海外化妆品合规全流程服务
深耕全球化妆品合规领域，我们为美妆品牌量身打造欧盟、英国、美国、澳大利亚、东盟、中国台湾、中国香港、日本、韩国、欧亚经济共同体等多国家及地区的合规解决方案，凭借对各区域法规体系的深度解读与实操经验，提供配方合规审核、标签规范审核、安全评估报告编制、PIF 产品信息档案筹备等全链条专业服务，助力品牌突破海外市场合规壁垒，实现高效、合规出海布局。
主要市场合规服务
欧盟及英国
提供 CPNP 通报、PIF 产品信息档案筹备、CPSR 安全评估报告、标签审核及责任人合规支持，帮助品牌进入欧盟及英国市场。
美国
围绕 FDA 合规要求，提供工厂注册、产品列名、标签审核、PFAS 风险评估及相关法规支持，降低进入美国市场的申报风险。
澳大利亚与东盟
根据各地监管要求，提供分类判定、标签与广告审核、PIF 档案筹备、合规申报与资料维护等服务。
中国台湾、日本、韩国及其他区域
结合当地法规要求，为品牌提供配方与标签审核、安全评估、产品登录 / 备案资料准备及本地合规主体对接支持。
核心合规服务模块
- 配方与标签审核：确认产品配方、成分、包装标识符合目标市场法规要求
- 安全评估报告编制：按不同地区法规要求准备安全评估报告
- PIF 产品信息档案筹备：整理行政文件、工艺、质量规格与功效资料
- 合规申报与备案：支持产品通报、注册、列名及后续合规维护
One-stop Compliance Services for Overseas Cosmetics
We are deeply rooted in the global cosmetics compliance field and tailor-made compliance solutions for beauty brands across multiple countries and regions including the EU, the UK, the US, Australia, ASEAN, Taiwan of China, Hong Kong of China, Japan, South Korea, and the Eurasian Economic Union.
Leveraging our in-depth interpretation of regional regulatory systems and practical experience, we provide a full range of professional services such as formula compliance review, label specification review, safety assessment report compilation, and PIF (Product Information File) preparation. We empower brands to break through compliance barriers in overseas markets and achieve efficient and compliant overseas expansion.
EU & UK Compliance Services
The EU boasts one of the most mature and stringent cosmetics regulatory systems worldwide. Its cosmetics regulations can be traced back to 1976 and have been revised and improved over decades. The current Regulation (EC) No 1223/2009 sets clear and strict provisions on product safety, compliance declaration, responsible person system, etc.
Although the UK is no longer part of the European Economic Area (EEA) after Brexit, it still follows the core EU compliance standards and adapts to local regulatory details. We provide comprehensive compliance support for brands entering the EU and the UK, with core services including:
- CPNP (Cosmetic Products Notification Portal) declaration on the unified EU online platform prior to product launch, covering the declaration of product category, formula, special ingredients (nanomaterials, CMR substances) and other full-dimensional information.
- Professional compilation of Product Information Files (PIF) in line with regulatory requirements, including product description, production process, GMP statement, efficacy proof and other complete contents.
- Compilation of authoritative Cosmetic Product Safety Reports (CPSR), integrating all required materials such as formula sheets, raw material quality inspection reports, microbial reports and stability reports in accordance with regulatory requirements.
Meanwhile, we ensure that label marking and ingredient usage comply with the compliance requirements of all member states of the EEA (27 EU member states plus Norway, Liechtenstein and Iceland), providing full support for the smooth entry of products into the EU and UK markets.
US Compliance Services
Cosmetics regulation in the US is subject to the dual constraints of federal and state regulations. At the federal level, it is governed by the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA Act).
The enactment of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) in 2022 marked the first major update to US cosmetics regulations since 1938, adding a number of core requirements such as facility registration, product listing, fragrance allergen disclosure, and PFAS risk assessment, which has further raised the compliance standards.
Based on our precise grasp of the US cosmetics regulatory system and the latest policies, we provide one-stop FDA compliance services for brands:
- Guiding the fulfillment of the responsible person's obligations such as product safety assurance, adverse reaction reporting, and fragrance allergen disclosure.
- Full agency of FDA facility registration, including the declaration of domestic and overseas facility information, connection of US agents for overseas facilities, application for Facility Establishment Identifier (FEI), as well as the filing of registration information changes and biennial annual updates.
- Completing the full process of product listing declaration, including the submission of core materials such as ingredient lists (including fragrances and colorants) and product categories, as well as annual listing updates and filing of information changes.
We also provide value-added services such as guidance on standard testing methods for asbestos in talc-containing cosmetics, PFAS safety risk assessment, GMP implementation guidance, and compliance review of professional product label marking, ensuring that products comply with both FDA federal regulations and specific state regulatory requirements.
Australia Compliance Services
Australia adopts a classified regulatory model for beauty products, dividing them into cosmetics and therapeutic goods based on their intended use, raw materials and efficacy claims. The two categories fall under different regulatory systems with significantly different compliance requirements: ordinary cosmetics are subject to industrial chemical-related regulations, while products with specific health efficacy claims such as sun protection are classified as therapeutic goods and subject to stricter supervision by the Therapeutic Goods Administration (TGA).
We provide a full range of services for cosmetics classification compliance and declaration in Australia, with core contents including:
- Professional determination of product category attribution to avoid compliance risks caused by misclassification.
- Assisting in the commercial registration of chemicals with the Australian Industrial Chemicals Introduction Scheme (AICIS), including the application for Australian Registered Body Number (ARBN) for overseas exporters and the payment of registration fees on behalf of clients.
- Confirming the chemical introduction category based on the characteristics of the chemical ingredients contained in cosmetics and completing the compilation of compliance reports or application for assessment.
- Guiding brands to fulfill the obligations of keeping relevant records of chemical introduction for at least 5 years and submitting annual reports.
We also review product labels and advertising content to ensure compliance with the product safety and label specification requirements of the Australian Competition and Consumer Commission (ACCC). For categories that may be classified as therapeutic goods, we provide professional guidance on TGA compliance declaration to facilitate the compliant access of brands to the Australian market.
ASEAN Compliance Services
The Association of Southeast Asian Nations (ASEAN), consisting of 11 member states including Malaysia, Thailand, Vietnam and Singapore, has fully implemented the ASEAN Cosmetic Directive (ACD) since 2008, aiming to unify cosmetics regulatory standards in the region and improve product quality and safety.
Although mutual recognition of compliance among member states has not yet been achieved and products need to complete separate declarations in each country for launch, the declaration processes and core compliance requirements of all countries tend to be unified, and all adopt a post-market supervision model.
With in-depth understanding of the detailed cosmetics regulatory rules of each ASEAN country, we provide comprehensive compliance declaration services for the entire ASEAN region:
- Assisting in preparing a full set of basic materials required for national declarations, including product formulas, label drafts, GMP certificates, free sales certificates, local company business licenses, power of attorney, etc., and optimizing the materials according to the differentiated requirements of each country.
- Completing separate product declaration filings for each ASEAN country, covering the submission of core contents such as product details, ingredient lists (including the content of restricted ingredients), and manufacturer/importer information.
- Professionally compiling ASEAN-compliant Product Information Files (PIF) after the completion of declaration, including administrative documents, raw material and finished product quality specifications, production processes, stability reports, safety assessment reports, efficacy reports and other complete contents.
We also provide guidance on the update and maintenance of PIF files, empowering brands to efficiently layout the entire ASEAN market.
Taiwan of China Compliance Services
Cosmetics regulation in Taiwan of China is under the charge of the Taiwan Food and Drug Administration (TFDA) affiliated to the local health authority. In accordance with the Cosmetic Hygiene and Safety Management Act, clear provisions are set on the ingredient usage, label marking and product registration of locally manufactured and imported cosmetics.
Starting from July 2024, all cosmetics except for specific solid handcrafted soaps must complete TFDA product registration before they can be legally launched, and imported cosmetics require Taiwan local enterprises as the sole registration subject.
We provide a full range of TFDA product registration services for cosmetics entering Taiwan of China, with core support including:
- Reviewing product formula ingredients to confirm compliance with the ingredient restriction requirements in Taiwan of China and accurately defining product categories.
- Assisting in connecting with legal local registration subjects (local manufacturers, commissioned manufacturers, importers).
- Guiding the registration of TFDA official platform accounts and providing full assistance in filling in product name, specifications, basic information and other contents, as well as the compliant import of formula ingredient lists (including content).
- Completing the full process of product registration declaration to ensure that products obtain legal launch qualifications smoothly.
We also provide follow-up services such as guidance on the change of product registration information, as well as related services including safety assessment and PIF document review.
Compliance Services for Japan, South Korea, Eurasian Economic Union & Hong Kong of China
For Japan, South Korea, the Eurasian Economic Union, Hong Kong of China and other countries and regions, we provide customized compliance solutions for brands in light of local cosmetics regulatory laws and market access requirements.
The core services include formula compliance review, label specification review, safety assessment report compilation, preparation of product filing/declaration materials, and connection with local compliance subjects. Relying on professional regulatory interpretation capabilities and practical experience, we help brands break through compliance barriers in various regions and achieve precise and efficient market layout.
Core Compliance Service Modules
Formula & Label Review
We conduct a full-dimensional review of product formula ingredients to confirm compliance with the ingredient usage restrictions and content standards of the target market. We also strictly review the marking content of product labels and packaging to ensure that product names, ingredient lists, responsible person information, usage instructions, etc. comply with local label regulations.
Safety Assessment Report Compilation
In accordance with the regulatory requirements of the target market, we integrate a full set of product materials and compile authoritative and compliant cosmetics safety assessment reports, which serve as the core basis for the compliant launch of products.
Product Information File (PIF) Preparation
In accordance with regional regulatory standards, we compile complete and standardized Product Information Files (PIF), covering administrative documents, formulas, production processes, quality specifications, safety assessments, efficacy proofs and other all contents. We also provide guidance on file update and maintenance to respond to official inspections.
Compliance Declaration & Filing
We act as a full agent for the compliance declaration of products such as filing, notification, registration and listing in the target market, including material preparation, platform submission, review follow-up, etc., realizing the one-stop trusteeship of the entire declaration process.
We have a professional team deeply rooted in the global cosmetics compliance field, which continuously tracks the regulatory update dynamics of various countries and regions and has accumulated rich practical declaration experience. From the pre-review of formula compliance in the product R&D stage, to the preparation of a full set of declaration materials and compliance declaration before launch, and then to compliance maintenance such as information changes and annual report submission after launch, we provide the whole life cycle compliance support for brands, tailor-made customized solutions, and make the overseas expansion of beauty brands more worry-free, professional and efficient.
