anexo i: relacin de productos de los que no se ha ...+201… · whitening fairness cream...

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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




Anexo II / 221

CM-026/2013





RAPEX Denominación



AEMPS

UE-A12-0089/13

MIR Agencies (AK) Fresh Look Ultra Whitening Fairness Cream


Umma Halal Reino Unido


Anexo II / 221

CM-027/2013

UE-A12-0090/13

CPHL Seven Herbal Ubtan With Sun Screen


Thara Stores Reino Unido


Anexo II / 221

CM-028/2013

UE-A12-0091/13

Raj Pharmacy Raj Beauty Cream




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





RAPEX Denominación



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


Fulya Kozmetik. Turquia


Anexo VI / 56

CM-043/2013





RAPEX Denominación



AEMPS

UE-A12-0123/13

DISNEY Wipes Baby Soft Care


Desconocido Turquia


Anexo VI / 56

CM-044/2013

UE-A12-0124/13

Bii Wipes With Cream Wet Towel KREMLI


Taha Kimya Kozmetik Turquia


Anexo VI / 56

CM-045/2013

UE-A12-0125/13

Bii Wipes Natural Wet Towel


Taha Kimya Kozmetik Turquia


Anexo VI / 56

CM-046/2013





RAPEX Denominación



AEMPS

UE-A12-0126/13

Nemdil Baby Wet Towels With Lotion, Deluxe Quality


Fulya Kozmetik Turquia


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





RAPEX Denominación



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


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


Anexo III / 8b No incluye las advertencias obligatorias

CM-054/2013





RAPEX Denominación



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





RAPEX Denominación



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


Ful Kozmetik Turquia


Anexo VI / 56

CM-138/2013





RAPEX Denominación



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



ANEXO II: Relación de productos de los que se ha encontrado IETM, la AEMPS ha realizado actuaciones.


RAPEX Denominación


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



ANEXO III: Relación de productos de los que no se ha encontrado IETM, la AEMPS ha realizado actuaciones.


RAPEX Denominación


Responsable


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



ANEXO IV: Notificación sólo para información (no se reflejan en la lista del Anexo V).


RAPEX Denominación


Responsable


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



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.



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.




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






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




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.





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





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.



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.





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.



Category: Cosmetics Product: Baby wipes Brand: Freshmaker Name: Freshmaker Baby Wet Wipes, Wet Towels With Lotion, extra





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




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




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





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


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






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



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




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.


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.




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.




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.



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.



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.


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.





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.




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.



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.




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.


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.



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.



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.


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.




address of the manufacturer, EAN, ingredients, pictures showing how to use the product, graphic symbols, etc. Country of origin: Romania


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.




marked with the address of the manufacturer, barcode, ingredients, pictures showing how to use the product, graphic symbols, etc. Country of origin: Romania

anexo i: relacin de productos de los que no se ha ...+201… · whitening fairness cream...

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