In May 2026, the National Health Commission of China issued Announcement No. 5 on 16 Categories of “Three-New Foods” including Peony Seed Oil, in which phytosterols were re-approved as a novel-food raw material. Sixteen years after its initial approval as a new-resource food in early 2010, this renewed announcement is far more than a simple re-filing. It represents systematic upgrades in permitted raw-material sources, manufacturing processes and compositional standards, opening a policy gateway for phytosterols to expand from health-food capsules into everyday consumer foods such as yoghurt and bakery products.

Phytosterols occur naturally and widely in vegetable oils, nuts and cereals, including corn oil, soybean oil and sunflower-seed oil. Yet their concentrations in ordinary foods are relatively low. To achieve an effective daily intake of 1 g phytosterols through regular diet alone, one would need to consume 5.8 kg of cauliflower or 8.4 kg of cherries, making it difficult to reach functional doses solely from food.

At molecular level, phytosterols share high structural similarity with human cholesterol — the foundation for their core physiological function. Upon entering the intestinal tract, phytosterols competitively occupy cholesterol-absorption sites, displacing cholesterol molecules. Unabsorbed cholesterol is then excreted via metabolism, an effect vividly described in the industry as “lowering cholesterol with plant-derived sterols”. Clinical research from the University of Hong Kong and multiple published studies confirm that daily intake of 1.5-2.4 g phytosterols can reduce LDL-C (low-density-lipoprotein cholesterol) by 7-10 %. In Europe, North America and Japan, phytosterols have long been incorporated into common foods such as margarine-style spreads, yoghurt and milk, establishing themselves as a well-proven functional ingredient for cardiovascular health. By contrast, within China over the past sixteen years, phytosterols were largely confined to capsule-form health foods, and its potential within mass-consumer markets remained untapped.

This updated NHC announcement delivers three major sets of revised standards that remove industrial bottlenecks. First, expanded permitted raw-material sources. Whereas the old standard only allowed soybean-oil distillates and tall-oil, the new regulation adds rapeseed oil, corn oil and sunflower-seed oil as legal starting materials, broadening upstream supply-chain options. Second, extended manufacturing-process scope. Beyond existing saponification, solvent-extraction and crystallization workflows, a new “esterification-distillation-crystallization” route is now accepted, supporting product development for varying purity grades and physical forms. Third, more rigorous compositional-ratio specifications. For tall-oil-derived phytosterols, updated safety-test data has revised the permitted ratios of β-sitosterol, campesterol and stigmasterol, further refining raw-material quality-control systems.

Though the re-announcement clarifies the regulatory status of phytosterols and lowers barriers for industrial roll-out, two practical hurdles — technical performance and regulatory matching — still stand before broad adoption within ordinary foods. Technically, phytosterols are lipophilic with poor water-solubility. Direct incorporation into food matrices readily triggers crystal precipitation, grainy mouthfeel and sedimentation, major pain-points that leave many food manufacturers “wanting-to-use but hesitant-to-adopt”. In recent years, modified processing technologies including microencapsulation, emulsification, matrix-entrapment and dispersion preparation have matured, effectively improving phytosterol solubility, dispersibility and bioavailability and resolving key technical obstacles.

On regulatory alignment: despite the novel-food-raw-material update, for a long time phytosterols lacked matching categories within food-production licensing classifications, leaving enterprises without clear administrative guidance for permit applications. With this official release and follow-up supporting rules gradually taking shape, large-scale applications are anticipated across yoghurt, plant-based milk, baked goods, functional beverages and other consumer scenarios.

Worldwide, multiple jurisdictions have built complete regulatory frameworks for phytosterols. Japan approved phytosterols as a food-for-specified-health-uses ingredient for lipid management in 1999. The US FDA granted an authorised health claim, specifying that daily intake of 1.3 g plant sterols may reduce coronary-heart-disease risk. The European Union permitted phytosterols for use in butter, milk, yoghurt and everyday foods in 2004, followed by corresponding approvals in the United Kingdom. Mature overseas regulations have fostered complete industrial chains. North-American and European suppliers dominate high-grade raw-material markets, with multiple well-known phytosterol-fortified food brands and proven commercial models.

Domestically, China has grown into a major global supply base for phytosterol raw materials. Upstream extraction relies on by products from soybean-oil deodorizer distillates, rapeseed-oil and rice-bran-oil refining. Core production capacities cluster in Shandong and Jiangsu provinces. Enterprises in Guangdong and Zhejiang focus on high-value deep-processing segments including microencapsulated formulations and cosmetic derivatives, forming a complete local supply chain.

Industry institutes forecast sustained global market expansion for phytosterols, projecting the global market to reach USD 1.939 billion by 2030. Backed by safety endorsements from authoritative bodies including the US FDA and EFSA, overseas fortifiedfood markets are highly mature. Within China, together with this novel-food-raw-material announcement and rising public awareness of blood-lipid health, phytosterols stand at the tipping-point for industrial take-off.

Reviewing its sixteen-year trajectory: when first approved in 2010, China’s functional-food sector remained in its early stage. Today, food-medicine-homology ingredients and functional everyday foods represent mainstream industry trends, and consumers are willing to pay for tangible health benefits. With policy relaxation, complete local supply chains and breakthroughs in modification technologies all converging, the mass-consumer era for phytosterols is arriving.

Even so, the industry should assess opportunities rationally: updated ingredient permissions will not automatically trigger explosive growth in finished products. Enterprises still need to advance formula development, sensory optimisation and consumer-market education, moving phytosterols beyond supplement capsules and onto ordinary household dining tables. Compliant deployment of novel-food raw materials and differentiated ingredient innovation have become core growth drivers for food-health enterprises.

Disclaimer: This article is industrial-sector news reporting. Functional descriptions draw upon publicly-available scientific literature and overseas published materials. It does not constitute product-efficacy promotion or medical advice.

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