ARTICLE 28 F&A Alternative Proteins Edition April 2023 ally Recognized as Safe (GRAS) route given that sufficient data to support the safety of the ingredient is available in peer-reviewed and published literature. For this pathway, a dossier containing the relevant data on the identity and safety of the ingredient is submitted to FDA for review. If the notification is successful, FDA will issues a “no-questions” letter resulting in the listing of the ingredient and GRAS notice to the Animal Food GRAS Notices Inventory6. Once an alternative protein has been approved by the FDA for use in animal feed, it can be legally marketed and sold to farmers and other animal producers. FDA encourages applicant companies to engage in discussion with them at the early stages of dossier compilation and submission to discuss the most suitable regulatory route and relevant data requirements. It is important for companies to work with regulatory affairs consultancies for the preparation of such discussions and to ensure that their alternative protein ingredients are properly evaluated and meet FDA regulatory requirements before entering the market. The Association of American Feed Control Officials (AAFCO) in the US has voted to allow Black soldier fly (Hermetia illucens) larvae to be used in adult dog food. No other approvals for the use of insects as a source of protein in animal feeds currently exists in the US. REGULATORY AFFAIRS AND HOW IT CAN ASSIST YOUR BUSINESS Regulatory Affairs plays a crucial role in ensuring the safety and efficacy of alternative proteins used in animal feeds. The use of these alternative proteins is subject to strict regulations, which are designed to protect animal health, food safety, and the environment. Regulatory Affairs professionals are responsible for navigating these complex regulatory frameworks and ensuring that products comply with all relevant laws and guidelines. By ensuring that alternative proteins used in animal feeds meet these requirements, regulatory affairs help to safeguard the health of animals and humans, while also supporting the growth of a sustainable and ethical food system. A regulatory affairs consultancy can provide valuable support to companies involved in the production or use of alternative proteins by helping them navigate the complex regulatory landscape. Regulatory affairs consultants have expertise in the regulations governing alternative proteins in different jurisdictions, depending on where these ingredients are intended to be used. They can assist companies in developing and implementing regulatory strategies that ensure compliance with all relevant laws and guidelines. This can involve conducting regulatory assessments of alternative proteins, preparing, and submitting regulatory applications, and providing ongoing support to ensure ongoing compliance. Regulatory affairs consultants can also help companies stay up to date with the latest regulatory developments and anticipate changes that may impact their business. The return on investment (ROI) for working with a regulatory affairs consultancy to assist with alternative proteins can be significant. By ensuring compliance with all relevant regulations and guidelines, companies can avoid costly penalties, delays, or even product recalls. Regulatory compliance can also help companies establish a reputation for safety, quality, and environmental responsibility, which can be a key differentiator in the marketplace. Additionally, regulatory affairs consultants can help companies streamline their regulatory processes, which can reduce costs and improve efficiency. Finally, by staying up to date with the latest regulatory developments, companies can better anticipate changes that may impact their business and proactively adjust their strategies, thereby improving their chances for long-term success. Ultimately, by investing in regulatory affairs consultancy services, companies can protect their brand, reduce risk, and position themselves for growth and profitability in the alternative protein market. CONCLUSION It's important to understand the regulatory requirements in the EU and the US to ensure that your products are safe and comply with all laws and guidelines. Hiring a regulatory affairs consultant can be highly beneficial in navigating the complex regulatory landscape and can save your company
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