This document discusses international rules and regulations regarding genetically modified organisms (GMOs). It provides an overview of GMO definitions, history, advantages, and disadvantages. It then examines regulations in different countries and regions, including the European Union, United States, China, Japan, and Brazil. The EU has very strict approval processes and labeling requirements, while the US regulates GMOs less strictly. Countries establish GMO policies based on economic, political, and social factors. Overall, regulations vary significantly internationally.

1. BIOSAFETY…
International rules and regulations for GMO’s
Laraib Zafar

2. CONTENTS
▪ GMOs
▪ History of GMOs
▪ Advantages of GMOs
▪ Disadvantages of GMOs
▪ Rules and regulations in international countries:
▪ EU
▪ US
▪ China
▪ Japan
▪ GMO security
▪ Laws in brazil
▪ GM banned countries
▪ conclusion

3. GMO’S
▪ Genetically modified organisms (GMOs)
Are living organisms whose genetic material has been artificially manipulated in a laboratory through genetic
engineering.
⮚ This creates combinations of plant, animal, bacteria, and virus genes that do not occur in nature or through traditional
crossbreeding methods

4. HISTORY OF GMO’S
▪ First GMO is created in 1973
▪ After an years of testing and research
GMO’S were introduced to farmers
▪ In 1990s ,genetically modified foods become
available in stores

5. ADVANTAGES OF GMO’S
▪ Improve the nutritional value of some food
▪ Reduce use of Pesticides and other toxic chemicals
▪ Desired characters are achieved in food in short time
▪ Best solution to the problem of world hunger

6. DISADVANTAGES
▪ Cause some toxic effects
▪ Genetically modified animals may suffer more health problems
▪ New allergies may arise
▪ Environmental risk of GMO’S

7. RULES AND REGULATION IN
INTERNATIONAL COUNTRIES

8. RULES IN EUROPEAN UNION:
▪ Europe is very conservative for GMOs. It has a comprehensive and strict legal regime on GMO’s. Here GMOs are
regulated at two authoritative levels:
▪ The European commission
▪ European food safety authority
▪ Reason of cautionary attitude of EU:
Two key reasons:
▪ To protect human animal ,health and welfare consumer interest and environment.
▪ To ensure such products may circulate freely within EU and economic area to ensure their effective functioning.
This is due to several reasons:
▪ Economic
▪ Political
▪ societal

9. Companies who want to sell and market their GMO-containing foods or feed must
find approval at country level:
▪ If approved , notify other countries via EC
▪ If any objection EC will conduct additional evaluations
▪ GMO products must clear strict evaluations and safety assessments. Then authorization is gained for 10
years by EC through a centralized procedure.
▪ At EU level EFSA conducts required risk assessment.
▪ Research is must prior to release.
▪ Then these GMO products are assigned a unique identifier and are labeled to allow public to make an
informed choice.
EU court system
make
preliminary
rulings
regarding the
interpretation of
EU legislation
on GMOs
An official list of
authorized GM
plants is available
at EU public
register of GM
food and feed.

10. ▪ GMO cultivation in EU is limited and under the current legal regime it may be banned ,member states have right to
temporarily ban cultivation or use of GMO.
Items required before release into environment:
▪ A dossier containing information.
▪ Environmental risk assessment
▪ Explicit consent
▪ A monitoring plan
▪ Disclosure of info to the public on release and results .
Considers Cartagena
protocol and
biodiversity and other
international
instruments for
regulation

11. RULES IN UNITED STATES
▪ GMOs are regulated in US under the coordinated framework for regulation of biotechnology. US is not that much
conservative for GMO as EU.
▪ Plant GMOs regulated by US department of Agriculture’s Animal and Plant Health Inspection Service.
▪ GMOs in food, drugs and biological products are regulated by The Food, Drug and Cosmetic Administration.
▪ GMO pesticides and microorganisms are regulated by the Environmental protection Agency.
▪ US doesn't have any federal legislation specifically for GMO.
▪ US is neither party of Cartagena protocol nor of biological diversity.
“Regulations should
focus on the nature of
products rather than the
process in which they
were processed.”
GMOs play significant
role in US economy.

12. Regulations and restrictions on Research, Production and Marketing:
▪ Introduction of GM plants require prior approval from APHIS by means of a notification.
▪ The GMO product that s structurally, functionally or compositionally different fro substances found currently in food
require premarket approval from FDA.
▪ To introduce a new drug into US market one must submit a New Drug Application to FD with detailed info on drug’s
safety and effectiveness.
▪ All biological products must get license from FDA before being introduced.
▪ All pesticides must be registered by EPA.
Labeling of GMOs:
There is no such law for labeling of GMO products.

13. RESTRICTION ON GMO’S IN
CHINA:
▪ Worldwide, countries have established GMO regulations based on their own economic, political and societal reasons.
▪ China is a party to the convention on biological diversity which become effective in 1933.
▪ China is also part of Cartagena protocol on biosafety to the convention on biological diversity, which entered in force
in 2005.
▪ Licenses have been granted for the import into china of three foreign GM crops: cotton, soybean and corn.

14. CONTI..
▪ In 2002, China started to require that all food products containing GMOs receive a safety assessment ang go through
an approval process, in addition to being labeled accordingly.
▪ The new law (food safety law) in china specifically includes an article on GM food that requires mandatory GMO
labeling.
▪ Punishments will be given to those who violate the labelling requirement.
According to article 15, while testing of agricultural genetically modified organisms need to move on from one testing
stage to the next one, the testing unit shall make a report with following material:
▪ Safety class of GMO.
▪ The inspection report issued by technical inspection body of GMO.
▪ Appropriate safety administration and precautionary measures.
▪ Summary report of previous testing stage.

15. RESTRICTION ON GMO’S IN
JAPAN
▪ In Japan, GMO’s in food are regulated under the Cartagena protocol.
▪ The Japanese government divides GMO regulation government authorities into different units.
▪ The ministry of environment and MAFF are responsible for assessing environmental safety and impacts on
biodiversity caused by GMO cultivation.
▪ MHLW assesses the safety of GMOs in foods, whereas MAFF assesses the safety of GMOS in animal feed.
▪ Labeling of GMO containing food is required.

16. GMO’S SECURITY
▪ Six global food powerhouses face fines of more than $1 million. The companies, which include PepsiCo
and Nestlé, failed to comply with a Brazilian law requiring companies to disclose products that
contain genetically modified organisms (GMOs). GMO labeling is required pursuant to Decree No.
4,680 dated December 22, 2003.
The law includes rules for biotechnology research, as well as rules for the production and marketing of
GMOs.

17. LAWS IN BRAZIL
▪ GMOs are regulated but not banned in Brazil. CTNBio, a group that was set up to regulate the biotechnology industry
in Brazil, is responsible for deciding whether specific GMOs can be used commercially in the country. Currently,
CTNBio has approved roughly fifty GMOs for commercial use. They include things such as beans, cotton, soy and
corn.
▪ The controversy concerning GMO labeling is not exclusive to Brazil. Many other countries also have GMO labeling
laws, some of them stricter than Brazil’s law. Even countries without laws requiring GMO labeling or GMO
restrictions often deal with controversy over GMOs. For example, in the United States, where there are currently no
federal restrictions on GMOs in food products, several major companies have promised to either eliminate GMOs in
their products or correctly label products that do contain them.

18. GENETICALLY MODIFIED BANNED
COUNTRY
⮚United States
⮚Japan
⮚New Zealand
⮚Germany
⮚In Ireland
⮚Austria, Hungary, Greece, Bulgaria and Luxembourg
⮚France
⮚Australia

19. CONCLUSION
Countries have established GMO regulations based on their own economic, political and societal reasons. A GMO index
to score different countries. The score is generated from six main parameters of GMO regulation: approval process, risk
assessment, labeling, traceability, coexistence and membership in international agreements. The EU and Japan lean
toward the more hard side for GMO regulation, whereas the U.S. represents the less-preventive side of the scale. There
is also a third group of countries that weigh the benefits of GMOs (lower production costs) and the risk of losing export
markets restrictive to GMOs. Countries with very dissimilar GMO regulations trade significantly less.