[Background for Promotion] 

○ (Background) According to Article 21 of the Health Functional Foods Act, health functional food manufacturers must inspect whether their self-produced health functional foods comply with standards and specifications, either directly or by entrusting the inspection to a testing and inspection agency pursuant to Article 6 of the Act on Testing and Inspection in the Food and Drug Administration, and preserve the records. 

○ (Problem) When self-quality inspections are entrusted to testing and inspection agencies, there is a mandatory provision* requiring the testing agencies to register the inspection results in the Laboratory Information Management System (LIMS, the Ministry of Food and Drug Safety's record management system). However, when manufacturing businesses perform self-quality inspections directly, there are no regulations requiring the installation and operation of a record management system to prevent the falsification of inspection results.

- Article 14 of the Act on Testing and Inspection in the Food and Drug Administration
- In addition, food, livestock product, and sanitary product manufacturers that directly perform self-quality inspections are also required to install and operate a record management system, raising potential issues of equity among similar industries. 

○ (Necessity) To enhance equity among identical or similar industries and improve safety and quality management—given that laboratories of businesses performing self-quality inspections directly also conduct GMP quality control inspections—it is necessary to install and operate a record management system to prevent the falsification of inspection results.

[Regulatory Details] 

○ Make it mandatory for health functional food manufacturing businesses that directly perform self-quality inspections to independently install and operate a record management system to prevent the falsification of inspection results.

- However, an exception rule is established to allow the use of the Laboratory Information Management System (LIMS) operated by the Ministry of Food and Drug Safety in cases where it is difficult to install and operate an internal system.