manufacturing, import and sales of feed produced with recombinant DNA techniques and thereby to ensure the safety of the feed.

The pre-market safety assessment of GM feed is not legally obligatory but voluntary since it is based on the Guidelines at present. However, taking the StarLink case into account, it was decided in April 2002 that the GM feed safety assessment would be imposed legally under an existing law"Law concerning Safety Assurance and Quality Improvement of Feed."

Table - Approval of GM crops in Japan

Table - GMO Safety Assessment Framework in Japan

4.Production and Trade of GM Crops

4.1 Commercial Cultivation of GM Crops in Japan

In Japan there is no domestic cultivation of GM crops for use as food or feed on a commercial basis at present. Only GM flower, GM carnation whose color was changed to blue, developed by a domestic firm together with an Australian one, was cultivated commercially on a small scale from 1999 to 2001. But, the company transferred the production site from Japan to other countries because of some reasons of productivity.

4.2 Import of GM Crops

Japan imports constantly a large amount of major crops such as corn and soybean from other countries including the United States, where some GM varieties are being produced commercially. GM varieties approved by the relevant Japanese ministries are being imported to Japan (see page 1).

5. Communication for Public Understanding

5.1 Consumer's Reaction to GM crops/foods/feeds in Japan

With the increasing commercialization of GM crops as foods and the emerging debate on their safety, concerns are growing among consumers in Japan, especially on their safety. Currently, it is said that many Japanese consumers are rather concerned about the safety of GM crops/foods/feeds in spite of the confirmation of safety by the Government. A number of NGOs such as consumer groups are taking an anti-GM crop position and some groups are conducting strong anti-GM crop/food/feed campaign. Most news in the mass media dealing with GM crops/foods also seem to be giving negative impression to the public. Some journalists and even scientists are undertaking anti-GM activities.

According to the result of a survey released in June 2000 on consumer reaction to GM foods by "Angus Reid Group," Japanese consumers hold the most negative views of GM foods among the eight countries polled. It concludes that 82 percent of Japanese consumers hold negative views. The percentage of consumers holding negative views in the other countries polled are also high and even in the United States and Canada, over half of the responding consumers are negative.

Figure - Negative view towards genetically modified foods

Another recent survey, which was conducted by researchers of a university in Japan, also shows a trend of declining positive views of GM crops/foods in general. According to this survey, supporters for pest-resistant GM crops has dropped from 52% in 1997 to 33% in 2000, and supporters for GM foods has dropped from 45% in 1997 to 31% in 2000.

Figure - Support for {GM foods} and {pest-resistent GM crops}

The above mentioned trend is confirmed by the other survey by the Tokyo metropolitan government. Reluctance to eat GM foods obviously increased during the last two years. Approximately ninety percent of consumers are unwilling to eat GM foods.

Figure - Reluctance to eat GM foods

Such negative reaction of consumers seems to be affecting positions of Japanese companies trying to develop GM crops. Considering the consumers' negative reaction, some of them have stopped or suspended their plans to develop GM crops.

The food industry has also been taking negative reactions since around the middle of 1999. For instance, almost all Japanese brewers have decided not to use materials derived from GM crops for beer. A number of food companies manufacturing Japanese traditional products such as Tofu and Natto from soybean have started using non-GM soybeans as materials and labelling the products as "GM soybeans not used." Consequently, the demand for non-GM crops segregated from GM crops through IP (Identity Preserved) Handling is growing.

5.2 Activities of the MAFF for obtaining Public Understanding

The activities for obtaining public understanding by MAFF started in 1995, one year before the first import of a GM crop to Japan.

The Government recognizes that public acceptance as well as safety assurance is essential to realize the potential of genetic engineering. Therefore MAFF strives for gaining public acceptance.

MAFF is actually undertaking the following activities directly or through a nonprofit public corporation "Society for Techno-innovation of Agriculture, Forestry and Fisheries (STAFF) "

5.2.1 Information Provision and Educational Activities

a) Information Brochure

MAFF publishes two types of brochures to enhance public understanding of biotechnology. The first one is entitled "Biotechnology in Daily Life." This publication is designed to give plain explanation on individual techniques of biotechnology related to agriculture and food including both modern biotechnology and traditional one, using photographs and graphics. The second one is "Q & A on GM crops for quick understanding," which answers frequently asked questions on GM crops. In addition to the explanation of some fundamental technical terms such as "DNA" and "Genetic Engineering," the brochure describes the potential of genetic engineering and the situation of development and application of GM crops etc., and answers questions on safety issues of GM crops. MAFF offers these brochures to the public free of charge. These are much in request, about 280,000 copies of these brochures have been distributed since 1995. The Q & A is shown also on the website of MAFF. Additionally, a few brief video program was produced for explanation of GM crops.

b) Website

MAFF has its Japanese website for biotechnology (http://www.s.affrc.go.jp /docs/genome/genome.htm) and thereby provides a range of information including the Q & A mentioned above, the regulation for environmental safety assessment of GMOs and the list of approved GM crops. Some of such information is provided also in English.

In addition, MHLW gives information through its website including answers to frequently asked questions on its food safety assessment of GM crops. (http://www.mhlw.go.jp/english/topics/food/index.html)

c) Intensive seminar

Annually STAFF organizes intensive one-week seminars during summer vacation season in Tsukuba where many national research institutes are located. The seminars aim at educating key persons such as high school teachers, dieticians, representatives of consumer groups, who may be able to work as mediator between the Government and consumers. The seminars are so designed that the participants can learn directly from governmental officers about the Government's policy for biotechnology, receive lectures on the most recent developments in biotechnology and conducts simple experiments on genetic manipulation (isolation of DNA, preparation of protoplast, gene insertion using genetic gun, in a laboratory, with biotechnology researchers).

d) Symposia, fora and short-term seminars

In addition to the intensive seminars, STAFF provides several opportunities for the public in various forms like symposia, fora or seminars so that the public can understand or discuss issues on agricultural biotechnology.

Other parties such as consumer groups and local governments also provide opportunities for the public to learn and discuss about biotechnology. MAFF and MHLW send their officer or researcher there in response to requests.

e) Exhibition

MAFF organizes once a year a large scale exhibition of agriculture, forestry and fisheries in Tokyo. MAFF and STAFF always exhibit agricultural biotechnology products with explanation and provide information using panels or brochures to respond to public information needs.

5.2.2 Communication Activities to Promote Consensus Building

In addition to the above mentioned activities aimed mainly at providing the public with information, MAFF started a new attempt in 2000 to promote consensus building through communication and discussion.

For example, in 2000 MAFF tried to apply a method called "Consensus Conference" to the theme "Benefits and Risks of GM crops" in order to obtain certain recommendations and/or suggestions from the citizens' panel consisted of citizens who were selected in a transparent manner from applicants.

The method of "Consensus Conference" was developed in Denmark in 1980's as a method for assessing a new technology. It has spread to other countries such as the Netherlands, New Zealand, Norway, Switzerland, the United Kingdom and the United States. In this method, some representatives of general and neutral citizens without preconception, compile consensus opinions on the new technology, through discussion, after being provided with necessary information.

As a result of discussion among panel members, the panel prepared in November 2000 a report "Opinions and Proposals of Citizens" on the basis of the discussion.

The report addressed nine important issues, background, genetic engineering technology and its future, advantage of the technology, safety of GM crops to the environment, safety to human health, systems and regulations for safety assurance, labelling of GM products, the fundamental situation of Japanese agriculture implications of the technology, international issues and information release from the Government.

It represents common understandings of the panel members. However, it also includes a small number of minority opinions such as claiming a moratorium of application of GMOs. The panel recognized the fact that biotechnology has been used widely and a number of products thereof have already bean circulated globally. It emphasized that any future development in the use of the genetic engineering technology should proceed with caution giving due consideration to both risks and benefits. From this point of view, the report emphasized the need for appropriate information release and research on long-term environmental effects, and the need for citizens themselves to try to seek appropriate balance between benefits and risks by weighting them.

In response to the report, MAFF started some research projects last year including new field research to investigate and compare potential long-term environmental effects of GM- and non-GM-rice, maize, soybean and rapeseed.

In 2001, MAFF held other citizen panels of which members were newly selected in order to obtain further opinions, in the areas of consumption and agricultural production.

6. Labelling of GM foods

6.1 Labelling of GM foods according to the JAS Law

In order to consider labelling requirements for GM foods, MAFF set up a food labelling committee in May 1997 consisting of a wide range of members including representatives of consumers, producers, distributors, and the academy etc. Some members, in particular those from consumer groups, strongly requested the Government to introduce mandatory labelling requirements for GM foods. Other members such as those from food industry had the opposite opinion. The committee deliberated on this issue based on the demands of consumers, the actual production, processing, and distribution, technical issues, and international situations, by holding many meetings which were open to the public. After extensive discussions, the committee published a final report in August 1999, which recommended a scheme for GM food labelling to be introduced, including labelling requirements for some types of GM foods.

The fundamental framework of the scheme proposed in the report is summarized in Annex 1.

The labelling requirements are set for whether the food is substantially equivalent to corresponding conventional foods and whether recombinant DNA or the protein produced thereof remains in the food.

MAFF decided to introduce the labelling system proposed by the committee to the Law Concerning Standardization and Proper Labelling of Agricultural and Forestry Products (JAS law). MAFF notified the public about relevant rules in March 2000. ("Quality Labelling Standard for Genetically Modified Foods" (its outline: Annex 2)). This regulation entered into force in April 1, 2001.

The following are key concepts of the system.

1) Recognizing that the safety of GM foods commercialized in the Japanese market is confirmed, the labelling bears no information on the safety.

The objective of the labelling requirements is to provide information on whether or not genetic engineering has been used, for consumers to make "informed choice." Namely, it doesn't inform consumers of risks or warn them.

2) The system gives due consideration to consumers' demands as well as the actual situation of production, distribution and food processing. As a result the system is reasonable, reliable, and practicable.

3) The system does not impose additional burden on domestic industries or exporting countries. (The system does not oblige producers or distributors to segregated GM crops provided that the labelling indicates "Not segregated from GMOs."

4) The system is legitimate within the framework of WTO Agreements.

Five agricultural products are covered by the labelling obligation. These are soybean, corn, potato, rapeseed and cotton seed. Also covered are twenty four types of processed foods derived from them in which recombinant DNA or the protein produced thereby still exists even after the manufacturing process (see Annex 2).

The key points of the labelling system on GM foods are as follows;

a) GM agricultural products (i.e., soybean, corn, potato, [oilseed rape, and cottonseed] ) which are equivalent to conventional ones in composition, nutritional value or intended use, etc., and processed foods derived from them in which recombinant DNA or resulting protein still exists even after processing, shall be labelled as "Genetically Modified" or "Not Segregated from GMOs";

b) Non-GM agricultural products and processed foods derived from them which have been segregated from GMOs during the production/distribution process by the identity preserved (IP) handling, do not require mandatory labelling. However, they may be labelled as "Segregated from GMOs" or "Non Genetically Modified";

c) GM agricultural products (i.e., high oleic acid soybean) which are significantly different from conventional ones in composition, nutritional value, etc., and processed foods made from these products (including foods subsequently processed from such foods), shall be labelled as "High Oleic Acid, Genetically Modified";

d) The permissible amount of adventitious presence of approved GM crops through appropriate IP handling is set to be no more than 5% by weight as reference;

e) Processed food made from agricultural products which are equivalent to conventional ones in composition, nutritional value or intended use, etc. in which recombinant DNA and resulting protein thereby dose not exist as a result of removal or decomposition during the manufacturing process, do not require mandatory labelling; and

f) If approved GM agricultural products are not the main ingredients, mandatory labelling is unnecessary. In this connection, "main ingredient" means any ingredient which is among the three most used ingredients on a weight basis and is 5% or more of the food by weight.

The list of food types requiring mandatory labelling if they are made from materials not segregated from GMOs, is subject to be reviewed every year under the GM Labelling Standard. The review is undertaken, taking into account relevant issues including advancement in the development, production and distribution of GM crops, new findings about progress in detection methods and consumers' concerns.

In 2001, after discussions in the sub-committee for this reviewing issue, the JAS Council submitted a report which recommended that some types of foods derived from potato should be added to the list, because it was concluded that recombinant DNA could be detected therein by using a new detection method. In fact recombinant DNA of a GM potato variety had been detected in several potato snacks on the market. Then, followed by collecting the public comments and the TBT announcement procedure based on WTO agreements, the MAFF notified the new list of food types requiring mandatory labelling on February 2002 which followed the Council's report. The new legislation will come into force on January 2003.

In addition, as for high-oleic acid soya bean and its products, of which the safety assessment is finished on March 2001, the MAFF has enforced such labelling as "high oleic acid, genetically modified" since January 2003.

6.2 Labelling of GM foods according to the Food Sanitation Law

In addition to the labelling requirements for consumers' choice under the JAS Law, the Sub-committee on Food Labelling published its report, saying that it was appropriate to introduce another labelling requirements for GM foods in accordance with the Food Sanitation Law, since food safety assessment for GM foods would be imposed legally under the law.

Under the Food Sanitation Law, the labelling requirements work to identify whether foods are produced by recombinant DNA techniques or not, due to the following concepts.

-- The mandatory labelling requirements lead to inspections of such foods for checking of adequacy of the labelling. And, if such foods are sold or distributed with no safety assessment or no label declaration, these actions violate the requirements of the labelling as well as the requirements of the safety assessment.

-- As for food additives, they have already been required to be labelled in order to identify food contents and make it possible for consumers to understand them, at the same time to undertake reviews of their safety for marketing based on certain provision of the Food Sanitation Law. In the similar way, it is possible to introduce the mandatory requirements for labelling of foods produced by recombinant DNA techniques and having undergone the examination of their safety assessments.

Although there are two types of GM food labelling requirements with different objectives, their ways and contents for application are harmonized and almost identical so as not to cause any confusion or trouble to the consumers and the industries. They entered into force at the same time in April 2001.

6.3 Current Situation of GM Food Labelling

Japan imports a great amount of soybean from the U.S.A. where GM soybean is produced widely.

It is said that since the decision to introduce the GM food labelling system in Japan, most of the Japanese manufactures of the processed foods of soybean origin with labelling obligation such as Tofu (soybean curd), have shifted raw materials from non-segregated soybean lot, possibly containing GM varieties to IP handled non-GM soybean lot, taking into consideration consumers' concern.

A half month after the labelling system had entered into force, a MAFF-related institution "Center for Food Quality, Labelling and Consumer Services" conducted a survey on a total of 5,661 samples of these processed food products which were on the market and required to be labelled unless their raw materials were segregated from GMOs through competent IP handling.

Fifty seven percent of the visually checked were labelled as non-GM. The rest 43% did not carry any declaration regarding GM, "not-segregated from GM" or "non-GM." This implies that all of them appeared to fall in the non-GM category, guessing from the labelling.

The institution bought 59 samples selected from the total of 5,661 subjected to the above survey for further examination. All of the 59 samples were labelled "non-GM " or without any declaration regarding GM. First, it analyzed the presence of recombinant DNA in each sample by a qualitative DNA detection method. Consequently, recombinant DNA was detected in 11 samples and it examined the IP handling records of these 11 samples to see whether it had been properly treated under an IP handling system. And then, it conducted a quantitative analysis of those recombinant DNA for which quantitative analytical method (s) has(ve) been established in 5 samples (corn products). Due to the lack of adequate quantitative analytical method(s), it was unable to analyze other 6 samples (soybean products) quantitatively. At last, it found that one of the five corn products contained GM ingredients at more than 5%. The level of 5% is the referential threshold, above which the commingling will not be regarded as adventitious. It was concluded that the product violated the labelling requirements and the Center ordered its producer to correct its labelling.

As for the food categories, such as soybean oil and soy sauce are not obliged to be labeled because in such foods any recombinant DNA or the protein produced thereby are not detected after processing. It is said that most of the Japanese manufactures of such foods continue using non-segregated soybeans which probably contain GM soybeans.

Regarding the cost of segregation or analytical test, there has not been reliable data. However, the recent data based on future prices in Japanese forward market of soybean imported from the United States shows that the price of IP handled non-GM soybean would be higher than that of non-segregated one by only a few percent in general. In some cases, the price of non-GM soybean is lower than that of soybean containing GM.

Generally speaking, the prices of foods derived from segregated soybeans such as non-GM Tofu and non-GM Miso, also seem not to have risen significantly.

7. Recent Experience

7.1 The StarLink Case

A genetically modified corn variety StarLink, whose safety has not yet been assessed for human consumption either in the United States or in Japan due to the lack of conclusive information on allergenicity, was detected from corn meal on the Japanese market. Since Japan imports the majority of its corn (more than 95%) from the United States, concerns and some confusion spread through the public in Japan.

In response to the case, the governments of both countries have established measures to ensure that every barge /railcar carrying corn for human consumption and for exportation to Japan shall be inspected and re-checked by the USDA and MHLW; the USDA shall ensure that the necessary measures for IP handling are carried out by traders at ports before shipment, and MHLW has monitored commodities to confirm that they do not contain StarLink when they are imported.

In addition, measures to ensure that every barge/railcar carrying corn for animal feed exported to Japan shall be inspected and re-checked by the USDA and the MAFF; the USDA shall ensure that the necessary measures for IP handling are carried out by traders at ports before shipment, and the MAFF monitors commodities to confirm that they do not contain StarLink when they are imported.

7.2 Contamination of Unapproved GM varieties

In 2001, two GM potato varieties ("New Leaf Plus Potato"& "New Leaf Y Potato") whose safety for human consumption had not been assessed in Japan, were detected in several potato snacks made from certain potatoes imported from the United States and Canada. The potato snacks were therefore taken off the market, pursuant to provisions of the Food Sanitation Law.

While the GM potato varieties had already been assessed for safety for human consumption and distributed in U.S. and Canada, they had not been approved for food use in Japan because its safety for human consumption had not yet been assessed by Japanese authority. Therefore, MHLW urged applicants to submit as soon as possible an additional data to facilitate the safety assessment.

Cosequently, New Leaf Plus Potato has already been approved under the Food Sanitation Law. New Leaf Y Potato is still being assessed.

In addition, recently a GM papaya variety produced in Hawaii has been also detected in Japnanese market, which has not yet been approved in Japan under the Food Sanitation Law. The GM papaya is currently under food safety assessment process.

Annex 1

****************Framework of GM food labelling**************

Classification 1

Foods (derived from GM crops) which are differ significantly from conventional foods in composition, nutritional value or intended use, etc. (ex: oil made from high-oleic acid GM soybean)

Labelling required

Classification 2

Foods (derived from GM crops) which are equivalent to conventional foods in composition, nutritional value or intended use, etc., and in which recombinant DNA or the protein produced thereby still exists even after processing. (ex: Tofu made from herbicide tolerant soybeans, Corn starch made from Bt corn, etc.)

Labelling required

(Note: Foods made from non-GM crops segregated from GM ones under an IP (Identity Preserved) Handling
No labelling required (Voluntary labelling like "non-GM" is allowed))

Classification 3

Foods (derived from GM crops) which are equivalent to conventional foods in composition, nutritional value or intended use, etc., and in which recombinant DNA or the protein produced thereby does NOT exist as a result of removal or decomposition during processing. (ex: soy sauce, corn oil, rapeseed oil etc.)

No labelling required

(Note: Voluntary labelling like "non-GM" is allowed in case of foods made from non-GM crops segregated from GM ones under an IP Handling)

********************************************************************

Annex 2

Labelling Requirements of Food Quality Labeling Standard
for Genetically Modified Foods

Classification of food Item Labelling requirement
* Classification 1
Genetically modified agricultural products (i.e., soybean) which are significantly different from conventional ones in composition, nutritional value, etc., and processed foods made from these products (including foods subsequently processed from such foods) 		<Designated foods>

(1)High oleic acid soybean

(2)Food which main ingredient is

(1)above (except defatted soybean)

(3) Food which main ingredient is

(2) above

 Labelling required
("Soybean [high oleic acid, genetically modified]", etc.)
* Classification 2
Agricultural products which have some genetically modified crops in their categories, which are equivalent to conventional ones in composition, nutritional value or intended use, etc., (i.e., soybean, corn, potato, [oilseed rape, and cottonseed]) and processed foods made from these products in which recombinant DNA or resulting protein still exists even after processing 		<Designated foods>
5 agricultural products
Soybean(incl. Green soybean(edible), Soybean sprouts), Corn, Potato, Rapeseeds, Cottonseeds
30 processed foods (groups)

(1)Tofu (Bean curd) and Tofu products

(2)Shimi-tofu, Okara(bean curd lees), Yuba (sheet of dried soybean casein)

(3)Natto(Fermented soybeans)

(4)Soya milk

(5)Miso(Fermented soybean paste)

(6)Boiled soybean

(7)Canned or Bottled soybean

(8)Kinako(Soybean flour)

(9)Roasted soybean

(10)Food of which main ingredient is any of the (1)-(9)

(11)Food of which main ingredient is soybean(for cooking)

(12)Food of which main ingredient is soybean powder

(13)Food of which main ingredient is soybean protein

(14)Food of which main ingredient is green soybean(edible)

(15)Food of which main ingredient is soybean sprouts

(16)Corn snacks

(17)Corn starch

(18)Popcorn

(19)Frozen corn

(20)Canned or Bottled corn

(21)Food of which main ingredient is corn flour

(22)Food of which main ingredient is corn grits(excl. Cornflakes)

(23)Food of which main ingredient is corn(for cooking)

(24)Food of which main ingredient is any of the (16)-(20)

(25)Frozen potato

(26)Dried potato

(27)Potato starch

(28)Potato snacks

(29)Food of which main ingredient is any of the (25)-(28)

(30)Food of which main ingredient is potato(for cooking)

 Ž¥Foods made from genetically modified agricultural products that has been treated under a IP handling
Labelling required
("Soybean[genetically modified]", etc.)

Ž¥Foods made from designated agricultural products that has been produced, distributed, or processed without segregation between GM agricultural products and non-GM agricultural products
Labelling required
("Soybean[genetically modified soybean NOT segregated]", etc.)

Ž¥Foods made from non-GM agricultural products that is confirmed that it has been treated under IP handling
No labelling required, Voluntary labelling is possible (Soybean [not genetically modified]", etc.)
* Classification 3
Processed food made from agricultural products which have some genetically modified crops in their categories, which are equivalent to conventional ones in composition, nutritional value or intended use, etc. (i.e., soybean, corn, potato, oilseed rape, and cottonseed) in which recombinant DNA and resulting protein thereby dose not exist as a result of removal or decomposition during the manufacturing process 		Ž¥Soy sauce
Ž¥Soybean oil
Ž¥Corn flakes
Ž¥Corn starch syrup
Ž¥Isomerized corn syrup
Ž¥Dextrin
Ž¥Corn oil
Ž¥Rapeseed oil
Ž¥Cottonseed oil
Food of which main ingredient is any of the above 		Ž¥No labelling required

Ž¥Voluntary labelling is possible (the above criteria is applicable)

1. Main ingredient means the ingredients that are ranked within the top three constituents in terms of the ratio of weight they occupy, and each weight ratio accounts for five or more percent of the total.

2. IP handling (Identity Preserved Handling) means management method in which segregation between genetically modified agricultural products and non-GM agricultural products is accomplished, under the care of a good manager at each stage of production, distribution and processing. Further, it must be verified by using documents clearly indicating that segregation has been made.

3. Labelling for processed foods made from potato will come into force on Jan. 2003.