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. |
|
|
2 |
4-Benzyloxyphenol and 4-ethoxyphenol |
103-16-2/622-62-8 |
/ |
|
|
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 |
|
/ |
/ |
Delete the ingredient |
|
40 |
1-Methoxy-2,4-diaminobenzene (2,4-Diaminoanisole; CI 76050) and their salts
|
615-05-4/ |
/ |
|
|
45 |
Nitrosamines e.g. Dimethylnitrosoamine; Nitrosodipropylamine; 2,2’-Nitrosoimino)bisethanol |
62-75-9/621-64-7/1116-54-7 |
/ |
|
|
54 |
Pyrogallol |
87-66-1 |
|
|
|
57 |
Sulfonamides (sulphanilamide and its derivatives obtained by substitution of one or more H-atoms of the –NH2 groups)and their salts |
|
/ |
|
|
83 |
Phytolacca spp. And their preparations |
60820-94-2/65497-07-6 |
/ |
Newly add CAS No. |
|
89 |
Strophantus species and their galenical preparations |
|
/ |
Delete the CAS No. |
|
91 |
Thevetia neriifolia Juss., glycoside extract |
90147-54-9 |
/ |
|
|
111 |
Biphenyl-4-ylamine(4-Aminobiphenyl) and its salts |
92-67-1/ |
/ |
Delete the CAS No. |
|
139 |
Dinitrophenol isomers |
51-28-5/329-71-5/573-56-8/25550-58-7 |
/ |
|
|
147 |
2-Methoxyethanol and its acetate (2-Methoxyethyl acetate) |
109-86-4/110-49-6 |
|
|
|
161 |
1-and 2-Naphthylamines and their salts |
91-59-8/134-32-7 |
/ |
|
|
164 |
Nitrofen |
1836-75-5 |
/ |
Modify the CAS No. |
|
168 |
Pentacholorophenol and its alkali salts |
87-86-5/131-52-2/7778-73-6 |
/ |
|
|
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 |
|
|
236 |
Areca catechu L. |
|
/ |
Delete the CAS No. |
|
272 |
4,5-Diamino-1-methylpyrazole and its HCl salt |
20055-01-0/ |
/ |
Newly add CAS No. |
|
273 |
N,N-Diethyl-m-aminophenol |
91-68-9/ |
/ |
Newly add CAS No. |
|
280 |
2-Methoxymethyl-p-aminophenol and its HCl salt |
29785-47-5/ |
/ |
Newly add CAS No. |
|
286 |
N-(2-Methoxyethyl)-p-phenylenediamine and its HCl salt |
72584-59-9/ |
/ |
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 |
/ |
|
|
304 |
N,N’-Diethyl-p-phenylenediamine and its salts |
6065-27-6/6283-63-2/93-05-0 |
/ |
|
|
305 |
N,N’-Dimethyl-p-phenylenediamine and its salts |
99-98-9/6219-73-4 |
/ |
|
|
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, |
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. |
|
|
Hydrogen peroxide |
7722-48-1 |
Teeth whitening products |
6% |
Note:
|
Modify the precautions. |


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