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Food Supplement Labeling Rules in the EU

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  Why Label Harmonization for Food and Food Supplements Matters in the EU In the European Union’s unified market—spanning 27 countries— label harmonization is not just a regulatory requirement: it’s a strategic business necessity . For food and food supplement manufacturers, standardized labelling across the EU ensures consumer protection , simplifies regulatory navigation , and enables uninterrupted cross-border trade . Despite the EU’s long-standing efforts to align food labelling rules, significant national-level discrepancies remain, making compliance a moving target for businesses operating across multiple member states. The Regulatory Foundation: What Governs EU Food and Supplement Labels? The EU has established a strong regulatory framework to ensure food safety, transparency, and fair marketing: Regulation (EU) No. 1169/2011 (INCO Regulation) Covers general food labeling requirements—such as nutrition declarations, allergen disclosures, a...
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What is an FAP (Food Additive Petition) | FDA Approval Guide

 A Food Additive Petition (FAP) is a formal request sent to the U.S. Food and Drug Administration (FDA) asking for permission to use a new food additive that isn't Generally Recognized As Safe (GRAS). This process helps make sure any new substance added to food is checked for safety before it's used by consumers. FAPs are required by the Federal Food, Drug, and Cosmetic Act (FD&C Act), Section 409.What is included in a food additive petition?A standard Food Additive Petition sent to the FDA must include:Chemical Identity and Composition – A full description of the additive’s molecular structure and makeup.Manufacturing Process – A complete explanation of how the additive is made, to ensure it's consistent and pure.Proposed Uses and Levels of Use in Food – The specific foods the additive will be used in and the maximum amount allowed.Toxicological and Safety Data – Detailed safety evaluations, including toxicology reports and how much people might be exposed to.Environm...
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EU BPR Compliance Guide for Disinfectant Products

 Household cleaning products that say they can kill bacteria, viruses, or other harmful germs, like disinfectants or antibacterial sprays, need to follow strict rules in the European Union. These products are covered by the EU Biocidal Product Regulations (BPR, Regulation (EU) No. 528/2012). This regulation makes sure that these products are safe for people, work well, and don't harm the environment.Here, we will go through the main steps needed to register these biocidal products in the EU and show how experts like Freyr can help companies handle this process smoothly.What is the BPR?The Biocidal Product Regulations (BPR) control how biocidal products can be sold in the EU. It ensures only safe, effective, and environmentally friendly products reach consumers. The regulation applies to a wide range of products used to control harmful organisms, including those found in homes, hospitals, and industrial settings.Explore More Regulatory InsightsUK BPR compliance  Know MoreBiocid...
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Red Dye 3 Ban: Global Shift to Natural Food Colors

 The global food industry is changing a lot because more people want clean-label products and governments are watching synthetic food additives more closely. A big part of this change is the U.S. Food and Drug Administration (FDA) deciding to stop using FD&C Red No. 3, also known as Erythrosine, in foods and dietary supplements. This decision affects manufacturers all over the world.At the same time, this change is making the market for natural food colors grow quickly. It’s expected to reach over $3 billion by 2030. For people who handle regulations and business leaders, the challenge is replacing the banned dyes and dealing with the many rules about ingredients, how products are labeled, and getting approvals in different countries.The reason behind the ban on Red Dye No. 3 is mainly because of health concerns. Studies on animals showed that it might be harmful, and the U.S. National Toxicology Program classified it as a possible cancer-causing substance. On January 15, 2025...
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EU/UK Cosmetic Regulation: Brand Success Strategies

  For cosmetic brands that are starting up or already active in the EU and UK, understanding the rules can be really challenging. But the brands that do really well don't just follow the rules—they use them to gain an edge over others. Here's how smart brands are succeeding by embracing compliance.Setting the Standard for Quality  Big global brands have built their reputation by being open about what's in their products and by going above and beyond what's required. They see following the rules not as something they have to do, but as a way to show they care about people's safety and do business ethically.Innovating Within the Rules  Regulations can actually help spark new ideas. For example, brands that change their formulas to avoid ingredients that are now banned, like certain microplastics or allergens, not only stay on the right side of the law but also attract customers who care about the environment and their health.Gaining Early-Mover Advantage  When new ru...
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How to Register Medicinal Products in New Zealand: Regulatory Requirements Explained

  New Zealand offers a transparent yet stringent Regulatory environment for therapeutic and medicinal products. Regulated under the Medicines Act 1981 and Medicines Regulations 1984, entry into the market requires careful navigation of Medsafe’s processes, technical documentation requirements, and pharmacovigilance expectations. This guide outlines the key steps, documentation formats, and submission pathways, for sponsors and Regulatory professionals targeting New Zealand. 1. Regulatory Oversight: Medsafe The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is the Regulatory agency responsible for evaluating the quality, safety, and efficacy of therapeutic products in New Zealand . Medsafe’s functions include: Review and approval of new medicines Regulation of changed and related products Market surveillance and pharmacovigilance Enforcement of labeling, advertising, and distribution standards 2. Product Classification Understanding product classification is es...
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Drug Registration Hong Kong: 10 Steps Regulatory Pathway

  Hong Kong’s pharmaceutical landscape is known for its rigorous and structured drug registration process, making it a vital checkpoint for global pharmaceutical companies targeting the Asia-Pacific market. The drug registration Hong Kong process is overseen by the Drug Office of the Department of Health, ensuring that only safe, effective, and high-quality medicinal products reach the public. Drug Registration Hong Kong Process: Complete Overview  To ensure a successful drug registration Hong Kong strategy, pharmaceutical sponsors must follow a sequence of regulatory steps—from submission through post-approval surveillance. Below is a detailed breakdown: 1. Submitting an Application Online  Companies must submit their applications via the  PHARMACEUTICALS REGISTRATION SYSTEM 2.0 (PRS 2.0)  in  Common Technical Document (CTD)  format. The application must include: Product details Manufacturing and GMP information Certificates of Pharmaceutical Product ...
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