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Legal procedure

Legal procedure of authorisation of placing GMOs on the EU market

By Manon Godot, January 2010

Procedure determined by the directive 2001/18/EC

The 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, repealing council directive 90/220/EEC, determines the legal procedure to follow in order for any person to be allowed to release into the environment GMOs, for placing them on the market within the community, or for any other purposes.

The article 2 of the directive defines a GMO as “any biological entity capable of replication or of transferring genetic material, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination“.

The directive’s purpose is to supervise “any intentional introduction into the environment of a GMO or a combination of GMOs for which no specific containment measures are used to limit their contact with and to provide a high level of safety for the general population and the environment;”

The procedure to follow in order to introduce a new GMO on the market as or in products, is defined in the directive 2001/18/EC, Part. C, and in the decision 1999/468/EC, articles 5, 7 and 8. The regulation 1829/2003/EC of the European parliament and of the council of 22 September 2003 on genetically modified food and feed also introduces new restrictions relatives to the authorization of GMOs.

  • Step1: Introduction of the request

A person who wants to introduce a GMO or a combination of GMOs as or in products on the market, has to submit a notification to the competent authority of its member state (Part C, art 13, 1). In Ireland, the authority competent to examine such request is the “Food Safety Authority” (FSAI). The notification must include the result of studies about the impact of the GMO on human health and the environment, an environmental risks assessment, the conditions for the placing on the market of the product, a proposal for labelling and packaging, etc.

  • Step 2: Transmission of the request to a European level

If the FSAI refuses the product to be introduced in the market, the refusal is notified to the person concerned.

If the FSAI’s answer is positive, the European Commission and the authority competent of each of the member states are informed of the request. If none of them express his disagreement within 60 days, the FSAI notifies to the person concerned the agreement, and also notifies it to the Commission and member states within 30 days. A country must formally disagree in order to block a product’s advancement; silence is considered consent.

  • If there is an objection

If the commission or a state member expresses an objection, the commission asks the opinion of a committee of Scientists, the European Food Safety Authority (EFSA). The EFSA provides an opinion about this question. The basis of the EFSA’s opinion is a scientific evaluation from a panel of experts on genetic engineering. The EFSA calls upon the EU reference laboratory to evaluate the detection methods provided by the applicant. The EFSA’s official opinion includes a suggestion for the product labelling, restrictions or conditions (such as a post-market monitoring system in response to the result of a safety assessment), detection methods used by the EU reference laboratory, an environmental monitoring plan for the GM plant, etc.  The EFSA submits its opinion to the Commission and to the member states. The opinion is made available to the public, except for certain aspects that could compromise the applicant’s economic interests by disclosing techniques and sensitive information to competitors.

After receiving the EFSA’s opinion, the commission submits a project to a regulatory committee: called “The Standing Committee on the Food Chain and Animal Health”. This Standing Committee represents all the member states, and the vote is done with a qualified majority (Treaty of Nice: 232 out of 321 votes are needed + represent at least 62% of the European population).  The opinion of the committee is sent back to the commission.

If the Commission agrees with the Standing Committee on a positive answer, the request is approved.  If the Commission agrees with the Standing Committee on a negative answer, the request is rejected.  If the Commission disagrees with the Standing Committee: the commission must take its position to the European Council of ministers (the Council of the European Union). The Council will inform the European Parliament.  The Council of the EU has 90 days to approve or reject the draft, with a qualified majority. If the draft is rejected, it is sent back to the Commission, which must revise its draft before presenting it again to the Council.  If the draft is approved, the decision comes into effect.

Once the new GMO has been allowed on the market, it is authorized for 10 years (Directive 2001/18/EC, Part. C, art. 15, 4.).  Under the Directive 2001/18/EC, numerous GMOs have been approved for different uses, some for cultivation, some for import and processing, some as feed and food. Varieties of agricultural products include maize, rape seed oil, soy bean and chicory. Several applications for the placing on the market of GMOs for authorisation under Directive 2001/18/EC are pending, e.g. maize, oil seed rape or cotton. Several applications have a scope which is restricted to import and processing, while some also include cultivation as a requested use. Products from numerous GMOs can legally be marketed in the EU. These are mainly processed foods derived from GM soy, maize, and rape seed oil, but also oil from cotton seed varieties, as well as GM sweet corn. Further applications for the placing on the market of GM food products have been introduced and are currently pending at different stages in the authorisation procedure. This mainly concerns products derived from GM maize, sugar beet and soy bean.

Publicity of the informations relative to GMOs / Independence of the organs of control

  • The EFSA

The European Food Safety Authority (EFSA) was legally created by a shared European Parliament and Council regulation No 178/2002, adopted on 22 January 2002.

About the independence of the organ, the official answer of the EFSA is the following: “EFSA was created in order to separate risk management from risk assessment and ensure an independent voice on risks associated with the food chain within the European Food [Safety Authority]. As a result, EFSA is funded from the Community budget but it is an independent organization. The Authority applies a robust set of internal mechanisms to safeguard the independence of its scientific work. All experts on Panels and in working groups are required to sign a commitment of independence and provide annual declarations of interest which are published on the EFSA website. In addition, Panel scientists are required to declare their interests at each meeting. All the final Opinions of EFSA’s Scientific Committee and Panels result from collective decisions, each member having an equal say with any minority views recorded. This process reinforces the impartiality and balance of EFSA’s outputs and protects against any undue influence”.

Let’s have a look at the legal texts, in order to check the guaranties of independence of this organ:

According to the regulation 178/2002 “laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety”, Ch. III, Section 2, article 25:  “The Management Board shall be composed of 14 members appointed by the Council in consultation with the European Parliament from a list drawn up by the Commission which includes a number of candidates substantially higher than the number of members to be appointed, plus a representative of the Commission”.

So all the members of the EFSA’s management board are designated by organs of the EU, representing either the interests of the EU, or the Member States.

Ch. III, Section 4, article 37 independence: “1.The members of the Management Board, the members of the Advisory Forum and the Executive Director shall undertake to act independently in the public interest. For this purpose, they shall make a declaration of commitment and a declaration of interests indicating either the absence of any interests which might be considered prejudicial to their independence or any direct or indirect interests which might be considered prejudicial to their independence. Those declarations shall be made annually in writing. 2.  The members of the Scientific Committee and the Scientific Panels shall undertake to act independently of any external influence. For this purpose, they shall make a declaration of commitment and a declaration of interests indicating either the absence of any interests which might be considered prejudicial to their independence or any direct or indirect interests which might be considered prejudicial to their independence. Those declarations shall be made annually in writing. 3. The members of the Management Board, the Executive Director, the members of the Advisory Forum, the members of the Scientific Committee and the Scientific Panels, as well as external experts participating in their working groups shall declare at each meeting any interests which might be considered prejudicial to their independence in relation to the items on the agenda”.

So the guaranties of independence of the EFSA and its members are ONLY and EXCLUSIVELY based on declarations of commitment and of interests.

Moreover, the EFSA has been funded and works with the European budget. Hence, this agency is completely dependent on the European Union from an economic point of view. This means research that might not be convenient for European governments could run the risk to see its budget cancelled? How can an entity declare itself independent, when it receives 100% of its budget from a public, governmental organisation? (This entity is analogous to the FDA of United States). Political and corporate pressures at any given time can influence any scientific finding by this organisation. Therefore, it cannot be independent or neutral.

As we said before, the EFSA make public its opinions, with the exception of “certain aspects that could compromise the applicant’s economic interests by disclosing techniques and sensitive information to competitors”. How can the European citizens and consumers make sure that the products they consume are safe, in a context where the economic interests of the companies take precedence over the publicity and the right to be informed? This flexible clause, which allows the companies to keep this sort of information private in order to protect their economic interests, paves the way for all sorts of abuses, as it prioritises economic interests over the public health and protection of the environment.

Criticisms have been also formulated about the quality of the EFSA’s data. (Cf. Doc. Greenpeace: The European Food Safety Authority: failing the consumers and the environment, April 2004). About GT73, “The data is often of poor quality, and where differences and irregularities have been found, these have not been followed up sufficiently. There is no sufficiently rigorous scientific consideration of high quality data.”

  • The role of the European Institutions in this procedure

Once the opinion of the EFSA is notified, the European Commission is going to agree or not agree with the statement formulated. If the Commission agrees with it, the placing of the GMO on the market can be approved, and it is the end of the procedure. The European Commission has in that case the last word, relative to the authorisation of a GMO.

However, the European Commission is composed with 27 commissioners, one per member state, designated by the European Parliament and Council, and represents the interests of the EU. How can we make sure that the European commission, an highly political institution, is going to give priority to the human health and the environment, rather than to the economic interests of the EU?

In the case of a disagreement between the Commission and the EFSA, the Council of the European Union will decide. This council, commonly referred to as council of ministers,  is composed of the ministers of the member states. Depending on the issue of the agenda, each country will be represented by the minister responsible for the matter. This organ of the EU is also highly political, as it represents the interests of the member states’ governments.

So one might wonder about the independence of its decisions with regards to economic interests of the states.

 

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