Preparing a PARNUT application in the EU requires a scientifically robust dossier demonstrating that the proposed dietetic feed fulfils its intended nutritional purpose and meets the safety and efficacy requirements. A successful application combines a clear scientific justification, appropriate supporting evidence and well-defined conditions of use.
The scientific requirements for demonstrating that a feed qualifies as a PARNUT are becoming increasingly clear. To support a more harmonised approach to PARNUT applications, the European Food Safety Authority (EFSA) has published draft guidance describing the scientific information expected under Regulation (EC) No 767/2009. Once finalised, the guidance is expected to improve consistency in dossier preparation across the European Union.
This article summarises the key points of EFSA’s draft guidance and explains what information companies should include in a PARNUT application, what scientific evidence may be required and how early planning can support a successful application.
What is a PARNUT?
Feed intended for particular nutritional purposes (PARNUTs), also known as dietetic feed, forms a specific category of feed under EU legislation. It is specifically formulated to satisfy the nutritional requirements of animals whose digestion, absorption, metabolism or excretion is, or could be, temporarily or permanently impaired.
Unlike ordinary feed, a PARNUT must demonstrate that its essential nutritional characteristics are suitable for a clearly defined nutritional purpose. This scientific justification forms the basis of every application.
According to the draft EFSA guidance, applicants should demonstrate not only that the proposed feed differs from conventional feed, but also why those differences are relevant to the intended nutritional purpose.
Why has EFSA published new guidance for PARNUT applications?
The European Commission requested EFSA to prepare scientific guidance describing the information required for applications concerning feed intended for particular nutritional purposes under Regulation (EC) No 767/2009.
The objective is to harmonise dossier preparation and ensure that applicants provide sufficient scientific evidence to demonstrate that the proposed dietetic feed:
- fulfils its intended nutritional purpose
- is safe for target animals
- does not compromise consumer safety, where relevant
- does not present unacceptable environmental risks
- supports animal welfare.
Although the guidance was published as a draft for public consultation, it already provides valuable insight into the scientific evidence EC is likely to expect in future PARNUT applications. Because PARNUTs are regulated under EU feed legislation, applications are dealt with by the EC. However, if the EC considers that scientific clarification is needed, it can request EFSA to assess the dossier and provide a scientific opinion.
What information should a PARNUT application include?
A successful PARNUT dossier begins with a clearly defined proposal for the intended use entry.
The application should specify:
- the particular nutritional purpose
- the essential nutritional characteristics
- the target animal species or category
- mandatory labelling declarations
- the recommended period of use
- any additional conditions of use.
Clearly defining these elements from the outset helps ensure that the remainder of the dossier is scientifically consistent.
How should a PARNUT be characterised?
The characterisation section explains why the proposed feed qualifies as a PARNUT and how it addresses the identified nutritional need.
For a new PARNUT, applicants should describe:
- the nutritional need
- the physiological impairment
- possible underlying causes
- the relationship between the proposed nutritional characteristics and the intended nutritional purpose.
Supporting evidence may include published scientific literature, clinical signs, biomarkers, pathophysiological information and other relevant scientific data. The conditions of use should also be fully described, including the feed type, administration method, target animals and duration of feeding.
What information should be provided about the dietetic feed?
Applicants should provide a detailed description of the dietetic feed, including its qualitative and quantitative composition.
Where relevant, the dossier should also include information on:
- manufacturing
- physical characteristics
- presentation
- analytical composition.
A comparison with conventional feed is particularly valuable. Applicants should explain how the proposed dietetic feed differs from ordinary feed and demonstrate that the claimed nutritional characteristics are achieved.
What scientific evidence is needed for a PARNUT application?
The scientific assessment focuses on both safety and efficacy. The safety assessment should address the proposed essential nutritional characteristics together with the ingredients responsible for achieving them. Depending on the product, this may include evaluation of:
- target animal safety
- consumer safety for food-producing animals
- environmental safety.
Where the proposed nutritional characteristics are achieved solely through EU-listed feed materials and authorised feed additives used under their approved conditions, the need for additional safety data may be very limited. The efficacy assessment should demonstrate that the proposed nutritional characteristics genuinely fulfil the intended nutritional purpose.
In some cases, a robust scientific literature review may provide sufficient evidence. However, where the mechanism of action has not been adequately established, in vivo studies may be required.
Need support with a PARNUT application?
Preparing a successful PARNUT application requires both scientific and regulatory expertise. A well-prepared dossier demonstrates that the proposed dietetic feed fulfils its intended nutritional purpose while meeting the requirements of EU legislation and EC/EFSA’s scientific expectations. Early planning and a well-structured dossier can help reduce regulatory uncertainties and support an efficient application process.
Medfiles supports companies throughout the PARNUT application process, including product classification, regulatory strategy, scientific literature reviews, dossier preparation, labelling assessments and regulatory advice for feed intended for particular nutritional purposes.
Authors:
Mari Eskola, Ph.D. | Team leader, Regulatory Science and Reports // Senior Regulatory Affairs Expert, Food and Feed
Mari Eskola joined Medfiles in 2021 and leads the Regulatory Science and Reports Team. Since starting at Medfiles, she has been involved in a wide range of projects relating to food, feed, and cosmetics safety.
Mari has nearly 30 years of broad international expertise in the chemical and regulatory safety of food and feed, acquired across the European Union, national authorities, and industry. At Medfiles, she brings over 15 years’ experience as a regulatory food and feed risk assessor. Mari developed her risk assessment expertise working for 10 years at the European Food Safety Authority (EFSA), where she conducted regulatory risk assessments of contaminants in food and feed. She also served as Acting and Deputy Head of the EFSA Contaminants Unit. She is a food chemist specialising in analytical chemistry and obtained her PhD in food science in 2002.
In addition, Mari has extensive food and feed research and regulatory experience from several European institutes, including the European Commission Joint Research Centre (EC JRC), the European Chemicals Agency (ECHA), Teagasc in Ireland, the University of Natural Resources and Life Sciences in Austria, and the former Finnish Food Safety Authority. She has international experience in project and people management and has authored numerous scientific publications, including many EFSA scientific opinions and risk assessments.
Jenni Liljavirta, Ph.D. | Director, Food and Feed
Jenni Liljavirta is responsible for operations, internal development, and sales and business development, working closely with internal teams to ensure efficient and commercially relevant services. Jenni holds a PhD in veterinary immunology and a Master’s degree in biochemistry and brings over a decade of experience in the food, feed, and biosciences industry.
Jenni joined Medfiles in 2025 and has led the Food & Feed Unit since 2026. Before joining Medfiles, she worked in international companies leading global research projects on bioactive ingredients, including pro‑, pre‑ and postbiotics, immune health, and microbiota, gaining valuable people leadership experience while coordinating multidisciplinary and international research teams.
She has extensive experience in animal nutrition and feed, including the design and conduct of pre‑clinical and in vitro studies for animal dietary supplements and feed additives, supporting safety, efficacy, and regulatory requirements. Jenni has also built regulatory affairs expertise by producing scientific and technical materials for regulatory applications and by actively following developments in the regulatory field. Jenni has authored multiple peer‑reviewed scientific publications and is an inventor on patent applications and invention disclosures (IDNs). In addition to her professional skills Jenni is fluent in Italian and has good comprehension of French.
Source: Based on the EFSA FEEDAP draft guidance on the information needed to support applications for feed intended for particular nutritional purposes (public consultation: 18 May–13 July 2026).
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