STC Number - 110

Agricultural biotechnology approval process

Maintained by: European Union
Raised by: United States of America
Supported by: Argentina; Australia; Canada; Philippines
First date raised: October 2001 G/SPS/R/25 paras. 102-105; See also STC 106
Dates subsequently raised: March 2002 (G/SPS/R/26 paras. 33-35)
June 2002 (G/SPS/R/27 paras. 56-57)
November 2002 (G/SPS/R/28 paras. 69-72)
September 2006 (WT/DS291/R, WT/DS292/R, WT/DS293/R)
June 2016 (G/SPS/R/83 paras. 4.44-4.46)
Number of times subsequently raised: 5
Relevant documents: Raised orally
Products covered: 02 Meat and edible meat offal; 03 Fish and crustaceans, molluscs and other aquatic invertebrates; 04 Dairy produce; birds' eggs; natural honey; edible products of animal origin, not elsewhere specified or included; 05 Products of animal origin, not elsewhere specified or included; 06 Live trees and other plants; bulbs, roots and the like; cut flowers and ornamental foliage; 07 Edible vegetables and certain roots and tubers; 08 Edible fruit and nuts; peel of citrus fruit or melons
Primary subject keyword: Other concerns
Keywords: Control, Inspection and Approval Procedures; Food safety; Genetically modified organisms (GMOs); Good Offices/Consultations/Dispute Settlement; Human health; Other concerns; Risk assessment; Territory protection; Transparency
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: 21/11/2006

Extracts from SPS Committee meeting summary reports

In October 2001, the United States expressed concern regarding the lack of a functioning approval process in the European Communities for agricultural biotechnology products. Since 1998, a de facto moratorium on approval of biotechnology products had been in place. The United Stated believed that under the SPS Agreement the European Communities was obligated to have a functioning approval process and decisions on pending applications should not be delayed. The United States urged the European Commission to restart the approval process as soon as possible. Canada was concerned that the European Communities was fundamentally altering the regulation of agriculture and food products to discriminate on the basis of how a product was produced rather than the product's characteristics. Canada also considered the proposed new EC regulations to be arbitrary, as they required labelling for highly refined products, such as oil that did not contain detectable DNA or protein, while not requiring similar controls on products that could present equal risk but were produced with other methods of development such as mutation breeding or mutagenesis. Moreover, the proposed regulations discriminated against products produced from genetically modified products, but not against products produced with genetically modified organisms such as cheese and wine. Canada argued that the proposed regulations were not commensurate with the risks and lacked scientific basis. Furthermore, the proposed regulations were fundamentally unworkable, as demonstrated by the one per cent threshold for the adventitious presence of GMOs.
The European Commission reaffirmed its interest and positive actions aimed at allowing the authorization procedures to continue. The recent meeting of the European Environment Council had started a very important discussion on proposals presented by the Commission to restart the authorization procedure.

In March 2002, the United States reported that no progress had been made on the EC approval system despite statements by various Commission officials. The de facto moratorium had resulted in the loss of over $200 million per year in US agricultural exports. New information given by Commission officials in February 2002 that the approval process would be restarted later in 2002 was welcome. Frustration in US commercial and political circles continued to increase. While the United States welcomed the establishment of the European Food Safety Authority, this did not address the fundamental problem of individual EC member States holding the approval process hostage to political concerns, with disregard for science and sound regulatory decision-making. Canada supported the US comments and noted that the March 1998 EC moratorium represented a de facto ban on a wide range of products. As such it violated not just the SPS Agreement, but also Article XI of the GATT. Argentina echoed the concerns expressed by the United States and Canada.
The European Communities noted the absence of procedures at the international level for approval of these types of products. The European Communities was following closely the work of the Codex ad hoc Taskforce on Biotechnology. Considerable efforts had been made to put together a consistent body of legislation to set up an authorization procedure for products resulting from biotechnology, with the aim of giving the producer legal certainty and transparency. The newly established EC Food Safety Authority was responsible for risk assessment and risk communication, but further time was needed to complete work by the European Parliament and the member States.
In June 2002, the United States indicated their frustration with the situation and noted that it was considering what steps to pursue. Canada observed that the EC moratorium essentially operated as a ban on imports of certain products for over four years, without any scientific basis. The moratorium resulted in trade disruptions and discrimination based on production methods without regard to the assessment of risks. Canada considered the EC moratorium to be inconsistent with the SPS Agreement and the GATT, and requested the European Communities to put in place a science-based approval process, as well as to consider alternative measures. The European Communities replied that the matter was following political procedures as previously described. At this time, the European Parliament was considering the matter, and the Council of Ministers should examine the documents in the coming months. Internal procedures had to be followed to apply the proposed Directive.

In November 2002, the United States stated that the EC moratorium had resulted in approximately 1 billion dollars loss of US exports to the European Communities. Even senior European Commission officials had publicly stated that the moratorium was illegal. The United States indicated that despite the recent adoption of EC Directive 01/18, the moratorium remained in place and trade continued to be blocked. The United States was of the view that the Commission had the authority and the power to act in the face of this illegal moratorium and it had chosen not to do so. The Commission's failure to take action on this issue was a matter of growing concern to the United States. Canada shared the concerns expressed by the United States and regretted the inability of the European authorities to take steps to ensure that EC member States met their SPS obligations. Canada called upon the European Communities to lift the moratorium as soon as possible.
Australia supported the views expressed by the United States and Canada about the lack of scientific basis for the EC moratorium. Australia was also concerned about the EC related proposals on genetically modified food and feed, and the traceability and labelling of genetically modified organisms (GMOs). Australia requested further information as to whether the European Communities had conducted a science-based risk assessment for its traceability regulations or based its measure on an international standard. The European Communities had confirmed in their previous responses that the research undertaken had confirmed that those GM foods and GM plants and derived products so far developed and marketed following usual risk assessment procedures had not shown any new risk to human health or the environment, beyond the usual uncertainties of conventional plant breeding, or risks that were likely to put in danger the chosen level of health or environmental protection in the European Communities. Given this explanation, Australia requested further clarification as to how, in the absence of an identifiable risk to human health, the proposed traceability system met SPS requirements.
The Philippines shared the concerns expressed by the United States and reiterated his country's position regarding traceability of GMOs. The Philippines noted that the European Communities had failed to demonstrate any scientific evidence that GMOs were not as safe as their conventional counterparts, and that there were not less trade restrictive measures available to manage the risk.
The European Communities noted that the Commission and the EC member States remained determined to put in place a regulatory framework to allow GMO and GM products to be marketed freely within the European Communities and noted that the progress had been made in that respect. The European Communities requested patience and understanding on this very sensitive dossier which was being dealt with at the highest level within the European Communities.

In June 2016, the United States shared its ongoing concerns with the delays in the European Union to approve products of biotechnology, hindering the ability of producers to bring new products to the market. As an example, the United States mentioned three soybean products that had been approved by the EU scientific body in June and July 2015, but were still awaiting the final approval by the Commission. The three applications for soybean products had been reviewed by member States in January 2016 and awaited action by the Commission. The United States expressed concern that their adoption by the Commission would be kept on hold until action was taken by the European Union to reauthorize glyphosate. The United States urged the European Union to approve these biotech products in a timely manner, regardless of unrelated matters, in order to comply with their obligations under the SPS Agreement.
Canada shared the concern expressed by the United States with undue delays in EU authorizations of the commercialization of biotech products. Canada urged the European Union to rectify the situation and adopt the authorizations in a timelier manner. As an illustration of the delays, Canada stated that the average authorization by the European Union for a biotech product took over six years, and that the college of commissioners took on average three and a half months after the vote in the appeal committee to make a decision on a biotech product. Canada expressed regret that such unjustified delays had recently impeded Canadian producers from commercializing certain soybean products from the 2016 season to the European Union.
The European Union responded that applications for GMOs approvals continued to be duly processed in line with the current EU legal framework and that as of 2015, 19 food and feed authorizations had been adopted. With regards to the three pending soybean applications, their authorization process by the Commission was in its final stages.