Why Choose Mandatory National Standards for Bile Acids?

       Ensuring Reliable Raw Materials

Mandatory national standards require bile paste, extracted after bilirubin removal, as the raw material to ensure the completeness and effectiveness of all active ingredients in the product. All bile paste entering Longchang Animal Health must be accompanied by an official inspection and quarantine certificate and must pass tests to meet the "Bile Paste Raw Material Quality Standards" before being stored. This process strictly eliminates any inferior bile paste.    

Research indicates that some manufacturers use by-products from pharmaceutical companies that have extracted chenodeoxycholic acid. Such inferior bile paste not only contains toxic and harmful substances but also lacks important bile acid components, offering no benefits to animals and potentially harming their health.

   

Innovative Production Processes

The production of bile acids involves steps like saponification (extraction), decolorization, acidification, purification, and drying. Market analysis shows that while feed additive production steps are similar across bile acid manufacturers, extraction methods differ, such as extraction-replacement, five-step chemical processes, column refining, enzymatic hydrolysis, and natural extraction.    

Lachance Group employs natural extraction using ultra-high temperature and pressure technology, preserving the natural active substances in bile while removing impurities and harmful elements. According to authoritative testing, none of the 18 amino acids were detected, nor was there any product homogeneity or animal origin concerns. The high-purity process can produce bile acid products with over 95% purity and 17% chenodeoxycholic acid content, ensuring excellent results in practical use.    

Currently, companies that comply with the national standards for bile acid production adopt this process, producing high-specification, high-purity products without harmful substances, which ensures animal health.

   

   

Standardized Testing Methods

Bile acid testing methods globally include acid-base titration, pre-column derivatization with high-performance liquid chromatography (HPLC)-fluorescence detectors, HPLC with differential refractive index detectors, and HPLC with mass spectrometry, among others.    

The national standards expert group compared HPLC-fluorescence and HPLC-refractive index methods based on sensitivity, selectivity, and cost-effectiveness, and validated these methods through testing. Both methods showed relative standard deviations under 5% for pig and goose bile acids in high and low concentration samples, but the refractive index method showed more variation, with a relative standard deviation (RSD) of about 8%. Thus, while both methods are suitable for determining bile acid content in feed additives, the fluorescence method offers better repeatability and sensitivity, especially for products with over 95% purity. Therefore, the fluorescence method was chosen as the arbitration method.    

Lachance Group uses the HPLC-fluorescence method for testing, verified by the National Quality Supervision and Testing Center, ensuring that the raw powder contains only pure bile acid components and accurately detects bile acids like deoxycholic acid ≥78% and chenodeoxycholic acid ≥17%.

   

Verification of Appearance

According to the Ministry of Agriculture's Announcement No. 2131, bile acids should appear as white or off-white powder with a slight fishy smell. The mandatory national standard similarly describes bile acids as white or off-white powder. Brown or yellowish powders may be raw bile that has been sun-dried or freeze-dried and ground. Such "bile acids" contain heavy metals, fats, proteins, and sterols, which compromise both efficacy and biosafety and can cause long-term harm to animal health. Thus, caution is essential when selecting bile acid products to ensure safety.    

Bile acids are crucial for animal health and cost-effective production. Industry peers must be vigilant in selecting bile acid products that meet mandatory national standards, ensuring safe, efficient, and sustainable animal farming. At the same time, market regulatory authorities should strengthen oversight of bile acid production and crack down on non-compliant production and sales to protect market order and farmers' rights. Together, we can promote the healthy development of agriculture and animal husbandry.

   

Since being approved as a new feed additive by the Ministry of Agriculture in 2014 (Announcement No. 2131), bile acids have gained widespread popularity in China's livestock industry. They are used in poultry, aquatic feed, and farming, and are exported to over 40 countries, including Brazil, Ecuador, Egypt, Turkey, Russia, and Australia.    

As a result, the market has seen a proliferation of bile acid products, some of which are of dubious quality. Currently, besides Longchang Animal Health, only a few companies have obtained production licenses for bile acids. Even among licensed producers, if raw materials, production processes, and testing standards do not comply with mandatory national standards, the safety and quality of the products cannot be guaranteed, posing significant risks to the safety of animal-derived foods.    

Mandatory standards are legal requirements designed to protect human health, safety, and property. Without these binding national standards, issues of quality and safety in bile acid feed additives could arise, jeopardizing not only domestic animal production but also China's reputation in the international market.    

The establishment of the mandatory national standard "Feed Additive Bile Acids" ensures the safety of these additives and their effective and safe application in animal production, ultimately safeguarding the safety of animal products and human health.