Technical Evaluation Mechanism for Special Food Registration in China

Notes:

• Designated testing agency: testing institutions which are appointed by the government to conduct relevant testing

• The 3rd party testing agency: testing institutions with legal qualification but without governmental appointment.

To complete the special food registration in China, enterprises need to entrust testing agencies to conduct relevant testing for their products, such as stability test, hygiene test and toxicology experiment. Take health food for example, by July, 2015, former CFDA had designated 58 labs for health food registration technical evaluation ^[1], however in Oct 2017, China CFDA unveiled the “Specification for Special Food Evaluation Technical Institution” ^[2], which begins a new supervision mechanism for testing agencies.

Interpretation on current technical evaluation mechanism [3]

According to the “Specification for Special Food Evaluation Technical Institution”, any legally qualified food testing agency can apply for filing with the competent authority. They should upload relevant information to “special food evaluation technical institution filing information system”, and enterprises requiring testing service can then choose from this list of approved testing institutions. Under this mechanism, the testing agencies bear the responsibility of the reports issued, and they are not allowed to outsource their tasks to other technical institutions once the commission contract was signed with enterprises.

The government is in charge of testing institution management. It will not raise the qualification threshold for testing agencies but will instead focus on substantiating the authenticity of the information that the institution submitted. The competent authority will conduct casual inspection on the accredited testing agencies and their filing information will be removed immediately once they are found unqualified.

“1+N” working management system is exclusively designed to supervise the testing agencies. “1” means that all testing agencies should uniformly follow a basic working standard involving personnel requirements, facility and equipment, archives management, complaints treatment and etc.; “N” refers to various technical standards that each products’ testing shall be subject to, which could be mainly classified into testing method standard, safety and function evaluation method, clinical trial technical standards. For example, the safety and function evaluation of health food products should strictly follow the “Technical Standards for Testing & Assessment of Health Food”, however, this document was abolished in July 2018 and there is no replacement currently (read more in CL news)

What is the major issue when operating this mechanism?

Information authenticity is the biggest problem occurred in the online filing system. A SAMR official revealed that often the information submitted to the online filing system does not totally conform to the rules, for example, some information required is missed, or the qualification changes are not updated in the system. Additionally the testing items’ names are not unified among various technical institutions. All these problems have greatly expanded the supervision difficulty and make enterprises confused.

Future administration: Interim and post-supervision will be the focus

The number of the 3^rd party testing agencies will grow in future and benefit from much more relaxed entry requirements. The government will attach greater importance to the interim and post-supervision of accredited testing institutions. An official from SAMR pointed out that the competent authority will stringently check the authenticity and consistency of filed information and qualification updates submitted by testing agencies. The reports issued will be randomly reviewed and the testing institution will be blacklisted and announced to the public if their report is found unqualified. Additionally, stratified administration may be applied to focus on testing intuitions with poor track records.

Interim and post-supervision is regarded as top priority for the whole testing industry and the competent authority is drafting detailed measures on these supervisory mechanisms. On Feb. 15, 2019, China SAMR announced it will collect the 2018 service data of inspection and testing industry ^[4], stipulating that each testing agency should upload the codes of effective reports and certificates during 2016-2018 to the online system, and such measure will continue on a quarterly basis since 2019. In this way, falsified or erroneous reports will be more efficiently weeded out and the public could also take part in supervision.

What does this mechanism mean for enterprises?

Undoubtedly the introduction of the 3^rd party testing agencies alleviated the shortage of testing resources in China. Now the report issuance rate is improved. It is said that enterprises will now be able to get their reports more quickly. Additionally, marketization of China’s testing industry has caused the fierce competition among those testing institutions, which means that the testing price is expected to be lower in future.

Although the 3rd party testing agencies seem to be more competitive in terms of testing service, one lab technician from a major testing institute revealed that currently, reports issued by the 3rd party testing agencies also have a higher rate of being rejected by the competent authority. As the technical institution filing mechanism is still under optimization, the report approval standard is not so transparent and there may be a transitional period before practically implementing new rules. Therefore, it will be better to choose those testing agencies that were previously accredited by the government especially during the initial phrase of this new mechanism.