Recently, the Decision of the Standing Committee of the National People's Congress on Amending the "Food Safety Law of the People's Republic of China" has included liquid infant formula in the registration system. In response to this, the State Administration for Market Regulation organized the revision of the Measures for the Registration and Administration of Product Formulas of Infant and Young Children Formula Milk Powder, clarifying that the registration of product formulas for liquid infant formula is subject to these measures, and publicly solicited opinions. Meanwhile, the State Administration for Market Regulation has also solicited public opinions on the relevant supporting documents for the formula registration of infant liquid milk products. It is learned that the new management measures and related supporting documents will come into effect on December 1 this year.
Successive issuance of regulations heralds a new pattern for the industry
The Requirements for Application Materials for Registration of Product Formulas of Liquid Infant Formula (Draft for Comments) formulated by the State Administration for Market Regulation clarified registration requirements from three key aspects: Firstly, it put forward requirements for the control of microbial risks in raw and auxiliary materials such as psychrophilic bacteria and thermophilic spores in raw milk; it also requires that production water in direct contact with products must be treated to meet at least the standards of drinking purified water, so as to ensure compliance with product quality and process requirements; Secondly, it requires the formulation of internal control evaluation standards, evaluation indicators, and testing methods for ensuring product system stability; Thirdly, it made specific requirements for production process verification, product inspection, and sterilization effect verification.
The Guidelines for Stability Studies of Liquid Infant Formula During Shelf Life (Draft for Comments) clarified the basic principles of stability studies, test samples and items, test methods, report contents, and key stability test items, providing guidance for enterprises to conduct stability studies of products during their shelf life. It is worth noting that in addition to defining requirements for the R&D, production, inspection, and stability studies of liquid infant formula, the Measures and relevant supporting documents also impose clear requirements on product packaging and naming, which will effectively prevent misleading consumers.
In accordance with registration requirements, a product name consists of a trade name and a generic name. Each product can only have one product name, and standardized Chinese characters shall be used for product names. Based on the applicable age range of infants, the generic names shall be: Liquid Infant Formula (0-6 months, Stage 1), Liquid Older Infants Formula (6-12 months, Stage 2) and Liquid Young Children Formula (12-36 months, Stage 3).
The market supervision department stated that in the follow-up, it will include liquid infant formula manufacturers in the key supervision scope, and conduct supervision and inspection, supervised sampling, and risk monitoring in accordance with the highest risk level, so as to ensure the quality and safety of liquid infant formula products and further safeguard the safety of food supply for infant and young children.
Industry insiders believe that measures such as incorporating liquid infant formula into registration management mark the advent of a new development pattern for the infant formula industry, and liquid infant formula products are expected to become a "new strategic track" for dairy enterprises to deploy.
Interplay of multiple factors: market yet to take shape
Liquid infant formula refers to a liquid product that uses water, raw milk, desalted whey (powder), vegetable oil, etc., as the main raw materials, with the addition of an appropriate amount of vitamins, minerals, and/or other raw materials, and undergoes high-temperature sterilization to achieve commercial sterility. It is generally stored and transported at room temperature, with a shelf life of no more than 12 months. Compared with infant formula milk powder, liquid infant formula requires more stringent control over microorganisms and stability.
Liquid infant formula first emerged in foreign markets in the 1970s. Currently, it is widely produced and sold in markets such as the United States, Germany, Finland, South Korea, and Japan. In China, liquid infant formula products appeared in the market in 2015. However, affected by factors such as short shelf life, relatively high prices, and Chinese people's dietary habits, the market has not yet formed a certain scale, and most products sold in the market are imported. Relevant data shows that at present, enterprises such as Synutra, Nestlé, Wyeth, Danone, Mead Johnson, Abbott and Babybio have all deployed in the liquid infant formula market. Except for Synutra, all other dairy enterprises are foreign-funded, and the production locations of liquid infant formula are mostly in France, Germany, the United States, Canada, etc.
At present, China's domestic liquid infant formula market is dominated by imports, with domestic enterprises absent. The market acceptance of liquid infant formula needs to be improved, which requires enterprises to make great efforts in promotion and marketing. Consumer education will be the primary challenge faced by major enterprises. The second challenge is cost. Costs related to production, transportation, and offline distribution are relatively high. In particular, offline distribution requires a large amount of human and material resources to drive the growth of product sales. Data shows that in the Chinese market, liquid infant formula products show a significant high-end pricing feature. The interplay of these factors has kept China's domestic liquid infant formula market in a sluggish state for a long time. Even though some enterprises have deployed in this field, it is difficult for them to break through the predicament.
Improved regulations: industry gets ready for takeoff
Based on the above background, infant formula milk powder has long been subject to a strict registration management system, while liquid infant formula only needed to complete filing procedures before being put on the market. However, in recent years, the market demand for liquid infant formula has increased. Relevant market research institutions predict that in the next few years, the scale of China's domestic liquid infant formula market will maintain a double-digit growth rate, becoming a new growth point for dairy enterprises. Including liquid infant formula into registration system means that enterprises are required to produce in strict accordance with the registered formulas and processes, and will bear corresponding legal responsibilities for illegal production—liquid infant formula will now be subject to the same strict standards infant formula milk powder. This reform aims to ensure product safety and controllable quality, raise the industry access threshold, and promote the standardized development of the market.
The implementation of the registration system for liquid infant formula has brought new opportunities and challenges to the industry's development. On the "new strategic track", domestic dairy enterprises are expected to seize the initiative by virtue of early deployment and registration experience, and achieve high-quality development of the industry through innovation-driven development and quality improvement. Industry insiders believe that the release of this policy signal will provide a direction for the high-quality development of infant formula products and put forward higher requirements for enterprises. To meet the registration requirements, relevant enterprises need to increase investment in R&D, production equipment, and quality control, so as to improve the technological content and quality level of their products.
Source: China Food News
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