Food Partner Network News The”Regulations on Supervision and Administration of Cosmetics” (hereinafter referred to as”Regulations”) implemented on January 1, 2021 There are clear regulations on the registration and filing of cosmetics and new cosmetic raw materials. On January 12, 2021, the State Administration for Market Regulation issued the”Administrative Measures for the Registration and Filing of Cosmetics” (hereinafter referred to as the”Measures”), which will come into effect on May 1, 2021.
Compared with the previous”Draft for Solicitation of Comments,” the officially announced Measures have deleted many contents. The Measures have six chapters and 63 articles. Chapter One It is the general rules, the second chapter is the registration and filing management of new cosmetic raw materials, the third chapter is the cosmetics registration and filing management, the fourth chapter is the supervision and management, the fifth chapter is the legal responsibility, and the sixth chapter is the supplementary provisions. The”Measures” implement the”four strictest” requirements,”delegation of control and service”, risk management, encouragement of innovation, etc., and implement the”Regulations” on the registration and filing of new cosmetics and cosmetic raw materials. So, what are the points that need to be focused on in the”Measures”? Through the analysis of the top and bottom two articles, FoodPartner.com will take everyone to sort it out.
1. Simplify the registration and filing process and improve efficiency
According to Article 4 of the Measures, “The state implements registration management for special cosmetics and new cosmetics Raw materials are subject to record management”. Articles 18 and 34 stipulate that”before the new cosmetics or common cosmetics are marketed or imported, the filing person shall complete the filing after submitting the filing materials through the information service platform according to the requirements of the State Drug Administration.” Compared with the previous process, the filing efficiency is greatly improved, which means that the company submits the materials as completing the registration and notification filing. After review, the supervisory personnel will make different treatments depending on the circumstances:file a case for illegal activities; suspend production, operation, or import if the product cannot be proved safe; supplementary information for general issues. Therefore, companies should shoulder the main responsibility, be more cautious or seek professional help before submitting the filing materials, and ensure the quality of their products. Relevant experts said, “This further clarifies that the filing of ordinary cosmetics is a real informative filing. There will be no review link before the market. The filing person can put the product on the market after completing the filing. This is not only to deepen the implementation of the decentralization service.”The internal requirements of reforming and optimizing the business environment are also measures to consolidate the main responsibility of enterprises and optimize the pre-listing filing process.”
Regarding the approval procedure for the notification of the renewal of the registration certificate, Article 44 of the “Measures” stipulates that “the accepting agency shall receive 5 The formal review of the application materials will be conducted within working days, and those that meet the requirements will be accepted, and a new registration certificate will be issued to the applicant within 10 working days from the date of acceptance, which greatly simplifies the approval procedures and shortens the processing time. It is worth noting that although the commitment system has accelerated the approval process, the requirements for product safety have not been reduced. The State Food and Drug Administration will strengthen supervision measures during and after the event to organize post-filing supervision and inspection of the filing materials submitted by the filing party. Once violations of laws and regulations are found, they will be strictly investigated and dealt with in accordance with the new regulations and related supporting regulations.
2, the approval of imported cosmetics is more stringent
The “Measures” deletes the “Imported cosmetics produced exclusively for my country, and relevant research and testing materials for Chinese consumers should be submitted in the draft for comments””Provisions. Although the”Measures” simplifies the registration and filing procedures of imported products, the requirements for filing materials are correspondingly increased. According to Article 34 of the Measures, once an enterprise submits the filing materials, it is a filing. If the review fails, the product cannot enter the domestic market. Industry insiders said that “the current imported cosmetics are actually imported for the record. If there are serious problems in the record, the record will be cancelled.” For imported products, the approval of imported cosmetics will be stricter, and the risks are undoubtedly greater.
3. Put forward higher requirements for domestic responsible persons to perform their obligations
According to Article 8 of the “Measures”, “If the registrant or filing person is overseas, an enterprise legal person in China shall be designated as the domestic responsible person. Domestic responsible person The following obligations shall be fulfilled:(1) In the name of the registrant and recorder, handle the registration and filing of cosmetics and new cosmetic raw materials; (2) Assist the registrant and recorder in carrying out cosmetic adverse reaction monitoring and safety monitoring and reporting of new cosmetic raw materials (3) Assist the registrant and recorder in implementing the recall of cosmetics and new cosmetic raw materials; (4) In accordance with the agreement with the registrant and recorder, bear the corresponding quality and safety responsibilities for the cosmetics and new cosmetic raw materials put on the domestic market; ( 5) Cooperate with the supervision and inspection work of the drug supervision and administration department”.
For the registration and filing of imported cosmetics, the state has strengthened the concept of”domestic responsible person”. In addition to the registration and filing of cosmetics and new cosmetic raw materials, it must Assist in the monitoring and recall of product adverse reactions, and assume corresponding quality and safety responsibilities for cosmetics and new cosmetic raw materials put on the domestic market. Therefore, some people in the industry said that after the implementation of the”Measures” on May 1 this year,”the value of the person in charge of cosmetics quality and safety will rise”,”many small and medium-sized enterprises and brands that do not have a person in charge of cosmetics quality and safety, after the introduction of the new measures, some Companies and brands may face elimination.”
4. The requirements for the person in charge of quality and safety have not been reduced
’s previous”Draft for Comments” stipulates that”have a quality management system suitable for the cosmetics to be registered and filed, and have established professional knowledge related to cosmetics quality and safety 、A person in charge of quality and safety with more than 5 years of experience in cosmetics production or quality management”. However, there is no such requirement in the officially announced Measures. It only needs to meet the requirements of Article 28 of the Measures, “Applicants for cosmetics registration and filing persons shall meet the following conditions:(1) It is a legally established enterprise or other organization (2) Have a quality management system that is compatible with applying for registration and filing cosmetics; (3) Having the ability to monitor and evaluate adverse reactions. The registration applicant applies for the registration of special cosmetics for the first time or the filing person conducts the filing of ordinary cosmetics for the first time, it shall Submit the certification materials that meet the requirements of the preceding paragraph”.
Many people think that the number of years and ability requirements of quality and safety managers have been reduced, but they are not. In Article 32 of the”Regulations”, the relevant requirements of the person in charge of quality and safety have been clarified”The cosmetics registrant, filing person, and entrusted production enterprise shall have a quality and safety person in charge, who shall undertake the corresponding product quality and safety management and product release responsibilities. Quality. The person in charge of safety shall have professional knowledge related to cosmetics quality and safety, and have more than 5 years of experience in cosmetics production or quality and safety management”. Therefore, the Measures no longer emphasize this requirement.
5. Requirements for raw material safety information submitted for registration and filing
Articles 29 and 30 of the Measures require that “registrants and filing parties of cosmetics shall comply with laws, administrative regulations, mandatory national standards, technical specifications and Registration and filing management and other regulations, carry out cosmetics research and development, safety assessment, registration filing inspection and other work, and submit the registration filing materials in accordance with the requirements of the cosmetics registration filing materials specification”,”the cosmetics registrant and the filing person shall choose to comply with laws, administrative regulations, and mandatory The raw materials required by national standards and technical specifications are used in the production of cosmetics, and they are responsible for the safety of the cosmetic raw materials they use. When applying for registration and filing, the registrant and recorder of cosmetics shall clarify the source of raw materials and the relevant information on the safety of raw materials through the information service platform.” .
This provision is equivalent to clarifying the filing work of raw material suppliers. At the same time, it also increases the workload of filing. The filing person and registrant must clarify the source of raw materials and raw material safety-related information, and they must collect relevant data from different raw material vendors, and the raw material vendors should also note related safety information as required. It can be seen that the”Measures” detailed the”Regulations” regarding the cosmetics registration and filing system, and the registrants and filing parties need to perform safety inspections and other obligations.
6. The requirement for product efficacy evaluation has not been cancelled, and supporting documents are to be released
After the release of the”Measures”, the relevant content on product efficacy evaluation in the draft for comments was deleted, but this does not mean that efficacy evaluation is not necessary. The relevant requirements for efficacy evaluation have been clarified in the Regulations.
Experts said, “When consumers buy cosmetics, the purpose is to achieve their expected effects after using the products. Therefore, in order to protect the legitimate rights and interests of consumers, The Regulations clarify that the efficacy management of cosmetics should be strengthened, and the efficacy claims of cosmetics should have sufficient scientific basis”,”It needs to be emphasized that strengthening management does not necessarily need to be included in registration or filing management. The Regulations specify the registrant and filing person of cosmetics. The summary of the basis of the efficacy claim should be published on a special website to accept social supervision. The stipulation is to manage through social supervision, rather than through the pre-market registration and filing management methods. Therefore, the”Measures” does not list the efficacy claim The relevant content of the document submission. This does not mean that the company does not need to prepare relevant documents. In the next step, the State Food and Drug Administration will formulate and publish supporting documents related to the management of cosmetic efficacy claims to clarify relevant requirements, and strengthen supervision and law enforcement to ensure relevant regulations Be practically implemented”.
The above is the introduction of some knowledge points of cosmetics registration and filing by Food Partners. The next issue will further explain the other contents of the registration and filing.
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