To go to main Food Law Index page, click here.
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.
I am delighted to be here today to present the new proposal for a regulation on genetically modified food and feed which is based exactly on these principles.
In short,
SAFETY
I have said it before and I will say it again. 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.
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. The intention is to prevent a StarLink type of situation occurring in Europe.
The proposal also establishes that the need for post-market monitoring has to be evaluated during the risk assessment and that monitoring requirements can be imposed as part of the authorisation, where appropriate.
AUTHORISATION PROCEDURE
In order to streamline and improve the efficiency of the current authorisation procedure for GM foods, the proposal envisages 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 which 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.
COSTS
Some claim that costs will rise significantly due to our new labelling proposals. We do not believe this to be the case.
This is confirmed by the experience so far: when the current labelling regime (based on DNA/protein) was introduced in 1997, it did not result in increased costs, despite the horrifying (double-digit) prediction of some interests. Similarly, when Norway introduced its current labelling regime (similar to the one now proposed), it did not provoke any price increase or disruption in trade.
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 a problem which is particular to GMOs. In the production of food, feed and seed, it is practically impossible to achieve products which 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.
The present proposal also takes into account the technically unavoidable traces of GM material and 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%.
CONCLUSION
This is a brief introduction to the main elements of the proposal on GM food and feed.
The two proposals presented to you today together with the recent adoption of the revised legislation on the deliberate release of GMOs into the environment will build up public confidence by responding to questions and concerns raised by the general public.
The proposals provide a high level of protection for human health and the environment and enables 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 picture.
The Commission has also launched a consultation on life sciences and biotechnology in preparation for a policy initiative planned later this year.
The consultation document - "Towards a strategic vision of life sciences and biotechnology" is mapping out the wide range of issues linked to the application of biotechnology and goes much beyond the development of gene-technology in the agri-food sector.
I see the proposals which we have 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.