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Information Details

Notice of the Central People's Procuratorate on Issuing the Technical Guidelines for Filling Cosmetic Formulations (No. 2 of 2023)

Release time:

2023-09-07 09:23

Technical Guidelines for Filling Cosmetic Formulations

1. Foreword

In order to further guide the filling of cosmetic formulations, these guiding principles are formulated in accordance with regulations such as the regulations on the Supervision and Administration of Cosmetics, the measures for the Administration of Cosmetic Registration and filing, the provisions on the Administration of Cosmetic Registration and filing materials, and the announcement of the State Food and Drug Administration on matters related to further optimizing the safety information management measures of cosmetic raw materials (No. 34 of 2023).

This guiding principle combines the different situations of the raw materials used in the formulation of cosmetic products, combs the specific issues involved in the filling, and provides suggestions and guidance for the filling of product formulations. Cosmetic registrants, filers or domestic responsible persons shall comply with the actual situation of cosmetic research and development and the basic requirements of this guiding principle when filling in the product formula.

These guidelines are formulated under the current regulations and standards and the current level of scientific cognition. With the update and improvement of regulations and standards, and the development of science and technology, they will be adjusted in due course.

2. scope of application

This guiding principle is applicable to guiding the filling of cosmetic product formula, including the requirements of formula ingredients, the filling form of formula, the name of raw materials, the content of raw materials, the main purpose of use and the filling of the remarks column of the formula table, and the filling of raw material safety information. Cosmetics registrants, filers or domestic responsible persons shall use these Guiding Principles under the premise of following relevant regulations and technical standards. If it meets the scope of application of other guiding principles at the same time, the technical suggestions or technical requirements of the corresponding guiding principles should also be referred.

3. General Principles

Cosmetic formula ingredients refer to the ingredients that are purposefully added to the product formula during the production process and play a certain role in the final product, including preservatives, sunscreens, hair dyes, colorants, moisturizers, pH regulators, viscosity regulators, etc. It does not include extremely trace ingredients (such as antioxidants, etc.) added to raw materials to ensure the quality of cosmetic raw materials and in the formula, the raw material itself with or residual technical process inevitable trace impurities, as well as in the product production process but not with other components of the chemical reaction, the final product does not work in the subsequent production steps to remove the processing aids.

The cosmetic registrant, the archivist or the domestic responsible person shall, in combination with the actual situation of the cosmetic raw materials used, judge whether the raw materials/raw material ingredients meet the requirements of the above cosmetic formula ingredients by means of relevant materials issued by the raw material manufacturer, consulting literature, conducting research and testing, etc. If they are not used as formula ingredients, they can choose not to fill in the product formula, however, the ingredients in the list of permitted preservatives in the "Cosmetic Safety Technical Specification" and the ingredients in the list of permitted sunscreens added to protect the product itself are excluded.

Cosmetic registrants, filers or domestic responsible persons shall be responsible for the quality of the selected raw materials. Raw materials/raw material ingredients that are not used as formula ingredients may not be filled in the product formula, but they should still be fully analyzed and safety evaluated.

4. Formula Filling Form

According to the formula form (Annex 1), fill in the raw material serial number, raw material name, percentage content, main purpose of use, etc.

(I) single component raw materials

If a cosmetic manufacturer mixes single-component raw materials in advance before feeding, the raw materials used for mixing shall be filled in the formula in the form of single-component raw materials, and the mixing process and process shall be filled in the production process section of the product.

(II) non-single component raw materials

Non-single component raw materials refer to raw materials containing two or more components. The components and corresponding contents shall be listed when filling in, except for the components of essence and raw materials that are not cosmetic formula components.

If the plant extract raw materials obtained from the mixed processing of various plants are used in the formula, the formula shall be filled in the form of non-single component raw materials, and each plant extract shall be listed separately as different components, and the percentage content of each component shall be filled in according to the raw material information.

(III) categories of raw materials

If the category of raw materials are used, the name of the category of raw materials shall be filled in accordance with the catalogue of used cosmetic raw materials (hereinafter referred to as the catalogue of raw materials), and the name of the specific raw materials shall be indicated as required. When the specific raw materials used are not included in the "Raw Material Catalog", the certification materials that the specific raw materials have been registered or filed in China shall be provided.

Name of 5. formula raw material

The name of the formula raw material includes the standard Chinese name, the international cosmetic raw material name (INCI name for short) or the English name.The name of the formula raw material shall use the standard Chinese name and INCI name/English name specified in the "Raw Material Catalog. If the formula uses new raw materials for cosmetics that are still under safety monitoring, fill in the name of the new raw materials that have been registered or filed.

The Chinese name must be consistent with the INCI name/English name. If the INCI name of the ingredients marked in the original package of the imported product is inconsistent with the name of the formula raw material, the corresponding explanation shall be made in the remarks column of the formula table.

For use as a colorant, fill in the colorant index number (CI number for short) specified in the "Cosmetic Safety Technical Specification" in the name column of formula raw materials, except for those without CI number; If the colorant is lake, "(lake)" shall be marked after the name of the colorant; If nano-raw materials are used, "(nano-scale)" shall be marked after the name of such ingredients ".

Percentage content of raw materials in 6. formula

The raw materials of the formula shall be arranged in descending order of content, and the content shall be calculated as mass percentage, and the total content of raw materials shall be 100.

If the formula contains propellant that is in direct contact with the product contents, the composition and content of the propellant shall be reported separately, with the total propellant content of 100, and the filling ratio of the propellant and the material body shall be marked.

If the formula addition amount fluctuates within a certain range and regulates the final product, such as pH regulator and viscosity regulator, the cosmetic registrant, the filing person or the domestic responsible person can fill in the typical value of the addition amount of such raw materials in the formula table according to the actual situation, or note the range value of the actual addition amount at the bottom of the formula table (Annex 2). If the actual addition amount range value is noted, the safety assessment will be carried out with the maximum addition amount, ensure that the product is safe and the quality is controllable within the range of addition amount.

Purpose of use of 7. formula raw materials

Cosmetic registrants, filers or domestic responsible persons shall mark the main purpose of use according to the actual role of raw materials in the product.

For cosmetics claiming the efficacy of hair dyeing, perm, freckle removing and whitening, sunscreen, alopecia preventing, acne removing, anti-wrinkle, dandruff removing and deodorizing, and cosmetics claiming new efficacy (except for special groups), the corresponding efficacy raw materials shall be marked in the purpose column of the formula table. If the above efficacy raw materials to be marked are not single components, the specific efficacy ingredients shall be specified in the purpose column of the purpose column.

Remarks column of 8. formula table

The further description of the raw materials filled in the formula table shall be marked in the remarks column of the formula table. For example, if hydrocarbon (except single component) raw materials from petroleum and coal tar are used, the chemical abstract index number (CAS number for short) of the raw materials shall be indicated; if denatured ethanol raw materials are used, the name and dosage of denaturant shall be indicated; if classified raw materials are used, the specific raw material name shall be indicated; if raw materials directly derived from plants are used, the specific use parts of the original plants shall be marked according to the instructions in the catalogue of the catalogue; if only "essence" raw materials are filled in the product formula table, if the product label identifies the specific fragrance components in the essence, and if the original packaging label of the imported product contains the specific fragrance components, it shall be explained in the remarks column of the formula table; If the formula raw materials have the same name but are filled in separately, the reasons for filling in the formula list are briefly marked in the remarks column, such as the raw materials have different molecular weights, different trade names, etc; the colorant used is a lake, and the kind of the lake used and the like should be described.

9. raw material safety information

Cosmetics registrants, filers or domestic responsible persons shall fill in and upload the safety information files of raw materials in accordance with the requirements of the Announcement of the State Food and Drug Administration on Further Optimizing the Safety Information Management Measures for Cosmetic Raw Materials (No. 34, 2023) and in combination with the actual situation of the raw materials used. Please refer to the relevant guidelines for filling requirements of raw material safety information. For raw materials that need to provide quality specifications issued by the raw material manufacturer in the safety assessment report, if the raw material safety information has been filled in, it may not be submitted repeatedly in the safety assessment report.

If the raw material manufacturer has registered in the cosmetic raw material safety information registration platform and obtained the raw material safety information submission code, the cosmetic registrant, the filing person or the domestic responsible person may also associate the raw material safety information through the submission code.

Safety assessment of raw materials/ingredients that are not 10. as ingredients in formulations

Ingredients/ingredients that are not part of the formula shall be described one by one in the product safety assessment data (Annex 3).

Cosmetic registrants, filers or domestic responsible persons shall be responsible for the quality of the selected raw materials. Raw materials/raw material components that are not used as formula components may not be filled in the product formula, but the raw materials/raw material components that are not filled in shall still be analyzed and evaluated in the product safety assessment data, such as the processing aids added in the product production process and removed in the subsequent production steps, and the residual amount shall be fully evaluated; assessment of the safety of ingredients with low content in raw materials produced by innovative technologies (e. g. trace cholesterol, phospholipids, etc. in liposomes); assessment of possible safety risks of raw materials/raw material ingredients not reported as formula ingredients in children's products, etc., to ensure product safety and quality control.

When the type and/or content of raw materials/raw material components not used as formula components change without affecting the product quality and safety, the cosmetic registrant, the archivist or the domestic responsible person shall update and maintain the product formula and product safety evaluation data; when the type and/or content increases and may affect the product safety evaluation conclusion, cosmetic registrants, filers or domestic responsible persons shall change the product safety assessment information.

Annex 1 Formula Table Style

1. formula table

Serial Number

Standard Chinese

Name

INCI Name/English Name

Raw material content (%)

Compound percentage (%)

Actual composition content (%)

Main purpose of use

Remarks

2. Recipe Table Attachment

Serial Number	Standard Chinese Name	Raw material submission code

Description: In principle, the effective figures of raw material content and actual ingredient content in the formula table shall not be less than one effective figure and not more than five effective figures.

Annex 2 Sample Formulation Form (Non-Formula Ingredients Not Filled)

Example of sunscreen formula

Serial Number	Standard Chinese Name	INCI Name/English Name	Raw material content （%）	Compound percentage （%）	Actual composition content (%)	Use Purpose	Remarks
1	Water	WATER	60.15	100	60.15	Solvent
2	Ethylhexyl Methoxycinnamate	ETHYLHEXYL METHOXYCINNAMATE	8	99.95	7.996	sunscreen
3	C12-15 alcohol benzoate	C12-15 ALKYL BENZOATE	7	46	3.22	Sunscreen: titanium dioxide (nano)
	Titanium dioxide (nano)	TITANIUM DIOXIDE（NANO）		39	2.73
	Alumina	ALUMINA		9	0.63
	hydrogenated polydimethylsiloxane	HYDROGEN DIMETHICONE		6	0.42
4	Bis-ethylhexyloxyphenol methoxyphenyl triazine	BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE	6	100	6	sunscreen
5	ethyl hexyl salicylate	ETHYLHEXYL SALICYLATE	4	100	4	sunscreen
6	Water	WATER	3	60	1.8	Humectant
	Butanediol	BUTYLENE GLYCOL		30	0.9
	Portulaca oleracea (PORTULACA OLERACEA) Extract	PORTULAC OLERACEA EXTRACT		9	0.27		Use parts: whole plant
	phenoxyethanol	PHENOXYETHANOL		0.4	0.012
	Benzophenone -4	BENZOPHENONE-4		0.1	0.003
7	denatured ethanol	Alcohol density.	2.5	100	2.5	Solvent	Denaturant: Benzodium, 0.0015%
8	C13-16 isoparaffins	C13-16 ISOPARAFFIN	2	100	2	emollients	CAS No.: 64742-47-8
9	Water	WATER	1.8	82	1.476	Humectant
	Algae Extract	ALGAE EXTRACT		10	0.18		Specifically palmate kelp (LAMINARIA DIGITATA) extract
	Arginine	ARGININE		5	0.09
	Sodium Hyaluronate	SODIUM HYALURONATE		2.6	0.0468
	methyl hydroxybenzoate	METHYLPARABEN		0.2	0.0036
	propyl hydroxyphenyl ester	PROPYLING ARABES		0.1	0.0018
10	Polysorbate -60	POLYSORBATE 60	1.6	100	1.6	Emulsifier
11	polydimethylsiloxane	DIMETHICONE	1	100	1	emollients	Different viscosity from No. 14 raw material
12	sortan stearate	SORBITAN STEARATE	0.7	100	0.7	Emulsifier
13	phenoxyethanol	PHENOXYETHANOL	0.6	100	0.6	Preservative
14	polydimethylsiloxane	DIMETHICONE	0.5	100	0.5	emollients	Different viscosity from No. 11 raw material
15	Xanthan gum	XANTHAN GUM	0.4	100	0.4	Thickener
16	CI 19140 (Lake)	CI 19140（LAKE）	0.35	100	0.35	Colorant	aluminum lake
17	(daily) flavor	FRAGRANCE	0.25	100	0.25	Fragrance
18	Citric acid	CITRIC ACID	0.15	100	0.15	pH regulator	The amount of filling is typical.
Total			100		99.9792		Non-formula ingredients are not filled in, so the actual ingredient content does not reach 100%

The filling of citric acid can also choose to note the range value of the actual addition amount at the bottom of the formula table. The reference remarks are as follows:

Citric acid is added to the formula, and the purpose of use is pH regulator to adjust the pH value of the system during the production process. The addition range is 0.1%~ 0.2%, and the water is adjusted to 100% in the formula table.

Attachment 3 Sample Schedule in Safety Assessment Report (to be filled together with non-formula components)

Example of sunscreen formula

Serial Number	Standard Chinese Name	INCI Name/English Name	Raw material content （%）	Compound percentage （%）	Actual composition content (%)	Use Purpose	Remarks
1	Water	WATER	60.15	100	60.15	Solvent
2	Ethylhexyl Methoxycinnamate	ETHYLHEXYL METHOXYCINNAMATE	8	99.95	7.996	sunscreen
2	butylated hydroxytoluene	BHT	8	0.05	0.004	sunscreen
3	C12-15 alcohol benzoate	C12-15 ALKYL BENZOATE	7	46	3.22	Sunscreen: titanium dioxide (nano)
	Titanium dioxide (nano)	TITANIUM DIOXIDE（NANO）		39	2.73
	Alumina	ALUMINA		9	0.63
	hydrogenated polydimethylsiloxane	HYDROGEN DIMETHICONE		6	0.42
4	Bis-ethylhexyloxyphenol methoxyphenyl triazine	BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE	6	100	6	sunscreen
5	ethyl hexyl salicylate	ETHYLHEXYL SALICYLATE	4	100	4	sunscreen
6	Water	WATER	3	60	1.8	Humectant
	Butanediol	BUTYLENE GLYCOL		30	0.9
	Portulaca oleracea (PORTULACA OLERACEA) Extract	PORTULAC OLERACEA EXTRACT		9	0.27		Use parts: whole plant
	1,2-Pentanediol	PENTYLENE GLYCOL		0.5	0.015
	phenoxyethanol	PHENOXYETHANOL		0.4	0.012
	Benzophenone -4	BENZOPHENONE-4		0.1	0.003
7	denatured ethanol	Alcohol density.	2.5	100	2.5	Solvent	Denaturant: Benzodium, 0.0015%
8	C13-16 isoparaffins	C13-16 ISOPARAFFIN	2	100	2	emollients	CAS No.: 64742-47-8
9	Water	WATER	1.8	82	1.476	Humectant
	Algae Extract	ALGAE EXTRACT		10	0.18		Specifically palmate kelp (LAMINARIA DIGITATA) extract
	Arginine	ARGININE		5	0.09
	Sodium Hyaluronate	SODIUM HYALURONATE		2.6	0.0468
	methyl hydroxybenzoate	METHYLPARABEN		0.2	0.0036
	propyl hydroxyphenyl ester	PROPYLING ARABES		0.1	0.0018
	Sodium bisulfite	SODIUM BISULFITE		0.1	0.0018
10	Polysorbate -60	POLYSORBATE 60	1.6	100	1.6	Emulsifier
11	polydimethylsiloxane	DIMETHICONE	1	100	1	emollients	Different viscosity from No. 14 raw material
12	sortan stearate	SORBITAN STEARATE	0.7	100	0.7	Emulsifier
13	phenoxyethanol	PHENOXYETHANOL	0.6	100	0.6	Preservative
14	polydimethylsiloxane	DIMETHICONE	0.5	100	0.5	emollients	Different viscosity from No. 11 raw material
15	Xanthan gum	XANTHAN GUM	0.4	100	0.4	Thickener
16	CI 19140 (Lake)	CI 19140（LAKE）	0.35	100	0.35	Colorant	aluminum lake
17	(daily) flavor	FRAGRANCE	0.25	100	0.25	Fragrance
18	Citric acid	CITRIC ACID	0.15	100	0.15	pH regulator	The amount of filling is typical.
Total			100		100