Taiwan to Implement New Standards for Restricted Ingredients and Preservatives from Jan 1 2020

Takehome:
TFDA has modified the requirements for restricted ingredients and preservatives in consideration of the fact that the standard for prohibited, restricted ingredients and preservatives in cosmetics may not be fully applicable to non-medicated toothpastes and mouthwashes.

On Dec 14, 2018, TFDA released 6 drafts of cosmetic regulations, which are 1) Standard for Usage and Limitation Requirements of Ingredients Used in Special-use Cosmetics 2) List of Prohibited Ingredients Used in Cosmetics 3) List of Restricted Ingredients Used in Cosmetics 4) Standard for Usage and Limitation Requirements of Preservatives in Cosmetics 5) List of Permitted Colorants Used in Cosmetics 6) Limitation Standards for Microorganism in Cosmetics. With the exception of the new list of the prohibited ingredients used in cosmetics (see number 2 above) which will become effective when Cosmetic Hygiene Safety Administration Act is implemented, the other 5 lists will become effective on Jan 1, 2020. Public consultation will last until Feb 12, 2019. Any suggestions can be submitted on Taiwan Public Policy Participation Platform.

1. Standard for Usage and Limitation Requirements of Ingredients Used in Special-use Cosmetics

Taiwan’s Cosmetic Hygiene Safety Administration Act classified cosmetics as general cosmetics and special-use cosmetics. Administrative Measures for Special-Use Cosmetics Certificate Issuance released on Dec 6 specified the scope of special-use cosmetics as sunscreen, hair dyes, hair perms, deodorants, teeth whitening and other cosmetics stipulated by TFDA.

Standard for Usage and Limitation Requirements of Ingredients Used in Special-use Cosmetics specifies the limitation standards, usage and precautions for special-use ingredients such as sun-screening agent, hair dye agent, hair perming agent, deodorant agent.

The new Act also stipulated that within a 5-year grace period, special-use cosmetics shall obtain a license from TFDA prior to importation or manufacture. Enterprises with the original medicated cosmetics license should:

1) Products manufactured before Dec 31, 2019 can be sold until expiration date;

2) If the ingredients used in medicated cosmetics do not comply with Standard for Usage and Limitation Requirements of Ingredients Used in Special-use Cosmetics, enterprises should apply for ingredient concentration changes or cancel the license for medicated cosmetics to TFDA;

3) If the ingredients used in medicated cosmetics are not in the list of Standard for Usage and Limitation Requirements of Ingredients Used in Special-use Cosmetics, but do comply with the limitation standards in EU, USA or Japan, then stakeholders do not need to apply for ingredient changes to TFDA.

2. New Requirements for Cosmetic Restricted, Prohibited Ingredients and Preservatives

Cosmetic Hygiene Safety Administration Act classified non-medicated toothpastes and mouthwashes as cosmetics (new cosmetic scope will be effective 1 year after the implementation of the new Act). Considering the standard for prohibited, restricted ingredients and preservatives in cosmetics may not be fully applicable to non-medicated toothpastes and mouthwashes, TFDA modified the requirements for these ingredient.

1）23 restricted ingredients for non-medicated toothpastes and mouthwashes are newly added and the limitation standards for several restricted ingredients are modified (details).

2）11 preservatives are deleted and 10 kinds of preservatives’ limitation standards are modified (details).

3）69 prohibited ingredients are newly added (details). After the implementation of Cosmetic Hygiene Safety Administration Act, any cosmetics which contain prohibited ingredients listed in the new inventory cannot be imported, manufactured, sold, supplied or displayed for sale in Taiwan. Prohibited ingredients that can comply with other limitation standards are listed in the following table:

Ingredients	Special requirements
Sodium perborate	Compliance with the limitation standards for non-medicated toothpaste and mouthwash
6-Methylcoumarin
Fluorine compounds (as Inorganic compounds)
Strontium compounds
Mercury and its compounds	Compliance with the limitation standards for preservatives
Hydroxy-8-quinoline and its sulphate	Can be used as the stabilizer of Hydrogen peroxide in hair dyeing and hair perming products, but shall not exceed 0.03% (calculated as base)
Hydrogen peroxide	Can be used for hair dyeing, perming and tooth whitening products as oxidizing agents
p-Phenylenediamine	Can be used for hair dyeing products
Chromium; Chromic acid and its salts	Compliance with the limitation standards for colorants
Selenium disulfide	Limitation standards should refer to the list of Restricted Ingredients Used in Cosmetics when used in hair products
Cantharidies tincture
Zirconium lakes, salts	Can be used in cosmetics as colorants

*Coslist will be updated once the new ingredient requirements are effective.

3. List of Permitted Colorants Used in Cosmetics and Limitation Standards for Microorganism in Cosmetics

List of Permitted Colorants Used in Cosmetics and Limitation Standards for Microorganism in Cosmetics are the same with the current list.

Limitation Standards for Microorganism in Cosmetics:

Product category	Limitation Standards for Microorganism	Other requirements
1. Cosmetics used around the eyes 2. Cosmetics used in the area contacting with mucous membranes 3. Baby cosmetics	≤ 100 CFU/g (ml)	No detection of Escherichia coli, Pseudomonas aeruginosa or Staphylococcus aureus
Other cosmetics	≤ 1000 CFU/g (ml)

New Punishment Rules:

Violations	Punishment (by the number of times)
Manufacture or import special-use cosmetics without license	Subject to fines ranging from a minimum of NT$ 10,000 to NT$ 1 million; For a severe violation, business will be suspended for at least 1 month to 12 months or ordered for close
Prohibited, restricted ingredients, preservatives, colorants or microorganisms exceed the limitations	Subject to fines ranging from a minimum of NT$ 20,000 to NT$ 5 million; For a severe violation, business will be suspended for at least 1 month to 12 months or ordered for close