From Nature Biotechnology November 2000 Volume 18 Number 11 pp 1137 - 1138
Italian GMO ban could spread
By Anna Meldolesi
The European Commission is under renewed pressure to reverse unjustified bans on GM products following Italy's rejection of GM maize produced by Monsanto, Novartis, AgrEvo, and Pioneer. In the first case of its kind, Italy is challenging the definition of "substantial equivalence" in boycotting GM products. If the Commission fails to act and unblock the regulatory impasse that has dogged the reversal of previous unjustified bans, it could be opening the doors to a new wave of embargoes that could be far more widespread.
The European Commission's Standing Committee on Foodstuffs is currently reviewing Italy's ban of the GM maize. The UK Advisory Committee on Novel Foods and Processes found the products to be substantially equivalent to conventional products between 1995 and 1997 and the Commission, therefore, approved them for EU-wide commercialization without the need for special safety testing. In a first for the EU, the Instituto Superiore di Sanita (Italian National Institute of Health) has challenged this ruling, claiming the products are not substantially equivalent to unengineered products because they contain traces of foreign Bt protein. As a result, the Italian government has banned the products, citing article 12 of the European regulation 258/97 covering novel foods and ingredients. According to article 12, an EU member state may ban a product if it has new reasons to believe the food endangers human health or the environment.
Paola Picotto, who is a member of Italy's Committee on Biotechnology, says "We have found [the products] present a level of foreign proteins between 0.04 and 30 parts per million. So according to a strict interpretation of the substantial equivalence rule, they can't be commercialized without undergoing a full authorization procedure."
Until now, the banning of the sale and use of GM products by individual EU member states has focussed on article 16 of the European directive 90/220 covering the deliberate release of GMOs into the environment. This clause allows a country to temporarily ban a product if there are "justifiable reasons" for doing so-basically, new scientific evidence that the product constitutes a risk to human health or the environment. Following invocation of article 16, the European Commission's scientific committees review the evidence. If the committees cannot justify a ban scientifically, a reversal of the ban requires a majority vote from the Regulatory Committee, which comprises EU state representatives. If the Regulatory Committee fails to reach a majority decision by a deadline set by the Chair, the Commission is supposed to provide a draft of proposals (in line with its scientific committees' findings) to the Council of Ministers, which comprises environment ministers from EU member states. If a majority decision by the Council of Ministers is not reached within three months, then the Commission is supposed to make a definitive ruling by adopting the proposals it came up with after reviewing the scientific committees' findings. This process is supposed to ensure the reversal of unjustified bans.
However, the reality is very different. There are currently 8 such bans (from 5 countries) outstanding (see Table 1). Countries have cited such concerns as Bt-resistance, negative affects of Bt pollen on non-target organisms, and outcrossing of GM plants with wild relatives. While the two most recent cases-Novartis's Bt corn in Germany and AgrEvo's GM maize in Austria-are still under review, the European Commission's scientific committees have found none of the others justifiable (http://europa.eu.int/comm/food/fs/sc/scp/index_en.html). But rather than being actively reversed, the bans remain; Austria's and Luxemborg's ban of Novartis' Bt maize, for instance, are still in place after three years.
The problem is that there is a political block at the points where a majority vote is required from member states-at the Regulatory Committee and at the Council of Ministers. For instance, the environment ministers of France, Italy, Austria, Luxembourg, and Denmark have agreed not to vote on matters concerning GM products at least until 90/220 has been revised, effectively preventing the Council of Ministers from being able to gain a majority vote (Nat. Biotechnol. 18, 589;MEDLINE). Moreover, the European Commission has made no attempt to take charge of the situation, resulting in a regulatory impasse whereby not only are unjustified bans not reversed, but there have been no new approvals for GM products since October 1998. Article 16 of 90/220 has, in effect, become a political instrument for arbitrary bans.
The fear now is that Italy's case will go the same way, opening up article 12 of 258/97 to abuse. In September, the Commissions' Scientific Committee on Food found Italy's invocation of article 12 not scientifically justifiable. The Commission's Standing Committee on Foodstuffs, like the Regulatory Committee in the 90/220 cases, is now required to come up with a majority vote. If it fails to do so, as in the 90/220 cases, the matter will fall to the Council of Ministers. Failure of the Commission to act if there is a deadlock would be particularly grave because banning of the four types of GM corn would extend to thousands of food products that contain them as ingredients.
Meanwhile, the Council of Ministers is currently considering a revised 90/220 and is expected to vote by the end of this year.:
