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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 higiene). La AEMPS no ha realizado actuaciones.
Número de notificación
RAPEX Denominación
Producto Finalidad Producto
Responsable Producto Tipo Incumplimiento Código
AEMPS
UE-A12-0084/13 Baby Blue Tattooo Ink
Tinta para tatuaje Desconocido
Riesgo químico de acuerdo a la resolución ResAP(2008)1 del Consejo de Europa: 5,04 mg/Kg de Hidrocarburos aromáticos, policíclicos (PAH)
CM-024/2013
UE-A12-0087/13
Golden Pearl Beauty Cream
Cosmético: blanqueante para la piel
Noshia hala Meat Reino Unido
Presencia de sustancia prohibida: 4750 mg/Kg de Mercurio
Anexo II / 221
CM-025/2013
UE-A12-0088/13
Shaheen Cosmetic Face Fresh Beauty Cream
Cosmético: blanqueante para la piel
Noshia hala Meat Reino Unido
Presencia de sustancia prohibida: 4620 mg/Kg de Mercurio
Anexo II / 221
CM-026/2013
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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 higiene). La AEMPS no ha realizado actuaciones.
Número de notificación
RAPEX Denominación
Producto Finalidad Producto
Responsable Producto Tipo Incumplimiento Código
AEMPS
UE-A12-0089/13
MIR Agencies (AK) Fresh Look Ultra Whitening Fairness Cream
Cosmético: blanqueante para la piel
Umma Halal Reino Unido
Presencia de sustancia prohibida: 3500 mg/Kg de Mercurio
Anexo II / 221
CM-027/2013
UE-A12-0090/13
CPHL Seven Herbal Ubtan With Sun Screen
Cosmético: blanqueante para la piel
Thara Stores Reino Unido
Presencia de sustancia prohibida: 620 mg/Kg de Mercurio
Anexo II / 221
CM-028/2013
UE-A12-0091/13
Raj Pharmacy Raj Beauty Cream
Cosmético: blanqueante para la piel
Noshia hala Meat Reino Unido
Presencia de sustancia prohibida: 470 mg/Kg de Mercurio
Anexo II / 221
CM-029/2013
UE-A12-0096/13
Intenze Siena Intenze Dragon Red Intenze Tangerine Intenze Banana Cream Intenze Lime Green
Tintas para tatuaje
Desconocido
Riesgo químico de acuerdo a la resolución ResAP(2008)1 del Consejo de Europa: 1753 mg/Kg de o-Anisidina
CM-030/2013
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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 higiene). La AEMPS no ha realizado actuaciones.
Número de notificación
RAPEX Denominación
Producto Finalidad Producto
Responsable Producto Tipo Incumplimiento Código
AEMPS
UE-A12-0097/13
TMT Lip Stick With Vitamin A,C,E
Cosmético: pintalabios
Obchodni centrum República Checa
Presencia de sustancias prohibidas: 323 mg/Kg de Cadmio
Anexo II / 68 151 mg/Kg de Plomo
Anexo II / 289
CM-031/2013
UE-A12-0121/13
Freshmaker Kids, Baby Wet Wipes, With Lotion
Cosmético: toallitas húmedas para niños
Fulya Kozmetik. Turquia
Presencia de sustancia prohibida en productos para menores de 3 años: Yodopropinil butilcarbamato (IPBC).
Anexo VI / 56
CM-042/2013
UE-A12-0122/13
Freshmaker Baby Wet Wipes, Wet Towels With Lotion, Extra
Cosmético: toallitas húmedas para niños
Fulya Kozmetik. Turquia
Presencia de sustancia prohibida en productos para menores de 3 años: Yodopropinil butilcarbamato (IPBC).
Anexo VI / 56
CM-043/2013
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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 higiene). La AEMPS no ha realizado actuaciones.
Número de notificación
RAPEX Denominación
Producto Finalidad Producto
Responsable Producto Tipo Incumplimiento Código
AEMPS
UE-A12-0123/13
DISNEY Wipes Baby Soft Care
Cosmético: toallitas húmedas para niños
Desconocido Turquia
Presencia de sustancia prohibida en productos para menores de 3 años: Yodopropinil butilcarbamato (IPBC).
Anexo VI / 56
CM-044/2013
UE-A12-0124/13
Bii Wipes With Cream Wet Towel KREMLI
Cosmético: toallitas húmedas para niños
Taha Kimya Kozmetik Turquia
Presencia de sustancia prohibida en productos para menores de 3 años: Yodopropinil butilcarbamato (IPBC).
Anexo VI / 56
CM-045/2013
UE-A12-0125/13
Bii Wipes Natural Wet Towel
Cosmético: toallitas húmedas para niños
Taha Kimya Kozmetik Turquia
Presencia de sustancia prohibida en productos para menores de 3 años: Yodopropinil butilcarbamato (IPBC).
Anexo VI / 56
CM-046/2013
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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 higiene). La AEMPS no ha realizado actuaciones.
Número de notificación
RAPEX Denominación
Producto Finalidad Producto
Responsable Producto Tipo Incumplimiento Código
AEMPS
UE-A12-0126/13
Nemdil Baby Wet Towels With Lotion, Deluxe Quality
Cosmético: toallitas húmedas para niños
Fulya Kozmetik Turquia
Presencia de sustancia prohibida en productos para menores de 3 años: Yodopropinil butilcarbamato (IPBC).
Anexo VI / 56
CM-047/2013
UE-A12-0138/13
Beautiful Parfum Eau de Parfum Diableau
Colonias / Perfumes
Parfum oils Made inFrance France
Presencia de sustancia prohibida: 2,9 mg/Kg de Safrol
Anexo II / 360
CM-049/2013
UE-A12-0139/13
Eternal Luk 3814 A Jungle Green Tattoo
Tinta para tatuaje
Stefan Gossner Body Cult GmbH Alemania
Riesgo químico de acuerdo a la resolución ResAP(2008)1 del Consejo de Europa: 21 µg/Kg de Benzeno-a-Pireno (BaP)
CM-050/2013
UE-A12-0140/13
Jet France Violet Rouge D 51 F
Tinta para tatuaje Yet France Company Francia
Riesgo químico de acuerdo a la resolución ResAP(2008)1 del Consejo de Europa: 4900 mg/Kg de Níquel
CM-051/2013
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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 higiene). La AEMPS no ha realizado actuaciones.
Número de notificación
RAPEX Denominación
Producto Finalidad Producto
Responsable Producto Tipo Incumplimiento Código
AEMPS
UE-A12-0146/13
Rani Kone Black Henna
Cosmético: tintas para tatuaje temporal de henna negra
Desconocido
Presencia de sustancia regulada en condiciones distintas de las establecidas: 2,25% de p-Fenilendiamina
Anexo III / 8b
CM-052/2013
UE-A12-0147/13
Moon Star Herbal Henna Burgundy
Cosmético: tinte capilar
Zam Zam (Luton) Limited Reino Unido
Presencia de sustancia regulada en condiciones distintas de las establecidas: 12,3% de p-Fenilendiamina
Anexo III / 8b No incluye las advertencias obligatorias
CM-053/2013
UE-A12-0148/13
Moon Star Herbal Henna Copper Brown
Cosmético: tinte capilar
Zam Zam (Luton) Limited Reino Unido
Presencia de sustancia regulada en condiciones distintas de las establecidas: 8,7% de p-Fenilendiamina
Anexo III / 8b No incluye las advertencias obligatorias
CM-054/2013
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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 higiene). La AEMPS no ha realizado actuaciones.
Número de notificación
RAPEX Denominación
Producto Finalidad Producto
Responsable Producto Tipo Incumplimiento Código
AEMPS
UE-A12-0169/13
Black TM Intenze Japaneze Black Sumi
Tinta para tatuaje
Killer Ink Ltd Reino Unido
Riesgo químico de acuerdo a la resolución ResAP(2008)1 del Consejo de Europa: 60,1 mg/Kg de Hidrocarburos aromáticos, policíclicos (PAH)
CM-073/2013
UE-A12-0170/13
Eternal Ink Nuclear Green
Tinta para tatuaje
Body Cult GmbH Alemania
Riesgo químico de acuerdo a la resolución ResAP(2008)1 del Consejo de Europa: 120 mg/Kg de o-Toluidina
CM-074/2013
UE-A12-0177/13
Ri-soft Colors Profi Colors Brown Black Eyebrow / Eyeliner
Tinta para tatuaje / Maquillaje permanente
Riso Cooperation GmbH Alemania
Riesgo químico de acuerdo a la resolución ResAP(2008)1 del Consejo de Europa: 72 mg/Kg de Niquel
CM-075/2013
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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 higiene). La AEMPS no ha realizado actuaciones.
Número de notificación
RAPEX Denominación
Producto Finalidad Producto
Responsable Producto Tipo Incumplimiento Código
AEMPS
UE-A12-0230/13
Pro-White Professional Teeth Whitening
Blanqueante dental
Pro White Ltd Reino Unido
Presencia de sustancia regulada en condiciones distintas de las establecidas: 12% de Peróxido de hidrógeno
CM-136/2013
UE-A12-0252/13
Ua Te Long Eye / Lip Liner Pencil
Cosmético: perfilador ojos / labios
Baby dress s.r.o. República Checa
Presencia de sustancia prohibida: Rosa 173,1 mg/Kg de Plomo Negro 2,49 mg/Kg de Plomo
Anexo II / 289
CM-137/2013
UE-A12-0260/13
Freshmaker Kids Baby Wet Wipes With Lotion
Cosmético: toallitas húmedas para niños
Ful Kozmetik Turquia
Presencia de sustancia prohibida en productos para menores de 3 años: Yodopropinil butilcarbamato (IPBC).
Anexo VI / 56
CM-138/2013
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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 higiene). La AEMPS no ha realizado actuaciones.
Número de notificación
RAPEX Denominación
Producto Finalidad Producto
Responsable Producto Tipo Incumplimiento Código
AEMPS
UE-A12-0266/12
Kartoffel “Erdäpfel” Spezial Crème [special potato cream]
Cuidado personal: crema para rejuvenecer la piel
ALWAG Alpenkräuter mbH Alemania
Contaminación microbiológica: Pseudomonas aeruginosa (13 x103
ufc/g) Bacterias aerobias mesofilas (>1x103
ufc/g) Enterobacterias spp
CM-139/2013
UE-A12-0270/13
Gala: 1. Hypnotic Attraction 2. Modern Charisma 3. Mysterious Attitude
Toallitas antibacterianas
Asil Cosmetics Rumania
Presencia de sustancia prohibida en productos para menores de 3 años: Yodopropinil butilcarbamato (IPBC). Anexo VI / 56
CM-140/2013
UE-A12-0271/13
Gala: 1. Parfum de Capsuni 2. Parfum de Mar Verde
Toallitas antibacterianas
Asil Cosmetics Rumania
Presencia de sustancia prohibida en productos para menores de 3 años: Yodopropinil butilcarbamato (IPBC). Anexo VI / 56
CM-141/2013
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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 Denominación
Producto Finalidad Producto
Responsable
Producto Tipo Incumplimiento Código AEMPS
Respuesta a las actuaciones de la
AEMPS
UE-A12-1932/12 DMK Alpha Fade Gel
Cosmético: blanqueante de la piel
Danné montague King Foia del Alcoi 5 033530 La Nucia (Alicante)
Presencia de sustancia prohibida: 1,5 % de Hidroquinona
Anexo II / 1339
CM-009-2013
El responsable ha informado que el producto no se comercializa en España
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ANEXO III: Relación de productos de los que no se ha encontrado IETM, la AEMPS ha realizado actuaciones.
Número de notificación
RAPEX Denominación
Producto Finalidad Producto
Responsable
Producto Tipo Incumplimiento Código AEMPS
Actuaciones de la AEMPS
UE-A12-0132/13 Bio Claire Skin Lightening Product
Cosmético: blanqueante de la piel
PAK’s Wholesale Reino Unido
Presencia de sustancia prohibida: Propionato de clobetasol
CM-616-2012
Se remitió, por su condición de medicamento, al Departamento de Inspección y Control de esta Agencia
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ANEXO IV: Notificación sólo para información (no se reflejan en la lista del Anexo V).
Número de notificación
RAPEX Denominación
Producto Finalidad Producto
Responsable
Producto Tipo Incumplimiento Código AEMPS
INFO-0053/13
Kuro Sumi graywash Shading Ink Kuro Sumi Tattoo Outlining Ink
Tintas para tatuaje
Killer Ink Ltd Reino Unido
Riesgo químico de acuerdo a la resolución ResAP(2008)1 del Consejo de Europa: 2,2 mg/Kg y 2,3 mg/Kg respectivamente de Hidrocarburos aromáticos, policíclicos (PAH)
CM-073/2013
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ANEXO V: 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
A12/1932/12 Finland Category: Cosmetics Product: Skin lightening product Brand: DMK Name: Alpha Fade Gel Type/number of model: ALP-3948 Batch number/Barcode: 2018 Description: A white plastic bottle containing 80 ml (2 fl oz) skincare lotion (skin lightener for normal or oily skin). Best Before 01/14. Country of origin: United States
Chemical The product poses a chemical risk because it contains 1.5 % of hydroquinone, the use of which is prohibited in cosmetics and personal hygiene products. The product does not comply with the Cosmetics directive 76/768/EEC.
Compulsory measures: Import rejected at border.
A12/0084/13 Germany Category: Chemical products Product: Tattoo Ink Brand: Tattoooo
Chemical The product poses a chemical risk because it contains 8 polycyclic aromatic hydrocarbons (PAH) (5.04 mg/kg), of which benzo[a]pyrene at a level of
Compulsory measures: Import rejected at border.
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Name: Baby blue Type/number of model: Unknown Batch number/Barcode: Unknown Description: Packaging: different plastic bottles 5ml with safety cap and adhesive label. Country of origin: China
0.10 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, polycyclic aromatic hydrocarbons may not exceed a certain concentration. The level of PAH detected in the sample exceeded the level of 0.5 ppm recommended in Resolution ResAP (2008) 1.
A12/0087/13 United Kingdom
Category: Cosmetics Product: Skin-lightening product Brand: Golden Pearl Name: Golden Pearl Beauty Cream Type/number of model: Unknown Batch number 79831 - Mfd. 06/06/2012 EXP.30/06/2014. Barcode: 9 240548 109914 Description: Yellow cardboard packaging containing whitening cream in a white plastic pot. Country of origin: Pakistan
Chemical The product poses a chemical risk because it contains a mercury compound (4750mg/kg) as a skin-lightening substance. The product does not comply with the Cosmetics Directive 76/768/EEC.
Voluntary measures: Withdrawal of the product from the market.
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A12/0088/13 United Kingdom
Category: Cosmetics Product: Skin-lightening product Brand: Shaheen Cosmetic Name: Face Fresh Beauty Cream Type/number of model: Unknown Batch number: No 1192 - MFG 1 3 12 EXP 1 3 14. Barcode: 1 41960 001908 Description: Yellow cardboard packaging containing whitening cream in a white plastic pot. Country of origin: Pakistan
Chemical The product poses a chemical risk because it contains a mercury compound (4620mg/kg) as a skin-lightening substance. The product does not comply with the Cosmetics Directive 76/768/EEC.
Voluntary measures: Withdrawal of the product from the market.
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A12/0089/13 United Kingdom
Category: Cosmetics Product: Skin-lightening product Brand: Mir Agencies (AK) Name: Fresh Look Ultra Whitening Fairness Cream Type/number of model: Unknown Batch number/Barcode: Unknown Description: Shiny Orange / Yellow cardboard packaging containing whitening cream in an orange plastic pot. Country of origin: Pakistan
Chemical The product poses a chemical risk because it contains a mercury compound (3500mg/kg) as a skin-lightening substance. The product does not comply with the Cosmetics Directive 76/768/EEC.
Voluntary measures: Withdrawal of the product from the market.
A12/0090/13 United Kingdom
Category: Cosmetics Product: Skin-lightening product Brand: CPHL Name: Seven Herbal Ubtan with Sun Screen Type/number of model: Unknown Batch number/Barcode: Unknown Description: Shiny Yellow cardboard packaging containing a yellow tube of whitening cream. Country of origin: Pakistan
Chemical The product poses a chemical risk because it contains a mercury compound (620 mg/kg) as a skin-lightening substance. The product does not comply with the Cosmetics Directive 76/768/EEC.
Voluntary measures: Withdrawal of the product from the market.
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A12/0091/13 United Kingdom
Category: Cosmetics Product: Skin-lightening product Brand: Raj Pharmacy Name: Raj Beauty Cream Type/number of model: Unknown Batch number/Barcode: Unknown Description: Sparkly orange cardboard packaging containing whitening cream in a pink plastic pot. Country of origin: Pakistan
Chemical The product poses a chemical risk because it contains a mercury compound (470mg/kg) as a skin-lightening substance. The product does not comply with the Cosmetics Directive 76/768/EEC.
Voluntary measures: Withdrawal of the product from the market.
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C/ CAMPEZO, 1 – EDIFICIO 8 28022 MADRID TEL: 91 822 54 90 FAX: 91 822 52 89
A12/0096/13 The Netherlan
ds
Category: Chemical products Product: Tattoo Ink Brand: Intenze Name: Unknown Type/number of model: Intenze sienna; dragon red; tangerine; banana cream and lime green Batch number/Barcode: INTENZE, tangerine, batch Y61W72045JMX40 lot ss85 exp 11/31/16 , INTENZE, dragon red, batch RD36Y61O45 lot ss85 exp 11/31/16 , INTENZE, banana cream, batch W66Y61O41IMX40 lot ss80 exp 06/30/16 , INTENZE, lime green, batch Y62W79G61IMX40 lot , INTENZE, sienna, batch W67Y61RX25 lot ss81 exp 07/31/16 Description: Transparent bottle of tattoo ink with an adhesive label and black top. Content 29.6 ml. Country of origin: United States
Chemical The product poses a chemical risk because it contains azo dyes releasing up to 1753 mg/kg of the aromatic amine o-anisidine which is a substance classified as carcinogenic, mutagenic and toxic. The presence of azo dyes is not compliant with Council of Europe Resolution "ResAP(2008)1 on requirements and criteria for the safety of tattoos and permanent make-up.
Compulsory measures: Withdrawal of the product from the market.
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C/ CAMPEZO, 1 – EDIFICIO 8 28022 MADRID TEL: 91 822 54 90 FAX: 91 822 52 89
A12/0097/13 Czech Republic
Category: Cosmetics Product: Lipstick Brand: Tmt Cosmetics Name: Lip Stick With Vitamin A.C.E Type/number of model: Shade of lipstick 03 Best before: 07.2012 Batch number/Barcode: 3760133128107 Description: The top part of the lipstick is transparent, the lower part is gold. On the bottom of the product there is a label indicating the manufacturer's name, shade 03 and nominal content 3.5 g NET WET. Country of origin: Unknown
Chemical The product poses a chemical risk because it contains 323 mg/kg of cadmium. Substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR) of category 1 and 2, such as cadmium and its compounds, are prohibited for use in cosmetic products. The product also contains 151 mg/kg of lead, which is classified as carcinogenic of category 1 and toxic for reproduction of category 2 The product does not comply with the Cosmetics Directive 76/768/EEC.
Compulsory measures: Withdrawal of the product from the market.
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C/ CAMPEZO, 1 – EDIFICIO 8 28022 MADRID TEL: 91 822 54 90 FAX: 91 822 52 89
A12/0121/13 Czech Republic
Category: Cosmetics Product: Baby wipes Brand: Freshmaker Name: Freshmaker kids, baby wet wipes, with lotion Type/number of model: PD: 03.2010 ED: 03.2013 Batch number/Barcode: 8697817871705 Description: Wet wipes (72 pcs) packed in a resealable package marked 'Alcohol Free, ph 5,5'. The package has a self-sealing, plastic, transparent, adhesive strip. Country of origin: Turkey
Chemical The product poses a chemical risk because it contains IPBC, Iodopropynyl butylcarbamate (CAS 55406-53-6). The product does not comply with the Cosmetics Directive 76/768/EEC.
Compulsory measures: Withdrawal of the product from the market.
A12/0122/13 Czech Republic
Category: Cosmetics Product: Baby wipes Brand: Freshmaker Name: Freshmaker Baby Wet Wipes, Wet Towels With Lotion, extra
Chemical The product poses a chemical risk because it contains IPBC, Iodopropynyl butylcarbamate (CAS 55406-53-6). The product does not comply with the Cosmetics Directive 76/768/EEC.
Compulsory measures: Withdrawal of the product from the market.
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C/ CAMPEZO, 1 – EDIFICIO 8 28022 MADRID TEL: 91 822 54 90 FAX: 91 822 52 89
Type/number of model: Version A: P: 11.2010 E: 11.2012 Version B: P: 10.2010 E: 10.2012 P: 03.2010 E: 03.2013 Batch number/Barcode: Version A: 8697817871408 , Version B: 8697817875543 Description: Wet wipes (72 pcs) packed in a resealable package made of orange plastic foil with pictures of strollers, baby bottles and teats. On the back of the product there is a label bearing the product's name in Czech, the inscription "strong, flexible wet wipes" and other graphic symbols. Country of origin: Turkey
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C/ CAMPEZO, 1 – EDIFICIO 8 28022 MADRID TEL: 91 822 54 90 FAX: 91 822 52 89
A12/0123/13 Czech Republic
Category: Cosmetics Product: Baby wipes Brand: Disney Name: Wipes DISNEY baby Soft Care Type/number of model: 07037.004 Batch number/Barcode:8690966014061 Description: DISNEY wet wipes (70 pcs) packed in a resealable package made of printed blue and green plastic foil. On the front of the product there are pictures of characters from the Winnie the Pooh stories and English inscriptions. On the back of the product there is glued white label stating the importer for the Czech and Slovak Republic. Country of origin: Turkey
Chemical The product poses a chemical risk because it contains IPBC, Iodopropynyl butylcarbamate (CAS 55406-53-6). The product does not comply with the Cosmetics Directive 76/768/EEC.
Compulsory measures: Withdrawal of the product from the market.
A12/0124/13 Czech Republic
Category: Cosmetics Product: Baby wipes Brand: bii Name: bii wipes With Cream Wet Towel KREMLI Type/number of model: ÜRT/22/12/2011, SKT/22/12/2013 Batch number/Barcode: Batch: PRT-OOO1, 07:06, 8699182380042
Chemical The product poses a chemical risk because it contains IPBC, Iodopropynyl butylcarbamate (CAS 55406-53-6). The product does not comply with the Cosmetics Directive 76/768/EEC.
Compulsory measures: Withdrawal of the product from the market.
CORREO ELECTRÓNICO [email protected] Pág. 23 de 37
C/ CAMPEZO, 1 – EDIFICIO 8 28022 MADRID TEL: 91 822 54 90 FAX: 91 822 52 89
Description: Wet wipes (72 pcs) packed in a resealable package made of pink plastic foil. On the back there are inscriptions in Czech “Soft, strong, flexible, wet baby wipes“, "Alcohol Free", etc. Country of origin: Turkey
A12/0125/13 Czech Republic
Category: Cosmetics Product: Baby Wipes Brand: bii Name: bii wipes Natural Wet Towel Type/number of model: ÜRT/21/12/2011 SKT/21/12/2013 Batch number/Barcode: batch: PRT-OOO1, 16:24, 8699182380011 Description: Wet wipes (72 pcs) packed in a resealable package made of green plastic foil. On the front of the product there is a picture of a teddy bear and English inscriptions. On the back there is also a description in Czech “ Soft, strong, flexible, wet baby wipes“, "Alcohol Free", etc. Country of origin: Turkey
Chemical The product poses a chemical risk because it contains IPBC, Iodopropynyl butylcarbamate (CAS 55406-53-6). The product does not comply with the Cosmetics Directive 76/768/EEC.
Compulsory measures: Withdrawal of the product from the market.
CORREO ELECTRÓNICO [email protected] Pág. 24 de 37
C/ CAMPEZO, 1 – EDIFICIO 8 28022 MADRID TEL: 91 822 54 90 FAX: 91 822 52 89
A12/0126/13 Czech Republic
Category: Cosmetics Product: Baby wipes Brand: nemdil Name: Baby Wet Towels with lotion, Deluxe Quality Type/number of model: P. NO: 085.2 PD: 07.12, ED: 07.15 Batch number/Barcode: 8697817872092 (on the closure) , 8697817872078 (on the back side of the packaging) Description: Wet wipes (72 pcs) packed in a resealable package made of cream coloured plastic foil. Country of origin: Turkey
Chemical The product poses a chemical risk because it contains IPBC, Iodopropynyl butylcarbamate (CAS 55406-53-6). The product does not comply with the Cosmetics Directive 76/768/EEC.
Compulsory measures: Withdrawal of the product from the market.
A12/0132/13 France Category: Cosmetics Product: Skin lightening product Brand: Bio Claire
Chemical The product poses a chemical risk because it contains corticosteroid, such as clobetasol
Compulsory measures: Withdrawal of the product from the market.
CORREO ELECTRÓNICO [email protected] Pág. 25 de 37
C/ CAMPEZO, 1 – EDIFICIO 8 28022 MADRID TEL: 91 822 54 90 FAX: 91 822 52 89
Name: Unknown Type/number of model: D113538 “L” P05/10 E05/13 Batch number/Barcode: Unknown Description: Skin lightening product packed in a white 30g tube inside a white cardboard box with navy blue print. Country of origin: Ivory Coast
propionate, which is prohibited by the Cosmetics Directive 76/768/EEC.
A12/0138/13 Czech Republic
Category: Cosmetics Product: Perfume Brand: Beautiful parfum Name: eau de parfum Diableu Type/number of model: Unknown Batch number/Barcode: 6937926316509 Description: Eau de toilette - glass bottle with a silver cap and a mechanical sprayer, filled with light turquoise liquid. Package - cardboard box wrapped in cellophane with claim Parfum oils made in France. Volume 55 ml, 1.9 fl.oz., 80% vol. On the front of the packaging, there is an inscription "Diableu". On the bottom of the glass bottle, the name of the product is indicated in Polish: Kamlen Duzy 4D POLSKA. The glass bottle is packed in a cardboard box with a cherub motif. The list of ingredients is incomplete
Chemical The product presents a chemical risk due to the presence of Safrole (2.9 mg/kg). The product does not comply with the Cosmetics Directive 76/768/EEC.
Compulsory measures: Withdrawal of the product from the market.
CORREO ELECTRÓNICO [email protected] Pág. 26 de 37
C/ CAMPEZO, 1 – EDIFICIO 8 28022 MADRID TEL: 91 822 54 90 FAX: 91 822 52 89
and some ingredients are indicated repeatedly in other languages. Best before: 04.2015 Open jar logo: 24M Country of origin: unknown
A12/0139/13 Slovenia Category: Chemical products Product: Tattoo ink Brand: Eternal luk Name: 3814 A Jungle green tattoo Type/number of model: Unknown Batch number/Barcode: Batch No. E46, Lot No. 087 Description: Tattoo ink 30 ml in original sealed bottle. Mfg. date 03/27/12; Use by: 03/27/15. Country of origin: Unknown
Chemical The product poses a chemical risk because it contains 21 ppb 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] Pág. 27 de 37
C/ CAMPEZO, 1 – EDIFICIO 8 28022 MADRID TEL: 91 822 54 90 FAX: 91 822 52 89
A12/0140/13 Slovenia Category: Chemical products Product: Tattoo ink Brand: Jet France Name: Violet rouge D 51 F Type/number of model: Disperjet Sterilizet Tattoo Dispersions Batch number/Barcode: Unknown Description: Tattoo ink in 30 ml original sealed bottle. Best before: 10-2013 Country of origin: France
Chemical The product poses a chemical risk because it contains up to 4900 mg/kg of nickel. According to the Council of Europe Resolution ResAP (2008)1, nickel levels in tattoo inks must be as low as technically achievable as nickel has a high allergenic potential. The application under the skin of tattoo inks containing nickel results in permanent contact with a sensitising allergen.
Voluntary measures: Withdrawal of the product from the market.
A12/0146/13 United Kingdom
Category: Cosmetics Product: Henna product Brand: Rani Kone Name: Black Henna
Chemical The product poses a chemical risk because it contains 2.25 % of Para phenylenediamine (PPD) which is classified as strongly sensitising. In addition, the labelling does not include the warnings
Compulsory measures: Seizure and destruction of the product.
CORREO ELECTRÓNICO [email protected] Pág. 28 de 37
C/ CAMPEZO, 1 – EDIFICIO 8 28022 MADRID TEL: 91 822 54 90 FAX: 91 822 52 89
Type/number of model: Unknown Batch number/Barcode: 6 281104 950147 Description: Henna paste for hand design. Foil bags in cardboard outer packaging (4bags of 10). Country of origin: Saudi Arabia
which should appear on products containing this substance. The product does not comply with the Cosmetics Directive 76/768/EEC.
A12/0147/13 United Kingdom
Category: Cosmetics Product: Hair dye Brand: Moon Star Name: Herbal Henna Type/number of model: Burgundy Batch number/Barcode: 01 Aug 2010, 8906003771041 Description: Hair dye supplied in foil bags in cardboard outer packaging. Country of origin: India
Chemical The product poses a chemical risk because it contains 12.3 % of Para phenylenediamine (PPD) which is classified as strongly sensitising. In addition the labelling does not include the warnings which should appear on products containing this substance. The product does not comply with the Cosmetics Directive 76/768/EEC.
Compulsory measures: Seizure and destruction of the product.
CORREO ELECTRÓNICO [email protected] Pág. 29 de 37
C/ CAMPEZO, 1 – EDIFICIO 8 28022 MADRID TEL: 91 822 54 90 FAX: 91 822 52 89
A12/0148/13 United Kingdom
Category: Cosmetics Product: Hair dye Brand: Moon Star Name: Herbal Henna Type/number of model: Copper Brown Batch number/Barcode: 01 Aug 2010, 8906003771058 Description: Hair dye supplied in foil bags in cardboard outer packaging. Country of origin: India
Chemical The product poses a chemical risk because it contains 8.7 % of Para phenylenediamine (PPD) which is classified as strongly sensitising. In addition the labelling does not include warnings which should appear on products containing this substance. The product does not comply with the Cosmetics Directive 76/768/EEC.
Compulsory measures: Seizure and destruction of the product.
CORREO ELECTRÓNICO [email protected] Pág. 30 de 37
C/ CAMPEZO, 1 – EDIFICIO 8 28022 MADRID TEL: 91 822 54 90 FAX: 91 822 52 89
A12/0169/13 Germany Category: Chemical products Product: Tattoo ink Brand: Black TM Name: Intenze Japaneze Black Sumi Product code: 841283, Ref. No: 220212D17001, Exp.: 04/30/2017 Batch number: BK 72IMX40, Description: Black plastic bottle with printed adhesive label: “Intenze Japaneze Black Sumi”. Country of origin: Unknown
Chemical The product poses a chemical risk because it contains 60.1 ppm polycyclic aromatic hydrocarbons (PAH). 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 PAH may not exceed 0.5 ppm.
Voluntary measures: Destruction of the product.
A12/0170/13 Germany Category: Chemical products Product: Tattoo ink Brand: Eternal Ink Name: Eternal Ink Nuclear Green Type/number of model: MHD 01/15 Batch number/Barcode: #E39, Lot #024 Description: Packaging: plastic bottle with application nozzle. Appearance: neon green tattoo ink. Consistency: viscous. Odour: alcoholic. Country of origin: United States
Chemical The product poses a chemical risk because it contains the aromatic amine o-Toluidine (120mg/kg) which is carcinogenic.
Voluntary measures: Withdrawal of the product from the market and destruction of the products.
CORREO ELECTRÓNICO [email protected] Pág. 31 de 37
C/ CAMPEZO, 1 – EDIFICIO 8 28022 MADRID TEL: 91 822 54 90 FAX: 91 822 52 89
A12/0177/13 Germany Category: Chemical products Product: Tattoo ink Brand: Ri-soft Colors Name: Profi Colors Brown Black Eyebrow / Eyeliner Type/number of model: Manufacturing code 1202026111221; date of manufacture: February 2012 Batch number/Barcode: Unknown Description: Folding white cardboard box containing a product information leaflet; milky-white plastic bottle with a white hinged click-shut lid and dosage aperture; adhesive label; 10 ml. Country of origin: Germany
Chemical The product poses a chemical risk because it contains 72 +/- 10 mg/kg of nickel. According to the Council of Europe Resolution ResAP (2008) 1, nickel levels in tattoo inks and permanent make-up must be as low as technically achievable as nickel has a high allergenic potential. The application under the skin of tattoo inks containing nickel results in permanent contact with a sensitising allergen. Also the product does not comply with the relevant National Standard.
Voluntary measures: Withdrawal of the product from the market. Compulsory measures: Ban on the marketing of the product and any accompanying measures.
CORREO ELECTRÓNICO [email protected] Pág. 32 de 37
C/ CAMPEZO, 1 – EDIFICIO 8 28022 MADRID TEL: 91 822 54 90 FAX: 91 822 52 89
A12/0230/13 United Kingdom
Category: Cosmetics Product: Teeth whitening pen Brand: Pro-White Name: Professional Teeth Whitening Type/number of model: Unknown Batch number/Barcode: Production Date: 31st July 2012. Expiry Date 31st July 2014 Description: Teeth whitening pen in the form of a cylindrical, purple coloured stick with a silver base and cap covering a brush applicator. The item is contained within a purple coloured cardboard pack displaying the product name, ingredients, usage instructions and company address in white print. Country of origin: United Kingdom
Chemical The product poses a chemical risk because it contains 12 % hydrogen peroxide thus exceeding the permitted level. The product does not comply with the Cosmetics Directive 76/768/EEC.
Voluntary measures: Withdrawal of the product from the market.
A12/0252/13 Slovakia Category: Cosmetics Product: Eye/Lip Liner Brand: Ua Te Long Name: Eye/Lip Liner Pencil Type/number of model: Item No. 39029675B288, MFD: 12-2010, EXP: 12-2013 Batch number/Barcode: 8592548296752 Description: Eye/lip liner pencil, black/pink. Each end is covered by a transparent plastic cap. Country of origin: China
Chemical The products pose a chemical risk because the pink colour contains 173.1 mg/kg of lead and the black colour contains 2.49 mg/kg. The product does not comply with the Cosmetics Directive 76/768/EEC.
Compulsory measures: Ban on the marketing of the product and any accompanying measures.
CORREO ELECTRÓNICO [email protected] Pág. 33 de 37
C/ CAMPEZO, 1 – EDIFICIO 8 28022 MADRID TEL: 91 822 54 90 FAX: 91 822 52 89
A12/0260/13 Slovakia Category: Cosmetics Product: Baby wet wipes Brand: Freshmaker kids Name: Baby wet wipes with lotion Type/number of model: PD:04.2011, ED:04.2013 Batch number/Barcode: 8697817871705 Description: 3 types of baby wet wipes with lotion contained in packaging with pictures of: 1) girl in pink clothing, 2) Snow White and the seven dwarfs, 3) Teddy bears. Original packages contain 72 pieces of baby wet wipes; the self-sealing packs are with or without clips. Country of origin: Turkey
Chemical The products pose a chemical risk because they contain IPBC, Iodopropynyl butylcarbamate (CAS 55406-53-6). The product does not comply with the Cosmetics Directive 76/768/EEC.
Voluntary measures: Withdrawal of the product from the market. Compulsory measures: Ban on the marketing of the product and any accompanying measures.
CORREO ELECTRÓNICO [email protected] Pág. 34 de 37
C/ CAMPEZO, 1 – EDIFICIO 8 28022 MADRID TEL: 91 822 54 90 FAX: 91 822 52 89
CORREO ELECTRÓNICO [email protected] Pág. 35 de 37
C/ CAMPEZO, 1 – EDIFICIO 8 28022 MADRID TEL: 91 822 54 90 FAX: 91 822 52 89
A12/0266/13 Austria Category: Cosmetics Product: Skin cream Brand: Unknown Name: Kartoffel "Erdäpfel" Spezial Crème - special potato cream. Type/number of model: Unknown Batch number/Bar code: 2208 Description: White plastic pot. Country of origin: Germany
Microbiological The product poses a microbiological risk because it contains a high level of Pseudomonas aeruginosa (up to 13 000 kbE/g). The product also contains an aerobic mesophilic bacteria count in a level higher than the guidance value of 1 000 kbE/g and a high level of enterobacteria. The product does not comply with the Cosmetics Directive 76/768/EEC.
Voluntary measures: Warning consumers of the risks.
A12/0270/13 Czech Republic
Category: Cosmetics Product: Antibacterial wet wipes Brand: gala Name: 1. Hypnotic Attraction 2. Modern Charisma 3. Mysterious Attitude Type/number of model: Unknown Batch number/Barcode: 3. Mysterious Attitude DAM 5528 EAN: 5944508125528, 2. Modern Charisma DAM 5542 5944508125542 , 1. Hypnotic Attraction DAM 5535, 5944508125535 Description: Wet wipes wrapped in a resealable package with a black coloured plastic strip marked with the brand name and a design with coloured leaves: DAM 5535-red, DAM 5542-green and DAM 5528-silver. The back of the product is marked with the
Chemical The product presents a chemical risk due to the presence of Iodopropynyl butylcarbamate (IPBC), which is banned in products intended for children under 3 years of age. The product does not comply with the Cosmetics Directive 76/768/EEC.
Compulsory measures: Withdrawal of the product from the market.
CORREO ELECTRÓNICO [email protected] Pág. 36 de 37
C/ CAMPEZO, 1 – EDIFICIO 8 28022 MADRID TEL: 91 822 54 90 FAX: 91 822 52 89
address of the manufacturer, EAN, ingredients, pictures showing how to use the product, graphic symbols, etc. Country of origin: Romania
A12/0271/13 Czech Republic
Category: Cosmetics Product: Antibacterial wet wipes Brand: gala Name: 1. parfum de Capsuni 2. parfum de Mar Verde Type/number of model: Unknown Batch number/Barcode: 1. parfum de Capsuni DAM 5184, 5944508125184 , 2. parfum de Mar Verde DAM 5177, 5944508125177 Description: Wet wipes wrapped in a resealable package with a red or green coloured plastic strip with a picture of a strawberry (DAM 5184) or an apple (DAM 5177). The back of the product is
Chemical The product presents a chemical risk due to the presence of Iodopropynyl butylcarbamate (IPBC), which is banned in products intended for children under 3 years of age. The product does not comply with the Cosmetics Directive 76/768/EEC.
Compulsory measures: Withdrawal of the product from the market.
CORREO ELECTRÓNICO [email protected] Pág. 37 de 37
C/ CAMPEZO, 1 – EDIFICIO 8 28022 MADRID TEL: 91 822 54 90 FAX: 91 822 52 89
marked with the address of the manufacturer, barcode, ingredients, pictures showing how to use the product, graphic symbols, etc. Country of origin: Romania
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