CFDA Start to Carry Out the Safety Assessment of 10 Cosmetic Ingredients

CFDA entrust Cosmetic Safety Risk Assessment Committee (CSRAC) to launch the safety assessment of 10 cosmetic ingredients. According to the CFDA requests, National Institutes for Food and Drug Control published a notice on Feb 24, 2016 that the cosmetics manufacturers and research institutes, who have ever usedthese 10 cosmetic ingredients, should provide support to committee for the using information. Any opinions shall be delivered to 010- 67095922 or posted to NO.2 Tian tan xi li, Bejing City (Postcode: 100053). The electronic versioncan be sent to Fenglan Zhangby email hzpbwh@nifdc.org.cn before May 1, 2016.

Background

Cosmetics safety risk assessment is considered as a reliable method to reflect the potential risk of cosmetics. It is globally accepted by developed countries such as USA, EU, Japan and etc. In November last year, CFDA has already invited public comments on the draft Guidelines on Safety Risk Assessment of Cosmetic Products. Great changes happened on the cosmetics regulations in 2015. It was implied that CFDA tend to strengthen the safety management of cosmetic ingredients. This is the first time for CFDA to carry out the safety assessment of cosmetic ingredients in 2016.

Main contents

1. List of 10 cosmetic ingredients

NO.	Index	Chinese Name	INCI Name/English Name
1	04953	欧荨麻（ URTICA URENS ）提取物	URTICA URENS EXTRACT
2	04954	欧荨麻（ URTICA URENS ）叶提取物	URTICA URENS LEAF EXTRACT
3	05717	噻克索酮	TIOXOLONE
4	06813	蜗牛分泌物滤液	SNAIL SECRETION FILTRATE
5	07301	荨麻（ URTICA THUNBERIANA;U.DIOICA ）提取物	IRAKUSA EKISU
6	07317	亚甲基二氧苯基甲基丙醛	METHYLENEDIOXYPHENYL METHYLPROPANAL
7	07639	野漆（ RHUS SUCCEDANEA ）果蜡	RHUS SUCCEDANEA FRUIT WAX
8	07898	异株荨麻（ URTICA DIOICA ）提取物	URTICA DIOICA (NETTLE) EXTRACT
9	07899	异株荨麻（ URTICA DIOICA ）叶粉	URTICA DIOICA (NETTLE) LEAF POWDER
10	07900	异株荨麻（ URTICA DIOICA ）叶提取物	URTICA DIOICA (NETTLE) LEAF EXTRACT

Note:

• TI OXOLONE was firstly recorded in IECIC (2003 version) published by MOH.
• URTICA URENS EXTRACT& METHYLENEDIOXYPHENYL METHYLPROPANAL was firstly recorded in IECIC (2014 version) published by CFDA.
• The other 7 ingredients were firstly recorded in INCI (2010 version).
• All of these 10 ingredients are not regarded as prohibited or limited components in EU.

2. Illustration forsubmitted information

The feedback form contains following content.

(For the template of Feedback Form, please click )

1) Using information of cosmetic ingredient.

• Basic information: Chinese name, INCI name/English name, purity level or purity range.
• Usage amount: annual amount per year used by cosmetic manufacturer and use level in one cosmetic product.
• Product information: name of cosmetic product using this ingredient, type of cosmetic product, approval or record-keeping number of cosmetic product, copy ofapproval or record-keeping documents.

2) Risk assessment materialof cosmetic ingredients

• If you have risk assessment material,it should be prepared based on draft Guidelines on Safety Risk Assessment of Cosmetic Products

Please post the paper document to the aforementioned mailing address. Meanwhile, the Feedback Form and electronic version of risk assessment material should be sent to abovee-mail address.

CIRScomments

• After searching from EU’s ingredient database-Cosing, 9 ingredients are recorded except URTICA DIOICA (NETTLE) LEAF POWDE. However, the records can’t reflect the safety of these ingredients.
• After searching from CIR of US, there is only the record of safetyassessment for RHUS SUCCEDANEA FRUIT WAX .Moreover, the data only focus on the assessment of animal toxicity test, mutagenicity test and clinical skin sensitization test. There is no detailed information about phototoxicity, photosensitivity and chronic toxicity/subchronic toxicity.
• SCCS do not assess these 10 ingredients either.
• Based on the above research results, the safety assessment of these 10 ingredients is inadequate in other countries as well.
• We can see the future way of post market management of cosmetic ingredients from the using information required by CFDA.
• The future risk assessment report of cosmetic ingredients should be prepared depending on the Guidelines on Safety Risk Assessment of Cosmetic Products. This will be a challenge for Chinese cosmetic manufacturers or ingredient suppliers.

Relevant Links

http://www.nicpbp.org.cn/CL0831/7829.html

http://www.cirs-reach.com/news-and-articles/guidelines-on-safety-risk-assessment-of-cosmetic-products-(draft)-issued-in-china-for-public-comments.html