From Cyclocarya paliurus Leaves to a Standardized Polyphenol Ingredient

 

核心结论 Key conclusion

中国在2013年批准“青钱柳叶”作为新食品原料，2026年又批准“青钱柳叶多酚”。这不是同一项批准的简单更新，而是从植物叶片冲泡使用进一步延伸到经过规定工艺生产、具有明确质量指标和食品使用范围的标准化原料。2026年的批准为产品开发建立了合规基础，但它是安全与使用条件方面的准入，不是对降血糖、降血脂或其他健康功效的认可。

China approved Cyclocarya paliurus leaves as a novel food ingredient in 2013 and approved Cyclocarya paliurus leaf polyphenols in 2026. The second decision is not merely an update to the first. It extends the regulatory framework from brewed leaves to a standardized ingredient produced through a defined process and controlled by explicit quality specifications and food-use conditions. The 2026 approval creates a compliant foundation for product development, but it is a safety and conditions-of-use authorization, not an endorsement of glucose-lowering, lipid-lowering or other health effects.

 The 2013 approval covered the leaves

国家卫生健康主管部门在2013年第10号公告中批准青钱柳叶等新食品原料。其核心是青钱柳植物叶片作为食品原料的使用，主要面向冲泡饮用场景。这一批准建立了青钱柳叶的食品身份，但没有定义一个高含量多酚粉末，也没有为多酚提取物设定总多酚、总皂苷和总黄酮指标。

In Announcement No. 10 of 2013, China’s national health authority approved Cyclocarya paliurus leaves among a group of novel food ingredients. The approval established the leaves as a food material, primarily for infusion. It did not define a concentrated polyphenol powder or establish specifications for total polyphenols, total saponins and total flavonoids.

The 2026 approval defines a processed ingredient

2026年第5号“三新食品”公告将青钱柳叶多酚列为新食品原料。官方定义要求以青钱柳叶为原料，采用热水提取、过滤、浓缩和干燥工艺生产。这一工艺定义非常重要，因为它限定了被安全评价和批准的原料类型。采用明显不同溶剂或工艺生产的提取物，不能在没有进一步法规判断的情况下自动视为同一获批原料。

Announcement No. 5 of 2026 included Cyclocarya paliurus leaf polyphenols as a novel food ingredient. The official definition requires Cyclocarya paliurus leaves as the source material and specifies hot-water extraction, filtration, concentration and drying. This process definition matters because it describes the material that was assessed and authorized. An extract produced with a substantially different solvent or process should not automatically be treated as the same approved ingredient without additional regulatory assessment.

获批技术要求还规定了感官、活性成分、水分、灰分、重金属和微生物指标。它不仅要求“多酚含量达标”，还要求总皂苷和总黄酮同时达到最低水平，这说明产品标准化需要关注一个组合指标，而不能只看单一的总多酚数字。

The technical requirements also cover sensory characteristics, active-component specifications, moisture, ash, heavy metals and microbiology. Compliance is not simply a matter of reaching a total-polyphenol number. Total saponins and total flavonoids must also meet minimum levels, creating a multi-parameter standardization requirement.

项目 Item	中国2026年技术要求 China 2026 requirement	检测表达 Basis
总多酚 Total polyphenols	不低于18.0 g/100 g Not less than 18.0 g/100 g	以没食子酸计 As gallic acid
总皂苷 Total saponins	不低于1.8 g/100 g Not less than 1.8 g/100 g	以人参皂苷Re计 As ginsenoside Re
总黄酮 Total flavonoids	不低于2.0 g/100 g Not less than 2.0 g/100 g	以芦丁计 As rutin
水分 Moisture	不高于6.0 g/100 g Not more than 6.0 g/100 g	成品控制 Finished-ingredient control
灰分 Ash	不高于12.0 g/100 g Not more than 12.0 g/100 g	成品控制 Finished-ingredient control
铅和总砷 Lead and total arsenic	分别不高于0.5 mg/kg Each not more than 0.5 mg/kg	污染物控制 Contaminant control

 

食用量需要按含量折算 Daily intake depends on assay

官方建议青钱柳叶多酚食用量不超过3克每天，这一数值以总多酚18克每100克的原料为基准。当产品的总多酚含量高于18%时，应按实际含量折算使用量，而不是仍然机械使用3克。对于成品企业而言，原料含量、配方添加量、单份食用量和标签建议用量必须形成一致的计算链。

The recommended intake is no more than 3 grams per day, calculated for an ingredient containing 18 grams of total polyphenols per 100 grams. When the ingredient has a higher total-polyphenol assay, the use amount must be converted proportionally rather than retaining 3 grams by default. For a finished-product manufacturer, ingredient assay, formulation level, serving size and labeled intake must form one consistent calculation chain.

项目 Item	中国2026年技术要求 China 2026 requirement	检测表达 Basis
总多酚 Total polyphenols	不低于18.0 g/100 g Not less than 18.0 g/100 g	以没食子酸计 As gallic acid
总皂苷 Total saponins	不低于1.8 g/100 g Not less than 1.8 g/100 g	以人参皂苷Re计 As ginsenoside Re
总黄酮 Total flavonoids	不低于2.0 g/100 g Not less than 2.0 g/100 g	以芦丁计 As rutin
水分 Moisture	不高于6.0 g/100 g Not more than 6.0 g/100 g	成品控制 Finished-ingredient control
灰分 Ash	不高于12.0 g/100 g Not more than 12.0 g/100 g	成品控制 Finished-ingredient control
铅和总砷 Lead and total arsenic	分别不高于0.5 mg/kg Each not more than 0.5 mg/kg	污染物控制 Contaminant control

 

官方建议青钱柳叶多酚食用量不超过3克每天，这一数值以总多酚18克每100克的原料为基准。当产品的总多酚含量高于18%时，应按实际含量折算使用量，而不是仍然机械使用3克。对于成品企业而言，原料含量、配方添加量、单份食用量和标签建议用量必须形成一致的计算链。

The recommended intake is no more than 3 grams per day, calculated for an ingredient containing 18 grams of total polyphenols per 100 grams. When the ingredient has a higher total-polyphenol assay, the use amount must be converted proportionally rather than retaining 3 grams by default. For a finished-product manufacturer, ingredient assay, formulation level, serving size and labeled intake must form one consistent calculation chain.

食品类别 Food category	最高使用量 Maximum level	说明 Note
乳及乳制品 Milk and dairy products	部分产品3 g/kg 3 g/kg for specified products	粉状产品按冲调后质量计算 Powders calculated after reconstitution
饮料 Beverages	3 g/kg或小包装30 g/kg 3 g/kg or 30 g/kg for small packs	固体饮料按冲调后计算 Solid beverages after reconstitution
果冻和巧克力 Jelly and chocolate	48 g/kg	需结合每日摄入量设计份量 Serving design must respect daily intake
糖果 Confectionery	60 g/kg	标签及单份用量仍需控制 Label and serving control still apply
冷冻饮品和蜜饯 Frozen products and preserves	30 g/kg	需验证稳定性和感官 Stability and sensory testing are needed
配制酒 Prepared alcoholic beverages	15 g/kg	不能延伸为保健功效宣传 Does not authorize health claims

 

标签与不适宜人群 Labeling and unsuitable populations

婴幼儿、孕妇和哺乳期妇女不适宜食用青钱柳叶多酚。使用该原料的产品应当按照公告要求标示不适宜人群和食用限量。企业还需要遵守食品标签、广告及产品所属类别的其他规定，不能因为原料获批就使用疾病预防或治疗语言。

Infants and young children, pregnant women and breastfeeding women are identified as unsuitable populations. Products containing the ingredient must declare the unsuitable groups and intake limit as required. Manufacturers must also comply with food labeling, advertising and category-specific rules. Approval of the ingredient does not permit disease-prevention or treatment language.

从法规批准到实际生产 From regulatory approval to manufacturing

国家层面的新食品原料批准与企业层面的食品生产许可是两个不同环节。前者说明特定原料在规定条件下可以进入食品体系；后者说明具体生产者的许可证是否覆盖该品种。湖北晟美康药业有限公司的食品生产许可证在“其他食品”品种明细中明确列有“青钱柳叶多酚”。公司现已正式投产，具备相应的生产和质量检验能力。

National novel-food approval and a manufacturer’s food production license are separate regulatory steps. The first establishes that a defined ingredient may enter the food system under specified conditions. The second confirms whether an individual producer is licensed for the relevant product category. The food production license of Hubei Shengmei Kang Pharmaceutical Co., Ltd. explicitly lists Cyclocarya paliurus leaf polyphenols under “other foods.” The company has commenced commercial production and has corresponding manufacturing and quality-testing capabilities.

这些事实可以证明企业已经取得相应生产许可并具备实际生产能力，但不应被扩大为“全国第一家”。具体产品规格及批次数据以正式COA为准。

These facts establish the company’s authorization and production capability, but they should not be expanded into a claim that the company was the first nationwide. Product specifications and batch-specific data are subject to the official certificate of analysis.

参考资料 References

National Health Commission of China. Announcement on Peony Seed Oil and 15 Other Three-New Foods. 2026 No. 5. https://zwfw.nhc.gov.cn/kzx/tzgg/sptjjxpzsp_224/202605/t20260528_3273.html

Official technical requirements for seven novel food ingredients including peony seed oil. 2026. https://www.nhc.gov.cn/sps/c100088/202605/488dacb045534128b6937a31dfdd1176/files/%E7%89%A1%E4%B8%B9%E7%B1%BD%E6%B2%B9%E7%AD%897%E7%A7%8D%E6%96%B0%E9%A3%9F%E5%93%81%E5%8E%9F%E6%96%99.pdf

National Health Commission of China. Announcement approving Cyclocarya paliurus leaves and other novel food ingredients. 2013 No. 10. https://zwfw.nhc.gov.cn/kzx/tzgg/xspylsp_225/201310/t20131030_1282.html