Genetically modified organisms: Replacement of Directive 90/220, and new proposals on the traceability and labelling of food containing GMOs, October 2001

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Publication Date 11/10/2001
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Genetically modified organisms are back on the menu in Brussels as the European Commission tries once more to end the ongoing three-year moratorium on the authorisation of new products containing GMOs. In a speech at the National Press Club in Washington on 9 October 2001, David Byrne, European Commissioner for Health and Consumer Protection said,

The climate for dialogue is now more propitious than previously. We have new environmental legislation on the statute book. And I have made proposals for new legislation that should allay any remaining, substantial concern. We are now intent on exploring with our Member States and applicant companies how we could in practical terms resume authorisations.
European Commission: Speech: SPEECH/01/442

To that effect, a meeting is scheduled for 16 October 2001 with Member States. It is the latest in a series of efforts made by the European Commission in 2001 to get the approvals process working again. In March proposals were adopted to amend Council Directive 90/220/EC and replace it with Directive 2001/18/EC; and in July the European Commission agreed on tough proposals concerning the traceability and labelling of food containing genetically modified food.

Background

According to a publication by EuropaBio, the global area of genetically modified crops has increased more than twenty-five fold during the five year period from 1996 to 2000. The total area of these crops in 2000 is estimated at 44.2 million hectares - approximately twice the area of the United Kingdom.

In response to this rapid growth in the industry there are now a large number of websites which deal with questions relating to biotechnology, genetic engineering, food safety, and the impact on the environment (some are listed below under 'Further information can be seen in these external links'). However, it is necessary to recognise that many of the organisations providing this information are coming to the questions involved with very committed perspectives.

For a reasonably balanced and objective introduction to questions relating to biotechnology and food safety have a look at the site provided by the Organisation of Economic Co-operation and Development (OECD), entitled Biotechnology at the OECD. In particular, look at the Frequently asked questions section.

General questions and definitions:

  • What is biotechnology?
  • What is genetic engineering?
  • How is biotechnology different from traditional breeding technologies?
  • How is it possible that genes from one organism can be processed by an unrelated organism?
  • What is a Genome?
  • What is substantial equivalence?
  • Is biotechnology necessary for the world to feed itself?

Safety issues and public concern

  • Are genetically modified foods safe to eat?
  • What is the impact of genetically modified crops on the environment?
  • Why is the public concerned about GM foods?
  • Why not just ban GM foods? Is it not better to be safe than sorry?
  • Are governments doing enough to improve food quality?
  • Are governments responding to the interests of consumers or those of the food and biotech industry?
  • What do we know about safety assessment?
  • What are the trade implications of biotechnology and other food safety and quality issues?
  • What is the link between on-going biotech and food safety concerns and the next round of the WTO trade talks?
  • Will the full-scale adoption of biotechnology give monopoly like powers over farmers and food production to a few multinationals?
  • How big is biotechnology?
  • Why are patents so important?
  • What are the industrial applications of biotechnology?

The OECD site also provides links to websites of organisations with relevant information.

GMOs and the European Union

Community legislation on GMOs dates back to the early 1990s and over the last decade it has been further expanded and clarified. Four Directives (90/219/EC; 90/220/EC; 90/679/EC; and 94/55/EC) cover the regulation of most biotechnological activities in the EU. The European Commission DG for Environment has produced a useful factsheet 'Facts on GMOs in the EU' which outlines European Union legislation in this field up until July 2000.

Until March 2001, Directive 90/220/EEC on the deliberate release of genetically modified organisms represented the main instrument for giving consent to experimental releases and for placing on the market of genetically modified organisms (GMOs). However, following a 1996 report on the implementation of Directive 90/220/, a proposal (COM (1998)85 final / OJ C139, 4.5.98, p1) was put forward by the European Commission in 1998 for a European and Council Directive to amend the Directive.

The objectives of the proposal were to:

  • extend and clarify the scope of the original Directive 90/220/EEC
  • to improve the administrative procedures
  • to harmonise decision-making between Member States on the basis of common principles of risk assessment
  • to improve the flexibility of Directive 90/220/EEC while maintaining a high level of protection for human health and the environment.

Further details of the objectives and the content of the proposal can be seen in European Commission Press Release IP/97/1044.

The proposal was subject to the co-decision procedure. To trace the full progress of the proposal through the policy-making process you can use these services.

  • OEIL (Legislative Observatory) (provides a full history of the proposal with summaries of each major stage in the process)
  • Pre-Lex (provides a full and concise calendar of the proposal, bibliographical references and some hyperlinks to full text sources)

The Conciliation Committee reached agreement on the joint text of the directive on 14 December 2001. Amongst the compromises agreed were:

  • A Commission undertaking to bring forward a legislative proposal on environmental liability before the end of 2001, which would also cover damage resulting from GMOs.
  • A commitment by the Commission to bring forward appropriate legislative proposals on labelling and traceability in the course of 2001 following the European Parliament's insistence on these rules.

The compromise package was adopted by the European Parliament on 14 February 2001 by 338 votes to 52 with 85 abstentions but it faced stiffer opposition in the Council of the European Union the following month. Six countries - France, Italy, Austria, Greece, Denmark and Luxembourg - all tried to block the new directive, arguing for the need for tougher rules on the labelling and traceability of GMOs, and on making producers liable for any environmental damage. Their stance was supported by the European Consumers' Organisation who maintained that consumers still required 'clear and transparent information'. However, Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms and repealing Directive 90/220/EC was formally adopted by the Council on 12 March 2001 despite abstentions by the French and Italian delegates.

Commenting on the adoption of the Directive, Environment Commissioner Margot Wallstrom said:

The adoption of this Directive represents an important first milestone towards the restoration of public and market confidence.
European Commission: Memo: MEMO/01/42

Fellow European Commissioner for Health and Consumer Protection, David Byrne added:

The regulatory framework must provide for a high level of protection for human health and the environment based on sound science and at the same time should also allow society to profit from the benefits of these new technologies. The adoption of the new legislation today is an important point of departure for further legislation on the use of GMOs in food, feed and seed. I am particularly committed to provide consumers with clear and precise information through labelling. I believe informed consumers should be able to make an informed choice and will ensure this rationale to the proposals in each sector.
European Commission: Memo: MEMO/01/42

New proposals on labelling and traceability

In a response to the demands of EU governments, the European Parliament and European consumer organisations, the Commission agreed on new proposals (COM (2001)182 final) concerning the traceability and labelling of food containing genetically modified organisms on 25 July 2001.

There are three key objectives to the proposals:

  • to introduce a system for tracing genetically modified organisms throughout the production chain with a centralised approvals process for GMOs for feed and food under the European Food Authority (EFA).
  • to label all GM foods including those derived from but no longer containing GMOs, such as highly refined products e.g. maize or soy oil.
  • to establish a 1% limit on the amount of GM material found accidentally in food or feed. These unauthorised GMOs, as well as products derived from them will not have to be labelled.

The Commission believe the proposals will help to allay consumer fears because they ensure detailed labelling of foods derived from GMO crops and traceability of products from the farm to the supermarket. David Byrne, the Health and Consumer Protection Commissioner pointed out that the latest proposals would be to the benefit of European consumers, saying,

These laws will ensure that the regulatory framework in the EU is up to the high standard consumers expect. After that it is for consumers to decide if they want to buy food produced from a GMO. The proposed labelling regime will allow consumers to make that choice.
European Commission: Press Release: IP/01/1095

Indeed, the proposals were met with generalised support from consumer groups. The European Consumer's Organisation (BEUC) welcomed the Commission's proposals, saying:

At first sight these proposals move a long way towards giving the consumers the possibility, previously denied to them, to choose whether or not to eat food and food ingredients derived from them

However, it was less sure about the proposal allowing for an acceptable amount of accidental GM contamination. This was a view shared by most consumer and environmental organisations. It has been viewed by many as a step back from the tough rules introduced with Directive 2001/18/EC since it allows for 'acceptable' contamination limits. Friends of the Earth have described it as a concession for the biotech industry to the detriment of European citizens, giving biotech companies a 'licence to pollute'; and Greenpeace suggested the proposal 'risked opening a hole in a dike, allowing for the first time unauthorised genetically modified organisms into the European Union market'.

Despite these criticisms, Byrne's colleague, Environment Commissioner Margot Wallstrom claimed that the latest proposals would build consumer confidence whilst helping to end the three year ban on GM products suggesting that, 'European companies will only be able to seize the opportunities provided by bio-technology if this confidence is established'.

Tensions with Trading Partners

Yet while the new proposals might open up the market to European companies they did not meet with much support beyond EU frontiers. Trading partners in the US, Canada and Argentina suggested the proposals would make the European market even more inaccessible.

The US trade in corn is worth about $18 billion and about 25% of the US' annual corn production is genetically modified so access to European markets is important to their agricultural economy.

The response in the US is likely to add to tension between the EU and the US over the countries' trading relationship. Both sides are preparing for the World Trade Organisation fourth ministerial conference from 9-13 November 2001 in Doha, Qatar which they hope could launch a new round of world trade talks. But the Commission's proposals could undermine Brussels' efforts as the EU's attitude to GMOs is seen as a key example of its approach to food safety and advances in biotechnology.

An End to the Moratorium on GM Products?

The proposals still have to go through the co-decision procedure with the European Parliament and the Council.

To trace the full progress of the latest proposals through the policy-making process you can use these services.

  • OEIL (Legislative Observatory) (provides a full history of the proposal with summaries of each major stage in the process)
  • Pre-Lex (provides a full and concise calendar of the proposal, bibliographical references and some hyperlinks to full text sources)

So far the European Commission's hopes that the legislative package would lead to a restart in the trade in GM crops seemed to have been misguided. The proposals have already faced stiff opposition from the Trade Commissioner Pascal Lamy, environmental groups, consumer groups and even Member States.

The meeting planned for the 16 October 2001 is yet another Commission attempt to restart the approvals process and end the three year moratorium on GMOs. It will bring together civil servants from the Member States and Commission officials in what is being described by the Commission as 'a purely technical explanatory meeting'. However, the Commission is likely to put pressure on Member States to restart authorisations because it feels it has fulfilled all requests by Member States as pre-requisites to lift the moratorium.

A working paper suggests that the Commission is seeking a two-fold increase in the amount of approved GM food in the EU and a three fold increase in the number of permitted crops even though the recently agreed proposals have yet to be adopted. The paper, prepared jointly by the Directorate General for Environment and the DG for Health and Consumer Protection, also claims that the standstill has serious implications for European industry, agriculture and research sectors. It compares the US where fifty GMOs have been approved for use in food with the European Union which permits food products from only thirteen GMOs to enter the marketplace. Even though Directive 2001/18/EC has yet to be put into force in national laws and the latest proposals, if adopted, would not enter into force until 2003 the Commission seems keen to press ahead with 'voluntary agreements' with GM firms.

This latest attempt by the Commission has already provoked widespread criticism from environmental groups ahead of the 16 October meeting. Gill Lacroix, Biotechnology Coordinator of Friends of the Earth Europe condemned the latest Commission initiative saying,

The public wants both informed choice and to know that GMOs have been thoroughly tested before they are allowed on the market. This move by the Commission to re-start GMO authorisations before new rules are in place on the basis of 'voluntary agreements' with biotech companies does not guarantee either.
Friends of the Earth Europe: Press Release: 5.10.01

With pressure mounting from EU trade partners, European research increasingly proving the safety of GM crops and all the legislation agreed it is unlikely that the moratorium on GM crops will continue. Ultimately, GM foods are likely to become so commonplace that European consumers and governments will have to accept some of them. David Bowe, a Socialist member of the European Parliament responsible for revisions to Directive 90/220 earlier this year, argues that 'People are fighting a losing battle. They're better off tackling it head on and getting the best regulations they can'.

Further information within European Sources Online:

European Sources Online: Topic Guides
Food Safety
Environment
European Sources Online: In Focus
The precautionary principle, April 2000
European Sources Online: European Voice
18.03.99: Parliament aims for classic EU compromise
25.03.99: GMO firms struggle to reap benefits
03.06.99: Bonn accused of sinking hopes of deal on GMOs
07.10.99: Anti-GMO cloud hangs over debate on EU legislation
28.10.99: MEPs vow to fight GM labelling 'insult'
06.01.00: Parliament split over rules for GM crops
10.02.00: Industry targets MEPs ahead of crunch vote on GMOs
06.04.00: MEPs divided ahead of key GMOs vote
20.04.00: GMO vote prompts call for swift action on liability
08.06.00: Move to bolster confidence in GMO policy
14.12.00: Greens seek to keep moratorium on GMOs
22.03.01: Call to water down GMO measures
17.05.01: Commission set for major GMO U-turn
26.07.01: Commission agrees tough plans for labelling of GMOs in food

Further earlier links within European Sources Online can be found by carrying out a search and inserting the phrase 'Genetically Modified Organisms' in the Search field.

Further information can be seen in these external links:
(long-term access cannot be guaranteed)

EU Institutions

European Commission: DG Agriculture
Economic Impacts of Genetically Modified Crops in the Agri-Food Sector
Genetic Resources and GMOs in agriculture
European Commission: DG Environment
Handbook for Implementation of EU Environmental Legislation - GMOs
European Commission: DG Health and Consumer Protection
Food Safety: From the Farm to the Fork
White Paper on Food Safety, 2000
Development of analytical methods for the identification and determination of genetically modified organisms in food and food ingredients
Messages from citizens on GMO legislation
Biotechnology
Consultation Document: Life Sciences and Biotechnology: A strategic vision
Advance copy of the working document on traceability and labelling of GMOs and products derived from GMOs
Messages from citizens on GMO legislation
European Commission: Joint Research Centre
Food products unit
Genetically Modified Organisms in food and the environment
European Commission: DG Press and Communication: Press Releases
25.07.01: Commission improves rules on labelling and tracing of GMOs in Europe to enable freedom of choice and ensure environmental safety (IP/01/1095)
24.07.01: Questions and Answers on the regulation of GMOs in the EU
International organisations
Food and Agriculture Organisation (FAO)
Homepage
Committee on Agriculture, 15th Session, 1999: Biotechnology
FAO Conference, 1999: Information Note on Biosafety
World Health Organisation (WHO)
Homepage
The establishment of ad hoc Intergovernmental Codex Task Force
Release of GMOs in the environment: is it a health hazard?
Codex Alimentarius
Homepage
Foods derived from biotechnology, 2000
National organisations
United Kingdom Food Standards Agency
Homepage
United Kingdom: Department for Environment, Food and Rural Affairs
Homepage
Release of GMOs in the EU
Genetically modified crops: Farm scale evaluations
A Consultation Paper on the implementation of Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, July 2001
United States: Food and Drug Administration (FDA)
Homepage
Bioengineered foods
Biotechnology
Business organisations
European Association for Bioindustries (EuropaBio)
Homepage
GMO Fact Sheet
12.4.00: Europe says yes to biotech
13.4.00: European bioindustries fully accept liability under existing national and EU laws
14.02.01: EP vote: Step forward to coherent legal framework for European biotechnology
16.03.01: European Parliament wants stronger support for biotechnology
26.03.01: Stockholm summit sees biotechnology as a priority
26.07.01: Commission decisions on GMO legislation
28.09.01: European biotech companies held back, says report
List of members (with hyperlinks)
Monsanto (part of Pharmacia)
Homepage
Biotech Knowledge Center
Facts on GMOs in the EU
Consumer organisations
The European Consumer's Organisation (BEUC)
Homepage
Consumers International
Homepage
Campaigns and Issues: Food
Helpful links
Consumers in Europe Group
Homepage
Consumers Union
Homepage
Genetically Engineered Food
National Consumers Council
Homepage
26.07.01: New GM food labelling plans: Good news for consumers
19.09.01: Consumer concerns over GM labelling
Trans Atlantic Consumer Dialogue (TACD)
Homepage
Genetically modified organisms
Consumer Concerns About Biotechnology And Genetically Modified Organisms (GMOS)
Environment organisations
Campaign to Ban Genetically Engineered Food
Homepage
Friends of the Earth
Tougher European regulation of GMOs? , 21.3.00
Friend of the Earth Europe: Biotechnology Programme
Greenpeace
Homepage
Genetic engineering
Genetically engineered food
European Parliament strengthens GMO rules, but Greenpeace disappointed at EP's -failure on key issue , 12.4.00
United Kingdom: National Environment Research Council
GMOs and the environment: scientific certainties and uncertainties
NOAH Gene-technology Group
Homepage
Development organisations
United Kingdom: Overseas Development Organisation
Homepage
The debate on genetically modified organisms: relevance for the South, 1999
Seeds of Power? - Genetically Modified Organisms
GMOs and NGOs: Biotechnology, the policy process and the presentation of evidence
The International Centre for Genetic Engineering and Biotechnology (ICGEB)
Biosafety webpages
One World
Homepage
Genetic engineering
Other organisations
Genetically Modified Food News
UK and World News
Who's Doing What
EurekAlert
Homepage
GMOs search results
Institute of Science in Society
Homepage
Press Releases
28.08.01 ISIS Report: Europe's New Rules could sink all GMOs
Soil Association
Homepage
GMO
GM News Digest
Biodiversity campaign
Agroecology/ Sustainable Agriculture Program
GMOs: Looking at both sides of the controversy
News Sources
BBC News Online:
17.03.99: GM links
06.04.00: GM food 'safe'
12.04.00: Euro parliament to debate GM food
12.04.00: EU rejects strict GM food controls
26.05.00: GM seed fears grow
23.01.01: World Trade Dilemmas
04.04.01: GM trials: in depth
03.05.01: GM trials: Farmers lobby ministers
21.05.01: The biological goldrush
FT.com:
26.07.01: EU plans tough GM label rules
26.07.01: Genes, greens and global trade disputes
16.02.01: Six EU states refuse to lift block on new modified crops
15.02.01: Tough new EU law opens way for GM crops
14.02.01: Europe approves laws for genetically modified organisms
New Scientist:
GM Food: Special report

Helen Bower
Assistant Editor, KnowEurope
Compiled: 12 October, 2001

The European Commission is to try once more to end the ongoing three-year moratorium on the authorisation of new products containing GMOs at a meeting with the Member States scheduled for 16 October 2001.

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