How to Apply for Health Food Filing for the Original Health Food Registrants? - Regulatory News - Food & Food Contact Materials

1. Who are the original health food registrants?

There are 2 different original health food registrants (hereinafter referred to as original registrants).

S.N.	Characteristics of their health food
Original registrants I	I. It is a registered health food; II. Its raw materials have been included in Health Food Raw Materials Directory (hereinafter referred to as the Directory) and can meet relevant technical requirements.
Original registrants II	I. The health food registration application was accepted before the release of the Directory; II. The raw materials have been included in the Directory and can meet relevant technical requirements.

PS. For above characteristics, if some raw materials or their dosage cannot meet the Directory and the filing technical requirements, but the registration applicant or certificate holder agrees to adjust in accordance with the Directory, he can also be regarded as the original registrant.

2. How to transform into health food filing for original registrants?

The original registrant shall submit application under CFDA technical evaluation institution for transforming health food registration to health food filing. If the information can meet the requirement, related electronic registration information of the product will be sent to filing management department. Meanwhile, the applicant will receive a written notice that informs him to submit filing application to filing management department.

2.1 Materials required for qualification confirmation of original registrants

I. Registration alteration application form and Letter of commitment for authenticity of the materials;

II. Application form of transforming registration to filing, with applicant’s seal and the signature of legal representative;

III. Copies of legally registered certificate of the applicant;

IV. Copies of the health food registration certificate and its annex (not required for unregistered products).

2.2 Transforming procedures

Objects	Transforming procedures
Original registrants I	Before the new health food registration system launched Submit materials in the health food filing system under the option of “original registrants”, then send paper materials with seals to CFDA accepting department. After the original registrant qualification confirmed, you can apply for filing in the health food filing system.
Original registrants I	After the new health food registration system launched Submit the alteration application of “transforming registration to filing” in the health food registration system. After the original registrant qualification confirmed, you can apply for filing in the health food filing system.
Original registrants II	Directly apply for alteration application with the CFDA technical evaluation institution, After the original registrant qualification confirmed, you can apply for filing in the health food filing system.

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