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Novel Food
Novel Food in EU law refers to food that was not consumed to a significant degree in the EU before 15 May 1997, when the first EU novel food regulation entered into force. The category covers a wide range of products: newly developed or innovative foods, foods produced with new technologies or processes, and foods traditionally consumed outside the EU but not previously established in the European market. The Commission gives examples such as new sources of vitamin K, Antarctic krill oil, chia seeds, noni fruit juice, and UV-treated foods such as milk, bread, mushrooms and yeast.
The EU approach is based on three main principles. Novel foods must be safe for consumers, they must be properly labelled so as not to mislead consumers, and, where a novel food is intended to replace another food, it must not be nutritionally disadvantageous for the consumer. These principles are central to the EU’s regulatory model and explain why novel foods cannot simply be marketed freely without prior scrutiny.
A key feature of the system is pre-market authorisation. The Commission states that novel foods require prior approval before they can be placed on the EU market, based on an evaluation carried out in line with the safety, labelling and nutritional principles set out in the legislation. This makes novel food a strongly preventive regulatory field: the emphasis is on prior assessment before market access rather than corrective action after products are already in circulation.
The EU also highlights a number of practical tools within this framework. These include the Union list of authorised novel foods, summaries of applications and notifications, and the Novel Food Status Catalogue, which helps indicate whether particular products are considered to fall under the novel food regime. Together, these instruments provide guidance both for businesses and for authorities in determining the regulatory status of products.
Where a food business operator is uncertain whether a product qualifies as novel, the Commission explains that the operator should consult the competent authorities of the EU country where it first intends to place the product on the market. This consultation process is governed by Commission Implementing Regulation (EU) 2018/456, showing that the EU framework includes not only substantive rules on authorisation but also procedural rules on status assessment.
Our support could also point to related policy areas such as nanomaterials in food, which may raise novel regulatory questions because of their engineered properties, and to the possibility that the Commission may terminate a procedure when an update to the Union list is not justified.
Overall, the we present novel food as a field where the EU seeks to combine innovation and market openness with strict pre-market control, scientific assessment and consumer protection.
The EU approach is based on three main principles. Novel foods must be safe for consumers, they must be properly labelled so as not to mislead consumers, and, where a novel food is intended to replace another food, it must not be nutritionally disadvantageous for the consumer. These principles are central to the EU’s regulatory model and explain why novel foods cannot simply be marketed freely without prior scrutiny.
A key feature of the system is pre-market authorisation. The Commission states that novel foods require prior approval before they can be placed on the EU market, based on an evaluation carried out in line with the safety, labelling and nutritional principles set out in the legislation. This makes novel food a strongly preventive regulatory field: the emphasis is on prior assessment before market access rather than corrective action after products are already in circulation.
The EU also highlights a number of practical tools within this framework. These include the Union list of authorised novel foods, summaries of applications and notifications, and the Novel Food Status Catalogue, which helps indicate whether particular products are considered to fall under the novel food regime. Together, these instruments provide guidance both for businesses and for authorities in determining the regulatory status of products.
Where a food business operator is uncertain whether a product qualifies as novel, the Commission explains that the operator should consult the competent authorities of the EU country where it first intends to place the product on the market. This consultation process is governed by Commission Implementing Regulation (EU) 2018/456, showing that the EU framework includes not only substantive rules on authorisation but also procedural rules on status assessment.
Our support could also point to related policy areas such as nanomaterials in food, which may raise novel regulatory questions because of their engineered properties, and to the possibility that the Commission may terminate a procedure when an update to the Union list is not justified.
Overall, the we present novel food as a field where the EU seeks to combine innovation and market openness with strict pre-market control, scientific assessment and consumer protection.
