海外食品及膳食补充剂合规服务介绍
我们深耕全球食品及膳食补充剂合规领域,聚焦多国家及地区监管政策,为食品品牌量身打造定制化合规解决方案,助力品牌高效突破海外市场合规壁垒,实现安全、合规、快速出海布局。服务覆盖东盟、欧盟、英国、美国、澳大利亚、新西兰、中国台湾、中国香港、日本、韩国、欧亚经济共同体等核心目标市场,以专业能力与丰富经验,为品牌出海保驾护航。
核心目标市场
欧盟与东盟
围绕食品配方、标签、法规咨询及部分市场产品注册提供全流程支持,帮助品牌精准匹配各区域法规要求。
澳新与美国
支持食品 / 特殊食品配料审核、包装宣称及标签审核、FDA 食品工厂注册及更新,以及膳食补充剂专项法规支持。
港澳台及其他区域
提供产品分类、配方审核、标签审核和产品注册支持,协助企业顺利拓展海外食品及膳食补充剂市场。
核心服务
- 食品原配料审核:核查原料、辅料、食品添加剂及营养强化剂使用合规性
- 标签审核及制作:按目标市场标签法规审核与优化标签内容
- 产品注册:根据目标市场要求提供注册流程协助与资料支持
- 法规咨询:提供定制化法规查询、解读及动态跟踪服务
Overseas Food & Dietary Supplement Regulatory Compliance Services
We specialize in global regulatory compliance for food and dietary supplement products, closely monitoring regulatory frameworks across multiple jurisdictions to deliver tailored compliance strategies for food brands and ingredient companies. Our services help clients efficiently overcome regulatory barriers, ensuring safe, compliant, and accelerated market entry into overseas markets.
Our service coverage includes ASEAN, the European Union, the United Kingdom, the United States, Australia, New Zealand, Taiwan, Hong Kong, Japan, South Korea, and the Eurasian Economic Union (EAEU). Leveraging strong regulatory expertise and extensive practical experience, we safeguard and support brands throughout their global expansion journey.
European Union (EU) Compliance Services
EU food safety policy is built on the principle of "from farm to fork", with legislation covering the entire food supply chain. Key regulations include the General Food Law, Food Information to Consumers Regulation, and Food Additives Regulation, all designed to protect consumer health and ensure the smooth functioning of the single market.
Core Services
Ingredient & Formulation Review
Comprehensive assessment of 100% of the product formulation, including raw materials, excipients, food additives, and nutritional ingredients. Compliance is evaluated on both qualitative and quantitative levels in accordance with EU regulations, with formal review reports and formulation optimization recommendations provided.
Label Review & Development
Verification of product labels against EU and Member State labeling requirements, or guidance on the preparation of compliant labels to reduce regulatory and advertising risks.
EU Food Regulatory Consulting
Customized regulatory interpretation, compliance consulting, and regulatory intelligence updates aligned with client-specific needs.
ASEAN
ASEAN does not operate under a unified regulatory framework for food and dietary supplements. Each Member State maintains distinct regulatory requirements, making precise regulatory alignment essential for market access.
Core Services
Product Classification & Formulation Review
Full formulation assessment with accurate ingredient classification and compliance evaluation for raw materials, excipients, and additives, supported by formal review reports and technical recommendations.
Label Review & Development
Label compliance assessment based on country-specific ASEAN labeling regulations, minimizing labeling and advertising non-compliance risks.
Product Registration Support
End-to-end assistance for food product registration across ASEAN markets, including documentation guidance, dossier review, laboratory testing coordination, application submission, and registration status tracking.
Regulatory Consulting
Tailored regulatory inquiries and compliance advisory services covering ASEAN food regulations.
Australia & New Zealand Compliance Services
Food compliance in Australia and New Zealand is governed by the Australia New Zealand Food Standards Code, which regulates ingredient use, food classification, and labeling requirements. Standards are jointly developed by Food Standards Australia New Zealand (FSANZ), and regulatory compliance is a prerequisite for market entry.
Core Services
Food / Special Food Ingredient Review
Comprehensive formulation assessment covering raw materials, excipients, additives, and nutritional ingredients, with quantitative and qualitative compliance evaluation and technical reports.
Claims & Label Review
Detailed review of labeling content and claims in accordance with Australia and New Zealand regulations, including product name, ingredient list, nutrition information panel, allergen declarations, and claims substantiation.
Australia & New Zealand Regulatory Consulting
Customized regulatory advisory services addressing market entry requirements, regulatory updates, and compliance strategies.
United States Compliance Services
The U.S. regulatory system for food and dietary supplements is well established and strictly enforced. Core legislation includes the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Food Safety Modernization Act (FSMA), and Title 21 of the Code of Federal Regulations (21 CFR), under the oversight of the U.S. Food and Drug Administration (FDA). The system emphasizes preventive controls and full supply-chain compliance.
Food Compliance Services
Ingredient & Formulation Review
In-depth evaluation of food formulations, assessing qualitative and quantitative compliance of ingredients, identifying regulatory risks, and providing mitigation solutions through comprehensive review reports.
Label Review & Development
Compliance review of food labels in accordance with U.S. labeling regulations, including Nutrition Facts panels, allergen statements, and ingredient declarations.
FDA Food Facility Registration & Renewal
Support for FDA food facility registration, DUNS number application, and biennial registration renewals.
Dietary Supplement Specialized Services
Dietary supplements in the U.S. are regulated under the Dietary Supplement Health and Education Act (DSHEA), which places primary compliance responsibility on manufacturers and distributors. Key requirements include facility registration, cGMP compliance, and New Dietary Ingredient (NDI) notifications.
Our qualified assessors deliver:
- Dietary Supplement Ingredient Review: Comprehensive compliance assessment of dietary supplement formulations, with technical review reports and formulation rationality recommendations.
- Dietary Supplement Label Review & Development: Review or preparation of FDA-compliant dietary supplement labels to mitigate enforcement risk.
- U.S. Regulatory Consulting: Customized regulatory advisory services, including hands-on compliance training, market entry assessments, and ongoing regulatory monitoring and alert services.
Hong Kong & Taiwan Compliance Services
Focusing on food and dietary supplement market access requirements in Taiwan and Hong Kong, we provide end-to-end compliance support to facilitate smooth regional market expansion.
Core Services
Product Classification
Accurate determination of regulatory product category and applicable compliance pathways.
Formulation Review
Comprehensive assessment of ingredients and formulation compliance with local regulatory requirements.
Label Review
Verification of label content against local labeling regulations to minimize non-compliance risk.
Product Registration Support
Full registration assistance to streamline approval processes and improve time-to-market efficiency.
We are committed to professionalism, efficiency, and precision. With deep regulatory expertise and extensive hands-on experience across global markets, we deliver one-stop overseas compliance solutions for food and dietary supplement brands, helping clients overcome regulatory barriers and achieve sustainable international growth.