2025-02 Press Release: Wanted: High-performing EFSA for the safety assessment of specialty food ingredients

Brussels, 12^th February 2025: For the first time since its creation, and following the implementation of the Transparency Regulation[1], the European Commission is evaluating the performance of the European Food Safety Authority (EFSA).[2] This is a unique opportunity to foster a cutting-edge and safe specialty food ingredient sector that enhances the global competitiveness and excellence of the European food and beverage industry.

Specialty food ingredients (including vitamins, fibres, functional carbohydrates, additives, special proteins, and fats and salt replacers) are incorporated into foods and beverages for their nutritional and/or technological attributes. Most specialty food ingredients must undergo a premarket authorisation process including a safety assessment from EFSA, before being allowed to be used.

The importance of food innovation for EU competitiveness

The variety of specialty food ingredients is the result of continuous and substantial investment in innovation by EU manufacturers to provide nutritional and technological solutions that meet the evolving societal demands for safe, healthy, tasty, convenient, sustainable and affordable foods and beverages.

However, submitting a novel food ingredient application to EFSA has become overly complex. On average, budget and resources have doubled, and the intake phase is now taking around 7 months instead of 30 days. Moreover, the risk assessment is influenced by ever-changing factors, such as numerous inquiries about well-built applications caused by experts’ limited understanding of food technology and production, not in line with real-world settings of ingredients’ development and production, especially at a pilot scale.

EU business operators are willing to provide EFSA with the essential information required to assess the ingredient’s safety. However, they are increasingly sceptical about the value of an EU application, as they perceive it as a waste of money and effort, which deters new applications. This sentiment is exacerbated by the prevalence of generic authorisations, not easily safeguarded by patents, in a competitive global context. The speed and consistency of EFSA’s scientific evaluations are essential for maintaining the economic viability and competitiveness of the specialty food ingredients industry in the EU.

A few quick fixes to reassure EU applicants

EU Specialty Food Ingredients believes that improvements can and should be made, such as:

• Revamp the interaction between applicants and EFSA with technical hearings, direct answers to applicants’ questions and serious consideration of industry’s feedback on EFSA draft guidance documents.
• Review and simplify the operational process, including confidentiality procedures, to ensure smoothness and reasonable amount of predictability.
• Strengthen EFSA experts’ understanding of food technologies and knowledge on food legislation.
• Prioritise EFSA resources for efficient risk assessment and communications, rather than for administrative operations.

While maintaining a clear distinction between assessing and managing risks, the European Commission has now the responsibility to ensure that EFSA performs risk assessments efficiently and proportionately. Urgent measures are necessary, recognising EU applicants of specialty food ingredients as valuable partners in a competitive international environment, without risking food innovation. EU Specialty Food Ingredients will participate in the open public consultation to share these concerns and looks forward to the Commission report expected in 2026.

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For more information and figures on innovation and applications:

• Factsheet: ‘Wanted: High-performing EFSA for the safety assessment of specialty food ingredients‘
• Factsheet: ‘Wanted: Practical EFSA to assess specialty food ingredients safety in real-world settings’

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[1] In 2019, the Transparency Regulation (EU) 2019/1381 was hastily adopted without conducting any prior economic assessment of its impact on the EU Specialty Food Ingredients sector. Consequently, EFSA had to swiftly adapt all their operational procedures by March 2021.

[2] https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14068-European-Food-Safety-Authority-evaluation-of-performance-2017-2024_en