PFP Statement on Court Ruling on mutagenesis

Trade

December 2019

Primary Food Processors (PFP) took note of the ruling of the European Court of Justice in case C-528/16 concerning mutagenesis techniques and their treatment under European GMO legislation. The organisation emphasised the need for greater legal clarity and regulatory certainty regarding the status of products developed through newer plant breeding methods.

According to the ruling, organisms obtained through newer mutagenesis techniques are considered genetically modified organisms under Directive 2001/18 and are therefore subject to the obligations of existing GMO legislation. At the same time, organisms produced through conventional mutagenesis methods with a long safety record remain exempt, although Member States may introduce their own national measures.

PFP believes the ruling creates significant legal uncertainty regarding the distinction between conventional mutagenesis techniques and newer plant breeding methods.

The organisation noted that the Court’s position differed from the opinion previously expressed by the Advocate General, who had concluded that products obtained through mutagenesis should not be subject to legislation governing genetically modified organisms.

PFP expressed concern that the ruling does not clearly define key concepts such as conventional mutagenesis techniques, newer mutagenesis methods or the precise powers available to Member States. According to the organisation, this lack of clarity creates uncertainty for operators throughout the food and feed supply chain.

The association warned that differing interpretations among Member States could lead to regulatory fragmentation and potentially affect crop varieties that have been cultivated and traded lawfully for many years.

PFP warns that legal uncertainty could create compliance challenges, regulatory fragmentation and supply chain disruption across the European Union.

PFP also highlighted concerns regarding international competitiveness. The organisation noted that several major agricultural producing regions outside the European Union do not regulate newer mutagenesis techniques in the same manner as traditional GMOs. This divergence may encourage agricultural production and innovation to move outside Europe while creating additional challenges for imports and raw material sourcing.

The association further questioned the practical enforceability of the ruling. According to PFP, many products developed through gene editing and newer mutagenesis methods may be indistinguishable from products obtained through conventional breeding or naturally occurring genetic changes.

PFP referred to scientific work conducted by the Joint Research Centre indicating that detecting products derived from certain new mutagenesis techniques presents significant technical challenges.

PFP argues that enforcement remains highly problematic because products developed through new mutagenesis techniques may be impossible to distinguish from conventional varieties.

Despite these concerns, PFP welcomed the Council’s request for the European Commission to conduct a study on the legal status of novel genomic techniques and assess whether additional legislative action may be required.

The organisation also highlighted the potential benefits of modern plant breeding innovation. These technologies may contribute to improved disease resistance, reduced pesticide use, greater drought tolerance, enhanced climate resilience, lower allergenicity, improved food quality and strengthened food safety.

PFP believes that regulatory uncertainty surrounding these technologies risks slowing innovation and reducing the competitiveness of European agriculture and food production. The organisation therefore calls for greater legal clarity and a science based framework capable of supporting innovation while maintaining high safety standards.

PFP supports further clarification of EU legislation to enable innovation, improve competitiveness and unlock the sustainability benefits of modern plant breeding technologies.

PFP members process approximately 220 million tonnes of raw materials and employ more than 120,000 people across the European Union.

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