Select Committee on European Union Twenty-Second Report


30 April 2002

By the Select Committee appointed to consider European Union documents and other matters relating to the European Union.


11576/01COM (01) 425: Draft Regulation on genetically modified food and feed.
11496/01COM (01) 182: Draft Regulation concerning traceability and labelling of genetically modified organisms and traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC.




1. No new genetically modified (GM) foods have been approved in the EU since 1998, because of an effective refusal by certain Member States[1] to participate in the approvals process until rules on traceability and labelling are in place. The European Commission has responded with proposals to extend the GM labelling regime but these have provoked controversy which could unintentionally result in this de facto moratorium being further extended. The Commission considers the moratorium illegal, and is concerned that it might be challenged through the World Trade Organisation (WTO). The Commission's proposals are intended to extend consumer choice, but the UK Government and the food industry have expressed concerns that they might prove difficult to implement in practice.

2. This Report is concerned specifically with the proposals for labelling of GM food and feed and the associated proposals on traceability. It addresses them from the practical viewpoint of how best to meet the needs of the consumer. It is not concerned with the wider aspects of regulating the use of genetically modified organisms (GMOs) and their implications for health and the environment. These have been the subject of separate studies.

3. In view of the current controversy over the proposals, Sub-Committee D (Environment, Agriculture, Public Health and Consumer Protection, whose Members are listed in Appendix 1, decided to conduct a short inquiry between January and April 2002. An invitation for evidence was issued on 21 December 2001 (Appendix 2). The Specialist Adviser to the inquiry was Professor Alan Malcolm, Chief Executive of the Institute of Biology.

4. A list of those who provided evidence and other information is in Appendix 3. The Committee would like to express its thanks to Professor Malcolm and the witnesses for their valuable contributions, which were helpful in focusing the inquiry on the key issues in an area of policy which tends to be as confused as it is complex. [2]

Box 1

GM and Biotechnology: basic terminology[3]

The term "GM" stands for the scientific or industrial process of "genetic modification" or the characteristics of material which has been "genetically modified". In simple language GM covers any of the following processes:

  • the deletion, change or moving of genes within an organism;
  • the transfer of genes from one organism to another (hence the term "transgenic");
  • the modification of existing genes or the construction of new genes and their incorporation into any organism.

"Genetic modification" is for practical purposes equivalent to and interchangeable with "genetic engineering". It does not extend to the generation of organisms using standard breeding techniques, including cloning, hybridisation or controlled pollination (as these do not involve modification of existing genes). Nor does it cover mutagenesis not involving genetic engineering techniques.

"GM organisms" (GMOs) are organisms produced directly by genetic modification and therefore contain GM material in the form of protein or DNA. "GM products" (including foods) may themselves be GMOs but also cover products derived from GM processes (including the use of GMOs as processing aids).

In the United States the term "biotechnology" (or "biotech"), is preferred to "GM". It should be noted, however, that although "GM" is a key tool of modern biotechnology it is not the only tool.


5. There have been a number of studies in recent years of different aspects of biotechnology and genetic modification by Parliamentary Select Committees. In the House of Lords, the European Communities Committee (as it then was) reported in 1998 on the implications for agriculture and the food industry of the Commission's proposals for amending the existing Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms.[4] These proposals were later to become Directive 2001/18/EC. The Report contains an extensive summary of the techniques of genetic modification, the place of GM in the wider context of biotechnology, the differences between GM and traditional breeding, the history and principles of regulation, differences between EC and US regulatory approaches, and international agreements relating to the movement of GMOs between countries. This summary holds good as a factual statement of the position as it stood at the time of the "moratorium" on EU approvals (paragraph 0) and we see no need to go over the same ground in the present Report.

6. The House of Lords Report came at a time of escalating media and public concern, particularly about the regulation of field trials of GM crops, which gave rise to inquiries and reports by separate House of Commons Committees, including a sequence of three by the then Agriculture Committee.[5] Its successor, the Environment, Food and Rural Affairs Committee, announced in February 2002 a brief inquiry into the current position in relation to GMOs, in particular developments since the Agriculture Committee's Report of March 2000 on segregation of GM Foods. The Committee began taking oral evidence in April.


7. In the course of taking evidence Sub-Committee D found it necessary to inform itself—or witnesses thought it necessary to inform the Committee—on many of the wider aspects of biotechnology and genetic modification in order to place the Commission's proposals in context. In preparing this Report, however, the Committee has focused specifically on the practicality of the proposals in meeting the needs of consumers.

8. As always, the recitals to the Commission's documents and their opening Articles cite a multiplicity of aims. The draft Regulation on Food and Feed (COM (01) 425) states as its principal objective:

9. The "consumers' interest" is backed by the recitals to the draft Regulation, which inter alia state that:

    ". . . clear labelling, irrespective of the detectability of DNA or protein resulting from the genetic modification in the final product, meets the demands expressed in numerous surveys by a large majority of consumers, facilitates informed choice and precludes potential misleading of consumers as regards method of manufacture or production (20). Additionally, the labelling should inform about any characteristic or property which renders a food or feed not equivalent to its conventional counterpart . . . as well as any . . . which gives rise to ethical or religious concerns (21)."

10. There is further discussion of these principles in the Commission's explanatory memorandum that accompanies the proposal. The draft Regulation on Traceability and Labelling (COM (01) 182) simply states that its objective is to facilitate "accurate labelling, environmental monitoring and withdrawals of products". Promotion of consumer choice is implicit in the reference to accurate labelling.

11. This Report accordingly takes as its starting point our belief that consumers and producers have a legitimate interest in seeking to choose between foods and animal feeds which have been produced (whether directly or indirectly) with the aid of genetic modification. We have noted that the reasons why consumers wish to make these choices are varied, but we have not made it our business to question whether their motives are rational or well supported by science. Our concern is how far it is practical to meet consumers' expectations and whether this can be done in a proportionate way, having regard to the realities of the situation—particularly in relation to the international market for bulk agricultural produce such as soya and maize.

Approval of GM foods and feed in the European Union

12. Under present EU rules all GM products must be assessed for their likely health and environmental impacts before they can be approved for deliberate release into the environment (i.e. planted as GM crops, marketed as GM foods, etc.). The "deliberate release" Directive that regulates this process was revised recently[6] to include new measures to refine safety assessment and enhance public confidence in the system. The Commission had also given an undertaking to introduce a more comprehensive labelling and traceability regime. The current proposals outlining such a regime were published in July 2001.

GM foods, food ingredients and animal feed

13. There are several different types of GM food and feeds:

Current and proposed GM labelling regulations

14. Under current EU regulations, it is the presence in the final food of detectable GM material that triggers labelling requirements. Any food or food ingredient produced from a GM source which contains detectable GM material has to be labelled. Under the Commission's new proposals the labelling regime would be extended to include all foods and animal feed produced from GM crops, irrespective of whether they contain detectable GM material. The proposals would impose labelling requirements for two categories of GM products that currently do not have to be labelled: foods and ingredients produced from GM organisms but which contain no GM material (e.g. highly refined oil from GM soybeans), and GM animal feed. A more detailed description of the Commission's legislative proposals is in Box 2 and a summary of existing and proposed labelling requirements is in the table after paragraph 0.

Box 2

The Commission's legislative proposals

The way in which the Commission has presented its proposals is confusing to the general reader. This stems from the need to amend or enlarge the scope of separate legislative instruments. As a result, a package of essentially interdependent measures has come forward in two documents (the titles of which are themselves confusing). Despite the numbering of the proposals, they are intended to be read, and taken forward, in parallel. It is convenient, however, to consider them in the following order, since the second one depends on the first one in so far as it takes the objectives of the overall package as given.

  • COM (01) 425: Authorising and labelling of GM foods and animal feeds, including products derived from GMOs. This proposal would replace existing EU authorisation procedures for GM foods, as contained in EC Regulation 258/97 (OJ L43, 14.2.97), and introduce for the first time rules for the authorisation of GM animal feed, within the general framework for the deliberate release into the environment of any GMO set by Directive 2001/18/EC (OJ L106, 17.4.01). The new authorisation procedures would assign a central role to the newly established European Food Safety Authority. Labelling would be required for all food and feed ingredients derived from GMOs, even when they are analytically identical to those derived from non-GM sources, instead of simply for food in which there is a detectable presence of DNA or protein resulting from genetic modification.
  • COM (01) 182: Harmonised system for tracing, identifying and labelling GMOs and food and feed products derived from GMOs at all stages of the production and distribution chain. This would be a new Regulation and would require some amendment of the framework Directive 2001/18/EC. Without such a provision for traceability, which enables the control and verification of labelling claims, the parallel provisions for labelling of GM-derived products and ingredients cannot be put into effect.

15. Because the new labelling proposals would apply to some products that contain no detectable GM material, enforcement could no longer rely solely on sampling and testing for GM material in the laboratory. Instead, the Commission has proposed a new traceability regime, where operators at each point in the marketing chain—farm, storage, transport, processing, distribution and marketing—would have to record and pass on details of the genetic modifications present in each shipment and product. The idea is to establish an "audit trail" for GM organisms and the foods and feeds derived from them.

16. The operative provisions on traceability would not come into force until the EU had established a system of "unique codes" for GMOs for purposes of identification. Since imports of GMOs into the EU are largely from third countries, the EU system would have to be consistent with mechanisms being developed under wider international organisations, including work on unique identification codes currently in hand in OECD. It would also need to conform to the requirements of the Cartagena Protocol on Biosafety (see Box 3).

Box 3

The Cartagena Protocol on Biosafety

This is the First Protocol to the Convention on Biological Diversity, which was agreed at the Rio Earth Summit in 1992 by the majority of the world's governments and sets out commitments for maintaining the world's ecological resources whilst allowing for sustainable development. The Protocol's overall objective is to "contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of GMOs resulting from modern biotechnology that may have adverse effects on conservation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focusing on transboundary movements".

To achieve this objective, the Protocol introduces two main procedures to control the movement of GMOs from one country to another:

  • A specific notification procedure which requires notification to, and the agreement of, the importing country before the export of a GMO (such as a seed) intended for deliberate introduction into the environment may proceed;
  • A separate procedure for GMOs for food, feed or for processing which enables an importing country to declare, via an information exchange mechanism, that it wishes to take a decision based on risk assessment information before agreeing to accept an import.

The Protocol is of particular benefit to developing countries who lack existing legislation on GMOs since it gives them the necessary information and means to decide, before accepting GMO imports, whether there may be adverse effects on the conservation and sustainable use of their particular habitats and wildlife. To date, 107 countries have signed the Protocol and 13 countries have ratified it. The EU and the Member States, including the UK, signed the Protocol in May 2000. On 13 March 2002 the Commission adopted a proposal for a Council Decision on the conclusion of the Biosafety Protocol, with a view to ratification of the Protocol by the Community (COM(2002)127 final).

17. Existing GM food labelling rules contain a one per cent threshold for the accidental ("adventitious or technically unavoidable") presence of GM material in food from non-GM sources below which labelling is not required. Currently this applies only to material from EU-approved varieties. The Commission now proposes that the threshold should apply to non-approved varieties too, provided that the GMO concerned has passed a safety assessment by the relevant EU scientific committee(s). Current technology is not reliable enough to support a general threshold of less than one per cent, although lower levels of detection are possible in some circumstances[7] (see Box 4).

Box 4

Detection methodologies for presence of GM material

Detection methodologies vary according to the nature of the food. According to evidence from several sources (e.g. the Food Standards Agency and the Food and Drink Federation), one per cent GM-derived material in the case of foods such as purified oils, sugars and starches (where there is not expected to be either protein or DNA present) would be well beyond either current or anticipated technology. Where protein is present, antibody-based methodologies should be capable in principle of detecting one per cent provided that the genetic modification results in a new protein being produced. This is often not the case. On the (comparatively rare) occasions where it is anticipated that DNA from the GMO is present in the food as consumed, it would be possible to use methods based on the highly sensitive polymerase chain reaction. However, this might not be reproducible, depending on the extent to which the food had been subjected to acid or heat treatment.

Labelling options

18. The Commission considered four options for GM food labelling (a-d below). The Food Standards Agency (FSA) evaluated the costs, benefits, risks and uncertainties of these, along with a fifth option (c+):

Extending the labelling requirements

19. The current labelling regime allows consumers to choose whether or not to buy products containing GM material. Under the proposed new regime (option c above), this choice would be extended to allow consumers to identify food derived from GM material. In opting for this approach, the Commission recognised that some consumers may wish to avoid GM foods for reasons other than concern over avoiding exposure to GM material. However, the proposals have raised concerns. The FSA suggests they are inconsistent, in that they do not require labelling of all foods produced using GM technology (see table above). It also sees potential problems in enforcing the proposed new regulations.

20. Some of the products (e.g. oil from GM soybeans) that would need to be labelled under the new proposals do not contain GM material. The GM status of such products cannot be verified by testing for GM material in the laboratory. Rather, verification will rely solely on the Commission's proposed "audit trail". Audit-based systems have been established for other foods (e.g. organic foods, fair trade tea/coffee and animal welfare-friendly meat) and enjoy high levels of consumer trust.

21. There would be exemptions from the labelling requirements where GMOs have only been used as processing aids. This practice is widespread in the wine, cheese[8] and brewing industries. Permission has also been given for their use in the baking industries, although we understand they are not yet in use in the UK. Vitamins used to fortify food and sold as "supplements" may also be products from GM-derived processing aids. Because they are only used as processing aids, they are present at well below one per cent even during the manufacturing steps and will have effectively have been removed entirely by the time the finished product emerges. Such exemptions would therefore provide no comfort to those whose objection to GM technology is based on ethical grounds.

22. Since the proposals would apply only from the point of entry into the EU, some have questioned how the GM "audit trail" would work in practice, particularly for imported bulk commodities such as GM soybeans and maize from North America and elsewhere.[9] The American Soybean Association (ASA) suggests that it would not be possible to implement an "audit trail" that allowed GM material to be traced back to the farm.[10] This is because international trade in grains is based on a commodity flow system where no distinction is made between GM and non-GM crops. For instance, in the US distribution system, GM and non-GM varieties are assembled into successively bigger batches—a typical shipment arriving in the EU contains up to 50,000 tonnes of crops originating from thousands of farms. For an "audit trail" starting at the point of entry into the EU, the importer would have to sample and test each shipment for its GM content. This information would be passed on to each operator in the chain and form the basis for verifying labelling requirements. ASA are concerned that such a system would be open to fraud (a concern shared by the FSA), and would incur considerable extra costs.

Introducing a "GM-free" scheme

23. The FSA sees option (b)—maintaining the current labelling regime and introducing a "GM-free" scheme—as representing the best balance between costs and benefits. Under this option, manufacturers could sell foods conforming to certain criteria as being "GM-free" (e.g. specifying measures to minimise contamination throughout the food chain and establishing a threshold for unavoidable with GM material). The Government sees this option as having advantages over the Commission's proposals as the current labelling rules are practicable and enforceable, and the introduction of a "GM-free" scheme would allow consumers to avoid GM technology if they so wish. US farmers also favour such an approach. They have been supplying "identity preserved" (IP) lines for years, including some IP "non-GM" lines. These are generally in smaller quantities and are kept entirely separate from the usual bulk distribution system through all stages of harvesting, transport, processing, etc. IP lines command a premium in the market to cover the additional costs incurred in maintaining integrity.

24. In general, consumer groups support option (c+)—the Commission's proposal to extend labelling requirements to include all foods produced from GM sources backed up with a "GM-free" scheme. There is strong support for the separation of GM and non-GM foods throughout the marketing chain and for measures to allow GM foods to be traced.

Summary of current and proposed GM labelling requirements

Labelling currently required?
Labelling required by Commission's proposals?
Labelling required by FSA's proposals?
Food produced from GM crops and containing GM material
Food produced from GM crops but not containing GM material
Food produced using GM organisms but not containing GM material (e.g. wine and cheese)
GM animal feed sold to livestock producers
Food from animals fed GM animal feeds
Non-GM foods with less than 1% presence of GM material
No (unless claimed to be "GM-free")

The wider picture

25. There has been a de facto moratorium on approvals of new GM products within the EU since 1998, pending revision of the deliberate release Directive.[11] This Directive is due to be implemented in national laws by October 2002; the Commission had hoped this would signal the end of the blockage in approvals, which it considers to be illegal. Several Member States have suggested that the approvals process should not be restarted until the new traceability and labelling regime is implemented; this could extend the blockage until mid 2003 and possibly into 2004. Any such extension could increase the likelihood of the EU facing action through the WTO. It is also possible that the Commission's labelling and traceability proposals might themselves be the subject of action through the WTO.

26. The EU's proposals on traceability and GMOs were notified to the WTO Committees on Sanitary and Phytosanitary Measures (SPS) and on Technical Barriers to Trade (TBT) in 2001. At meetings of those Committees, most recently in March 2002, the US has complained about the lack of scientific justification for the de facto moratorium, and Canada has suggested that the proposals discriminate against products produced by GM technology, thus raising the question whether they might be perceived as a barrier to trade.

27. The assessment of rules for the regulation of GMOs fall within the remit of the WTO Committee on Trade and Environment (CTE), set up in 1994 at the end of the Uruguay Round. The Committee also aims to clarify the relationship between WTO rules and the specific trade obligations of certain multilateral environmental agreements (MEAs), such as the Convention on Biological Diversity and the Cartagena Biosafety Protocol (see paragraph 0 and Box 3). Another issue, to be examined in the CTE as well as the TBT Committee, is that of policies on eco-labelling (i.e. labelling which provides information on the environmental characteristics of a product) and whether existing WTO rules stand in the way of such policies.[12]

1   Initially Austria, Denmark, France, Greece, Italy and Luxembourg; later joined by Belgium. Back

2   In summarising the essential features of the Commission's proposals we have drawn heavily on the Parliamentary Office of Science and Technology's Postnote No 172, February 2002, "Labelling GM Foods". We are grateful to the Director of POST for agreeing to the note being used in this way. Back

3   Based on a simple definition in the Report of the New Zealand Royal Commission on Genetic Modification, 27 July 2001. Back

4   ECC 2nd Report, Session 1998­99, EC Regulation of Genetic Modification in Agriculture, HL Paper 11, 15 December 1998. Back

5   Science and Technology Committee (May 1999), Scientific Advisory System: Genetically Modified Food, First Report, 1998-99, HC 286-I/II.; Environmental Audit Committee (May 1999), Genetically Modified Organisms and the Environment: Co-ordination of Government Policy, Fifth Report, 1998-99, HC 384-I/II.; Agriculture Committee (June 1999), Genetically Modified Organisms, Sixth Report, 1998-99, HC 427; Agriculture Committee (March 2000), The Segregation of Genetically Modified Foods, Third Report, 1999-2000, HC 71-I/II; Agriculture Committee (July 2000), Genetically Modified Organisms and Seed Segregation, Eighth Report, 1999-2000, HC 812. For an account of reactions to the House of Lords Report, the various House of Commons Reports and subsequent developments in government policy, see Institute for European Environmental Policy, Manual of Environmental Policy: the EU and Britain, Elsevier Science Ltd, Oxford (updated every six months), at section 7.14. Back

6   i.e. Directive 2001/18/EC, adopted in March 2001. Back

7   Evidence to the inquiry from FSA (p 56 at paragraph 5.2), BBSRC (p 84 at paragraphs 9-10), Food and Drink Federation (Q 37) and Friends of the Earth (QQ 103-5). Back

8   An example is chymosin ("vegetarian rennet"). Back

9   According to the FSA, the US grows 68% of the world's GM crops, Argentina 22%, Canada 6% and China 3%. In the US alone 70% of its soya bean crop is GM, 75% of its cotton crop, 50% of oilseed rape and 25% of maize (evidence to the inquiry, p 55 at paragraph 3.1, footnote). Back

10   Evidence pp 77-78. Back

11   Directive 2001/18/EC. Back

12   Information about the Committee is on the WTO's website at Back

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