In 2019, the promulgation and implementation of various new regulations and policies have made the cosmetic industry develop significantly both at the regulatory level and at the enterprise management level. How much do you know about the relevant policies issued by the State Drug Administration and major events in the field of cosmetics supervision? We sort it out for you:
| Officially released | |||
Regulations / Announcements / Notifications | Release date | Effective date | Key points |
| Announcement on incorporating 9 inspection methods included the detection method of free formaldehyde in cosmetics into the technical specifications for cosmetics safety (2015 edition) (2019 No. 12) | 2019/3/13 | 2020/1/1 | "Detection Method of Free Formaldehyde in Cosmetics" "Chemical Ingredients for Cosmetics in vitro Short-term Exposure of Rabbit Corneal Epithelial Cells" "Skin Sensitization: Local Lymph Node Test: DA" "Skin Sensitization: Local Lymph Node Test: BrdU-ELISA" "Chemical raw materials in vitro skin sensitization: direct peptide reaction test ""Test method for cantharidin and nitrogen mustard in cosmetics" "Test method for 10 kinds of α-hydroxy acids in cosmetics" "Bacterial reverse mutation test" "Teratogenicity test" 9 test methods. Among them, the first five detection methods are newly detection methods and are included in the “Cosmetics Safety Technical Specification (2015 Edition)”. |
| Keqiang Li signs the State Council Order Promulgated the "Decision of the State Council on Amending Certain Administrative Regulations" | 2019/3/18 | 2019/3/18 | Amend the "Regulations on the Hygiene Supervision of Cosmetics ", integrate two administrative licenses of the administrative license for cosmetic production and the administrative license for cosmetic hygiene together. |
| Announcement on the cancellation of 36 items of certification (No. 34 of 2019) | 2019/4/22 | 2019/4/22 | If the certification documents set by the departmental regulations listed in the annex involve the modification of the departmental regulations, the implementation shall be suspended after the departmental regulations are modified in accordance with the procedures. There are 3 items involved in cosmetics: Opinions on the review of sanitary conditions for the production of domestic special-purpose cosmetics (the approval of domestic special-purpose cosmetics is no longer required for the applicant to submit this matter) Opinions on the production, marketing, supervision of domestic special-purpose cosmetics, or the product's unlisted review. Declaration of Lost (Applicant for the reissue of a cosmetic production license is no longer required, a notified commitment is instead) |
Announcement on matters related to the implementation of the application of the renewed commitment system for administrative licensing of special-purpose cosmetics | 2019/5/27 | 2019/6/30 | Issued the renewal work requirements for the administrative license of cosmetics and the sample self-examination commitment report for the renewal of cosmetics approval |
| Announcement of the NMPA on the Implementation of the Practice Code for the Inspection of Cosmetics for Registration and Record (No.72 of 2019) | 2019/9/10 | 2019/11/1 | In order to further regulate cosmetics registration and record inspections, and to ensure the inspections are open, fair, and scientific, the SFDA has formulated and issued the "Specifications" to cancel the original qualifications and designations. Make full use of high-quality social resources, optimize inspection workflow, standardize inspection project requirements, improve inspection work efficiency, and provide strong technical support for cosmetics safety supervision. |
| Notice of NMPA on including testing methods for hormonal components in cosmetics and testing methods for anti-infective drugs in cosmetics into the technical specifications for cosmetics safety (2015 edition) (2019 No. 66) | 2019/9/27 | 2019/9/27 | Added 63 detection methods for hormones and 36 anti-infective drugs. |
| Solicit opinions | |||
Regulations / Announcements / Notifications | Release date | Effective date | Key points |
| NMPA publicly solicits opinions on the " Measures for the Recording of Non-Special Use Cosmetics (Consultation Draft)" | 2019/5/27 | 2019/6/15 | Domestic and imported non-special cosmetics will be managed consistently, national and local authority perform their duties, from "Local responsible units in China" to "domestic responsible person", strengthen industry self-discipline, respond to industry calls, animal toxicity test exemption, and so on. |
| NMPA publicly solicits opinions on the "Interim Provisions on the Administration of Overseas Inspection of Cosmetics (Draft for Solicitation of Comments)" | 2019/11/22 | 2019/12/22 | A total of 5 chapters, 36 articles, and 6 supporting documents. In order to clarify the requirements and contents of overseas inspections, in accordance with the principles of fair competition and domestic and foreign consistency, and with reference to relevant work procedures for overseas inspections of pharmaceutical and medical devices, the "Regulations" have been formulated to ensure that the overseas inspection process is standardized, open and fair, and the inspection results are objective, fair and effective. |