Ceci est une version HTML d'une pièce jointe de la demande d'accès à l'information 'Correspondance about environmental and food safety standards in relation to TTIP'.




 
Ref. Ares(2014)1095316 - 08/04/2014
Ref. Ares(2016)7049618 - 19/12/2016
EUROPEAN COMMISSION 
HEALTH AND CONSUMERS DIRECTORATE-GENERAL 
 
Safety of the Food Chain 
  Biotechnology 
 
      Brussels,  
SANCO/E1/
 sanco.ddg2.e.1(2014)933921 
Dear 
,  
Subject: 
WTO ruling on genetically modified seed and food/proposal for a 
reversal of burden of proof. 

Thank you for your email of 9 February 2014 to President Barroso regarding 
international trade of GMOs and the need for a reversal of proof as regards 
demonstration of safety of these GMOs on health and the environment. The President has 
asked that I, as the head of the unit responsible for GMOs, respond on his behalf. 
I would like to confirm you that the European system for authorisation of GMOs is 
precisely built upon the principle of “reversal of proof” you are calling for. Indeed the 
EU legislation provides for a well-defined regulatory framework on GMOs and 
particularly Directive 2001/18/EC1 and Regulation (EC) No 1829/20032, which is 
recognised as being among the strictest worldwide. According to this framework a GMO 
can be placed on the EU market for food and feed use or for cultivation only after having 
been through a thorough risk assessment, performed by the applicant and evaluated by 
the Member States and the European Food Safety Authority (EFSA). This risk 
assessment has to demonstrate that the GMO is safe for human and animal health and for 
the environment.  
In practice, this means that the applicant holds the responsibility to prove the safety of 
the GMO by compiling a precisely defined set of data/studies on all possible areas of 
environmental risks, including potential for plant-to-plant gene transfer to compatible 
relatives, or the environmental impacts due to interaction with target organisms and non-
target organisms. Applicants also has the obligation to propose a post-market 
environmental monitoring plan within the application. Member States and EFSA are 
responsible for assessing the submitted application and may require supplementary 
information or clarifications from applicants. When adopting their opinion, Member 
                                                 
1   Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the 
deliberate release into the environment of genetically modified organisms and repealing Council 
Directive 90/220/EEC, OJ L 106, 17.4.2001 
2   Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 
on genetically modified food and feed, OJ L 268, 18.10.2003 
 
Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 22991111 
Office: 
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