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There is no doubt about the enormous potential of biotechnology.
For instance, we can now treat children suffering from retarded growth, without risking contaminating them with Creutzfeldt-Jacobs Disease. Contrast this with the position when we had to rely on growth hormones extracted from cadavers. I need not remind you that the latter practice led to a number of tragic deaths of children.
We can also alleviate the sufferings of haemophiliacs with unlimited sources of coagulation factors free from the HIV or Hepatitis C viruses, which have killed many patients. For that alone, I think we should be grateful to biotechnology.
Take the situation on rare diseases. As most of them are caused by genetic disorders, the advances in gene technology will contribute very much to the understanding of the causes of these diseases and perhaps lead to cures.
However, the perceived absence of benefits to the final consumer is one of the main impediments to a more generalised social acceptance of the use of GMOs in agri-food production.
Life sciences and biotechnology are in a stage of exponential growth. They open up a vast range of potential in terms of future benefits, competitive advantage, economic growth and employment opportunities.
In line with the European Union's strategic goal of becoming the most competitive and dynamic knowledge-based economy in the world, the Commission is placing particular emphasis on the potential of life sciences and biotechnology.
Only two weeks ago we published a consultative Communication "Towards a strategic vision of life sciences and biotechnology".
This document is mapping out the wide range of issues linked to the application of biotechnology and raises many of the same questions as we are discussing here today.
One of the key messages from this Communication is that the potential we are envisioning can only be realised if there is broad public support. We see an increasing need for awareness and enlightened policy decisions based on rational fact.
Very often the debate on GMOs has generated more heat than light. We must ensure, as political leaders, that the unbiased facts on biotechnology are placed before our citizens to see and understand. Too many false claims have been made which do not reflect the science-based approach to food safety that I advocated since coming into office. I am, therefore, calling on all sides to have a rational debate and to take a balanced approach.
In this assembly, I am sure that I do not need to remind you that the Commission is committed to the development of sound and coherent policies in the general interest of Europe and our citizens.
But the legitimacy of that commitment can only be fully realised by building widespread consensus with all stakeholders in Europe public authorities, scientists, business, consumers and the body politic at large. All players have to confront their responsibilities and obligations towards their fellow partners.
Through this process, we are seeking to develop the strategic potential of life sciences and biotechnology over the long-term. This debate must avoid the pitfalls of short-term solutions
Turning now more specifically to the questions the Presidency has framed. Last December's OECD report pointed out that, at this stage, strong conclusions on the economic impacts of genetically modified crops cannot be drawn.
Though expected profits are often considered a major factor in the adoption of genetically modified varieties, available studies do not, in general, give consistent evidence of profit increases for adopters compared to non-adopters. Results vary across regions, crops and years. Increased costs of the technology are not uniformly compensated for by yield increases or reductions in pesticide and herbicide use.
Moreover, contrary to what is the case for pharmaceuticals, most of the GMOs currently on the market are not geared to deliver specific, clear benefits for the consumer.
From a consumer point of view, this has given rise to scepticism, independent from safety questions, and I am sympathetic to the fact that for some applications of biotechnology, the benefits may not be so obvious at this stage.
I believe, however, that the public attitude towards GM food can change once products with clear benefit to consumers are marketed.
However, before we even get to that stage, we must ensure that the optimal regulatory environment is in place. Consumers, whether they be farmers or shoppers, must have confidence in the regulatory framework.
A high level of protection, consumer choice and transparent, uniform and efficient authorisation procedures are key elements in fostering social acceptance and trust in the application of biotechnology to food and feed.
In this regard, I would like to draw your attention to the two proposals on biotechnology adopted by the Commission in late July and which are based exactly on these principles.
Our first legislative proposal, which concerns GM food and feed,
The second proposal on traceability, establishes harmonised and coherent Community requirements for traceability of GMOs as well as for GM food and feed.
Safety is essential for the future success of biotechnology in Europe. In the minds of the European public, safety is the most important ingredient of their food. Compromising on food safety is not the way forward, and, as you would expect, I do not intend to go down that route.
The overarching principle of the new proposal is that GM food and feed must not present a risk for human health, animal health or the environment.
Therefore, GM food and feed have to undergo mandatory pre-market authorisation involving a scientific assessment of potential risks. Only if concluded to be safe should such products be allowed to be placed on the market.
Whilst this principle is not new as regards genetically modified food, the proposal establishes for the first time the same, clear and stringent rules at Community level for feed derived from GMOs.
There are further important principles for authorisation in respect of GM food or feed. These are that
In the case of feed, it must be established that it must not harm the consumer by impairing the distinctive features of animal products.
Learning from the US experience with StarLink, the proposal provides that GMOs likely to be used as food and feed have to be authorised for both uses or not at all. Our intention is to prevent a StarLink type of situation occurring in Europe.
The proposal also establishes that the need for post-market monitoring of GM food and feed has to be evaluated during the risk assessment and that monitoring requirements can be imposed as part of the authorisation, where appropriate.
I do not intend this morning to go into the detail of our proposals. I will circulate some summary details of other aspects of our package, including how the European Food Authority will carry out scientific risk assessments as part of the authorisation procedure, revised labelling requirements, and how we propose to handle adventitious presence of GMOs.
The two proposals, together with the recent adoption of the revised legislation on the deliberate release of GMOs into the environment, will, I believe, build up public confidence by responding to questions and concerns raised by the general public.
The proposals provide for a high level of protection for human health and the environment and will enable consumers to exercise their freedom of choice.
However, it does not end here. I am still working on future proposals notably in the seeds sector to complete the regulatory picture.
I see the proposals, which I have briefly presented to you today, as an integrated part of the strategic vision which I hope will contribute to a rational and balanced debate about the future of biotechnology in Europe and lead to increased public acceptance of the use of biotechnology.
May I thank the Presidency again for their initiative in organising this informal Council around the theme of new technologies in agriculture. I regard this as an important input into the wider debate the Commission has initiated about the future potential of life sciences and biotechnology.
Annex - Summary details of draft Regulations on GM Food/Feed and Traceability European Commissioner David Byrne
Authorisation Procedure
In order to streamline and improve the efficiency of the current authorisation procedure for GM foods, we envisage that the European Food Authority will carry out the scientific risk assessment.
The procedure will cover both the environmental, human and animal health aspects of GM food and feed.
Companies wishing to market a GM food or feed are required to submit an application to the European Food Authority. Apart from scientific data to demonstrate the safety of the product, the application also has to include a method for detection. The detection method is to be validated by the European Reference Laboratory on GMOs and will be made available to control authorities to facilitate their work.
Decisions to authorise GM food and feed shall be taken at European level on the basis of the scientific opinion of the European Food Authority. The proposal includes the establishment of a Community Register of Genetically Modified Food and Feed, which should contain information concerning all authorisations. To ensure transparency the Register shall be made available to the public.
Authorisations shall be limited to 10 years, being renewable for 10 years periods, upon application to the European Food Authority.
The company that holds an authorisation has to ensure that any conditions or restrictions, which have been imposed in the authorisation, are respected.
Transparency of the decision-making process and the involvement of the public in the authorisation process will also be improved. A summary of the application for approval and the opinion of the European Food Authority shall be made available to the public and the public may make comments to the Commission before the final decision to authorise a GM food or feed.
In order to further ensure clarity, transparency and a harmonised framework for authorisation, the proposal does not include the simplified procedure enshrined in the Novel Foods Regulation for foods that are considered to be substantially equivalent to existing foods.
The use of this regulatory short-cut procedure has proven to be controversial in recent years. There is now international consensus that, whilst substantial equivalence is a key step in the safety assessment process of GM foods, it is not a safety assessment in itself.
Labelling
All foods, whether pre-packaged or not, are subject to extensive labelling requirements under EC legislation. The objective of the new proposal is to inform consumers about the exact nature and characteristics of the food to enable them to make individual choices.
The purpose of labelling is not to inform the consumer about the safety or lack of safety of a food.
If a food is unsafe it cannot be placed on the market. There is no question of allowing it on the market but warning the consumer about a potential hazard.
The current EU labelling scheme provides that GM foods have to be labelled if traces of DNA or protein resulting from the genetic modification are detectable in the final product.
I believe that we can do better than that. The choice that I want to give Europe's consumers is very simple - "I can choose whether or not to buy food produced from a GMO".
The Commission's proposal reinforces the labelling of genetically modified products by ensuring labelling of:
These requirements respond to an overwhelming need to enable the consumer or users to exercise freedom of choice. Moreover, I believe that an appropriate labelling scheme is one of the key issues in ensuring and fostering increased public confidence and acceptance of the application of gene-technology in the agri-food sector.
Traceability
The proposal on traceability provides the basis for accurate labelling and facilitates withdrawal of GMOs in case an unforeseen risk should come to light. As you know the revised Directive on the release of GMOs into the environment introduces mandatory monitoring of GMOs. The traceability proposal is also designed to facilitate such monitoring.
Adventitious Presence
An issue which arises from the cultivation of GMOs is the possibility of the presence of minute traces of unauthorised GMOs in food and feed. These traces may be technically unavoidable during cultivation, harvest, transport and processing.
Whether we like it or not this has become a reality. This is not an issue that is particular to GMOs. In the production of food, feed and seed, it is practically impossible to achieve products that are 100% pure.
The current EU labelling provisions already addresses this problem by providing for a 1% threshold for adventitious presence of traces of approved GM material and a basic element of our legislation on seeds is to provide purity criteria to ensure legal certainty for seed producers and farmers.
The present proposal also takes into account the technically unavoidable traces of GM material.
Apart from providing for the possibility of establishing a labelling threshold, it sets up specific conditions under which technically unavoidable presence of unauthorised GMOs could be permitted.
In the EU, the Scientific Committees have already assessed a number of GMOs and concluded that they do not pose a danger to the environment or to human health. However, these GMOs are still pending final approval and some of them have now been awaiting approval for quite some time.
The proposal allows for these GMOs which have received a positive opinion from an EU Scientific Committee to be present in a food or feed up to a maximum of 1%.