China Consults on Special Food Registration Onsite Inspection Requirements

As revealed by SAMR notice released on July 17th, 2019, SAMR is now soliciting public opinions on Onsite Inspection Work Procedures for Special Food Registration (For Trial). Here're the details.

Main Content

General rules

• This regulation applies to the onsite inspection of domestic and imported special food registration. Special food here refers to health food, infant formula and FSMP (food for special medical purpose).

• During the onsite inspection, SAMR will examine manufacturers’ capability of D&R (development and research), clinical experiment, production, testing and the raw data. Sampling inspection of products may be conducted if necessary.

• SAMR is allowed to further examine the production of raw material, auxiliary material and packaging material provided necessary.

Work procedures

• SAMR is responsible for the supervision and management of onsite inspection. After getting the registration application, Special Food Evaluation Authority shall

• evaluate the materials attached with registration application

• notify the inspection authority in written forms within 5 working days

• inform applicants (manufacturers) to prepare for the onsite inspection

• inform applicants of the recipe/products that need to be in production status during the inspection

• After receiving the notification from the evaluation authority, Special Food Inspection Authority shall

• inform applicants of the onsite inspection date and relevant requirements three days before the inspection in written forms; inform the local SAMR in written forms as well.

• conduct the onsite inspection, usually 3-5 inspectors or entrust a qualified third party to carry out the inspection.

• after the examination, the inspection team shall submit the report, problems, written information, records and investigation materials to the inspection authority

• submit the inspection report and result to the evaluation authority in written forms

Notice for applicants/manufacturers
Enterprises who are going to receive the onsite inspection shall

• confirm the inspection schedule through the system or in writing within 30 working days after receiving the notification from the evaluation authority. If the applicant fails to confirm the inspection schedule in time, the application will be rejected. Besides, applicants shall neither falsify materials nor delay, impede, avoid, refuse the onsite inspection.

• be ready for the onsite inspection and offer necessary assistance during the inspection process, including further examination for the production of raw materials, mailing samples, etc. Target products shall be in the state of production during the inspection.

• the official language during the overseas onsite inspection is Chinese, so the inspection materials needed during the inspection shall be written in Chinese. Applicants shall also equip enough onsite interpreters and be responsible for the translation errors.

• the whole onsite inspection procedures usually include the first meeting, onsite inspection, internal discussion and a final meeting. During the inspection process, the expert team is allowed to investigate the facilities by printing materials, recording, videoing, etc. Enterprises staff are not allowed to attend the internal discussion.

• ensure the contact info is reachable, otherwise, the application will be rejected, etc.

Further onsite inspection specifications will be formulated later. In case of any discrepancy or inconsistency between other regulations about onsite inspection and this regulation, this regulation prevails.

Feedback Collection

Any comments should be sent to SAMR prior to August 15, 2019, via following channels:

1. Go to SAMR website (http://www.samr.gov.cn/hd/zjdc/) and leave comments under this consultation draft

2. Send emails to [email protected] with attached feedback format

3. Send your feedback to ChemLinked, we’ll help submit instead

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