European legislation governing the marketing of GMOs is necessary. Regulations and directives, implemented gradually, are now followed by the countries of the European Union to protect people and their environment, and are explained by Daniele Franzone (former director general of the environment at the European Commission).

Areas concerned by GMOs

Genetically modified organisms ( GMOs ) are part of a larger field: life sciences and biotechnology . It is recognized that life sciences are the next wave of the knowledge economy after information technology , creating new opportunities for our societies and economies. They also raise important political, social and ethical issues that have given rise to a wide debate that is far from over.

This debate is a sign of the vitality and richness of our societies, but all too often it has focused on GMOs, perhaps because of their use for food and feed, and on certain issues of nature. ethics. Life sciences and biotechnology go far beyond GMOs. They enable new and innovative approaches to global health care to meet the needs of an aging population and poor countries. In addition, they can offer new ways to protect the environment, including the bioremediation of air , soil, water or the development of cleaner industrial processes based, for example, on the environment..

Conscious of economic and social issues, the European Commission adopted on 23 January 2002 the communication ”  Life sciences and biotechnology – a strategy for Europe” , in which it develops its analysis and presents a plan of action, consisting in specific measures involving in many cases a plurality of actors: Commission, Member States, Community institutions, professional operators, civil society. I would like to quote a passage from this communication to highlight the stakes: ” Europe is at a crossroads today: we must actively develop responsible policies from a forward-looking global perspective, or [we] will be confronted with the policies set by others in Europe and Europe. the world. […] The Commission believes that the political choice of Europe is not to know whether to respond to the challenges posed by new knowledge […], but how to respond to it  .

This communication is being examined by the other Community institutions, the Economic and Social Committee having adopted its opinion in mid-September 2002. The question also concerns the public opinion which, in the spirit of the principles of European governance, is to play a major role in future political decisions.

The communication speaks of a strategy for Europe, not just for the Community. In the perspective of accession, the candidate countries and their companies are called upon to contribute to the definition of this policy, which concerns us all.

Guidelines for the regulation of GMOs

It is important to highlight the guidelines of the Community rules.

• In line with the approach taken in areas where prior authorization is required for placing on the market, authorization is granted only after a thorough scientific risk assessment which concludes that there is no danger to health and the environment.
• In the event that scientific evidence is insufficient, uncertain or inconclusive and potential risks are deemed unacceptable by policy makers, risk management measures should be based on the precautionary principle .
• Procedures must be transparent and include not only public information, but also participation in the licensing process. In other words, the public must be informed of the submitted application (and of these essential parts) and of the scientific evaluation in order to be able to give its opinion on the required authorization. This applies both to the placing on the market of GMOs and their use for research and development purposes.
• The regulatory requirements must be proportional to the identified risk and comply with the international obligations of the Community. It’s about striking the right balance between health and environmental protection requirements, on the one hand, and the interest of research and industry not to be subject to unnecessary constraints and bureaucratic.

It is not up to the public authority (and the political decision-maker) to be in favor or against GMOs. It must ensure that the authorization process respects the principles I just stated, so that the consumer can make his choice, based on his personal judgment. What postulates another aspect: through a reliable and easy to understand labeling, the consumer must know if the product he buys contains GMOs or is derived from GMOs.

Given the reluctance and concerns of public opinion, also disoriented by mad cow disease (BSE) and dioxin contamination of food , EU regulations have evolved to comply with the guidelines above.

Contained use of genetically modified microorganisms

The major revision of Directive 90/219 / EEC on the contained use of genetically modified microorganisms (GMMs) by Directive 98/81 / EC of 26 October 1998 and subsequently by Directive 2009/41 / EC of 2009; ensures minimum harmonization at Community level and allows Member States to introduce more stringent health protection or environmental rules.

The deliberate release of GMOs

The repeal from 17 October 2002 of Directive 90/220 / EEC on the deliberate release into the environment of GMOs and its replacement by Directive 2001/18 / EC. It is not possible to mention here all the innovations introduced by this directive. It is sufficient to recall the greater harmonization of the principles relating to scientific risk assessment, public participation in the authorization procedure, mandatory surveillance after the placing on the market (monitoring), the limited duration of the authorization and its possible renewal, the forecast of deadlines throughout the phases of the procedure. The characteristics of Directive 2001/18 / EC have been summarized as follows: harmonized framework, science-based, transparentand predictable. This Directive requires many steps of implementation are adopted by a simplified procedure (known in EU jargon, “comitology”).

Traceability

The traceability is the ability to track GMOs for human consumption throughout the chain of production and distribution. It is governed by Regulation 1830/2003 / EC dated 2004.

The labeling of GMOs

Regulation 1829/2003 / EC requires the labeling of food products containing GMOs or GMO-derived products intended for human consumption. Since 2004, Regulation 1830/2003 / EC imposes the same labeling on food, even for animals, as soon as the food contains more than 0.9% of GMO.

A final remark: at the time of accession, the new member states will have to apply the acquis communautaire as it stands at that time, unless specific transitional rules are included in the Act of Accession itself. Cooperation between the candidate countries, the Commission and the current Member States will minimize the difficulties and uncertainties that may arise.