Novel Food Authorisation EU – Explained

What is the EU Novel Food Authorisation?

Novel foods are foods and food ingredients that were not used for human consumption to a significant degree within the European Union before 15 May 1997. The EU Novel Food authorisation is the official approval procedure that ensures such products are assessed for safety, nutritional value, and consumer suitability before they can be placed on the market.

The legal basis is Regulation (EU) 2015/2283 of the European Parliament and of the Council, which has been in force since 1 January 2018, replacing the earlier Regulation (EC) No 258/97. The regulation applies across all EU member states and is implemented by the European Commission in cooperation with the European Food Safety Authority (EFSA).

Which Products Fall Under Novel Food?

The novel food category is broad and covers a wide range of product groups:

• New foods of plant or animal origin (e.g. chia seeds, moringa)
• Insects and insect-based products (e.g. mealworms, migratory locusts)
• Foods from new production processes (e.g. UV-treated foods, high-pressure processing)
• Nanotechnology-based foods and ingredients
• Vitamins, minerals, and other substances from new sources or produced by new processes
• Cell-cultivated foods (e.g. cultivated meat)
• Algae and microalgae and their extracts

The Authorisation Procedure at a Glance

The process for obtaining EU novel food authorisation is clearly structured and involves several key steps:

1. Application Submission

Food business operators or applicants submit a complete application to the European Commission via the central online portal. The application must include comprehensive scientific data on the safety, composition, production process, and proposed conditions of use of the product.

2. Safety Assessment by EFSA

The EFSA (European Food Safety Authority) conducts an independent scientific risk assessment. This covers aspects such as toxicity, allergenicity, nutritional value, absorption behaviour, and potential interactions. EFSA typically has nine months to deliver its opinion.

3. Decision by the European Commission

Based on the EFSA opinion, the European Commission, together with the member states, decides on the authorisation. If approved, the product is added to the Union list of authorised novel foods, which is publicly accessible.

4. Labelling Requirements

Authorised novel foods are subject to specific labelling requirements. For example, foods containing insect-derived ingredients must carry allergen warnings. All labelling must be transparent and understandable for consumers.

Simplified Procedure: Traditional Foods from Third Countries

For foods that have a documented history of safe use in a non-EU country, known as traditional foods from third countries, Regulation (EU) 2015/2283 provides for a simplified notification procedure. In these cases, it is sufficient to demonstrate at least 25 years of safe use in a country outside the EU.

Data Protection and Data Exclusivity

An important aspect of the current authorisation framework is data protection for applicants: newly submitted scientific data can be protected for a period of up to five years. During this time, no competitor may use this data in their own application without the consent of the original applicant.

Relevance for Health and Nutrition

The novel food authorisation has direct relevance for public health. It ensures that new food products pose no risk to consumers before they reach the market. At the same time, it enables innovation in the food industry that can contribute to food security, sustainability, and meeting evolving nutritional needs.

References

1. European Parliament and Council of the European Union: Regulation (EU) 2015/2283 on novel foods. Official Journal of the European Union, 2015. Available at: https://eur-lex.europa.eu
2. European Food Safety Authority (EFSA): Novel food. EFSA, Parma, Italy. Available at: https://www.efsa.europa.eu/en/topics/topic/novel-food
3. European Commission: Novel food - Food Safety. Available at: https://food.ec.europa.eu/safety/novel-food_en