Select Committee on European Communities Second Report - Written Evidence


Registration of the first genetically modified maize (Bt-maize) of Novartis Seeds

  1. Novartis Seeds AG (former Ciba-Geigy AG) has developed a genetically modified maize, which protects itself against its major pest, the European corn borer. This insect reduces harvest by around 7 per cent worldwide, corresponding to a loss in production of around 20 millions tons of grain. The protection is conferred by the introduction into the maize genome of a gene (called "the Bt gene"), which encodes for an insecticidal protein (called "the Bt protein"). This genetically modified maize will be further referred to as "Bt-maize".

  2. In addition to the Bt-maize, Novartis Seeds' genetically modified maize contains two marker genes used as technical aids:

    —  the "bla gene", used during preparation of the material prior to transformation of the plants and which does not confer any particular property to the maize plant; and

    —  the "bar gene", increasing the plant tolerance to phosphinothricin, a herbicidal compound used to identify those plants which have been successfully modified.

  3. The registration for commercialization of this Bt-maize began in the United States and in the European Union in 1994, and was followed by similar requests in further countries. Due to the variety of national legislation, even within a given country, several dossiers had to be filed in order to cover the different aspects such as environmental clearance, food clearance and feed clearance. Novartis Seeds always submitted the same basic data package to all agencies, adapting the content to the scope of the request (e.g., environmental data were not included into applications for food clearance) and the form of the presentation according to the local requirements. The following table summarizes the time required to get approval by the various agencies in the various countries:[34]


CanadaAgriculture—Canada 11
Health—Canada 8
JapanMinistry for Agriculture 10
Ministry for Health 10
ArgentinaMinistry for Agriculture 8
EuropeEU—Dir. 90/220/EEC 27
NL-Ministry for Agriculture 6
NL—Ministry for Health 12
DK—Ministry for Health 7
CH—Ministry for Agriculture 14
CH—Ministry for Health 14

  4. It is obvious from this table that the registration of Bt-maize under the EU Directive 90/220/EEC, took about twice as long as other similar approvals. A history of the regulatory approval of Bt-maize under Directive 90/220/EEC, as well as its analysis from the point of view of the notifier, is presented below.

  5. Directive 90/220/EEC requires the notifier to choose a EU Member State to which to submit the application. Novartis Seeds submitted its request to the French Ministry of Agriculture on November 7, 1994. France was chosen because most of the development work for Bt-maize had been conducted in France, and because this country would represent a significant market for Bt-maize. After evaluation by the French biosafety commission (Commission due Génie Biomoléculaire), the dossier was transmitted to the EU-Commission at the end of February 1995, and from there to the 14 other EU-Member States, as foreseen by the procedure under Directive 90/220/EEC.

  6. Most of the Member States restarted the evaluation procedure already conducted by France, and raised additional questions. Questions continued to be raised even after the official deadline for this had expired (60 days). Two Member States raised formal objections, therefore the dossier had to be referred to the Regulatory Committee under Directive 90/220/EEC ("Committee 21") for vote. The questions and objections focused mainly on:

    —  the fact that the EU-Regulation on Novel Food was not yet in place at that time. The scope of food safety assessment under Directive 90/220/EEC was not clearly defined and no labelling for food products derived from Bt-maize could be made mandatory; [35]

    —  the articulation on the aspects to be reviewed under Directive 90/220/EEC and under Directive 914/414/EEC for plant protection products; questions on the use and on the metabolism of the herbicidal compounds in Bt-maize were raised;

    —  insect resistance management: the file discussed extensively the potential for the target insects (the corn borers) to develop resistance against the Bt-protein, outlined the research conducted or to be conducted in this area and the possible ways to address this potential agronomic problem, but in 1994 did not include a formal antiresistance management strategy. During the first years of commercialisation, sufficient non Bt-maize would be available for maintaining susceptible insect populations without selection pressure (unstructured refuges), thus fully allowing time to develop and implement an antiresistance strategy as necessary, based on scientific data and with the full support of the authorities. In addition, it was argued that Directive 90/220/EEC provides only for environmental safety assessment and should therefore not address potential agronomic problems;

    —  the presence of the bla-gene in Bt-maize.

  As can be seen, most of the objections were of a procedural nature.

  7. The submission of the application for formal vote at Committee 21 took nearly one year. During this time, the objections could not be removed despite extensive discussion on the scope of the safety assessment under Directive 90/220/EEC and the submission by Novartis Seeds of extensive documentation (literature data, experimental results, experts' opinion) supporting the safety of the bla gene in Bt-maize. The vote took place in April 1996: seven member States accepted the products, four rejected it and four abstained. Because of these abstentions, the qualified majority was not reached and the dossier had to be referred to the Council of Ministers. The Council of Ministers discussed the file in June 1996 but did not come to a conclusion within the allocated time-frame. The EU-Commission therefore submitted the dossier to three EU Scientific Committees (Food, Animal Nutrition and Pesticides), asking them precise questions regarding the safety of Novartis' Bt-maize. These three committees unanimously concluded that Bt-maize was safe for humans and the environment. Based on this conclusion, the EU-Commission "approved" the product on 18 December 1996. This approval was formally granted on 5 February, 1997, by the French authorities.

  8. If 5 February, 1997, was an important date for the commercialization of Novartis Seeds Bt-maize in the European Union, it was by no way the end of the procedure. Austria and Luxembourg immediately introduced safeguard measures against Bt-maize invoking Article 16 of Directive 90/220/EEC. The measures have not yet been withdrawn, despite the opinion of the scientific committees (re-consulted specifically to consider the Austrian objections), of the EU-Commission and of several Member States. The deadline for dealing with such safeguard measures (90 days) have expired long ago. Italy also introduced temporary safeguards measures, but withdrew them in October 1997.

  9. In the EU, maize hybrids have to be registered into national/European catalogue in order to be sold. An authorization for the genetic modification under Directive 90/220/EEC is a prerequisite for the registration of each specific hybrid carrying this precise genetic modification. The registration of Novartis Seeds Bt-maize hybrids was delayed until early 1998 in France and Spain because of the transgenic nature of the maize . . . although this "transgenic nature" had been approved in February 1997. Bt-maize was offered to the European farmer for the first time for the 1998 planting season.

  10. Grain harvested from Novartis Seeds Bt-maize will enter the food chain. The question of the labelling of the food product has not yet been entirely resolved. As Novartis Bt-maize was placed on the European market before the entry into force of the Novel Food Regulation, food products derived from this maize do not fall within the scope of this Regulation. The EU-Commission issued in September 1997 a Regulation rendering mandatory the labelling of certain food products derived from this maize (Regulation 1813/97). Another Regulation, fixing some rules for this labelling, has just been accepted on 26 May 1998, but the "details" are still not all fixed. The food industry is therefore facing the difficult situation of not knowing how to legally market food products which they have the full right to use.

  11. The regulatory pathway for market approval of Novartis Seeds Bt-maize was long and "rocky". The reasons for this are numerous:

    —  the file submitted by Novartis Seeds under EU Directive 90/220/EEC was the first one to ask for cultivation and all uses of a genetically modified plant, whose product would enter the food and feed chains. It was therefore a learning exercise for both regulators and notifiers. By raising concrete questions, Novartis Seeds' application made the authorities aware of the lack of clarity regarding the scope of the risk assessment to be conducted under Directive 90/220/EEC, or under other EU legislation (pending Novel Food Regulation, Directive 91/414/EEC . . . ). Different interpretations among the Member States or between the Member States and the Commission often resulted in objections or abstention, which were thus not related to the safety of Bt-maize;

    —  the vote in Committee 21 took place in April 1996. At this time, European regulators and the European media were heavily debating about mad cow disease, new technology, food safety . . . Although scientifically incorrect, an association with gene technology was made;

    —  the debate in the media and in the political arena increased since 1994 and is still increasing today. The procedural problems encountered by the Novartis Bt-maize dossier were often presented in media as safety issues. The changing position of certain Member States during the review process reflects the impact that the public debate had on the regulatory process;

    —  the lack of clarity on labelling and the shift in policy from a "safety or ethic-related labelling" (thus only for certain types of genetic modification) to an "information labelling" (applicable to all types of genetic modification) increased the confusion.

  12. In conclusion, the registration of Novartis Bt-maize was a pioneering walk in a moving landscape. The European regulatory framework has to become more transparent, predictable and compatible with other regulatory systems worldwide, while maintaining its scientific scrutiny. In the same way as unclear procedures have led to a perception of "unsafe products", it is now time for clear procedures to re-build trust in safe products.

34   Birds of Conservation Concern was produced by RSPB, BirdLife International, Wildfowl and Wetlands Trust, The Game Conservancy Trust, British Trust For Ornithology, The Hawk and Owl Trust, Wildlife Trusts, and The National Trust. Back

35   Grey partridge, quail, stone curlew, turtle dove, skylark, song thrush, spotted flycatcher, red-backed shrike, tree sparrow, linnet, twite, bullfinch, cirl bunting, reed bunting and corn bunting. Back

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