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FAQs Regarding the Person in Charge of Quality and Safety
To make sure the person in charge of quality and safety is fully capable to undertake product quality and safety management and product release responsibilities in accordance with the law,
l The enterprise who has applied for two or more production licenses is not allowed to appoint the same natural person to be their person in charge of quality and safety.
l The person in charge of quality and safety is not allowed to serve concurrently for different registrants/notifiers.
l The registrant/notifier and entrusted production enterprise are allowed to appoint the same natural person to be the person in charge of quality and safety only when they belong to the same group company and implement the same quality management system, and the entrusted production enterprise accepts the commission on cosmetic production from the registrant/notifier.
Article 28 of the Measures stipulates that: “The person in charge of quality and safety shall assist the registrant/notifier, legal representative and main responsible person of the entrusted production enterprise to undertake the product quality and safety management and product release responsibilities in accordance with the accountability system.”
To keep the production quality management system in operation, the person in charge of quality and safety is allowed to authorize another person to fulfil his duties on behalf of him with the written approval of the legal representative or the main responsible person, and the authorized person shall be professionally qualified. To guarantee the traceability of the authorization, information such as the time when the person in charge of quality and safety grants the authorization, the person authorized, and the issues authorized shall be faithfully recorded. The person in charge of quality and safety shall supervise the performance of the authorized person, and the legal obligation that he assumes shall not be transferred.
Article 63 of the Measures explicitly states: “The labeling process shall be conducted by the enterprise that completes the last production process of contacting cosmetic contents.” This article intends to prohibit unlabeled cosmetics from leaving the factory, which may result in a failure to trace the products.
“Labeling process” refers to the production process to label on the primary packaging of cosmetics. It should be noted that, for imported cosmetics whose original packaging has been labeled and can guarantee the traceability, it is not mandatory to get labeled with Chinese stickers by the enterprise that completes the last production process of contacting cosmetic contents.
According to the Cosmetic Supervision and Administration Regulation and Supervision (CSAR) and the Measures, cosmetic registrant/notifier and entrusted production enterprise shall establish and implement product sales recording system.
It is not mandatory for cosmetic operators such as malls or supermarkets to comply with this provision, but they shall take effective measures to guarantee the traceability of the products. When other cosmetic operators are the target customers, the cosmetic operators are encouraged to establish and implement the product sales recording system.
ChemLinked Comments
l According to the CSAR, the person in charge of quality and safety shall have legal knowledge or professional knowledge of cosmetics quality and safety, and more than five years of experience in cosmetic production or quality and safety management. Subject to the strict qualification, cosmetic enterprises are likely to suffer a shortage of qualified personnel. With the further clarification given by NMPA, the group company gains permission to appoint the same person in charge of quality and safety for the subsidiaries, which can improve the efficiency of talent use and ease the current talent shortage to a certain extent.
l The person in charge of quality and safety is allowed to authorize a person of the same enterprise to fulfil duties on his behalf, but it needs to be emphasized that his legal liabilities are not transferred to the authorized person. In consideration of this emphasis, the person in charge of quality and safety should thoroughly evaluate the working competence, experience, etc. of the authorized person before the authorization. Otherwise, once the arbitrary authorization leads to product safety issues, the person in charge of quality and safety will be held strictly accountable.
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