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Regulations on genetically modified food and feed
Introduction
Steps in EU policy and European Parliament's role
The European Parliament has equal decision-making power with the Council of Ministers in the area of food safety and food labelling. Much of the information in this page relates therefore to legislation where Parliament has had a direct impact on EU law.
For information on European Commission guidelines concerning GM crops, please see "Guidelines for the development of national strategies and best practices to ensure the co-existence of genetically modified crops with conventional and organic farming" on the European Commission's website.
Clear labelling of GMOs
A great deal of scepticism has surrounded genetically modified organisms in Europe, unlike the United States where GM food is considered perfectly normal. In response to this public concern, the EU decided to introduce strict legislation on GMOs. The European Parliament's main contribution to this legislation was to insist on clear labelling, to enable Europe's consumers to choose whether or not to eat GM products.
Genetically modified organisms, and in particular their use in food crops, have been the focus of intense public debate throughout the European Union. Industry argues that GM crops pose little risk and have enormous potential benefits. On the other hand, environmentalists point to a perceived lack of knowledge and understanding of the risks, while consumers have complained that GM products have been foisted upon them and that the labelling system is not transparent and hampers choice.
After imposing a moratorium in 1998 on sales of genetically modified food and the use of genetically modified crops, the EU set out to address consumers' concerns by introducing a range of GMO-related legislation based on the precautionary principle: when in doubt, say no. All this legislation had to be approved by the European Parliament.
First of all, the Commission drafted a directive on sales of GM food products in the shops and the release of GM crops into the natural environment by farmers. During negotiations with national governments, Parliament successfully argued that any GMOs allowed during a trial period in Europe should be registered and details made available to the public. Thus, when GMOs are used for commercial farming purposes, their locations will have to be notified to the authorities and made public. In this directive, which entered into force in 2001, MEPs also called on the Commission to bring forward special legislation on labelling and traceability of GMOs and on the Cartagena Protocol on Biosafety with reference to GMOs.
Source: Europarl: http://www.elections2004.eu.int/highlights/en/709.html
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Regulations in force
Regulation 1829 / 2003 on geneticaly modified food and feed [ full title ] was adopted by the European Parliament and EU Ministers on 22 September 2003 and published in the Official Journal on 18 October 2003. It became directly applicable six months after publication, ie. from 18 April 2004.
Regulation 1830 / 2003 on traceability and labelling of genetically modified organisms, food and feed products [ full title ] was also adopted on 22 September 2003 and published on 18 October 2003. It became directly applicable 90 days after publication, ie. from 18 January 2004
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Aims of the Regulations
The objectives of Regulation 1829/2003 on geneticaly modified food and feed are:-
- To provide the basis for a high level of protection of human life and health, animal health and welfare, environment and consumers' interest in relation to genetically modified food and feed.
- To lay down Community procedures for the assessment, authorisation and supervision of genetically modified food and feed.
- To lay down provisions for the labelling of genetically modified food and feed.
Amongst the main points:-
- genetically modified food and feed will only be authorised for placing on the Community market after a scientific evaluation of any risks for human and animal health and the environment;
- harmonised labelling requirements for genetically modified food and feed to provide final users with accurate information on the composition and properties of the product;
- the labelling requirement applies to food or feed products containing GMO material in a proportion higher than 0.9 per cent of the food ingredients considered individually, even where the presence of these products is adventitious or technically unavoidable;
- food additives, flavourings, feed materials, feed additives containing, consisting of or produced from GMOs fall within the scope of the Regulation;
- operators must avoid the unintended presence of GMOs in other products.
Source: Legislative Observatory http://www.europarl.europa.eu/oeil/file.jsp?id=212202
Regulation 1830/2003 on traceability and labelling provides a framework for the traceability of products containing genetically modified organisms (GMOs), and food and feed produced from GMOs, with the objectives of facilitating accurate labelling, monitoring the effects on the environment and on health, and the implementation of the appropriate risk management measures including, if necessary, withdrawal of products.
The main provisions are:-
- Traceability: information concerning the presence of GMOs in products must be transmitted throughout the commercial chain and must be retained for five years;
- Labelling is required of all foods produced from GMOs irrespective of whether there is DNA or protein of GM origin in the final product;
- GM-food: accurate labelling of food and food ingredients produced from GMOs allows consumers to exercise their freedom of choice. The label has to indicate "This product contains genetically modified organisms" or "... produced from genetically modified (name of organism)".
- GM-feed: the Regulation introduces for the first time comprehensive labelling requirements for both GM feed and GM food.
- Authorisation procedure: "one door one key" procedure for scientific assessment and authorisation of GMOs, GM food and GM feed.
- Scientific risk assessment by the European Food Safety Authority (EFSA). Its opinions are made available to the public, who have the possibility to make comments. Products authorised shall be entered into a public register of GM-food and -feed.
[ See EFSA's "Science" pages on their website: http://www.efsa.eu.int/science/catindex_en.html ]
Source: Legislative Observatory http://www.europarl.europa.eu/oeil/file.jsp?id=212632
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European Parliament impact and debates
The GMOs Regulations were heavily amended by the European Parliament. The Commission accepted either fully or in part 54 of the 111 amendments put forward by the European Parliament at its first reading and revised its proposal consequently.
The final compromise package was adopted in Council of Ministers by qualified majority, with the United Kingdom, Luxembourg, Austrian and Danish delegations voting against.
The proposals were steered through Parliament by Karin SCHEELE (PES, Austria).
Below are excerpts of the parliamentary debate on July 1st, 2003, and a link to the full transcript.
For the Liberals, Chris DAVIES (LibDem, North West) confessed to being a "sceptic" rather than an outright opponent of GMOs. He recognised that the use of these new substances could bring about a reduction in pesticides and that, at present, there was not a proven health risk. On the other hand, there were fears over threats to the environment and the need to avoid a trade war. On the whole, he felt the pace of developments was proceeding too fast and that a delay in taking a final decision would be no bad thing.
Chris Davies MEP |
Davies– Madam President, this issue divides our Member States as it does people across the world, sometimes with an intensity comparable to religious conviction. I confess to having no such absolute certainties. I am a sceptic rather than an opponent of genetically modified crops. I acknowledge that they may bring about benefits in terms of the reduced use of pesticides and herbicides, that there are no proven health risks – or none yet established – and that GM crops could, across the world, be grown in circumstances which would not permit the growth of conventional crops.
However, I see no certain gains from growing GM products in Europe. I believe changes in European and American trade policies are likely to prove of greater benefit to developing nations, and I have fears that we could be making mistakes that will have unforeseen consequences for our environment.
A common framework of policies is needed if we are to avoid the risk of a trade war with the United States, with appeals to the WTO, and to curb the risk of divisions amongst ourselves across the European Union.
I await with interest the result of the field trials currently being carried out in my own country, to see whether they provide any evidence on the effects of biodiversity. I am pleased to hear that the Commission's proposals for guidelines on the subject of coexistence are on schedule. It is vital that these ensure that conventional and organic growers should not lose out as a result of this technology. They must be protected from the risk of financial loss, and the proposals here should allow individual Member States to take significant steps to prevent cross-contamination – at least that is the hope.
There is a strong sense that we are all being driven too fast by narrow commercial interests, mainly concentrated in the United States. As a result, I have no doubt that this is an imperfect package and we will have to return to this subject. In the meantime consumers must be given the information to make their own choices and, if this ultimately slows the development of this technology while more research is undertaken, then that may be no bad thing.
Editors' note:
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Jill EVANS (Plaid Cymru, Wales) stated that 93% of consumers wanted a choice as to whether to buy GM products or not. However, Mrs Evans pointed out that this would not be a complete choice since accidental contamination of 0.9 % would not be included within the scope of the directive. Mrs Evans did recognise the fact that these thresholds could be altered when better detection technologies became available. In Wales, she said the issue of co-existence was particularly sensitive and the Welsh Assembly had tried to impose strict regulations on separating GM and non-GM products, but the Commission had stated that in the long-term these would not be viable.
Jill Evans MEP |
Evans– The labelling of all genetically modified food and animal feed will give consumers in Europe what 93% of them are asking for: the choice of whether or not to buy GM products. Meat producers, for example, will be able to avoid using GM feed for the first time through labelling. It is not complete choice, because of the threshold levels for authorised – and temporarily for unauthorised – GMOs if their presence is adventitious or technically unavoidable. These levels are too high, but they can be reviewed in the light of developments in technology.
Under the new regulations GM food and animal feed will have to go through a strict authorisation procedure – not just a notification process – and once on the market they can be monitored for effects on the environment. However, as other colleagues have mentioned, of central importance are the measures which can now be taken by Member States to avoid the contamination of other products by GMOs.
Coexistence has become a major issue since we started discussions on these reports, and conventional and organic farmers, and food producers, as well as consumers, will welcome the proposals before us today. I represent Wales, a country where the National Assembly tried to implement separation distances between GM and non-GM crops, only to be informed by the Commission that this action was not legally sustainable. About a quarter of agricultural land in Wales is under agri-environmental schemes, or registered as organic, so this is of crucial importance to the economy as well as to the environment. I am sure that my constituents will be very pleased that action can now be taken on coexistence. I particularly welcome the fact that it is clear here that producers and users of GMOs must take all necessary measures to prevent contamination of other products so the burden is not on the conventional farmer.
These new regulations will defend the fundamental principle of consumer choice and we will see people exercising that choice by not growing GM crops and by not buying GM food.
Editors' note:
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Caroline JACKSON (Conservative, South West), stated that the development of GM products was very useful and would help to ensure better food supplies and reduce the use of environmentally damaging pesticides and herbicides. As far as the thresholds for labelling were concerned, Mrs Jackson stated that the amounts were very low and almost undetectable. Mrs Jackson also wanted to know what action the Commission would take once these directives were adopted, if a particular country decided to impose a new moratorium on GM foods.
Caroline Jackson MEP |
Jackson – I, along with the majority of the British Conservative MEPs and the majority of members of my group, see genetic modification as an interesting and potentially very useful development for mankind and for our environment. Genetic modification of plants and seeds holds out the possibility of better food production in harsh climates and of assuring future food supplies to a fast-growing world population. It also holds out the possibility of reducing artificial agricultural inputs, notably pesticides and herbicides, whose use can cause collateral environmental damage.
The Committee on the Environment, Public Health and Consumer Policy has heard no convincing evidence that GM foods are a threat to human health or to biological diversity. If we had, we would have been very reluctant to see these proposals adopted at all. As it is, this debate has been remarkable for the chorus of Greens, Liberal Democrats and Socialists hymning the prospects of GM foods subject to safeguards.
Some MEPs may still want to differ from the Council over the question of the thresholds but we should remember here that we are talking about very tiny amounts. The text we adopt will specify that GM presence of more than 0.9% of any ingredient will trigger the labelling requirement. That is a tiny amount. Let us be honest. The 0.9% tolerance level is, in itself, on the very margin of detectibility. There is something bizarre about Europeans putting in place such requirements when consumers in other parts of the world do not insist on them, when there is no health evidence that supports them, and when we are probably legislating for the technically impossible.
I have one question for the Commission. If this legislation is adopted, and if some countries are reluctant to lift their moratorium on genetically modified foods, what action will it take? |
David BOWE (Lab, Yorkshire and the Humber) stressed that GM technology should primarily benefit consumers. He said the main objective of the proposed legislation was to ensure genuine choice. He did, however, recognise the imperfections in the labelling regime. He said that the consumers deserved the best deal that science could offer and it was impossible to define every ingredient in every product.
David Bowe MEP |
Bowe – Madam President, we have to recognise that this is another step in the process of making sure that, when we deal with this new technology, it works for the benefit of human beings and not against them. We have seen already other pieces of legislation come before this House, for one of which I was the rapporteur, which were part of the jigsaw creating the total picture of control over genetically modified organisms.
With this particular piece of legislation we have to recognise a number of things. The main objective of this legislation and the agreements around it is to give people the right to make a genuine choice about GM products. We have listened to the concerns of people across Europe calling for the right to make an informed choice about GM food. We are trying to put in place a labelling and information scheme that makes the choice a reality. I have some sympathy with the remarks made by Mr Maaten about the imperfections of this scheme; nevertheless we have to work within the boundaries of what is scientifically provable and practically possible to implement.
We live in an imperfect world, and the use of thresholds reflects the reality. Organic regulations allow for the presence of up to 5% non-organic ingredients. In practical terms that means that an organic readymeal could contain minor ingredients like herbs and spices which are not readily available in organic form. We do not label very low levels of residues of pesticides or chemical contaminates in foodstuffs although we know they are present.
In any labelling regime there are bound to be imperfections. There has to be a cut-off point where the practical and the scientific reality cuts in. That is the best we can do with the science we have. One of the ingredients in the pizza that you might eat tonight might be a salami sausage but not every constituent ingredient of that sausage will appear on the pizza-box label.
Our job is to make the best deal that science allows. Our priority has to be to give the consumer real choice.
Editors' note: Mr Bowe reported in 1999, 2000 and 2001 on a proposal for a directive on the deliberate release into the environment of genetically modified organisms - link to the Directive adopted.
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Caroline LUCAS (Greens, South East) also opposed the lifting of the moratorium. Labelling and traceability rules would not be sufficient to give the green light to widespread use of GMOs, she argued, pointing out that she felt contamination was inevitable. Furthermore, with increased licensing, there was a risk that normal food would be forced off the market. EU guidelines were not sufficient, she felt, adding that there was a need to improve the consultation system as far as the UK was concerned.
Caroline Lucas MEP |
Lucas – Mr President, we need new regulation on labelling and traceability and it must be as rigorous as possible. But my key point is that even if tough new rules are adopted tomorrow, as we hope, this should not be seen as a green light to lift the de facto moratorium. These directives do not address properly the very real risk of contamination of non-GM and organic agriculture with GM varieties. Nor do they provide for liability rules to cover farmers who are victims of such contamination.
Research by the Commission, by the European Environment Agency and by the Department for Environment in my own country all conclude that licensing GM crops will almost inevitably lead to widespread contamination of non-GM crops.
If we are to ensure that the public has the right to choose to reject GM we must ensure not only that GM is labelled, but also that non-GM continues to exist. Unless we can address the problem of contamination, that cannot be guaranteed. I do not believe Mr Fischler's guidelines will be adequate. The moratorium therefore must stay in place.
Finally, there are a number of national consultation processes going on in the Member States on GM crops. It is vital that those processes are taken seriously. It is therefore a matter of much regret that the UK Government's process has been under-funded and badly publicised. Its deadline must be extended if we are not to conclude that government ministers have already decided in favour of GM cultivation.
Editors' note:
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Commissioner Margot WALLSTRÖM, in her reply to the debate, stated that it was not a question of whether to "say yes or no to GM foods". She pointed out that the EU imported some 35 million tonnes of soya per year. She defended the Commission's proposals on traceability and labelling and stated that risk assessment was always central in all proposed legislation. The Commissioner also said that it was time for the EU to enact and enforce its legislation which, as a consequence, would end the de facto moratorium on GM products within the EU.
Margot Wallström,
Commissioner for the Environment
(1999-2004) |
Wallström, Commission - In this debate I can trace a wish to be in a different debate about saying 'yes' or 'no' to GMOs. This is not the situation. We are not discussing whether to say 'yes' or 'no' to GMOs. Maybe this would have been easier, but we have passed that stage. We already import into the European Union 35 million tonnes of soya every year. This is a fact. It is not fair to say that we have not tried to act according to the situation.
We have revised Directive 2001/18/EC about placing live GMOs on the market. We have proposed traceability labelling. We have looked at food and feed proposals. We have added this. We have written a new text into the environmental liability proposal. We are always discussing ways to complement the existing legislation in order to meet the concerns of citizens in the European Union.
What we have proposed reflects these concerns and, at the same time, the potential of this new technology. This is exactly what it addresses. We see that there is probably a lot of potential in using GM techniques, but we also see that there are risks. That is why we now have much stricter legislation in place. That is why we are tracing and labelling these products. That is why we have added a text in the environmental liability proposal. This is exactly what we have taken into consideration. We are trying to do our part and to take our responsibility. That is the only way to address such a complex and difficult issue.
We must demonstrate to the rest of the world, including the US, that it works. This is how we do it. We make a risk assessment, we trace it, we label it and we make sure that we have this correct balance.
That is why, as my colleague, Mr Byrne, has said, the Commission will take its responsibility. As you know, the process also leaves it very much up to Member States to demonstrate that they can work with this issue, but if they are not willing to do it the Commission will certainly take responsibility. Once again my thanks go to the rapporteurs and to all in the House for a very exciting debate. |
Transcription of the full debate on
http://www.europarl.europa.eu/omk/sipade3?L=EN&PUBREF=-//EP//TEXT+CRE+20030701+ITEM-005+DOC+XML+V0//EN&LEVEL=3&NAV=X
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Implementation in the UK
The Food Standards Agency and the Department for Environment, Food and Rural Affairs consulted over a 12-week period on draft documents that described the scope of the new rules and draft domestic legislation for enforcing the EC regulations. This consultation ended on 25 June 2004.
The national regulations in England for food and feed have now been signed and laid in Parliament and came into force on 4 October 2004. Similar regulations will apply in Scotland, Wales and Northern Ireland. A separate Statutory Instrument on traceability and labelling will come into force on 8 October 2004.
Source and links:
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Related issues
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Useful documents and websites
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Full title of Directive / Decision, reference of publication in the Official Journal, link to the texts.
Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed - Official Journal of the European Union No L268 of 18 October 2003 - on-line on the European Commission's website at http://europa.eu.int/
Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC - Official Journal of the European Union No L268 of 18 October 2003 - on-line on the European Commission's website at http://europa.eu.int
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Further information: Simon Duffin, EP Office, London Tel: 020 7227 4300
(Online October 19th, 2004) | |