Tunisia—The Use of Modern Biotechnology in Tunisia – Regulatory Framework

Regulation of genetically modified organisms (GMOs) started in the 1990s in the United States, and European Union (EU) adopted two different approaches for GMO regulations: one based on the “substantial equivalence” and the other on the “precautionary approach” and the “right to know” of the consumer. Other countries developed their regulations in between these two concepts. However, despite the underlying opposite approaches, both countries recognized some common aspects in GMO regulation that cover different aspects of the cultivation and commercialization of GM crops, such as approval, risk assessment, labeling, traceability, and coexistence; but also aspects related to the development of new GM crops, such as rules for laboratory and field trials and intellectual property rights (IPR) protection (Vigani and Olper, AgBioforum 18:44–54, 2015). Regulation of biotechnology and GMO has a direct effect on trade and market (Gruere, An analysis of trade related international regulations of genetically modified food and their effects on developing countries, EPT discussion paper 147. International Food Policy Research Institute, Environment and Production Technology Division (EPT), Washington, DC, 2006; Gruere et al., Rev Int Econ 17:393–408, 2009; Vigani and Olper, Food Policy 43:32–43, 2013, AgBioforum 18:44–54, 2015). Despite the efforts of the Codex Alimentarius and of the Biosafety Protocol in searching for international agreement on labeling and rules for the trans-border movements of GMOs, to date there is no consistent and harmonized set of rules to regulate GMOs. This is partially due to the different food security strategy in developing and developed countries (Vigani and Olper, AgBioforum 18:44–54, 2015). Hence the “wait and see” attitudes of most developing countries, including Middle East and North African (MENA) countries, which fear that the implementation of any particular regulations may have a direct effect on their current and future agricultural exports to countries with stringent regulations (Zarrilli, International trade in GMOs and GM products: National and multilateral legal frameworks, Policy issues in international trade and commodities study series, 29. United Nations Conference on Trade and Development, New York/Geneva, 2005).