PFP statement on ECJ ruling on mutagenesis | 2019

Trade

December 2019

Primary Food Processors (PFP) took note of the European Court of Justice ruling in Case C-528/16 concerning mutagenesis techniques and their treatment under European GMO legislation. The organisation highlighted the need for greater legal certainty and regulatory clarity regarding products developed through modern 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 EU GMO legislation. Organisms produced through conventional mutagenesis methods with a long safety record remain exempt, although Member States may establish their own national measures.

PFP believes the ruling creates significant uncertainty by failing to clearly define the distinction between conventional mutagenesis and newer mutagenesis techniques.

The organisation noted that the Court’s decision differs from the opinion previously expressed by the Advocate General, who had concluded that products obtained through mutagenesis should not be regulated under GMO legislation.

PFP expressed concerns regarding the lack of clarity surrounding several key concepts, including the definition of conventional mutagenesis techniques, the scope of newer breeding methods and the powers available to Member States. According to the organisation, this uncertainty could lead to inconsistent implementation across the European Union.

The association warned that some Member States could potentially apply GMO requirements to crop varieties developed through mutagenesis techniques that have been used safely and legally for decades.

PFP warns that regulatory uncertainty could create compliance challenges, supply chain disruption and inconsistent implementation across Member States.

The organisation also highlighted concerns regarding imported raw materials and international competitiveness. Many countries outside the European Union do not regulate newer mutagenesis techniques as GMOs, creating a significant divergence between European and international regulatory frameworks.

According to PFP, this difference could encourage agricultural production and innovation to move outside Europe while creating additional challenges for sourcing imported raw materials needed by European food and feed industries.

PFP further argued that the ruling presents significant enforcement difficulties. Many products developed through gene editing and newer mutagenesis methods may be scientifically indistinguishable from products obtained through conventional breeding or naturally occurring genetic changes.

PFP argues that many gene edited products cannot be reliably distinguished from conventional varieties, making practical enforcement extremely difficult.

The organisation referenced scientific findings indicating that current analytical methods face major limitations in identifying products developed through certain new mutagenesis techniques.

PFP also highlighted the potential benefits of plant breeding innovation. These technologies may improve disease resistance, reduce pesticide use, strengthen drought tolerance, support climate adaptation, reduce allergenicity, improve food quality and enhance food safety through lower contamination risks.

According to the association, restricting access to these technologies could undermine innovation and reduce the competitiveness of European agriculture and food production.

PFP believes modern plant breeding techniques can support sustainability, climate resilience, food quality and long term food security.

PFP welcomed the Council decision requesting the European Commission to undertake a review of novel genomic techniques and assess whether additional legislative action may be necessary.

The organisation concluded that further clarification of EU legislation is essential to provide legal certainty, support innovation and ensure the long term competitiveness of European agri food supply chains.

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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