The Technical Safety Standards for Cosmetics (2015) Will Come Into Effect by Dec 2016 - Regulatory News - Personal and Home Care Products

The Cosmetics Standard Experts Committee recently deliberated and passed The Technical Safety Standards for Cosmetics (TSSC 2015). TSSC2015will come into effect by Dec 1st, 2016.

Background

It has been 8 years since Hygienic Standards for Cosmetics (2007) was issued. The Hygienic Standard for Cosmetics (HSC 2007) was compiled based on Cosmetics Directive of theCouncil European Communities, 76／768／EEC, and amendments until 21st Nov2005. Based on HSC 2007, TSSC 2015 is revised with latest global cosmetics safety and supervision standards. The new contents include the adjustment of safety risk substances, updated list and testing methods of banned and restricted ingredients. However, given that the technical requirements and evaluation methods of oral care cosmetics areimmature, they are not included in the TSSC 2015.

Main changes

1) Content

HSC 2007	TSSC 2015
Part 1 General Rules Definition of cosmetics: Products which can be spread on the outer surface of human body(e.g. skin, hairs, nails, lips, etc.),for the purpose of cleaning, perfuming, changing appearance, deodorizing, protecting, and keeping in good condition by way of smearing, spraying or other similar means.	Part 1 Summary
Part 2 Toxicological test methods (17 items)	Part 2 Banned and Restricted Ingredients
Part 3 Hygiene safety test methods (28 items)	Part 3 Positive list of preservatives, colorants, hair dyes and sunscreen agents
Part 4 Microbiological test methods (6 items)	Part 4 Physiochemical tests methods (77 items)
Part 5 Human safety and efficacy evaluation methods (4 items)	Part 5 Microbiological tests methods (6 items)
	Part 6 Toxicological tests methods (17 items)
	Part 7 Human safety tests methods (3 items)
	Part 8 Human efficacy evaluation tests methods (4 items)

2) Adjustment on banned and restricted ingredients

Item		HSC 2007	3rd Draft TSSC	TSSC 2015
Banned ingredients	Chemical substance	1208	1288	1290
Banned ingredients	Plant or animal-derived	78	98	98
Restricted ingredients	Preservatives	56	51	51
	Sunscreen agents	28	27	27
	Colorants	156	157	157
	Hair dyes	93	75	75
	Others	73	47	47

* If you would like to get the detailed list of banned and restricted ingredients or to know which ingredient is added to or deleted on the TSSC 2015. Please send your request to service@cirs-group.com.

3) Adjustments on the requirements for microbiological control in cosmetics

Items	HSC 2007	TSSC 2015
Aerobic bacterial count	≤500(CFU/mL or CFU/g) for cosmetics used around eyes, lips and intended for children/babies	Same as HSC 2007
Aerobic bacterial count	≤1000(CFU/mL or CFU/g) for other common cosmetics not mentioned above	Same as HSC 2007
Moulds and yeasts count	≤100(CFU/mL or CFU/g)	Same as HSC 2007
Thermotolerant coliform bacteria	Negative	Same as HSC 2007
Staphylococcus aureus	Negative	Same as HSC 2007
Pseudomonas aeruginosa	Negative	Same as HSC 2007

4) Adjustments on the limit level of hazardous substances in cosmetics

Item	HSC 2007	TSSC 2015
Hg	≤1mg/kg except organomercury used as preservative in cosmetics around eyes.	Same as HSC 2007
Pb	≤40mg/kg	≤10mg/kg
As	≤10mg/kg	≤2mg/kg
Methanol	≤2000mg/kg	≤2000mg/kg
Cd	Not Specified	≤5mg/kg
1,4-Dioxane	Not Specified	≤30mg/kg
Asbestos	Not Specified	Negative

5) Adjustments on the test and evaluation methods

Item	Comparison between TSSC 2015 and HSC 2007
Physiochemical tests methods	60 test methods for banned and restricted ingredients are added* and 2 test methods for Sr and total fluorine deleted.
Microbiological tests	Description specified and structure adjusted.
Toxicological tests	Description specified and structure adjusted.
Human safety and efficacy evaluation tests	Divided into separate part.Preparation method for highSPF value standard substance is added
Efficacy evaluation tests	Focus on the test of sun-screening cosmetics.

*The list for test methods added:

Banned ingredients: Fluconazole and other 8 kinds of components, Minocycline hydrochloride and other 6 kinds of components, Enoxacin and other 9 kinds of components, Estriol and Other 6 kinds of Components, Minoxidil and other 6 kinds of components, 6-Methyl coumarin, 8-methoxypsoralen and other 3 kinds of components, Psoralen and other 3 kinds of components, 4-Aminoazobenzene and Benzidine, Biphenyl-4-ylamine and its sylamine, Acid Yellow 36 and other 4 kinds of components, α-Chlorotoluene, Aminocaproic Acid, Benzo [а] pyrene, Acrylamide, Chlormethine, Desloratadine and other 14 kinds of componentsand, Dioxane, Diethylene glycol, Ethylene oxide and Methyloxirane, Methanol, Procainamide and other 6 kinds of components, Diethyl maleate, Minoxidil, Asbestos, Tretinoin and Isotretinoin, Dimethylphthalate and 9 kinds of components, Dibutylphthalate and 7 kinds of components, Dichloromethane and 14 kinds of components, Ethanol Ethanol and other 36 kinds of components.

Restricted ingredients: Hydrogen peroxide, Resorcinol, Quinine, Oxyquinoline, Salicylic acid, Musk ketone, Free Hydroxide.

Preservatives: Benzyl alcohol, Benzoic acid and sodium benzoate, Phenoxyisopropanol, Benzalkonium chloride, Ammonium chloride, Benzethonium chloride and Cetalkonium Chloride, ChloromethylIsothiazolinone and Other 11 kinds of Components, Chlorphenesin, Triclocarban, Sorbic acid and Dehydroacetic, Salicylic acid and other 4 components.

Sunscreen agents:Phenylbenzimidazole Sulfonic Acid and Other 14 kinds of Components, Denzophenone, Titanium dioxide, Diethylaminohydroxybenzoyl hexyl benzoate, Diethylhexylbutamidotriazone, Benzylidene camphor sulfonic acid, Zinc oxide.

Colorants: Basic Orange 31and other 6 components, CI 59040 and other 9 components.

Hair dyes: p-Phenylenediamine and Other 7 kinds of Components, p-Phenylenediamine and Other 31 kinds of Components.

CIRS Comments:

Oral care products are not included in the definition of cosmetics in TSSC 2015. But this kind of products will be managed as cosmetics when the technical requirements and evaluation methods are mature;
There are new requirements for the control of Pb, As, Cd, 1,4-Dioxane and Asbestos. It will be a challenge for domestic manufacturers in the process of controlling harmful substances in cosmetics ;
More safety risk substances added to the list of banned ingredients and less restricted ingredients contained in the new standard.
More physiochemical testing methods added to the Technical Safety Standard for Cosmetics so as to be referred for the supervision of cosmetics.
Compared with the 3rd Draft TSSC,Methyldibromoglutaronitrile(CAS No. 35691-65-7) and Sodium iodate (CAS No. 7681-55-2) are added to the banned ingredients list of TSSC 2015.
There are 1397 items on theList of Substances Prohibited in Cosmetic Productsestablished in EU cosmetics regulations EC No 1223-2009 and related amendments while TSSC 2015 has 1388substances on the banned list. In addition, the limit level of hazardous substances in cosmetics (such as Pb, Hg, As, etc.) is exactly the same with EU standards and even stricter than the US standards. These amendments show CFDA’s determination to rebuild cosmetics management model and adapt to international market.

Source:

http://www.sfda.gov.cn/WS01/CL1272/140161.html
http://www.cirs-reach.com/news-and-articles/technical-safety-standard-for-cosmetics-(draft)-issued-for-public-comments-for-the-third-time.html

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