In the EU, all products derived from biotechnology must receive approval by the EU authorities and those in the Member States (MS) before they are allowed to be used in food and feed or sold as seed. Approval implies that the products are safe and are neither harmful to human or animal health nor to the environment.
The EU animal feed sector is deficient in vegetable protein and relies on imports of soybeans to meet its protein needs. Feed exporting countries, such as Argentina, Brazil, Canada, and the United States have increasingly adopted biotechnology.
The EU regulatory procedures for approving biotech products take a significantly longer time than those in supplier countries. Differences in the speed of authorizations have led and continue to lead to situations where products are approved for commercial use outside the EU but not within the EU. These asynchronous approvals can result in trade disruption. Since the EU applies zero tolerance for the presence of unauthorized biotech products in food and feed, shipments of agricultural commodities destined for the EU may be and have been rejected if traces of such products are detected at the point of entry. Commission Regulation (EC) No 619/2011 provides for a “technical solution” on low level presence (LLP) by allowing 0.1 percent presence of EU unapproved biotech products in feed. However, this tolerance is not useful as it is too low to be commercially viable and thus deters exports to the EU. As a result, the EU animal sector is put at severe risk.
Politics and consumer misperception play a central role in the EU decision-making process. Applications for biotech product approval may not move at the Commission because the use of such a product in staple food for example is very sensitive.
The European Food Safety Authority (EFSA) risk assessment requirements are becoming more stringent because of concerns that the resultant scientific opinion will be over- scrutinized. As a result, it costs millions of dollars to submit an application to the EU.
Only two biotech crops have ever been approved for cultivation in the EU as some Member States (MS) block cultivation on spurious scientific grounds. On September 26, 2013, the European Court of Justice (ECJ) found that the European Commission had failed to forward an application, submitted by Pioneer Hi-Bred in 2001, for cultivation of GM 1507 corn in a timely manner. After not being able to reach an agreement in 2009 in the Commission’s Standing Committee, the Commission failed to put the matter to vote in the Council “without delay”. The ECJ also criticized the Commission for unnecessarily resubmitting the Pioneer application to EFSA seven times. The cultivation application under discussion has been waiting for 12 years.
On March 3, 2014, the issue was put to the General Affairs Council which gave no opinion. As pre-Lisbon rules apply, the Commission is obliged to adopt the proposal. To date, the Commission has not adopted its proposal.
The Commission has asserted that the approval of another biotech crop for cultivation necessitates the introduction of a system for MS to opt out of cultivating approved biotech crops for non-scientific reasons. EU legislation governing plant biotechnology currently allows MS to ban the cultivation of biotech crops in their territories if new scientific evidence suggests that such cultivation could be harmful to the environment, or human or animal health. Since many MS have historically used spurious science to invoke this “safeguard clause,” in 2010 the Commission proposed an amendment to the legislation that would allow MS to opt out of cultivating approved biotech crops for non-scientific reasons. This proposal failed to achieve a consensus at Council. In March 2014, the Greek Presidency of the Council tabled a compromise proposal which includes elements that both pro- and anti-biotech MS could accept. On June 12, 2014, the Environment Council reached a political agreement with almost unanimous support on the draft Directive reflecting the compromise proposal, and the political agreement was formally adopted by the Council at First Reading. The Italian Presidency is expected to begin negotiations in Second Reading with the newly elected European Parliament in early fall 2014. Discussion there may become complicated due to the strong representation of extremist parties in the new Parliament.
Thirteen Countries endorse International Statement on Low Level Presence (LLP) of Biotech Products
In September 2012, 13 countries endorsed an International Statement on Low Level Presence (LLP) as part of a joint effort to address the risk to trade arising from LLP occurrences. By endorsing the statement, all 13 countries made a commitment to continue to work collaboratively to address the overarching problem of asynchronous approvals of biotech products, while trying to mitigate the impact of LLP situations in food and feed.
Joint Statement on Plant Biotechnologies
USDA supports the safe and appropriate use of science and technology, including biotechnology, to help meet agricultural challenges and consumer needs of the 21st century. As part of a multinational effort to address trade and food security challenges arising from disparities in countries’ regulatory systems governing biotech products, the United States has endorsed the “Joint Statement on Innovative Agricultural Production Technologies, particularly Plant Biotechnologies” (published April 13, 2013).
For more information on biotechnology in the EU, see GAIN Report “EU 27 Agricultural Biotechnology Annual” of July 12, 2013.