CSAR Subsidiary Regulations: China Details Cosmetic Safety Assessment Requirements

On Jul. 29, 2020, China opened a public consultation on Technical Guidelines for Cosmetic Safety Assessment, one of CSAR's subsidiary regulations. On Apr. 9, 2021, the finalized Technical Guidelines for Cosmetic Safety Assessment (hereinafter referred to as “the Technical Guidelines”) was officially published and will take effect on May 1, 2021. ¹

Cosmetic registrants and notifiers can conduct cosmetic safety assessments on their own or entrust professional institutions. Cosmetic product safety assessment should be based on the assessment of all the ingredients and possible risk substances. If there are chemical or biological interactions between certain ingredients, the risk substances or potential safety risks arising from the interactions should also be assessed.

Transitional Measures

To ensure a smooth transition, China NMPA also introduced the following transitional measures:

Starting from Jan. 1, 2022, cosmetic registrants and notifiers shall conduct cosmetic safety assessments in accordance with the Technical Guidelines and submit product safety assessment documents when applying for special cosmetics registration or general cosmetics notification.
Considering that there is a gap between the safety assessment capacity of China's cosmetic industry and that of the developed countries, cosmetic registrants and notifiers can submit a simplified version of the product safety assessment report before May 1, 2024.

Contents of the Cosmetic Product and Ingredient Safety Assessment Report

The Technical Guidelines clarify the content of the safety assessment report of cosmetic ingredient and product.

Cosmetic Product Safety Assessment Report

Cosmetic Ingredient Safety Assessment Report

1. Abstract

2. Product introduction

3. Product formula (list all the ingredients and their percentages in descending order)

4. Formula design principles (only for children cosmetics)

5. Safety assessment of each ingredient in the formula: hazard identification, dose-response assessment, exposure assessment, risk characterization

6. Assessment of possible risk substances

7. Risk control measures or recommendations (such as warning, application methods, target users)

8. Safety assessment conclusions, generally including product physical and chemical stability assessment conclusions; product microbiological stability assessment conclusions; human safety data, including clinical data, consumer use research, adverse reaction records; testing conclusions, assessment conclusions of each ingredient)

9. Signature of the safety assessor

10. Resume of the safety assessor, including the assessor’s educational experience, cosmetic industry experience, professional training experience, etc.

11. References

12. Annexes, including testing reports, proof of involved ingredients quality specifications, etc.

1. Abstract

2. Ingredient physical and chemical properties

3. Safety assessment process: hazard identification, dose-response assessment, exposure assessment, risk characterization

4. Analysis of assessment results, including the analysis of the completeness, reliability, and scientificity of the documents in the assessment process and data uncertainty analysis.

5. Risk control measures or recommendations

6. Conclusion of safety assessment

7. Signature of the safety assessor

8. Resume of the safety assessor, including the assessor’s educational experience, cosmetic industry experience, professional training experience, etc.

9. References

10. Annexes, including testing reports, proof of involved ingredients specifications. If there is a risk substance, the risk substance assessment conclusion and documents or the risk substance testing report shall be provided.

Notes:

The safety assessment documents shall be updated in time as needed, and the storage period should be at least ten years after the shelf life of the last batch of products on the market.

Recognized Evidence for Simplified Safety Assessment Report

Before May 1, 2024, cosmetic registrants and notifiers can submit a simplified version of the product safety assessment report. The simplified report can adopt one of the following evidence in sequence to prove the safety of each ingredient in the formula. The specific evidence types are ranked in the table.

No.	Evidence	Adoption Requirements
1	The restricted ingredients, permitted preservatives, permitted sunscreens, permitted colorants, and permitted hair dyes listed in the Safety and Technical Standards for Cosmetics 2015 (STSC).	They must meet the use requirements in STSC.
2	Safety limits or conclusions published by domestic or foreign authoritative organizations (e.g., WHO, FAO, SCCS, CIR), such as conclusions on the safe use of cosmetics, acceptable daily intake, tolerable daily intake, reference dose, generally recognized as safe (GRAS), etc.; Ingredient standards for fragrance published by the International Fragrance Association (IFRA).	If there are restrictions (such as irritation requirements, etc.), the restrictions must be met. Combined with the ingredient historical use concentration, product or ingredient toxicological test or the human trial results, the safety limit or conclusion can be adopted; If there is only a systemic toxicity assessment conclusion, the limits or conclusions can be adopted after assessing the local toxicity of the product (e.g., irritation) based on the ingredient historical use concentration, product or ingredient toxicological test or human trial results.
3	The ingredient concentration in the enterprise’s marketed product (has been on the market for at least three years) of the same application method and application area	The ingredient use concentration should not be higher than the historical use concentration in the enterprise; otherwise, a safety assessment should be carried out in accordance with the Technical Guidelines; The ingredients historical use concentration of products with high exposure and long contact time can be adopted for products with low exposure and short contact time, but the rationality should be explained based on the analysis of target user, application area, and application method.
4	Ingredient highest historical use concentration announced by the regulatory authority.	The ingredient concentration in the products to be assessed should not be higher than the highest historical use concentration announced by the regulatory authority.
Notes: For ingredients or risk substances that cannot use any of the above-mentioned evidence to prove their safety, they shall be assessed for safety in accordance with the Technical Guidelines.

The content of the simplified report is similar to the full report, but the simplified report can use the highest historical use concentration in the enterprise’s marketed product and announced by the regulatory authority to prove the ingredient safety. Stakeholders may visit the English Translation of the Technical Guidelines for the detailed comparison between the simplified report and the full report.

Qualification Requirements for Safety Assessors

Cosmetic safety assessors should meet the following requirements:

Have professional knowledge of cosmetics quality and safety such as medicine, pharmacy, biology, chemistry, or toxicology, understand the cosmetic or ingredient production process and quality and safety control requirements, and have more than five years of relevant professional experience;
Be able to consult and analyze chemistry, toxicology, and other related literature information, analyze, assess, and interpret relevant data;
Be able to analyze cosmetics' safety fairly and objectively and conduct safety assessments based on a comprehensive analysis of all available data and exposure conditions, and be responsible for the scientificity, accuracy, authenticity, and reliability of the assessment report;
Be able to regularly receive corresponding professional training, learn relevant knowledge of safety assessment, understand and master new safety assessment theories, techniques and methods, and use them in practice.

Industry Comments

China previously issued a draft IECIC 2021, newly adding the ingredients' highest historical use concentration. When conducting safety assessment, the ingredients' highest historical use concentration in IECIC may be used as a reference to prove the ingredient safety.
The finalized Technical Guidelines do not clarify whether to recognize foreign safety assessment reports or foreign safety assessors. Also, the high requirements for safety assessors and the current shortage of such talents in China may become challenges for enterprises to conduct safety assessments in the future.
Ligang Jiang, the Chief R & D Officer from Proya Cosmetics Co., Ltd, once said, "The Technical Guidelines have very high requirements for cosmetic safety assessment in China. In the future, it is almost an impossible task to complete the development of a new product from conception to market launch within 3 months like now." ²

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CSAR Subsidiary Regulations: China Details Cosmetic Safety Assessment Requirements

Transitional Measures

Contents of the Cosmetic Product and Ingredient Safety Assessment Report

Recognized Evidence for Simplified Safety Assessment Report

Qualification Requirements for Safety Assessors

Industry Comments

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