On Dec. 17, 2014, CFDA released a draft announcement to optimize the testing and acceptance procedures for health food registration. The period for public consultation is until Dec. 31, 2014.
General testing and acceptance procedures for health food registration after optimization:
1. The applicant should prepare legal registration documents including the business license, trial production qualification documents, product formula, production techniques, enterprise standard, sources of raw materials and additive materials, batch process record, three batches of pilot production verification data as well as any other materials useful for field inspection. The efficacy/iconic composition, testing method of physicochemical indexes, and any other important parameters that may influence the testing results should be identified in the enterprise standard.
2. The samples provided by the applicant should be accompanied by a complete minimum sales package. If a non-standardized package is used, the specific requirements on sample disposal as well as the necessity and rationality for using non-standardized packaging should be provided to the testing agency in writing, which should be submitted together with the registration declaration materials. If field inspection is required, the applicant should also provide the trial production record of the samples with non-standardized packaging. The samples for toxicology testing and animal testing should be the same unless otherwise specified.
3. After receiving the application for sampling inspection, CFDA should conduct a field inspection, sampling inspection and sample sealing inspection (local CFDA will carry out field inspection for the manufacturer's qualification, dossiers, etc. and take the samples after sealing from the manufacturer, which will be sent to other testing agencies for re-testing). The requirements for these inspections will be based on the information supplied in submitted materials. The inspections will require inspection of samples produced using non-standardized packaging, designating a reexamination agency, and sealing relevant declaration materials. Sampling inspection will not be conducted if the field inspection does not comply with relevant requirements.
4. For imported health foods, the registration acceptance authority of the CFDA should designate the reexamination agency after receiving the application for testing from domestic executive offices or 3rd party agencies entrusted by imported health food applicants.
5. After receiving the notice of testing and the product samples, health food testing agencies should carry out the testing for registration and reexamination in time, and conduct full-item testing strictly according to the enterprise standard and testing method provided by the applicant before finally issuing a testing report. The qualification of the testing agency will be cancelled if it refuses to do a reexamination without a good reason.
6. After receiving the testing report and reexamination report, the applicant should submit them as declaration materials. Relevant statements and documents should be submitted if the product name, enterprise’s name and address are changed prior to registration acceptance.
We provide full-scale global food market entry services (including product registration, ingredient review, regulatory consultation, customized training, market research, branding strategy). Please contact us to discuss how we can help you by 
