UpcomingMandatory

GB7300.405-2025

Feed additives—Part 4:Enzymes—α-galactosidase

饲料添加剂 第4部分:酶制剂 α-半乳糖苷酶

GB 7300.405-2025 is an upcoming mandatory Chinese national standard for Feed additives—Part 4:Enzymes—α-galactosidase. It appears in the Food compliance cluster with a product safety focus and has an implementation date of Jul 1, 2026.

Applicability depends on product scope, certification route, competent authority notices and transition rules. Requst for the translation or verify source before using this record in a compliance decision.

Compliance overview

Scope and applicability

This standard applies to solid feed additives containing α-Galactosidase, specifically those produced through fermentation using *Aspergillus niger* as the strain, followed by separation and optional carrier addition. It is mandatory for manufacturers producing this specific enzyme for the Chinese animal feed market. It does not apply to liquid formulations or enzymes derived from other microbial strains.

Technical requirements

The standard establishes comprehensive criteria for α-Galactosidase, categorized into appearance and physical properties, quality indicators, and hygiene parameters. For physical properties, the product must exhibit uniform color, good flowability, and be free from mold or off-odors. The quality indicators section mandates specific minimum enzyme activity levels, maximum moisture content, and particle size distribution requirements to ensure product efficacy and stability. The hygiene indicators are critical for safety, setting strict maximum limits for heavy metals including total arsenic, lead, cadmium, and mercury. Manufacturers must also ensure the absence of Salmonella and control mycotoxins such as aflatoxin B1, zearalenone, and deoxynivalenol (DON). Carriers used in the formulation must comply with the relevant *Feed Raw Material Catalog* and *Feed Additive Variety Catalog*.

Testing methods

Testing protocols are clearly defined to verify compliance. Enzyme activity is measured using spectrophotometry as specified in NY/T 4361. Physical tests include moisture determination per GB/T 6435 and particle size analysis using a two-sieve method. Heavy metal contamination (arsenic, lead, cadmium, mercury) is assessed using atomic absorption spectroscopy and other referenced chemical analysis methods. Microbiological evaluations for Salmonella and coliforms follow GB/T 13091 and GB/T 18869 respectively, while mycotoxin levels are quantified via liquid chromatography-tandem mass spectrometry.

FAQs

What is the definition of an α-Galactosidase activity unit in GB 7300.405-2025?

One activity unit (U) is defined as the amount of enzyme required to release 1 μmol of p-nitrophenol from a 5 mmol/L p-nitrophenyl-α-D-galactopyranoside solution per minute at 37°C and pH 5.5.

Are there specific batch size limits for production under this standard?

Yes, a production batch is defined as products of the same specification manufactured with the same strain, fermentation process, and conditions. The maximum batch size shall not exceed 60 tons.

Which tests are mandatory for factory release inspection?

The mandatory factory release inspection items include appearance and properties, α-Galactosidase activity, and moisture content. Full type testing covering all technical and hygiene requirements must be conducted at least every six months.

The summary above provides a high-level overview of GB 7300.405-2025. To ensure complete compliance for your feed additive products entering the Chinese market, a precise and professional translation of the full technical specifications is essential. Purchase our high-quality English translation of GB 7300.405-2025 today to access all detailed parameter tables, testing procedures, and regulatory limits.

Applicability hints

Type
Product
CCS
B46
ICS
65.120
Competent department
Ministry of Agriculture and Rural Affairs
Technical committee
National Technical Committee on Feed Industry of Standardization Administration of China