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On August 28, 2020, China National Institutes for Food and Drug Control (NIFDC) released the draft Instructions for New Cosmetic Ingredient Registration and Notification Dossiers for public consultation [1], which is one of the subsidiary regulations of CSAR. Any suggestions can be mailed to ChemLinked ([email protected]) prior to September 14, 2020, and we'll submit to the NIFDC.
Background
Before a new cosmetic ingredient is used to produce cosmetics in China, it must be registered with NMPA. Since there is no classified management and the review criteria have not been refined with the ingredient characteristics, only 10 new ingredients have been approved from 2008 to 2020.
The CSAR issued on June 29 stipulates that new cosmetic ingredients shall be managed based on risks [2]. New high-risk ingredients are required to be registered with NMPA and obtain approval, while low-risk ingredients will be subject to notification management. Registrants and notifiers need to report the new ingredients' use and safety data to the NMPA annually for three years.
This Instruction is formulated to guide and regulate the NCI registration and notification in China.
Key Points of the Instruction
1. Dossiers categories required for registration and notification are consistent
Although new low-risk ingredients are subject to notification management, the safety standards are not relaxed. The dossiers categories required for registration and notification are the same.
No. | Dossiers |
1 | Application Form |
2 | R&D Report |
3 | Preparation Technique |
4 | Stability |
5 | Quality Control Standards |
6 | Safety Assessment |
7 | Functional Basis |
8 | Technical Requirements |
9 | Samples |
For anti-hair loss, anti-acne, anti-wrinkle, anti-dandruff, and antiperspirant ingredients subject to notification management, the requirements on safety dossiers are the same with high-risk ingredients (preservatives, sunscreens, colorants, hair dyes and freckle-removing/whitening agents), which means additional tests should be carried out [3].
Ingredient Efficacy | Application Form | Special Requirements for Toxicological Tests |
High-risk ingredients: Preservatives, sunscreens, colorants, hair dyes, freckle-removing and whitening ingredients | Registration | The following additional tests are required:
|
Relative high-risk ingredients: Anti-hair loss, anti-acne, anti-wrinkle, anti-dandruff, and antiperspirant ingredients | Notification | |
Other ingredients | Notification | The above tests are not required |
2. Testing requirements are refined
1) Laboratory qualification and method adoption basis
Testing Items | Laboratory Qualification Requirements | Method Requirements | |||
Qualification | Notes | Method Adoption Basis | Notes | ||
Physical and chemical test, and microbiological test | / | 1. May be carried out by the registrant or notifier on their own or carried out under the entrustment of a testing institution possessed of corresponding capabilities;
2. Where the registrant or notifier conducts the test on their own, a self-statement pledging the truthfulness and objectivity of the results shall be provided. | 1. Safety and Technical Standards for Cosmetics (STSC)
2. Pharmacopeia of the People’s Republic of China
3. National standards | Testing methods shall be adopted in priority in the order of STSC, Pharmacopeia, and national standards. | |
Toxicological test | 1. CMA 2. CNAS 3. Internationally accepted GCP or GLP | / | 1. If the methods not included in the STSC are adopted, it shall follow the internationally accepted methods or national standards, etc.;
2. If the methods adopted are inconsistent with those specified in STSC, evidence of consistency results obtained by both methods shall be provided. | ||
Efficacy evaluation | Preservatives, sunscreens, freckle-removing and whitening, and new efficacy | 1. CMA 2. CNAS 3. internationally accepted GCP or GLP | / | l Human trial Guidelines for Cosmetic Efficacy Claim Evaluation
l Other evaluation methods 1. Safety and Technical Standards for Cosmetics 2. Pharmacopeia of the People’s Republic of China 3. National standards | Evaluation methods except for human trials shall be adopted in priority in the order of STSC, Pharmacopeia, and national standards. |
New ingredient with other efficacies | / | 1. May be carried out by the registrant or notifier on their own or carried out under the entrustment of a testing institution possessed of corresponding capabilities
2. Where the registrant or notifier conducts the test on their own, a self-statement pledging the truthfulness and objectivity of the results shall be provided | |||
2) Conditional acceptance of alternative method data
Although China has been actively promoting the research and validation of alternative methods, due to the late start, currently only 6 alternative methods have been included in STSC. The current dossiers' requirements for NCI registration are still based on toxicological data on animal testing.
The safety assessment documents of new cosmetic ingredients used abroad may involve multiple alternative methods not included in STSC. In order to be in line with international regulations, the Instruction stipulates that the data derived from the toxicological testing method (not in the STSC but is validated by an international authoritative alternative method validation agency) can be accepted, if the evidence proving the consistency of results obtained from the toxicological testing method and the existing testing methods in China is submitted.
Evidence of Consistency Results Obtained by Both Methods |
* The evidence should include contents such as briefly described research process of the test method, comparative research data of not less than 10 test substances, result analysis, conclusions, and original texts, etc. |
*International Authoritative Alternative Method Validation Agencies include: OECD, ICCR, ICCVAM, EURL-ECVAM, JaCVAM, etc.
If animal testing alternative methods are used, appropriate Integrated Approaches to Testing and Assessment (IATA) should be selected according to the ingredient's structural characteristics and specific toxicological endpoints to evaluate the ingredient safety.
Moreover, the Instruction also stipulates that the toxicological test documents can be:
applicant’s test documents;
scientific literature documents;
contents published on the official websites of domestic and foreign governments and international organizations.
Scientific literature documents shall be logically related to the new ingredient applied for, that is, the source, use purpose, use specification, application or use scope, safety use, and other restricted conditions of ingredients shall be consistent with those of the new ingredients applied for.
3) Clarify efficacy evaluation requirements
Ingredients | Efficacy Evaluation Documents |
Preservatives, sunscreens, freckle-removing and whitening ingredients, anti-hair loss, anti-acne, anti-wrinkle, anti-dandruff, and antiperspirant ingredients | Provide at least one of the following testing documents:
*The mechanism of the new ingredient possessed of the applied efficacy shall be clarified |
Other new ingredients | Provide at least one of the following testing documents:
|
4) Add stability testing requirements
Documents about new ingredients’ stability include the stability testing data, shelf life, storage conditions, etc. The stability testing shall be designed according to ingredients’ characteristics, generally including destructive tests, accelerated tests, and long-term preservation tests.
Stability Testing Documents | High-risk/Relative high-risk ingredients | Low-risk ingredients |
Destructive test documents | Submit when registration/notification | Submit when notification |
Accelerated testing documents | ||
Long-term preservation testing documents |
| Submit long-term preservation testing documents of three batches of large-scale production ingredients that have initially passed production validation within the three-year monitoring period |
3. Requirements for nanomaterials and biotechnology sources ingredients are added
In this Instruction, the definition of nanomaterials is given, and specific dossiers (such as research reports, preparation technique, quality control standards, and safety assessment) requirements for nanomaterials and biotechnology sources ingredients are proposed. Moreover, additional toxicological testing requirements for nanomaterials and biotechnology sources ingredients are added.
Ingredients | Application Area | Additional Toxicological Testing Requirements |
Nanomaterials | Intended for skin | l Skin absorption test/Dermal absorption test l Inhalation toxicity test (such test is required when inhalation exposure is possible) |
Biotechnology sources ingredients | l Skin absorption test/Dermal absorption test l Immunogenicity/toxicity test |
Other Noteworthy Points
Detailed test data, laboratory qualification analysis, etc. shall be attached if the safety assessment report is issued by an international authoritative safety assessment agency.
When notifying a new cosmetic ingredient, the notifier shall commit that the ingredient does not have preservative, sunscreen, coloring, hair dyeing or freckle-removing/whitening function. For multi-functional ingredient, it shall be regulated in the strictest way.
The registrant and notifier shall submit a monitoring report through the registration and notification system annually for three years. If an emergency occurs, the registrant or notifier shall submit an emergency report.
Main Structure of the Instruction
Chapter One Basic Requirements |
|
Chapter Two Registration and Notification Dossiers Requirements |
|
Chapter Three Dossiers Requirements for the Monitoring Period Management |
|
Table One New Cosmetic Ingredient Registration and Notification Dossiers Requirements | |
Attachment One New Cosmetic Ingredient Registration and Notification Application Form | |
Attachment Two Technical Requirements for xx Ingredient Used in Cosmetics | |
Attachment Three Sample of Cosmetic New Ingredient Monitoring Report | |
Attachment Four Sample of Cosmetic New Ingredient Emergency Report | |
Related Resources:
For detailed interpretation of new cosmetic ingredient and finished product registration and notification dossiers requirements, please stay tuned for our webinars on Sep 11 and Sep 17.
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English Translation: Instructions for New Cosmetic Ingredient Registration and Notification Dossiers
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English Translation: Technical Guidelines for Cosmetic Safety Assessment
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