# Myths and Realities about Genetically Modified Food: A Risk-Benefit Analysis
## 2 Legislative Framework of Genetically Modified (GM) Crops
### The EU Regulatory Framework of GMOs  
The EU has set up a legal framework to disseminate GMOs on markets to ensure high protection levels for human/animal health and the environment. The aim of this regulatory framework is to confer in the authorization process a high degree of transparency. It is based on three basic principles: pre-market authorization based on a prior risk assessment; traceability; labeling [27]. GM foods and feeds in the EU can be approved provided that they successfully pass rigorous safety assessments [28]. The procedures to assess and authorize GM foods and feeds appear in the following documents: (1) Directive 2001/18/EC, which regulates the authorization of deliberate releases and placing GMOs on the market; (2) EC Regulation No. 1829/ 2003, which provides a specific authorization procedure of GM foods and feeds [29; 30]. These documents provide rules for GMO safety assessments by regulating GM food and feed production, GMO imports, and the release of GMOs into the environment [18].  
A GMO authorization is granted as long as no adverse health or environmental effect is identified. In the EU, the European Food Safety Authority (EFSA) plays the main role in risk assessments [27]. The EFSA's role is to assess the safety of new GMOs and to provide scientific advice before Europe's risk managers make decisions (the European Commission and EU Member States). EFSA assessments are made according to applicants' scientific dosiers and any other relevant scientific data. They bear in mind these aspects: (1) molecular characterization; (2) comparative analysis between the GM plant and its conventional counterpart; (3) evaluation of potential toxicity and allergenicity; (4) evaluation of potential environmental impacts. According to EU legislation, all Member States can decide about cultivating GM crops in their territories. Once a GMO is authorized, it usually receives a 10-year EU market license. Later, it must be re-assessed by the EFSA before any more re-authorization decisions are made [28].  
Labeling and traceability rules guarantee operators and consumers access to crucial GMO information [27]. In line with EC Regulation No. 1829/2003 on GM food and feed and No. 1830/2003 on the traceability and labeling of GMOs, products consisting of or containing authorized GMOs or produced from GMOs must be clearly labeled as such. These requirements do not apply to foods containing \(<0.9\%\) authorized GM material as long as the GM material is technically or adventiously unavoidable [27; 31]. The EU framework sets a traceability and labeling threshold for approved GMOs, and a \"zero tolerance\" policy exists for unapproved GMOs. What they mean is that unapproved GMOs in the EU cannot be sold [31]. Several EU Member States have enacted their own national regulations that permit the voluntary labeling of \"GMO-free food or feed\" or \"food that originates from animals not fed GM feed\" [32].  
The EU GMO regulation includes effective enforcement provisions. Those applicants who wish to place GMOs on the EU market must set up and submit an acceptable detection method, positive and negative control samples, and certified reference material. These methods form part of the national authorities' control and inspection systems to make sure that any GMOs placed on the market have been duly approved and labeled according to legislation [27].