Refined Shrimp Peptide Concentrate: Economic and Policy Implications of Novel Food Regulation and Waste Valorization in the Blue Economy

1. Introduction

Regulation (EU) 2015/2283 on novel foods has. redefined the governance of food innovation in the European Union, updating and consolidating the regulatory framework since 1997 [1]. It introduced a centralized Union list and EFSA-based safety assessment to ensure that new foods can be placed on the market guaranteeing a high level of protection for human health and consumer safety. Within this framework, marine-derived ingredients such as refined shrimp peptide concentrates from processing by-products emerge as paradigmatic cases, where regulatory compliance, technological innovation, and sustainability objectives flow together. Beyond safety, Regulation (EU) 2015/2283 explicitly acknowledges the need to support innovation and improve the functioning of the internal market by harmonizing procedures and timelines [1]. The centralized electronic application system and the option to traditionally notify food products that have already been proven safe in third countries are designed to reduce administrative burdens and accelerate access to the EU market. At the same time, the Regulation is increasingly being interpreted in light of broader EU policies, including the Farm to Fork Strategy, the Circular Economy Action Plan, the Zero Waste Initiative, and the Blue Economy Agenda, which overall promote resource-efficient and low-environmental impact food systems. [2]. Thus, novel foods become regulatory "gateways" through which sustainable technologies and value chains can be scaled up, provided they demonstrate both safety and societal benefits. Within sustainable food innovation, novel foods play a strategic role in diversifying protein sources, enhancing nutritional quality, and reducing the environmental footprint of food production. Alternative proteins from insects, algae, microorganisms, and by-products can reduce land use, water consumption, and greenhouse gas emissions compared with conventional livestock, while contributing to food and nutrition security in a context of growing global demand [3]. The valorization of seafood by-products is a particularly up-and-coming sector, since large quantities of shells, heads, and scraps are currently underutilized or treated as waste, despite their content of proteins, peptides, lipids, chitin, and bioactive compounds. [4]. Transforming these wastes into novel food ingredients aligns with circular economy principles by closing material loops, improving resource efficiency, and creating new economic opportunities along the seafood value chain. Shrimp processing illustrates these dynamics clearly: shells and heads from species such as Pandalus borealis represent a significant waste stream with associated environmental and disposal costs, but also a rich source of peptides and other bioactives [5]. Technologies such as enzymatic hydrolysis, membrane filtration, and drying can convert these by-products into refined peptide concentrates with demonstrated functional properties, including angiotensin-converting enzyme (ACE) inhibitory activity and potential benefits for blood pressure regulation. When such products are intended for use as food ingredients in the EU, they typically fall under the novel food regulation and must undergo EFSA evaluation, as exemplified by the scientific opinion on refined shrimp peptide concentrate (RSPC) [6]. This regulatory pathway not only scrutinizes their safety and nutritional suitability, but also implicitly structures their market access and integration into health-oriented, high-value applications. The present manuscript situates RSPC as a case study at the intersection of food regulation, shrimp by-product valorization, sustainable food value chain and the circular blue economy. First, it analyses how Regulation (EU) 2015/2283 and EFSA’s scientific assessment shape the development and authorization of RSPC, with particular attention to compositional criteria, toxicological evidence, and clinical data. Second, it explores how the production of RSPC operationalizes circularity by converting shrimp processing waste into a high-value ingredient, thereby contributing to waste reduction, resource efficiency, and “zero waste” strategies in the seafood sector. Third, it positions RSPC within the broader blue economy framework, examining how marine bioresource valorization can support resilient coastal value chains, green jobs, and the objectives of the EU Circular Economy and Blue Economy policies. Connecting these dimensions, the paper aims to demonstrate how the novel food framework can serve not only as a safety gatekeeper, but also as an enabling tool for sustainable innovation in marine-derived foods.

2. Materials and Methods

2.1. Shrimp By-Product Valorization: A Key Challenge for Circularity and Sustainable Seafood Systems

At the global level, the shrimp processing industry generates substantial quantities of by-products, primarily consisting of shells, heads, and exoskeletal fractions, which can account for approximately 40–60% of the total biomass depending on the species and processing methods [7]. According to the Food and Agriculture Organization (FAO), global crustacean production has exceeded 10 million tonnes annually, with shrimp representing a dominant share of aquaculture and capture fisheries. Based on these estimates, shrimp processing alone is responsible for the generation of several million tonnes of by-products each year, highlighting the scale of this underutilized resource and concerns on their food waste impact on environments [8].

Traditionally, shrimp by-products have been treated as low-value waste and are often disposed of through landfill, incineration, or, in some cases, marine discharge, generating both environmental pressures and economic costs. The World Bank estimates that global food loss and waste generates economic losses exceeding USD 900 billion annually, with seafood supply chains contributing significantly due to high perishability and processing waste fractions. Disposal costs for seafood by-products can range from 50 to 150 EUR per tonne depending on local regulations and treatment requirements, representing a direct economic burden for processing industries [9].

From an environmental perspective, shrimp processing residues are characterized by high organic load, including proteins, lipids, and minerals, with biochemical oxygen demand (BOD) values that can exceed 20,000 mg/L in untreated effluents. If not properly managed, these residues may contribute to eutrophication, oxygen depletion, and ecosystem degradation in coastal areas. Furthermore, the decomposition of organic waste generates greenhouse gas emissions, contributing to the overall environmental footprint of seafood production systems [10].

From an economic standpoint, the disposal of shrimp by-products represents not only a cost but also a loss of valuable biomass rich in functional compounds. Seafood processing by-products are estimated to account for up to 60–70% of total biomass in shellfish processing, highlighting a substantial untapped economic potential [11]. In contrast, valorization pathways can significantly increase the economic value of these materials: chitin, for example, can reach market prices of 10–20 EUR/kg depending on purity and application, while astaxanthin is among the highest-value natural carotenoids, with prices ranging from 2,000 to over 7,000 EUR/kg in nutraceutical markets.

In response to these challenges, increasing attention has been directed towards the recovery and valorization of shrimp processing side streams within a circular economy framework. Shrimp by-products are a rich source of high-value compounds, including chitin, astaxanthin, and proteins and peptides with functional and bioactive properties [12]. The global chitin and chitosan market is projected to exceed USD 20 billion by 2030, reflecting growing demand across food, pharmaceutical, agricultural, and environmental applications [13].

Technological advances in biorefinery approaches, including enzymatic hydrolysis, fermentation, and membrane separation processes, have enabled the efficient extraction and transformation of these compounds into value-added products [14]. In particular, the production of bioactive peptides through controlled hydrolysis represents a high-value valorization pathway, enabling the conversion of low-value waste into functional ingredients with potential health benefits and market applications in the nutraceutical sector.

This approach aligns with the principles of the blue economy by promoting resource efficiency, reducing environmental burdens associated with waste disposal, and supporting the development of new value chains within the seafood sector. Importantly, this transition reflects a shift from cost-center waste management practices to value-generating processes, with significant implications for economic sustainability, industrial competitiveness, and the resilience of marine-based food systems.

In this perspective, shrimp by-products should no longer be considered merely as a disposal problem, but rather as a strategic economic resource within a circular and bio-based economy.

A comparative overview of conventional disposal and valorization pathways for shrimp by-products is presented in Table 1, highlighting the transition from cost-intensive waste management practices to value-generating circular bioeconomy processes supported by recent advances in seafood by-product valorization [11,12].

3. Discussion

3.1. Safety Evidence to Support Their Use as Food for Human Consumption

Although RSPC originates from foods (i.e., shrimp) that have been consumed by humans for centuries, its safety cannot be assumed a priori because of potential differences in composition and possible alterations induced by the industrial extraction and purification processes used to obtain it from shrimp waste materials, which may alter its safety profile. On the one hand, the impact of manufacturing process variables was appropriately assessed to support its safety as a novel food. The risk of contamination by proteases used during industrial processing has been assessed, and the filtration step was properly validated to exclude the presence of impurities in the final products. On the other hand, safety was assessed through an in-depth evaluation of the composition and the nutritional and toxicological characteristics of RSPC [15]. In particular, most of the available evidence was obtained from derivatives of P. borealis (northern shrimp), which is particularly abundant in Atlantic Ocean. These consist mostly of short peptides (max. 24 aa): about 99.9% of all peptides in the final products are small peptides with a molecular weight lower than 2 kDa, which could be readily hydrolyzed to individual amino acids before systemic uptake. From a nutritional point of view, such peptide concentrate showed an amino acid profile similar to shrimp meat, suggesting that no differences in toxicity have been expected compared with products already present in the diet. This was further confirmed by acute toxicity and genotoxicity studies conducted by the sponsors: no adverse effects and/or chromosomal aberrations were observed in mouse models treated up to 2,000 mg/kg [Safety of shrimp peptide concentrate as a novel food pursuant to Regulation (EU) 2015/2283, EFSA Journal, doi: 10.2903/j.efsa.2018.5267]. Overall, the results supported the safety of the authorized maximum daily dose of 1,200 mg. Indeed, this is the dose used in clinical studies to investigate whether RSPC may help maintain healthy blood pressure levels and support cardiovascular health. This interest grounds on previous literature evidence on a specific ACE-inhibitory activity of the small peptides contained in Shrimps, particularly when peptides with high concentrations of Gly and Pro were used [16,17]. The potential effects of RSPC on blood pressure were investigated in a total of 206 subjects with mild or moderate hypertension [15,18]; evidencing a significant reduction in systolic blood pressure versus placebo over the 8-week intervention, without safety concerns. In this light, RSPC was authorized around 2017-2018 in Canada, before (2017), and in the EU, after (2018), as novel food [19].

3.2. Regulatory Framework and Market Perspectives: Current Regulatory Status in the EU and the US

Regulation (EU) 2015/2283 defined an updated authorisation framework for novel foods before placing on the market, defined as foods without a significant history of consumption in the European Union before 15 May 1997 and falling under certain categories, including ingredients of animal origin obtained through post-1997 processes that significantly modify composition or structure. Within this framework, refined marine peptide concentrates produced from shrimp processing by-products, such as enzymatically hydrolysed P. borealis shells and heads, define as novel foods because the resulting peptide fractions differ substantially from conventionally consumed shrimp and lack a documented history of consumption in the EU.

Market access is contingent upon inclusion in the Union list of authorised novel foods, following a centralised procedure whereby food business operators submit a dossier to the European Commission and then to EFSA, which conducts a risk assessment [20]. The dossier must provide detailed information on raw material sourcing, manufacturing steps (e.g., hydrolysis, purification and drying), product specifications (including peptide content and molecular weight distribution), stability, anticipated intake levels, and a comprehensive toxicological package, ideally complemented by human data. EFSA evaluates these data in line with the precautionary principle, with particular attention to potential allergenicity related to the crustacean origin, process-induced changes in composition, and the margin of safety at proposed use levels. A favourable opinion from EFSA allows the European Commission to adopt an implementing act adding the ingredient to the Union list, together with binding conditions for its use, such as authorised food categories (typically food supplements), maximum daily doses for specific population groups, and any mandatory labelling requirements, including allergen information. This structured approach not only ensures a high level of consumer health protection but also provides regulatory certainty for food operators seeking to position marine-derived peptide concentrates as high-value ingredients within a circular blue bioeconomy.

In the United States, marine peptide concentrates intended for use in dietary supplements are regulated under the Federal Food, Drug, and Cosmetic Act within the framework for dietary ingredients and new dietary ingredients (NDI) [21]. A shrimp-derived peptide concentrate is considered a dietary ingredient by virtue of its amino acid and peptide nature, but if it was not marketed in dietary supplements before 15 October 1994, it is generally classified as an NDI. In such cases, manufacturers or distributors are required to submit a pre-market NDI notification to the Food and Drug Administration at least 75 days before marketing the supplement [22]. The notification must demonstrate a “reasonable expectation of safety” under the proposed conditions of use and therefore includes data on ingredient identity, manufacturing process, specifications, anticipated intake, and toxicological evidence, which may encompass animal studies and, where available, human data. Unlike the EU novel food system, the NDI process does not culminate in a formal authorisation or admission in a technical list; instead, FDA receives the notification, can raise objections if appropriate, and retains enforcement powers if subsequent information indicates safety concerns. [1]. As a result, marine-derived peptide concentrates obtained from shrimp by-products are evaluated case-by-case, with the regulatory focus placed on safety substantiation rather than on the novelty of the process or the circularity of the raw material. Overall, the EU and US systems illustrate two distinct but convergent pre-market paradigms for marine bioactive peptides: a highly codified authorisation with explicit conditions of use in the EU, and a notification-based, risk-oriented model in the US, both of these aspects must be addressed by developers who aim to valorise shrimp by-products by transforming them into marketable and scientifically validated functional ingredients.

Table 2. Key regulatory differences specific to marine peptides.

ASPECT	EU – NOVEL FOOD (RSPC EXAMPLE)	US – NDI (SHRIMP PEPTIDE CONCENTRATE EXAMPLE)
LEGAL TRIGGER	“Novel food” if no significant EU consumption pre-1997, or new process significantly alters composition/structure, including marine peptide concentrates from by-products.	“New dietary ingredient” if not marketed in supplements before 15 October 1994, regardless of traditional food use of the source species.
PROCEDURE TYPE	Centralised authorisation: EFSA risk assessment, Commission implementing act, inclusion in Union list with binding conditions (dose, categories, labelling notes).	Pre-market notification: 75-day NDI notification to FDA, no formal authorisation act, no central positive list; FDA can object or take enforcement action.
DATA REQUIREMENTS	Full novel food dossier; detailed composition of peptide mixture (e.g., >87% peptides, size distribution), production from shrimp by-products, stability, toxicology, human trials, allergenicity.	Sufficient data to support a “reasonable expectation of safety”: identity, manufacture, specs, intake estimates, toxicology; level of detail negotiated case-by-case via NDI guidance.
OUTCOME FOR SHRIMP PEPTIDES	Explicit authorisation as a novel food ingredient in food supplements at up to 1 200 mg/day for adults, with documented margin of exposure.	Acceptance (no objection) of an NDI notification allows marketing, but conditions (e.g., dose, target population) are not codified in a harmonised list.
POLICY CONTEXT	Strongly linked to precautionary principle and to EU strategies on blue bioeconomy and circular use of marine by-products, valorising waste streams under strict pre-market control.	More risk-based and flexible; accommodates marine bioactives from by-products within the dietary supplement market, with FDA intervening mainly when safety concerns emerge.

Table 2. Key regulatory differences specific to marine peptides.

ASPECT	EU – NOVEL FOOD (RSPC EXAMPLE)	US – NDI (SHRIMP PEPTIDE CONCENTRATE EXAMPLE)
LEGAL TRIGGER	“Novel food” if no significant EU consumption pre-1997, or new process significantly alters composition/structure, including marine peptide concentrates from by-products.	“New dietary ingredient” if not marketed in supplements before 15 October 1994, regardless of traditional food use of the source species.
PROCEDURE TYPE	Centralised authorisation: EFSA risk assessment, Commission implementing act, inclusion in Union list with binding conditions (dose, categories, labelling notes).	Pre-market notification: 75-day NDI notification to FDA, no formal authorisation act, no central positive list; FDA can object or take enforcement action.
DATA REQUIREMENTS	Full novel food dossier; detailed composition of peptide mixture (e.g., >87% peptides, size distribution), production from shrimp by-products, stability, toxicology, human trials, allergenicity.	Sufficient data to support a “reasonable expectation of safety”: identity, manufacture, specs, intake estimates, toxicology; level of detail negotiated case-by-case via NDI guidance.
OUTCOME FOR SHRIMP PEPTIDES	Explicit authorisation as a novel food ingredient in food supplements at up to 1 200 mg/day for adults, with documented margin of exposure.	Acceptance (no objection) of an NDI notification allows marketing, but conditions (e.g., dose, target population) are not codified in a harmonised list.
POLICY CONTEXT	Strongly linked to precautionary principle and to EU strategies on blue bioeconomy and circular use of marine by-products, valorising waste streams under strict pre-market control.	More risk-based and flexible; accommodates marine bioactives from by-products within the dietary supplement market, with FDA intervening mainly when safety concerns emerge.

3.3. Circular and Blue Economy Dimensions

The transition towards circular economy models in the seafood sector is increasingly recognized as a strategic priority to address resource inefficiencies, environmental pressures, and economic sustainability challenges. Within this framework, waste-to-value strategies aim to transform processing side streams into high-value products, thereby closing material loops and reducing dependency on primary resources. According to FAO, the sustainable management and valorization of aquatic bioresources are central to the concept of Blue Transformation, which promotes more efficient, inclusive, and resilient aquatic food systems [10].

In the seafood sector, circular economy approaches are particularly relevant due to the high proportion of by-products generated along the food value chain. It is estimated that up to 30–50% of total fish and seafood biomass is lost or discarded during processing, representing a significant inefficiency in resource use [8]. Waste-to-value strategies, including the recovery of bioactive compounds, proteins, and biopolymers, enable the reintegration of these materials into productive systems, supporting a transition from linear to circular production models.

From an environmental perspective, the adoption of circular approaches can substantially reduce the ecological footprint of seafood production. The valorization of by-products contributes to waste reduction and improves overall resource efficiency, limiting the need for primary raw materials and reducing pressures on marine ecosystems. According to the European Commission, circular economy strategies have the potential to reduce greenhouse gas emissions in the EU by up to 450 million tonnes of CO₂ equivalent by 2030, mainly through improved resource efficiency and waste valorization [23].

In the seafood sector, reducing waste streams is particularly relevant given the high biological value of discarded materials. FAO estimates that improving utilization of fisheries and aquaculture by-products could significantly enhance resource efficiency and contribute to global food security, reducing pressure on primary production systems [8]. In addition, circular bioeconomy strategies are associated with reductions in energy use and water consumption across processing stages, particularly when integrated biorefinery approaches are applied [10].

From an economic perspective, the transition towards circular models enables the creation of new value chains and the diversification of revenue streams. The Organisation for Economic Co-operation and Development highlights that circular economy practices can generate substantial economic benefits by increasing resource productivity and reducing material costs, which in some industrial sectors can represent up to 40–60% of total production costs [24]. In seafood systems, this translates into the opportunity to convert low-value by-products into high-value compounds for food, feed, and nutraceutical applications.

The bioeconomy sector already represents a significant economic component in Europe. According to the European Commission, the EU bioeconomy employs over 17 million people (around 8% of total EU employment) and generated an estimated turnover of up to €2.7 trillion in 2023, highlighting its strategic role in supporting sustainable growth and circular innovation [25]. Within this context, marine bioresources and seafood side streams are increasingly recognized as strategic assets for the development of high-value bio-based industries.

From a social perspective, circular and blue economy strategies contribute to job creation and regional development, particularly in coastal and rural areas. The expansion of activities such as biomass recovery, processing, and biorefinery operations supports the creation of “green jobs” and enhances local economic resilience. According to the International Labour Organization, the transition to a greener economy could generate up to 24 million new jobs globally by 2030, particularly in sectors related to sustainable resource management, circular production systems, and bio-based industries [26]. Overall, the integration of circular and blue economy principles in seafood systems enables a systemic transition from waste management to resource valorization, delivering combined environmental, economic, and social benefits. This approach strengthens the sustainability and competitiveness of marine-based industries while contributing to broader policy objectives related to climate change mitigation, resource efficiency, and inclusive growth.

4. Results

4.1. Challenges and Future Directions

Despite the promising potential of marine-derived novel foods such as refined shrimp peptide concentrate (RSPC), several challenges remain influencing their large-scale adoption and integration into sustainable food systems.

One of the primary concerns relates to allergenicity and consumer safety. As RSPC is derived from crustaceans, it falls within one of the major allergen groups identified under European food law, requiring strict risk assessment and clear labeling requirements. In fact, EFSA emphasizes that allergenicity assessment remains a critical component in the authorization of novel foods, particularly when processing technologies may alter protein structures and potentially affect allergenic potential [27]. Ensuring consumer safety therefore requires not only robust toxicological and clinical evidence but also continuous post-market monitoring.

In addition to safety aspects, industrial scalability and cost-efficiency represent key challenges for the commercialization of marine bioactive compounds. While laboratory-scale processes such as enzymatic hydrolysis and membrane filtration have demonstrated high efficiency, their upscaling to industrial levels often involves significant capital investment and operational costs. According to FAO, the adoption of innovative processing technologies in fisheries and aquaculture sectors is frequently constrained by economic barriers, particularly for small and medium-sized enterprises [10]. Achieving cost-competitive production therefore requires process optimization, economies of scale, allocation of funds to help in the transition and integration within existing seafood processing infrastructures.

Consumer acceptance is another critical factor influencing the market success of marine-derived novel foods. Despite increasing interest in sustainable and functional foods, products derived from by-products or “waste” streams may face perception barriers related to food safety, quality, and cultural acceptance. The European Commission has highlighted that consumer trust and transparency are key drivers for the adoption of novel foods, particularly in the context of sustainability-oriented innovations [23]. Effective communication strategies, including clear labeling, health claims supported by scientific evidence, and education on circular economy benefits, are therefore essential to enhance consumer acceptance.

From a policy perspective, the integration of novel food innovation into circular and blue economy strategies requires coordinated regulatory and economic frameworks. While Regulation (EU) 2015/2283 provides a robust safety-based authorization system, further alignment with circular economy and bioeconomy policies is needed to fully support the valorization of marine by-products. The Organisation for Economic Co-operation and Development emphasizes that policy coherence across innovation, environmental, and economic domains is essential to enable the development of sustainable blue bioeconomy sectors [28].

Looking ahead, future developments should focus on enhancing the sustainability and economic viability of marine-derived novel foods through integrated approaches combining technological innovation, regulatory support, and market development. In particular, the implementation of techno-economic assessments and life cycle analysis will be crucial to quantify the environmental and economic performance of valorization pathways. At the same time, fostering collaboration between research institutions, industry stakeholders, and policymakers will be essential to scale up innovative solutions and ensure their successful integration into resilient and circular food systems.

Overall, addressing these challenges will be fundamental to unlocking the full potential of marine bioresources within the blue economy, enabling the transition towards more sustainable, resource-efficient, and economically viable food production models.

5. Conclusions

Refined shrimp peptide concentrate represents a concrete example of how novel food regulations, scientific safety assessments, and circular bioeconomy objectives can converge to support sustainable food innovation. By converting shrimp processing by-products into a high-value ingredient with documented functional potential, RSPC illustrates the broader shift from linear waste disposal to resource-efficient valorization within the blue economy. Its development highlights the importance of strong regulatory frameworks in safeguarding consumer safety, while enabling the responsible placing of innovative marine-derived foods on the market. In parallel, the RSPC case highlights that scientific evidence alone without regulatory clarity and transparency, industrial scalability, allergenicity management and consumer acceptance is not enough. Looking to the future, integrating techno-economic analysis, life cycle assessment, value chain assessment, and health policy coherence into the areas of food safety, sustainability, and innovation will be essential to unlock the full potential of marine by-products. From this perspective, RSPC is not only an innovative ingredient, but also a paradigmatic model of how food systems can evolve towards greater resilience, circularity, and sustainable value creation.