--- title: "\"Blue Hat\" Certificate: 3 Options for Selling Health Food in China" date: 2025-02-19T09:50:15Z modified: 2025-10-29T07:16:24Z permalink: "https://www.tmogroup.asia/insights/china-blue-hat-certification/" type: post status: publish excerpt: "" wpid: 88851 categories: - China eCommerce - Cross-border eCommerce - Health & Beauty tags: - China eCommerce - Cross-border eCommerce - Health & Beauty - Health supplements featured_image: "https://www.tmogroup.asia/wp-content/uploads/2025/02/china-health-food-blue-hat-certification.png" author: TMO Group timestamp: 2025-10-29T07:16:24Z --- China’s _Health Food\*_ market is one of the largest and fastest-growing in the world, driven by an increasing focus on wellness, aging population concerns, and rising disposable incomes. However, for foreign brands looking to enter this lucrative space, the regulatory landscape can be a significant barrier. > TMO has over 7 years of experience offering [Health and Beauty-tailored strategies](https://www.tmogroup.asia/solutions/health-beauty-ecommerce/) for China entry and eCommerce growth. At the heart of this challenge lies **China’s ‘Blue Hat’ certification, the strict regulatory approval required for selling health food products through traditional trade channels.** The State Administration for Market Regulation (SAMR) enforces rigorous testing and certification processes to ensure product safety and efficacy, which can take years and carry significant costs for each product registered. For brands that want to enter China **quickly and cost-effectively**, there is a **workaround—Cross-border eCommerce (CBEC)**. Through CBEC sales channels such as WeChat, Branded eCommerce, and Multi-vendor Marketplaces, international brands can sell directly to Chinese consumers **without needing ‘Blue Hat’ certification**. This approach significantly reduces the time-to-market and regulatory hurdles, allowing brands to test demand before making deeper commitments. > We previously discussed the main [Entry Models and Sales Channels for Foreign Supplement Brands in China](https://www.tmogroup.asia/wp-content/uploads/wp-mfa-exports/post/entering-chinas-market-for-foreign-health-supplements.md). This article will explore the 3 main regulatory paths for sales of health food products, the limitations of each approach, and strategic recommendations for brands evaluating their China entry strategy. By the end, you’ll have a clear understanding of whether CBEC or full registration is the right path for your health food business in China. > _\*The term "Health Food" (健康食品, jiànkāng shípǐn) refers to products that promote overall health and offer specific nutritional benefits. Examples of product classification in other regions include "Dietary Supplements" for US, "Food Supplements" in EU, and "Food with Health Claims (FHC)" in Japan._ ## **1. The "Blue Hat**" Label: Selling **Supplements with Regulatory Approval** ![](https://www.tmogroup.asia/wp-content/uploads/2017/11/ecommerce-nutrition-product-china-tmo-blue-hat-sign-registration.jpeg) _China's "_Blue Hat" logo for Approved Health Food products According to the **State Administration for Market Regulation (SAMR)**, each Health Food product**—**a special category of food emphasizing functional or nutritional value, with dosage instructions, and suitable or unsuitable population groups**—**must undergo individual registration as per the Food Safety Law of the People’s Republic of China, and the specific procedure will depend on two product categories: > **Recent Development: [(2025) China to Revise Policy for Imported Food Manufacturers](https://www.tmogroup.asia/wp-content/uploads/wp-mfa-exports/post/china-revise-food-import-regulations.md)** #### a) **SAMR Registration ("Big Blue Hat") for Functional Foods** - Mandatory for **products** with one of the 24 claims listed in the Directory of Health Functions Available to be Claimed by Health Food, such as boosting immunity, aiding digestion, or improving sleep quality. - Applicable to products whose active ingredients are out of the scope of the Health Food Raw Material Catalogue (including 87 materials as well as prohibited ones), or products being imported to China for the first time. - Involves **clinical trials in China, extensive safety evaluations, and efficacy testing**, making it a **time-consuming (2-3 years) and costly** pathway. Once approved, products receive a **Blue Hat certification number** that is valid for 5 years, allowing them to be sold in traditional retail and eCommerce channels with approved health claims. #### b) SAMR Filing ("Small Hat") for Nutritional/Dietary Supplements - Applicable to Vitamin and Mineral supplements, including those being imported to China for the first time; and other general dietary supplements that do not have active ingredients nor provide energy. - Unlike the full registration, this streamlined process **typically takes 6-12 months**, requires **less stringent testing**, is **more affordable**, and doesn't require renewal. However, brands cannot make explicit functional claims beyond general nutritional benefits. In addition, there are **other requirements for Health Food products**, independent of the certification method: - Only products that have been sold for at least on year in the country of production are eligible for registration/filing. - Must comply with China's National "GB Standards" for labelling and use of substances. - Brands should further ensure they **abide by the country's Advertising Law**, which prohibits certain claims like guaranteeing the efficacy of a product. - Overseas manufacturers shall register their premises with China's General Administration of Customs (GACC). > TMO's **[China Digital Compliance Services](https://www.tmogroup.asia/services/digital-compliance/)** ensure your eCommerce operation in China is fully compliant with the latest regulations according to your industry and business model. ## **2. Cross-border eCommerce (CBEC): A Workaround to the Blue Hat Policy** Contrary to the General Trade model, [**Cross-border eCommerce** in China](https://www.tmogroup.asia/solutions/china-market-entry/) has proven to be an excellent way for international brands to quickly and cost-effectively establish a presence, test market demand, and build consumer trust in Mainland China. While it has certain limitations on the permitted sales channels, it is the **preferred operational model for most foreign health supplement brands since it bypasses the need for "Blue Hat" certification**, allowing for the sales of products as "General Food", legally and directly reaching Chinese consumers. - **No ‘Blue Hat’ Registration Required** – Avoids the lengthy and costly approval process. - **Faster Market Entry** – Products can be sold immediately once listed on CBEC platforms. - **Foreign Labeling Permitted** – No need for localized packaging and compliance with China’s domestic food labeling laws. - **Lower Initial Investment** – Reduces regulatory, testing, and administrative costs. - **Access to Premium Consumer Market** – Many Chinese consumers actively seek imported health food products due to perceived higher quality. #### **Selling Health Supplements as General Food via CBEC** One of the most significant advantages of CBEC is its ability to **bypass China’s strict ‘Blue Hat’ regulations** by categorizing cross-border purchases as **personal-use imports** rather than traditional retail transactions. This distinction means that products sold via CBEC: - **Do Not Require SAMR Approval** – Unlike domestic sales, cross-border products do not have to undergo local safety and efficacy testing. - **Are Exempt from Local Labeling and Packaging Rules** – CBEC sellers can maintain their original international branding and formulations. - **Operate Under China’s ‘Positive List’** – As long as products fall within the [CBEC ‘Positive List’ of approved imports](https://www.tmogroup.asia/china-positive-list/), they can be legally sold without additional approvals. - **Avoid the Need for a Local Entity** – Unlike traditional market entry, brands can sell via CBEC without setting up a business entity in China. #### 5 **Steps to Selling Health Food in China via CBEC** 1. **Confirm Product Eligibility** – Ensure the product is listed in China’s **CBEC ‘Positive List’**, which determines what can be sold via cross-border channels. 2. **Choose a CBEC Sales Model** – Select between [**direct shipping** from overseas or the **bonded warehouse model**](https://www.tmogroup.asia/wp-content/uploads/wp-mfa-exports/post/cross-border-ecommerce-logistics-in-china-bonded-zone-or-direct-shipping.md), which offers faster delivery. 3. [Determine your Sales Channels](https://www.tmogroup.asia/wp-content/uploads/wp-mfa-exports/post/entering-chinas-market-for-foreign-health-supplements.md) – Leverage WeChat, Branded eCommerce, and Marketplaces to expand your reach. 4. **Work with Logistics and Payment Providers** – Partner with CBEC-compliant **warehouses, fulfillment centers, and payment solutions** such as Alipay or WeChat Pay. 5. **Develop a Marketing Strategy** – Leverage **Key Opinion Leaders (KOLs), influencer marketing, and [Social Commerce](https://www.tmogroup.asia/solutions/social-commerce/)** to promote the product to Chinese consumers. #### Challenges and Limitations of CBEC While **Cross-border eCommerce (CBEC)** offers a shortcut into China’s health food market, it comes with certain **restrictions and risks** that brands should be aware of: - **No Specific Function Claims:** Products sold via CBEC cannot claim to **cure, prevent, or improve specific health conditions** unless they have a **Blue Hat** certification. **Marketing must be cautious**—brands can only mention **general nutrition benefits** (e.g., "Supports overall wellness" vs. "Boosts immune function"). This limitation affects **branding, positioning**, and **consumer trust**. Without the ability to make specific health claims, it can be difficult for products to stand out in a crowded health-focused market. - **Restrictions on Purchase Volume:** CBEC products are considered **personal-use imports**, meaning consumers can only buy a limited quantity per transaction. This **caps potential sales volume** compared to products with full registration, which can be sold in larger quantities through a wider range of channels. - **Limited Retail Expansion:** CBEC products cannot be sold in **physical stores** or general online marketplaces like **Tmall Domestic** and **JD.com Main**. Brands relying solely on CBEC miss out on major **distribution channels**, including **supermarkets** and **pharmacies**, which are critical for scaling in the Chinese market. - **Competitive & Costly Marketplaces:** The heavy reliance on CBEC platforms means intense competition with **established international and domestic brands**. **Marketing costs** (ads, KOLs, live streaming, etc.) on platforms like **[Tmall Global](https://www.tmogroup.asia/wp-content/uploads/wp-mfa-exports/post/tmall-global.md)** and **[JD Worldwid](https://www.tmogroup.asia/wp-content/uploads/wp-mfa-exports/post/how-to-sell-using-jd-com.md)[e](https://www.tmogroup.asia/wp-content/uploads/wp-mfa-exports/post/how-to-sell-using-jd-com.md)** can be high, which makes it difficult for new or smaller brands to break through without substantial budgets. - **Potential Future Policy Risks:** China has tightened **CBEC regulations** in the past, and **future regulatory changes** could further restrict CBEC as a long-term strategy. Brands should have a **backup plan** for transitioning into **general trade** or exploring **Blue Hat certification** in case CBEC becomes more restrictive. > You may also like: [China Health & Food Supplements Industry Report](https://www.tmogroup.asia/downloads/china-health-supplements-industry-report/) ## **3. CBEC vs. Blue Hat Certificate: Which Is Right for Your Brand?** When evaluating whether to pursue **Cross-border eCommerce (CBEC)** or undergo the **‘Blue Hat’ registration** process, health food brands must carefully assess their **goals, timelines, and resources**. | Aspect | **CBEC** | **‘Blue Hat’ Registration** | | --- | --- | --- | | **Regulatory Approval** | No local SAMR approval required | Full SAMR approval required (2-3 years) | | **Product Testing** | No local safety/efficacy testing | Clinical trials and efficacy testing required | | **Time to Market** | Products can be sold immediately | Can take 2-3 years to gain approval | | **Cost** | Lower initial investment | High costs (testing, trials, admin fees) | | **Sales Channels** | Only CBEC platforms (e.g., Tmall Global) | Traditional retail + eCommerce channels | | **Marketing Restrictions** | No restrictions on health claims | Must follow strict health claim guidelines | | **Product Labeling** | Foreign labeling permitted | Must comply with domestic regulations | | **Market Entry Speed** | Fast (months) | Slow (2-3 years) | | **Risk** | Lower risk of non-compliance | Higher risk of rejection or delays | While **Cross-border eCommerce (CBEC)** is a useful shortcut for entering China’s health food market, it may not be the right fit for all brands, especially those with long-term growth goals or specific marketing strategies. > Read how [TMO has successfully helped many well-known healthcare brands](https://www.tmogroup.asia/work/) enter the Chinese market. #### When Aiming for Large-Scale Offline Retail and Pharmacy Sales... - **‘Blue Hat’ certification** is crucial for brands that want to expand into **physical retail stores** or **pharmacies** in China. Without this certification, products are limited to online CBEC platforms, and brands miss out on the vast market of **brick-and-mortar** stores where health food products are commonly sold. - Offline channels offer a larger customer base, especially among consumers who prefer to purchase health products in-store, where they can seek advice or physically inspect products. #### If the Brand Wants Long-Term Local Presence and Full Regulatory Approval... - **‘Blue Hat’ registration** ensures that products are fully approved by China’s **SAMR** (State Administration for Market Regulation), which provides regulatory security for long-term market operations. - This certification allows brands to establish a **strong local presence** and gain consumer trust, as Chinese consumers tend to be more confident in products that are fully certified by regulatory bodies. Over time, this boosts **brand credibility** and positions the product as a **premium, trustworthy option**. #### When Functional Claims and Strong Branding Credibility might be Critical for Market Success... - If your health food product makes specific **functional claims** (e.g., "Boosts immune function" or "Supports heart health"), **‘Blue Hat’ certification** is a necessity. - For many consumers, the **ability to make health-related claims** is a major driver of purchasing decisions. Without **Blue Hat certification**, your product cannot legally claim to treat, prevent, or improve specific health conditions, which could limit its appeal, especially in a competitive market. - Additionally, products with **‘Blue Hat’ certification** carry more weight in the marketplace, offering stronger **branding credibility** and enabling **more effective marketing** through health claims and endorsements. ## 4. Building a Winning CBEC Health & Beauty Strategy with TMO When it comes to entering China’s health food market, there’s no one-size-fits-all solution. Your decision to pursue **Cross-border eCommerce (CBEC)** or **"Blue Hat**" **registration** depends on your **business priorities** and **long-term goals**. - If Speed-to-Market and Low Regulatory Barriers are the Priority, CBEC is the Best Choice - If Full-Scale China Market Entry is the Goal, Investing in ‘Blue Hat’ Registration Makes Sense A smart strategy for many health food brands is to start with **CBEC** to test product demand and market reception without significant upfront costs. Once you’ve gained traction and have a better understanding of consumer preferences, you can then make the decision to pursue **Blue Hat registration** if necessary to scale further and take advantage of the full range of benefits that come with regulatory approval. #### Consult with China eCommerce and Regulatory Experts for a Tailored Strategy Entering China’s market can be complex, especially for health food products. If you are looking for an eCommerce Agency to support you in taking your project from 0 to 1, **TMO has vas experience in helping global brands implement a successful entry strategy for Health Products**. [Reach out to us](https://www.tmogroup.asia/contact/) to discuss how we can support your China Entry project with: - Market Scan - Digital Compliance - Product Feasibility check, pre-filing, and other applications - Go-to-market and entry strategy design - eCommerce Web and Mini-program development. - Social Commerce - Digital Marketing Execution ## Topics **Categories:** [China eCommerce](https://www.tmogroup.asia/wp-content/uploads/wp-mfa-exports/taxonomy/category/blog-china-e-commerce.md), [Cross-border eCommerce](https://www.tmogroup.asia/wp-content/uploads/wp-mfa-exports/taxonomy/category/cross-border-ecommerce.md), [Health & Beauty](https://www.tmogroup.asia/wp-content/uploads/wp-mfa-exports/taxonomy/category/health-beauty.md) **Tags:** [Cross-border eCommerce](https://www.tmogroup.asia/wp-content/uploads/wp-mfa-exports/taxonomy/post_tag/cross-border-ecommerce.md), [Health supplements](https://www.tmogroup.asia/wp-content/uploads/wp-mfa-exports/taxonomy/post_tag/health-supplements.md)