regulation of genetically modified organisms (gmos)

The Law Library of Congress, Global Legal Research Directorate (202) 707-5080 (phone) • (866) 550-0442 (fax) • [email protected] • http://www.law.gov

Regulation of Genetically Modified Organisms (GMOs)

People's Republic of China • European Union

Japan • Russian Federation

March 2003

LL File No. 2003-14490 LRA-D-PUB-000251

This report is provided for reference purposes only. It does not constitute legal advice and does not represent the official opinion of the United States Government. The information provided

reflects research undertaken as of the date of writing. It has not been updated.

jgon

Rectangle

2003-14490

LAW LIBRARY OF CONGRESS

PEOPLE’S REPUBLIC OF CHINA

REGULATION OF GENETICALLY MODIFIED ORGANISMS (GMOs)

In the People’s Republic of China, research, production, marketing, and import or export of GMO products or raw materials are all regulated. Domestic and imported GMOs require safety certification and are subject to classification and to strict safety evaluation procedures, and GMOs and processed products containing GMO materials must be labeled. Licenses are required for the production and marketing of GMOs. For import/export items, the stipulated approval period for GMO safety certificates is 270 days. However, that period has been cut and paperwork has been simplified under interim measures, due to expire in September 2003, that allow for the issuance of an interim safety certificate within 30 working days.

Genetically Modified Organisms (GMOs) in the People’s Republic of China (PRC)

are governed chiefly by the Ministry of Agriculture’s Regulations on Safety

Administration of Agricultural Genetically Modified Organisms, effective as of May 23,

2001;1 three implementing measures on safety evaluation, import safety administration,

and labeling, effective as of March 20, 2002;2 and health safety measures for GMO

products issued by the Ministry of Health, effective as of July 1, 2002.3

1 The Regulations were adopted by the State Council on May 9, 2001, and promulgated on May

23, 2001. For the Chinese text, see 22 ZHONGHUA RENMIN GONGHEGUO GUOWUYUAN GONGBAO

(Gazette of the State Council of the PRC, hereafter STATE COUNCIL GAZETTE) 6-11 (Aug. 10, 2001), or

http://www.agri.gov.cn/zcfg/t20021107_22655.htm; for an unofficial English translation, see USDA Foreign Agricultural Service GAIN Report #CH1024, via www.usda.gov. The Regulations apparently

upgrade the Implementation Regulations on Safety Administration of Agricultural Biological Gene

Engineering adopted by the Ministry of Agriculture on Apr. 25, 1996 (promulgated on and effective as of

July 10, 1996).

2 All of the Measures were adopted by the Standing Committee of the Ministry of Agriculture on

July 11, 2001, promulgated on Jan. 5, 2002, and effective Mar. 20, 2002. For the Chinese texts, see http://www.agri.gov.cn/blgg/t20020910_2589 (Measures for the Safety Evaluation Administration of

Agricultural GMOs); http://www.agri.gov.cn/zcfg/t20021104_21411.htm (Measures for the Safety

Administration of Agricultural GMO Imports); and http://www.agri.gov.cn/blgg520020910_2611.htm

(Measures for Agricultural GMO Labeling Administration). For an unofficial English translation of the

three sets of Measures, see USDA Foreign Agricultural Service GAIN Report #CH2002, via

www.usda.gov.

3 Reviewed and approved by the executive committee of the Ministry of Health on Dec. 11,

2001, promulgated on Apr. 8, 2002, and effective as of July 1, 2002. For the Chinese text, see

LAW LIBRARY OF CONGRESS – 2

In addition, the Ministry of Agriculture has issued two sets of Management

Procedures on Interim Measures for Imported Agricultural GMO Products.4 The key feature of these Interim Procedures is to allow normal trade in GMO products to continue during

the lengthy 270-day Safety Certificate application process through the issuance of

Interim Certificates that can be processed within 30 days and that permit the conclusion

of Customs and labeling formalities.

Scope

The Regulations apply to anyone engaged in agricultural GMO research, testing,

production, processing, management, and import/export activities within the PRC’s

territory (art. 2) and are designed to strengthen control over such activities.5

“Agricultural GMOs” (hereafter, GMOs) under the Regulations refer to animal and plant

organisms whose genome constitution has been changed by using genetic engineering

technology used in agricultural production or agricultural product processing. These

chiefly include:

· genetically modified animals, plants (planting seeds, breed livestock, breed

fowl, aquatic seedlings), and microorganisms

· genetically modified animal and plant organism and microorganism products

· products directly processed from genetically modified agricultural products

· planting seeds, breed livestock, breed fowl, aquatic seedlings, pesticides,

veterinary medicines, fertilizers, and additives that contain genetically modified animal, plant, or microbial ingredients (art. 3, para. 1)

http://www.moh.gov.cn/wsflfg/blgz/200205100031.htm; for an unofficial English translation, see USDA

Foreign Agricultural Service GAIN Report #CH2031, via www.usda.gov.

4 For the Chinese texts of Circulars 190 of Mar. 10, 2002, and 222 of Oct. 11, 2002, and

accompanying Interim Agricultural GMO Measures, see

http://www.agri.gov.cn/blgg/t20021016_14351.htm http://www.agri.gov.cn/blgg/t20021011_12790.htm,

respectively. For an unofficial English translation of the Circulars and Interim Measures, see USDA

Foreign Agricultural Service GAIN Report #CH2052 and #CH2051 , via www.usda.gov.

5 China Issues New Regulations on Genetically Modified Products, KYODO (citing Xinhua News

Agency), June 7, 2001, via Foreign Broadcast Information Service (FBIS) online subscription database.


Restrictions on GMOs

Classification

GMOs are classified into one of four classes depending on the nature of their

potential danger to humans, animals, plants, microorganisms, and the ecological

environment (art. 6), ranging from no risk to high risk.6

Safety Certificate for GMOs

A Safety Certificate must be obtained for GM planting seeds, breed livestock,

breed fowl, and aquatic seedlings, as well as for planting seeds, breed livestock,

breed fowl, aquatic seedlings, pesticides, veterinary medicines, fertilizers, and

additives using GMOs or containing GM ingredients, before regular formalities of

examination and registration or evaluation and approval can be processed. The Safety Certificate is issued only after a safety evaluation has been successfully passed (arts.

16, 17). Testing typically involves three stages: medium testing (i.e., small-scale tests), environmental release, and product testing (art. 13).

Government Approval for Research or Testing

The Regulations prescribe that joint ventures and foreign-owned companies must

obtain government approval in order to do research on or test genetically altered

products (art. 18). GMOs introduced into the PRC for research and testing must have

undergone relevant research and testing abroad, among other requirements (art. 31).

Licenses

Licenses are required for production of GM planting seed, breed livestock, breed

fowl, or aquatic seedlings and for marketing GMOs in the PRC (arts. 19, 26).

Individuals and organizations engaged in production must also report on and/or obtain

approval for experiments on producing, processing, importing, and exporting transgenic

plants, animals, and microbes.

Labeling

GMO products must be clearly labeled when sold within PRC territory; unlabeled

products will not be sold (art. 28). A label should indicate the name of the GM

materials and, if there are special restrictions on where it may be sold, the area in

which it will be sold (art. 29). The State is to place GMOs under a labeling system

and publish a list of GMOs included under the system. The list of the first group of

6 Art. 9, ¶2, Measures for the Safety Evaluation Administration of Agricultural GMOs, supra

note 2. Apparently former guidelines on agricultural biological engineering had a more detailed risk

description system. KYODO, id.


GMOs to be included under the labeling system covers soybeans, corn, rapeseed, cotton

seed, and tomatoes.7 Based on the implementation date of the relevant implementing measures, items in these five categories of GMOs should be clearly labeled as GMO

products if they were made available on the market after March 20, 2002. However, it

was reported in December 2002 that despite export to and apparent consumption of GMOs

in China, “GMO labels are hardly found on the Chinese market nearly nine months after

the government released its labeling scheme in March.”8

Export/Import Restrictions

Any foreign company that exports GM planting seeds, breed livestock, breed fowl,

and aquatic seedlings, or planting seeds, breed livestock, breed fowl, aquatic

seedlings, pesticides, veterinary medicines, fertilizers, and additives using GMOs or

containing GM ingredients, to the PRC must submit an application to the agricultural

administrative department in charge. They must meet certain requirements in order to

be allowed to undergo product testing. Testing is permitted only if the exporting

nation or region allows the use of those products for the same purpose and sells them in their domestic markets; has verified the products’ safety for humans, animals,

microorganisms, and the environment through scientific testing; and has established

appropriate safety administration and measures to prevent problems. Upon completing

the product testing, meeting safety evaluation standards, and receiving the Safety

Certificate, the applicant can undertake the regular import procedures of examination

and registration or evaluation and approval (art. 32). Those who export GMOs as raw

materials to the PRC must go through a similar process (see art. 33).

The Regulations stipulate that the agricultural administrative department in

charge and the State Entry-Exit Inspection and Quarantine departments are to decide

whether to approve or reject the Safety Certificate application within 270 days from

the date of receiving it, and inform the applicant of their ruling (art. 36). However,

to lessen the impact that such a long application process would have on the import of

GMO products–in particular soy beans, in the case of the United States GMO exports to

the PRC, the government has allowed foreign exporters to apply for temporary

certificates until September 20, 2003.9 The approval process of these one-time Interim

7 Art. 2 and Appendix, Measures for Agricultural GMO Labeling Administration, supra note 2.

Any listed GMO must be labeled; unlabeled or mislabeled GMOs are not to be imported or sold (art. 3,

¶2).

8 Nestle Denies GMO Accusations, CHINA DAILY, Dec. 6, 2002, via LEXIS/NEXIS, News

Library, Curnws File.

9 Initially, the temporary measures were to last until Dec. 20, 2002, but in Oct. 2002, that

deadline was extended to Sept. 2003. China Enacts Rules on Genetically Modified Organisms, Mar. 22,

2002, CHINA BUSINESS; Officials Say GMO Tests on Track , XINHUA, Mar. 17, 2003, both via


Certificates is to take only up to 30 working days once the relevant documents have

been verified.10 Imports of GM products that arrive without the Safety Certificate and the relevant approval documents, or that do not match the Certificate or approval

documents, are to be rejected or destroyed. If their label does not meet the labeling

requirements, imported goods cannot enter the PRC until they are re-labeled (art. 38).

Prepared by Tao-tai Hsia

Chief, Eastern Law Division and

Wendy I. Zeldin Senior Legal Research Analyst

March 2003

LEXIS/NEXIS, News Library, Curnws File.

10 Circular 222 and Interim Measures, supra note 4.

2003-14490


EUROPEAN UNION

REGULATION OF GENETICALLY MODIFIED ORGANISMS

Introduction

Community action in the areas of public health, safety, and protection of the

environment and the consumer must aim at a “high level of protection.”1 Based on this

treaty-based mandate, and in order to create a common market on biotechnology, the

European Commission adopted its first legislative initiative on genetically modified

organisms (GMOs) in the 1990s. The increased commercial use of GMOs has generated

serious public discussion throughout Europe. The latest food crises with bovine spongiform encephalopathy (BSE) (also known as mad cow disease) and dioxin in Europe

have made the public very sensitive and concerned about food safety. The pervasive

sentiment among European consumers is that GMOs may have harmful effects on public

health and the environment. Many feel they are entitled to be informed as to whether

or not there are any GMOs in food products, and as a result they want accurate

information through clear and explicit labeling. All these reasons have prompted the

European Commission to play a very active role in this field. In addition to the

legislation in force, the Commission has prepared a number of proposals that cover

major issues affecting GMOs, such as labeling, traceability, liability, etc.

A number of these provisions may have trade implications. As a rule, any food

imported into the Community from third countries must be in compliance with all the

regulations and directives governing food aspects. In particular, the current

legislation in force concerning marketing and labeling of GMOs requires that any food

products consisting of, or containing, GMOs imported and marketed in the Community

must meet the criteria established. Some of the key provisions –such as notification procedure, environmental risk assessment, or the requirement of carrying a label

consisting of the phrase “genetically modified organisms”– may have an adverse impact

on the U.S. food industry with possible financial repercussions. According to a U.S.

official, the cost may amount up to US$4 billion a year for U.S. companies.2 While

U.S. representatives voice their concerns with European officials and hope for a

possible solution before resorting to WTO mechanisms, the Europeans claim that “[U.S.]

1 The Commission, the Council and the Parliament in exercising their respective powers, at the same time

take into account any news developments in these areas based on scientific facts. EC Treaty, art. 95.

2 Alan Sipress and Marc Kaufman, U.S. Challenges EU’s Biotech Food Standards, WASHINGTON POST, Aug. 24, 2001.


administration is trying to impose U.S. acceptance of biotech food on a European public

that does not believe these products are safe.”3

On the other hand, the European Commission maintains that its legislative

initiatives on GMOs are consistent with its international obligations and take in

consideration the conditions established by the Cartagena Protocol on Biosafety to the

Convention on Biological Diversity. At the same time, the Commission is committed to

ensure that the treaty requirement of “high level of protection” to humans and

environment is respected and enforced.

Genetically Modified Organisms (GMOs)

Legislation in Force

· Directive 2001/18/EC on the deliberate release into the environment of GMOs4

repealed Directive 90/220/EEC and entered into force on October 17, 2002. This

is an horizontal Directive and aims to protect human health and the environment

from the release of GMOs.5

· The scope of the Regulation on Novel Food and Novel Food Ingredients extends to

products which are derived from GMOs, such as tomato paste or catsup made from

a GMO tomato.

· Commission Regulation (EC) No. 50/2000 governs the labeling of foodstuffs and

food ingredients containing additives and flavorings that have been genetically

modified or have been produced from GMOs.6

· Commission Regulation (EC) No. 49/2000 of January 10, 2000, amended Council

Regulation (EC) No. 1139/98 concerning the compulsory indication on the labeling of certain foodstuffs produced from GMOs, in particular other those provided

for in Directive 79/112/EEC.7

3 Id.

4 2001 O.J. (L 106).

5 Genetically Modified Micro-organisms (GMMs) are regulated by Directive 90/219/EEC as amended by Directive

98/81/EC on the contained use of GMMs for research and industrial purposes.

6 2000 O.J. (L 006).

7 2000 O.J. (L 006).


Pending Legislation

· Regulation of the European Parliament and of the Council on GM food and feed8

· Regulation of the European Parliament and of the Council concerning traceability and labeling of GMOs and traceability of food and feed products produced from

GMOs9

· Regulation concerning the environmental risk assessment in respect of GM plant

varieties

· Directive on the prevention and restoration of significant environmental damage

to include damage from GMOs and GMMs

· Regulation on the trans-boundary movements of GMO (The proposal aims to implement

certain provisions of the Cartagena Protocol on Biosafety through the

establishment of a common system of notification and information for exports to

third countries.)

Definition

The legislation in force distinguishes between a “genetically modified organism”

and a product derived from GMOs that contains GMOs that are not living. Directive

2001/18/EC defines a GMO as “an organism, with the exception of human beings, in which

the genetic material has been altered in a way that does not occur naturally by mating

and/or natural recombination.” Pursuant to the same Directive, “deliberate release”

means “any intentional introduction into the environment of a GMO or a combination of

GMOs for which no specific containment measures are used to limit their contact and to provide a high level of safety for the general population and the environment.” Under

the Directive, the authorization for the deliberate release and placing on the market

of a GMO is limited to 10 years, which can be renewed.

The Scientific Commission on Plants (SCP) has approved the commercial release

of approximately 18 GMOs since the first legislation was put into effect in 1990.

Since October 1998, the EU has imposed a de facto moratorium on further approvals of GMOs. The Scientific Committee on Food, which is in charge for opinions related to novel foods, has approved three cases of food of plant origin (tomato and maize) and

8 EUR. PARL. DEB. (COM 425) 2001 final, Brussels.

9 EUR. PARL. DEB. (COM yyy) 2001 final, Brussels.

LAW LIBRARY OF CONGRESS – 4 four on products of microbial origin.

10 The position of the United States is that such

a moratorium constitutes a technical barrier to trade and violates WTO rules.11

Deliberate Release of GMOs

Deliberate release of GMOs into the environment without following the standard

authorization procedure is prohibited.12 The Directive advocates that GMOs be

introduced into the environment upon following the “step by step” principle, that is,

each step may be taken only upon confirmation that is safe to do so. If new information

indicates that the specific GMO poses a threat to human health and the environment,

then the release can be either suspended or terminated. The steps that must be taken

for the deliberate release or placing in the market of GMOs by companies are outlined

below.

· Environmental Risk Assessment: Such an assessment is critical to identify any

dangers of the GMOs, either direct or direct, long or short term, on human

health and the environment.

· Notification at the National Level: The competent authority of the Member State

where the release will take place must be notified. The notification must include the environmental risk assessment, accurate instructions of use, as well

as labeling and packaging information. The authority shall respond within 90

days of receipt of notification whether the application has been approved.

· Informing the Public: During the notification process, the public must also be

kept abreast and must have access to publicly available data on the internet.

· Informing the Member States: When the national authority approves the release,

it must inform the other Member States through the Commission. If no objections

are raised, consent is granted by the Member State. If, on the other hand,

there are objections, then a decision is made at the Community level.

· Decision Made at the Community Level: The Commission requests expert opinions

from the various scientific committees. If such committees concur, the

Commission proposes a draft decision to the Regulatory Committee, composed of

representatives of the Member States, for a second opinion. If the answer is

affirmative, the Commission adopts the decision, otherwise the draft decision

10 Questions and Answers on the Regulation of GMOs in the EU, MEMO/02/160, Brussels, Oct. 15, 2002.

11 Charles W. Smitherman III, The World Trade Organization Adjudication of the European Union -United States

Dispute Over the Moratorium on the Introduction of New Genetically Modified Foods to the European Common Market: A Hypothetical Opinion of the Dispute Panel, 30 GA J. INT’L & COMP. L. 475 (Spring 2002).

12 Art. 6 covers the standard authorization procedure.


is sent to the Council. The Council may either adopt it by a qualified majority

or reject it.

Pursuant to 2001, Directive initial authorizations will be valid for a maximum period of 10 years. Under its provisions, it is mandatory to consult not only the

Scientific Committee but also the European Parliament in decisions authorizing the

release of GMOs.

Marketing of GM Foods

The Novel Food Regulation (EC) No. 258/97 applies to food and food ingredients

which are produced from GMOs or which contain such organisms. It also lays down rules

for authorization and labeling of such foods.

The full authorization procedure is similar to that established by Directive

2001/18/EC. The applicant, the person who intends to market a food or food ingredient

produced from GMOs, must submit a request to the Member State and a copy to the

Commission. Information must also be forwarded to the other Member States. If the

Members disagree, then the Commission must decide after consultation with the experts

and adopt a decision from the Regulatory Committee.

Foods derived from GMOs which no longer contain GMOs and are similar to other

existing foods are subject to a less cumbersome procedure. A notification of the

Commission is required by the companies when they market the product along with an

expert’s opinion that the product is “substantially equivalent” to an one already in

the market.

Labeling

As Mr. David Byrne, the European Commissioner for Health and Consumer Protection,

emphasized, the intent of strict labeling requirements for GMOs and products derived

from GMOs is not to inform the consumers as to whether a particular food is safe,

rather to provide them with a choice to make an informed decision.13

The labeling requirements for GMOs are prescribed by the 2001 Directive. It requires that labeling either in a label or in an accompanying document must include

the following minimum information:

· a commercial name

· the statement “This product contains genetically modified organisms.”

· the name of the GMO

13 Speech of David Byrne, Proposal for a regulation on GM Food and Feed, at the European Parliament,

Brussels, Sept. 11, 2001.

LAW LIBRARY OF CONGRESS – 6 · name and full address of the person who marketed the product, i.e., either the

manufacturer, distributor, or importer

· information on accessing the public register

Pursuant to the Novel Food Regulation, food and food ingredients must be labeled

if they meet the following criteria:

· presence of a GMO

· any characteristic which makes the food/ingredient no longer equivalent to the

existing food because of its composition, nutritional value or effects, or

intended use, together with the information about the method by which it was obtained

· presence of materials not usually present in equivalent foodstuffs which may have implications for the health of certain parts of the population

· presence of materials not usually found in existing equivalent foodstuffs which

raise ethical concerns

Council Regulation (EC) No. 1139/98 of May 26, 1998, provides for the compulsory

labeling of certain foodstuffs produced from particular GMOs other than those provided

for in Directive 79/112/EEC.14 Regulation No. 1139/1998 was amended by Commission

Regulation (EC) No. 49/2000, which deals with accidental contamination of food with

GMO material. It is also known as the “Threshold Regulation” because it requires that

foodstuffs must be labeled where material derived from GMOs can be found in food ingredients in a proportion above 1 percent of the food ingredients individually

considered.

Regulation No. 50/2000 establishes labeling requirements of foodstuff and food

ingredients which contain additives and flavorings that have been genetically modified

or have been produced from GMOs. Thus, in the list of ingredients, after the indication

of an additive or a flavoring, the phrase “produced from genetically modified” in

parentheses must follow.15 The other option is to have an asterisk next to the additive

or flavoring and the above phrase in a footnote.

The proposal for a regulation concerning traceability and labeling of GMOs and

traceability of food and feed products produced from GMOs extends the labeling requirements to: a) all foods produced from GMOs, regardless of whether DNA or protein

of GM origin is found in the final product (i.e., this group will comprise highly

14 1998 O.J. (L 159).

15 Regulation No. 50/2000, art. 4.

LAW LIBRARY OF CONGRESS – 7 refined oils and any other products, produced thereof), and b) all genetically modified

feed.

Placing Imports on the Market

Anyone who intends to place in the market or import in any EU Member State a

GMO, or a product containing or consisting of a GMO, must submit notification to the

national competent authority. The notifier may market a GMO only upon receiving a

written consent to do so. The consent, which will be valid for a certain period of

time, will lay down the conditions for the placing in the market, such as handling,

packaging, use, etc.

The provisions of the Directive extend to imports. Any products that contain

or consist of GMOs cannot be imported into the Community unless it complies with its

requirements.

Food or food ingredients produced from GMOs can be marketed16 in the European

Union, only upon compliance with the criteria established by the Novel Foods Regulation.17 Such products must be reviewed and authorised by the European Food

Authority at the Community level. Under the full authorization procedure, an

individual who intends to market such a product must apply to the competent authority

of the Member State where the product will be marketed for the first time. The

authority will review the product and decide if an additional review is warranted. If

the Commission and the Member State agree that no second review is required, the Member

State will authorize the marketing of the product.

If other Member States object, then the European Commission must issue a decision,

based on the opinion of the Standing Committee for Foodstuffs, authorizing the marketing

of the product. The decision contains detailed information as to the conditions of

use, labeling information, etc.

Foods derived from GMOs but no longer containing GMOs that are “substantially

equivalent” to existing foods may be subject to a less cumbersome procedure. Companies are obliged to notify the European Commission prior to marketing the product and submit

16 Before the above Regulation came into force two GMO products, soya beans and maize, had already been

marketed Commission Decision 96/1281/EC of Apr. 3, 1996, concerning the placing on the market of genetically

modified soya beans with increased tolerance to the herbicide glyphosate, pursuant to Council Directive 90/220/EEC.

1996 O.J. (L 107) and Commission Decision 97/98/EC of Jan. 23, 1997, concerning the placing on the market of

genetically modified maize with the combined modification for insecticidal properties conferred by the Bt-endotoxin

gene and increased tolerance to the herbicide glufosinate ammonium pursuant to Council Directive 90/220/EEC. 1997

O.J. (L 031).

17 Regulation (EC) No. 258/97 of the European Parliament and of the Council of Jan. 27, 1997, concerning

novel foods and novel food ingredients. 1997 O.J. (L 043).

LAW LIBRARY OF CONGRESS – 8 justification that the product is substantially equivalent or an opinion issued by the

responsible body of a Member State.

Traceability

Currently, there is no uniformity in the legislation of Member States regarding

traceability issues of GMOs. Directive 2001/18/EC introduces a general traceability

requirement which obliges Member States to ensure traceability at all stages of

marketing for GMOs.18 However, it does not define traceability, neither does it refer

to the objectives of such as system. A draft regulation concerning the traceability

and labeling of GMOs provides a comprehensive framework for areas not covered by the

Directive. It defines traceability as the “ability to trace GMOs and food and feed products produced from GMOs at all stages of their placing on the market through the

production and distribution chains.” For identification purposes, GMOs will be assigned

numeric or alphanumeric codes which will facilitate the retrieval of information

relevant to GMO.

Under the same proposed regulation, importers of products from third countries

especially bulk shipments of commodity crops will be obliged to specify the identity of these products if they contain GMOs. If the exporter has not included this

information, then importers will have to undertake sampling and analytical testing.

Subsequent legislation will provide the technical guidance on the methods to be followed

for sampling and testing.

As the Commission states, the reasons for introducing the concept of traceability

for GMOs and products derived thereof, are as follows:

· possibility to withdraw products when a risk to human health or the environment is established

· identification and monitoring of long terms impact on human, animal health, and the environment in general

· assist in labeling, since a traceability system can provide information to be

used for labeling

Upon adoption of this proposal, Member States are required to ensure traceability

at all stages of the placing on the market, including importation of GMOs. Consequently,

Members must ensure that business operators transmit and retain information on products that contain or are produced from GMOs at each stage of the placing on the market. In

particular, business operators must:

18 Art. 4, ¶ 6.

LAW LIBRARY OF CONGRESS – 9 · have systems and procedures in place to identify to whom and from whom products

are made available

· for GMOs intended to be deliberately released into the environment, operators

must transmit specific information regarding the identity of the GMOs that a product contain

· for GMOs intended for food, or feed, operators may either transmit the specified

information or transmit a declaration that the product will be used only as food or feed along with the identity of the GMO the product may contain

· inform the next operators in line that the product is produced from GMOs

· keep records for 5 years and must disclose such records to the competent

authorities

In practice, traceability starts with the company that develops a GMO, for example a genetically modified seed. The company must inform any purchaser of the

seed that it is genetically modified, along with additional information to ensure the

easy identification of the specific GMO. Moreover, the company must keep records of

all subsequent purchasers of the seed. Ensuing, the farmer is obliged to inform any

buyer of the harvest that comes from genetically modified seed and also keep data of

the operators who have purchased the product.19

Genetically Modified Seeds

Directive 98/95/EC regulates the use of genetically modified seeds. Under its

provisions, national authorities that have permitted the use of such a seed in their

territory must notify the Commission. The Commission will verify whether such

authorization conforms to the proper procedure and will include in the Common Catalogue

of Varieties of Agricultural Plant Species. Afterwards, the specific seed is permitted

for marketing purposes throughout the EU.

Prepared by Theresa Papademetriou

Senior Legal Specialist

March 2003

19 The information provided above is taken from a Memo prepared by the Commission on Questions and Answers on

the Regulation of GMOs in the EU. MEMO/01/277 Revised (Brussels, Oct. 29, 2001).

2003-14490


JAPAN


Safety Assessment of Genetically Modified Organisms

The Specifications and Standards for Foods, Food Additives and Other Related

Products1 imposes a mandatory requirement for the safety assessment of foods and food

additives that are or that contain genetically modified organisms (GMOs), based on

article 7 of the Food Sanitation Law,2 which enables the Minister of Health to set

standards of food safety. Any genetically modified (GM) foods and food additives that

have no safety assessment shall be neither imported nor sold in Japan.

To receive a safety assessment, an applicant must submit the necessary documents

to the Minister of Health in accordance with the Procedures of Application for Safety

Assessment3 and the Standards for Manufacturing.4 The result of the Minister’s safety

assessment will be published in the official gazette.

Guidelines for Application of GMOs in Agriculture, Forestry, Fisheries, and Food

Industry

The Ministry of Agriculture, Forestry, and Fisheries issued the Guidelines for

Application of GMOs5 in Agriculture, Forestry, Fisheries, the Food Industry and Other

Related Industries. The Guidelines provides that, before utilizing a GM plant, a

person must confirm that the plant will not have a new impact on the agriculture and

ecology of Japan. The standards are different between the two stages of application: application in a simulated model environment (confined field test), and application in

an open system.

1 Koseisho kokuji (Ministry of Health and Welfare (MHW) Announcement), No. 232 (May 1, 2000).

2 Law No. 233 of 1947.

3 MHW Announcement, No. 233 (May 1, 2000).

4 MHW Announcement, No. 234 (May 1, 2000).

5 The term “genetically modified organisms” is used in place of the more common translation of “recombinant

DNA organisms.”


Other Guidelines

There are several other guidelines for safety assessment or assessment of impact

on environment as follows:

· Guidelines for GM Experimentation in University Research Facilities by the Ministry of Education

· Guidelines for GM Experimentation (guidelines for experimentation in all

research facilities other than university facilities) by the Science and Technology Agency

· Guidelines for Safety Assessments of Application of GMOs in Feed by the Ministry of Agriculture, Forestry, and Fisheries

· Guidelines for Safety Assessments of Application of GMOs in Feed Additives by the Ministry of Agriculture, Forestry, and Fisheries

· Guidelines for the Manufacture of Pharmaceuticals, Etc., Utilizing GM Technology by the Ministry of Health and Welfare

· Guidelines for the Industrialization of GM Technology by the Ministry of

International Trade and Industry (MITI)

Labeling

Under the Law Concerning Standardization and Proper Labeling of Agricultural

and Forestry Products6 and the Food Sanitation Law, very similar labeling systems for

agricultural products and processed foods produced using GMOs are required.7

The agricultural products and processed foods which are subject to the labeling

system are soy, corn, potato, colza, and cottonseed. Highly processed food made of

soy and other products so that protein derived from food produced using GMOs is

dissolved, such as soy sauce, corn flakes, and mashed potatoes, are exempt from the

labeling requirements. Three labeling methods are provided: when GM crops are used,

the product must be labeled as “Using Sorted GMOs” or “GMOs”; when crops that are not

sorted, the products must be labeled as “GMOs Not Sorted”; and when no genetically

modified crops are used, “GMO Free” labels can be used voluntarily, though such labels

6 Niorin busshino kikakuka oyobi hinshitsu hyoji no tekiseika ni kansuru horitsu, Law No. 175 of 1950.

7 The Standards Set by the Minister of Agriculture, Forestry and Fisheries based on art. 7, ¶ 1 of the

Standards for Labeling Concerning Recombinant DNA; art. 7, ¶ 1 of the Standards for Labeling of Fresh Foods; art. 7,

¶ 1 or the Ministry of Agriculture, Forestry and Fisheries Announcement 517 of 2000; art. 5, Item 1, Me, of the Food Sanitation Law Enforcement Order, MHLW Ordinance No. 23 of 1948.

LAW LIBRARY OF CONGRESS – 3 are not required. The label of “GMO” is not required if the use of GMOs is five

percent or less of the total weight of the product.

Prepared by Sayuri Umeda

Japanese Law Specialist

March 2003

2003-14490


RUSSIAN FEDERATION


Legislation that relates to the problem of genetically modified medicines, food,

and food products was issued in 1997, and provided for licensing of all activities

related to the research, production, development, use, and trade of genetically

modified organisms (GMOs). The Interdepartmental Commission for Problems of Genetic

Engineering Activity, which includes representatives from different executive agencies,

academia, biological research institutions, medical circles, and military services,

was established under the Prime Minister of Russia. The duty of the Commission is to

develop government policy in regard to the problems of biological research and the use

of genetically modified products, and to control its implementation.

Foreign economic operations with genetically modified microorganisms (GMMs) are

subject to government control. The special export control procedure in regard to such

organisms was elaborated by Government Regulation No. 634 of August 29, 2001.1

According to the Russian Federal Law on Export Control, the President of the Russian

Federation approves the list of GMMs allowed for export from Russia.

In order to provide better monitoring of genetically modified (GM) food products,

the National Register of Genetically Modified Food Products was established according

to Resolution No. 7, on April 6, 1999, of the Chief of the Russian State Sanitation

and Epidemiological Service.2 After July 1, 1999, all GM food products, GM raw

materials, and GM food additives manufactured, distributed, or sold over-the-counter

in Russia must be registered with this Register. The registration is valid for 3

years and may be extended for an additional 5 years.

All food products received from GM sources must pass federal sanitation,

epidemiological, genetic, and technological testing. The Federal Ministry of Health

Protection assigned a number of research institutions to conduct such tests. The test

includes the evaluation of the submitted technical documentation and samples of food

products. The conclusion must be signed by the Chief Sanitation Officer of the Russian

Federation.3 In December 2000, the Government decided to introduce further biological

testing for genetically engineered products in order to determine whether a genetically

1 Sobranie Zakonodatelstva Rossiiskoi Federatsii [Russian official gazette, SZ RF] 2001, No. 34, Item 3751.

2 GENNAIA INZHENERIIA: SBORNIK PRAVOVYH DOKUMENTOV [Genetic Engineering: Collection of Legal Acts], Moscow, Ministry

of Health Protection, 2001, at 93-94.

3 Id. at 76.


altered new organism poses any danger in comparison to the original.4

The sale of GM food, food products, and medicines in Russia without appropriate

labeling on the packaging is forbidden. The Ministry of Health Protection Resolution

No. 12 of September 12, 1999, introduced three types of labeling GM products, products based on GM sources, and products containing components received from GM sources.

5 To

clarify these requirements, the Resolution referred to a further Instruction issued by

the Chief Sanitation Officer of the Russian Federation on May 22, 2000. It contains

a list of food products and medicines made from GM raw materials containing protein

and DNA that require special labeling on their packaging.6 Food products made from GM

raw materials that do not contain protein and DNA are listed in the Instruction as not

requiring such mandatory labeling on their packaging.

Prepared by Peter Roudik

Senior Legal Specialist

March 2003

4 SZ RF 2000, No. 51, Item 4996.

5 ZASCHITA PRAV POTREBITELIA [Consumer Protection], Moscow, Yurait, 2001, at 37.

6 Supra note 4, at 52.

regulation of genetically modified organisms (gmos)

Documents