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Taiwan to Modify the List of Ingredients Prohibited in Cosmetics and Ingredients Used in Special-Use Cosmetics

On Aug 30, 2018, Taiwan FDA sent 2 drafts of Ingredients Prohibited in Cosmetics and Ingredients Used in Special-use Cosmetics to Importers and Exporters Association of Taipei for their opinions. The ingredient names and notes were modified, and 68 ingredients were newly added in the list of Ingredients Prohibited in Cosmetics. The limitation standards and precautions of 2 ingredients in Special-use Cosmetics Ingredients List (Other Ingredients) were modified...

Takehome:

On Aug 30, 2018, Taiwan FDA sent 2 drafts of Ingredients Prohibited in Cosmetics and Ingredients Used in Special-use Cosmetics to Importers and Exporters Association of Taipei for their opinions.

The ingredient names and notes were modified, and 68 ingredients were newly added in the list of Ingredients Prohibited in Cosmetics. The limitation standards and precautions of 2 ingredients in Special-use Cosmetics Ingredients List (Other Ingredients) were modified. Public consultation will last until Sep 17. If you have any suggestion, you mail [email protected].

Main changes in Ingredients Prohibited in Cosmetics are shown in table 1, 68 newly added prohibited ingredients are shown in table 2, and main changes in Special-use Cosmetic Ingredients List are shown in table 3.

Table 1:

Taiwan New List of Ingredients Prohibited in Cosmetics (Contrast with the current version)

The Original No.

Ingredient Name

CAS No.

Note

Amendments

1

Mercury and its compounds (Except as otherwise specified in Standard for Usage and Limitation Requirements of Preservatives in Cosmetics)

7439-97-6

The limit of the total residue of heavy metal mercury in the finished product is 1 ppm if natural residual is unavoidable technically due to the ingredients or others used during the process of producing.

  1. Modify the ingredient name
  2. Modify the note

2

4-Benzyloxyphenol and 4-ethoxyphenol

103-16-2/622-62-8

/

  1. Modify the ingredient name
  2. Newly add CAS No.

22

Cadmium and its compounds

7440-43-9

The limit of the total residue of heavy metal Cadmium in the finished product is 5 ppm if natural residual is unavoidable technically due to the ingredients or others used during the process of producing.

Modify the note

33

Fluorine compounds(as Inorganic compounds)

/

/

Delete the ingredient

40

1-Methoxy-2,4-diaminobenzene (2,4-Diaminoanisole; CI 76050) and their salts

 (4-Methoxy-m-phenylenediamine HCL)

(4-Methoxy-m-phenylenediamine sulfate;CI 76051)

615-05-4/6219-67-6

/

  1. Modify the ingredient name
  2. Modify the CAS No.

45

Nitrosamines e.g. Dimethylnitrosoamine; Nitrosodipropylamine; 2,2’-Nitrosoimino)bisethanol

62-75-9/621-64-7/1116-54-7

/

  1. Modify the ingredient name
  2. Modify the CAS No.

54

Pyrogallol (Pyrogallic acid; 1,2,3-Benzenetriol)

87-66-1

Except for use in hair dye products

  1. Modify the ingredient name
  2. Delete the note

57

Sulfonamides (sulphanilamide and its derivatives obtained by substitution of one or more H-atoms of the –NH2 groups)and their salts

63-74-1

/

  1. Modify the ingredient name
  2. Delete the CAS No.

83

Phytolacca spp. And their preparations

60820-94-2/65497-07-6

/

Newly add CAS No.

89

Strophantus species and their galenical preparations

84604-18-2

/

Delete the CAS No.

91

Thevetia neriifolia Juss., glycoside extract

90147-54-9

/

  1. Modify the ingredient name
  2. Newly add CAS No.

111

Biphenyl-4-ylamine(4-Aminobiphenyl) and its salts

92-67-1/2113-61-3

/

Delete the CAS No.

139

Dinitrophenol isomers

51-28-5/329-71-5/573-56-8/25550-58-7

/

  1. Modify the ingredient name
  2. Newly add CAS No.

147

2-Methoxyethanol and its acetate (2-Methoxyethyl acetate)

109-86-4/110-49-6

 

  1. Modify the ingredient name
  2. Newly add CAS No.

161

1-and 2-Naphthylamines and their salts

91-59-8/134-32-7

/

  1. Modify the ingredient name
  2. Modify the CAS No.

164

Nitrofen

1836-75-5

/

Modify the CAS No.

168

Pentacholorophenol and its alkali salts

87-86-5/131-52-2/7778-73-6

/

  1. Modify the ingredient name
  2. Newly add CAS No.

208

1,2-Benzenedicarboxylic acid, dipentylester, branched and linear; n-Pentyl-isopentylphthalate; di-n-Pentyl phthalate; Diisopentylphthalate

605-50-5/84777-06-0/131-18-0

The limit of the total residue of phthalate esters in the finished product is 100 ppm if natural residual phthalate esters is unavoidable technically due to the ingredients or others used during the process of producing.

  1. Modify the ingredient name
  2. Newly add CAS No.
  3. Modify the note

236

Areca catechu L.

89957-52-8

/

Delete the CAS No.

272

4,5-Diamino-1-methylpyrazole and its HCl salt

20055-01-0/21616-59-1

/

Newly add CAS No.

273

N,N-Diethyl-m-aminophenol

91-68-9/68239-84-9

/

Newly add CAS No.

280

2-Methoxymethyl-p-aminophenol and its HCl salt

29785-47-5/135043-65-1

/

Newly add CAS No.

286

N-(2-Methoxyethyl)-p-phenylenediamine and its HCl salt

72584-59-9/66566-48-1

/

Newly add CAS No.

295

2,4,5-Trimethylaniline/2,4,5-Trimethylaniline hydrochloride

137-17-7/21436-97-5

/

Add a new ingredient category

300

[4-[(4-Aminophenyl)(4-iminocyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine and its hydrochloride salt (Basic Violet 14; CI 42510)

632-99-5/3248-93-9

/

  1. Modify the ingredient name
  2. Newly add CAS No.

304

N,N’-Diethyl-p-phenylenediamine and its salts

6065-27-6/6283-63-2/93-05-0

/

  1. Modify the ingredient name
  2. Newly add CAS No.

305

N,N’-Dimethyl-p-phenylenediamine and its salts

99-98-9/6219-73-4

/

  1. Modify the ingredient name
  2. Newly add CAS No.

309

Hydroxyethylaminomethyl-p-aminophenol and its salts

110952-46-0/135043-63-9

/

Newly add CAS No.

315

Methyl alcohol

67-56-1

The limit of the total residue of methyl alcohol in the finished product is 2000 ppm if natural residual is unavoidable technically due to the ingredients or others used during the process of producing.

Modify the note

337

Barium salts

 

/

Except for Barium sulfate and its salts, Barium sulfide, lakes and pigments.

Modify the note

Note:

The medical ingredients (including controlled drugs) that have not been announced or approved by the central competent authority may not be used.

Table 2:

68 newly added prohibited ingredients

No. (In the new list)

Ingredient Name

CAS No.

330

Substances with androgenic effect

/

331

2,2,2-Trichloroethane-1, 1-diol

302-17-0

332

N,N-bis(2-Chloroethyl)methylamine N-oxide and its salts

126-85-2

333

Chlormethine(INN) and its salts

51-75-2

334

Cyclophosphamide(INN) and its salts

50-18-0

335

Cobalt benzenesulphonate

23384-69-2

336

Dichloroethanes(ethylene chlorides) e.g. 1,2-Dichloroethane

107-06-2

337

O,O’-Diethyl-O-4-nitrophenyl phosphorothioate

56-38-2

338

Barbiturates

/

339

Metaldehyde

9002-91-9

340

Triamterene(INN) and its salts

396-01-0

341

Thiotepa(INN)

52-24-4

342

Trichlormethine (INN) and its salts

555-77-1/817-09-4/6138-32-5

343

Furocoumarines (e.g. trioxysalen(INN), 8-methoxypsoralen, 5-methoxypsoralen)except for normal content in natural essences used. In sun protection and in bronzing products, furocoumarines shall be below 1 mg/kg.

298-81-7/484-20-8/3902-71-4

344

2,3,7,8-Tetrachlorodibenzo-p-dioxin(TCDD)

1746-01-6

345

1,2-Epoxybutane

106-88-7

346

3,3-Bis(4-hydroxyphenyl)phthalide (Phenolphthalein(INN))

77-09-8

347

Ethyl acrylate

140-88-5

348

Cobalt sulphate

10124-43-3

349

Nickel monoxide; nickel oxide;bunsenite

1313-99-1/11099-02-8/34492-97-2

350

Nickel dioxide

12035-36-8

351

Nickel sulfide; nickel sulfide; millerite

16812-54-7/11113-75-0/1314-01-4

352

Hydrocarbons, C4, 1,3-butadiene-and isobutene-free, if they contain>0.1% w/w Butadiene

95465-89-7

353

Benzo[def]chrysene;(=benzo[a]pyrene)

50-32-8

354

Pitch, coal tar, high-temp., heat-treated, if it contains>0.005% w/w benzo[a]pyrene

121575-60-8

355

Dibenz[a,h]anthracene

53-70-3

356

Benz[a]anthracene

56-55-3

357

Benzo[j]fluoranthene

205-82-3

358

Benz[e]acephenanthrylene

205-99-2

359

Benzo[k]fluoranthene

207-08-9

360

Chrysene

218-01-9

361

2,3-Dibromopropan-1-ol

96-13-9

362

1,3-Dichloropropan-2-ol

96-23-1

363

alpha-Chlorotoluene(Benzyl chloride)

100-44-7

364

Methyloxirane(Propylene oxide)

75-56-9

365

1,2-Epoxy-3-phenoxypropane(Phenylglycidyl ether)

122-60-1

366

2,3-Epoxypropan-1-ol(Glycidol)

556-52-5

367

Urethane (Ethyl carbamate)

51-79-6

368

2-Nitropropane

79-46-9

369

2-Nitroanisole

91-23-6

370

2,4-Dinitrotoluene; Dinitrotoluene, technical grade

121-14-2/25321-14-6

371

5-Nitroacenaphthene

602-87-9

372

2,6-Dinitrotoluene

606-20-2

373

1-Methyl-3-nitro-1-nitrosoguanidine

70-25-7

374

4,4’-(4-lminocyclohexa-2, 5-dienylidenemethylene) dianiline hydrochloride

569-61-9/479-73-2

375

o-Toluidine based dyes

/

376

(Methyl-ONN-azoxy)methyl acetate

592-62-1

377

Furan

110-00-9

378

1,3-Propanesultone

1120-71-4

379

Sulfallate

95-06-7

380

Erionite

12510-42-8

381

Disodium 4-amino-3-[[4’-[(2,4-diaminophenyl)azo][1,1’-biphenyl]-4-yl]azo]-5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate

1937-37-7

382

Disodium[5-[[4’-[[2,6-dihydroxy-3-[(2-hydroxy-5-sulphophenyl)azo]phenyl]azo][1,1’-biphenyl]-4-yl]azo]salicylato(4-)]cuprate(2-)

16071-86-6

383

Resorcinol diglycidyl ether

101-90-6

384

Divanadium pentaoxide

1314-62-1

385

Chlordecone

143-50-0

386

Chlorothalonil

1897-45-6

387

Dodecachloropentacyclo[5.2.1.02,6.03,9.05,8]decane (Mirex)

2385-85-5

388

4,4’-Carbonimidoylbis]N,N-dimethylaniline] and its salts

492-80-8

389

Acetamide

60-35-5

390

1-Vinyl-2-pyrrolidone

88-12-0

391

α, α-Dichlorotoluene

98-87-3

392

Isoprene(stabilized); (2-Methyl-1, 3-butadiene)

78-79-5

393

1-Bromopropane; n-Propyl bromide

106-94-5

394

Chloroprene (stabilized); (2-Chlorobuta-1,3-diene)

126-99-8

395

4,4’-Bis(dimethylamino)benzophenone;(Michler’s ketone)

90-94-8

396

1,4-Dichlorobenzene(p-Dichlorobenzene)

106-46-7

397

Creosote, if it contains>0.005% w/w benzo[a]pyrene

8001-58-9

Table 3:

Taiwan New Special-use Cosmetics Ingredients List  (Other Ingredients) (Contrast with the current version)

Ingredient Name

CAS No.

Product Category

Limitation Standard

Restriction/Precaution

Amendments

Salicylic acid

69-72-7

/

More than 0.5~2%

Prohibited to use for children under the age of 3(except for hair shampoo).

 

Note (Except for hair shampoo): Prohibited to use for children under the age of 3.

  1. Modify the limitation standard
  2. Add new restrictions
  3. Modify the language of the note

Hydrogen peroxide

7722-48-1

Teeth whitening products

6%

Note: need to be labeled

  1. If you have any discomfort (such as redness, swelling, pain, etc.) in your gums or mouth, please stop using and consult a dentist;
  2. If you have tooth sensitivity during use, please stop using and consult a dentist;
  3. Not recommend children under the age of 12, pregnant or lactating women to use it;
  4. Do not use if your gum tissue or the mouth has lesions or are allergic to the ingredients of this product;
  5. Avoid improper swallowing;
  6. Avoid contact with eyes when using this product. If you accidentally touch your eyes, rinse immediately with water;
  7. Do not smoke or chew betel nuts during the use of tooth whitening agents;
  8. Try to avoid direct contact with the gums during use;
  9. Use for more than 14 days, should be used in accordance with the instructions of the dentist;
  10. This product should be placed out of reach of children and avoid direct sunlight.

Modify the precautions.

 

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