Freyr Solutions

 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...

 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...

 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...

  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...

  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...

  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 ...

  South Korea’s IND application process is regulated by the Ministry of Food and Drug Safety (MFDS), offering a globally aligned and streamlined pathway for initiating clinical trials. With a 30-day review window and a strong focus on safety and compliance, the South Korea IND application process helps sponsors fast-track drug development while meeting Regulatory expectations. South Korea IND Application Process: Key Phases and Requirements  Introduced in 2002, the South Korea IND application framework supports the safe and efficient development of innovative therapies. Overseen by the MFDS, it aligns with global best practices and ensures clinical trials in South Korea meet international quality and safety standards. 1. Pre-Submission Preparation  Before initiating the application, sponsors must classify the drug—new chemical entity (NCE), biologic, biosimilar, or reformulated product. All submissions follow the ICH  Common Technical Document (CTD)  format. Key...

  Sustainability is rapidly becoming a defining factor in nearly every industry, and  labeling practices worldwide  are no exception. With escalating pressure from regulators, consumers, and environmental advocates, companies are transforming their labeling strategies to meet stringent sustainability standards. The shift is not just about compliance but also represents a prime opportunity for businesses to differentiate themselves through environmental stewardship, enhanced transparency, and innovation. This blog explores how sustainability will shape the future of labeling practices on a global scale. 1. Adoption of Eco-Friendly Labeling Materials and Processes The foundation of sustainable labeling lies in the selection of environmentally friendly materials. Traditional labels often use plastics, inks, and adhesives that are harmful to ecosystems and challenging to recycle. The future, however, belongs to biodegradable, compostabl...

  The pharmaceutical industry in Canada is witnessing a paradigm shift towards digital transformation, driven by evolving Regulatory requirements and the need for efficiency and transparency. At the heart of these changes lies the management of Structured Product Labeling (SPL) and Structured Product Monograph (SPM) - two (2) pivotal electronic formats that standardize the submission, maintenance, and communication of critical drug information to Regulatory agencies such as Health Canada. To succeed in this dynamic landscape, organizations must master the art of  end-to-end SPL/SPM lifecycle management . This involves a robust process from initial content authoring through subsequent submissions, updates, and long-term maintenance. What Are SPL and SPM, and Why Do They Matter? SPL  is an XML-based format prescribed by health authorities like the FDA for submitting structured drug product information; it ensures data consistency, machine readability, an...