I'm aware that this is treading on dangerous ground and I shall attempt to avoid various minefields. Nevertheless describe where we are coming from at the present time. To set the scene a little

The EU is the world's largest international trader with a 20% overall share worth well over $A 5,OOObn per year and with a domestic market of 375 million people turning over an equivalent amount domestically, to contribute to our GDP worth over $A1 S trillion. (AUS=$AS65bn)

And within 10 years time the Union will have enlarged to take in an additional 10 million people.

Exports of goods make up almost 10% of our GDR and imports over 9%. Trade is a significant contributor to our employment levels, and we have a balance of trade surplus.

• We depend on world trade, and those who suggest we are drawing behind our shutters are talking nonsense, moreover we have no choice but to take a position regarding the major movements influencing it, eg. Environmental considerations, biotechnology, or the WTO process itself.

As regards our place in the food markets of the world, we are the world's largest importers of food products and with fewer exports we run a deficit of $Al6bn. Food imports constitute about 10% of our imports and 7% of our exports. cf. the US with a trade surplus each year worth about $A6Obn]

So the trade in food is very important to our economy and increasingly the focus of consumer attention and not a little concern.

Consumers are the bottom line. Markets can be created and developed with new products but consumers have to be convinced that buying them is in their best interests. Fail to take them with you, fail to point out the costs as well as the benefits make a mistake and you and the product are gone. And consumers may choose not to accept whatever scientific evidence is on offer at the time.

BSE and its putative links to v.CJD caused a loss of faith in science at the time. As Sir Leon Brittan said in the US "We (consumers) were told this disease could not go from animals to human beings and we were given every kind of assurance years ago. Now somebody stands up and says that we're not so sure now. Welt if you change your position on that, how can we be so sure you're right in saying that these GMOs are okay?"

The fabric of concern was woven tighter by the addition of fears over cases of salmonella, listeria and E.coli. pesticides residue levels and anti-microbial resistance.

Here the failures to deliver a system of safe food by science and the authorities, national or European Union, were more directly obvious including deaths of consumers.

The most recent Belgian case of dioxin transmission to meat and dairy products via animal feed again was clear, direct and provable and just as with BSE the message for consumers, despite assurances, was that the system could fail. Moreover, experts and politicians were found out lying in some circumstances. Eg. the UK Chief Inspector of Health, denying any link between BSE and JK. Likewise Belgian authorities only informed the Commission of the dioxin issue 3 months after they were aware of it.

Worse still was the suggestion in May this year that Transmissible Spongiform Encephalopathy (TSEs) might after all be caused by bacteria or bacterial toxins. The UK Ministry of Agriculture decided to sponsor one theory based on the view that TSEs may be due to infection by virulent bacteria which stimulate a high immune response and that the spongy brain tissue might arise from an auto-immune effect in which antibodies attack the brain tissue.

Other scientists and veterinarians point to the dose dependence of BSE and suggest this indicates a bacterial toxin. Meat and bone meal contain gut tissue, which could transmit bacterial infection. The rogue prion theory may yet fail

These issues of course sit within a broader movement to shift diet and food consumption into different channels.

The major industry that has grown up around dieting, weight loss, the links to cancer and heart disease from ingestion of saturated fats, the role of meat in general, red meat in particular, the role of red wine, the place of food additives and colorants, the iron, calcium and folic acid debates, etc, etc, etc. And each test, theory and "proven" outcome being countered at a fast or slow rate of knots by a later study, at least questioning or destroying the previous finding.

In July 1999, as part of our six-monthly surveys of consumers, we looked at food safety in general; the factors which determine safety; safety and retail outlets; information sources and labelling.

This showed that consumers had more confidence when foods had undergone national (66%) or European (43%) controls as opposed to controls undertaken by distributors (29%). 80% wanted more and stricter controls especially at the production stage. Producers were considered the least credible when revealing details on food while consumer associations were considered the trust-worthiest (50%).

The results varied across products, eg. bakery products, most reliable, and across Member States. The Dutch stood out with a very high confidence level even on additives and preservatives [50% of all MS consumers surveyed accepted food was safe if it had no pesticides or hormones and when controlled by competent bodies]. The Greeks were more wary.

Overall, consumers had great uneasiness - only 7% thought information supplied by government agencies is totally true and only 11% had that view of the European Commission, only 26% believe information is unbiased with 42% considering it is biased towards producer interests.

However, whilst scientists are judged to be the most truthful (36%) along with educators (33%) the former are seen to defend producer interests while the latter, consumer interests.

Our prime piece of legislation is a Council Directive of 1990. The introductory paragraphs explain why we felt we needed to control living organisms released into the environment either for experimental or commercial purposes:

• that they may reproduce and cross national frontiers, and because the effects of such releases may be irreversible;
• the need to protect human health and the environment:
• because rules either in effect or in preparation could create unequal competition or trade barriers to products containing such organisms, thereby affecting the working of the Single Market;

• the need for a case-by-case evaluation of potential risks arising from a release with a step-by-step evaluation.

The competent authority of a Member State has to be notified of any intention to release and an EC authorisation procedure then must be followed.

The notification must have a technical information dossier with a full environmental risk assessment, safety and emergency responses and, for products, conditions for use and proposed labelling and packaging.

The consent to release of the MS national authority is required and no MS can prohibit, restrict or impede such products on their territory where the conditions imposed on the product are respected.

However, Article 16 provides that where a MS has justifiable reasons to consider that a product with written consent constitutes a risk to human health or the environment, it may provisionally restrict or prohibit the use and/or sale of that product on its territory. It must inform the Commission and other MS of its reasons. The Commission then makes a decision within three months.

Article 21 covers a situation where, despite a MS approval to release, another MS opposes such a release into the Single Market. A committee of MS representatives₁ chaired by the Commission then may give a positive response. If it gives a negative decision or no opinion, the issue goes to the Council, which votes with a qualified majority. If Council has not acted within 3 months, the Commission decides the issue.

Annex II of the legislation describes in great detail the information, which must be provided by the manufacturer or the importer, of the product. This includes the identification and detection techniques and their reliability, information on predators, preys, parasites, symbiants and hosts, potential for genetic transfer and exchange with other organisms, their genetic stability, their pathogenicity toxigenicity, virulence, etc. their ability to colonise and activate latent viruses, etc. etc. and their antibiotic resistance.

Specific conditions for use, handling, labelling and packaging must be provided.

So the assessment process and system itself is rigorous, but a MS must given consent for release if it meets the risk assessment criteria.

As I mentioned earlier, the acceptability of GMOs varied across our Member States, some coming from a stronger ('natural is good' need to protect the environment, animal welfare (no testing cosmetics on animals), purity in food, organic farming, strong consumer and broadsheet press) background than others.

In June 1998 the Commission announced plans to begin a legal action over France's reluctance to adopt EU legislation permitting the planting and use of EC approved GM maize and rapeseed. France had put a 2-year moratorium on all GM rapeseeds.

In addition France, along with Austria and Luxembourg, had not adopted EU legislation allowing the use of Bt maize, originally proposed by France for EU-wide use.

In France a court had accepted the view of an environmental lobby group that the approval for GM maize on the national register was incomplete and lacked information on antibiotic resistance. The Commission insisted that there is no free choice on whether to implement Community legislation and that along with Austria and Luxembourg, France faced similar European Court of justice action.

Along the way of course the press whipped up a frenzy with visions of "Frankenstein foods" reminding readers that thalidomide was earlier considered safe, as was asbestos, DDT, 24D and 245T and what about high tension lines and why won't mobile phone manufacturers give out details of the emission ratings, and what is causing the rapidly declining sperm count in males? Why are the frogs disappearing?

Meanwhile the UK House of Lords [Genetically unmodified?] about to be politically modified, reported they could find no reason to doubt the safety of foods approved by the present regulatory process although the use of antibiotic-resistant marker genes should be phased out as soon as possible. One multinational company involved praised their Lordships for distinguishing scientific fact from science fiction.

It followed an earlier announcement by the UK Department of the Environment, Transport and the Regions (DEIR) that they would press for a three-year moratorium on GM crop planting as a response to public concerns.

Along the way Marks & Spencer, working with its over 1000 suppliers, managed to identify GM-free alternatives for any GM ingredients while Sainsbury's eliminated GM ingredients from its own brand range. Boots, the chemists, said they had no plans to move to GM freedom.

Meanwhile fringe group activists were attacking GM poplar trees, which were environmentally friendly in that they would have cut the amount of energy and chlorine, used in pulp making.

Others destroyed experimental plantings of crops, sometimes hitting the correct target and sometimes not as in the recent case in the UK.

The UK Prime Minister was led to announce that there was an absence of any scientific evidence that GM foods could be harmful and eat a GM tomato, which had a fish gene, inserted in it.

There were confusing happenings in the UK over the effect on rats' growth, health and immune response from being fed potatoes modified to include a GNA lectin (protein derived from snowdrop bulbs).

The DETR then announced it would conduct a 3 year trial to monitor the environmental effects of GM crops when scaled up from small plots to farm scale, eg. pairing with non-GM crops, spillage, crop losses, effect on weeds and wildlife and on succeeding crops.

Assuming the trials were trouble-free, further limited commercial plantings would be authorised in 2001 with approved GM crop varieties available in 2003.

It was all getting rather confused.

It was getting even more confusing.

There was mounting pressure for a revision to Directive 90/220.1998 saw the first proposal. This followed a 1997 Communication on Biotechnology. This recognised that the EU approach was based on "the precautionary principle", said to be "a political decision exercised in conditions of scientific uncertainty".

Between the principle of banning (or not authorising) a product until science has shown its complete harmlessness and the principle of not banning (or authorising) until science proves a real risk, there is wide room for application of a reasoned precautionary principle.

Guidelines lay down general conditions without being legally binding but unwarranted recourse could be seen as justification for disguised economic protectionism

Aims of the revision are - to extend and clarify the scope of 90/220, speed up the procedures and strengthen more uniform decision taking between MS based on common principles for risk assessment. The danger was seen to be that regulation might unnecessarily hinder the potential for technological innovation.

Attitudes were reflected in "This growth sector has not yet reached its full potential and its cruising speed". 'This new technology will maintain the competitiveness of Europe on the world market and will make a major contribution to economic growth by enhancing the competitive position of industry and agriculture".

For those standing ready to accuse the attitude of the EU to GMOs as another example of its policy of protectionism₁ these words should be framed over the bed head

Under proposed revisions is the possibility of having a common Risk Assessment Group among MS where conflict resolution would take place on a scientific basis as is the case in Community legislation for foods, pharmaceutical’s and feeds.

To develop a 'simplified procedure' for placing GMOs on the market was said to require more experience than was assessed to exist at present in the Commission's view. It would prepare it when sufficient scientific knowledge became available. There was a need to account for "the specific sensitivity and awareness of the public in Europe", ie. limited experience with certain uses of the new technology and a lack of clarity.

Following submission of the reform proposal for 90/220 to the European Parliament, almost 100 amendments were proposed. The Commission accepted 46 of them by March 1999.

These included: use of the "precautionary principle"; retrieval of GMOs in the event of acute risk; consultation of the European Group on Ethics in Science and New Technologies; lodging of GMO samples with MS authorities; the concept of risk assessment to include immediate and possible delayed risk.

Where is the EU placed in September 1999? Under the Novel Foods legislation (see page 13) 8 derived products (but no viable GMOs themselves) have been authorised.

Under 90/220, 18 products have been approved for marketing and 1,475 field releases have occurred.

Products accepted for placement on the market include

• a live liquid vaccine for foxes to vaccinate against rabies;
• an immunant for Aujesky's disease in pigs;
• commercial rapeseed;
• soybean (imports from Monsanto) for animal foods not cultivation;
• soybean for cultivation for seed production, for breeding, for food feed and industrial processing (AgrEvo);
• maize (CIBA-Geigy, now Novartis) for seed silage, animal feed and industrial processing;
• chicory - for seed;
• GM streptococcus thermophilus T102 for glass ampoule antibiotic testing kits for milk.

What were the properties?

• Insertion of a gene to make the plant tolerant to spraying herbicide glufosinate ammonium or to herbicide glyphosate.

What are the alleged benefits?

• Reduced use of herbicides (remember it is chemical companies often researching the products) means lower costs for farmers,
• resistance to pestilence increases yield and lower food prices, third world benefits.

Alleged risks:

(Whilst strictly not on the agenda topic, it could be argued that it is strongly related. The US basically does not support labelling certainly where there is assessment that a GM product is "substantially equivalent" to an existing hybrid product. In their view therefore the act of labelling creates a trade barrier.]

Directive 79/112 Article 4 allows the Commission to introduce particular labelling requirements for specified foods.

This compels consumer information labelling indicating "the presence of an organism which has been genetically modified". It covers foods and ingredients "which may contain both GM and conventional produce". Suppliers may indicate their product is not a novel food and that GM products have not been used.

The concept of "no longer equivalent" as applied to food requiring labelling is based on "scientific assessment based on appropriate analysis. The presence of material "which may have implications for the health of certain sections of the population" (eg. allergenics) or "which give rise to ethical concerns" are also dealt with.

Basically the Commission's approach to labelling laid down in 1997 was to ensure consumers and users of GMO products and ingredients have as complete and transparent information as possible on live GMOs, processed GMOs and their derivatives whether of Community origin or imported.

The purpose is to give consumers clear, honest, neutral and scientifically sound information on the GM origin of products. The categories cover:

• mandatory labelling - "contains GMO-based substances" where this can be scientifically proved
• mandatory labelling - "may contain GMO-based substances" where material of GMO origin cannot be excluded
• voluntary labelling - "does not contain GMO-based substances" where
• GMOs or derivatives are not present

These principles were also proposed bearing in mind the EU's international obligations, ie. The Commission is of the view that labelling does not create a technical barrier to trade or put it in breach of Article 3 of GATT (see below).

• When 98/1139 was adopted Council asked the Commission to do two more things:

1. Determine a "de minimis" threshold for use in "adventitious contamination" of ingredients.
2. Explore the creation of a "negative list" of ingredients, which would not need to be labelled because they do not contain protein nor DNA resulting from GM.

• At the present stage of analytical methodology, science may not be able to deliver a negative list. Any list would need to be updated as the science improves.

Part of the gene technology debate also concerns the patenting, marketing and sale of genetic material and gene technologies. Particular concern has been expressed in some quarters that only large corporations, multinational companies and governments would be able to afford to take out these patents. What would be the consequences in a developing country, for example where patenting of a whole species becomes the intellectual property of one company?

Countries are handling the GMO issue very delicately in the run-up to the Millennium Round. Critics suggest the US is fearful of possible demands to re-open the Sanitary and Phytosanitary Agreement. The SPS agreement was placed on a 'scientific evidence only' basis for quarantine barriers in the Uruguay Round.

It is not immediately clear that food safety measures in a genetic risk assessment sense, fit into the SPS agreement.

The Technical Barriers to Trade (TBT) Agreement provisions are softer because the list of "legitimate objectives" is not comprehensive.

The "substantial equivalence" argument with perhaps an indistinguishable analytical difference between GM and non-GM perhaps moves the discussion to the Article 3.4 of the GATT Agreement arena, ie. Affording non-discriminatory treatment for a country's products.

To date there have been four major dispute settlements under SPS and none under TBT. Clearly the beef hormone issue and GMO concerns are linked and at the heart of the European food safety focus. US critics saw the former as an attempt to protect the EU beef sector post-BSE. This was a total misreading of the cause and most likely the science [our deadline scientific analysis showed beyond reasonable doubt that ~7 Beta Oestradiol (a natural hormone in meat) was in tact a carcinogen.

Clearly there is no way that the EU can allow in food products which are assessed as likely to damage the health of consumers. EU tests produced evidence, which was especially potentially dangerous for pre-pubertals.

The US view is (simplistic by EU consumer standards) if there is no immediate evidence of damage - produce and ship it. Trust the scientist and the regulator. The Europeans know science has not advanced far enough to give certainty. Europeans want risk elimination while Americans accept risk limitation. European consumers will not accept that transnational companies are allowed to prise open markets at potentially their expense. [Role of TNCs in banana case]

Some critics of the current WTO situation regard the international acceptability of food production techniques as the "fourth dimension" (tariffs, quotas, quarantine) and note the erosion of consensus regarding reliance on science as the foundation for testing and approvals. Some, including perhaps the Commission, argue for an embodiment of the precautionary principle within the SPS itself.

Those who maintain a belief in the sanctity of science providing the answer, including some within the WTO bureaucracy, may favour a separate and independent WTO scientific service.

US Secretary of Agriculture, Glickman, in his US National Press Club speech in mid-July, indicated he would now support some kind of informational labelling for GMO products and an arm's length regulatory process by key government regulators. Sir Leon Brittan acknowledged that an agreement on GMO crops would be moved ahead by agreement to label.

In August two major international biotechnology companies (Monsanto and AgrEvo) indicated their willingness to adjust their operations to accommodate revisions proposed for 90/220.

The end of July saw the Commission pass three new GM products (sugar beet and two rapeseeds) to the MS for approval. Commissioner Bjerregaard noted it was highly unlikely MS would approve them as not a single product had been passed throughout the last year. In June, EU Environment Ministers agreed to a moratorium (of sorts) whereby they would hold up any new GMOs reaching the market until 90/220 had been reformed. A new Directive is unlikely to be in place before 2002.

[The Ministers were conscious of the need to find a proper legal basis. Keen to avoid a definitive moratorium, which would be challenged as a trade barrier by the US and its biotechnology sector in the WTO.]

MS therefore refer to the Amsterdam Treaty whereby MS may ban on scientifically justified, environmental or health concerns. The question is whether Article 95.5 affords an avenue for suspension, with Commission consent. The Ministers are stressing strongly the application of the "precautionary principle", no fast tracking, no automaticity and ethical tests.

But there was some good news coming out of the EU in August. A project, funded by the EU, 'Carotene-plus', successfully incorporated the production of beta-carotene into rice. Whilst turning the rice yellow, it will help prevent severe vitamin A deficiency in the 140m-250m preschool children in the developing world reducing measles mortality by 50%, diarrhoea mortality by 33%, and overall mortality by 23%.

Produced under contained facilities (ie. laboratories) I am sure EU consumers will feel reassured on the role the product will play and that MS will ensure speedy acceptance for its ultimate release. Free access to the seed will be provided for subsistence farmers.

As a Welshman, it was good to know Wales was involved - the two plant genes involved came from the daffodil!

There is also a Welsh connection in the scientific development of this, which led to the current position. Some years back when the new strain of super rice was developed involving the plant breeding station in Aberystwyth

It can be argued that this saved millions of lives in India and was instrumental in creating the current position whereby India is a net exporter of cereals. However, the current state of world expansion and our heightened awareness of the need to protect biological diversity require us to look at new ways of meeting the demand for food.

In a recent speech, John Watson of CSIRO noted "that the current world population is close to 6 billion and at the present rate of increase will double in the next 50 years. This rate of human population growth will demand a much greater advance in food productivity than was the case with super rice. Whether it can be met by even more intensive agriculture without irreparably damaging our environment would seem unlikely"

So for the EU hopefully you would have understood that we the Commission are currently in advance of consumer opinion in the Member States and we are constrained at present to err on the side of prudence. That will only change when we are able to take people with us.

We must also try and ensure that our relationships with other players in this difficult terrain is based on collaboration so that we avoid a potentially very harmful trade war, for example, with the United States.

To conclude on a positive note we are very pleased that Australia seems to be moving towards our approach rather than the US approach. This came out clearly in the Health Ministers decision regarding labelling of GMOs in food last month.