Analysis of China's Regulatory Requirements for Potentially Allergenic Cosmetics

Common Allergens Found in Cosmetic Products

Regarding the common allergens in cosmetics, the U.S. Food and Drug Administration (FDA) compiles scientific information, including natural rubber, certain fragrances, preservatives, colorants, and metals. ¹

1. Natural rubber

Natural rubber, and it is sometimes labeled as "rubber latex".

2. Fragrance

Fragrances, whether naturally derived or chemically synthesized, are generally considered the most common allergens in cosmetics. While the specific components of fragrance are typically not listed on the ingredient label, they are uniformly labeled as "fragrance" or "flavor".

As released by the EU, the below 26 common fragrances may lead to allergy:

China has proposed labeling requirements for fragrance allergens in children's cosmetics. Technical Guidelines for Children's Cosmetics (Draft for Comments), released on April 11, 2022, encourages the avoidance of fragrances and flavors in children's cosmetics, especially those that may contain any of the above 26 fragrance allergens. If a fragrance that contains these allergens is used,

• A full safety assessment must be conducted;

• For leave-on products whose fragrance allergens exceed 0.001%, or rinse-off products with a concentration of fragrance allergens exceeding 0.01%, the specific name of the allergen must be labeled, accompanied by the guiding word "Contains Allergens".

3. Preservatives

Preservatives in cosmetics play an important role in inhibiting the growth and reproduction of microorganisms. However, they are also among the most common allergens and may cause contact dermatitis. To address this issue, cosmetics manufacturers have implemented various measures, such as reducing preservative amounts, selecting safer alternatives, and utilizing specialized containers to prevent contamination.

Common preservative allergens include:

1) Methylisothiazolinone (MIT, 2682-20-4)

2) Methylchloroisothiazolinone (CMIT, 26172-55-4)

3) Formaldehyde and formaldehyde-releasing ingredients:

• 2-Bromo-2-Nitropropane-1,3-Diol (52-51-7)

• 5-Bromo-5-Nitro-1,3-Dioxane (30007-47-7)

• Diazolidinyl Urea (78491-02-8)

• Dmdm Hydantoin (6440-58-0)

• Imidazolidinyl Urea (39236-46-9)

• Sodium Hydroxymethylglycinate (70161-44-3)

• Quaternium-15 (4080-31-3, 51229-78-8)

4. Colorants

Common colorant allergens include:

• p-Phenylenediamine (PPD, 106-50-3)

• Coal tar colorant

5. Metals

Common metal allergens include:

• Nickel

• Gold

China's Testing Requirements for Allergenicity of Cosmetics

1. Skin sensitisation testing requirements for cosmetic products

Regarding skin sensitisation testing for cosmetic products, three situations may require such testing. ² The relevant testing requirements and permitted testing methods are shown in the table below.

2. Permitted testing methods for skin sensitisation

At present, the cosmetic sensitisation testing methods accepted by NMPA can be divided into two categories: animal testing and non-animal testing.

1) Animal testing

2) Non-animal testing

Currently, the only non-animal testing method accepted by NMPA is In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA).

It should be noted that currently,

• There is no non-animal testing method that can independently evaluate the skin sensitisation potential of a test substance. It is necessary to select an appropriate testing method based on the actual nature of the test substance and use a combination strategy to fully evaluate the skin sensitisation potential for cosmetic ingredients;

• For finished cosmetic products, only animal testing methods (BT and GPMT) can be accepted to evaluate skin sensitisation.

China's Special Requirements related to Allergenicity of Cosmetics

1. Cosmetic Efficacy Claims

According to Standards for Cosmetic Efficacy Claim Evaluation, if a cosmetic product claims to be suitable for sensitive skin, it must be evaluated for its efficacy claims. This requires evidence such as human body efficacy evaluation test data or consumer use test data to support the claim.

The commonly used human body efficacy evaluation test is the human patch test, including the closed patch test and HRIPT. The closed patch test involves placing suspected allergens in an appropriate proportion in a patch tester and applying it to the subject's back or forearm flexion for 24 hours. Skin reaction will be evaluated by professionals at half an hour, and 24 hours to 48 hours after the application. When cosmetics have irritating results that are difficult to judge, HRIPT is additionally required. To ensure compliance with the human patch test requirements, enterprises can refer to the draft Technical Guidelines for Human Patch Test issued by NIFDC on April 27, 2023.

2. Cosmetic Adverse Reaction Monitoring

On October 1, 2022, NMPA implemented the Measures for the Management of Cosmetic Adverse Reaction Monitoring (hereinafter referred to as the “Measures”), setting out systematic requirements for the monitoring of adverse reactions of cosmetics.

According to the Measures, cosmetics registrants and notifiers are required to establish and implement a cosmetics adverse reaction (e.g. skin allergy) monitoring and evaluation system. The system requires actively collecting reports from entrusted manufacturers, cosmetics operators, medical institutions, consumers, and other relevant parties concerning adverse reactions to their marketed cosmetics. In addition, cosmetic registrants and notifiers must analyze and evaluate adverse reactions that are serious and may cause greater social impact, and compile self-inspection reports accordingly.

Further Reading

• Fragrance Allergens Labeling Regulations for Cosmetics in Global Major Countries

• EU to Extend the Individual Labelling Requirement for 56 Newly Identified Fragrance Allergens in Cosmetics

• Canada Proposes to Require Cosmetics to Be Labeled with Fragrance Allergens