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Infant Formula Milk Powder Registration Rules Take Effect on 1 October

The China Food and Drug Administration announced that the Administration Measures for the Registration of Formulas of Infant Formula Milk Powder will come into effect from 1 October. The new rules will increase the entry barriers to the infant formula milk powder industry, which is expected to improve order in the market.

Divided into six chapters with 49 clauses, the rules create a registration threshold which tightens production requirements. Based upon the drug management system of the country, the rules require infant formula products to be subject to formula registration administration whether produced in or imported into China and applicant qualifications are under stringent requirements.

Only infant formula milk powder production enterprises satisfying the following requirements can apply for infant formula products registration: with appropriate capabilities in research and development, production and inspection, satisfying the powdered infant formula foods’ good manufacturing practice requirements, having implemented the hazard analysis and critical control point system, the products are manufactured in accordance with relevant laws, carrying out batch testing of products produced in accordance with relevant legal provisions and items stipulated by infant formula milk powder food safety standards.

Meanwhile, the rules will restrict the number of formulas to help people make informed consumption choices. At present, many domestic enterprises use a sales strategy of “similar formulas, different brands, increase publicity, expand the market". Simply put, it forms a plurality of "new formula" by slightly changing the composition and content of a formula to produce different products of different brands which are to be sold in different sales channels, misleading consumers to buy through the hype and causing confusion for consumption.

The rules require each company in principle can only apply at most for nine formula products within three series, aiming to limit the number of formulas to reduce the malicious competition and establish high-quality domestic brands. In order to optimise its production capacity to meet market needs, the rules allow a wholly-owned subsidiary to use registered formula products of another wholly-owned subsidiary subordinated to a single group company.

In product labelling and specification, the applicant is required to submit the application together with samples of label and instructions, and materials for proofs for description in the label and instruction, and provide detailed provision in statement made in the labels and instructions.

For example, for products which claim to be raw milk, raw powdered milk and other raw materials sources, the applicant is required to clearly identify the source of the product as it is; prohibited to use ambiguous terms such as "imported milk source", "source from pasture abroad", "ecological pasture" and "imported raw materials"; prohibited from explicitly or implicitly expressing in the label and instruction that the products may increase intelligence, build up resistance, increase immunity or protect the intestine, etc.

Domestic sales of infant formula milk powder whether produced in or imported into China are subject to uniform formula registration provisions in accordance with the national treatment principle provided in WTO. In compliance with the WTO’s national treatment principle, domestic and foreign enterprises are subject to uniform laws and requirements for marketing permission, which help protect the uniformity in registration, conditions, procedures and requirements of health products, reflecting fairness in law enforcement.

The rules emphasise shared work in confidentiality. Authorities and personnel participating in registration application, technical review, on-site verification, sampling and experts forum of infant formula milk powder shall comply with the confidentiality requirement for trade secrets divulged in the registration. Relevant persons should also keep confidential the commercial secrets they get to know in the entire registration of infant formula milk powder products. At the same time, the applicant should label and specify source of the trade secret of the application material in accordance with relevant state regulations.

For details of the Measures in Chinese, please see:


Content provided by Picture: HKTDC Research
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