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

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.	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%

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

Chapter 3, Safety and Technical Standards for Cosmetics

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