CFDA Seeking Public Opinions on Contents of Safety and Technical Standards for Cosmetics

In order to further improve the registration management of cosmetics, CFDA organized and proposed modifications in relevant contents of the Safety and Technical Standards for Cosmetics (Chapters 1, 2, 3 and 6), and publicly solicit opinions on this revised version on 7th September 2018. Enterprises and individuals can send their feedback to CFDA via email (hzpbwh@nifdc.org.cn) by 10th, October 2018 (please see attached for the feedback form).

Chapter 1, Safety and Technical Standards for Cosmetics

No.

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After

Reason for modification

1

Chapter 1, Overview

3.4 Hazardous substance limit requirement
Asbestos, shall not be detected*

Asbestos, shall not be detected*。

Note: asbestos shall not be detected based on the detection limit of the corresponding test method under this technical standard,

Correction. Add supplement information.

2

Chapter 1, Overview
2.13 Body use cosmetics: cosmetics claimed to be used on body skin (do not include head and facial skin).

Body use cosmetics: cosmetics claimed to be used on large areas of skin on torso and/or limbs.

The previous definition is not accurate.

CIRS Interpretation

The testing method for asbestos detection on P315 of Safety and Technical Standards for Cosmetics specifies the requirements for measuring asbestos content in powdered cosmetics and their raw materials using X-ray diffractometer and polarizing microscope. Reference documents include GB/T2007.1 General Rules for Sampling and Sample Preparation of Bulk Mineral Products, Manual Sampling Method; and JJG629 Polycrystalline X-ray Diffractometer. This method is from CFDA’s letter of consentment [2009] No. 136 Asbestos Detection Method in Powdered Cosmetics and Their Raw Materials. Existing domestic and international testing methods for asbestos detection include stereoscopic microscopy (SM), polarized microscopy (PLM), X-ray diffraction (XRD), scanning electron microscopy/energy dispersive spectrometer (SEM/EDS), transmission electron microscopy/energy dispersive spectrometer (TEM/EDS), phase contrast microscopy (PC), infrared spectroscopy (IR), differential thermal analysis (DTA), neutron activation analysis (NAA) and so on. Different detection methods are with different detection limits. Therefore, the supplement information on asbestos detection requirement in the revised Safety and Technical Standards for Cosmetics is more accurate and scientific.

The definition of the application site for body use cosmetics is consistent with that in Classification Specifications for Cosmetics (Draft Version).

Chapter 2, Safety and Technical Standards for Cosmetics

No.

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After

Reason for modification

3

Table 1 Banned ingredients in cosmetics
No. 301 Antibiotics

Anti-infective drugs

According to the principles of drug classifications.

4

Table 3 Restricted ingredients in cosmetics

Add 3 ingredients: Potassium Methoxysalicylate, Dimethoxytolyl Propylresorcinol, and Phenylethyl Resorcinol

The restricted ingredients and their requirements are added according to the Notice on Approving the Use of Potassium Methoxysalicylate as Cosmetic Raw Material [2007] No. 141 from Ministry of Health, Notice No. 16, 2012 and Notice No. 71, 2012 from CFDA.

No.

Name of substance

Restrictions

Application conditions and precautions that must be printed on the label

Chinese name

English Name

INCI name

Application and/or scope of use

Max. concentration allowed in cosmetics

Other restrictions and requirements

48

甲氧基水杨酸钾

Potassium 2-hydroxy-4-methoxybenzoate

Potassium Methosysalicylate

 

3%

Shall not be used in products for children under 3 years old.

Contain Potassium Methosysalicylate, do not use for children under 3 years old.

49

二甲氧基甲苯基-4-丙基间苯二酚

 

Dimethoxytolyl Propylresorcinol

Creams, lotions, gels, masks and other skincare products

2%

 

 

50

苯乙基间苯二酚

 

Phenylethyl Resorcinol

Skin use products

0.5%

 

 

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5

Table 3 Restricted ingredients in cosmetics
Note (6): α-hydroxy acid refers to a carboxylic acid with hydrogen on α-carbon substituted by a hydroxyl group, such as tartaric acid, glycolic acid, malic acid, lactic acid, citric acid, etc. Salts refer to their sodium, potassium, calcium, magnesium, ammonium, and alcohol amine salts. Esters refer to methyl, ethyl, propyl, isopropyl, butyl, isobutyl and phenyl esters, etc.

α-hydroxy acid refers to a carboxylic acid with hydrogen on α-carbon substituted by a hydroxyl group, such as tartaric acid, glycolic acid, malic acid, lactic acid, citric acid, mandelic acid, α-hydroxyoctanoic acid, α-hydroxydecanoic acid, gluconic acid, lactobionic acid, etc. Salts refer to their sodium, potassium, calcium, magnesium, ammonium, and alcohol amine salts. Esters refer to methyl, ethyl, propyl, isopropyl, butyl, isobutyl and phenyl esters, etc.

Mandelic acid, α-hydroxyoctanoic acid, α-hydroxydecanoic acid, gluconic acid, and lactobionic acid are categorized as α-hydroxy acids in IECIC, so this is specified in the note to Table 3 in Safety and Technical Standards for Cosmetics to regulate the use of these substances.

CIRS Interpretation

The updated version adds restrictions of 3 new raw materials that have been approved in 2007 and 2012 to the list of 47 existing restricted ingredients. According to the Notice from the Ministry of Health on the Approval of Potassium Methoxysalicylate as a Raw Material for Cosmetics (MOH [2007] No. 141), the maximum allowed concentration of potassium methoxysalicylate in cosmetics is 3%, with the required raw material specifications: 1) purity >98%; 2) heavy metal <20ppm, Arsenic <2ppm. Another restriction and requirement for potassium methoxysalicylate in the revised version of Safety and Technical Standards for Cosmetics is that it cannot be used in “products for children under 3 years old”. And the phrase of “Do not use for children under 3 years old” should be indicated on the label. However, the restriction does not reflect the specification requirements of this raw material in the Notice from MOH [2007] No. 141. The possible reason may be that the main impurity of this substance is heavy metal, and the limit requirement for heavy metals in the Safety and Technical Standards for Cosmetics is more stringent than that from the Notice.

From Notice No. 16 in 2012 from CFDA, 2 new cosmetic raw materials: Polymethacryloyl and Dimethoxytolyl Propylresorcinol were approved to be used in cosmetics. Polymethacryloyl is a moisturizing agent according to the technical document, and this is a low-risk ingredient regardless of the material property or the purpose of use, hence it is not added to the list of restricted ingredients as we can see from the above table. But the function of dimethoxytolyl propylresorcinol is skin and tone conditioning on specific body parts. Similarly, from Notice No. 71 in 2012 from CFDA, the function indicated in the technical document for phenylethyl resorcinol is whitening, by inhibiting the activity of tyrosinase to reduce the forming of melanin. According to the Regulations on Supervision and Administration of Cosmetics (Draft Version), whitening ingredients are classified as high-risk ingredients together as preservatives, colorants, sunscreens and hair dyes. Therefore, dimethoxytolyl propylresorcinol and phenylethyl resorcinol are regulated with strict limitations for use as a whitening ingredient.

Since 2004, a total of 10 new cosmetic raw materials have been approved. Please see table 1 for the summary of restriction requirements and functions for these approved new cosmetic ingredients.

Table 1 New Cosmetic Ingredient Approved in 2004 - 2018

Name of Raw Material

Time of Approval

Is it in IECIC 2015?

Function

Any Restriction Requirements?

Alkyl (C12-22) Trimonium Chloride (Bromide)

2004/6/14

Yes

Preservative/non-preservative

Yes

Potassium Methoxysalicylate

2007/4/26

Yes

Bleaching agent

Yes

9.69% Methylisothiazolinone

2007/5/28

Yes

Preservative

Yes

Carnitine Tartrate

2008/6/3

Yes

-

Yes

Lathyrus Odoratus Flower Extract

2008/8/6

Yes

Skin Conditioning

Yes

Fructooligosaccharides

2008/8/6

Yes

Moisturizing/skin conditioning

Yes

Polymethacryloyl Lysine

2012/3/19

Yes

Moisturizing

No

Dimethoxytolyl Propylresorcinol

2012/3/19

Yes

skin and tone conditioning on specific body parts

Yes

Phenylethyl Resorcinol

2012/12/5

Yes

Whitening

Inhibiting the activity of tyrosinase to reduce the forming of melanin.

Yes

Elaeagnus mollis diel Oil

2014/10/30

No

Matrix material for skincare cosmetics.

Fatliquoring, moisturizing, antioxidizing, anti-aging.

No

Chapter 3, Safety and Technical Standards for Cosmetics

No.

Before

After

Reason for modification

6

Table 4 Allowed preservatives in cosmetics

No. 31 Methylisothiazolinone: maximum allowed concentration in cosmetics is 0.01%

Methylisothiazolinone: maximum allowed concentration in cosmetics is 0.0015%. Scope of application: wash-off products.

According to the revised European Union regulation EU 2017/1224, methylisothiazolinone is banned to be used in leave-on products. The maximum allowed concentration in wash-off products is 0.0015%. EU 2017/1224 released on 6th July 2017 stated that only products meet the new regulation can be sold in EU’s market after 27th January 2018. And after 27th April 2018, products that do not meet with the new regulation are banned in the EU market.

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Table 4 Allowed preservatives in cosmetics

No. 32 Mixture of methylchloroisothiazolinone and methylisothiazolinone with magnesium chloride and magnesium nitrate (methylchloroisothiazolinone : methylisothiazolinone = 3:1) maximum allowed concentration in cosmetics is 0.0015%

Maximum concentration in cosmetics is 0.0015% (calculated as the mixture of methylchloroisothiazolinone : methylisothiazolinone = 3:1)

Clarify the active materials.

8

Table 4 Allowed preservatives in cosmetics

No. 35 4-Hydroxybenzoic acid and its salts and esters

Single ester: 0.4% (calculated as acid); mixed esters: 0.8% in total (calculated as acid); the sum of its propyl ester and salt, or butyl ester and salt should not exceed 0.14%.

Single ester: 0.4% (calculated as acid); mixed esters: 0.8% in total (calculated as acid); the sum of its propyl ester and salt, and butyl ester and salt should not exceed 0.14%.

The previous expression is not clear.

9

Table 5 Allowed sunscreen agent in cosmetics

A note is added:

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

At the moment, some non-special use cosmetics such as BB creams, CC creams, cushion foundations, etc. contain large amounts of chemical sunscreen agents while not registered as sunscreen cosmetics. This note is added to the revised version in order to regulate the use of sunscreen agents in non-special use cosmetics.

10

Table 7 Allowed hair dye agent in cosmetics
No. 36 6-Methoxy-2,3-pyridinediamine and its HCl salt (HC blue No. 7): maximum allowed concentration in cosmetics in oxidizing hair dye products: 0.68 (calculated as free radicals); in non-oxidizing hair dye products: 0.68 (calculated as free radicals)

6-Methoxy-2,3-pyridinediamine and its HCl salt (HC blue No. 7): maximum allowed concentration in cosmetics in oxidizing hair dye products: 0.68% (calculated as free radicals); in non-oxidizing hair dye products: 0.68% (calculated as free radicals)

Correction. Add the unit symbol “%”.

11

Table 7 Allowed hair dye agent in cosmetics
No. 75 Other colorants that allowed to be used in hair dye products

Other colorants that allowed to be used in hair dye products(4)

Note (4): refers only to Galla Rhois Gallnut Extract

Clarify the scope of the term.

12

Testing method for sunscreen agent

5.1 Ethylhexyl PABA in table 1 under Phenylbenzimidazole Sulfonic Acid and Other 14 Kinds of Components.

Changed to: Ethylhexyl dimethyl PABA

Consistent with ingredient name in the table of allowed sunscreen agent.

13

Allowed preservatives in cosmetics (table 4)

Note (1) d: all products containing formaldehyde or ingredients in this table that can release formaldehyde should label “contains formaldehyde”, and banned to be used in spray products if formaldehyde concentration in finished product exceeds 0.05% (calculated as free formaldehyde).

Note (1) d: all products containing formaldehyde or ingredients in this table that can release formaldehyde should label “contains formaldehyde” and banned to be used in spray products.

Clarify label requirement.

CIRS Interpretation

The competent authority has mainly revised on allowed preservatives, sunscreen agents and hair dye agents in Chapter 3 of Safety and Technical Standards for Cosmetics. According to the revised EU 2017/1224, methylisothiazolinone is banned to be used in leave-on products, and the maximum allowed concentration to be used in wash-off products is 0.0015%. China also adopts this new EU standard to adjust the restriction requirement on this ingredient. In note (1) d of table 4, it is stated that as long as there is formaldehyde or ingredients that can release formaldehyde contained in the cosmetic product, “contains formaldehyde” should be stated on the label. It is more stringent compared to the previous requirement [“contains formaldehyde” should be labeled only when the concentration of formaldehyde in finished product exceeds 0.05% (calculated as free formaldehyde)]. Commonly used preservatives are DMDM hydantoin, paraformaldehyde, formaldehyde and so on.

A note is added for allowed sunscreen agent: the sum of all chemical sunscreen agents in non-sunscreen cosmetics (except perfumes and nail polish products) should be less than 0.5%. This note is mainly aimed at products with high content of sunscreen agents but not registered as sunscreen products, such as some BB cream, CC cream, and cushion foundations. Normally, products with no claim of SPF or PA can be registered as non-special use products. However, based on the requirement in the Measures on the Management of Cosmetics Administrative Licensing and Inspection (CFDA 2010 No. 82), additional testing on sunscreen agents, skin allergy test and skin phototoxicity test should be conducted when the content of sunscreen agents (excluding TiO2 and ZnO) in a non-special cosmetic product ≥ 0.5%. According to latest review requirements, if the used sunscreen agent in formula is not in the list of 15 regular sunscreen agents (phenylbenzimidazole sulfonic acid, benzophenone-4 and benzophenone-5, PABA, benzophenone-3, isoamyl p-methoxycinnamate, 4-methylbenzylidene camphor, ethylhexyl dimethyl PABA, butyl methoxydibenzoylmethane, octocrylene, ethylhexyl methoxycinnamate, ethylhexyl salicylate, homosalate, ethylhexyl triazone, methylene bis-benzotriazolyl tetramethylbutylphenol and bis-ethylhexyloxyphenol methoxyphenyl triazine), and there exists available testing method on the sunscreen agent (excluding TiO2 and ZnO), additional testing should be conducted.

The revision for allowed hair dye agent is made mainly for “other colorants that are allowed in hair dye products” in No. 75 of the list, and specified Galla Rhois Gallnut Extract which is the only approved plant extract hair dye agent in China by now. For other plant extract hair dye ingredients, new ingredient registration should be done in prior to product registration.

Chapter 6, Safety and Technical Standards for Cosmetics

The revised contents for salmonella typhimurium/reversion mutation test in Safety and Technical Standards for Cosmetics (2015) are as follows:
  • The original reference standard National Standard for Food Safety GB 15193.4-2014 Bacteria Reversion Mutation Test has been revised in terms of the latest international guidelines.
  • The original standard combinations of test strains are TA97, TA98, TA100 and TA102 in Safety and Technical Standards for Cosmetics (2015). The revised version added TA1535. TA1537, TA97, and TA97a can be replaced by each other in the test. Salmonella typhimurium TA102 or Escherichia coli WP2uvrA or Escherichia coli WP2uvrA (pKM101) can be replaced by each other in the test.
  • The Safety and Technical Standards for Cosmetics (2015) has provided a clear number of spontaneous reverted colonies for TA97, TA98, TA100 and TA102 used in the Ames test. However, current international guidelines including OECD471, ICH S2(R1) and FDA Redbook haven’t specified the range of spontaneous reverse mutation of strains. Therefore the revised version requires each laboratory to establish its own historical comparison database to make it more scientific.
  • The revised version added relevant reference data for using fenaminosulf (dexon) as a positive control, which makes the specifications more thorough.
  • The content of data processing and result judgment is modified for more explicit and clearer expression.

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CFDA seeking public opinions on contents of Safety and Technical Standards for Cosmetics

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