Guidelines on Safety Risk Assessment of Cosmetic Products (Draft) Issued in China for Public Comments

Nov 10 2015, CFDA invite public comments on the draft of Cosmetics Safety Risk Assessment Handbook. Any opinions shall be sent to 010-88330729 by fax and hzpc@cfda.gov.cn by email before Dec 10 2015 .

Background

Cosmetics safety risk assessmentis considered as a reliable method to reflect the potential risks of cosmetics and is globally accepted by developed countries such as USA, EU, Japan and etc. To a certain extent, it can replace the toxicological tests of finished products. In 2010, CFDA initially issued The Guidance for Risk Assessment ofPotential Safety Risk Substancesin Cosmetics (CFDA [2010] No. 339) to briefly describe the risk assessment process. On Dec 2013, CFDA published The Announcement on the Adjustment of Cosmetics Registration and Record-keeping Administration (CFDA [2013] No. 10). According to the announcement, the toxicological tests for domestic non-special cosmetics may be waived on the condition that the risk assessment result is sufficient to verify the safety of products. Moreover, a safety risk assessment report is compulsory for the registration of domestic special cosmetics and imported cosmetics. However, there is no official guidance for the safety evaluation of cosmetic products in China. Therefore, the draft Guidelines on S afety Risk Assessment of Cosmetic Products (GUIDELINES) is compiled based on the Guidance for Safety Evaluation of Cosmetic Products(version 11) in Europe, continuous updates shall be maintained.

1. Applicability

2. Basic principleand requirements

3. Requirementsfor the assessors

4. Process ofassessment

5. Toxicology

6. Risk assessment of cosmetics ingredients

7. Safety evaluationof cosmetics products

8. Example report

9. Annotations

The overall concepts of the GUIDELINES can be summarized into following main points:

l Applicable to the risk assessment of cosmetic ingredients and risk substances. (refer to Chapter 1)

l Safety risk assessment report should be updated timely and kept for ten years from the expiration date of last batch of market products. (refer to Chapter 2)

l Toxicological tests in animals are required when the safety risk assessment report is not enough to prove the safety of cosmetic products (refer to Chapter 2)

l A complete safety evaluation report of finished products should include the risk assessment of each ingredient and risk substancecontained in cosmetics. (refer to Chapter 3)

l A bachelor degree(Medicine, Pharmacy, Chemistry, Toxicology or relevant professions) and at least 5 years relevant professional experienceare required for the assessors. (Refer to Chapter 3)

l Procedures of risk assessment contain hazard identification,evaluation of dose-response relationship, exposure evaluation and description of risk features. (Refer to Chapter 4)

l Risk assessment can be waived for preservatives, sunscreen agents, colorants and hair dyes included in the positive list of Technical Safety Standard for Cosmetics.(Refer to Chapter 6)

l The risk assessment report issued by CIR and SCCS will be accepted when it complies with Chinese cosmetic regulations. (Refer to Chapter 6)

l The safety limit published by WHO, FAO, OECD and other foreign authorities can be accepted when it complies with Chinese cosmetic regulations. (Refer to Chapter 6)

l IFRA standard will be available as a reference for the evaluation of perfumes in China based on meeting the Chinese cosmetics regulations as well. (Refer to Chapter 6)

l Physio-chemical property is very important to predict the specific characteristics of toxicology. More specific info is required for different sources of ingredients (mineral, plant, animal and biotechnology) and flavors . (Refer to Chapter 6)

l Human skin patch should be conducted to test the skin irritation or skin sensitization after the safety risk assessment of finished product is fulfilled. (Refer to Chapter 7)

How to make a complete safety evaluation report of finished cosmetic products?

Step 1	Gathering all related testing data of each ingredient* (physiochemical property, toxicology, crowd safety)
Step 2	Other test data required for finished product (physiochemical stability test, microbiology and human safety test)
Step 3	Other info required for finished product (formula, use method, function, application amount, etc)
Step 4	Risk assessment of each ingredient and risk substance - hazard identification - evaluation of dose-response relationship - exposure evaluation** - description of risk features***
Step 5	Analysis of safety risk assessment result
Step 6	Safety risk control measures or suggestions
Step 7	Conclusion of cosmetic product safety evaluation

Sample reports for Cosmetics Ingredient Risk Assessment ( ) and Cosmetics Product Safety Evaluation( ) are provided to illustrate detailed information required in the pre-market approval.

* For flavors or ingredients derived from mineral, animal, plant or biotech, additional information shall be provided. ( )

** It is determined by evaluating the exposure body parts, intensity, frequency, and time of duration.

*** Margin of safety(MoS) is used to evaluate the risk of threshold compounds. The ingredient is considered to be safe if MoS ≥ 100. It is applicable to cosmetics intended for use in children.

No	Conditions
1	The risk assessment can be waived for the ingredients on the positive list of Technical Safety Standard for Cosmetics, including preservatives, sun-screening agents, colorants and hair dyes, etc.
2	The risk assessment result from authoritativeinstitutions(CIR, SCCS, etc.) shall be adopted if it is compliant with related Chinese regulations.
3	The safety limitation data(TDI, RfD, ADI, etc.) provided by foreigninstitutions(WHO, FAO, OECD and etc.) shall be adopted if it is compliant with related Chinese regulations.
4	The evaluation result of fragrance ingredient from the standard of IFRA shall be adopted if it is compliant with related Chinese regulations.

Ø It will save much more time to fulfill the process of pre-market approval of imported cosmetics so as to shorten the whole time of placing the cosmetics to China market when safety evaluation report of finished products is available to replace the toxicological tests.

Ø The cosmetics approved in EU might be easier to be approved in China as result of similar requirements of safety risk assessment between EU and China.

Ø It will be a challenge for domestic manufacturers. In other words, the requirements of record keeping for domestic non special use cosmetics are becoming more stringent.

Ø The safety of fragrant ingredients needs to be assessed as part of full safety evaluation report of finished products.

Ø CFDA will tend to strengthen the post market supervision of cosmetics.

Source : http://www.sfda.gov.cn/WS01/CL0781/134401.html