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Information Details

Detailed interpretation of the latest "Guidelines for Filling in Cosmetic Raw Material Safety Information Registration Platform" in 2023

Release time:

2023-09-06 09:22

Detailed interpretation of the latest "Guidelines for Filling in Cosmetic Raw Material Safety Information Registration Platform" in 2023
On September 4, 2023, in order to further standardize and guide the filling of the cosmetic raw material safety information registration platform, in accordance with the relevant requirements such as the Regulations on the Supervision and Administration of Cosmetics, the Measures for the Administration of Cosmetic Registration and Filing, 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), the Central People's Procuratorate organized and formulated the "Guidelines for Filling in Cosmetic Raw Material Safety Information Registration Platform" (hereinafter referred to as the "Guidelines"), and simultaneously completed the update of the submission system in the afternoon of the same day.

New Anrun Consulting has carried out a detailed analysis of the new guidelines. The full text of the new guidelines is attached below, and the corresponding interpretation is carried out in important parts for the reference of customers.

The submission system has been updated:

Major changes!

Only the raw materials included in the Catalog of Used Cosmetic Raw Materials (2021 Edition) can be submitted in the form of single-component raw materials, and compound raw materials cannot be submitted.

How to submit the compound raw materials of raw material manufacturers? The following submission strategies are for your reference:

1., if the compound raw materials are composed of the main ingredients and other ingredients (such as antioxidants, etc.) added to the raw materials to ensure the quality of cosmetic raw materials, only the main ingredient information needs to be filled in, and other trace ingredient information needs to be filled in the process brief or raw material quality and characteristic indicators.

According to the Technical Guidelines for Filling in Cosmetic Formulation issued on September 4, 2023, the ingredients of cosmetic formula 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 the extremely small amount of ingredients (such as antioxidants, etc.) added to the raw materials in order to ensure the quality of cosmetic raw materials and in the formula, the inevitable trace impurities in the technical process carried or left by the raw materials themselves, and the processing aids removed in the subsequent production steps that are added in the product production process but do not react with other ingredients and do not work on the final product.

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.

2., if the content of each component in the compound raw material is greater than 1%, or you can consider submitting each single component in the component to obtain a single submission code.

It should be noted that the single component submission should be carried out by the corresponding manufacturer, and the raw material supplier who only carries out the compounding operation cannot submit it.

Guidelines for Filling in Cosmetic Raw Material Safety Information Registration Platform

Article 1 In order to implement the main responsibility of enterprise quality and safety and ensure product quality and safety, in accordance with the "Regulations on the Supervision and Administration of Cosmetics", "Administrative Measures for the Registration and Filing of Cosmetics" (hereinafter referred to as the "Measures") and the "State Food and Drug Administration on Further Optimizing the Safety of Cosmetic Raw Materials Announcement on Matters Related to Information Management Measures (No. 34, 2023)" and other relevant regulations, prepare this guide.

Article 2 In order to facilitate enterprises to fill in cosmetics safety information materials, the State Food and Drug Administration has established a cosmetics raw material safety information registration platform (hereinafter referred to as the raw material platform), which is mainly used for the "Catalog of Used Cosmetic Raw Materials (2021 Edition)" (hereinafter referred to as "Catalog") The unified registration of relevant safety information of used cosmetic raw materials included.

Article 3 This guide is used to guide raw material manufacturers to standardize the use of raw material platforms. Raw materials with independent serial numbers in the Catalog are suitable for registering safety information on the raw material platform.

Article 4 Raw material manufacturers shall, in accordance with the requirements of relevant laws and regulations and technical specifications, register raw material safety information through the raw material platform, and be responsible for the authenticity and integrity of the content of the registered raw material safety information.

Article 5 The manufacturer of cosmetic raw materials may submit the safety information of cosmetic raw materials by itself, and may also authorize overseas or domestic legal person enterprises to submit and maintain the safety information of raw materials. Only one enterprise can be authorized to submit the safety information of raw materials of the same quality specification.

Among them, the manufacturer of cosmetic raw materials refers to the enterprise that is responsible for the safety of raw materials, which can be the actual production enterprise of raw materials, the affiliated enterprise belonging to the same group company as the actual production enterprise of raw materials, or the entrusted enterprise in the entrusted production of raw materials.

Article 6 Cosmetic raw material manufacturers or authorized enterprises shall fill in the enterprise information form in accordance with the Provisions and upload the following documents:

A scanned copy of the seal of the (I) enterprise information form;

Certificate of the main body of the (II) raw material manufacturer;

If the (III) is authorized to submit, the authorization letter issued by the manufacturer of cosmetic raw materials shall also be uploaded at the same time.

If the overseas raw material manufacturer submits it on its own, or authorizes the overseas enterprise to submit it, the main body certification document of the raw material manufacturer shall be notarized by the Chinese notary office or confirmed by the Chinese embassy (consulate), and the relevant documents shall be uploaded together with the main body certification document. Where an overseas raw material manufacturer authorizes a domestic enterprise to submit a report, the domestic authorized enterprise shall verify the enterprise subject and relevant information of the overseas raw material manufacturer.

Article 7 The safety information of cosmetic raw materials mainly includes the contents related to the safety of raw materials, such as the quality specifications of raw materials, the control of safety risk substances, the safety risk assessment conclusion of raw materials, etc., and the filling style is shown in the annex.

Article 8 The relevant information of raw material quality specifications includes basic information and process description, raw material quality and characteristic indicators.

Article 9 Information related to the control of safety risk substances includes risk information and control indicators.

Article 10 Where an authoritative institution at home and abroad has organized a safety risk assessment of the relevant raw materials and has a relevant assessment conclusion, it shall fill in the relevant information of the safety risk assessment conclusion such as the name of the assessment institution and the assessment conclusion.

Article 11 After the raw material manufacturer completes the registration of the raw material safety information on the raw material platform as required, the raw material platform will automatically generate the corresponding raw material safety information submission code.

Article 12 The raw material safety information submission code consists of the corresponding serial number of the raw material in the Catalog, the raw material manufacturer's code, and the raw material platform registration serial number.

The raw material safety information submission code is only for the cosmetics registrant and the filing person to fill in the raw material safety information when the product is registered and filed, and is provided by the raw material manufacturer to the cosmetics registrant and the filing person, and the raw material platform is not publicized to the public.

Article 13 As the main body responsible for product quality and safety, the registrant and the filing person of cosmetics shall examine and evaluate the authenticity and integrity of the contents of the raw material safety letter provided by the raw material manufacturer. If it is believed that there is a problem with the authenticity, the raw material shall not be used; if it is believed that there is a problem with the integrity, the cosmetic registrant and the filing person may supplement and collect the corresponding raw material safety information, and submit the raw material safety information by filling in the information by themselves. At the same time, explain the problems existing in the raw material submission code.

Attachment

Filling style of safety information of cosmetic raw materials

[1. basic information and process brief]]

Name of raw material

Chinese Name *

INCI Name/English Name

Serial number in Catalog of Used Cosmetic Raw Materials

Remarks
Nano raw materials need to note "(nano-scale)"; If hydrocarbons from petroleum and coal tar are used, CAS number shall be noted, except for single components. If the colorant is lake, you can choose to note "(lake)" and explain the type of lake used.

Raw material classification and key characteristics

a. Basic characteristics of raw materials

Single compounds with well-defined structure

£ Polymer/mixture

Other mixtures

B. Sources of raw materials

£ Synthesis

£ Plants (direct source)

£ Plant (indirect source)

£ Animals (direct source)

£ Animals (Indirect source)

Algae and macrofungi (direct source)

Algae and macrofungi (indirect source)

Bacteria, fungi or other single-celled organisms

£ Mineral

£ Other

c. Raw material production methods

£ Natural Presence

chemical synthesis

£ Physical comminution/pressing/separation only

Solvent extraction

Hydrolysis

Fermentation or cell/tissue culture using genetic engineering techniques

£ Other general fermentation or cell/tissue culture

£ Other

d. Other characteristics

Peptide

£ Protein

£ Nano raw materials

£ Flavor

in cosmetics

Recommended amount of addition

Resident cosmetics

XX-XX %

Leaching cosmetics

XX-XX %

Other Restrictions on Use

Formula taboo

It is not recommended to use with the following raw materials:

XX 、 XX 、 XX……

Other Restrictions on Use

Warning language

Raw material properties *

Color

Smell

Form

Description of physical and chemical properties

Solubility

(Water soluble/fat soluble/insoluble/other, check as required; Log Pow is optional)

□ water soluble □ fat soluble □ insoluble □ others

Lipid-water partition coefficient Log Pow:

Other Nature

Production Process Overview *

A brief overview of the production process:

£ Plants (direct source)

£ Animals (direct source)

Algae and macrofungi (direct source)

Latin name *

Theoretical feed ratio

Serial Number

Item Name

Numerical

Unit

……

Fermentation or cell/tissue culture using genetic engineering techniques

Gene Donor Organisms *

Original genetic information *

Gene Modification Information *

Vector construction *

Engineering Bacteria Information or Cell/Tissue Source *

Latin name *

……

£ Other general fermentation or cell/tissue culture

Engineering Bacteria Information or Cell/Tissue Source *

Latin name *

……

2. raw material quality and characteristic index]

Raw material identification method

Raw material quality and characteristic index
Serial Number	Indicators *	Molecular formula	CAS No.	Theoretical value *		Inspection method
Serial Number	Indicators *	Molecular formula	CAS No.	Numerical	Unit	Inspection method
Single compounds with well-defined structure
1				XX-XX
2	……
3	……
£ Polymer/mixture (First, select "Chinese name" from the "raw material composition" information, then generate the following fixed items, and supplement other contents by themselves)
1	degree of polymerization			XX-XX
2	average molecular weight			XX-XX	Da
3	……
£ Plant material (direct source) (First, select "Chinese name" from the "raw material composition" information, then generate the following fixed items, and supplement other contents by themselves)
1	First check (index component, total component, evaporation residue, solid content, loss on drying/moisture, ignition residue, typical physical and chemical index, other) from the drop-down menu, and then fill in the specific index name
2	……
3	……
Peptide (First, select "Chinese name" from the "raw material composition" information, then generate the following fixed items, and supplement other contents by themselves)
1	Number of amino acids *	……		XX-XX
	Types of amino acids *	Drop-down menu "other" fill in......
	Characterization of sequence, composition or structure *	……
	Average molecular weight *			XX-XX	Da
	Amino acid sequence (oligopeptide raw materials should be clear amino acid sequence)	(Fill in, you can upload PDF at the same time)

2	……
3	……
£ Protein (First, select "Chinese name" from the "raw material composition" information, then generate the following fixed items, and supplement other contents by themselves)
1	Number of amino acids *			XX-XX
	amino acid type	Drop-down menu "other" fill in......
	Characterization of sequence, composition or structure *	……
2	Average molecular weight *			XX-XX	kDa
3	……
£ Nano raw materials (First, select "Chinese name" from the "raw material composition" information, then generate the following fixed items, and supplement other contents by themselves)
1	Particle size range *			XX-XX	nm
2	Average particle size * (Quantity Size Distribution)	(The average particle size of the two forms, generally at least one should be optional)		XX-XX	nm
3	Average particle size * (mass size distribution)			XX-XX	nm
4	Surface Modification *	(Insert "None" if no surface finish is present)
5	……
Note: The above items are required for some types of raw materials; Other types of raw materials, according to the actual situation to fill

3. risk information and control indicators (if necessary)

Heavy metal risk
Serial Number	Quality Control Item/Risk Name Substance *	CAS No.	Limit requirements *		Remarks
Serial Number	Quality Control Item/Risk Name Substance *	CAS No.	Numerical	Unit	Remarks
1	Basic drop-down menu: Lead/Arsenic/Mercury/Cadmium/Other (Editable if selected)		XX-XX	Mg/kg
2
……
Microbiological risk
1	Basic drop-down menu: Total number of colonies/total number of molds and yeasts/thermotolerant coliform bacteria/staphylococcus aureus/pseudomonas aeruginosa/others (editable after selection)		XX-XX	/g /mL CFU/g CFU/mL
2
……
Pesticide residue risk
1			XX-XX
2
……
Other risks
1	Basic drop-down menu: Methanol/dioxane/asbestos/formaldehyde/diethylene glycol/phenol/acrylamide/secondary alkane amine/nitrosamine/1,3-butadiene/hydroquinone/benzene/others (editable after selection)		XX-XX
2
……

[Evaluation conclusion of 4. international authority] (optional)

Assessment Agency	Evaluation quantity or safety limit		Constraints	Assessment Report
Assessment Agency	Numerical	Unit	Constraints	Assessment Report
Basic drop-down menu: SCCS/CIR/IFRA/WHO/FAO/Other (Editable if selected)	……	……	Basic drop-down menu: Resident Class/Rinsing Class/Other (editable after selection)	(Upload PDF)
	……	……	……
	……	……	……
……
……

[Brief Description of Requirements for Use in Other 5. Industries] (Optional)

[6. other issues that need to be explained] (optional)

Note:

1. Items marked with "*" in the filling style are required.

2. According to the raw material classification and key feature information checked by the enterprise, the following items filled in the raw material safety information part are set as default. Raw material manufacturers should be based on the actual situation of raw materials and regulatory requirements, to determine whether it is applicable. If the filling items set by default are not applicable, you can fill in "/"; If the contents required to be filled in in the regulations are not included, you can add filling.

3. If the name of the raw material fails to include some specific information and needs further remarks, it can be filled in the corresponding remarks column. For example, nano-raw materials should be noted "(nano-scale)"; If hydrocarbons derived from petroleum and coal tar are used (except for single components), CAS number shall be noted (see Annex 1 for the reference list); If the colorant is lake, the remark "(lake)" can be selected and the type of lake used can be explained.

4, oligopeptide raw materials should be clear amino acid sequence; When filling in the sequence, 20 natural amino acids should use Chinese names or standard three-letter or one-letter abbreviations, see attachment 2.

5. For raw materials of plants (direct source), animals (direct source), algae and macrofungi (direct source), fill in the theoretical feeding ratio according to the production process, such as necessary solvents or stabilizers, preservatives, antioxidants, etc. added in the production process, according to the amount of 1000kg added.

6. For other types of raw materials, such as raw materials for chemical synthesis, in the production process, such as adding stabilizers, preservatives, antioxidants, etc., the raw material quality and characteristic indicators column fill in the addition ratio of the substance in the raw materials.

Reference list of raw materials with CAS number

Serial Number	Chinese name	INCI Name/English Name
00083	C10-11 isoparaffins	C10-11 ISOPARAFFIN
00084	C10-12/naphthene	C10-12 ALKANE/CYCLOALKANE
00085	C10-12 isoparaffins	C10-12 ISOPARAFFIN
00086	C10-13 isoparaffins	C10-13 ISOPARAFFIN
00094	C11-12 isoparaffins	C11-12 ISOPARAFFIN
00095	C11-13 isoparaffins	C11-13 ISOPARAFFIN
00128	C12-14 isoparaffins	C12-14 ISOPARAFFIN
00154	C12-15 isoparaffins	C12-15 ISOPARAFFIN
00166	C12-20 isoparaffins	C12-20 ISOPARAFFIN
00167	C13-14	C13-14 ALKANE
00168	C13-14 isoparaffins	C13-14 ISOPARAFFIN
00169	C13-15	C13-15 ALKANE
00170	C13-16 isoparaffins	C13-16 ISOPARAFFIN
00179	C15-19	C15-19 ALKANE
00180	C15-23	C15-23 ALKANE
00186	C18-21	C18-21 ALKANE
00219	C7-8 isoparaffins	C7-8 ISOPARAFFIN
00224	C8-9 isoparaffins	C8-9 ISOPARAFFIN
00228	C9-11 isoparaffins	C9-11 ISOPARAFFIN
00229	C9-12	C9-12 ALKANE
00231	C9-13 isoparaffins	C9-13 ISOPARAFFIN
01699	pure ozokerite	CERESIN
01909	Ozokerite	OZOKERIES
04183	Mineral oil	MINERAL OIL
04184	Mineral oil essence	MINERAL SPIRITS
04185	Petrolatum	PETROLATUM
06127	paraffin wax	PARAFFIN
06783	microcrystalline wax	MICROCRYSTALLINE WAS
06784	microcrystalline wax	MICROCRYSTALLINE WAX
07661	Liquid paraffin	PARENTS

Attached are the Chinese names and standard abbreviations of 20 kinds of natural amino acids.

Serial Number	English Name	Chinese name	Three-letter abbreviation	Single letter abbreviation
1	Alanine	Alanine	Ala	A
2	Arginine	Arginine	Arg	R
3	Asparagine	Asparagine	Asn	N
4	Aspartic acid	Aspartic acid	Asp	D
5	Cysteine	Cysteine	Cys	C
6	Glutamine	Glutamine	Gln	Q
7	Glutamic acid	Glutamic acid	Glu	E
8	Glycine	Glycine	Gly	G
9	Histidine	Histidine	His	H
10	Isolecine	Isoleucine	Ile	I
11	Leucine	Leucine	Leu	L
12	Lysine	Lysine	Lys	K
13	Methionine	Methionine	Met	M
14	Phenylalanine	Phenylalanine	Phe	F
15	Proline	Proline	Pro	P
16	Serine	Serine	Ser	S
17	Threonine	Threonine	Thr	T
18	Tryptophan	Tryptophan	Trp	W
19	Tyrosine	Tyrosine	Tyr	Y
20	Valine	Valine	Val	V