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Taiwan Releases Requirements for Ingredients, Labeling and Packaging of Hair Dye Products

Taiwan FDA released two announcements related to hair dye products on April 13, 2018. The first announcement stipulates new requirements relating to the addition of warnings on labeling, specifications and packaging of hair dye products, which will enter into force on Jan 1, 2019. The second announcement regulates the effective dates of the amendment of "Medicated or Poisonous Ingredients List of Hair Dye Product" and the transitional measures for existing medicated cosmetics (hair dye) certificate holders...

Takehome:

Taiwan FDA released two announcements related to hair dye products on April 13, 2018. The first announcement stipulates new requirements relating to the addition of warnings on labeling, specifications and packaging of hair dye products, which will enter into force on Jan 1, 2019. The second announcement regulates the effective dates of the amendment of "Medicated or Poisonous Ingredients List of Hair Dye Product" and the transitional measures for existing medicated cosmetics (hair dye) certificate holders.

Additions of Warnings on Labeling, Specification and Packaging of Hair Dye Products

The specific requirements are as follows:

1. Pre-use warnings:

  • Read the instructions carefully in advance and use the product in strict accordance with its usage methods;
  • The hair dye product may cause allergic reactions;
  • Do not use the product on any parts of body excluding eyebrows and eyelashes;
  • Do not use hair dye product just after shaving;
  • Mix use of different brands of hair dye products may be harmful;
  • Do not perm in a week before and after dyeing.

2. In-use warnings:

  • Gloves should be worn while dyeing;
  • It is best to consult a dermatologist before using or performing sensitivity test on skin;
  • Avoid contact with face or neck. In case of contact , wash immediately;
  • Avoid contacting with eyes. If accidentally get the product into eyes, wash immediately with amount of running water and seek medical treatment in time.

3. Users shall avoid using the product under any of the following circumstances:

  • People who had allergy and physical discomfort resulted from using hair dye products (including other brands);
  • People have allergy effect after skin sensitivity test;
  • People with swollen and bruised head, neck and face or with skin diseases;
  • People have allergies or inflammations of scalp and skin and other health conditions (such as: in sick, convalescence, menstruation and pregnancy)
  • Patients with renal diseases or hematologic diseases;
  • Others who are not suitable for hair dyeing.

4. Storage warnings:

  • To be stored away from children;
  • To be stored from heat and direct sunlight.

Medicated or Poisonous Ingredients List of Hair Dye Product

Taiwan FDA modifies the requirement for medicated or poisonous ingredients of hair dye product. The amendments are listed in the following table:

Taiwan New Requirements for Medicated or Poisonous Ingredients of Hair Dye Product (Contrast with the previous draft version)

The Original No.

Ingredient Name

INCI Name

CAS No.

Limitation Standards

Restrictions/ Precautions

Amendments

Oxidability

Inoxidability

13

N-(4-aminophenyl)aniline

N-Phenyl-p-phenylenediamine

101-54-2

3%

 

 

Modify the ingredient name

22

4,4'-[1,3-Propanediylbis(oxy)]bisbenzene-1,
3- diamine and its tetrahydrochloride salt

1,3-bis-(2,4-Diaminophenoxy) propane/
1,3-bis-(2,4-Diaminophenoxy) propane HCl

81892-72-0/
74918-21-1

1.2% (count as free base)
1.8% (count as
tetrahydroch
loride salt)

1.2% (count as free base)
1.8% (count as tetrahydroch
loride salt)

 

Add new restrictions on inoxidability

44

Hydroxyethyl-3,4- methylenedioxyaniline and its hydrochloride

Hydroxyethyl-3,4-methylenedioxyaniline HCl

94158-14-2

1.50%

 

1) Can not be used with nitrosating agent;
2) Limitation of nitrosamines: 50 microgram/kg (ppb);
3) Shall be maintained in non-nitrite container.

Modify the ingredient name

63

1-Methyl-2,6-bis(2-hydroxyethylamino)-benz ene

2,6-Dihydroxyethylaminotoluene

149330-25-6

1%

 

1) Can not be used with nitrosating agent;
2) Limitation of nitrosamines: 50 microgram/kg (ppb);
3) Shall be maintained in non-nitrite container.

Modify the ingredient name

64

Ethanol, 2-((4-amino-2-nitrophenyl)amino)-

HC Red No. 3

2871/1/4

0.45%

3%

1) Can not be used with nitrosating agent;
2) Limitation of nitrosamines: 50 microgram/kg (ppb);
3) Shall be maintained in non-nitrite container.

Modify the ingredient name

104

Ammonia

Ammonia

7664-41-7/
1336-21-6

6% (count as NH3)

 

 

Delete its precaution

Stakeholders wanting to know details about the revised requirements of hair dye ingredients can refer to it in our cosme-list.

The new requirements will be implemented from Jan 1 2019. Before the effective date existing medicated cosmetics (hair dye) certificate holder shall comply with the following transitional measures:

  • If the product is manufactured on and before Dec 31 2018, it can be sold until its expiration date;
  • For the usage of main ingredients which were approved but now don't comply with new requirements, the applicant should apply for ingredient modification or repeal the certificate before Jan 1 2019;
  • If the original main ingredient used in the product or its category (oxidability or inoxidability) 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 modification.
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