What is the approval process

for import of GMOs in the EU?

Risk assessment of GM plants
1.RESEARCH & DEVELOPMENT
OBJECTIVE: Select the best
1000 opportunities identified
performing plant with the lowest
likelihood of adverse effects

9 years
2 opportunities selected on average

2.Safety assessment R
COMPARATIVE ASSESSMENT: IS THE GM AS SAFE AS ITS CONVENTIONAL COUNTERPART?
> Field trials : GM vs. non-GM • Agronomic characteristics (yield, height, etc.)
• Phenotype (appearance) • Composition (compounds, nutrients, allergens, etc.)

MOLECULAR CHARACTERISATION FOOD/FEED SAFETY

> What DNA was put into the crop? > Testing on animals
• Rats : 90 days of feeding
> How many genes were put into the crop?
to rule out adverse effects

+
> Where in the host genome is the inserted DNA located?
> Digestibility study
> Is expression of the gene(s) stable? The introduced protein is exposed to enzymes present in
> Characterize the insert on molecular level or analyse gastric and intestinal fluids
the product on a molecular level, such as location and
> Bioinformatic analysis
stability of the inserted gene, the number of genes
Do new compounds or altered levels of
inserted, etc. compounds in GM show similarities with

+ known toxins or allergens ?

> Animal feeding trials
• Chickens: 42 days of feeding

UP TO
2 years
POTENTIAL ENVIRONMENTAL IMPACT
> Evaluate potential adverse effects on the
environment + for nutritional assessment in case
of compositional changes case-by-case

R
REGULATORY DOSSIER
If the product is found to be as safe as its conventional counterpart,
the dossier is submitted to the European Food Safety Authority (EFSA)

6 PRINCIPLES

3.EFSA review
RISK ASSESSMENT
• Science-based
• Case by case analysis
• Precautionary principle
R
• History of safe
usage/consumption EVALUATION OF RISK FOR HEALTH SCIENTIFIC OPINION
(include lessons learned AND ENVIRONMENT > EFSA declares the GM product safe
from the past)
NO CAN
During this process applicants are often asked CER
• Compliance with interna- NO MUTTA
to provide more information for clarification AGENES
IS
tional quality standards
!
SAFE
NO HEA
LLTT
(OECD, ISO, GLP) CONCE H
RNS
• Weight of evidence
approach
29 months on average

Risk management Phase

R
AUTHORISATION BY VOTING BY EU MEMBER DRAFT PROPOSAL
R

EUROPEAN COMMISSION STATES FOR AUTHORISATION

yes
Draft
no

19 months
on average

After approval applicants are

obliged to monitor and report
any potential adverse effects
on the environment