China’s dietary supplement market is a tantalizing prospect for global companies, but the traditional “health food” registration process can be a formidable barrier. In 2023, a startling statistic emerged: not a single imported health food product received registration approval from China’s State Administration for Market Regulation (SAMR). This regulatory bottleneck has led innovative companies to explore an alternative route: entering the Chinese market as “food” products.

The Food vs. Health Food Divide

Defining the Categories

• Food: According to GB 4789.1-2016, food refers to substances that are traditionally consumed by humans, including drinks, chewing gum, candy, solid beverages, etc., as well as substances used in food processing.
• Health Food: As per the Food Safety Law, health foods are foods with specific health functions or vitamins and minerals that are suitable for specific groups of people and regulate bodily functions.

Key Regulatory Differences

The regulatory landscape for food and health food products in China differs significantly. Food products generally face a more streamlined process, with fewer regulatory hurdles to overcome. According to the “Administrative Measures for Registration and Filing of Health Foods” (SAMR Order No. 26), health foods undergo a rigorous registration process that involves extensive documentation, testing, and often clinical trials.

Time to market is a crucial factor for many companies. Food products can typically enter the market within 2-4 months, subject to compliance with relevant standards and regulations. In contrast, health food registration can be a lengthy process, often taking 2-5 years from initial application to final approval.

The cost implications are also substantial. Food products incur lower registration fees and testing costs, making them an attractive option for companies looking to test the Chinese market. Health food registration, on the other hand, requires significant investment in clinical trials, dossier preparation, and expert consultations.

It’s important to note that while food products have a simpler path to market, they are still subject to strict safety and quality standards. Companies must ensure compliance with all relevant food regulations and standards, including those related to ingredients, additives, and labeling.

Navigating the Food Product Pathway

1. Product Assessment

• Review ingredients against GB 2760-2014 (Food Additive Standard)
• Ensure compliance with GB 14880-2012 (Nutritional Fortification Standard)
• Assess potential regulatory red flags (e.g., novel food ingredients)

2. Formulation Considerations

• Adapt formulations to meet GB 29921-2021 (Limits of Pathogens in Food)
• Avoid restricted ingredients like ephedra or kava kava

3. Labeling and Claims

• Adhere to GB 7718-2011 (General Standard for Food Labeling)
• Understand permitted function claims for food (e.g., “supports bone health” vs. “prevents osteoporosis”)
• Avoid health claims reserved for registered health foods

4. Market Entry Process

While there is no specific registration process for most food products in China (apart from GACC registration for overseas manufacturers), companies must ensure compliance with all relevant food safety standards and regulations. This includes:

• Ensuring product formulation meets all applicable standards
• Obtaining necessary test reports from accredited laboratories
• Preparing compliant labeling and packaging
• Registering with GACC for overseas manufacturers
• Working with a licensed Chinese importer

The timeline for market entry can vary but typically ranges from 2-4 months, depending on the product complexity and the company’s preparedness.

5. Quality and Safety Standards

• Implement HACCP principles as per GB/T 27341-2009
• Consider voluntary GMP certification (GB/T 31227-2014)
• Conduct regular testing to ensure compliance with GB 2762-2017 (Contaminants in Food)

Case Study: Success Story

Probiotics: Solid Beverage Strategy

A leading probiotics company successfully entered the Chinese market by positioning their product as a solid beverage. By complying with the relevant food standards, including GB 7718-2011 for labeling and GB 29921-2021 for microbial limits, they were able to introduce their probiotic strains to Chinese consumers without going through the lengthy health food registration process. This approach allowed them to establish brand presence and educate consumers about their specific probiotic strains, capitalizing on the Chinese consumers’ high level of awareness and interest in probiotics and their functions.

Challenges and Considerations

Entering the Chinese market as a food product offers significant advantages in terms of speed and cost, but it’s not without challenges. One of the primary considerations is the limitation on marketing claims. While health foods can make specific health claims from an approved list, food products must be more cautious in their marketing language, focusing on general function statements rather than specific health benefits.

The regulatory landscape in China is dynamic, and companies must stay alert to potential changes. There’s always the possibility of stricter regulations being introduced for food supplements in the future, which could impact market access or product positioning.

Competition in the Chinese market is intense, with products facing rivalry not only from other food supplements but also from registered health foods. This requires companies to have a strong marketing strategy and clear value proposition to stand out in a crowded marketplace.

One significant factor working in favour of food product entrants is the sophistication of Chinese consumers. They are generally well-educated about dietary supplements and are adept at reading and interpreting ingredient lists. This consumer knowledge extends to specific probiotic strains and their purported functions, allowing companies to communicate product benefits effectively even within the constraints of food product regulations.

Conclusion

Entering China’s dietary supplement market as a food product offers a faster, more cost-effective route to this lucrative market. However, success requires careful navigation of China’s complex food regulations and standards.

Ready to explore your options for entering China’s supplement market? Knudsen&CRC offers expert product screening and regulatory guidance to ensure your compliance with Chinese food regulations. Contact us today to accelerate your market entry strategy.