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EMA Environmental Risk Assessment (ERA) Guideline
The European Medicines Agency (EMA) has introduced an updated Environmental Risk Assessment (ERA) Guideline, effective September 2024, reshaping how pharmaceutical companies evaluate and mitigate the environmental impacts of their products. The new framework reinforces scientific rigor, transparency, and pharmaceutical sustainability, ensuring that every human medicinal product (HMP) undergoes a systematic and evidence-based assessment of its potential ecological risks. This
EU Packaging Compliance for Supplements: France, Spain & Italy
Environmental Labeling for Dietary Supplement Packaging in Europe: What Brands Need to Know As Europe accelerates its shift toward a circular economy, environmental labeling requirements for dietary supplement packaging have become a critical compliance obligation. France, Spain, and Italy—three of the region’s largest supplement markets—have implemented distinct rules for packaging disposal instructions, creating a fragmented Regulatory landscape that challenges brands oper
China Cosmetic Regulations & CSAR Compliance Updates 2025
Navigating China’s Evolving Cosmetics Regulations: What Brands Need to Know in 2025 China’s cosmetics market is booming, presenting massive opportunities for global beauty brands. But entering this high-growth landscape requires more than an innovative formula or a trending ingredient. As the world’s second-largest beauty market , China enforces rigorous and continually evolving regulations to protect consumer safety, ensure product quality, and increase transparency. For br
Herbal Supplements in Asia: Key Regulatory Challenges
Herbal and Exotic Ingredients: Unlocking Opportunities in Asia’s Fast-Growing Dietary Supplement Market The global dietary supplement industry is expanding rapidly as consumers increasingly seek natural, plant-based wellness solutions. Herbal and exotic ingredients—such as ashwagandha, turmeric, ginseng, and gojiberries—are at the forefront of this shift. But for companies aiming to enter key Asian markets like Japan, Korea, and China , success requires not only product innov
FSMA Rule 204: FDA Food Traceability Rule Explained
Understanding FSMA Rule 204: Strengthening Food Traceability in the U.S. The FDA’s Food Traceability Rule (21 CFR Part 1, Subpart S) —implemented under Section 204(d) of the Food Safety Modernization Act (FSMA) —sets forth stringent new requirements for enhanced traceability records for certain high-risk foods. Designed to improve food safety and accelerate outbreak response, this rule mandates comprehensive visibility across the supply chain for products most prone to contam
OPSS & UK Cosmetics Compliance
OPSS: Ensuring Cosmetic Safety and Compliance in the United Kingdom In the United Kingdom, the safety and compliance of cosmetic products are overseen by the Office for Product Safety and Standards (OPSS) —the national authority responsible for regulating product safety across multiple sectors. OPSS plays a central role in ensuring that cosmetics available in the UK market meet stringent standards designed to protect consumers and maintain industry integrity. Established in 2
Plant-Based Collagen Alternatives in JKC
In recent years, the demand for plant-based alternatives has expanded beyond beauty products into the food and dietary supplement sector. A plant-based collagen alternative is an innovative ingredient designed to replicate the benefits of traditional animal-derived collagen. This trend is particularly relevant in Japan, South Korea, and China (JKC) , where consumer interest in sustainable, ethical, and health-conscious products is rapidly increasing. What Is Plant-Based Coll
What is Document Reusability in Cosmetics? Guide & Benefits
Document reusability is the practice of leveraging validated regulatory documents across multiple product notifications or submissions. Instead of recreating files from scratch for every product variant, companies reuse existing, verified documents—saving both time and resources. As cosmetic regulations become more harmonized globally, this approach is gaining importance, particularly for brands expanding across multiple regions. Common Reusable Documents Regulatory document
Japan Detergent Market: Quasi-Drug & MHLW Regulatory Guide
Market Access in Japan for Detergents: Key Regulatory Insights Why Japan? Japan is a highly regulated and quality-conscious market. Compliance with safety, labeling, and regulatory classification is crucial for both importers and local manufacturers. Detergent Classification Detergents in Japan are categorized based on function and composition: Category Regulation Examples Quasi-drugs PMD Act (Pharmaceutical and Medical Device Act) Antibacterial, deodorizing, disinfectant H
ECOCERT COSMOS: Achieve Sustainable Cosmetics Compliance
ECOCERT COSMOS Certification: A Mark of True Sustainability in Cosmetics Sustainability is now a key factor in consumer choices, especially in the cosmetics and personal care industry. More than ever, customers seek brands that actively protect the planet. One of the most credible ways to demonstrate this commitment is through ECOCERT COSMOS Certification . What Is COSMOS Certification? The COSMOS Standard is a globally recognized certification for organic and natural cosmet
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