The Regulation on the Supervision and Administration of Cosmetics (“Regulation”), an important regulation in the cosmetics industry, was promulgated on June 29th, 2020 and came into force on January 1st, 2021. Subsequently, on April 1st, 2021, the National Medical Products Administration (“NMPA”) launched an information service platform for cosmetics registration and record-filing, which is used for the management of cosmetics registration and record-filing.
On May 1st, 2021, the Administrative Measures for the Registration and Record-filing of Cosmetics (the “Record-filing Measures”), a supporting document formulated by the NMPA in accordance with the Regulations, came into force, further regulating the registration and record-filing of cosmetics. This article summarizes the key compliance points of the import record-filing and declaration of general cosmetics after the new policy is implemented for your reference.
I. Definition of Imported General Cosmetics
1. Definition of Cosmetics:
According to Article 3 of the Regulation, cosmetics “refer to daily chemical and industrial products that are applied to the skin, hair, nails, lips and other surfaces of the human body by smearing, spraying or other similar methods for the purpose of cleaning, protecting, beautifying and dressing up.”
2. General Cosmetics:
According to Article 16 of the regulation, general cosmetics are cosmetics other than special cosmetics. Special cosmetics refer to cosmetics used for hair dyeing, perm, freckle removal, whitening, sunscreen, anti-hair loss and cosmetics claiming new effects.
3. Imported Cosmetics:
According to Article 61 of the Record-filing Measures, where the last contact content of a cosmetic product is completed in China, the cosmetic product is deemed as a domestic product; where the last contact content of a cosmetic product is completed overseas, the cosmetic product is deemed as an imported product; where the last contact content is completed in Taiwan, Hong Kong or Macao, the administration of imported products shall apply mutatis mutandis (generally the same, but altered, when necessary).
In addition, products used together with others or combined packaging products that are applied for registration or filing in the name of one product and the last contact content of any dosage is completed overseas, it shall also be subject to the administration of imported products.
4. Imported General Cosmetics:
Although imported general cosmetics are not defined in the relevant provisions, based on the foregoing provisions, we can conclude that:
Imported general cosmetics, that is, where the last contact of the contents of any dose of cosmetics is completed abroad and which do not belong to cosmetics deemed as “Special cosmetics” belong to imported general cosmetics and shall be subject to record- filing administration.
II. Cosmetics Requirements for Filing Entities of Imported General Cosmetics
1. The Requirements of the Filing Subject
The filing person of imported general cosmetics shall meet the following conditions:
- Enterprises or other organizations established according to law;
- Have a quality management system suitable for cosmetics on record;
- Ability to monitor and evaluate adverse reactions.
In addition to conducting inspection in accordance with the requirements of mandatory national standards, technical specifications and filing inspection regulations, the cosmetic filer shall also conduct a cosmetic safety assessment and set up a special post of quality and safety director.
It should be noted that if the filing person is overseas, it cannot directly declare, and the enterprise’s legal person in China shall be designated as the responsible person domestically and shall perform the following obligations:
- Handle the filing of cosmetics and new cosmetics raw materials in the name of the filing person;
- Assist the filer in monitoring adverse reactions of cosmetics and safety monitoring and reporting of new cosmetics raw materials;
- Assist the filer in the recall of cosmetics and new cosmetics raw materials;
- Undertake corresponding quality and safety responsibilities for cosmetics and new cosmetic raw materials put on the domestic market in accordance with the agreement with the filer;
- Cooperate with the supervision and inspection of the drug regulatory department.
2. Requirements for the Domestic Responsible Person
When filing general cosmetics for the first time, the domestic filer and the domestic responsible person shall submit the following user information and relevant materials:
- Information form of the person filing and resume of the person in charge of quality and safety;
- Overview of the quality management system of the filer;
- Overview of adverse reaction monitoring and evaluation system of filers;
- The overseas filing person shall submit the information form of the domestic responsible person;
- The original power of attorney of the domestic responsible person and the original notarial certificate;
- If the recorder has the right to produce by itself or entrust an overseas production enterprise to produce, it shall submit the information form of the production enterprise and the information of the person in charge of quality and safety. If the production enterprise is overseas, it shall submit the original of overseas production specifications.
III. Record Filing Procedures for Imported General Cosmetics
The import of general cosmetics shall be subject to filing management. Before importation, the filing person shall complete the filing after submitting the filing materials through the cosmetics registration and filing information service platform in accordance with the requirements of the NMPA.
When filing, the filing person shall submit the following materials:
a. Cosmetic registration information form and relevant materials;
b. Product name information;
c. Product formula;
d. Standards for product implementation;
e. Sample product label;
f. Product inspection report;
g. Product safety assessment data.
For products that have been filed, the following points shall be noted:
a. If importation at a port other than the provincial administrative region where the domestic responsible person is located is intended, the filing person shall fill in the information of the import port and the contact person for customs clearance through the information service platform.
b. The product name shall not be changed without justified reasons.
c. Without sufficient scientific basis, the efficacy claim shall not be changed at will.
d. The product formula shall not be changed at will, except for minor changes in the product formula due to changes in the source of raw materials and other reasons.
e. If it is no longer produced or imported, the filing person shall timely report to the drug regulatory department responsible for the filing administration to cancel the filing.
Conclusion
In the face of the new regulations on the supervision of the cosmetics industry, the administrative supervision of the cosmetics industry is becoming more and more strict, and the compliance pressure faced by enterprises is also increasing accordingly. This is especially true for overseas cosmetics brands and domestic partners entering the Chinese market. Therefore, we suggest that enterprises:
Firstly, be familiar with product types and place great importance on product classification. Since different categories of products correspond to different regulatory requirements, enterprises should correctly classify their products according to regulatory provisions and clarify whether they need to register or record. After determining the category, clarify the filing procedures and requirements. For the filing of imported general cosmetics, the enterprise shall prepare corresponding documents and materials in combination with the regulatory requirements and make the correct application.
Secondly, be familiar with the regulatory provisions and communicate with the regulatory authorities in due course. During the filing application and actual operation of general cosmetics, the enterprise shall be familiar with the regulatory regulations and requirements, maintain communication with the regulatory authorities and ensure compliance with the regulatory requirements, avoiding being subject to regulatory penalties due to poor communication of relevant information.
Last but not least, seek professional advice, as in view of the extent of the filing procedure, there are many documents and detailed regulations, and therefore many compliance points that need to be adhered to. If an enterprise encounters corresponding problems, it shall seek the help of professionals to meet the compliance requirements of the filing process.
