Infant formula: Alternative protein study and regulatory roadmap

我们**与爱丽丝一起成长**。2024年春天，我们将为12个月以上的儿童推出一种以植物为基础的、不含酒精的强化成长饮料。我们是专门为免疫受损和植物性疾病的儿童制造的。联合创始人艾米的女儿艾丽斯患有多种食物过敏，这是我们的灵感所在。我们的最终目标是创造一种以植物为基础、低过敏的婴儿配方奶粉，提供一种普遍的、现成的、有营养能力的选择。它将使需要替代饮食的婴儿茁壮成长，特别是无法母乳喂养的婴儿。如果英国要提供包容性喂养选择，我们的创新至关重要。然而，目前还没有登记的低过敏性蛋白用于婴儿配方奶粉。我们的目标是成为改变世界的市场竞争者，但在有力证据支持安全有效的婴儿营养产品和支持监管授权方面，没有捷径可走。该项目是获得用于婴儿配方奶粉的替代低过敏蛋白注册所需的几个创新步骤中的第一步。这将导致进一步的创新工作，包括授权档案和临床试验，以证明适宜性和成长性的验证，然后我们才能在目标市场(英国、欧盟、美国)进行蛋白质来源授权和最终注册，以使我们的产品能够商业化。我们的项目将汇集学术界、临床、政府和行业领域的领先专家，以制定可行性研究和监管路线图，以探索适宜性、确保有效性和安全性，并将支持监管授权进入市场。作为研究的一部分，我们将找到最合适的植物性蛋白质来源。将召开一次科学讲习班，审查收集的证据和一揽子数据提案，以提供验证和公布的产出。它旨在为政府的食品/医疗保健战略提供信息，强调为婴儿提供更具包容性的营养选择。我们可发表的研究可能会成为催化剂--打开更多的研究机会，创造关于替代蛋白质、未来政府健康战略以及医疗保健、医疗专业人员和公众知识的思维转变。政府的食品战略审查建议，政策举措应该促进健康、可持续发展、饮食可获得性，并确保食品供应“提供安全、健康、负担得起的食品；无论(人们)住在哪里，也不管他们赚多少钱。”随着牛奶成为全球儿童最常见的食物过敏，以及以植物为基础的生活日益增长的趋势，需要改变以挑战和颠覆一个静止的行业和目前有限的选择。

We are **Grow with Iris**. In spring 2024 we are launching a plant-based, free from, fortified growing up drink for children aged 12 months plus. We are made specifically for immunocompromised and plant-based children. Co-founder Amy's daughter Iris lives with numerous food allergies and is our inspiration.Our ultimate goal is to create a plant-based, hypoallergenic infant formula to provide a universal, off-the-shelf, nutritionally capable option. It would enable babies needing alternative diets to thrive, especially infants unable to be breastfeed. Our innovation is vital if the UK is to deliver inclusive feeding options. However, there is currently no hypoallergenic protein registered for use in infant formula. We aim to become a world-changing, market contender, but there are no shortcuts in terms of robust evidence to support safe and efficacious infant nutrition products and the supporting regulatory authorisation.This project is the first of several innovative steps required to gain the registration of an alternative, hypoallergenic protein for use in infant formula. It would lead on to further innovative work including an authorisation dossier and clinical trial to prove validation of suitability and growth, before we could work on the protein source authorisation and eventual registration in target markets (UK, EU, US) to enable us to commercialise our products. Our project will draw together leading experts in academia, clinical, government and industry fields to produce a feasibility study and regulatory roadmap to explore suitability, ensure efficacy and safety and will support regulatory authorisation to access markets. As part of the study, we would find the most suitable plant-based source of protein. A scientific workshop will be convened to review gathered evidence and data package proposals to provide validation and the outputs published. It aims to inform government food/healthcare strategy, highlighting more inclusive nutrition options for infants. Our publishable study could become a catalyst -- opening up more research opportunities, creating a shift in thinking about alternative proteins, future government health strategies and the knowledge of healthcare, medical professionals and the public. The government food strategy review suggests policy initiatives should boost health, sustainability, accessibility of diets and secure food supply that "Delivers safe, healthy, affordable food; regardless of where (people) live or how much they earn." With cow's milk being the most common global food allergy in children and a growing trend in plant-based living, change is needed to challenge and disrupt a static industry and the current limited options.