Regulatory standards and compliance of L-leucine in food additives

The regulatory standards and compliance of L-leucine as a food additive mainly involve aspects such as scope of use, dosage limits, and quality specifications. The relevant details are as follows:

Regulatory Standards

Chinese Standards

According to National Standard for the Use of Food Nutrition Fortifiers (GB 14880) and relevant announcements, L-leucine can be used as a nutrition fortifier. Its quality specifications must comply with Food Additive: Branched-Chain Amino Acids (L-Leucine, L-Isoleucine, L-Valine) (QB/T 5633.1-2021), which specifies technical requirements, test methods, inspection rules, as well as marking, packaging, transportation, and storage of L-leucine.

Additionally, it can be used as a food flavoring, with its application complying with the provisions of National Standard for the Use of Food Additives (GB 2760).

International Standards

The U.S. Food and Drug Administration (FDA) regulates that L-leucine can be safely used as a nutritional additive in food, with quality specifications meeting the requirements of the Food Chemicals Codex (FCC). The dosage limit is 6.4% of the total protein mass in food.

Compliance Key Points

Compliance with Scope of Use

As a nutrition fortifier, L-leucine can be applied in special dietary foods (e.g., sports nutrition products, where L-leucine addition is permitted).

As a food flavoring, it can be used in various foods but must adhere to the usage regulations for food flavorings in GB 2760, and shall not be used in food categories excluded from Table B.1.

Compliance with Dosage Limits

When used as a nutrition fortifier, L-leucine must be added in accordance with the dosage limits specified in relevant standards.

When used as a food flavoring, each flavor component in the prepared essence shall not exceed the maximum allowable usage and maximum allowable residue levels specified in GB 2760.

Compliance with Quality Specifications

The L-leucine used must meet corresponding quality specification requirements. Indicators such as content, specific rotation, loss on drying, chloride, and sulfate shall conform to standard provisions to ensure its safety and effectiveness.