STC Number - 106

Regulations on genetically modified food and feed

Maintained by: European Union
Raised by: United States of America
Supported by: Argentina; Australia; Canada; Egypt; Israel; Jordan; Singapore; Chinese Taipei
First date raised: October 2001 G/SPS/R/25 paras. 40-44; See also STC 110
Dates subsequently raised: March 2002 (G/SPS/R/26 paras. 45-56)
April 2003 (G/SPS/R/29 paras. 84-87)
June 2003 (G/SPS/R/30 para. 168)
Number of times subsequently raised: 3
Relevant documents: G/TBT/N/EEC/6 G/TBT/N/EEC/7 G/SPS/N/EEC/149 G/SPS/N/EEC/150 G/SPS/GEN/397 G/SPS/GEN/398 G/SPS/GEN/399
Products covered:
Primary subject keyword: Food safety
Keywords: Food safety; Genetically modified organisms (GMOs); Human health; Risk assessment; Technical Barriers to Trade (TBT)
Status: Partially resolved
Solution: Consultations requested on 13/05/2003 (WT/DS291/1). Single panel established for disputes DS291, DS292 and DS293 on 29/08/2003. Panel report (WT/DS291/R) was adopted on 21/11/2006. Suspension of concessions authorized on 15/02/2008; Arbitration requested on 7/02/2008 (WT/DS291/34). Panel report (WT/DS292/R) adopted on 21/11/2006. Mutually agreed solution notified on 15/07/2009 (WT/DS292/40). Panel report (WT/DS293/R) adopted on 21/11/2006. Mutually agreed solution notified on 19/03/2010 (WT/DS293/41).
Date reported as resolved:

Extracts from SPS Committee meeting summary reports

In October 2001, the representative of the United States highlighted concerns over the EC TBT notification of its 25 July proposals on traceability and labelling of agricultural biotechnology products (G/TBT/N/EEC/6 and EEC/7). The European Communities had not notified these proposals under the SPS Agreement, yet the EC proposal made clear that it was intended to address "unforeseen adverse effects to human health and animal health". These issues related directly to the SPS Agreement and the representative of the United States encouraged the European Communities to provide a SPS notification as soon as possible.

The representative of Argentina shared the concerns of the United States regarding the EC TBT notifications. Genetically modified food did not affect health and the compulsory labelling required by the EC measure was not in Argentina's view consistent with the standards contained in the TBT Agreement. Argentina sought clarification as to whether or not the labelling requirements extended to the compulsory labelling of pharmaceutical products for human or animal use which could have been made with genetically modified ingredients.

The representative of Canada supported the United States in its concerns given that one of the purported objectives of the EC regulations concerned human health. If the measures were notified under the SPS Agreement, then different questions could be asked to those raised in the TBT Committee. If, as the EC delegate appeared to suggest, the labelling requirements were intended merely to cover consumer information needs, and not food safety or human health objectives, then discussion in the SPS Committee would not be necessary. Both Canada and the United States sought clarification as to whether the draft EC regulations covered food safety or human health.

The representative of the European Communities observed that a TBT Committee meeting had been held three weeks prior to the SPS Committee. Requests made to the European Communities to prolong the consultation period had been accepted and this period would run until the end of the year. The main objective of the regulations was to make sure that consumers were duly informed of the products they buy. Two other key issues were also identified: traceability and labelling. The EC representative stated that discussion should continue in the TBT Committee, especially since delegations had raised questions in that forum, and the European Communities reserved its position on any other matters until the comments in the TBT Committee were known. While the European Communities was not against discussing these matters in any other fora, no decision had been taken as to whether this was necessary.

Replying to Argentina's concerns, the EC representative stated his understanding that the labelling of pharmaceuticals containing GM ingredients was covered by different legislation.

In March 2002, the representative of the United States noted that the EC measure would require a lengthy food safety review for all biotech foods, and for the first time, biotech feeds, which would also need to be labelled. Products already authorized for food or feed use within the European Union would have to be re-authorized within nine years of their first placement on the market. The stated objective of this regulation was to protect health, environment and consumers and to prevent deceptive practices. However, the proposed regulation failed to distinguish the protection of health and the environment, from perceived consumer desires. The regulation would be more trade restrictive than necessary and could create substantial difficulties for countries which imported US agricultural products for processing and further export, without addressing the identified concerns and potential hazards. The United States suggested that without affordable testing and enforcement, the proposed regulation left room for fraud, and he encouraged the European Commission to examine the feasibility of implementing the regulation, and to analyze its potential regulatory impact.

The representative of the United States further noted that the new EU Food Authority (EFA) would undertake the risk assessments for biotech food and feed, and provide technical and scientific information. But the European Commission could propose an outcome inconsistent with the risk assessment or other safety and technical information considered by EFA. This left room for political interference of the type that had led to the existing moratorium on the approval of biotech products. Furthermore, the EC legislation set a "no risk" level which could effectively block the regulatory process since no product could ever be guaranteed to have "no risk". The United States had already provided its comments directly to European Communities regarding this notification.

The representative of Canada appreciated that the European Communities had notified these proposed regulations under the SPS Agreement, since his country believed that they clearly fell within the scope of the Agreement. The primary concern expressed by Canada in the comments they had provided directly to European Communities was that certain elements of these proposals lacked the needed scientific basis.

The representative of Israel expressed concern with the trend of Members' requiring traceability and mandatory labelling for biotech food and feed products, a requirement not based on scientific information. He hoped that these Members could find less trade restrictive measures to address their concerns.

The representative of Jordan stated that his country supported the consideration of the safety of GM products on the basis of risk assessment as provided in the SPS Agreement. Requirements imposed on the products at later stages would result in unjustified costs that affected the competitiveness of products in markets, and resulted in greater restrictions on developing countries.

The representative of Argentina supported the US and Canadian statements regarding this proposed regulation, as these measures could cause serious economic damage to Argentina.

The representative of Taipei, China, stated that safety assessment of all GM products should be based on scientific evidence to ensure that the products were as safe as their conventional counterparts. He stressed the need for all Members to work together in particular to strengthen risk communication. Taipei, China, considered that an appropriate labelling scheme was necessary to respect consumers' right to know and to choose. Voluntary labelling had been introduced in Taipei, China, in January 2001, and mandatory labelling would be applied in three phases starting in January 2003. Information about the regulations of Taipei, China, was available at www.doh.gov.tw.

The representative of Singapore requested the European Communities to take account of all the concerns raised to ensure that the implementation of the regulations did not impose a disguised restriction on trade. She drew attention to the potential impact of the EC regulation on countries which processed and re-exported goods imported from the United States.

The representative of Egypt supported the statements of the United States and Jordan. He expressed particular concern that the measures could result in difficulties for developing country exports, and might become unnecessary obstacles to trade.

The representative of the European Communities recalled that the European Commission had notified these regulations also under the TBT Agreement, and that the TBT Committee had held detailed discussions at the technical level the previous week. The European Communities had notified these measures also under the SPS Agreement because many Members had expressed interest in the SPS Committee, but he believed that a large part of these proposals fell within the scope of Article 2.2 of the TBT Agreement. The European Communities had extended the time-period to allow Members to submit comments also in response to the SPS notifications. The comments received had been very similar to those received in response to the TBT notification, and the European Communities would make a combined response to comments received about both notifications.

The representative of the European Communities further reported that the draft regulation had been adopted by the EC College of Commissioners and sent to the EU Parliament and the EC Council for their final decisions. The comments received by the EC Commission, as well as the responses to these, would be provided to the EC member States, the EC Council and Parliament. It was unclear how long the process would take and when any decisions might be made. He noted that the EFA would be a scientific body with responsibility to do independent risk assessment. Its advice would be sent to the EC Commission and Council for the appropriate risk management decisions, a procedure consistent with the Codex guidelines, since it was not appropriate for the risk assessment body to also make the risk management decisions.

The representatives of the United States, Argentina and other Members indicated appreciation that the European Communities had notified these proposed measures also to the SPS Committee, and had provided additional time for Members to submit comments on the proposals.

In April 2003, the representative of the United States recalled his previous criticisms that the European Communities' biotechnology policies breached both EC laws and WTO rules. By blocking imports on an unscientific basis, the European Communities was interfering with the use of safe food products that could stem global hunger, improve nutrition and benefit the environment. The United States was of the view that the European Communities should lift its moratorium on biotech products and it was consulting with others to determine the most expeditious way to achieve this goal.

The representative of Canada echoed the concerns of the United States and urged the European Union to restart its biotechnology approval process. The representative of Australia stated that although Australia was not a major GM producer and was not directly affected by the EC moratorium, it shared many of the concerns raised by the United States and Canada with regard to the lack of science based decision-making. The representative of Argentina also shared the concerns expressed by the United States.

The representative of the European Communities informed the Committee on the state of progress on biotechnology approval, labeling and traceability (G/SPS/N/EEC/149 and 150). On 17 March 2003, the Council of Ministers adopted a common position on each of these proposals and the legislative proposals had now returned to the European Parliament for a second reading under the codecision procedure. The second reading should be concluded at the beginning of July 2003, which implied that the proposals should be adopted before the end of 2003. Once approved, the labeling and traceability proposals should make it possible for the moratorium on biotechnology approvals to be lifted since EC member States had imposed the moratorium in the absence of a clear regulation on traceability and labeling. In the interests of transparency, the European Commission could provide the common position of the Council to the SPS Committee, although this was not yet the final text. The biotechnology approval procedure envisaged in Directive 2001/18 was now operational and the EU Scientific Committee had given its opinion as to the procedure necessary to conduct a risk assessment. The opinion was available on the internet. Nineteen new or revised submissions had been received since the start of 2003 and the assessments had begun in accordance with the provisions of the Directive. The European Commission was awaiting comments from the Scientific Committee (a panel of independent scientists) on the risk assessments. The outcome of the risk assessments would of course depend on the quality and conformity of the scientific data being submitted to determine the effects of GMOs on human health and the environment. As such, the representative of the European Union was hopeful that a solution to the issues raised by the United States and other delegations would be quickly found.

The representative of Chile, referring to the Secretariat paper on Specific Trade Concerns, suggested that countries send in written comment about how their concerns had been resolved so that at the subsequent meeting comments would only be made on pending issues.

In June 2003, the representative of the United States informed Members that they and other interested parties had had consultations with the European Communities on biotechnology under the dispute settlement procedures on 19 June 2003. The consultations had not been particularly productive and the United States was now considering its next step. Canada indicated that they had participated as a third party in the US consultations, and had as well requested its own consultations with the European Communities. These consultations had been held on 25 June 2003, and Canada was also considering its next step. Argentina noted that it has also requested consultations with the European Communities, and had as well participated in the US consultations.