Tips for Cosmetic Enterprises to Label Fragrance Allergens in South Korea

South Korea requires enterprises to use fragrance allergen labeling on the packaging of cosmetics starting from Jan 1, 2020 ^[1]. Cosmetics packaging labeled according to the previous regulations can be used before Jan 1, 2021. The 25 fragrance allergens are:

*Only when fragrance allergens exceed 0.01% in rinse-off products or 0.001% in leave-on products, do fragrance allergen labeling requirements need to be followed.

On Dec 31, 2019, South Korea released Guideline for Cosmetics Fragrance Allergens Labeling ^[2], which answers several FAQs of fragrance allergens labeling.

Q1. How to distinguish between rinse-off products and leave-on products?
A1: Rinse-off products refer to products that need to be washed off after application to the skin, hair, etc. (e.g., shampoo, hair conditioner).

Q2: Whether the fragrance allergens should be labeled according to their content?
A2: The labeling method and order are not determined according to the content of allergens, but it is recommended to refer to the labeling method of full ingredients.

Q3: Whether the fragrance allergens should be labeled separately or written in “Precautions for use”?
A3: The purpose of fragrance allergens labeling in the full ingredient list is to ensure the safe use of the product for the consumers who are allergic to those fragrances.

Therefore, if fragrance allergens are separately labeled, consumers may misunderstand that only those ingredients may cause allergies. So do not label the fragrance allergens separately or in "Precautions for use."

Q4: For cosmetics with a capacity of more than 10mL (g) but less than 50mL (g), is it necessary to label fragrance allergens?
A4: Fragrance allergens can be omitted due to insufficient area, but relevant information should be available on the homepage.

For such small-capacity cosmetics, it is recommended to label fragrance allergens if the packaging area is sufficient.

Q5: Is it necessary to label fragrance allergens contained in natural essential oils or plant extracts?
A5: If essential oils or extracts extracted from the flowers, leaves, and stems of plants are used for the function of fragrance, or the ingredient has the characteristics of a fragrance, allergens must be labeled.

Q6: Is it possible to distribute cosmetics manufactured in 2020 (made from existing ingredients that are manufactured in 2019) after Jan 1, 2021?
A6: Cosmetics manufactured in 2020 (made from existing ingredients that are manufactured in 2019) can be distributed until the expiration date.

However, allergens are recommended to the label on the packaging through sticking a new label.

Q7: Should fragrance allergens be listed on the responsible distributor's homepage or online retailer's website?
A7: Online retailer’s website shall list the fragrance allergens.

Q8: Is it necessary to include fragrance allergens when reporting ingredient lists?
A8: If the fragrance allergen is labeled on the packaging, it must be included in the ingredient list report.

Q9: Proof materials for fragrance allergens
A9: Responsible distributors shall prepare a “manufacturing certificate” or “product standard” that records fragrance allergens, or reliable materials provided by the manufacturer that can prove the product contains fragrance allergens, such as experimental results, ingredient specifications, etc.