[Updated] China Expands Recognized Ingredient Safety Data for Safety Assessment Report

1. Restricted ingredients, permitted preservatives, permitted sunscreens, permitted colorants, and permitted hair dyes listed in Safety and Technical Standards for Cosmetics (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.; or ingredient standards for fragrance published by the International Fragrance Association (IFRA);

3. The ingredient concentration in the enterprise’s marketed products that have been on the market for at least three years with the same application method and application area;

4. Ingredients' highest historical use concentration announced by the regulatory authority.

1. Restricted ingredients, permitted preservatives, permitted sunscreens, permitted colorants, and permitted hair dyes listed in STSC;

2. Assessment conclusions published by international authoritative agencies specializing in cosmetics safety assessment;

3. Safety limits or conclusions published by authoritative organizations such as WHO and FAO;

4. Ingredient Usage Information of Marketed Products published by regulatory authorities;

5. Three-year usage history of ingredients;

6. Safe consumption history;

7. High molecular polymers with stable structure and properties (excluding ingredients with high biological activity).

Note:

• Both "Ingredient Usage Information of Marketed Products published by regulatory authorities" and the "three-year usage history of ingredients" cannot be used to prove the safety of freckle-removing and whitening agents;

• The "Ingredient Usage Information of Marketed Products published by regulatory authorities" cannot be used to prove the safety of anti-hair loss agents anti-acne agents, anti-wrinkle agents (excluding physical anti-wrinkle agents), anti-dandruff agents, deodorants, and ingredients with high biological activity;

• If the intended use remains the same as before, the "three-year usage history of ingredients" can be used to prove the safety of anti-hair loss agents, anti-acne agents, anti-wrinkle agents (excluding physical anti-wrinkle agents), anti-dandruff agents, deodorants, and ingredients with high biological activity.

1

Restricted ingredients, permitted preservatives, permitted sunscreens, permitted colorants, and permitted hair dyes listed in STSC

They must meet the use requirements in STSC.

Enterprises should provide ingredient safety-related information in accordance with registration and notification requirements.

2

Assessment conclusions published by international authoritative agencies specializing in cosmetics safety assessment

e.g. Ingredient safety assessment conclusions published by SCCS or CIR

1. Assessment conclusions shall meet the below conditions after analysis:

• Conclusions that comply with China's cosmetic regulations and usage conditions can be adopted;

• For ingredients with restricted use conditions, the conclusions can be adopted if the specified conditions are met.

2. When assessment conclusions from different authoritative agencies diverge, enterprises should scientifically and reasonably adopt relevant assessment conclusions. The reliability and relevance of the data should guide the selection process.

The safety assessment documents should explicitly state the safety assessment agency and the assessment conclusions. Additionally, the safety assessment report should be archived for future reference.

3

Safety limits or conclusions published by authoritative organizations such as WHO and FAO

e.g. Acceptable daily intake (ADI), tolerable daily intake (TDI), reference dose (RfD), substances generally recognized as safe (GRAS), ingredient standards for fragrance published by the International Fragrance Association (IFRA) and China Standardization Administration, safe usage amounts of freckle-removing and whitening agents published by regulatory authorities at home and abroad, etc.

1. Assessment conclusions shall comply with China's cosmetic regulations and usage conditions after analyzing relevant data;

2. In the absence of local toxicity data, an assessment of local toxicity should be conducted by taking into account the specific application site and application method of the product;

3. When assessment conclusions from different authoritative agencies diverge, enterprises should scientifically and reasonably adopt relevant assessment conclusions. The reliability and relevance of the data should guide the selection process.

The safety assessment documents should explicitly state the safety limits or sources of conclusions. Additionally, the relevant documents should be archived for future reference.

4

Ingredient Usage Information of Marketed Products published by regulatory authorities

It can provide reference for product safety assessment.

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5

Three-year usage history of the same ingredients, sourced either from the same enterprise or from other authorized enterprises

1. In the case of ingredients that have been used domestically and internationally for three years or more, the following conditions must be met for both the ingredients used historically and the ingredients under assessment:

• The ingredient with a usage history and the ingredient to be assessed must be the same ingredient (with the same ingredient serial number in IECIC), and the concentration of the main functional component and solvent should be consistent;

• Their application sites and methods must be identical;

• The concentration of the ingredient to be assessed in the formulation should be lower than the historical usage concentration;

• If the marketed products containing the ingredient have adverse reactions records, those reactions must not pertain to the safety of the ingredient itself.

2. The ingredient’s historical use concentrations of products with high exposure and long exposure time can be utilized to assess the safety of ingredients used in products with low exposure and short exposure time. However, the the appropriateness of such utilization must be thoroughly analyzed considering factors such as the target population, application site, and application method. If required, an assessment of local toxicity should be conducted to ensure safety.

When registering or notifying cosmetics, the following documents are required to demonstrate the 3-year usage history:

1. Concentration of the main functional component and solvent Proof that the ingredients used historically and the ingredients under assessment are the same ingredient;

2. For registered cosmetics, the registration certificate and product formula that is consistent with the submitted formula during registration should be provided. For notified cosmetics and cosmetics marketed overseas, the production and input records with ingredient concentration or calculable ingredient concentration should be provided, along with the notification certificate (the notification certificate is not required for products exclusively marketed abroad);

3. Description of adverse reaction monitoring;

4. Proof of sales data. Registrants and notifiers should analyze the sales situation, and the results can reflect the safety of the ingredient used by the population.

• If the terminal retail cosmetics sales volume is used as the proof of sales performance, the cumulative sales volume over the three years should be at least 10,000 pieces;

• If the factory quantity of cosmetics manufacturers is used as the proof of sales performance, the cumulative factory quantity over the three years should be at least 30,000 pieces;

• Sales data of the products with the same ingredients from the same group company can be combined. The exposure amount and contact time should be explained.

5. Authorization letter issued by the ingredient manufacturer or the cosmetics manufacturer using the same ingredient (applicable when providing the 3-year usage history documents of other authorized enterprises);

6. Any other relevant documents.

6

Safe consumption history

1. A comprehensive and in-depth investigation should be conducted regarding the ingredient’s consumption history, production processes, and related factors to ensure the safe edible characteristics of the ingredient itself and the raw materials used in its preparation;

2. Such ingredients can be exempted from systemic toxicity assessment during the safety assessment process, but instead, local toxicity assessment can be performed considering the product application site and application method.

Documents substantiating the safe consumption history should originate from regulatory and supervisory departments at or above the provincial level in the fields of food, agriculture, health, and related areas, or technical institutions possessing relevant functions of and capabilities for food safety risk assessment. These documents should be publicly available that carries a certain level of authority;

2. In the assessment process, a comparative analysis should be conducted between the information provided in the documents pertaining to the safe consumption history and the corresponding information regarding the ingredients under assessment. The consistency or correlation between the two sets of information should be thoroughly explained;

3. If the information provided in the documents pertains to the raw materials, and the ingredient undergoes further processing on the basis of these raw materials, comprehensive proof of the alignment between the raw materials and the ingredient is required. This proof should encompass aspects such as ingredient sources, production processes, actual composition, and usage specifications. Moreover, the processing method employed should be basically consistent with the food processing method, such as utilizing only water extraction, cooking, etc. If necessary, an analysis of the changes and enrichment of the ingredient should be performed.

7

High molecular polymers with stable structure and properties (excluding ingredients with high biological activity)

For chemically synthesized polymers composed of one or more structural units connected by covalent bonds, with an average relative molecular mass greater than 1,000 Daltons, and with less than 10% concentration of oligomer whose relative molecular mass is less than 1,000 Daltons, with a stable structure and properties, transdermal absorption may not be considered in the safety assessment. Instead, a local toxicity assessment can be conducted, taking into account the product application site and application method.

1. Structural units;

2. Average molecular weight;

3. The concentration of oligomer with a relative molecular mass less than 1,000 Daltons;

4. Research documents Explanatory material for ingredients that demonstrate no biological activity.