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 one biotech crop, Monsanto’s MON 810 corn, is approved for cultivation in the EU. MON 810 corn was cultivated in Spain, Portugal, the Czech Republic and Slovakia in 2016 (latest available data) with Spain representing almost 95 percent of the total area of 136,337 hectares cultivated. MON 810 corn cultivation represented only 1.55 percent of total EU corn planted in 2016.
In March 2015, Directive (EU) 2015/412 allowed MSs to restrict or ban the cultivation of EU-authorized Genetically Engineered (GE) plants in their territories for non-scientific reasons. Nineteen MSs have opted out of GE plant cultivation for all or part of their territories.
In March 2017, three GE corn crops for cultivation received “no opinion” from the Appeal Committee (authorization of Bt 11, 1507 and renewal of MON 810). The European Commission has asserted that the “opt-out” Directive has had a positive impact on authorizations given the progress of these crops through the authorization process. However, at the time of writing, the College of Commissioners has yet to decide on these authorizations and authorization renewal.
Court of Justice of the European Union’s Judgement on Adoption of Emergency Measures
On September 13, 2017 the Court of Justice of the European Union found that MSs may not adopt emergency measures regarding GE food and feed unless it is evident that there is a serious risk to health or the environment (Case C-111/16 Giorgio Fidenato and Others). More specifically, the judgement refers to the Italian Government’s request to the European Commission to adopt emergency measures to prohibit the cultivation of MON 810 corn in light of new scientific studies carried out by two Italian research institutes. In the event, the Commission concluded that there was no new science-based evidence to support the Italian Government’s request. Despite this, the Italian Government issued a decree prohibiting the cultivation of MON 810 on Italian territory.
The existing legislation provides that the safeguard clause may be invoked by a MS if it finds new scientific evidence to suggest that cultivation of the GE crop would result in serious risk to human or animal health or the environment. Those MS that do not support biotechnology have invoked the safeguard clause using “spurious science”. The Court’s judgement reinforces the existing legal provisions.
European Commission Proposal to amend Comitology Rules
On February 14, 2017, the European Commission proposed to amend the comitology rules as provided by Regulation (EU) 182/2011. The proposal, which is subject to co-decision by Council and Parliament, aims to make MS take responsibility for decision making by:
– making only votes cast in favor or against count in Appeal Committee;
– allowing a second referral to Appeal Committee at Ministerial level;
– making public MS’ votes cast;
– allowing referral to the Council of Ministers.
Although the proposal would, in theory, apply to all areas of EU law-making, it is clearly aimed primarily at the decisions made in the sensitive biotechnology sector. If adopted, the proposal would add up to six months to the decision-making process.
Analysis suggests that the adopted proposal on its own would not significantly impact voting patterns, and the College of Commissioners would still decide on authorizations.
To date, there has been no significant movement by the legislature on the proposal. More specifically, MS do not seem enthusiastic to discuss or progress the issue.
European Commission Proposal to allow MS to “opt out” from using EU-authorized GE Plants
In April 2015, Health and Food Safety Commissioner Andriukaitis announced his review of the EU biotech authorization process, which would allow MSs to “opt out” of using EU-authorized GE plants. In October 2015, the European Parliament (EP) rejected the “opt out” for use proposal. Members of the EP both for and against increased use of biotechnology decried the proposal as unworkable and inconsistent with the EU’s single market and WTO obligations. Proponents of the technology were concerned that the proposal would lead to import bans while NGOs considered that it did not go far enough. As a result, the EP requested the European Commission to withdraw the proposal, which the Commission declined to do. After rejection by the EP, the proposal is now formally tabled with the Council, although it remains highly unlikely that MSs will vote on the proposal. Essentially, in the absence of an agreed proposal, the Commission has asserted that the unwillingness of the EP and MSs to support the proposal in effect is an acceptance of the existing rules. In response, the EP has adopted various non-binding resolutions against GE events. These resolutions have no legal impact and are more an act of political posturing by the EP.
European Commission Proposal on Environmental Risk Assessment of GE plants for Import and Cultivation
In October 2016, the European Commission proposed an amendment to Directive 2001/18/EC (“…on the deliberate release into the environment of genetically modified organisms”) regarding environmental risk assessment of GE plants. The Commission is obliged to update the Annexes to that Directive as regards the environmental risk assessment, with a view to incorporating and building upon the EFSA’s 2010 guidance on the environmental risk assessment of GE plants by April 3, 2017.
The Commission asserts that the proposal:
– reflects technical guidance that has already been implemented;
– implies no new requirements or fundamental changes;
– maintains a “case-by-case” approach.
At the end of 2017, the proposal was sent to the EP and Council for a three month scrutiny period.
New Plant Breeding Techniques (NBTs)
Currently, GE organisms regulated by the EU are primarily produced through transgenic breeding techniques, where genes are moved from one non-closely related species to another. Plant breeders around the world are increasingly using New Plant Breeding Techniques (NBTs), which refer to genome editing and modification techniques that allow the introduction of sequence-specific changes in the plant genome.
There is a longstanding debate in the EU about whether or not these techniques lead to products that are subject to the current EU GMO legislative framework (EU Directive 2001/18/EC), since an expensive and lengthy authorization procedure should be avoided for end products that contain no foreign DNA or are completely indistinguishable from conventionally bred crops. EU scientists, plant breeders, biotech and seed industry, and Member States (MS) urged the European Commission to clarify the legal status of the NBTs and their application, but the Commission was waiting for the ruling of the European Court of Justice (ECJ) on four questions that were raised by the French Supreme Court. The French Supreme Court referred four questions about innovative biotechnologies and mutagenesis to the ECJ, asking for further recommendations on whether herbicide resistant rapeseed varieties obtained by new forms of mutagenesis should be subject to the GMO approval process or not.
On January 25, 2018, the ECJ issued its judgment that organisms created through many newer genome editing techniques are to be regulated as genetically modified organisms (GMOs) in the EU. More information about the judgment can be found in the GAIN Report “EU Court Extends GMO Directive to New Plant Breeding Techniques“. The Commission is currently assessing the judgment and has not come up yet with an official statement.
- GAIN Report – 2019 EU 28 Agricultural Biotechnology Annual
- Advisory Legal Opinion Expected for New Plant Breeding Techniques
- GAIN Report – EU Court Extends GMO Directive to New Plant Breeding Techniques