Important matters about new raw materials of cosmetics

Today, the State Drug Administration officially issued the "Regulations on the Management of Registration and Filing Data of New Cosmetic Raw Materials" (hereinafter referred to as the "Regulations") (No.31 of 2021), which established an important framework for the management of new raw materials in the regulatory system of the Regulations on Cosmetics Supervision and Administration (hereinafter referred to as the "Regulations"). Like the previously issued Measures for the Administration of Cosmetic Registration (hereinafter referred to as the "Measures"), the regulations will be implemented on May 1, 2021. According to Xiao 'an's previous news, the registration and filing system of new raw materials for cosmetics will also be launched before May 1, 2021, and friends who need to register and file new raw materials can prepare now.

After soliciting opinions from the society twice, the officially released regulations require more detailed information on the registration and filing of new raw materials, and the required information can better meet the requirements of safety management of new cosmetic raw materials. The following Xiao 'an summarizes the officially released regulations, methods and regulations, and combs out the important contents related to the registration and filing of new cosmetic raw materials.

 

I. registrant/filer of new cosmetic raw materials

Domestic enterprises: The registration/filing authority can be opened by filling in basic information and submitting an overview of the security risk monitoring and evaluation system through the service platform.

Overseas enterprise: the enterprise legal person in 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 submit the original power of attorney and notarial certificate of the domestic responsible person to open the registration/filing authority.

* Obligations to be performed by domestic responsible persons include registering and filing new cosmetics raw materials in the name of registrants and filers; Assist registrants and filers to carry out safety monitoring and reporting of new cosmetic raw materials; Assist registrants and filers in the recall of new cosmetic raw materials; In accordance with the agreement with the registrant and the record holder, bear the corresponding quality and safety responsibility for the new raw materials of cosmetics in China; Cooperate with the supervision and inspection work of the drug supervision and administration department.

 

II. Applicability of New Cosmetic Raw Material Management

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

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

 

III. The registration of new raw materials for cosmetics dual-track management

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

Filing: New raw materials except for registration

* The difference between registration and filing is that new raw materials suitable for filing can be put into use after submission of information; However, the materials of new raw materials suitable for registration must be reviewed and approved by the review committee before being used in cosmetics, and the review period is generally from 6 months to 1 year.

 

IV. Requirements for Registration and Filing Materials

Cosmetic registration and filing materials are required to be classified 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 registration or filing management. See the final schedule of the article for details.

In the past, when communicating with customers and friends, Xiao 'an found that most of the concerns focused on the requirements of "safe use history of cosmetics listed overseas for more than three years" and "safe consumption history".

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

Those who meet all the following conditions can be regarded as new raw materials that have been used safely for more than three years in cosmetics listed overseas:

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

B cosmetics containing the raw materials shall be listed overseas for no less than 3 years;

C. Relevant evidential materials that can prove that there are enough people using cosmetics containing the raw materials abroad;

D cosmetics containing the raw materials listed overseas have not experienced serious adverse reactions or group adverse reactions caused by the raw materials;

E. there is no relevant literature report that this raw material may cause harm to human health.

With one of the following conditions, it can be regarded as a new raw material with a safe eating history:

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

B safe edible raw materials issued by relevant supervision and management departments, technical institutions or other authoritative institutions at home and abroad.

 

 

V. Post-registration management

(1) samples of new raw materials for cosmetics are kept for future reference

The registrant, filing person or domestic responsible person of new cosmetic raw materials shall keep samples of new raw materials for future reference. Samples of new raw materials for cosmetics should have complete packaging and labels, and the labels should include the names of registrants, filers or domestic responsible persons of new raw materials, Chinese names of raw materials, INCI names, production dates and use periods, storage conditions and other information.

(2) Reporting system

The new cosmetics raw materials that have been registered and put on record shall be subject to safety monitoring system. The period of safety monitoring is 3 years, starting from the date when cosmetics that use new raw materials of cosmetics for the first time get registered or complete the filing.

During the period of safety monitoring, only the registrant, filer or its authorized person of new cosmetic raw materials can use the new cosmetic raw materials to produce cosmetics. When applying for registration and filing of related cosmetics, it should be confirmed by the registrant and the filing person of new cosmetics raw materials through the information service platform.

During the monitoring period, the registrants and filers of new cosmetic raw materials shall submit annual reports through the online system according to the regulations. If they find any situations that need to be reported to the technical review institution according to the regulations or other situations that need to be reported, they shall immediately collect relevant information and submit them to the technical review institution through the information service platform.

annual report

Information on cosmetics registrants, filers or entrusted production enterprises that use new raw materials to produce cosmetics;

Information on cosmetics produced with new raw materials, including product name, product registration certificate or filing certificate number, product production, import and sales quantity, etc.;

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

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

Management system and measures for risk monitoring and evaluation of cosmetics produced by cosmetics manufacturers using new raw materials.

The method stipulates the circumstances that need to be reported

Other countries (regions) find serious cosmetic adverse reactions or group adverse reactions suspected to be caused by the use of similar raw materials;

Other countries (regions) cosmetics laws, regulations and standards 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 raw materials.

 

IV. included in the catalogue of used cosmetics raw materials

Three years after the expiration of the safety monitoring of new cosmetic raw materials, the technical evaluation institution shall put forward opinions to the State Drug Administration on whether the new cosmetic raw materials meet the safety requirements.

For new cosmetic raw materials with safety problems, the State Drug Administration shall cancel the registration or cancel the record; If there is no safety problem, it shall be included in the catalogue of used cosmetic raw materials by the State Drug Administration.

 

 

Scenario分类 资料要求		Scenario1	Scenario2	Scenario3	Scenario4	Scenario5	Scenario6
一、基本信息	1.注册或备案原料信息表	○	○	○	○	○	○
二、研制报告	2.研发背景	○	○	○	○	○	○
	3.原料基本信息	○	○	○	○	○	○
	4.原料使用信息①	○	○	○	○	○	○
	5.功能依据资料	○	○	○	○	○	○
	6.研制相关的其他资料	○	○	○	○	○	○
三、制备工艺 及质量控制标准	7.制备工艺简述	○	○	○	○	○	○
	8.稳定性试验数据	○	○	○	○	○	○
	9.质量规格指标及其检验方法	○	○	○	○	○	○
	10.可能存在的安全性风险物质及其控制等资料②
四、安全性评价	11.毒理学安全性评价综述	○	○	○	○	○	○
	12.急性经口或急性经皮毒性试验③	○	○	○	○
	13.皮肤和眼刺激性/腐蚀性试验	○	○	○	○	○	○
	14.皮肤变态反应试验	○	○	○	○	○
	15.皮肤光毒性试验④
	16.皮肤光变态反应试验⑤
	17.致突变试验	○	○	○	○
	18.亚慢性经口或经皮毒性试验	○	○		○
	19.致畸试验	○
	20.慢性毒性/致癌性结合试验	○
	21.吸入毒性试验⑥
	22.长期人体试用安全试验	○
	23.其他毒理学试验⑦
	24.安全性评估报告	○	○	○	○	○	○
五、其他资料	25.新原料技术要求	○	○	○	○	○	○
	26.可能有助于化妆品新原料注册和备案的其他资料⑦

Scenario 1: It is used for the first time at home and abroad with the functions of antisepsis, sun protection, coloring, hair dyeing, freckle whitening, hair loss prevention, acne removal, wrinkle resistance (except physical wrinkle resistance), dandruff removal and deodorization, as well as other new cosmetic raw materials with high biological activity;

Scenario 2: New raw materials that are used for the first time at home and abroad and do not have anti-corrosion, sun protection, coloring, hair dyeing, freckle whitening, hair loss prevention, acne removal, wrinkle resistance (except physical wrinkle resistance), dandruff removal and deodorization functions;

Scenario 3: New raw materials without anticorrosion, sun protection, coloring, hair dyeing, freckle whitening, hair loss prevention, acne removal, wrinkle resistance (except physical wrinkle resistance), dandruff removal and deodorization, and can provide sufficient evidence to prove that the raw materials have been used safely in cosmetics listed overseas for more than three years;

At the same time, it can provide the safety assessment report that the international authoritative safety assessment agency concluded that it is safe to use in cosmetics or the human safety inspection report under ethical conditions, but it may not provide the acute oral or acute percutaneous toxicity test data;

Scenario 4: It has the functions of anticorrosion, sun protection, coloring, hair dyeing, freckle whitening, hair loss prevention, acne removal, wrinkle resistance (except physical wrinkle resistance), dandruff removal and deodorization, and can provide sufficient evidence to prove that the raw material has been used safely in cosmetics listed overseas for more than three years;

Scenario 5: New cosmetic raw materials with safe consumption history (the parts used by raw materials should be consistent with the edible parts), and the risk assessment of raw materials should be carried out according to the exposure and use methods of raw materials;

Scenario 6: Chemically synthesized polymer with one or more structural units connected by covalent bonds, with an average relative molecular weight greater than 1000 Daltons, and oligomers with a relative molecular weight less than 1000 Daltons with less than 10% and stable structure and properties (except raw materials with high biological activity).