A Brief Analysis to the Draft of Safety and Technical Standards for Cosmetics (2022 Edition)

In order to implement the Cosmetics Supervision and Administration Regulations (hereinafter referred to as the Regulations) and to further improve the technical regulation system of cosmetics safety, on 31 Mar. 2022, the National Institutes for Food and Drug Control has issued the draft of Safety and Technical Standards for Cosmetics (2022 draft edition) for public consultation.

The Safety and Technical Standards for Cosmetics is an important technical regulation for cosmetics supervision and the research and development of cosmetics in China, which is formulated based on the Regulations Concerning the Hygiene Supervision over Cosmetics (1989). Since the release of the Standards in 2015, the Standards have been revised for 8 times. Moreover, after the issuance of the Regulations in 2020 and a series of supporting documents, the concept, mechanisms, and systems for cosmetic supervision has been dramatically changed. As a result, it is urgent to revise the corresponding parts prescribed in the Standards.

The framework of the draft Standards is basically unchanged, with a total of eight chapters.

Table 1 Comparison between the 2015 Edition and the 2022 Draft Edition

	2015 Edition	2022 Draft Edition
Chapter 1	Overview: including scope, terminology and definitions, general requirements for cosmetic safety	Overview: including scope, terminology and definitions, general requirements for cosmetic safety
Chapter 2	Requirements for prohibited and restricted components of cosmetics: including the requirements for 1388 prohibited raw materials and 47 restricted raw materials;	The inventory of prohibited and restricted ingredients for cosmetics: including the requirements for 1393 prohibited raw materials and 44 restricted raw materials
Chapter 3	Requirements for permitted components of cosmetics: including 51 preservatives, 27 sunscreens, 157 colorants and 75 hair dyes.	The inventory of permitted cosmetic ingredients: including 48 preservatives, 26 sunscreens, 156 colorants and 73 hair dyes.
Chapter 4	Methods of physical and chemical examination: 77 methods were included	Methods of physical and chemical examination: 67 methods were included
Chapter 5	Methods of microbiological examination: 5 methods were included	Methods of microbiological examination: 5 methods were included
Chapter 6	Methods of toxicological test: 16 methods were included	Methods of toxicological test: 24 methods were included
Chapter 7	Methods of human safety test: 2 methods were included	Methods of human safety test: 2 methods were included
Chapter 8	Methods of human efficacy evaluation test: 3 methods were included	Methods of human efficacy evaluation test: 5 methods were included

The major revisions are as follows:

1. Overview

According to the Regulations, Provisions on the Administration of New Cosmetic Ingredients Registration and Filing Data, Classification Catalogues of Efficacy Claims and Provisions on the Cosmetics Supervision and Administration Regulations of Children, the terms and definitions of prohibited raw materials, sunscreens, hair dyes, rinsing cosmetics products, eye cosmetics and substances with safety risks are revised and improved. Some terms are standardized and perfected, for example, "component" is standardized as "ingredient".

General requirements for cosmetics pH value are newly added: pH value of cosmetics should be between 2.0 and 11.5 (excluding 2.0 and 11.5) , except there are other relevant stipulations in the Standards. Combined with the adjustment of raw material management, modify the limit value of Mercury and delete "except for eye cosmetics containing organic mercury preservatives" in the remark columns of Table 2 in the 2015 edition.

2. Inventory of Prohibited and Restricted Ingredients for Cosmetics

NMPA released a notice (No.74, 2021) to update the Inventory of Prohibited Cosmetic Ingredients in China. The updates cover: the prohibited ingredients list (Table 1) and list of prohibited plants (animals) for cosmetics (Table 2) are adjusted, ingredients are sorted in English or Latin alphabetical order, and some ingredient information is corrected. In addition, according to the current situation of the industry and the relevant international environmental protection and chemical management regulations, "Mercury and its compounds (except mercury compounds in cosmetic preservatives)" in the prohibited ingredients list is changed to "Mercury and its compounds" .

Boric acid, Borate and Tetraborate (other than the ingredients listed in the prohibited ingredients list), Tetraborate, 8-Hydroxyquinoline, Formaldehyde, Nitromethane and Dichloromethane that are currently listed in the restricted ingredients (Table 3) list will be deleted from the list , as these substances will be included in the prohibited ingredients list under the 2022 draft edition. Other limits and requirements for 1,3-bis(hydroxymethyl)imidazolidine-2-thione are changed from "prohibited to use in spray products" to "prohibited to use in spray and aerosol products". In accordance with the Regulations and Cosmetic Classification Rules and Classification Catalogue, the limits of "inorganic sulfites and bisulfites" for "(c) automatic tanning products for facial use" and "(d) automatic tanning products for body use" are deleted. Considering that "TOLUENE is irreplaceable in some products, the use requirement for TOLUENE is added: "products for finger (toe), the maximum allowable concentration is 25%. Prevent children from holding, and only for adults". According to a notice on the inclusion of several testing methods, including the testing method for free Formaldehyde, into the Safety and Technical Standards for Cosmetics (2015 edition) (No. 12, 2019), notes of α-hydroxy acid was refined. In addition, the text formats of some ingredients are adjusted to avoid ambiguity.

3. Inventory of Permitted Cosmetic Ingredients

Benzylchlorophenol, Formaldehyde and Paraformaldehyde, Phenyl mercuric salts, including Phenylmercuric Borate as well as Thiomersal that are currently listed in the permitted preservatives list are deleted from the list, as these substances will be included in the prohibited ingredients list under the 2022 draft edition. According to the notice (No. 141, 2020) of the NMPA on approval of 4 ingredients as cosmetics raw materials, Ethyl Lauroyl Arginate HCL were added as a permitted preservative with the maximum allowable concentration of no more than 0.4% in cosmetics. The scope of use and restrictions: do not apply to lips and use in sprays and aerosol products; Conditions of use and precautions must be marked on the label: avoid contact with eyes and take appropriate measures if it occurs. The scope of use and restrictions for Chlorobutanol, Dehydroacetic acid and its salts and Glutaraldehyde are changed from "prohibited to use in spray products" to "prohibited to use in spray and aerosol products". The scope of use and the restrictions of Triclosan are partly amended, from Deodorant (non-spray) to "deodorant (non-spray and aerosol )". The scope of use and restrictions of Iodopropynyl Butylcarbamate are standardized, from “do not use in body cream and body milk” to "do not use in body cosmetics". The maximum allowable concentration for cosmetic containing "Methylchloroisothiazolinone and Methylisothiazolinone mixed with Magnesium Chloride and Magnesium Nitrate (Methylchloroisothiazolinone: Methylisothiazolinone 3:1)" shall be calculated based on the active substances. As a result, it is revised from 0.0015% to 0.0015% (based on a mixture of Methyl Chloroisothiazolinone and Methyl Isothiazolinone 3:1).

3-Benzylidene Camphor , which is included in the prohibited ingredients list under the 2022 draft edition, is deleted from the list of permitted UV Filters (Table 5) .

GALLA RHOIS extract and related notes which are currently listed in the permitted colorants list (Table 6), are deleted from the lists and added into the list of permitted hair dyes under the 2022 draft edition.

"2-Chloro-p-phenylenediamine" and "2-Chloro-p-phenylenediamine sulfate" are deleted from the list of permitted hair dyes (Table 7) ; Article 75 under the 2015 edition, other colorants permitted for hair dye products, are deleted; galla rhois extracts or gallic acid are added into the list of permitted hair dyes . Other restrictions and requirements include: when used in conjunction with ferrous sulfate, only allowed to use in hair dye products; It is not restricted by this clause when used for other purposes. The 2022 draft edition also made some corrections, for instance, the maximum allowable concentration for "6-methoxy-2-methylamino-3-aminopyridine hydrochloride (HC Blue no. 7)" when used in cosmetics shall be0.68%. In the 2015 edition, it is 0.68, which is a mistake.

4. Methods of Physical and Chemical Examination

Compared with the 2015 edition, the 2022 draft editions adds 4 new test methods , including Cimetidine, fluorescent whitening agent, α -Arbutin, β -Arbutin, Hydroquinone and Phenol as well as Acrylamide, and revise 15 test methods , such as replacing the original method with high-throughput test method, deleting duplicate test methods, and deleting duplicate test items in some test methods.

According to the relevant regulations of raw material management, the physical and chemical inspection methods are divided into several parts, including general rules, prohibited ingredients, restricted ingredients, preservatives, UV filters, colorants, hair dyes and others, It is made clear in the general rules that "the classification and ordering in this chapter does not represent the categories of ingredients to be tested involved in the method", and information about reagents, raw materials to be tested and their evaluation basis which are easily misunderstood in practical inspection are added. The actual specifications for the reagents are supplemented: Unless otherwise specified, the specifications shall be: Hydrochloric acid (36% ~ 38% (g/g) HCl); Sulfuric acid (95%-98% (g/g) H2SO4), Perchloric acid (70%-72% (g/g) HClO4), Acetic acid refers to Glacial Acetic acid and Glacial Acetic acid containing over 99% C2H4O2, Phosphoric acid (over 85% (g/g) H3PO4), Ammonia water (25% ~ 28% (g/g) NH3), and Hydrogen peroxide (about 30% (g/g) H2O2).

In addition, the text format and style were unified, for instance, the Chinese name and the English name of the raw material to be tested are standardized, information including the Chinese name, CAS number, molecular formula and molecular weight of the standard material is given in the appendix, the expression of detection limit is unified, and some methods of detection are amended.

5. Methods of Microbiological Examination

According to the relevant national standards such as Chinese Pharmacopoeia (2020 Edition), the relevant terms, symbols and characters in the texts are standardized and revised.

6. Methods of Toxicological Tests

The sequencing of toxicological test methods is standardized by referring to the Regulations and its supporting documents and considering the continuity of standard planning; the text format and style is unified and standardized; product category and dosage form name are standardized, for example, "hair growth " is revised as "anti-hair loss " and "aerosol products" as "spray or aerosol products".

Compared with the 2015 edition, the 2022 draft edition adds 8 test methods , all of which were disclosed in previous NMPA public notices, including "skin corrosive rat transdermal resistance test", "in vitro rabbit corneal epithelial cell short-term exposure test", "local lymph node test: "DA", "Local lymph node test: BRDU-ELISA", "Direct peptide reaction test", "in vitro 3T3 neutral red uptake phototoxicity test", "skin photoallergy test", and "in vitro Mammalian cell micronucleus test", and revises 2 test methods , namely "bacterial recovery mutation test" and " teratogenicity " , which were also notified in the previous announcement by NMPA (Notice No.12, 2019).

In addition, to solve the problems found in previous work, some test requirements were clarified, such as refining the pre-test requirements, clarifying the dose design, data processing and result judgment requirements.

7. Methods of Human Safety Test

Under the existing standard, cosmetics should complete necessary toxicological inspections and obtain a written proof before they are tested on human.. Cosmetic products that fail to pass the toxicological inspections shall not be tested on human. Under the 2022 draft edition, cosmetics products should complete necessary safety evaluations and obtain a written proof before they are tested on human. Products with unqualified safety evaluations shall not be tested on human.

Under the requirements of the Regulations and Standards for the Evaluation of Cosmetics Efficacy Claims, the description regarding applicable product categories is deleted. Based on the progress of medical research and the experience of registration and filing inspection, the participants’ inclusion and exclusion requirements, and sampling methods of products in different dosage forms were adjusted and improved.

8. Methods of Efficacy Evaluation Test

According to the 2015 edition, necessary toxicological tests and human skin patch tests should be completed with a written proof issued before the human efficacy test is carried out. But based on the 2022 draft edition, necessary product safety evaluation should be completed first with a written proof issued. Products that fail to pass the safety evaluation will not be tested for human efficacy.

Besides, under the 2022 draft edition, methods of anti-freckle and whitening efficacy test and methods of anti-hair loss efficacy test cosmetics were included, and the format of methods of efficacy evaluation test was unified. Some technical parameters, such as skin color range, standard product formula and selection, were refined, clarified and corrected. With reference to ISO standards and combined with the requirements of registration and filing, the determination principles of waterproof performance test results of sunscreen products were clarified.

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