Analysis of China's Regulatory Requirements for Potentially Allergenic Cosmetics

For consumers with sensitive skin, certain cosmetic ingredients may trigger allergic reactions. Factors such as ingredient composition, concentration, and purity, as well as product usage conditions, application sites, skin contact time, use frequency, and storage can all impact sensitisation. In light of this, the cosmetics industry is increasingly prioritizing the use of safe and effective ingredients in their products. To ensure regulatory compliance in China, enterprises must be vigilant about allergenic ingredients and comply with relevant testing requirements. This article provides an overview of common allergens found in cosmetics and outlines 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:

Group A

Amyl cinnamal (122-40-7), Amyl Cinnamal Alcohol (101-85-9), Benzyl Alcohol (100-51-6), Benzyl Salicylate (118-58-1), Cinnamyl Alcohol (104-54-1), Cinnamal (104-55-2), Citral (5392-40-5), Coumarin (91-64-5), Eugenol (97-53-0), Geraniol (106-24-1), Hydroxycitronellal (107-75-5), Hydroxyisohexyl 3-cyclohexene carboxaldehyde (31906-04-4), Isoeugenol (97-54-1)

Group B*

Anise Alcohol (105-13-5), Benzyl Benzoate (120-51-4), Benzyl Cinnamate (103-41-3), Citronellol (106-22-9), Farnesol (4602-84-0), Hexyl Cinnamal (101-86-0), Butylphenyl Methypropional (80-54-6), Limonene (5989-27-5), Linalool (78-70-6), Methyl 2-Octynoate (111-12-6), Alpha-Isomethyl lonone (127-51-5)

*Allergy reports of fragrances in group B were less frequent than in group A.

Supplement

Evernia Prunastri (Oakmoss) Extract (90028-68-5), Evernia Furfuracea (Treemoss) Extract (90028-67-4)

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.