At Argenta, we partner with you to simplify regulatory complexity. With extensive experience across food chain products in the EU and beyond, we deliver practical regulatory and scientific support—from early development through approval—to help you achieve compliant and efficient market access.
From early development stages, Argenta can assess the legal status and regulatory classification of your product to determine whether registration is required and, where applicable, identify the most appropriate and efficient path to market, helping you anticipate regulatory risks and navigate an evolving legislative landscape.
We conduct detailed gap analyses to evaluate existing data against current regulatory requirements, enabling the development of structured action plans including effective allocation of time and resources to support successful regulatory submissions and approvals.
Our expert scientific teams perform thorough, compliant literature reviews to support regulatory dossiers. By identifying and critically assessing relevant scientific publications, we ensure robust evidence based support for regulatory decision making on topics such as toxicity, allergenicity, microbial safety or efficacy.
Argenta can act as your strategic point of contact with regulatory authorities, supporting pre-submission discussions or coordinating responses to authority questions. Our experience ensures clear, consistent, and effective communication throughout the regulatory process.
We also provide customised training sessions tailored to the specific needs of your team. From regulatory fundamentals to advanced specific topics, our training programmes support internal knowledge building and strengthen regulatory awareness across your organisation.
In the EU and GB, feed additives are substances intentionally added to feed or water to enhance feed quality and/or the quality of food of animal origin. Before entering the market, feed additives must successfully undergo a premarket safety and efficacy assessment via a centralised authorisation procedure.
Feed materials include products of vegetable or animal origin—whether in their natural state or derived from industrial processing—as well as organic or inorganic substances. Depending on the product, a regulatory notification may be required prior to market placement.
Feed for particular nutritional purposes (PARNUTs) may only be marketed when the intended use is listed in official legislation and the product meets the defined essential nutritional characteristics for that purpose.
Argenta supports you by confirming product status and regulatory classification and identifying the most efficient regulatory pathway to market. We guide you through required notifications and/or registrations, helping ensure compliance and smooth, timely market access.
In other key leading markets, including the United States, Argenta provides expert regulatory support across established pathways such as GRAS determinations, Animal Food Ingredient Consultations (AFIC), Scientific Review of Ingredient Submissions (SRIS), and Food Additive Petitions (FAP)—helping you select and confidently navigate the route best suited to your product.
Foods or food ingredients that were not consumed to a significant degree in the EU before 1997 are considered novel foods, such as alternative proteins ranging from plant-based protein isolates, single-cell protein & insect protein to lab-grown products developed from cultivated animal cells. These products cannot be placed on the EU or GB market without first undergoing a rigorous safety assessment to demonstrate they are safe for human consumption. Argenta supports novel food strategies from regulatory feasibility through dossier development and authority engagement.
Food enzymes, additives, and flavourings may only be marketed following a common authorisation procedure. Argenta helps you navigate the complex regulatory framework, advising on classification, data requirements, and the technical and scientific elements needed to support inclusion or amendment of substances on the Union List.
Foods intended for special groups are formulated to meet the specific nutritional needs of defined populations, including infants and young children, patients requiring medical nutrition, and individuals managing body weight. Key categories include infant and follow-on formula, processed baby foods, foods for special medical purposes (FSMPs), and total diet replacements. These products are subject to strict compositional, labelling, and safety requirements. Argenta provides regulatory support to ensure compliance and appropriate market positioning.
Food labelling and advertising must not mislead consumers. In the EU, nutrition and health claims are tightly regulated to protect consumers and ensure fair competition. Health claims may only be used if authorised by the European Commission following a scientific evaluation by EFSA. Argenta supports the development, substantiation, and authorisation of compliant health claims, helping align regulatory approval with commercial objectives.
In the United States, foods and ingredients may be regulated under different pathways depending on their intended use and composition. Products may fall under conventional foods, dietary supplements, or food additives, with routes such as Generally Recognized as Safe (GRAS) determinations, Food Additive Petitions (FAPs), or New Dietary Ingredients (NDI) as appropriate. Argenta supports clients in identifying the correct regulatory classification and pathway, developing robust scientific justifications, and engaging with regulators to facilitate compliant and efficient access to the U.S. market.
At every stage of development, Argenta partners with you to transform regulatory complexity into a strategic advantage—bringing products to market faster and more efficiently.
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