Inventory of Existing Cosmetic Ingredients in China - IECIC(2014)
In China, new cosmetic ingredient to be used for cosmetics production must be approved by Chinese food and drug administration authorities(now CFDA)first. For a long time, the China Food and Drug Administration (CFDA) has relied on IECIC 2003, an internally circulated list of cosmetics ingredients, in determining whether an ingredient is new. This has caused lots of trouble within the industry due to the limited number of ingredients on IECIC (2003) and the difficulty of getting a new ingredient approved. Therefore, to strengthen the safety management of cosmetic ingredients and make determination criteria more transparent, CFDA has published a consolidated Inventory of Existing Cosmetic Ingredients in China(2014) for public consultations.
The comparison between IECIC 2003 and IECIC 2014 Draft is listed as follows:
| IECIC 2003 | IECIC 2014 Draft |
|---|---|
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The IECIC(2014 Draft) can be accessed here.
The Chinese version of IECIC(2003) is available upon request free of charge. If you are interested, please contact service@cirs-reach.com.
We can help you search both IECIC(2003) & IECIC(2014 Draft), determine if an ingredient is new or not and identifiy maximum allowable use level if there is any restriction in IECIC & hygienic standard for cosmetics(2007) in China. This service costs RMB 100 per ingredient depending on the number of cosmetic ingredients to be searched. Please note that the first ingredient search is free of charge.
Registration of New Cosmetic Ingredient with SFDA
If an ingredient is new, it must be registered with the SFDA prior to being used in cosmetics in China. If a new cosmetic ingredient is to be imported into China on its own or in finished cosmetic products, the manufacturer of the new ingredient or finished cosmetic products must register the new ingredient with the Chinese SFDA. Usually, a Chinese responsible agent needs to be appointed for the registration work.
What is New!
24 Jan 2014, CFDA has published a notice to invite public comments on
the amendment of new cosmetic ingredient registration management
rules. The new rules give new cosmetic ingredient registrants a protection period of 4 years. More info can be found here.
The following documents are required for the registration of a new cosmetic ingredient in China according to the guidelines for the registration and technical review of new cosmetic ingredients published in 2011[4].
- Application form for hygiene license for new cosmetic ingredient;
- A research & development report consisting of the following information:
- Background of research, R&D process and relevant technical files;
- The source of ingredient, physiochemical properties, molecular structure, molecular structure, molecular weight;
- Purpose in cosmetics, supporting proof, scope and extent of use in cosmetics;
- Brief description and diagram of production process;
- Standards for quality and safety control of ingredient (including qualitative and quantitative test methods and specifications for the ingredient and impurities, etc);
- Toxicology safety assessment data including safety assessment of risk substances;
- Power of Attorney in case of using an agent;
- Other information which are helpful to review;
More info about registration of a new cosmetic ingredient with China SFDA can be found here.
Note: If a new cosmetic ingredient is not listed on Inventory of Existing Chemical Substances Produced or Imported in China (IECSC), it must be registered with CRC of MEP. More info can be found here.
Other Requirements of Ingredients in Cosmetics
The Hygienic Standard for Cosmetics published by the Ministry of Health in 2007 has banned over 1200 chemicals in cosmetics and restricted the use of 73 chemicals, 56 preservatives, 156 colorants, 28 sun block agents and 93 dyes in cosmetics. Before applying for hygiene license or record-keeping certificate for finished cosmetics, companies shall make sure their formula meets the requirements of this hygienic standard.
About Us
CIRS a leading provider of comprehensive chemical compliance services for companies doing businesses in/with EU and China with a strong focus on chemical compliance.
Our services for Europe include REACH only representative, REACH (pre-)registration, SIEF/consortium representation, REACH SDS, C&L notification, classification of substances and mixtures, CLP labeling, and auditing support.
Our services for China cover new substance notification, registration of the import and export of toxic chemicals, registration of hazardous chemicals, classification and labeling in according to China GHS, Chinese SDS, risk assessment, pesticides, registration of cosmetics and new cosmetic ingredients with SFDA. We also deliver the most up-to-date regulatory information about chemical control laws in China.
In addition to above services, CIRS works with its global regulatory consulting partners to provide one-stop solutions to you regarding global chemical compliance.
Contact Us
If you would like to obtain the final or draft version of IECIC or would like to check if your substance is approved for use in cosmetics in China, please contact:
Ms April Guo, Head of Cosmetics Regulatory Affairs, CIRS China
Specialized field: application for hygiene License, record-keeping certificate for imported cosmetics, safety evaluation of cosmetics and cosmetic ingredients, standard labelling for cosmetics, SDFA registration, CIQ label, etc.
- Ms April Guo, CIRS China Office
11F Building 1, Dongguan Hi-Tech Park, 1288 Chunbo Road, Binjiang District, Hangzhou 310052, China
Tel: +86-571 8720 6555 | Fax: +86-571 8720 6533
Email: april.guo@cirs-reach.com
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