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Information Details

Important contents related to the registration and filing of new raw materials for cosmetics

Release time:

2021-03-05 12:00

The State Drug Administration today officially issued the "Regulations on the Administration of Registration and Filing Materials for New Cosmetics" (hereinafter referred to as the "Regulations" Announcement (No. 31 of 2021), establishing the "Regulations on the Supervision and Administration of Cosmetics" (hereinafter referred to as the "Regulations") An important framework for the management of new raw materials in the regulatory system. Like the previously issued "Measures for the Administration of Cosmetics Registration" (hereinafter referred to as the "Measures"), the regulations will be implemented on May 1, 2021. According to the information obtained by Xiao 'an before, the registration and filing system for new cosmetics raw materials will also be launched before may 1, 2021. friends who need registration and filing for new raw materials can now prepare for it.

After two times of soliciting opinions from the society, the officially issued regulations have more detailed requirements for the registration and filing materials of new raw materials, and the required materials can better meet the requirements for the safety management of new raw materials for cosmetics. The following Xiao An summarizes the officially issued regulations, methods and regulations, and gives you an overview of the important contents related to the registration and filing of new raw materials for cosmetics.

1. cosmetics new raw materials registrant/filer

Domestic enterprises: through the service platform to fill in basic information, submit security risk monitoring and evaluation system overview can be opened registration/filing authority.

Overseas enterprises: an enterprise legal person within the territory of China shall be designated as the domestic responsible person, and the domestic responsible person shall fill in the basic information and an overview of the security risk monitoring and evaluation system, and at the same time submit the original power of attorney of the domestic responsible person and its notarial certificate to open the registration/filing authority.

* The obligations of the domestic responsible person include the registration and filing of new cosmetics raw materials in the name of the registrant and the filing person; Assist the registrant and the filing person to carry out the safety monitoring and reporting of new cosmetics raw materials; Assist the registrant and the filing person to carry out the recall of new cosmetics raw materials; In accordance with the agreement with the registrant and the filing person, bear the corresponding quality and safety responsibility for the new cosmetics raw materials put into the territory; cooperate with the supervision and inspection work of the drug supervision and administration department.

2. cosmetics new raw material management applicable situation

(1) New raw materials for cosmetics, that is, natural or artificial raw materials suitable for cosmetics for the first time in China are new raw materials for cosmetics.

(2) To adjust the purpose of use, safe usage, etc. of the used cosmetic raw materials, apply for registration and record in accordance with the new raw material registration and record requirements.

Dual-track Management of Registration and Filing of New Raw Materials for 3. Cosmetics

Registration: High-risk raw materials with anti-corrosion, sun protection, coloring, hair dyeing, spot removal and whitening functions

Filing: New raw materials other than those subject to registration

* The difference between registration and filing is that new raw materials suitable for filing can be put into use after the materials are submitted. However, the new raw materials suitable for registration need to be reviewed and approved by the review committee before they are used in cosmetics. The review period is generally 6 months to 1 year.

Requirements for 4. registration and filing materials

The registration and filing materials of cosmetics require classification requirements by information such as the use history and efficacy of raw materials in cosmetics or food at home and abroad, which is not directly related to the adoption of registration or filing management. See the final schedule of the article for details.

In the process of communicating with customers and friends in the past, Xiao An found that the focus was mostly on the requirements of "more than three years of safe use history in cosmetics listed abroad" and "safe consumption history" certification.

These two items are detailed in the officially issued regulations, as follows:

l If all the following conditions are met, it can be regarded as a new raw material that has been used safely for more than three years in cosmetics listed abroad:

A. The quality specifications, purpose of use, application or scope of use of the new raw materials are the same as those of the raw materials used in the cosmetics listed abroad, and the safe use of the new raw materials is not higher than that of the cosmetics listed abroad;

B. Cosmetics containing such raw materials shall not be listed abroad for less than 3 years;

C. Relevant evidence materials that can prove that the cosmetics containing the raw materials have sufficient users abroad;

D. The cosmetics containing the raw material listed overseas have not had any serious adverse reactions or group adverse reactions caused by the raw material;

E. The raw materials involved in the possible harm to human health related literature reported.

L meet one of the following conditions, can be regarded as a new raw material with a history of safe consumption:

A. Food raw materials that have obtained food safety certification or other corresponding qualifications from relevant supervision and management departments in China;

B. Safe edible raw materials issued by relevant domestic and foreign supervision and management departments, technical institutions or other authoritative institutions.

Management after 5. registration and filing

(1) New raw material samples of cosmetics are retained for future reference

The registrant, the recordholder or the domestic responsible person of the new raw materials of cosmetics shall keep the samples of the new raw materials for future reference. Samples of new cosmetic raw materials shall have complete packaging and labels, and the labels shall include the names of registrants, filers or domestic responsible persons of the new raw materials, the Chinese name of the raw materials, INCI name, production date and service life, storage conditions and other information.

(2) Reporting system

Has been registered, completed the record of new cosmetics raw materials to implement safety monitoring system. The period of safety monitoring is 3 years, from the date of registration or filing of cosmetics for the first time using new cosmetic ingredients.

Within the period of safety monitoring, only the new cosmetic raw material registrant, the filing person or its authorization can use the new cosmetic raw material to produce cosmetics. When applying for registration and filing of relevant cosmetics, it shall be confirmed through the information service platform by the registered person and the filing person of the new raw materials of cosmetics.

During the monitoring period, registrants and filers of new cosmetic raw materials shall submit annual reports through the online system according to the provisions of the measures. When they find that they need to report to the technical review organization according to the measures, or other situations that need to be reported, they shall immediately collect relevant information and submit it to the technical review organization through the information service platform.

l Annual report

Cosmetics registrant, filer or entrusted production enterprise information using new raw materials to produce cosmetics;

Cosmetics information produced using new raw materials, including product name, product registration certificate or filing certificate number, product production or import, sales quantity, etc;

Supervision and sampling, investigation and recall of cosmetics produced with new raw materials;

The adverse reaction monitoring system, statistical analysis of adverse reactions of cosmetics produced with new raw materials, and measures taken by cosmetics manufacturers;

The risk monitoring and evaluation management system and measures taken by cosmetics manufacturers for cosmetics produced with new raw materials.

l Measures stipulate the circumstances to be reported

Other countries (regions) found suspected due to the use of similar raw materials caused by serious cosmetic adverse reactions or adverse events;

The laws, regulations and standards of other countries (regions) raise the use standards, increase the use restrictions or prohibit the use of similar raw materials;

Other situations related to the safety of new cosmetic ingredients.

6. included in the catalog of used cosmetic raw materials

Three years after the expiration of the safety monitoring period of new cosmetic raw materials, the technical review agency shall submit to the SDA an opinion on whether the new cosmetic raw materials meet the safety requirements.

For new cosmetic raw materials with safety problems, the registration or filing shall be canceled by the SDA; if no safety problems occur, the SDA shall include them in the catalogue of used cosmetic raw materials.

Situation classification Information Requirements		Scenario 1	Situation 2	Situation 3	Situation 4	Situation 5	Situation 6
1. basic information	1. Registration or filing of raw material information form	○	○	○	○	○	○
2. Development Report	2. R & D background	○	○	○	○	○	○
	3. Basic information of raw materials	○	○	○	○	○	○
	4. Raw material use information ①	○	○	○	○	○	○
	5. Functional basis information	○	○	○	○	○	○
	6. Development of other relevant information	○	○	○	○	○	○
3. preparation process and quality control standards	7. Brief description of preparation process	○	○	○	○	○	○
	8. Stability test data	○	○	○	○	○	○
	9. Quality specification indicators and their inspection methods.	○	○	○	○	○	○
	10. Information on possible safety risk substances and their control ②
4. safety evaluation	11. Overview of toxicological safety evaluation.	○	○	○	○	○	○
	12. Acute oral or acute transdermal toxicity test ③	○	○	○	○
	13. Skin and Eye Irritation/Corrosion Tests	○	○	○	○	○	○
	14. Skin allergy test	○	○	○	○	○
	15. Skin phototoxicity test ④
	16. Skin photoallergy test ⑤
	17. Mutagenic test	○	○	○	○
	18. Subchronic oral or transdermal toxicity test	○	○		○
	19. Teratogenic Test	○
	20. Chronic Toxicity/Carcinogenicity Combination Test	○
	21. Inhalation toxicity test ⑥
	22. Long-term human trial safety test	○
	23. Other toxicological tests ⑦
	24. Safety Assessment Report	○	○	○	○	○	○
5. other information	25. Technical requirements for new raw materials	○	○	○	○	○	○
5. other information	26. Other information that may contribute to the registration and filing of new ingredients for cosmetics

Case 1: The first use at home and abroad with anti-corrosion, sun protection, coloring, hair dyeing, freckle whitening, hair loss prevention, acne, anti-wrinkle (except for physical anti-wrinkle), dandruff, deodorization and other first use at home and abroad with high biological activity of new cosmetic raw materials;

Case 2: first used at home and abroad, does not have anti-corrosion, sun protection, coloring, hair dyeing, whitening, anti-hair loss, acne, anti-wrinkle (except physical anti-wrinkle), dandruff, deodorant function of new raw materials;

Case 3: New raw materials that do not have the functions of anti-corrosion, sun protection, coloring, hair dyeing, freckle whitening, hair loss prevention, acne removal, anti-wrinkle (except for physical anti-wrinkle), dandruff removal and deodorization, and can provide sufficient evidence to prove that the raw materials have been used safely in cosmetics listed abroad for more than three years;

If the safety assessment report or the human safety inspection report under the ethical conditions can be provided at the same time that the international authoritative safety evaluation organization concludes that it is safe to use in cosmetics or the human safety inspection report under the ethical conditions, the acute oral or acute transdermal toxicity test data may not be provided;

Case 4: A new raw material that has the functions of anti-corrosion, sun protection, coloring, hair dyeing, freckle whitening, hair loss prevention, acne removal, anti-wrinkle (except physical anti-wrinkle), dandruff removal and deodorization, and can provide sufficient evidence to prove that the raw material has been used safely for more than three years in cosmetics listed abroad;

Case 5: new cosmetic raw materials with a history of safe consumption (the parts of the raw materials used should be consistent with the edible parts), and the risk assessment of the raw materials should be carried out according to the exposure amount and use mode of the raw materials;

Case 6: chemically synthesized by one or more structural units, linked by covalent bonds, with an average relative molecular mass greater than 1000 Daltons, and a relative molecular mass less than 1000 Daltons, the oligomer content is less than 10%, and the structure and properties are stable (except for raw materials with high biological activity).

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