IA #53-06 - REVISED 3/7/96, "Automatic Detention of Cosmetics Containing
Illegal Colors", REVISED ATTACH A - 9/15/04, ATTACH B - 6/24/04
NOTE: This alert has been revised to rename and reformat the
alert. In addition, the firms and products identified in
Import Alert #53-11, "Automatic Detention of Cosmetics From
Stargazer London Due to Illegal Colors" and Import Alert
#53-13, "Automatic Detention of Eye Cosmetics Containing D&C;
Red #10" have been added to Attachment A of this alert.
Upon the issuance of this revision, Import Alerts #53-11 and
53-13 are cancelled. Additional changes are bracketed by
asterisks (***).
TYPE OF ALERT: Automatic Detention
***(Note: This import alert contains guidance to FDA field
personnel only. It does not establish any requirements or
create any rights or obligations on FDA or on regulated
entities.)***
PRODUCTS: ***Cosmetics***
PRODUCT CODES: ***See attachment***
PROBLEM: ***Illegal Colors (UCNC, UCET, MLLM)***
PAC FOR
COLLECTION: 29002
COUNTRY: ***See attachment***
MANUFACTURER/
SHIPPER: ***See attachment***
MANUFACTURER/
SHIPPER I.D.#: ***See attachment***
IMPORTER'S
I.D. #: N/A
CHARGE: "The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that it appears to contain ***a color
additive which is unsafe*** within the meaning of Section
721(a) which renders it adulterated under Section 601(e)."
RECOMMENDING
OFFICE: DIOP (HFC-170);
Los Angeles District (HFR-PA250);
Cincinnati District (HFR-MA440);
New York District (HFR-NE1515).
REASON FOR
ALERT: ***This alert, which initially issued in 1985, was based on
the detention of make-up kits with eye area cosmetics from
Taiwan containing illegal color additives. Problems with
eye make-up products and other cosmetic products have
continued and the list of responsible firms has grown.
During the latter part of 1990, Cincinnati District sampled
a shipment of cosmetics manufactured by A.Z. Nadar Cosmetics
and Hair Products d/b/a Stargazer, London, England.
Analysis of the samples, which included mascaras, eye dust,
rouge, and lipstick, revealed the presence of prohibited
FD&C; Red #7 and FD&C; Red #2, as well as other unidentified
colors.
In 1993, analysis of an eye color compact collected by New
York district revealed the presence of D&C; Red, a delisted
synthetic color additive.***
***In 1995 LOS-DO sampled and analyzed twenty samples of
shampoo manufactured by CIA. Distribuidora Del Centro, San
Jose GTO, Mexico in a six month time frame. Of the twenty
samples, six were refused and nine were detained for
undeclared colors. These samples all contained
unsafe/illegal and/or undeclared colors. The unsafe/illegal
colors included non-permitted external D & C Red #10,
Ponceau 4R and other undeclared colors.***
GUIDANCE: Districts ***may detain, without physical examination,***
shipments of identified products from those firms listed in
Attachment A.
Districts ***may detain, without physical examination, ***
all entries of eye make-up and make-up kits containing eye
make-up from Taiwan except from those shippers listed in
Attachment B.
The method for color analysis is from AOAC's book
Newburger's Manual of Cosmetic Analysis 2nd edition, Chapter
19, "Determination of Colors in Cosmetics" p.118.
***Fastips Issue #47, page 6, should also be consulted when
analyzing for colors in shampoos, cream rinses and
conditioners.***
***For questions of issues concerning science, science
policy, sample collections, analysis, preparation, or
analytical methodology, contact the Division of Field
Science at (301) 443-3320 or 3007.***
PRIORITIZATION
GUIDANCE: III
FOI: No purging is required.
KEYWORDS: Illegal colors, colors, cosmetics, lipstick, eye make-up,
shampoo, conditioner.
PREPARED BY: Alwin Collins, DIOP, 301-443-6553.
DATE LOADED
INTO FIARS: March 7, 1996
Attachment A - Import Alert #53-06 Revised 9/15/04
Manufacturers/Shippers on Automatic Detention
PRODUCT
FIRM PRODUCT CODE PROBLEM
CHINA (CN, 280)
Elle Jewelry "Corp. Eye Shadow Lithol Rubine BCA,
37-3 Nong Gong Road 53C- - 03 Phloxine
Yiwu City 3/28/03 Brilliant Blue FCF
Zhejiang, China
FEI # 3003727191
Fuzhou Jianing Cosmetic Co.,Ltd. Make-up Kits Illegal Colors
First Road, Taijiang Area 53C--08 (see below)
Fuzhou, Fujian 4/3/97
China
FEI# 1000404863
PROBLEM: Undeclared D&C; Red #6 or #7 in the lip pencil and blush
components; D&C; Red #6 or #7, and D&C; Red #27 or #28, and
undeclared FD&C; Red #40 in the eye shadow component.
Guangzhou (Sino Foreign) Make Up Kits 53C08 See below
Irene Cosmetic Co., Ltd. #A28, #A30, & for specific
No. 39, Yuan Thiu 4th #A203 problems.
Hein Road
Guangzhou, China (Mainland)
FEI #3000129222
MID #CNGUAIRE39GUA
PROBLEM
Make up kit #28 - Contains one or more non-permitted colors (e.g., Lake Red C
the Sodium Salt, C.I. 15585, was formerly certified as D & C Red No.8; and the
Barium Salt, C.I. 15585:1, formerly certifiable as D & C Red No.9).
Make up kit #A30 - Contains one or more non-permitted colors (e.g., Hansa
Yellow formerly certifiable as EXT. D & C Yellow No.5).
Make up kit #A203 - Contains one or more non-permitted colors (e.g., Rhodamine
B, the Chloride Salt, C.I. 45170, was formerly certifiable as D & C Red No.
19; and the Stearate Salt was formerly certifiable as D & C Red No. 37).
Guangzhou Win Kale Stationry Co Face Paint Crayons Lithol Rubin
26 Centre Rd. Cand-Tou 53G 09 B or Lithol
Nan-Kang, Huang Pu 53G 04 Rubin BCA
Guangzhou, China 4/2/03
FEI #3003806832
Shenzhen Yada Cosmetic Co. Ltd. Eye Shadow Kit Rhodamine B,
4/F 02 Bld Fuzhao Center Buxin Rd. Press Powder Red AC
Shenzhen, China 53C- 03
FEI # 3003177305 53C- -08
53G- -02
3/28/03
Yiwu Siya Cosmetics Co., Ltd. Lip Glitter ** See Below
109-1 Cosmetic Market (Lil' Divas Club)
Binwang Road 53G[][]05
Yiwu, Zhejiang 53G[][]99
China 4/12/04
FEI #3004107014
SHIPPER
Art Craft Ltd.
309 Pennsylvania Avenue
Concord, Ontario
Canada
FEI #3004044701
* Contains non-permitted Rhodamine B (CI 45170, formerly certifiable as D&C;
Red No. 19); non-permitted Ponceau 4R, (CI 16255) and undeclared Brilliant
Blue FCF (CI 42090, certifiable as FD&C; Blue No. 1)
Zhejiang Yiwu Meixue Eye Shadow non-permitted color
Makeup Co. Ltd. 53C[][]03 additive Phloxine B
Qingkou Industrial Park 7/22/03
Qingkou Yiwu Zhejiang China
FEI #3003700280
Tana Cosmetics Manoa Self Tanning Solution Brilliant
Box 102801 "Egypt Wonder Quicktan" Black,
Bielefeld, Germany 53M- - 02 Amaranth,
FEI # 1000386802 53M- - 99 Tartrazine
01/21/04
HONG KONG (HK, 435)
Carlon Industries Ltd Sweet & Lovely Beauty Non-permitted
Blk H. 4/F Century Ind Sets Erythrosine and
Centre 53C[][]03 Sunset Yellow
33-35 Au Pui Wan Street 11/16/01 FCF
Fo Tan. Shatin, Hong Kong
FEI# 3003344438
Chen's Industrial Co. Eye Repair 53C[][]04 D&C; Red #33
Front Portion 5/FL Complex
16 Granville Road (Monsfalay)
Kowloon, Hong Kong 7/11/97
FEI #1000427204
G T Plus Limited Deluxe cosmetic set Rhodamine B, C.I.
29-43 Ashley Road, 4/F 53C[][]03 Solvent Blue 14
Kowloon Centre, Tsimshatsui 6/17/03
Kowloon, Hong Kong
FEI# 1000146371
Manufacturer:
Laptide Industries Ltd. Yellow Glitter Body Unidentified Yellow Color
Room 1505 Wash (Shower Gel)
Nan Fung Commercial Centre 53J [][] 01
19 Lam Lok Street Pink Glitter Body Non-permitted color
Kowloon Bay, Hong Kong Wash (Shower Gel) (Former D&C; Red No. 19,
FEI #3004044703 53J [][] 01 Rhodamine B)
Orange Glitter Body Non-permitted color
Wash (Shower Gel) (Former D&C; Red No. 19,
53J [][] 01 Rhodamine B)
10/3/03
Shipper:
Art Craft Ltd.
309 Pennsylvania Avenue
Concord, Ontario, Canada
FEI #3004044701
Law Tai Hang Products Ltd. Face paints Tartrazine (certifiable
12-22 Tai Yuen Street 53G[][]09 as FD&C; Yellow #5);
Blk. B, 4/F, Shui Wing 1/11/01 Sunset Yellow FCF (cert-
Ind. Bldg. ifiable as FD&C; Yellow
Kwai Chung, Hong Kong #6); Allura Red AC
FEI# 3003211186 (certifiable as FD&C; Red #40
Wapiti International Body Glitter and Rhodamine B,
Rm 821, Nan Fung Comm. Ctr. Hair Highlighter and a mixture
19 Lam Lok St., Kowloon Bay 53Y- - 99 of synthetic
Kowloon, Hong Kong 53G- - 99 organic colors
FEI# 3003734899 53G- - 04 not specifically
53F- - 99 permitted for use
53F- - 06 in the area of
2/23/04 the eye.
ITALY (IT, 480)
***ROAN S.p.A. Pupa Elypsis eye 53C[][]03 D&C; Red #10
Via De Gasperi 22 color compact
Casatenovo, Italy 8/10/93
MID# ITROASPA22CAS
FEI# 1000140862***
KOREA (KR, 515)
Charmzone Co., Ltd. NCS232 New Control Cream Amaranth
106-16 Chungdam-Dong Special Set (formerly
Kangnam-ku, 50A--60 certifiable
Seoul,Korea as FD&C; Red
Republic of (South) #2)
FEE #3000086069
Color Eye Cream FD&C; Red No. 4
53L 01 (Non-permitted
9/22/02 Color)
Julia Limited Eye shadow 53C[][]03 FD&C; Yellow #6 and
656-54 Duengchon-Dong colors resembling
Kangseo-Gu D&C; Red #30 and
Seoul, 157-030, Korea D&C; Red #7
MID# KRJULLIM6565SEO
FEI# 1000288973
Mycosmetic Co. Ltd. Eye Shadow Illegal Colors
14-2 Yeoido-Dong (Light Yellow (see below)
Yeungdeungpo-Gu ES-27)
Seoul, Korea 53C[][]03
FEI #3003514597 10/9/02
Problem: Undeclared Tartrazine (certifiable as FD&C; Yellow # 5; aka CI 19140, E102), non-
permitted Sunset Yellow FCF (certifiable as FD&C; Yellow # 6; aka CI 15985, E110), non-
permitted Lithol Rubine BCA (certifiable as D&C; Red # 7; aka CI 15850)
***MEXICO (MX, 595)
Colgate Palmolive SA De CV M Bath Bar Soap/
Presa De La Angostura 225 P 3 53J--01
Carretera Mexico-Toluca Km 15.5 10/01/99
Mexico D.F. Mexico
FEI# 1000300384
COLOR(S):
Verde 7(i.e. Green 7) - non-permitted color additives
Amarillo 74(i.e. yellow 74) - non-permitted color additives
Desarrollo de Mercados RYT Cherry Blossom Color - FD&C; Red No. 1
de Mexico, S.A. de C.V. Shampoo 1/14/99
Privada Rhin 53ED-06
650-A Col. Mirador
Monterrey N.L., Mexico RYT Conditioner/Cream Rinse Color - FD&C; Red No. 2
FEI# 3000188907 53ED-05 1/14/99
Fabrica de Jabones Mariano "Anti Bacterial" Soaps/53J[][]01
Salgado S.A. de C.V. a) Tip Fresh (Green Label)*
Paseo Tollocan y Marie Curie b) Tip Joven (Yellow Label)*
Toluca, Mexico 01/12/00
FEI #3000239603
* Tip Fresh (Green Label) lists the following colors: "Green 7" and "Blue 15." Tip Joven
(Yellow Label) lists "Yellow 1" and "Orange 4." These color additives as listed are neither
permitted nor do they appear to come from certified batches.
Industrias Wet Line S.A. de C.V. Extreme Hair Gel Undeclared
Privada del Gallo 1525, Col. (Green) Tartrazine
Aurora 53ED-99 (Certifiable as
Guadalajara, Jalisco, Mexico 4/6/04 FD&C;) Yellow #5)
FEI #3004163751
Sanborn Hermanos Theatrical Body Cream Ponceau 4R,
Viaducto Miguel Alemanno 705 53L 03 and color additives
Mexico City, Mexico 8/20/01 resembling
FEI # 3002874996 Sunset Yellow FCF
and Tartrazine
TAIWAN (TW, 281)
***All firms Eye make-up 53C[][]03 Illegal colors***
and kits 53C[][]08
containing eye make-up
Color Shine Cosmetic Lip Gloss 53GC05 Red 27
Industry Co. 7/11/03 Yellow 6
NO. 48, Nan Kung St. Blue 1
Yung Kang City Organic Red
Manganese Violet Organic Pink
Tain,Hsien 710
Taiwan, R.O.C.
FEI# 3003749513
De Evan International Limited Lip Color Contains
10 F/4, No. 171 53G -- 05 Non-Permitted
Chang An East Rd., Sec. 2 53G -- 99 Rhodamine B
Taipei, Taiwan 8/24/04
FEI# 3004437172
First and Best Co., Ltd. Body Glitter Contains non-permitted
Rm 4B-05, No. 5, Hsin-Yi Rd. 53G[][]99 Ponceau 4R and synthetic
Sec. 5 (PO Box 109-0531) 11/9/01 color additives resembling
Taipei, Taiwan Xylene Red B and
FEI# 1000268603 erythrosine
Golden Benz & Co., Ltd. Makeup Kits CI 15825
6F No. 114 Sec 2 53C--08 (certifiable as
Chung Shan North Road 53G--09 D & C Red #7)
Taipei, Taiwan 6/12/01
FEI# 1000455987 CI 47005
(certifiable as
D & C Yellow
#10)
CI 42090
(certifiable as
FD & C Blue #1)
JMU Ching Enterprise Co., Ltd. Make-up Kits Illegal Color
No. 36 Lane 222 Ming Shen Rd.
Hsinchu City 53G--09 D&C; Orange
Taiwan 3/24/97 #17 in the
FEI# 3000226133 lip pencil
compoment
Superier Traders Lip Glitter Contains Erythrosine
International Ltd. 53G--05 (Certifiable as FD&C; Red
2 Fl. #415 Hsinyi Rd. 8/13/01 No. 3)and Brilliant Blue
Sec. 4 FCF(certifiable as FD&C;
Taipei, Taiwan Blue No.1 in part for
FEI #6635 Eye area only)
Body Glitter Contains Erythrosine
53Y[][]99 (Certifiable as FD&C;
10/2/01 Red No. 3) and
Brilliant Blue FCF
(Certifiable as FD&C;
No. 1 in eye-area only)
Taiwan Ox Burning Make-up Kit (Lipstick w/Glitter) (See below
Prods. Co. 53GY-09 for expla-
6/F No. 32 Lane 39 Sec. 2 Lipstick/53GK-05 nation)
Keelung Rd. Taipei Body Glitter/53GC-99
Taiwan 8/23/01
FEI #3003105008
Lipstick portion of the make-up kit was found to contain Lithol Rubin B Ca (certifiable as D&C;
Red #7); it was also reported to contain an unidentified yellow color.
Body glitter portion of the make-up kit was found to contain Rhodamine B (formerly certifiable as
FD&C; Red #19) and Brilliant Blue FCF (certifiable as FD&C; Blue #1). In addition, it was also
indicated that this product also contains an unidentified color additive declared as "glitter" whose
identity has not been determined.
Lithol Rubin B Ca (certifiable as D&C; Red #7), and Brilliant Blue FCF (certifiable as FD&C; Blue
#1) are not permitted on cosmetic products unless they come from FDA-certified batches.
Timesource Enterprise Duo Blue/Pink Non-permiited Brillant
Co., Ltd. Eye Pens Blue FCF and mixture of
2F No. 156 Hei-An Street 53C[][]99/53C[][]03 synthetic fluorescent
Taipei, Taiwan 09/19/01 color additives
FEI# 3003049035 including dibromofluorescein
and
eosine.
Touchstone Trading Lipstick 53G[][]05 FD&C; Red #19 and
Keelung, Taiwan 10/29/92 FD&C; Red #8
MID# TWTOUTRA25TAI
FEI# 1000110074
Manufactuer:
Yumark Enterprises Corp. Roll on glitter Contains nonpermitted
67 Tun Haw South Road 53Y[][]99 color additives Xylene
Taipei, Taiwan 6/10/04 Red B, Allura Red AC,
FEI# 3004468579 Brilliant Blue FCF and
Tartrazine
Shipper/ Labeled distributor for the above:
Art Craft Ltd.
633 Edgeley Blvd.
Concord, Ontario, Canada
FEI# 3001649897
(Office)
Wingo International Co. Ltd. Lip Tint Amazing Glaze Non-permitted
AKA: Metro Cosmetics (Strawberry Blast) unidentified
Industry Co. (Strawberry Dazzle) red oil soluble
6th Floor-1 No. 60 (Tangerine Tickle) color detected
Section 4 53G[][]05 in all three
Chung Shiang East Rd. 9/29/03 products.
Taipei, Taiwan Undeclared
FEI# 3004006490 6/24/04 Quinoline Yellow
(Name change) Detected in
Tangerine Tickle.
And
Wingo International Co. Ltd. (Factory)
No. 423, Zhong (Chung) Shan South Rd.
Tainan Hsien 710
Yung Kang City, Taiwan
FEI# 12654
UNITED KINGDOM (GB, 925)
***A.Z. Nadar Cosmetics Eye dust 53C[][]03 FD&C; Red #7 and
and Hair Products two unidentified
d/b/a STARGAZER colors
P.O. BOX 609 Gypsy Rose rouge 53G[][]07 FD&C; Red #2
London, SW3 4NS, England
MID# GBAZNAD609LON Mascara 53C[][]06 one to three
FEI# 1000359677 unidentified colors
Lipstick 53G[][]05 One unidentified color
Stargazer has also used the following shipping address on some entries.
Showroom
Unit 5B
9 Brighton Terrace
London SW9 8DJ, England
MID# GBSTAGAZ9LON
FEI# 1000269231***
Beauty Without Cruelty, Ltd. Lipstick- 53G[][]05 D & C RED #19
37 Avebury Avenue Ice Melon
Tonbridge, Kent
TN9 ITL United Kingdom
FEI #1000504949
MID #GBBEAWIT37KEN
Attachment B - Import Alert #53-06 Revised 6/24/04
Manufacturers/Shippers Of Eye Make-up From Taiwan Exempt from Automatic Detention
Chao Ling Chemical Industry Co., Ltd. 2/28/91
P.O. Box 442
Hsinchu, Taiwan
MID# TWCHALIN21HSI
FEI# 12658
Manufacturing Plant: Chin Ming Chemical Co., Ltd.
9, Lane 8, Gong Shyue Rd.
Taichung, Taiwan
MID# TWCHIMIN9TAI
FEI# 12659
Chian Zong International Co., Ltd. 11/21/94
7 Hsing Kung Road, Wang Tang Tsun
Yung Kang Hsiang, Tainan Hsien, Taiwan
MID #TWCHIZON7TAI
FEI# 1000255152
Ever Bilena Cosmetics, Inc. 1/12/95
No. 17 Lane 77 Chang
An Rd., Hsi China
P.O. Box 111 Nan Kang
Taipei, Taiwan
MID# TWCHIFON77TAI
MID# TWCHIFON111TAI
FEI# 1000204084
Galisa Cosmetics International Corp. 8/25/92
No. 72 Pao-Chung Rd.
Taipei, Taiwan
MID# TWGALCOS72TAI
FEI# 1000109489
Gold Regency Trading International 3/3/95
P O Box 957
Tainan, Taiwan
MID #TWGOLREG957TAI
FEI# 1000311593
Golden Aristocrat Enterprise Company 3/3/95
#2 Lane 26, Hwu-Meei First Street
Tainan, Taiwan
MID# TWGOLAR2TAI
FEI# 1000311592
Healthcome Cosmetics Corp. 1/22/90
4-5/F. No. 528 Chung Yan Rd.
Nankang, Taipei, Taiwan
MID# TWHEACOS45HSI
FEI# 12651
Imei Chemical Enterprise Makeup Kits 9/24/96
Limited 53C03 and 53C08
No. 171 Tahu Road
Haishan Li,
Hsinchu City, Taiwan
FEI #12646
MID #TWIMECHE171HSI
International Cosmograce Corp. 10/5/93
F. 8-1, No. 65, Sung Te Road
Taipei, Taiwan
MID# TWINTCOS65TAI
FEI# 1000145049
Kwai Yu International Corp. 10/2/91
P.O. Box 32-10
Taipei, Taiwan
MID# TWKWAYU3210TAI
FEI# 12652
Mei Kuai Cosmetics Company 2/28/94
No. 121 Lane, 145 Sec. 1 An Ho Road
Tainan, Taiwan
MID# TWMEIKUA121TAI
FEI# 1000153156
Mei Shual Cosmetics Co. Ltd. 12/22/92
No. 71, Lane 96 Da Shing St.
Tainan, Taiwan Change in Address
FEI# 1000114498 9/19/01
Michitoy International Petite Miss Compact 9/4/97
Co., Ltd. Blue Eye Shadow
11F #159 Sec 2 53C[][]08
Hsin Hai Road
Taipei, Taiwan
FEI #1000234163
Mostwell Co., Ltd. 2/16/90
P.O. Box 39 HSI-CHIN
Taipei, Taiwan
MID# TWMOSCO39TAI
FEI# 12630
Obtain Ideal Chemistry Company (OIC) 2/12/90
4 Fl., No. 39, Lane 697
Tun Hwa South Road
Taipei, Taiwan
MID# TWOBTIDE39TAI
FEI# 1000182419
Parnasse Chemical Industrial 9/1/93
Sec 3 Nan Kang Rd
Taipei, Taiwan
MID #TWPARCHETAI
FEI# 1000144685
Prince Chemical Ind. Co., Ltd. 3/9/90
No. 12 Hsin Jen Road
Tainan, Taiwan
MID# TWPRICHE12TAI
FEI# 12631
Rich Corty Industrial Corporation 8/14/89
4F, 299 Section 4, Chung Shiao Road
Taipei, Taiwan
MID# TWRICCOR299TAI
FEI# 12628
Shiseido Asia Pacific Co., Eye Shadow
Ltd. 53C[][]08
37 Bao-Ching Road 7/24/03
Taipei, Taiwan
FEI# 3002718885
Sun Beauty Cosmetic Co., Ltd. 9/25/92
(Subsidiary of Prince Chemical Industrial Co., Ltd.)
Tainan, Taiwan
MID# TWSUNBEATAI
FEI# 1000109579
Thai Ho Cosmetics Co., Ltd. 2/14/92
39 Da Ye Street
Da Fa Industrial District
Da Liau Hsiang, Kaohsiung Hsien, Taiwan
MID# TWTHAHO39DAL
FEI# 1000285570
Tonnie Cosmetics Co., Ltd. Eyeshadow
29 Hsin Chung Rd. 53C--03
An Pin Industrial District 5/11/04
702 Tainan
Taiwan
FEI# 1000297401
Wingo International Co., Ltd. (Factory) 3/19/90
No. 423, Zhong (Chung) Shan South Rd.
Tainan Hsien 710 6/24/04
Yung Kang City, Taiwan (Name and address change)
FEI# 12654
Wu Reng Trading Co., Ltd. 8/30/89
1st Floor, No. 1-4, Lane 7
Ching Tien ST., Taipei 10619, Taiwan
MID# TWWUREN14TAI / FEI# 12629