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On Nov. 16, 2016, China CFDA released the finalized version of two supplementary documents for infant formula recipe registration which will serve as a practical guidance for the implementation of “Administrative Measures for Registration of Infant and Young Children Milk Powder Formula Recipes” released by CFDA on 8 Jun 2016. These include:
Items and Requirements of Application Materials for Registration of Infant and Young Children Milk Powder Formula Recipes (Trial)
Key Points and Judging Principles of Onsite Verification and Inspection of Registration of Infant and Young Children Milk Powder Formula Recipes (Trial)
Major amendment in the trial version of “Items and Requirements of Application Materials for Registration of Infant and Young Children Milk Powder Formula Recipes” (hereafter call the trial version) are detailed in Part (II) of the new application material contents. Compared to the draft versions, the trial versions have deleted some impractical elements and simplified the compilation of registration dossiers. Amendments are outlined below: For full clarification please contact our technical team on [email protected].
Item 1 Applicant qualification evidential document
Product name infringement
The trial version deletes the requirement that the IF product should not use names with identical pronunciation or similar names as approved drugs, FSMPs or other IF products in the registration application form. This has been replaced by a product name infringement exemption guarantee letter requirement which must be provided by the applicant.
Product names for individual stages of a single product line
A slight change has been made to product naming requirements. Previously stage 1, stage 2 and stage 3 formulas for a single product line required identical names. Under the new rules, the three stages can use the same or similar product names, and an applicant can change the name of individual stages in a single product line with similar product name.
Item 4 Product formula
Listing order of ingredients
Many enterprises were concerned that the requirement for all ingredients to be listed in a specific order based on relative quantities could reveal important information about product development and infringe on CBI. Based on this the authority now allows ingredients and compound ingredients (including compound food additives) with a concentration of less than 2% of total volume to be listed in any order.
Concentrations of raw materials and auxiliary material
The trial version also clarifies that the concentrations of all raw materials and auxiliary ingredients can be adjusted within reasonable limits. The final expression should be a number, but followed with the floated range.
Item 5 Formula research and development report
Formula research and development description
Requirements relating to the ingredient selection process and product development have been removed in the final version of the application materials. The IF registration dossier requirements now focus on formula characteristics, development rationale, market research and relevant research related to comparability with natural breast milk or nutritional profile.
Market data, history of safe consumption and safety verification
Previously, applicants were required to submit at least 5-years of market data relating to history of safe consumption, lack of adverse events as key criteria to substantiate safety. However, in China, the implementation of “Rules for Examination on Production Licensing for Baby Formula Manufacturers” in 2010 has meant that most Chinese IF manufacturers have adjusted their formulas over the last 5 years. Considering this issue, the requirement has been amended from “more than 5 years” to “since its first introduction”, which slightly loosens data requirements.
Product packaging and stability verification
Stability research is required for IF products. The revised application materials emphasize the requirements to detail the physicochemical stability of packaging. Applicants must submit a stability research and status confirmation of all products in all package types. The CFDA is also drafting guidelines for conducting stability testing.
Formula Originality and Differentiation
The trial version further clarifies the requirements to substantiate formula originality, uniqueness and differentiation from other product lines. Key components should include a comparative analysis with breast milk or relevant nutritional research. This can include a rationale for selection of specific macronutrients or specific micronutrients with desirable influence on infant physiology. Raw and auxiliary material types and corresponding concentrations can be presented in tables.
R&D relating to production processes
All requirements relating to production process R&D including processing verification in item 5 have been removed in the trial version.
Item 6 Description of production process
Process verification
The processing verification requirement has been removed from item 5 and combined with the content in item 6. The description is much more detailed and comprehensive in item 6. A processing verification report of at least 3 batches of samples and an analysis of processing stability is required.
Semi-finished product
Requirements to outline quality control methods and requirement for semi-finished products have been removed.
Item 7 Product testing reports
Self-testing or third-party testing report
The trial version clarifies that product testing reports can be generated by authorized food testing institutions. Manufacturers that submit a full testing report conducted on a minimum of 3 batches produced through commercial production line and generated by a qualified testing institution will be exempt from sample testing by the review team. This will accelerate the registration review period.
Item 9 Other documentation required
Purchasing contracts and supplier audit
Purchasing and sales contracts are no longer required. Requirements relating to safety verification of suppliers of raw materials are detailed.
Item 10 Requirement for labels and product use instructions
Instructions
The original draft required submission of a sample IF product label and product usage instructions which has been removed. The trial version clarifies that applicants should just note lack of labeled usage instructions in the registration dossier. The trial still specifies that the label and samples of all packaging sizes should be submitted. The CFDA will issue document to detail the labelling requirement.
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