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The landscape of health food and supplements regulations in China has seen significant updates, primarily focused on notification and registration procedures. These changes are critical for businesses aiming to introduce or maintain health food products in the Chinese market. This blog will explore the recent updates, emphasizing the implications for both nutrient supplements and health food with functional claims.
1. Health Food Notification in China: Streamlining Approvals
China’s regulatory authorities have made substantial progress in streamlining the health food notification process, particularly for nutrient supplements. As of now, 24 nutrient supplements and ten (10) functional raw materials have been approved for notification. This process simplifies market entry, enabling businesses to navigate the Chinese regulatory framework more efficiently.
Key Categories for Notification:
- Vitamins and Minerals: The approved nutrient supplements include a comprehensive range of vitamins (A, D, B1, B2, B6, B12, niacin, folic acid, biotin, choline, C, K, pantothenic acid, E, and β-carotene), minerals (Calcium, magnesium, potassium, manganese, iron, zinc, selenium, and copper), and Docosahexaenoic acid (DHA). These products cater to specific target groups such as children [above one (01) year], adults, pregnant women, and lactating mothers.
- Non-Nutrient Raw Materials: A diverse array of non-nutrient raw materials has also been approved. These include fish oil, melatonin, CoQ10, spirulina, broken Ganoderma lucidum spore powder, whey protein, soy protein isolate, and various forms of ginseng (Ginseng Radix et Rhizoma, American ginseng, and Reishi). These materials are linked to specific functional claims like assisting in lowering blood lipids, improving sleep, enhancing immunity, and providing antioxidant benefits.
Understanding and complying with the notification process is crucial for ensuring that these products meet the stringent safety and efficacy standards set by Chinese regulatory bodies. For international businesses, this knowledge is vital for compliance and successful market entry.
2. Updated Technical Guidelines for Health Food Registration in China
The registration process for health food products, particularly those with health function claims, has been updated with new technical guidelines. These guidelines, implemented since 2020, cover a wide range of testing and evaluation requirements:
- Safety Testing and Evaluation: The 2020 guidelines emphasize the importance of safety testing, including toxicological assessments of raw materials. This ensures that all health food products on the market are safe for consumption.
- Function Claims Testing: The updated 2023 guidelines introduce specific methods for testing and evaluating the claimed health functions of food products. This includes both animal and human consumption tests, depending on the claim. For example, claims like "helps enhance immune function" or "helps regulate body fat" require robust evidence to support them.
These guidelines are essential for businesses seeking to market health food products with specific functional claims. Compliance with these regulations not only ensures legal entry into the market but also builds consumer trust in the efficacy of the products.
3. Introduction of New Functional Claims and Raw Materials in China's Health Food Sector
China's State Administration for Market Regulation (SAMR) and its Center for Food Evaluation (CFE) have initiated the introduction of new health function claims and raw materials into the regulatory framework. This initiative aims to enhance the scope of health food products available in the market and encourage innovation within the industry.
New Functional Claims:
- Cognitive and Stress Management: New health claims under development include functions like enhancing learning capabilities, managing stress, and promoting physical fitness.
- Disease Prevention: There is also a focus on preventive health functions, such as reducing the risk of high blood pressure, managing type 2 diabetes, and addressing anxiety.
The introduction of these new claims will require rigorous technical evaluation, as outlined in the "Implementing Rules for Technical Evaluation of New Functions and Products of Health Food (Trial)". Businesses are encouraged to apply for new functions simultaneously with product registration to expedite the process.
4. Compliance with Labeling and Ethical Standards in China’s Health Food Industry
Another critical update in the regulatory framework is the standardization of labeling and ethical guidelines for health food products. The SAMR's 2023 guidelines on standardized labeling ensure that health food products are accurately represented to consumers. This includes clear and truthful claims about the health benefits of the products, which must be supported by scientific evidence.
Moreover, the ethical review guidelines for population trial food tests, introduced in 2023, ensure that human trials conducted for health food products adhere to the highest ethical standards. This is particularly important for products claiming to improve health functions, as these trials provide the evidence needed to support such claims.
5. How Can Freyr Help Navigate China's Health Food Regulations?
Navigating the evolving regulatory landscape in China can be challenging, however, Freyr’s regulatory experts are here to assist. With our extensive experience in global regulatory affairs, we provide comprehensive support to ensure your health food products meet all necessary requirements.
- Regulatory Strategy and Compliance: Freyr offers tailored regulatory strategies to help you understand and comply with the latest Chinese health food regulations. Our experts stay updated with all regulatory changes, ensuring your products remain compliant.
- Product Registration and Notification: Whether you need assistance with product registration or notification, Freyr can manage the entire process—from dossier preparation to submission and liaising with regulatory authorities.
- Scientific and Technical Support: Our team provides scientific and technical expertise to support the development and substantiation of health claims, ensuring your products meet the rigorous testing and evaluation standards set by the Chinese authorities.
- Labeling and Marketing Compliance: Freyr also assists in developing compliant labeling and marketing materials, ensuring your products are accurately represented and meet all regulatory requirements.
Conclusion
The recent updates to China's health food and supplements regulations highlight the country's commitment to ensuring the safety and efficacy of these products. For businesses, understanding and adapting to these changes is essential for success in the Chinese market. By staying informed, investing in research, and engaging with regulators, companies can not only comply with the regulations but also thrive in this dynamic industry. Freyr is ready to support your journey, providing the regulatory expertise needed to ensure your products succeed in the competitive Chinese market.
