Which Place for Genetically Modified Organisms in the EU ?

1er juillet 2008 | Par Alison Gatt

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Four years after the EU’s moratorium on GMO authorisation was lifted, the EU remains divided on the issue. The European population is not fond of what has come to be called Frankenfood and in the Council many Member states refuse to accept the authorisations granted by The European Food Safety Authority. GMOs are a highly divisive political issue.

The Commission’s authorisation of Novartis Bt Maize in October 1996, granted in spite of heavy Member State opposition during the June 1996 Council, triggered a controversy in GMO authorisation. Austria and Luxembourg immediately banned the authorised maize, and the European Parliament condemned the authorisation as an irresponsible unilateral action.

The situation culminated in June 1999, a de facto moratorium on GMO authorisation was created following declarations by Greece, France, Denmark, Italy and Luxembourg that authorisation would be rejected until adequate regulations were adopted. This moratorium was eventually declared illegal by a WTO panel, in proceedings instituted against the EU by the USA, supported by Canada and Argentina.

In the meantime, a number of reforms were undertaken, leading to a new regulatory framework for GMOs and the consequent lifting of the moratorium in 2004, as signalled by the authorisation of two maize lines that year. Directive 2001/18/EC regulates the authorisation of GMOs for deliberate release into the environment and for placing on the market of GMOs as industrial products (cultivation, importation or processing). On the other hand, Regulation 1829/2003 regulates the placing on the market of GMOs intended for food or feed. Labelling and traceability requirements are laid down in Regulation 1829/2003 itself and in Regulation 1830/2003.

The current GMO regulation framework has been described by the Commission as the strictest in the world and has therefore come under fire from the biotech industry, farmers and a number of third countries where GMO cultivation is widely accepted.

Being strict

The current GMO regulation framework has been described by the Commission as the strictest in the world.

Nevertheless, this has not spared the EU’s authorisation procedure from criticism by environmental organisations claiming that systematic authorisation is endangering biodiversity, while the general public remains sceptical about what has come to be called Frankenfood.

In fact, since the lifting of the moratorium, several authorisations have been granted. However, all authorisations were given by the Commission by default in accordance with the regulatory comitology procedure, since Member States have been divided down the middle, hence failing to muster the qualified majority necessary to adopt or reject the Commission’s authorisation proposal. Furthermore, many Member States have invoked the safeguard clause, banning various authorised GMOs from their territory.

The biotechnology industry and farmers have therefore warned that the EU’s authorisation procedure is too inefficient and ineffective, hindering technological and scientific development as well competitiveness. Those who take an anti-GMO stance on the other hand accuse the Commission of proceeding to authorise GMOs despite significant Member State and public opposition.

The authorisation procedure

An application for authorisation of a GMO is filed with the National Competent Authority of a Member State together with various accompanying documents, including scientific studies. The European Food Safety Authority (EFSA) carries out its scientific assessment and issues an opinion on the GMO’s safety or otherwise, while the public has 30 days within which to make observations.

The decision regarding authorisation of the GMO is then taken in accordance with the regulatory comitology procedure. The Commission submits the draft to the Standing Committee on the Food Chain and Animal Health (Scofcah), which may approve or reject it by QMV. In the absence of a decision either way, the proposal is referred to the Council, which also decides on the basis of QMV. Where no decision is reached in Council, the Commission makes the final decision by default.

How was it again ?

The decision procedure regarding authorisation of the GMO is complicated.

Directive 2001/18 also enshrines the precautionary principle and provides a safeguard clause, allowing a Member State to provisionally restrict or prohibit the use or sale of a GMO in its territory if it has detailed grounds for considering that it constitutes a risk to human health or the environment. The invocation of this clause must immediately be notified to the Commission and the other Member States, triggering the regulatory comitology procedure again, following the Commission’s consultation of EFSA.

Controversies So far, EFSA has never given a negative opinion on an application and the Commission has always proposed authorisation in accordance with the scientific opinion. However, Scofcah and Council have never succeeded in reaching QMV in favour or against the proposed authorisation, leaving the final decision to the Commission. On its part, the Commission has always proceeded to adopt its proposed decision, authorising the GMO in question in the face of opposition by a significant number of Member States.

EFSA has attracted accusations of not maintaining independence and objectivity, while the quality of its assessments has also been criticised. In fact, the scientific community too is divided on GMOs, particularly with regard to those containing antibiotic-resistant marker genes, which pose greater cause for concern.

Strong criticism has also been levelled at the Commission for merely rubber-stamping EFSA’s opinion in spite of Member State resistance and widespread public opposition. According to Eurobarometer 64.3, GM food is considered morally unacceptable, a risk for society, not useful and not to be encouraged, with only 27% of Europeans supporting it. Nevertheless, it is debatable whether the Commission can do otherwise since the comitology procedure stipulates that when no decision is taken in Council, “the proposed implementing act shall be adopted by the Commission”. Moreover, although the Commission is not explicitly bound to follow EFSA’s opinion, it must give reasons for which are sufficiently founded as to justify the divergence. This may be inferred from ECJ judgements in the field of food safety, such as Pfizer (T-19/99), where the Court of First Instance held that : “The statement of reasons must be of a scientific level at least commensurate with that of the opinion in question”.

While environmental NGOs and much of the public may criticise the Commission for invariably granting authorisation however, the biotech industry and farmers continue to attack the length of the procedure and the fact that it is too cumbersome compared to other states, particularly the USA. Biotechnology is also considered by some as the solution to the hunger problem in developing countries, accusing the EU’s GMO authorisation process of holding back competitiveness and development of such countries. However arguments to this effect are met with some scepticism, given that most genetically modified crops are used as feed and not food.

Tomatoes

Biotechnology is also considered by some as the solution to the hunger problem in developing countries.

Given that Member States which oppose the authorisation of a given GMO are unable to prevent its authorisation in the absence of a QMV, many have resorted to the invocation of the safeguard clause. EFSA has in all cases found that the new information submitted does not justify the national safeguard measures adopted and the Commission has subsequently submitted draft proposals requiring the lifting of such bans. However, the Ministers in the Environment Council have almost consistently confirmed the validity of the national bans, whether because such member States themselves disagree with the authorisation of the GMO in question or simply because they take the view that a Member State’s decision to ban a GMO within its territory should be respected. The result is therefore that GMOs continue to be authorised, but many subsequently banned by a number of dissenting Member States, hence undermining the effectiveness of the authorisation procedure, and attracting further criticism.

The present situation

The Commission recently broke with its systematic default authorisation of GMOs submitted for approval. On May 7th 2008, it opted instead to refer back to EFSA a number of applications upon which the Council had failed to decide by QMV, including a particularly controversial application concerning the cultivation of a genetically-modified potato, intended to produce starch for industrial use, but the residues of which would be fed to livestock.

This has led to mixed reactions, with some environmental organisations describing it as a vote of no confidence in EFSA and others arguing that the back reference was unnecessary since the applications should have been rejected outright. On the contrary, the biotech industry reacted with disappointment arguing that farmers are being denied access to much needed, well-established technology.

The outcome of these applications remains to be seen. The Commission’s decision to refer the applications back to EFSA may, however, be perceived as a turn towards a more cautious approach to GMO authorisation. This would be considered a substantial blow by the biotech industry which considers this a breach of EU law. In fact, BASF, which developed the abovementioned genetically modified potato, has even threatened legal action against the Commission for the delay in authorising the said potato.

It should in any case be noted that the only type of GMO cultivated in the EU is Bt maize in Spain, France, Germany, Portugal and the Czech Republic. Furthermore, there are no genetically modified fruits and vegetables on the EU market and any genetically modified plants authorised in the EU are not intended for direct use. Nevertheless, various common ingredients such as flour, modified starch and a number of additives, which are used in products such as sweets, bread or pastry, commonly involve genetic engineering.

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