China Cosmetic Safety Assessment Requirements Update

Latest Update:

The National Medicinal Products Administration (NMPA) has just announced a series of optimisations on the management of cosmetic safety assessments in China. The major adjustments includes:

1. Classification on cosmetic safety assessment submission requirements to allow low-risk general use cosmetics to only require submission of a safety assessment abstract up-front, with the full report archived by the cosmetic enterprise for future reference.
2. Simplified versions of safety assessments receive an extension of acceptance until May 1st, 2025. A measure to minimise duplication of R&D resource investments by cosmetic enterprises.

The NMPA has further indicated they will be providing the following measures:

Strengthen technical guidance and improve cosmetics safety assessment capabilities by develop and publish guidance on:

• Read-across
• Threshold of toxicological concern
• Integration approaches on testing and assessments
• Identification and assessment of possible risk substances in cosmetic raw materials
• Product stability and packaging compatibility requirements
• Preservative efficacy testing requirements

Integrate raw material data and improve the convenience of using raw material data by develop and publish guidance on:

• Cosmetic ingredient data usage requirements
• Index of cosmetics safety assessment data from authoritative organisations
• Information on existing cosmetic ingredient usage
• Raw material data sharing platform and drive collaboration between authoritative organisations and the cosmetic industry

Innovate the mechanism of safety assessment report evaluation procedures to promote speed and quality of cosmetic products to the market:

• Introduce classification on cosmetic safety assessment submission requirements based on risk management principles
• Provide principles of product safety testing in absence of raw material safety data

Promote the construction of safety assessment systems and improve product safety assurance standards

• Strengthen scientific research, technical capabilities and utilisation of new technologies/methods for cosmetic safety assessments
• Guide cosmetic enterprises to continuously improve product quality and safety assurance capabilities
• Support training of professional talents and promote the establishment of a safety assessor qualification system
• Strengthen exchanges and technical cooperation with industry associations, cosmetics companies, cosmetic raw material companies, safety assessment institutions, experts and scholars, etc.

It is expected that these guidance would be made available in the coming 12 months of the transition period extension where simplified version of safety assessment would continued to be acceptable.

Reference: https://www.nmpa.gov.cn/xxgk/ggtg/hzhpggtg/jmhzhptg/20240422172542190.html

On 19th April 2021, the National Medical Products Administration (NMPA) published the Technical Guidelines for Cosmetic Safety Assessment (2021 Version), aiming to standardise and guide the Cosmetic Safety Assessment. The guidelines came into force on 1st May 2021, and requires that applicants must conduct and submit cosmetic product safety assessment reports since 1st January 2022.

According to the NMPA Technical Guidelines, the safety of ingredients is the precondition of safety of cosmetic products. Risk assessment of cosmetic ingredients includes assessment of ingredients themselves and of the risk substances that may also be present; cosmetic products are generally recognised as a combination of various ingredients and shall be assessed based on all the ingredients and risk substances. If certain ingredients are confirmed to have chemical and/or biological and other interactions, the risk substances generated and/or the potential safety risk arising from the interactions shall be assessed.

The NMPA Technical Guidelines provide both Full Version and Simplified Version examples of cosmetic product safety assessment reports. Prior to 1st May 2024, cosmetics applicants have been able to submit a Simplified version of the product safety assessment report in accordance with the relevant requirements of the Technical Guidelines.

On 4th March 2021, the National Medical Products Administration (NMPA) published the Provisions for Management of Cosmetic Registration and Notification Dossiers, which stipulates that General Cosmetics may be exempted from submitting toxicological testing report of the product (including animal tests) under the following conditions;

• The manufacturer has obtained a production quality management system, such as Good Manufacturing Practice (GMP) which is issued or certified by the competent government department of the country where it is located. And;
• The product safety risk assessment result can fully confirm the product safety

However, animal toxicological test cannot be exempted in the following circumstances:

1. The product claims to be used by infants and children;
2. The product uses new cosmetic ingredients that are still under safety monitoring;
3. The product is a Special-Use cosmetic;
4. According to the results of quantitative grading, the notifier, domestic responsible person or manufacturer are listed as priority entities for supervision by the NMPA, due to safety concerns.

(Provisions Article 33; in force since May 1, 2021).

Cosmetic safety assessment reports are therefore a mandatory document for any cosmetic products intended to be placed onto China market.

In particular for General Cosmetics that could meet the above conditions, the cosmetic safety assessment report is critical to fulfill product notification requirement, to ensure product safety and exempt the requirement for animal testing.

On 16th June 2020, the State Council of the People’s Republic of China issued the Cosmetic Supervision and Administration Regulation (CSAR), which requires that Cosmetics (General and Special Use) must submit Cosmetic Product Safety Assessment Report for product notification or registration. The applicants shall either conduct a safety assessment by themselves or by entrusting a professional institution. The personnel undertaking the safety assessment shall possess professional knowledge related to cosmetics quality and safety and have more than 5 years of relevant professional work experience (CSAR Article 19, Article 21; CSAR was in force since January 1, 2021).

How Delphic HSE can help:

Delphic HSE was the first 3rd party consulting company that participated the China cosmetic safety assessment guideline establishment since 2019, providing sample report content, format, and technical key points suggestions during industry discussions with China authorities. Delphic began the China cosmetic safety assessment service in line with the full version report requirements from the beginning. In June 2021, soon after the new regulations came into force, Delphic issued the first full version cosmetic safety assessment report for China under CSAR for the first General Cosmetic product notifications among the whole cosmetic industry.

Delphic has built up a strong raw material tox profile database in line with the full version cosmetic safety assessment guidelines requirement, which has about 2000+ ingredients tox data in dual language (Simplified Chinese and English) and Delphic has issued more than 700 full version cosmetic safety assessment reports in dual language in the past 3 years. Delphic has extensive experience in addressing China Authorities challenges on cosmetic safety assessment reports and we are also familiar with the Authorities safety assessment report review successful criteria. With the end of the transition period for the simplified version of cosmetic safety assessment report coming, Delphic, along with other cosmetic industry stakeholders, have provided many full version cosmetic safety assessment implementation recommendations to the China Authorities, with the aim of solving key technical difficulties currently faced by the industry. These include, data gaps for many commonly used cosmetic ingredients, the limitations on TTC and Grouping/Read Across applications etc.

Delphic HSE currently offer below China Cosmetic Safety Assessment and Regulation Compliance services:

• Full version of Cosmetic Safety Assessment Report in dual language (Chinese and English)
• Simplified version of Cosmetic Safety Assessment Report in dual language (Chinese and English) – until May 2024
• CSAR Gap Analysis Service
• Raw Material Safety Information Notification (Annex 14) Service