Considerable effort is made annually to bring new and novel ingredients to market, but the approaches needed to ensure regulatory compliance and commercial viability can be unclear which hinders development and increases costs for the sector. This manuscript considers the steps necessary to minimise any issues. Whilst there are differences in pet, aquaculture, livestock and human food product development, they all follow the same basic principles.

Market attractiveness

Suppliers may enter new markets if they see growth potential. Between 2023-2024, global feed volume changes grew most in pet food at 4.5% against dairy (3.2%), equine (2.3%) and beef (1.8%), and disease-challenged markets poultry (1.7%), swine (-0.6%) and aquaculture (-1.1%) (1). Pet food growth was attributed to premiumisation, increased pet ownership and continued product innovation (1).

Global pet food revenue is predicted at USD 162bn for 2026 with 5-6% CAGR within the coming decade (2,3). In contrast, global human functional food market revenue is predicted at USD 190bn with 3.4% CAGR (4). Despite lower volumes (about one-tenth of swine, one-fifteenth of poultry and two-thirds of aquafeed), higher margins and prospects in pet food attract suppliers serving the agricultural or human food industry, and novel ingredient producers. Caution should be applied to interpreting these figures: the three largest markets Europe, North America and Latin America saw 1.6%, 2.3% and 2.8% growth, respectively. The higher average resulted from the surge in the other markets of Asia-Pacific (11%), Africa (60.3%) and Oceania (7.4%); the Middle East saw only 0.9% growth (1). The large figures may reflect a move from feeding table scraps to commercial diets alongside a low baseline (1, 5), not lending itself for novel ingredients.

Novel ingredients and alternatives

Ingredients include human food ingredients, animal feed materials, food/feed additives, or medical ingredients. Existing ingredients may enter another market, whereas novel or innovative materials require approval regardless of market. Aside from officially listing, manufacturers must consider the target species; e.g. cocoa is listed in the official EU catalogue of feed materials (6), but toxic to dogs.

In the EU a food is ‘novel’ if “not used for human consumption to a significant degree within the Union before 15 May 1997” (7). The US applies the Generally Recognised As Safe (GRAS) framework to materials not consumed before 1958 (8), although US regulations are under review (9, 10, 11, 12). In Singapore the Novel Food Framework concerns ingredients that have not been eaten for the past 20 years by humans (13), whereas pet food is covered mainly through import (14). If substances have been consumed before, then countries may still require approval including demonstrated history of safe consumption. Novel ingredient approval focusses on safety, whereas functional foods must demonstrate efficacy and appeal to consumers to justify their introduction.

Introducing a novel ingredient risks commoditisation which can be at odds with supplying a high-quality ingredient which provides additional biological and technical benefits, such as improved gut health or lower price. For example, manufacturers of novel proteins have been attracted to the steep rise in popularity of alternative proteins (15), attributed to health benefits, animal welfare and the environment (16, 17, 18). Market research alongside limited scientific work underlines that consumers rate multiple health and wellbeing claims above sustainability, and animal welfare over reducing carbon footprint (19). Insufficient clarity, consistency and substantiation behind sustainability claims (20) results in consumer scepticism (21, 22), partly explaining this rating. Thus, novel ingredients must be more than a mere ‘alternative’ and scientifically substantiated claims must align with consumer appreciation.

Steps to take

This article describes the steps to market for a new ingredient, including relevance to target market, testing technofunctionality, and meeting the production needs of manufacturers.

Conceptualisation

For any new ingredient, there is a need to define the scope and ultimate target market(s). Trusted partners can help map out the most cost- and time-effective approach while ensuring market and regulatory appropriateness. Potential conflict between the desires of the ingredient owner, the target market requirements and the country- and market-specific regulations need to be overcome in the early development phase to ensure smooth progress. The programme of work should allow flexibility of growth and derivation of the ingredient as the requirements of the target market are identified and additional benefits recognised. At a minimum during the early phases, there is a need to understand the material, its main characteristics, and potential markets.

Network

Assessment of the concept by trusted partners in the relevant industry/industries increases confidence in valorisation, ensuring a realistic market approach alongside identifying key benefits within scope. Expert guides allows faster and more efficient progress with reduced risk of failure, ensuring studies are appropriately designed to give as much commercial and scientific information as possible.

Literature review

An initial gap analysis helps determine the work needed prior to marketing and sales of new ingredients. All available internal and external data should be critically assessed and mapped across to the various regulatory, technical and biological requirements for the target species. Ensuring the information is robust is vitally important to minimise costly additional studies later on. Gaps in the data should determine the studies required, including those that may add value to the new ingredient beyond a straightforward commodity. These data can be split into the “known knowns” e.g. prior use, and regulatory approvals, and the “known unknowns” e.g. safe limits, and benefits and impacts can be inferred but require validation.

Characterisation

The ingredient or food matrix should be analysed to confirm its applicability for the target species, including ensuring it provides the appropriate nutritional and technical composition, has no or limited antinutritional or toxicopathic components, and likely to be acceptable to regulators and consumers. Decisions follow to either proceed in the targeted market, to choose a different area, or not pursue introduction of this ingredient into that sector.

Technical pilot

At this stage appropriate pilot scale feeds can be produced that contain sufficient elements to demonstrate how the ingredient behaves within a matrix compared to a control feed. Measurements of physical properties can determine an appropriate inclusion level that does not detrimentally affect final product quality. In later development phases, including during in vivo phases of the project, more commercially relevant formulations should be produced at scale.

Safety

Any new ingredient needs to be assessed for potential toxicological effects in the target species at the expected inclusion level, or after repeated ingestion. An initial assessment of published data and / or databases should be undertaken for all components of the ingredient, and its potential for harm in a new species. For example, whilst cocoa may be (broadly) safe as an ingredient in humans (23), it is clearly toxic to a number of animals including poultry, rabbits, dogs, pigs, cattle, and horses due to the presence of theobromine (24,25). However, control of theobromine levels may allow incorporation into some animal feeds (26). Safety studies should have appropriate numbers of test subjects and groups for sufficient duration to demonstrate an effect in the target species and can include assessment of effects on reproduction, growth or health outcomes (27,28). In theory, novel ingredients could be approved in less than 2 years but often takes 3-5 years.

Relevance

To proceed from characterisation and demonstrating safety to the market, relevance must be considered e.g. demonstrating health benefits of an excellent amino acid profile bears little relevance if included in feed at a 0.1% inclusion rate. Market studies show varying levels of consumer willingness to pay for different claims, and should be considered in deciding on the topic of study (29, 30).

Nutritional trials

After establishing a safe upper limit, the ingredient needs to be tested in a feed matrix to ensure it is palatable and digestible. Initial studies can use a standard formulation to confirm palatability, whereas the end of the development process may require more complex, commercially relevant formulations. Approaches include use of sensory panels where feeds are assessed for taste, smell and visual preferences in humans (31, 32) and pets (33), including single-bowl or multiple choice assays (33, 34, 35). Use of artificial tongues in assessing palatability in foods is in its infancy but holds promise for rapid, cost-effective screening of new ingredients (36). Inclusion of taste-masking components or palatability enhancers, and of different processing can be used to improve feed intake (37, 38, 39, 40, 41).

Digestibility and bioavailability of ingredients ensures that they provide appropriate levels of nutrition. The inclusion level determined through safety assessment and a palatability trial may need to be adjusted once digestibility has been assessed. Several approaches have been developed with good agreement between the methods, including in vitro methods such as INFOGEST (42, 43, 44) and other artificial gut systems (45, 46, 47, 48, 49, 50, 51), as well as in vivo approaches including the caecectomised rooster model (52, 53, 54, 55, 56) and measurement in the target species (57, 58, 59, 60, 61). In vivo digestibility can be measured directly by comparing levels in the feed and faeces (28) or by using inert markers in diets (60). In-life phases of digestibility trials typically take a few days, but acclimation and analysis add time to the process (62). The quality and bioavailability of proteins and amino acids can be determined through the use of PDCAAS and DIAAS-like scores, comparing the proportion of amino acids in the diet and their digestibility with their daily requirements in the target species (44, 52, 63).

Functional trials

Depending on the market, some new ingredients may have additional functionalities conferring health benefits. These may be identified or promulgated during the initial gap analysis. However, these should be validated using well designed studies to support marketing and regulatory affairs. Claims can vary from improvements in overall growth or weight management, through to improved gut health, immune support, skin and coat quality, joint health, reduced disease impact and a range of other possibilities. Some studies can be conducted in parallel with specific studies e.g. a safety study can and should measure blood parameters or microbiome, both of which can be used to support specific claims. Because of the nature and complexity of some studies, duration and cost vary, ranging from several thousands to over a million Euros and take from days to years to complete. The balance between costs and product value as well as the welfare of animals used in in vivo trials need to be considered before commencing these studies.

Product applications

Part of identifying the target market includes determining the product format that best lends itself to the ingredient. Functionality and bioavailability of ingredients can be affected differently by the pH of the feed matrix, the pressure during pelleting, or heat during the retort process. The storage and distribution of final product vary depending on the industry, which may in turn affect shelf-life or stability of the ingredient. Furthermore, packaging and storage of the finished product must be considered, e.g. clear bottles stored in the fridge carry different implications to sealed bags in an ambient environment.

Regulatory and Quality

To guarantee product quality the manufacturer should consider technofunctionality, guaranteed analytical composition, as well as shelf-life and storage conditions. The ingredient must be registered and approved for use by the relevant authorities, which differ per type of material, target market and geographical area. Feed materials authorisation by the European Committee for adoption into the Catalogue of Feed Materials takes 1-2 years (6). In contrast, notification of the ingredient on the industry-managed Feed Materials Register can list an ingredient in a few days. The latter does not include a safety assessment, however, feed manufacturers must adhere to regulations applicable to safety concerns and hygiene and therefore still require safety data (64,65). For animal feed there are differences in hygiene requirements between plant-derived materials and animal by-products (64). Whether an ingredient is expected to be ingested by humans (food) or animals including pets (feed) plays a key role in the regulatory pathway to follow in supplying the market (66).

Translation

Production of primary scientific papers, technical documents, white papers and trade articles can support the marketing of any new product although some data may be technically sensitive or lend itself to being patented and these should clearly be protected. The work conducted needs to be coalesced from highly technical, scientific or regulatory language into publicly accessible language. This ensures that the correct information is available to all parties and that the messaging is appropriate. Direct marketing to the consumer for the pet and human food sectors is essential to ensure a clear understanding for the new ingredient and may use simpler metrics. In contrast, for the feed sector, these metrics are more technical and may need a balance between economic return and any substantiated claims. The economics of the ingredient need to be considered. If cost of production exceeds that of current, established ingredients and the new proposed ingredient fails to bring additional technical or biological benefits then it is unlikely to be accepted by the industry. Some of these costs can be predicted early in the development process, but careful financial management should ensure value for money.

Development of any new or existing ingredient in animal and human nutrition can be complex and requires a careful balance across multiple competing priorities. Robust data supporting any claims are essential to ensure compliance and to improve revenues. Whereas early development may require a degree of flexibility to stress test an ingredient, later studies will require a more structured approach, ensuring strict adherence to local, national and global regulatory requirements and quality metrics to ensure compliance. Marketing and sales will need to work closely with manufacturing, logistics and science teams to ensure products are ready for the consumer. This may be relatively straightforward within the same company but becomes complex once external clients are factored into the process. Careful project management and oversight is critical to maintain timelines and to reassure shareholders of a return on their investment. In the absence of oversight, ingredient development times and costs can rapidly and uncontrollably increase. Therefore, it is critical that trusted internal and external partners, able to support development and willing to supply critical thinking to the process are utilised. Although there are marked differences, complexities and options across the different target species and in the regulatory, analytical, technical and scientific requirements for ingredients, there are some broad principles that can be applied. It is hoped that this paper provides a suitable roadmap to guide the reader towards the main areas required.

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