regulation of genetically modified organisms (gmos)
TRANSCRIPT
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.
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.
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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.
LAW LIBRARY OF CONGRESS – 4
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
LAW LIBRARY OF CONGRESS – 5
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
LAW LIBRARY OF CONGRESS
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.
LAW LIBRARY OF CONGRESS – 2
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).
LAW LIBRARY OF CONGRESS – 3
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.
LAW LIBRARY OF CONGRESS – 5
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
LAW LIBRARY OF CONGRESS
JAPAN
REGULATION OF GENETICALLY MODIFIED ORGANISMS
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.”
LAW LIBRARY OF CONGRESS – 2
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
LAW LIBRARY OF CONGRESS
RUSSIAN FEDERATION
REGULATION OF GENETICALLY MODIFIED ORGANISMS
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.
LAW LIBRARY OF CONGRESS – 2
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.