Taiwan Implements New Requirements for Ingredients and Hair Dye Products Claims on Jan 1 2019

Early on April 13, 2018, Taiwan FDA released 2 amendments of Medicated or Poisonous Ingredients List of Hair Dye Products and Standard of Mandatory Claims for Hair Dye Products on the Label, Instruction and Packaging, which entered into force on Jan 1, 2019 (CL News).

1) Medicated or Poisonous Ingredients List of Hair Dye Products Medicated or Poisonous Ingredients List of Hair Dye Products

In the new list, the hair dye ingredients part adds columns including INCI name, CAS Number and restriction/precaution, and refines the column "limitation" to "limitation standard (oxidative/non-oxidative)". Some hair dye ingredients have been deleted, while 33 new ingredients are added to make a total of 104 hair dye ingredients. Besides, limitation and requirements of some ingredients are adjusted. For example, the maximum limits of Toluene 2, 5-diamine was 4% in the past (Toluene 2, 5-diamine), but in the new list, it stipulates a maximum limit of 2% (free base) and 3.6% as a sulfate salt.

Currently hair dye products should obtain a medicated cosmetic certificate. Some conditions/prerequisites of the certificate need to be adjusted to ensure compliance with the new requirements:

If the product is manufactured before Dec.31, 2018, it can be sold until its expiration date;
If the original ingredient used in the product is not on the new list, but complies with the published standard of any country of EU, US or Japan, the applicant can be exempted from certificate update.

*Click here to see all the ingredient requirements changes effective in the past 2018.

2) Standard of Mandatory Claims for Hair Dye Products on the Label, Instruction and Packaging

TFDA amended Standard of Mandatory Claims for Hair Dye Products on the Label, Instruction and Packaging. Stakeholders who hold a medicated cosmetic certificate should change relevant information according to the new Standard or apply for certificate update. Detailed comparison between current and previous claim requirements are listed in the table:

Current Standard (effective)	Previous Standard
1. Pay attention to the following things before using the hair dye product: Carefully read the specification before using, and follow instructions exactly; The hair dye agent may cause irritation; Mustn't be applied to anywhere except for eyebrow, eyelash and other areas covered with hair; Avoid use after refining or shaving the face; When mixing different brands of hair dye agent together, it may cause damage; Can't wave hair within one week after dyeing.	1. Users should follow these safety instructions: If not necessary, try avoid dyeing; Please use large amount of water to wash the scalp after dyeing; Wear gloves when dyeing; Carefully read specification on the package before using; Never blend with other brands of hair dye products, or it will cause unpredictable damage.
2. Precautions for conducting the dyeing: Wear gloves when using the product Suggest visiting a dermatologist or conduct a skin irritation test before using; Avoid contacting with the face or neck; if you accidentally touch the face or neck, rinse off immediately; Avoid contacting with eyes; if accidentally get into eyes, rinse with large amount of water and visit doctor immediately; If any skin abnormality occurs after dyeing, visit doctor immediately.	3. (Original Item 3) Precautions for conducting the dyeing: Avoid the drug or shampoo flowing into eyes when washing the hair, if product accidentally get into eyes, rinse off with normal or warm water immediately and visit ophthalmologist. Never apply eye drops by yourself; Try to not contact with skin of face or neck, if this accidentally touch happens, rinse off immediately; Mustn't be applied to anywhere except for eyebrow, eyelash, beard and other parts covered with hair; Avoid using after refining or shaving the face; Wash hands thoroughly after dyeing every time.
3. Avoid using this product when the following conditions occur: If symptoms such as irritation or other illness were caused by the hair dye agent (not limited to this product); Abnormal symptoms after irritation test; User has swelling or wound in head, neck or face, or existing dermatological disease; Irritation or inflammation on scalp or skin, or other physical conditions(illness, recovery phase, menstrual period, pregnancy); Kidney disease or blood disease; Other conditions that not are not suitable for hair dyeing.	2. (original Item 2) Precautions before using the product: Skin test before dyeing; Wash the inner side of wrist or skin behind the ear with soap, and then wipe with absorbent cotton; According to the usage of hair dye agent, blend with several drops of test fluid; Apply the drops of test fluid to cleaned skin in size of NTD 10 coin, keep it naturally dry and don’t touch it within 48 hours; If itchiness, swelling or other abnormal reactions occur within 48 hours, rinse off immediately and do not dye hair. After 48 hours, if it is assured that no abnormal symptoms occurred, then the hair dye product can be used. Do not use hair dye under the following conditions: 1) Redness and bubble raised on skin after skin test; 2) Swelling, wound or skin disease on the head, neck or face; 3) The possibility of pregnancy or certain conditions of pregnancy; 4) Menstrual period, postpartum period, other disease and recovery phase.
4. Storage Precaution: Place the product out of children's reach; Avoid high temperature and direct sunlight.	4. Other Precautions: If swelling or other adverse reactions occur after dyeing, visit a dermatologist immediately and avoid touching affected area using hands; Don't wave hair within one week after dyeing; Place the product out of children's reach; Avoid high temperature and direct sunlight.