China: Mandatory Registration of Infant Formula Recipes


Posted By: Selerant RSA

On June 6, 2016, China Food and Drug Administration (CFDA) published CFDA Decree No.26 regulating registration of recipes of infant formula products. After one year of preparations, CFDA published Administrative Measures for the Registration of Recipes for Formula Powder Products for Infants and Young Children (Original Chinese version, for English version click here) on June 8, 2016 and it will enter into force on October 1, 2016. The measures were notified to the WTO as TBT 1165 in January 2016.

The measures (the regulation) have been published according to the provisions of Articles 74 and 81 of China Food Safety Law, in order to address problems of excessive numbers of infant recipes available in the market, formulas lacking scientific research, confusion between different brands and recipes and overall exaggeration in advertising etc. in China market. All the infant formula milk powder formulations have to be registered by the Food and Drug Administration departments under the State Council. Product recipes should be submitted as part of the registration application, together with research reports indicating the scientific formulations and safe ingredients.

Towards consistency for domestic and imported products

As part of the effort looking to implement the approach of "internal and external consistency" management in China, import of milk powder has also been included in the new rules. Measures require that both infant formula manufactured and sold in China, and infant formula imported to be sold on Chinese market, must obtain CFDA certificate of recipe registration, before being placed on the market. Applicant should be with appropriate research and development capabilities, production capacity and capacity testing of infant formula milk powder production enterprises. Applicant includes the overseas company intending to export to China and those producing and selling infant formula in China.

The Ministry of Finance has announced the "Cross-border E-commerce Retail Imported Goods List" (Chinese version, no English version yet available) and GACC Announcement No.26, 2016 on Cross-Border E-Commerce Retail Import/Export Control (Original Chinese version, for English version click here) give the relevant explanation stipulating that infant formula sold in China through cross-border e-commerce retail imports, must obtain a certificate of registration of product recipe, after January 1, 2018.

Infant formula definition

The infant formula, in the regulation, refers to milk and milk protein products (as the main raw material), to which only vitamins, minerals and (or) other components have been added, and the product has undergone a physical processing method turning it into a powder. It is suitable for healthy infants and young children’s diet. The infant formula recipes refer to raw materials, food additives and their usage, and product nutrient content. The regulation is prohibiting promotion of health functions related to the recipe that would mislead the consumers.

How many recipes can be registered?

The regulation requires that in case the same enterprise wishes to apply for the registration of two or more of the same age product formulations, there should be a significant difference between the product formulations. No more than three series of nine kinds of formulations are allowed. A wholly owned subsidiary of the same group of companies’ registered infant formula recipes can be produced by using other wholly owned subsidiary within the company, but other wholly owned subsidiary should obtain infant formula recipes registration and infant formula production license.

Labeling and Claims

The regulation is setting strict demands for product labels and instructions related to the claims. First of all, the content of the product formulation which is to be registered, labeling and registration number must be consistent. Secondly, the applicant has to standardize the product name, list of ingredients, nutrition facts, sources of raw materials, labeling and other product labeling information. And lastly, regulation prohibits associating claims with the product label or instructions for use. For example, it is prohibited to make health claims associated with: disease prevention or treatment, implying connection with health effects, increase of immune resistance, protection of the intestinal tract and other health-related functions.
"Not added", "does not contain", "zero added" and other phrases emphasizing the content or absence of certain substances are not allowed. The exaggerated or violation of scientific principles, and inconsistence of product formulation registered and claims are also forbidden.
The new regulation enters into force October 1, 2016.