ADMINISTRATIVE MEASURES FOR REGISTRATION OF FORMULAS OF INFANT FORMULA MILK POWDER PROMULGATED
On June 6, 2016 the China Food and Drug Administration [CFDA] officially promulgated the "Administrative Measures for the Registration of Formulas of Infant Formula Milk Powder" (RoF Measures) which was previously drafted and released for Comments on September of last year. While the new law will not go into effect until October 1, 2016, its impact will have great implications regarding the future of China's Infant Powdered Milk Formula Industry and its consumers therein.
The People's Republic of China currently views the Infant Powdered Milk Formula Industry as greatly unregulated and oversaturated, which is why this bill's final revision (49 articles in six chapters) takes a rather strict approach towards supervising all possible forthcoming dubious practices.
Firstly, the process by which a company may register their product for sale in the Chinese market has been made more comprehensive and is saturated with many stages of checks from various sectors of the CFDA bureaucracy. Undoubtedly the most crucial component to successfully completing said registration lies with abiding by the bill's numerous new regulations regarding the product's formula and composition. It is important to note that both foreign and domestic companies must have their certification cases approved if they are to manufacture, sell and/or import their products within the PRC.
Application materials include:
1. Application form for registration of infant formula milk powder
2 The qualification proof documents of the applicant
3. Quality and Safety Standards approval for both raw and auxiliary ingredients
4. Research & Development reports of the product formula
5. Manufacturing process instructions
6. Product inspection reports
7. Evidentiary materials of the research and development, production and inspection capabilities
8. Additional materials needed to prove the safety and scientific value of the formula.
With these rigorous quality checks, it is clear that the People's Republic of China is quite focused on ensuring that these commodities, solely used by infants, are as safe as possible. Furthermore, the PRC has chosen to deal with the problem of excessively similar and numerous Infant Powdered Milk Formula products by limiting the number and makeup of each production model any given enterprise can have.
The RoF Measures separate products into three stage classifications based on the age of the intended infant consumer. Stage One is for infants 0 - 6 months of age, Stage Two is for infants 6 - 12 months of age and Stage Three is for infants 12 - 36 months of age. For an enterprise to have multiple infant formulas in a given stage classification, the actual composition of the formula must not only meet all of the aforementioned requirements but also be significantly different than the other products in the given stage classification that said company produces.
Additionally, a given Wholly-Owned Foreign Enterprise [WOFE] may only have a total of nine products on the market regardless of how they are distributed amongst the three stage classifications, as long as they all follow the above significant distinction rule. However, if the umbrella company that owns a given WOFE has an additional WOFE that also produces Infant Powdered Milk Formula, then they too may utilize the same formula as long as it has already passed registration with the CFDA. In this way, companies with multiple operating WOFEs may work around the nine product limit outlined by the RoF Measures.
Although the large number of qualifications and materials needed to apply for the certificate may be viewed as rather cumbersome, enterprises can take solace in the fact that the CFDA will inform them of their product's rejection within at least 20 workdays after all inspections and forms have been completed. After successfully completing all requirements and receiving certification approval from the People's Republic of China, it should be noted that the given registration certificate will be valid for up to five years.
Any change made to the product, whether it be to the actual formula's composition, manufacturing process, packaging, etc. must be submitted for re-approval and have a new registration certificate issued. Please see the registration process flowchart below for more information on how approvals will be managed.
It is equally important to be aware that the RoF Measures do not solely apply to the ingredients therein and the composition thereof the actual formula of a given Infant Powdered Milk Formula product. This new legislation gives uniformly strict attention to their packaging as well.
Packaging qualification guidelines include but are not limited to as follows:
1. Must receive approval of the product label and instructions by the CFDA,
2. Must only contain accurate, adequately specific and non-exaggerated information given on the packaging regarding the product's origin, stage classification, ingredients, nutritional information, etc.
3. Must not claim/imply to give exaggerated benefits an Infant Powdered Milk Formula product cannot have such as the ability to increase intelligence, be absolutely necessary for infantile development, prevent disease, etc.
Although the penalties are still quite small (CNY 10,000 to CNY 30,000) in comparison with the risks and damages that illegal manufacturers might cause to infant's health, it should be obvious that any violations in the registration process will result in the refusal of the registration certificate, and that any violations of the regulations outlined by the RoF Measures will have serious legal consequences, such as having their license revoked and a ban on re-applying for the license within 3 years, which in serious cases may escalate up to criminal liability. Enterprises in the Infant Powdered Milk Formula Industry are urged to take action towards applying for and completing their registration as soon as possible so as to avoid any possible lengthy waiting periods.
