Q&A | China’s New Feed and Feed Additives: Application Procedures, Testing Requirements, and Data Protection

Applications for new feed materials and feed additives are a key component of feed regulatory compliance in China. The process involves multiple stages, extensive testing requirements, and complex regulatory details. To help companies quickly understand key issues and avoid common pitfalls, we have compiled the following Q&A covering frequently raised questions on regulatory classification, application procedures, testing requirements, and data protection.

Q1: What regulatory management system does China adopt for feed materials and feed additives?

A: China adopts a positive list management system. Only substances included in the relevant catalogues may be legally manufactured and used. The two main catalogues are:

Catalogue of Feed Materials: Primarily covers basic nutritional ingredients that provide energy, protein, and other nutrients. It specifies the permitted varieties and their characteristics, but generally does not restrict the intended applications or target animal species. Part IV of the Catalogue lists single feed materials.

Catalogue of Feed Additive Varieties: Covers substances added in small or trace amounts, including nutritional additives, enzyme preparations, preservatives, and microorganisms. It generally specifies the additive category, applicable scope, and target animal species.

Q2: Under what circumstances is an application for a new feed material or feed additive required?

A: An application is required in the following circumstances:

A newly developed single feed material that has not previously been approved for use in China requires an application as a new feed material.

A feed additive that has not been approved for use in China requires an application as a new feed additive.

An already approved product may also require a new application in the following circumstances: Expansion of the target animal species or intended application scope of a feed additive; Product specifications that do not meet the requirements of the Feed Additive Safety Use Specifications; Major changes to the manufacturing process.

Q3: Which authorities are responsible for regulating new feed materials and feed additives?

A:

Application acceptance: Government Service Hall of the Ministry of Agriculture and Rural Affairs (MARA).

Technical review: Agricultural Genetically Modified Organisms Safety Committee (for products manufactured using genetically modified microorganisms); National Feed Evaluation Committee.

Final approval: Animal Husbandry and Veterinary Bureau of MARA.

Q5: What is the five-year monitoring period (data protection period)?

A: The five-year monitoring period starts from the date the approval certificate is issued. Newly approved domestic feed materials and feed additives are eligible for a five-year monitoring period (data protection period). During this period, MARA will generally not accept applications from other companies for the same substance.

Q6: Can multiple companies be commissioned to manufacture a product during the monitoring period?

A: Under the current regulatory framework, an application is generally linked to one designated manufacturing company. In principle, contract manufacturing should be arranged with the designated manufacturer.

Q7: What are the differences in application procedures between conventional products and products manufactured using genetically modified microorganisms?

A: Products manufactured through fermentation using genetically modified microorganisms:

A two-step procedure applies: First, obtain an Agricultural GMO Safety Certificate. After obtaining the safety certificate, submit the application for the new feed material or feed additive.

Note: For products involving genetically modified technologies in the feed sector, the GMO safety certificate must be obtained separately before proceeding with the feed application. This differs from the regulatory procedure for food products.

Conventional products manufactured without genetically modified technologies: No GMO safety certificate is required. Companies may directly follow the application procedure for new feed materials or feed additives.

Q8: How long does the overall application process usually take?

A: The overall process, from project initiation to approval, generally takes approximately two years.

Q9: What additional safety assessment studies are required for microbial fermentation products?

A: General studies for microbial products: Strain identification; Whole-genome sequencing; Analysis of virulence and antimicrobial resistance genes; Phenotypic antimicrobial resistance testing; Animal pathogenicity studies; Detection of viable microorganisms remaining in the final product.

Additional studies for products manufactured using genetically modified microorganisms:Analysis of residual foreign DNA in the final product; Analysis of residual foreign proteins in the final product.

Q10: Are toxicological studies mandatory? Can they be waived?

A: For routine applications, toxicological studies must generally be conducted at designated institutions in accordance with applicable regulatory requirements.

Waivers may be possible for a very limited number of special feed materials, but each case must be assessed individually. Companies are advised to consult the authorities in advance.

Q11: If an ingredient has already been approved for use in food, does it still require a separate approval for use in feed?

A: Yes. Food and feed are subject to two independent regulatory systems in China. Human and animal metabolic systems differ, and safety assessments for human food cannot automatically replace those required for animal feed.

Q12: Does expanding the target animal species of an approved feed additive require a new application?

A: Yes. Different target animal species may have different safety profiles and tolerances. Expanding the applicable target animal species is considered an application for a new feed additive and requires the relevant evaluation studies for the additional target species.

Q13: If the manufacturing process undergoes major changes or the substance structure changes, will the product still be subject to another company's five-year monitoring period?

A: If the molecular structure changes or a major manufacturing process change as defined by the regulations occurs, the resulting product may be considered a different product. In such cases, it is not subject to the five-year monitoring period associated with an existing approval certificate and may be submitted as an independent application.

Q14: If an EFSA assessment report is already available overseas, can animal studies be directly waived for an application in China?

A: Overseas assessment reports may be used as supporting references but do not automatically qualify a product for exemption from animal studies. If the company has access to the original and complete study data, it may request a pre-submission consultation. Experts will then determine whether the existing data can be accepted for the Chinese application.

What Can CIRS Do for You

Established in 2007, the CIRS Group is a leading product safety and regulatory consulting firm. CIRS has branch offices in the Republic of Ireland, South Korea, the United States, the United Kingdom, Japan, and China. CIRS Group utilizes its technical expertise, various resources, and international network to provide one-stop compliance services, from regulatory compliance, laboratory testing, and R&D to data services across multiple industries. This includes chemicals, cosmetics, food and food beverages, medical devices, agrochemical products, disinfectants, and consumer goods. It helps clients gain a competitive advantage by reducing business risks associated with regulatory affairs.

The vast majority of members in CIRS Food Business Division have over 10 years of professional experience in food compliance, with more than 80% holding Master’s or Doctoral degrees in food-related disciplines. The CIRS toxicology expert team consists of 24 Chinese Certified Toxicologists (DCST), 2 American Board Certified Toxicologists (DABT), and 1 European Registered Toxicologist (ERT). CIRS has provided one-stop food compliance services to over 1,000 domestic and international food and related enterprises. Leveraging its technical expertise, diverse resources, and global network, the CIRS Food Business Division offers global food compliance services, including but not limited to:

• Health food registration and filing in China;
• Application for “Three New Foods (new food additives, new food raw materials and new food-related products” in China;
• U.S. GRAS, NDI, and CAP notifications;
• EU Novel Food, food additives, and food enzymes applications; and
• Application for new feed ingredients and feed additives in China, the U.S., and the EU.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.