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ANEXO I: Relación de productos de los que no se ha encontrado IETM, o no están registrados en esta Agencia (en el caso de
productos de estética). La AEMPS no ha realizado actuaciones.
Número de
notificación
RAPEX
UE-A12-0064/13
UE-A12-0399/13
UE-A11-0025/13
Denominación
Producto
Finalidad
Producto
Tipo Incumplimiento
Código
AEMPS
Kuro Sumi Tattoo
Outlining Ink
Riesgo químico de
acuerdo a la resolución
ResAP(2008)1 del
Consejo de Europa:
Tinta para tatuaje 20,13 mg/kgde
Hidrocarburos
aromáticos, policíclicos
(PAH)
CM-021/2013
Fantasia Flesh Tone
Riesgo químico de
acuerdo a la resolución
ResAP(2008)1 del
Tinta para tatuaje Consejo de Europa:
196 mg/kgde Bario
61 mg/kgde Cromo
1170 mg/kgde Circonio
CM-291/2013
Glitter Hair Spray
Aerosol de color
para el cabello
Presencia de sustancia
prohibida:
CI 45170
Anexo II / 400
CM-306/2013
CORREO ELECTRÓNICO
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ANEXO I: Relación de productos de los que no se ha encontrado IETM, o no están registrados en esta Agencia (en el caso de
productos de estética). La AEMPS no ha realizado actuaciones.
Número de
notificación
RAPEX
UE-A12-0452/13
UE-A12-0453/13
Denominación
Producto
Opoola Art Nail
Ellis Cosmetic Artificial
Nails
UE-A12-0454/13
K.nail Art Nails
UE-A12-0455/13
Nail Art Fiore Fashion
Collection
Finalidad
Producto
Pegamento para
uñas postizas
Pegamento para
uñas postizas
Pegamento para
uñas postizas
Pegamento para
uñas postizas
Tipo Incumplimiento
Presencia de sustancia
prohibida:
Ftalato de dibutilo
Anexo II / 675
Presencia de sustancia
prohibida:
Ftalato de dibutilo
Anexo II / 675
Presencia de sustancia
prohibida:
Ftalato de dibutilo
Anexo II / 675
Presencia de sustancia
prohibida:
Ftalato de dibutilo
Anexo II / 675
Código
AEMPS
CM-313/2013
CM-314/2013
CM-315/2013
CM-316/2013
CORREO ELECTRÓNICO
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ANEXO I: Relación de productos de los que no se ha encontrado IETM, o no están registrados en esta Agencia (en el caso de
productos de estética). La AEMPS no ha realizado actuaciones.
Número de
notificación
RAPEX
Denominación
Producto
Finalidad
Producto
Tipo Incumplimiento
Presencia de sustancia
prohibida:
Ftalato de dibutilo
Anexo II / 675
Código
AEMPS
Design Nail
Pegamento para
uñas postizas
UE-A12-0475/13
Fantasia Lining Black
Riesgo químico de
acuerdo a la resolución
ResAP(2008)1 del
Tinta para tatuaje Consejo de Europa:
CM-340/2013
186 µg/Kg de Benzeno-aPireno (BaP)
UE-A12-0509/13
Sante 100 % Pflanzen
Haarfarbe
Tinte en polvo
para el cabello
UE-A12-0458/13
Contaminación
microbiológica:
Bacterias aerobias
mesofilas (9 x 104 ufc/g)
CM-317/2013
CM-374/2013
CORREO ELECTRÓNICO
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ANEXO I: Relación de productos de los que no se ha encontrado IETM, o no están registrados en esta Agencia (en el caso de
productos de estética). La AEMPS no ha realizado actuaciones.
Número de
notificación
RAPEX
Denominación
Producto
Finalidad
Producto
Henna black
UE-A12-0514/13
Henna gold blond
Tinte en polvo
para el cabello
Henna coppery red
Pegamento para
uñas postizas
UE-A12-559/13
Nail Art Beds Set
UE-A12-560/13
Meilu Series Design
Nails Nail Art. Beautiful Pegamento para
uñas postizas
Nails of Charming
Ladies
Tipo Incumplimiento
Contaminación
microbiológica:
Bacterias aerobias
mesofilas
Henna black
(1,4 x 105 ufc/g)
Henna gold blond
(1,9 x 104 ufc/g)
Henna coppery red
(2,6 x 104 ufc/g)
Presencia de sustancia
prohibida:
Ftalato de dibutilo
Anexo II / 675
Presencia de sustancia
prohibida:
Ftalato de dibutilo
Anexo II / 675
Código
AEMPS
CM-375/2013
CM-411/2013
CM-412/2013
CORREO ELECTRÓNICO
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ANEXO I: Relación de productos de los que no se ha encontrado IETM, o no están registrados en esta Agencia (en el caso de
productos de estética). La AEMPS no ha realizado actuaciones.
Número de
notificación
RAPEX
Denominación
Producto
Finalidad
Producto
Tipo Incumplimiento
Código
AEMPS
Contaminación
microbiológica:
Bacterias spp
Crema para el
(2,6 x 106 ufc/g)
CM-429/2013
cuidado de la piel
Pseudomonas aeruginosa
(6,0 x 104 ufc/g)
UE-A12-0580/13
Alwag Skin Cream
Real Potato Cream
UE-A12-0587/13
Crema para el
Inoar Professional Hair
cuidado del
Treatment Product
cabello
Sustancia fuera de las
condiciones establecidas:
CM-430/2013
7,0 % de formaldehído
CORREO ELECTRÓNICO
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ANEXO II: Relación de productos de los que se ha encontrado IETM, la AEMPS ha realizado actuaciones.
Número de
notificación
RAPEX
UE-A12-1807/12
Denominación
Producto
Disney Princess Champú
Finalidad
Producto
Cosmético:
Champú
Tipo Incumplimiento
Presencia de sustancia
prohibida:
29,4 mg/kg de Dioxano
Anexo II / 343
Código
AEMPS
CM-883-2012
Respuesta a las
actuaciones de la
AEMPS
El responsable ha
informado que el
producto no se
comercializa en España
CORREO ELECTRÓNICO
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ANEXO III: Notificación sólo para información (no se reflejan en la lista del Anexo IV).
Número de
notificación
RAPEX
INFO-0081/13
Denominación
Producto
Whiteness Perfect Tooth
Whitening Product
Finalidad
Producto
Blanqueante dental
Tipo Incumplimiento
Código
AEMPS
Presencia de sustancia
regulada en condiciones
distintas de las establecidas:
6,7% de Peróxido de
hidrógeno
(En España los blanqueantes
dentales con concentración
CM-342/2013
de peróxido de hidrógeno
libre o liberado superior al 6%
tienen la consideración legal
de Productos de Higiene,
dentífricos)
CORREO ELECTRÓNICO
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ANEXO IV: Alertas europeas transmitidas a través del Sistema RAPEX recibidas en la AEMPS
(tal y como se publican en la página Web de la Comisión Europea)
No. Ref.
Notifying
country
Product
Danger
Measures adopted by notifying
country
A12/1807/12
Germany
Category: Cosmetics
Product: Shampoo & bath gel
Brand: Disney
Name: Disney Princess
Type/number of model: Unknown
Batch number/Barcode:
95943001531000000300
OECD Portal Category:
Description: Shampoo and bath gel,
microbiologically tested; sold in a
printed, plastic bottle with hinged lid.
Country of origin: Greece
Chemical
This product presents a chemical risk because it
contains 29.4 mg/kg dioxane. This product does not
comply with the Cosmetic Directive.
Voluntary measures: Withdrawal of the
product from the market and destruction of
the product.
A12/0064/13
Germany
Category: Chemical products
Product: Tattoo Ink
Brand: Kuro Sumi
Name: Kuro Sumi Tattoo Outlining Ink
Chemical
The product poses a chemical risk because it
contains 7 polycyclic aromatic hydrocarbons (PAH)
(20.13 mg/kg), with a benzo[a]pyrene content of
Compulsory measures: Withdrawal of the
product from the market
CORREO ELECTRÓNICO
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A12/0399/13
Slovakia
Type/number of model:
Batch number/Barcode: LOT# KSOL
110407, batch 04/07/11
OECD Portal Category:
Description: Packaging: the sample
was provided in two colourless glass
containers with metal screw-on caps.
Country of origin: Japan
0.34 mg/kg, which is classified as carcinogenic.
According to the Council of Europe Resolution
ResAP (2008) on requirements and criteria for the
safety of tattoos and permanent make-up, PAH shall
not exceed a concentration of 0.5 ppm.
Category: Chemical products
Product: Tattoo ink
Brand: Fantasia
Name: Flesh Tone
Type/number of model: 3026
Batch: 1758 Model: 30 ml
Batch number/Barcode:
OECD Portal Category:
Description: Tea rose tattoo ink in a
30 ml plastic bottle.
Country of origin: United States
Chemical
The product poses a chemical risk because it
contains 196 ppm of barium, 61 ppm of chromium
and 1170 ppm of zirconium. According to the
Council of Europe Resolution ResAP (2008) on
requirements and criteria for the safety of tattoos
and permanent make-up, the level of barium may
not exceed 50 ppm and the level of chromium may
not exceed 0.2 ppm. The product does not comply
with the national legislation.
Voluntary measures: Recall of the
product from end users
CORREO ELECTRÓNICO
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FAX: 91 822 52 89
A12/0452/13
Czech
Republic
Category: Clothing, textiles and
fashion items
Product: False nails
Brand: Opoola
Name: Art Nail
Type/number of model: Item No 2618
Batch number/Barcode: Unknown
OECD Portal Category:
Description: Set of artificial green
nails (12 pcs) with decorations packed
in a pink cardboard box. The product
contains an orange tube of glue.
Country of origin: China
Chemical
The product poses a chemical risk because the glue
contains dibutyl phthalate (DBP).
Compulsory measures: Withdrawal of the
product from the market. Warning
consumers of the risk.
A12/0453/13
Czech
Republic
Category: Clothing, textiles and
fashion items
Product: False nails
Brand: Ellis Cosmetic
Name: Artificial nails / ••••••• !
•"#$%
Type/number of model: Unknown
Batch number/Barcode: MU 1501
600 PC / EAN: 6933322215019
OECD Portal Category:
Description: Set of artificial nails (12
pcs) with different colours or
decorations, packed in a cardboard
box. The product contains an orange
Chemical
The products pose a chemical risk because the glue
contains dibutyl phthalate (DBP).
Compulsory measures: Withdrawal of the
product from the market. Warning
consumers of the risk.
CORREO ELECTRÓNICO
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tube of glue with a white cap.
Country of origin: China
A12/0454/13
Czech
Republic
Category: Clothing, textiles and
Chemical
fashion items
The products pose a chemical risk because the glue
Product: False nails
contains dibutyl phthalate (DBP).
Brand: K.nail
Name: Art Nails
Type/number of model: NaturalNo KP & 806
Batch number/Barcode: Unknown
OECD Portal Category:
Description: Set of artificial nails (10
pcs) with 'French manicure' decoration
and an orange tube of glue. Packed in
a plastic bag attached to a cardboard
label. On the back of the label there are
instructions for use and warnings in
English.
Country of origin: China
Compulsory measures: Withdrawal of the
product from the market. Warning
consumers of the risk.
CORREO ELECTRÓNICO
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A12/0455/13
Czech
Republic
Category: Clothing, textiles and
fashion items
Product: False nails
Brand: Nail Art
Name: Fiore fashion collection
Type/number of model:
Item No.TN97714
Batch number/Barcode:
EAN: 8418868977129
OECD Portal Category:
Description: Set of artificial nails (24
pcs) with different colours and
decorations, packed in a pink
cardboard box. The product contains a
blue tube of glue.
Country of origin: China
Chemical
The products pose a chemical risk because the glue
contains dibutyl phthalate (DBP).
Compulsory measures: Withdrawal of the
product from the market. Warning
consumers of the risk.
CORREO ELECTRÓNICO
[email protected]
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A12/0458/13
Czech
Republic
Category: Clothing, textiles and
fashion items
Product: False nails
Brand: Unknown
Name: Design Nail
Type/number of model: MU 1498,
600 PC / CTN
Batch number/Barcode:
EAN: 6933322214982
OECD Portal Category:
Description: Set of artificial nails (12
pcs) with different decorations, packed
in a pink cardboard box. The product
contains an orange tube of glue with a
white cap.
Country of origin: China
Chemical
The products pose a chemical risk because the glue
contains dibutyl phthalate (DBP).
Compulsory measures: Withdrawal of the
product from the market. Warning
consumers of the risk.
CORREO ELECTRÓNICO
[email protected]
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A12/0475/13
Germany
Category: Chemical products
Product: Tattoo ink
Brand: Fantasia
Name: Lining Black
Type/number of model: Art. No. 3029
Batch number/Barcode: Batch 1762
OECD Portal Category:
Description: Black tattoo ink in a 125
ml glass bottle with screw cap. Bestbefore date 05/2014.
Country of origin: United States
Chemical
The product poses a chemical risk because it
contains 186 ppb of Benzo(a)pyrene (BaP).
According to the Council of Europe Resolution
ResAP (2008) on requirements and criteria for the
safety of tattoos and permanent make-up, the level
of Benzo(a)pyrene (BaP) may not exceed 5 ppb.
Voluntary measures: Withdrawal of the
product from the market.
CORREO ELECTRÓNICO
[email protected]
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FAX: 91 822 52 89
A12/0509/13
Slovakia
Category: Cosmetics
Product: Hair dye
Brand: Sante
Name: 100 % Pflanzen Haarfarbe
Type/number of model: maroon
Batch number: 12030537/ 4 025089
041887
Batch number/Barcode:
OECD Portal Category:
Description: Powder hair dye (100g) –
maroon colour, packed in a brown and
white cardboard box.
Country of origin: Germany
Microbiological
The product poses a microbiological risk due to the
presence of mesophilic aerobic microorganisms to
the amount of 9.0 x 104 cfu/g. The product poses a
serious microbiological risk for consumers.
Compulsory measures: Withdrawal of the
product from the market
A12/0514/13
Slovakia
Category: Cosmetics
Product: Natural hair dye
Brand: Henna
Name: Henna black, Henna gold
blond, Henna coppery red
Type/number of model: 1) Henna
Microbiological
The products pose a microbiological risk due to the
presence of mesophilic aerobic microorganisms in
amount as follows: 1)1.4 x 105 cfu/g 2) 1.9 x 104
cfu/g 3) 2.6 x 104 cfu/g
Compulsory measures: Withdrawal of the
product from the market
CORREO ELECTRÓNICO
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black 2) Henna gold blond 3) Henna
coppery red
Batch number/Barcode:
1) 8 594008 780023 /date of production
14/02/2012 /expiration date:
14/02/2014
2) 8 594008 780047 /date of production
03/10/2012 /expiration date:
03/10/2014
3) 8 594008 780115 /date of production
10/08/2012 /expiration date:
10/08/2014
OECD Portal Category:
Description: Natural powder hair dyes
(33g) – black, gold blond, coppery red,
packed in cardboard boxes. The packs
contain plastic gloves and caps.
Country of origin: Czech Republic
CORREO ELECTRÓNICO
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A12/0559/13
Czech
Republic
Category: Clothing, textiles and
Chemical
fashion items
The products pose a chemical risk because the glue
Product: False nails
contains dibutyl phthalate (DBP).
Brand: Unknown
Name: Nail Art Beds Set
Type/number of model:
Item No.CH-1103-01 1000 A
Batch number/Barcode:
8809271033067
OECD Portal Category:
Description: Set of 10 yellow plastic
nails with decorations. The product is
packed in a decorated cardboard box
with a transparent window and contains
a tube of glue with a white cap, a small
tube containing orange liquid, a brush
and a box with multi-coloured glitter
beads and sticks.
Country of origin: China
Compulsory measures: Withdrawal of the
product from the market and warning
consumers of the risk.
CORREO ELECTRÓNICO
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A12/0560/13
Czech
Republic
Category: Clothing, textiles and
fashion items
Product: False nails
Brand: Meilu Series
Name: Design Nails Nail Art. Beautiful
Nails of Charming Ladies.
Type/number of model: Series #A-01
Batch number/Barcode: Unknown
OECD Portal Category:
Description: Set of 10 white plastic
nails with an orange tube of glue.
Packed in a plastic bag inside a purple
carton with a transparent window.
Country of origin: China
Chemical
The products pose a chemical risk because the glue
contains dibutyl phthalate (DBP).
Compulsory measures: Withdrawal of the
product from the market and warning
consumers of the risk.
A12/0580/13
Germany
Category: Cosmetics
Product: Skin cream
Brand: Alwag
Name: Echte Kartoffel Creme
Type/number of model: Unknown
Batch number/Barcode: Batch 23.61
OECD Portal Category: 53000000
Beauty/ Personal Care/Hygiene
Description: Skin cream in a round
white plastic jar with label. Part of label
serves as security seal. Best-before
date 09/2014
Country of origin: Germany
Microbiological
The product poses a microbiological risk because it
contains a high level of Pseudomonas aeruginosa
(up to 60.000 cfu/g). The product also contains an
aerobic mesophilic bacteria count of 2.600.000
cfu/g, which is a level higher than the guidance
value of 1.000 cfu/g for this kind of product. The
product does not comply with the Cosmetics
Directive 76/768/EEC
Voluntary measures: Withdrawal of the
product from the market,
Warning consumers of the risks
CORREO ELECTRÓNICO
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A12/0587/13
The
Netherlan
ds
Category: Cosmetics
Product: Hair treatment product
Brand: INOAR professional
Name: G.Hair, Formula Original Alema
Type/number of model: Unknown
Batch number/Barcode:
7898277570028 batch 10.2012 L.0421
OECD Portal Category: 53000000
Beauty/ Personal Care/Hygiene
Description: Hair treatment product in
yellow1 liter plastic bottle.
Country of origin: Brazil
Chemical
The product poses a chemical risk because it
contains 7.0% of formaldehyde. The product does
not comply with the Cosmetics Directive.
Compulsory measures: Withdrawal of the
product from the market
CORREO ELECTRÓNICO
[email protected]
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