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STC Number - 452
European Court of Justice Opinion 528/16 on organisms obtained by mutagenesis
United States of America
First date raised:
Dates subsequently raised:
Number of times subsequently raised:
Primary subject keyword:
Genetically modified organisms (GMOs); Risk assessment; Technical Barriers to Trade (TBT); Labelling; Traceability; Biotechnology; Human health; Food safety
Date reported as resolved:
Extracts from SPS Committee meeting summary reports
In November 2018, the United States raised its concerns about the European Court of Justice (ECJ) ruling regarding the forms of mutagenesis that qualified for the exemption contained in EU Directive 2001/18/EC on the Deliberate Release into the Environment of Genetically Modified Organisms. The United States noted that the ruling carried the effect that all products of genome editing were subject to the risk assessment and review requirements, labelling, and monitoring obligations, as well as traceability laws currently applied to products falling under the scope of Directive 2001/18/EC. The European Union was taking steps to now clarify how the Commission and the EU member States would implement this ruling. The United States was concerned that the implementation of this ruling would lead to unjustified barriers to trade in products of genome editing, as well as stifle the agricultural research and innovation necessary to prevent hunger and malnutrition in the coming decades, while ensuring environmental sustainability of agricultural activities. The United States invited the European Union to provide the scientific basis for the regulatory distinctions made across the products of mutagenesis, whereby products of random mutations induced by chemicals or radiation were exempted from any regulatory review, and products with precise mutations induced through biotechnology were subject to protracted premarket regulatory review. The United States also requested the European Union to inform the Committee of its plans to implement the ECJ ruling, particularly with respect to how it was considering risk in assessing options related to import controls, detection and traceability. Finally, the United States noted its long experience with the European Union, in the context of the EC Biotech dispute settlement proceedings, and subsequent efforts to reach compliance. The United States urged the European Union to work with other countries that were taking science-based approaches to the oversight of products of genome editing.
Argentina and Paraguay shared the concerns raised by the United States, and requested the European Union to implement the ruling in a manner consistent with the provisions of the WTO, particularly those of the SPS Agreement.
The European Union explained that the ECJ had provided important clarification on the scope of application of the EU GMO legislation (Directive 2001/18/EC) in relation to organisms obtained by mutagenesis techniques. As a consequence, the GMO legislation was applicable to organisms obtained by new mutagenesis techniques. According to the Court judgement, organisms obtained by means of techniques or methods of mutagenesis, which had conventionally been used in a number of applications and had a long safety record, were exempted. The European Commission was currently analyzing the ruling together with EU member States to ensure its proper implementation. Operators in and outside the European Union remained responsible for ensuring that products which were placed on the market were safe and complied with all relevant regulatory requirements. The European Union further explained that the ruling had not extended the scope of the legislation, but had clarified how it should be read. The current EU legislation on GMOs was based on science and had been in place since the 1990s, following which it had been updated in 2001. In the European Union's view, this regulation was consistent with the WTO Agreements, and the European Commission had no plans to propose an amendment to the current legislation in the short term.
The European Union also addressed several concerns raised in other fora regarding the distinction between these products obtained by mutagenesis techniques and other products obtained by conventional techniques. The European Union noted that different scientific bodies and experts had acknowledged that identifying the techniques used to obtain certain products could be challenging. EU member States and the Commission were currently considering the issue. In addition, the joint research centre (JRC) was addressing the issue together with the European Network of GMO laboratories to support the competent authorities of member States in this task. The European Union recalled that the question of detection of certain GM products was already posed by some processed products in which no DNA was present, e.g. GM sugar. In this respect, the legislation included the need to ensure traceability throughout the chain, even when detection at a later stage was not possible. The European Union indicated that the Commission would carefully analyze the ruling from a legal perspective, including the status of products obtained from new techniques, and reflect on further action. The European Union also addressed comments related to the difference in its approach as compared to other parts of the world. In this regard, the European Union underscored its precautionary approach to the development of environmental and safety regulations, which was enshrined in its treaties, and reflected the high importance that EU citizens attached to safe food and environmental protection. The European Union remained open to continue discussing this issue on a bilateral basis within the framework of the regular dialogue on biotechnology with its trade partners.
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