China Consults on the Amendment to Safety and Technical Standards for Cosmetics and the Draft of 2018 Chinese Version of INCI

1

Chapter 1 Overview

2.13 Body cosmetics

Body cosmetics: cosmetics used on the body skin, excluding the head skin.

Body cosmetics: cosmetics designated for use on large areas of the skin such as the trunk and/or the limbs.

The original definition is inaccurate.

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3.4 Restriction on hazardous substances

Asbestos, not be tested out*

Asbestos, not be tested out*

(Note: There is no minimum acceptable concentration of Asbestos.)

Erratum, supplement note.

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Chapter 2 Prohibited/Restricted Ingredients Used in Cosmetics

List 1: Prohibited Ingredients Used in Cosmetics, No.301

Antibiotics

Anti-infective drugs

Standardize according to drug classification principles.

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List 3: Restricted Ingredients Used in Cosmetics

Newly add 3 substances:

• Potassium Methoxysalicylate,
• Dimethoxytolyl Propyl resorcinol,
• Phenethyl Resorcinol.

[See detailed information of the three substances in Table 1 below]

Increase stringency of limitations for these substances and their requirements according to the MOH’s No.141 notice of 2007, CFDA’s No.16 and No.71 Announcements of 2012.

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List 3 Restricted Ingredients Used in Cosmetics

Note (6): α-hydroxy acids are carboxylic acids substituted with a hydroxyl group on the adjacent carbon, such as tartaric acid, glycolic acid, malic acid, lactic acid, citric acid, etc. “Salts” refer to their sodium, potassium, calcium, magnesium, ammonium, and alkanolamine salts. “Esters” refer to their methyl, ethyl, propyl, iso-propyl, butyl, iso-butyl and phenyl esters.

Note (6): α-hydroxy acids are carboxylic acids substituted with a hydroxyl group on the adjacent carbon, such as tartaric acid, glycolic acid, malic acid, lactic acid, citric acid, mandelic acid, α-hydroxycaprylic acid, α-hydroxycapric acid, gluconic acid, lactobionic acid, etc. “Salts” refer to their sodium, potassium, calcium, magnesium, ammonium, and alkanolamine salts.

Mandelic acid, α-hydroxycaprylic acid, α-hydroxycapric acid, gluconic acid, lactobionic acid have been approved as α-hydroxy acids substances in IECIC. To regulate the use of these substances, it is specified in the Note (6) of the standard.

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Chapter 3 Permitted Ingredients Used in Cosmetics

List 4: Permitted Preservatives Used in Cosmetics, No.31

2-Methylisothiazol-3(2H)-one

Maximum concentration in cosmetics: 0.01%

2-Methylisothiazol-3(2H)-one

Maximum concentration in cosmetics: 0.0015%

Application scope and requirements: Rinse-off cosmetics

According to the revised EU regulations 2017/1224, 2-Methylisothiazol-3(2H)-one is prohibited from the use in leave-on products. And the maximum allowable concentration in rinse-off products is 0.0015%. The EU Regulation 2017/1224 was released on July 6, 2017, and requires that only products meet the new regulations will be allowed to enter the EU market since Jan. 27, 2018; the products fails to meet the regulations are banned from sale in the EU since April 27, 2018.

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List 4: Permitted Preservatives Used in Cosmetics, No.32

Mixture of 5-chloro-2-methylisothiazol-3(2H) -one and 2-methylisothiazol-3(2H)-one with magnesium chloride and magnesium nitrate(of a mixture in the ratio 3:1 of 5-chloro- 2-methylisothiazol 3(2H)-one and 2-methylisothiazol-3 (2H)-one )

Maximum concentration in cosmetics: 0.0015%

Maximum concentration in cosmetics: 0.0015% (a mixture in the ratio 3:1 of 5-chloro- 2-methylisothiazol 3(2H)-one and 2-methylisothiazol-3 (2H)-one)

Clarify the effective substances. 

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List 4: Permitted Preservatives Used in Cosmetics, No.35

4-Hydroxybenzoic acid and its salts and esters

Maximum concentration in cosmetics:

Single ester 0.4% (acid),

Mixed ester in total 0.8% (acid)

Sum of its propyl ester and its salt, and its butyl ester and its salt should be  respectively no more than 0.14%

Maximum concentration in cosmetics:

Single ester 0.4% (acid),

Mixed ester in total 0.8% (acid)

Sum of its propyl ester and its salt, its butyl ester and its salt should be no more than 0.14% (acid)

The original expression is not accurate.

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List 4 Permitted Preservatives Used in Cosmetics

Note (1)：d. For all cosmetics containing formaldehyde or substances releasing formaldehyde listed in this standard, if the concentration of the formaldehyde of the finished product exceeds 0.05%, then the product has to be labeled “contains formaldehyde”, and is forbidden to be used in aerosol products.

d. For all cosmetics containing formaldehyde or substances releasing formaldehyde listed in this standard, the product has to be labeled “contains formaldehyde”, and is forbidden to be used in aerosol products.

Clarify requirements of note.

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List 5 Permitted Sunscreens Used in Cosmetics

Add a new note.

Note (3): The sum of all chemical sunscreens used in non-sunscreen cosmetics (except perfumes and nail polish products) should be less than 0.5%.

Currently, some non-special use cosmetics such as BB cream, CC cream, air cushion powder add a large amount of chemical sunscreen agents, but not apply for registration/filing as sunscreen cosmetics. To regulate the use of sunscreen agents in non-special use cosmetics, the note is added.

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List 7 Permitted Hair Dyes Used in Cosmetics, No.36 6-Methoxy-2-methylamino-3-aminopyridine HCl

Maximum concentration in cosmetics:

• Oxidized hair dye products：0.68(Free radical)
• Non-oxidized hair dye products：0.68 (Free radical)

Maximum concentration in cosmetics:

• Oxidized hair dye products：0.68%(Free radical)
• Non-oxidized hair dye products：0.68% (Free radical) 

Erratum，increase the unit “%”.

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List 7 Permitted Hair Dyes Used in Cosmetics

No. 75 Other colorants permitted to be used in hair dye products

Other colorants permitted to be used in hair dye products^（4）
Note (4): It only refers to the GALLARHOIS extract.

Clarify the scope of the provision.

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Chapter 4 Physical and Chemical Testing Methods for Cosmetics

5. Testing Methods of Sunscreens, 5.1 Phenylbenzimidazole Sulfonic Acid and Other 14 Kinds of Components

Table 1 The detection limit, detection concentration, lower limit of quantitation and concentration limit of quantification of this method,

No.7 PABA ethylhexyl

No.7 Ethylhexyl dimethyl PABA

Keep consistent with the ingredient name in the Permitted Sunscreens List.

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甲氧基水杨酸钾

Potassium 2-hydroxy-4-methoxybenzoate

Potassium Methoxysalicylate

3%

Not for use of children under the age of 3.

Contains Potassium Methoxysalicylate.

Not for use of children under the age of 3.

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二甲氧基甲苯基-4-丙基间苯二酚

Dimethoxytolyl Propyl resorcinol

Facial cream, lotion, gel, mask and other skin care products

2%

50

苯乙基间苯二酚

Phenethyl Resorcinol

Products for use on skin

0.5%

1

Title

8 Salmonella Typhimurium / Reverse Mutation Assay

8 Bacterial Reverse Mutation Assay

Modify the name of the test.

2

Scope

1

The standard specifies the basic principles, requirements and methods for salmonella typhimurium/reverse mutation assay.

1

The standard specifies the basic principles, requirements and methods for bacterial reverse mutation assay.

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Definitions

2.5

salmonella typhimurium/reverse mutation assay

2.5

Bacterial reverse mutation assay

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2.5

The test method that measures histidine reversion (his- to his+) induced by chemicals causing base changes or frameshift mutations in Salmonella typhimurium histidine auxotroph mutants.

2.5

The test method that measures amino acid deficiency type→prototrophic back mutation induced by chemicals causing base changes or frameshift mutations in histidine or tryptophan auxotroph mutants.

Modify the definition.

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Principle

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Salmonella typhimurium histidine auxotroph mutants are deficient in the synthesis of histidine. The mutants are unable to grow in a medium free of histidine. Only a small quantity of spontaneous revertants) will grow. If there is existence of mutagens, it will cause the reverse mutation of the mutants to the prototrophs, which will grow and form visible colonies. Therefore, it is able to determine if the test substance is a mutagen.

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Salmonella typhimurium histidine auxotroph mutants are deficient in the synthesis of histidine. The mutants are unable to grow in a medium free of histidine. Only a small quantity of spontaneous revertants will grow. Escherichia coli tryptophan auxotrophic strain cannot synthesize tryptophan, so only a small quantity of spontaneous revertants will grow in the medium lacking tryptophan. If there is existence of mutagens, it will cause the reverse mutation of the mutants to the prototrophs, which will grow and form visible colonies. Therefore, it is able to determine if the test substance is a mutagen.

Increase the test principle of escherichia coli.

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Culture media and reagents

5.1

0.5mmol/L histidine-biotin solution

5.1

0.5mmol/L histidine solution- 0.5mmol/L tryptophan solution- 0.5mmol/L biotin solution

Increase tryptophan solution.

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5.2

Preparation: after mixing the above components, the mixture is sterilized under 0.103MPa for 30 min. 20mL of 0.5mmol/L histidine-biotin solution is added to the medium during the test.

5.2

Preparation: after mixing the above components, the mixture is sterilized under 0.103MPa for 30 min. 20mL of 0.5mmol/L histidine solution- 0.5mmol/L tryptophan solution- 0.5mmol/L biotin solution is added to the medium during the test.

Increase the preparation of tryptophan.

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5.10.1

Histidine-biotin plate

5.10.1

Histidine- tryptophan-biotin plate

Increase the preparation of histidine- tryptophan-biotin plate.

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5.10.2

Ampicillin plate and ampicillin/tetracycline plate

5.10.2

Add “Sterilized hydrochloric tryptophan aqueous solution (0.5g/100mL)  10mL” in the “composition”

Modify the preparation of ampicillin plate and ampicillin/tetracycline plate.

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Test strains

6.1

The recommended combination of strains is S. typhimurium TA97, TA98, TA100 and TA102.

6.1

Use the following strains as a standard combination:

Salmonella typhimurium TA1535；

Salmonella typhimurium TA97 or TA97a or TA1537；

Salmonella typhimurium TA98；

Salmonella typhimurium TA100；

Salmonella typhimurium TA102 or E.coli WP2uvrA or E.coli WP2uvrA（pKM101）

Increase the selection of strains.

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Identification of biological characteristics

6.2

6.2

(1) Add evaluation criteria of TA97a、TA1535、TA1537、WP2uvrA and WP2uvrA（pKM101）identification

(2) As for “bacterial colonies with spontaneous reversion”, each laboratory should establish its own historical comparison database based on other laboratory data, and form a practical range suitable for the laboratory. Meanwhile, laboratory background data should be consistent with the literature reports.

Newly add the evaluation criteria for the identification of  TA97a, TA1535, TA1537, WP2uvrA and WP2uvrA (pKM101) and the reference scope of bacterial colonies with spontaneous reversion.

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Histidine deficiency

6.2.1

Histidine deficiency

6.2.1

Histidine / tryptophan deficiency

Modify the name

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6.2.1

Principle: Salmonella typhimurium histidine auxotroph mutants are unable to produce histidine. The mutants can grow only in a medium containing sufficient histidine supplement and cannot grow in the absence of histidine.

Principle: Salmonella typhimurium histidine auxotroph mutants are unable to produce histidine. The mutants can grow only in a medium containing sufficient histidine supplement and cannot grow in the absence of histidine. Tryptophan auxotroph mutants are unable to produce tryptophan. The mutants can grow only in a medium containing sufficient tryptophan supplement and cannot grow in the absence of tryptophan.

Increase the identification principle of tryptophan deficiency.

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Sensitivity to ultraviolet light

6.2.4

Principle: the test strains with △uvrB mutation are sensitive to ultraviolet light. When radiated by ultraviolet light, the test strains are unable to grow. However, the wild-type parent strain with excision repair enzyme can grow as usual.

6.2.4

Principle: the test strains with △uvrB/A mutation are sensitive to ultraviolet light. When radiated by ultraviolet light, the test strains are unable to grow. However, the wild-type parent strain with excision repair enzyme can grow as usual.

Increase △uvrA.

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Spontaneous reversion

6.2.6

Identification: add 0.1 mL of the enriched broth containing the test strain to the test tube having 2 mL overlay agar medium with histidine/biotin. After mixing, the medium with the test strain is poured on the bottom agar plate. When the agar is solidified, the plate is incubated at 37℃ for 48 hours. After the incubation period, the number of revertant colonies per plate is counted.

6.2.6

Identification: add 0.1 mL of the enriched broth containing the test strain to the test tube having 2 mL overlay agar medium with histidine/tryptophan /biotin (If E. coli is not used in the test, no tryptophan is added). After mixing, the medium with the test strain is poured on the bottom agar plate. When the agar is solidified, the plate is incubated at 37℃ for 48 hours. After the incubation period, the number of revertant colonies per plate is counted.

Modify the “histidine/biotin” to “histidine/tryptophan /biotin (If E. coli is not used in the test, no tryptophan is added.)”.

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Reversion—diagnostic assay

6.2.7

6.2.7

Increased the reversion response of dexon.

Increased the reversion response of dexon.

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Plate incorporation method

10.2

When performing the test, 2mL of overlay agar medium containing 0.5mmol/L histidine-biotin solution is dispersed in test tubes.

When performing the test, 2mL of overlay agar medium containing 0.5mmol/L histidine-tryptophan-biotin solution is dispersed in test tubes (If E. coli is not used in the test, no tryptophan is added).

Modify the “0.5mmol/L histidine/biotin” to “0.5mmol/L histidine/tryptophan /biotin (If E. coli is not used in the test, no tryptophan is added.)”.

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Data processing and result evaluation

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If the number of revertant colonies for the test substance is twice or above compared to the number in solvent control and a dose-response relationship is observed, the test substance is considered to be positive in the mutagenicity assay. Under any dose level, the test substance shows positive response and the result is reproducible.

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If the number of revertant colonies for the test substance TA1535, TA1537, WP2uvrA is three times or above compared to the number in solvent control, and if the number of revertant colonies for the test substance TA97、TA97a、TA98、TA100、TA102、WP2uvrA（pKM101）is twice or above compared to the number in solvent control, and is in any of the following circumstances, the test substance is considered to be positive in the mutagenicity assay:

(1) Dose-response relationship is observed;

(2) Under any dose level, the test substance shows positive response and the result is reproducible.

Increase the positive judgment standard of TA97a, TA1535, TA1537, WP2uvrA and WP2uvrA (pKM101) and modify the expression of the positive judgment of the test substance.