Background: Due to the absence of relevant regulations, there is some uncertainty on rules regarding manufacture of a health food and an ordinary food in the same production line. However, considering the possibility of cross-contamination during food production, Chinese authorities in different provinces can implement different management methods. For example, Guangdong has given permission to manufacture these two products in the same line but not at the same time, while some provinces may still hold opposing opinions or unclear attitudes.
On Feb 28, 2020, Shanghai SAMR released a Guideline permitting the manufacturing of health food and ordinary food in the same production line in Shanghai, provided enterprises comply with the following requirements:
The layout of the manufacturing site shall be rational enough to avoid cross-contamination and can control factors like dust effectively.
The manufacturing condition, dosage form, and production technique of ordinary foods shall be the same as that of health food.
It is forbidden to produce health food and ordinary food in the same line in an ordinary food workshop that hasn’t passed the health food manufacturing license review.
Enterprises shall upgrade the manufacturing quality management system to assure its production process control complies with the quality management system of health food production and meet further requirements raised in this guideline.
Furthermore, before applying for a health food manufacturing license, enterprises planning to manufacture ordinary food in the same production line need to explain whether the production technique, condition, and management system of ordinary food complies with health food manufacturing license requirements and this guideline.
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