China Solicits Public Opinions on Innovative On-site Inspection Methods for Infant Formula and FSMP Registration

After the release of China’s new infant formula GB standards and following supervision rules¹, the adjustment of infant formula recipes and the preparation of new recipe registration are in full swing. (All recipes need to follow the new GB requirements prior to Feb 22, 2023.) To overseas players, on-site inspection, a key step during the recipe registration, was their major hindrance to obtain the approval. Due to factors like geographic position, understaffed inspection team, pandemic, etc., it takes too long for overseas enterprises to receive an on-site inspection or to pass it. 

To better boost industrial development and improve supervision efficiency, on June 23, 2021, China announced to solicit public opinions on innovative on-site inspection methods for infant formula recipe registration and FSMP product registration through a questionnaire². (English translation of this questionnaire is attached at the end of this article.) For the supervision of overseas on-site inspection, the questionnaire proposed four methods. The public can rate their support to these proposed methods and express their concerns and difficulties might meet in the questionnaire. 

The four proposed methods are:

1. Cooperation with overseas competent authorities by signing memorandums. Overseas authority should designate inspection institutes to carry out the on-site inspection in their country and overseas technical institute should receive the training from SAMR, etc.

2. Video inspection. SAMR will organize experts to review documents together with video inspection. But entrusted third-party institutes or overseas competent authorities should prove the authenticity of the information.

3. Third-party institute inspection. These institutes should be subject to the supervision of SAMR. Once illegal operations are found, the formula recipes will be annulled (SAMR may also carry out inspection), involved enterprises cannot register recipes within one year, and institutes can no longer carry out the inspection service, etc.

4. Self-inspection by enterprises. Enterprises should be responsible for the inspection result. Once SAMR initiates overseas inspection and finds the inspection result is very different from the actual situation, or there are non-compliant items, recipes will be annulled, etc.

Attachment: English version of this questionnaire

The supervision of overseas manufacturer inspection

**How to evaluate support degree by figures

1 means “totally disagree”

2 means “don’t support but can support after adjustment”

3 means “hold moderate views”

4 means “support, but it can be better after optimization”

5 means “totally support”

1. Cooperate with and entrust overseas competent authorities to conduct the inspection:

• Sign memorandum of cooperation with overseas competent authorities;

• Inspection institutes should be designated by overseas competent authorities to carry out the on-site inspection work in the country.

• Overseas technical institutes need to receive the training from SAMR and be qualified for conducting the on-site inspection;

• Inspection result should be recognized by overseas competent authorities and will be published by SAMR.

2. Video inspection:

• SAMR will organize experts to conduct the inspection, combining dossier review together with remote video inspection;

• Enterprises should support and cooperate with experts when it come to network, equipment, staff, etc.

• The authenticity of information should be proved by third-party institutes entrusted by SAMR, overseas competent authorities or third-party institutes entrusted by overseas competent authorities.

3. Third-party institute inspection:

• Enterprises entrust third-party institutes to conduct the on-site inspection;

• Third-party institutes should be capable and certified to conduct manufacturing inspection;

• Inspection institutes should receive relevant training;

• Third-party institutes should be responsible for the inspection result. The inspection result should be open to the public by institutes and enterprises.

• Third-party institutes should be subject to the supervision of SAMR. Once falsification or illegal operation are found, the infant formula recipes of enterprises will be annulled, and enterprises cannot apply for recipe registration in 1 year. Third-party institutes will be put on the blacklist, which will be announced to the public, and can no longer conduct the inspection.

• SAMR can conduct the inspection at a certain time. Once the inspection result is very different from the published result, or there are non-compliant items compared with the judging principle, SAMR will annul the recipes and will announce it through notices.

4. Self-inspection by enterprises

• Enterprises should submit declaration and self-inspection report during the recipe registration procedure, and they should be responsible for the inspection result.

• SAMR will initiate overseas registration inspection when the time comes. Once the inspection result is very different from the released result, or there are non-compliant items compared with the judging principle, SAMR will annul the recipes and will announce it through notices.

 5. Other suggested methods for overseas inspection

______________________________________________________________________

6. In which situation that you think on-site inspection can be simplified or can be exempted from? Give your specific reasons and judging principle.

Include the following information:

1) Product type (infant formula/FSMP)

2) Form (simplify the on-site inspection/free from the on-site inspection)

3) Applicable situation and reasons

4) Judging principle and reasons

7. About the organization of innovative on-site inspection, any other feasible ideas or suggestions?

______________________________________________________________________

8. Any opinions and suggestions for the on-site inspection method at present?

______________________________________________________________________

Stakeholders can visit the website and fill the questionnaire directly by themselves, or may also email the feedback to ChemLinked and CL will help with the submission.