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Data compiled on January 21st, 2015 revealed that the number of the enterprises granted a cosmetics production license certificate was 3880, and the number of individual licensed cosmetic products was 275,127. With the rapid development of China's cosmetics industry the current cosmetics safety standard "Hygienic Standard for Cosmetics 2007" (hereinafter "the Standard 2007") lacks the specific provisions to adequately regulate China's industry evidenced by the large number of cosmetic related adverse events reported by the CFDA since it took over regulatory responsibility from the MoH. In an effort to remedy this situation the National Institutes for Food and Drug Control (NIFDC), commissioned by CFDA, revised the Standard, and published the "Safety Technical Standard for Cosmetics (draft)" for comments on February 3, 2015 for public consultation.
What is the function of Safety Technical Standard (or Hygienic Standard)?
"Regulations concerning the Hygiene Supervision over Cosmetics" is a mandatory legal national regulation issued by the State Council which is the highest organ of State administration. "Hygienic Standard for Cosmetic" is the technical standard of "Regulations concerning the Hygiene Supervision over Cosmetics", providing the evaluation indicators of cosmetic quality. Based on this regulation, if cosmetic ingredient enterprises and finished products enterprises want to sell their cosmetic in China legally, their products must comply with Standard 2007, including purity, formula, labels, tests, evaluations and so on. The "Safety Technical Standard (draft)" is revised and updated based on the Standard 2007. If it enters into effect in the near future, it will replace the Standard 2007 and become a new mandatory regulation.
The difference between the Hygienic Standard for Cosmetics (2007) and Safety Technical Standard (draft)
"Safety Technical Standard (draft)" was supplemented and perfected based on the "Hygienic Standard". It also combined with the requirements and changes of the recent international and domestic cosmetics safety regulation, and also referenced other relevant regulatory documents. The following changes can be seen:
The framework
The framework of the two standards can be seen in the following table.
Hygienic Standard for Cosmetics | Safety Technical Standard for Cosmetics (draft) | ||
Framework | Content | Framework | Content |
General Principle | Cosmetic scope Definition General requirements Appendixes | Main Text | Cosmetic scope Definition General requirements |
Toxicological tests | The requirements of 16 kinds of toxicological tests | Appendixes | Prohibited ingredient lists Restricted ingredient lists Toxicology test Physical and chemical test Microbiology test Human safety test Efficacy evaluation test |
Hygienic chemical tests | The test methods of 27 kinds of prohibited or restricted substances | ||
Microbiological tests | The test methods of 5 kinds of microorganism | ||
Safety and efficacy evaluations in human | The test methods of SPF water resistance and PFA | ||
The framework of the new draft is composed of five parts and all contents are presented in text rather than appendixes. The first part (General Principle) contains general hygienic requirements for cosmetic and the prohibited and restricted lists.
Compared with the Standard 2007, "Safety Technical Standard (draft)" the framework is more logical. Standard 2007 is divided into two parts, the main text and appendixes. The text only includes cosmetic scope, definition and general requirements for safety technology, excluding prohibited and restricted substances. And the ingredient lists are presented in form of appendixes.
The content
1 The main text
The main text is updated based on the Standard 2007 and the draft version released on February 3, 2015, there are 3 significant changes:
| Hygienic Standard for Cosmetics | Safety Technical Standard (draft) for Cosmetics |
Definition | Cosmetics refer to chemical products for daily use intended to be applied on any surface of human body (such as skin, hair, nails, oral, lips etc.). | Cosmetics refer to chemical products for daily use intended to be applied on any surface of human body (such as skin, hair, nails, oral, lips etc.), teeth and oral mucosa. |
Ingredient Label | none | Requirements of ingredient label. |
Hazardous substance limit | Mercury: 1 mg/kg Lead: 40 mg/kg Arsenic: 10 mg/kg Carbinol: 2000mg/kg | Mercury: 1 mg/kg Lead: 10 mg/kg Arsenic: 2 mg/kg Cadmium: 5 mg/kg Carbinol:2000 mg/kg Dioxane and asbestos: undetectable |
(1) Definition
In line with the changes in the regulatory responsibilities of the CFDA, "Safety Technical Standard (draft)" includes "oral care products" into the definition of cosmetics in China. But this draft doesn't contain relevant technical requirements about oral care products, because the relevant technical requirements and test evaluation methods have not been developed. We believe it will be supplemented by other official guidance in the future.
(2) Ingredient Label
The draft also provides detailed provisions about the ingredient label. The label should clearly state the ingredient information (including, but not limited to, standard Chinese name, INCI name, CAS number and / or EINECS number), manufacturer name, purity or content, production lot number or production date, expiration date, etc.
If the ingredient are hazardous chemicals, the product label should meet China GHS requirements;
If the ingredient is from animals or plants, the label should clarify its origin and the parts used;
If the ingredient is of foreign origin and approved in its country of origin is from animal tissue or blood products, the label should clarify its origin and quality specifications.
(3) Hazardous substance limit
The limits of lead have been changed from 40mg/kg to 10mg/kg and the limits of arsenic from 10mg/kg to 2mg/kg, and prohibited dioxane and asbestos, which is the same as "Regulation (EC) No 1223/2009". The limit of cadmium has also been changed to (5 mg/kg), although in the EU regulations it belongs to the prohibited substance list. On the whole, these adjustments have aligned China's standards with the EU standards.
2 The Annex
The different kinds of ingredients between the Standard and draft about the annex can be seen in the following table.
| Hygienic Standard for Cosmetics | Safety Technical Standard (draft) for Cosmetics | |
List of prohibited Ingredients | Prohibited Ingredients | 1208 kinds | 1288 kinds |
Prohibited animal and plant components | 78 kinds | 98 kinds | |
List of and restricted ingredients | Preservatives | 56 kinds | 51 kinds |
Sunscreens | 28 kinds | 27 kinds (deleting 4-Aminobenzoic acid) | |
Colorants | 156 kinds | 156 kinds (replacing ACID RED 95 by GALLA RHOIS GALLNUT EXTRACT) | |
Hair dyes | 93 kinds | 73 kinds (adding 2 while deleting 21 substances) Adjusting the requirement of maximum concentrations of oxidized and non-oxidized hair products | |
Others | 73 kinds | 47 kinds(added 30 while deleting 4 substances) | |
Test and evaluation methods | Toxicological and microbiological tests | No changes | |
Physical and chemical tests | Test methods of 27 kinds of prohibited or restricted substances | Test methods of 79 kinds of prohibited or restricted substances (adding 50 substances while deleting strontium and total fluoride, and adding ) | |
Human efficacy evaluation tests | Scope: cosmetics use for bodybuilding, breasts, hair growth, hair removal. | Scope: cosmetics use for bodybuilding, breasts, hair growth, hair removal and leave-on products (test result is pH≤3.5 or enterprise standard is pH≤3.5) | |
Test area: forearm flexor, mastoid process and used part 5×5cm2, 0.3~0.5g(mL)/t | Test part: forearm flexor only. 3×3cm2, 0.025~0.035g(mL)/t | ||
Human safety tests | Interval of time for volunteers retest: 1 month | Interval of time for volunteers retest: 2 month | |
Biggest tagged value: SPF 30+ | Biggest tagged value: SPF 50+ | ||
Methods to prepare P7 P7 SPF value: Mean=4.47 SD=1.297 | Methods to prepare P2, P3, P7 P7 SPF value: Mean=4.4 SD=0.2 | ||
(1) The list of prohibited Ingredients
The new draft added 80 Ingredients and 20 animal and plant components to the prohibited list. In general, it included 2 modifications in 2010 of the annex of the Standard, also aligning with the European standard. For example, the "Commission Regulation (EU) No 358/2014" and "Commission Regulation (EU) No 658/2" added Isobutylparaben and its salts, Benzylparaben, Pentylparaben, and N-(2-Nitro-4-aminophenyl)-allylamine (HC Red No 16) and its salts to the prohibited list on the basis of "Regulation (EC) No 1223/2009" China's new regulation has also followed.
(2) The list of and restricted ingredients
In the preservatives list, the draft adjusted the limit of maximum concentration of formaldehyde and paraformaldehyde, 3-Iodo-2-propynylbutylcarbamate, 4-Hydroxybenzoic acid and its salts and esters. For example, the maximum concentration of the formaldehyde and paraformaldehyde in the Standard is 0.05% and it is forbidden in the oral hygiene and lip products. But in this draft its maximum concentration was adjusted to 0.02%, 0.01% and 0.0075% according to different products types and in some conditions it also can be used in the oral hygiene and lip products. And we can see the same change about Benzethonium chloride. Meanwhile, the mixture of 5-Chloro- 2-methyl-isothiazol-3 (2H)-one and 2-methylisothiazol-3(2H)-one can't be used with 2-Methylisothiazol-3(2H)-one in leave-on products any more. And the draft added the purity standard about Triclocarban. These changes are the same as the "Commission Regulation (EU) No 483/2013" and "Commission Regulation (EU) No 1003/2014".
Generally, the changes above stick to the new definition of cosmetic and are consistent with the European Union cosmetic standard.
(3) Test and evaluation methods
In the physical and chemical tests, the methods of arsenic (deleted spectrophotometry), lead (deleted differential potentiometric stripping and spectrophotometry extracted by dithizone) , cadmium (deleted differential potentiometric stripping), thioglycolic acid (added HPLC) and formaldehyde (added HPLC) were adjusted and the test standard of strontium and total fluoride was been deleted.
The biggest change about the evaluation methods is the SPF label. The draft adjusted the biggest tagged value of SPF from 30 to 50. If the difference between the SPF value of tested sample and standard substance is greater than 50, the label of products can be marked SPF 50+. Specific label requirements can be seen in the table as following:
SPF value | Label requirements |
SPF<2 | Can't claim the sunscreen function |
2≤SPF≤50 | Tagged value≤test value |
SPF>50,and SPF- standard value≤50 | The biggest tagged value is SPF50 |
SPF>50,and SPF- standard value>50 | The tagged value only can be SPF50+ |
Generally speaking, the SPF and UVA test method almost is the same as ISO 24444: 2010 (E) and SO 24442: 2011 (E). So these changes can facilitate the development of cosmetic trade.
The influence to the industry
As a whole, the "Safety Technical Standard (draft)" improves the test standards and safety requirements. If the draft is put into effect without further dramatic modification, it will bring with it huge changes in market access requirements and regulatory obligations. On one hand, it will improve the quality of products and ensure the safety of products for consumers. On the other hand, it will be a big challenge for manufacturers and distributors.
As a consumer, the public can be more confident in the safety of the products circulating on the market primarily due to the stricter regulatory requirements. Moreover, sunscreen product regulatory requirements will align with international rules.
As for cosmetic manufacturers, making their products compliant with this standard is the primary task. The manufacturer must optimize their production processes to meet the higher standard as specified in the draft and some may even have to modify their product formula based on the new prohibited and restricted lists. Regarding testing facilities, the needs to develop new testing methods is an obvious requirement. Both non-special use cosmetics and special-use cosmetics will be affected because of the stricter heavy metal limits and new rules governing SPF values. CFDA usually will issue another support document articulating the requirements of testing facilities. The draft sets the bar even higher for China’s cosmetic industry and is now noticeably aligned with the EU regulatory framework.
Reference
[1] Safety Technical Standard for Cosmetic (draft)
[2] Hygienic Standard for Cosmetic (2007)
[3] Commission Regulation (EU) No 358/2014
[4] Commission Regulation (EU) No 658/2
[5] Commission Regulation (EU) No 483/2013
[6] Commission Regulation (EU) No 1003/2014
[7] OECD Guidelines for Testing of Chemicals
[8] USEPA OPPTS Harmonized Test Guidelines
[9] ISO 24444: 2010 (E). Cosmetics Sun protection test methods
[10] ISO 24442: 2011 (E). Cosmetics Sun protection test methods
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