ANEXO I: Relacin de productos no notificados al CPNP, o que no … · 820 mg/Kg de Mercurio Anexo...

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ANEXO I: Relación de productos no notificados al CPNP, o que no están registrados en esta Agencia (en el caso de productos de higiene personal). La AEMPS no ha realizado actuaciones.

Número de notificación

RAPEX Denominación

Producto Finalidad Producto

Responsable Producto Tipo Incumplimiento Código

AEMPS

UE-A12-0603/13

Coppola Keratin Complex Repair Therapy- Intense RX

Cosméticos para el cabello

European Beauty Distribution S.r.L. Italia

Presencia de sustancia regulada en condiciones distintas de las establecidas: 0,8 % de Formaldehído (producto 1) 0,5 % de Formaldehído (producto 2)

CM-435/2013

UE-A12-0657/13 Plastica Dos Fios Selagem Termica


B Team S.r.L. Italia

Presencia de sustancia regulada en condiciones distintas de las establecidas: 7,7 % de Formaldehído total 7,4 % de Formaldehído libre

CM-455/2013





RAPEX Denominación



AEMPS

UE-A12-0670/13

Whitesmile Home whitening 35% Carbamide Peroxide

Blanqueante dental

Whitesmile GmbH Alemania

Presencia de sustancias reguladas en condiciones distintas de las establecidas: hasta 13,2 % de Peróxido de hidrógeno

CM-466/2013

UE-A12-0683/13

Inecto Superblack - guaranteed permanent hair colour creme


Mahd Bélgica

Presencia de sustancia prohibida en productos cosméticos: m-Fenilendiamina

Anexo II / 1204

CM-468/2013

UE-A12-0684/13 Electric Ink 4011 Light Brown

Productos de estética: Tintas para tatuaje

Magic Moon Tattoing GmbH Alemania

Riesgo químico de acuerdo a la resolución ResAP(2008)1 del Consejo de Europa: 710 µg/Kg de 3,3'-Diclorobencidina

CM-469/2013





RAPEX Denominación



AEMPS

UE-A12-0704/13

Paul Mitchell XG Processing Cream


Mitchell Europe SRL Unip Italia

Se han detectado casos de intolerancia y de alergias a este producto en relación a la introducción de nuevas fragancias.

CM-472/2013

UE-A12-0724/13 Dragonhawk Tattoo ink


Jochen Hirsch GmbH Alemania

Riesgo químico de acuerdo a la resolución ResAP(2008)1 del Consejo de Europa: 1577 mg/Kg de 4-metil-m-fenilendiamina

CM-473/2013

UE-A12-0725/13 Classical Tattoo ink Red (Peach)


Simone Firsch GmbH Alemania

Riesgo químico de acuerdo a la resolución ResAP(2008)1 del Consejo de Europa: 1331 mg/Kg de 4-metil-m-fenilendiamina

CM-474/2013





RAPEX Denominación



AEMPS

UE-A12-0777/13

Larissa Lait de Beaute Carotte

Cosmético: Blanqueante para la piel

Desconocido

Presencia de sustancia prohibida: Hidroquinona

Anexo II / 1339

CM-480/2013

UE-A12-0778/13

Clairmen Lightening Program For Men- Cream Formula

Cosmético: Blanqueante para la piel

Desconocido

Presencia de sustancia prohibida: Hidroquinona

Anexo II / 1339

CM-481/2013

UE-A12-0779/13

Lulanjina Skin lightening product

Cosmético para el cuidado de la cara

Desconocido

Presencia de sustancia prohibida: 24000 mg/Kg de Mercurio

Anexo II / 221

CM-482/2013

UE-A12-0780/13

E`Yôute Whitening spot removing cream


Desconocido


Anexo II / 221

CM-483/2013





RAPEX Denominación



AEMPS

UE-A12-0782/13

Speckle Doctor White Skin Care - Skin Magic Power Instauration


Desconocido


Anexo II / 221

CM-484/2013

UE-A12-0789/13

Yimei Whitening spot-removing suit


Durdur Shop Noruega


Anexo II / 221

CM-485/2013

UE-A12-0790/13

Universal Black Sumi Black

Productos de estética: Tinta para tatuaje

I Max International S.r.l. Italia

Riesgo químico de acuerdo a la resolución ResAP(2008)1 del Consejo de Europa: 1151 µg/kg de Hidrocarburos aromáticos, policíclicos (PAH)

CM-486/2013





RAPEX Denominación



AEMPS

UE-A12-0801/13

Orient Pearl Whitening pearl beauty & spot removing suite


Garihaween Noruega


Anexo II / 221

CM-509/2013

UE-A12-0807/13

Paint Glow Products Neon Body Paint

Cosmético: Pigmentos no permanentes

Dance Factory Ltd t/a Extreme FX Reino Unido

Contaminación microbiológica: Pseudomonas aeruginosa

(1,5 x 104 ufc/g)

CM-510/2013

UE-A12-0811/13

E`Yôuth Skin-lightening product

Cosmético para el cuidado y la limpieza de la piel

Durdur Shop Noruega


Anexo II / 221

CM-511/2013

UE-A12-0812/13

CPHL Seven Herbal Wrinkle De Crease

Cosmético: Crema antiedad

Garihaween Noruega

Presencia de sustancia prohibida:

820 mg/Kg de Mercurio Anexo II / 221

CM-512/2013





RAPEX Denominación



AEMPS Eternal ink Tangerine

CM-539/2013

Eternal ink Lime Green

CM-540/2013 UE-A12-0826/13

Eternal ink Old Orchid


Tattoosafe/TS Trading B.V. Holanda

Riesgo químico de acuerdo a la resolución ResAP(2008)1 del Consejo de Europa: Poseen las aminas aromáticas: o-toluidina 5-nitro-o-toluidina

CM-541/2013

UE-A12-0867/13

Traditionelle Bierkosmetik Bierbad

Cosmético: Aceite de baño

Bohemia Cosmetics República Checa

El producto puede confundirse con un alimento y posee un alto riesgo si se ingiere por qué contiene alta concentración de surfactantes

CM-535/2013

UE-A12-0874/13

Silverback Tattoo ink


Tattoo Goods Alemania

Riesgo químico de acuerdo a la resolución ResAP(2008)1 del Consejo de Europa: 25,03 mg/kg de Hidrocarburos aromáticos, policíclicos (PAH)

CM-542/2013





RAPEX Denominación



AEMPS

Eternal ink Bright orange

CM-543/2013

UE-A12-0903/13

Eternal ink Caramel


Lev. Medische Groothandel V.O.F Holanda

Riesgo químico de acuerdo a la resolución ResAP(2008)1 del Consejo de Europa: Poseen las aminas aromáticas: 156 mg/kg de o-toluidina 135 mg/kg de 2,4-toluenediamina 972 mg/kg de o-anisidina

CM-544/2013

UE-A12-0908/13

Alla Prima Prima Black


Tattoo Goods Alemania

Riesgo químico de acuerdo a la resolución ResAP(2008)1 del Consejo de Europa: 2,2 mg/kg de Hidrocarburos aromáticos, policíclicos (PAH)

CM-545/2013

UE-A12-0943/13

Biotek Bioprogram Newgex


Biotek srl Italia

Presencia de sustancias reguladas en condiciones distintas de las establecidas: 1% de Cetrimida

CM-572/2013



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


RAPEX Denominación


Responsable

Producto Tipo Incumplimiento Código AEMPS

Respuesta a las actuaciones de la

AEMPS

UE-A12-0631/13 BioNaza Cosmetics KeraVino Premiere Brazilian Keratin System

CM-441-2013

UE-A12-0632/13

BioNaza Cosmetics Diamond Premiere Brazilian Keratin System

CM-442-2013

UE-A12-0636/13 BioNaza Cosmetics Choco Hair Brazilian Keratin Chocolate

CM-443-2013

UE-A12-0672/13 BioNaza Cosmetics KeraHair Premiere Brazilian Keratin System


Ferrer & Winter Import S.L. C/ Diego de León 29-2ªdcha 28006 Madrid

Presencia de sustancia regulada en condiciones distintas de las establecidas: Más del 0,2% de Formaldehído libre

CM-467-2013

El responsable ha informado que los productos que se comercializan en España son de lotes diferentes a los notificados en el Rapex. A solicitud de la AEMPS la empresa ha enviado un análisis del contenido de formaldehído libre para cada uno de estos productos en el que se indica que todos ellos están muy por debajo del 0,2% permitido.



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


RAPEX Denominación


Responsable


Respuesta a las actuaciones de la

AEMPS

UE-A12-0637/13 Pazzini Spazzola Progressiva Fluido Gel Extra


Pluinca S.L. C/ Beato Diego de Cádiz 8-10 03009 Alicante

Presencia de sustancia regulada en condiciones distintas de las establecidas: 1,4 % de Formaldehído total 1,3 % de Formaldehído libre

CM-444-2013

El responsable ha informado que el producto no se comercializa en España



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


RAPEX Denominación


Responsable


INFO-0106/13 Tattoo Ink Lining black Productos de estética: Tintas para tatuaje

Micky Sharpz Supplies LTD Reino Unido

Riesgo químico de acuerdo a la resolución ResAP(2008)1 del Consejo de Europa: 79 µg/Kg de a-Benzopireno

CM-436/2013

A11/0036/13 SC Johnson Nixoderm Cosméticos para el cuidado de la piel

Haz Afro Cosmetics Ltd Reino Unido

Presencia de sustancias reguladas en condiciones distintas de las establecidas: 6,0 % de Acido benzoico 2,5 % de Acido salicílico

CM-456/2013

INFO-0115/13 Teeth Whitenning Gel (pen) Type TT-P01 Blanqueante dental

Royalestic OU Estonia

Presencia de sustancias reguladas en condiciones distintas de las establecidas: 10,0 % de Peróxido de carbamida

CM-457/2013



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


RAPEX Denominación


Responsable


A11/0045/13 Black Rose Kali Mehaude


S.K. Mathon B.V. Holanda

Presencia de sustancias reguladas en condiciones distintas de las establecidas: 0,9 ±,0,5 % de p-Fenilendiamina

CM-513/2013

INFO-0148/13

Ultradent Products Teth Whitening set “Opalescemce – Tooth Whitening System”

Blanqueante dental

U.P. Dental GmbH Alemania

Por la concentración de H2O2 presente en el producto no puede utilizarse en menores de 18 años

CM-514/2013

INFO-0149/13 Eternal Ink triple Black ” Productos de estética: Tintas para tatuaje

Units 2-4 Parliament Business Centre Reino Unido

Riesgo químico de acuerdo a la resolución ResAP(2008)1 del Consejo de Europa: 5,6 mg/Kg de Hidrocarburos aromáticos, policíclicos (PAH)

CM-546/2013



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


RAPEX Denominación


Responsable


INFO/0173/13 Kuro Sumi Tattoo Outlining Ink


Fine Line Tattoo & Piercing Alemania

Riesgo químico de acuerdo a la resolución ResAP(2008)1 del Consejo de Europa: 2,7 mg/Kg de Hidrocarburos aromáticos, policíclicos (PAH)

CM-578/2013



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

A12/0603/13 Italy Category: Cosmetics Product: Hair treatment products Brand: Coppola Name: Keratin Complex Repair Therapy – Intense RX Type/number of model: Ionic keratin protein restructuring serum Batch number/Barcode: 1. 9492248912 (50ml) – 2. 9492249984 (473ml) OECD Portal Category: 53000000 - Beauty / Personal Care / Hygiene Description: The product is sold in two formats: 1. Rigid, metal-coloured 50 ml bottle with pump cap and dispenser. The liquid is clear with a fruity scent. Enclosed in a black box with fluorescent pink and white lettering; 2. Black plastic 473 ml bottle with pump cap. Country of origin: Brazil

Chemical The product poses a chemical risk due to the presence of 0.8% (product 1) and 0.5% (product 2) free and liberated formaldehyde, above the permitted levels. The product does not comply with the Cosmetics Directive 76/768/EEC.

Compulsory measures: Withdrawal of the product from the market



A12/0631/13 Italy Category: Cosmetics Product: Hair treatment products Brand: BioNaza Cosmetics Name: KeraVino – Premiere Brazilian Keratin System Type/number of model: Unknown Batch number/Barcode: 1. 5248700201 (236 ml) , 2. 5248700213 (473 ml), 3. 5248700207 (976 ml) OECD Portal Category: 53000000 - Beauty / Personal Care / Hygiene Description: The product is sold in three formats: 1. plastic bottle with pump cap (236 ml); 2. plastic bottle with pump cap (473 ml); 3. plastic bottle with screw cap and brown label (976 ml). Country of origin: Brazil

Chemical The products pose a chemical risk because they contain 0.9% (Product 1.), 1.7% (Product 2.) and 1.5% (Product 3.) of free and liberated formaldehyde and 0.9% (Product 1.), 1.7% (Product 2.) and 1.6% (Product 3.) of free formaldehyde, above the permitted levels (0.2%). The products do not comply with the Cosmetics Directive.


A12/0632/13 Italy Category: Cosmetics Product: Hair treatment products Brand: BioNaza Cosmetics Name: Diamond – Premiere Brazilian Keratin System Type/number of model: Unknown Batch number/Barcode: 1. 5248700224 (119 ml), 2. 5248700211 (236 ml),

Chemical The products pose a chemical risk because they contain 1.3% (Product 1. and 3.), 1.0% (Product 2. and 4.) of free and liberated formaldehyde, and 1.7% (Product 1.), 1.0% (Product 2. and 4.), 0.8% (Product 3.) free formaldehyde, above the permitted levels (0.2%). The products do not comply with the Cosmetics Directive.




3. 3600029145 (354 ml), 4. 5248700220 (946 ml) OECD Portal Category: 53000000 - Beauty / Personal Care / Hygiene Description: The product is sold in four formats: 1. plastic bottle with spray cap and black label (119 ml); 2. plastic bottle with pump cap (236 ml); 3. plastic bottle with pump cap (354 ml); 4. plastic bottle with screw cap and black label (946 ml). Country of origin: Brazil

A12/0636/13 Italy Category: Cosmetics Product: Hair treatment products Brand: BioNaza Cosmetics Name: Choco Hair – Brazilian Keratin Chocolate Type/number of model: Unknown Batch number/Barcode: 5248700206 OECD Portal Category: 53000000 - Beauty / Personal Care / Hygiene Description: The product is sold in four formats: 1. plastic screw-cap bottle, brown label, spray (119 ml); 2. plastic screw-cap bottle, brown label (473 ml); 3. plastic screw-cap bottle, brown label (946 ml). Country of origin: Brazil

Chemical The products pose a chemical risk because they contain 1.8% (Product 1. and 2.), 1.4% (Product 3.) of free and liberated formaldehyde and 1.7% (Product 1.), 1.4% (Product 2.) and 1.2% (Product 3.) of free formaldehyde, above the permitted levels (0.2%). The products do not comply with the Cosmetics Directive.




A12/0637/13 Italy Category: Cosmetics Product: Hair treatment product Brand: PAZZINI Spazzola progressiva Name: Fluido Gel Extra Type/number of model: Unknown Batch number/Barcode: 8010820012376 OECD Portal Category: 53000000 - Beauty / Personal Care / Hygiene Description: Grey plastic bottle with screw cap (1 000 ml). Country of origin: Brazil

Chemical The product poses a chemical risk because it contains 1.4% of free and liberated formaldehyde and 1.3 % of free formaldehyde, both above the permitted levels of 0.2%. The product does not comply with the Cosmetics Directive.


A12/0657/13 Italy Category: Cosmetics Product: Hair treatment product Brand: Plastica Dos Fios Name: Selagem Termica Type/number of model: Unknown Batch number/Barcode: 7898927206871 OECD Portal Category: 53000000 -

Chemical The product poses a chemical risk because it contains 7.7% free and liberated formaldehyde and 7.4% free formaldehyde, above the permitted levels (0.2%). The product does not comply with the Cosmetics Directive.




Beauty / Personal Care / Hygiene Description: Pink plastic bottle with a screw cap (1000 ml). Country of origin: Brazil

A12/0670/13 Germany Category: Cosmetics Product: Teeth whitening product Brand: Whitesmile Name: Home whitening 35% Carbamide Peroxide Type/number of model: Unknown Batch number/Barcode: Batch 12070 OECD Portal Category: 53000000 - Beauty / Personal Care / Hygiene Description: Colourless teeth whitening gel with air bubbles. It has a light, fresh and aromatic fragrance. The composition shown on the packaging is 35% carbamide peroxide, and ~12.2% hydrogen peroxide.The product comes in a transparent plastic syringe with black application tip in white and blue collapsible box. Country of origin: Germany

Chemical The product poses a chemical risk because it contains up to 13,2 % of hydrogen peroxide, which exceeds the permitted level. 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



A12/0672/13 Italy Category: Cosmetics Product: Hair treatment product Brand: BioNaza Cosmetics Name: KeraHair – Premiere Brazilian Keratin System Type/number of model: Unknown Batch number/Barcode: 1. 5248700202 (946 ml), 2. 5248700210 (473 ml), 3. 5248700201 (236 ml), 4. Unknown (119 ml) OECD Portal Category: 53000000 - Beauty / Personal Care / Hygiene Description: The product is sold in four formats: 1. plastic bottle with screw cap and blue label (946 ml); 2. plastic bottle with screw cap and blue label (473 ml); 3. plastic bottle with pump cap (236 ml); 4. plastic bottle with spray cap and blue label (119 ml). Country of origin: Brazil

Chemical The products pose a chemical risk because they contain 2.3% (Product 1.), 2.4% (Product 2.), 0.7% (Product 3.) and 2.6% (Product 4.) of free and liberated formaldehyde and 2.5% (Product 1. and 2.), 0.9% (Product 3.) and 2.5% (Product 4.) of free formaldehyde, above the permitted level (0.2%). The products do not comply with the Cosmetics Directive.


A12/0683/13 Belgium Category: Cosmetics Product: Hair dye Brand: Inecto Name: Superblack - guaranteed permanent hair colour creme - 28ml Type/number of model: 1/32633 BB 01 2015

Chemical The product poses a chemical risk because, according to the label, it contains m-phenylenediamine which is classified as strongly sensitising, and must not be present in hair dyes. The product does not comply with the Cosmetics Directive 76/768/EEC.




Batch number/Barcode: 6002058000036 OECD Portal Category: 53000000 - Beauty / Personal Care / Hygiene Description: Black hair dye consisting of a 28 ml tube with hair colour creme and a 23 ml brown bottle with solution. The product, which is packed in a black cardboard box with white and pale orange lettering, includes plastic gloves and a leaflet with instructions in English, French and Portuguese. Country of origin: South Africa

A12/0684/13 Germany Category: Chemical products Product: Tattoo ink Brand: Electric Ink Name: 4011 Light Brown Type/number of model: Article No 401130 Batch number/Barcode: Batch: 2161 OECD Portal Category: 53000000 - Beauty / Personal Care / Hygiene Description: Opaque brown liquid in small brown bottle with colour printing. Country of origin: Brazil

Chemical The product poses a chemical risk because it contains a concentration of 710 mg/kg of 3.3'-d-dichlorobenzidine (aromatic amine). According to the Council of Europe Resolution ResAP (2008)1 on requirements and criteria for the safety of tattoos and permanent make-up, aromatic amines such as 3.3'-d-dichlorobenzidine should not be present in tattoo ink.

Voluntary measures: Withdrawal of the product from the market



A12/0704/13 Germany Category: Cosmetics Product: Hair traitment product Brand: Paul Mitchell Name: XG Processing Cream Type/number of model: XG Processing Cream 5 Volume 1.5 % 1000 ml; XG Processing Cream 10 Volume 3.0 % 1000 ml; XG Processing Cream 20 Volume 6.0 % 1000 ml; XG Processing Cream 30 Volume 9.0 % 1000 ml; XG Processing Cream 40 Volume 12.0 % 1000 ml Batch number/Barcode: Unknown OECD Portal Category: 53000000 - Beauty/Personal Care/Hygiene Description: Hair traitment product in white plastic bottles with coloured labelling. Country of origin: Italy

Chemical The products pose a chemical risk because intolerance and alergic reactions have arisen in connection with the introduction of new fragrances. Cases of intolerance and allergic reactions reported. The product does not comply with the Cosmetics Directive 76/768/EEC.

Voluntary measures: Warning consumers of the risks

A12/0724/13 Germany Category: Chemical products Product: Tattoo ink Brand: Dragonhawk Tattoo Name: Unknown Type/number of model: 1. True Magenta 2. Dark Red Batch number/Barcode: Unknown OECD Portal Category: 53000000 - Beauty / Personal Care / Hygiene Description: Tattoo ink in a 1/4 oz. plastic bottle with dropper and protective caps.

Chemical The product poses a chemical risk because it contains up to 1577 mg/kg of 4-methyl-m-phenylendiamine. According to the Council of Europe Resolution ResAP (2008) on requirements and criteria for the safety of tattoos and permanent make-up, the aromatic amines as 4-methyl-m-phenylendiamine with carcinogenic effects, should neither be present in tattoos and PMU products nor released from azo-colorants.

Compulsory measures: Import rejected at border



Country of origin: China

A12/0725/13 Germany Category: Chemical products Product: Tattoo ink Brand: Classical Tattoo Name: Unknown Type/number of model: Red (Peach), 5 ml Batch number/Barcode: Unknown OECD Portal Category: 53000000 - Beauty / Personal Care / Hygiene Description: Tattoo ink in a opaque transparent plastic bottle with attached lid and spray nozzle with cap. Country of origin: China

Chemical The product poses a chemical risk because it contains up to 1331 mg/kg of 4-methyl-m-phenylendiamine. According to the Council of Europe Resolution ResAP (2008) on requirements and criteria for the safety of tattoos and permanent make-up, the aromatic amines as 4-methyl-m-phenylendiamine with carcinogenic effects, should neither be present in tattoos and PMU products nor released from azo-colorants.


A12/0777/13 Portugal Category: Cosmetics Product: Body milk Brand: Larissa Name: Lait de Beaute Carotte Type/number of model: Action rapide Batch number/Barcode: Unknown OECD Portal Category: 53000000 -

Chemical The product poses a chemical risk because it contains the ingredient hydroquinone (1,4-dihydroxy benzene), the use of which is prohibited in cosmetics and personal hygiene products. The product does not comply with the Cosmetics Directive 76/768/EEC.




Beauty / Personal Care / Hygiene Description: Moisturizing body milk in an orange plastic bottle with gold, green, white and black characters and orange cap. Volume 250 ml. Country of origin: Ivory Coast

A12/0778/13 Portugal Category: Cosmetics Product: Skin lightening product Brand: Clairmen Name: Lightening Program For Men- Cream Formula Type/number of model: Unknown Batch number/Barcode: Unknown OECD Portal Category: 53000000 - Beauty / Personal Care / Hygiene Description: Cream in a plastic container of 300 ml with a black cap. The labelling on the back part bears the list of ingredients and the indications " Contains Hydroquinone. Keep out of reach of children. Do not expose yourself to sunshine. Product colour change does not affect product quality in any way" in French and English. Country of origin: Democratic Republic Of Congo

Chemical The product poses a chemical risk because it contains the ingredient 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.




A12/0779/13 Norway Category: Cosmetics Product: Skin lightening product Brand: Lulanjina Name: Unknown Type/number of model: Unknown Batch number/Barcode: Barcode: 69362177100256 Batch: AE0622A06 OECD Portal Category: 53000000 - Beauty / Personal Care / Hygiene Description: The product is packed in a red cardboard box with a picture of a Chinese woman and print in Chinese. Country of origin: China

Chemical The product poses a chemical risk because it contains a mercury compound (24000 mg/kg) as a skin-lightening substance. The product does not comply with the Cosmetics Directive 76/768/EEC.


A12/0780/13 Norway Category: Cosmetics Product: Skin lightening product Brand: E`Yôute Name: Whitening spot removing cream Type/number of model: Unknown Batch number/Barcode: 6932511250213 OECD Portal Category: 53000000 -





Beauty / Personal Care / Hygiene Description: Whitening spot removing cream packed in a red cardboard box with a picture of a woman's face. Country of origin: China

A12/0782/13 Norway Category: Cosmetics Product: Skin lightening product Brand: Speckle Doctor Name: White Skin Care - Skin Magic Power Instauration Type/number of model: Unknown Batch number/Barcode: Batch number: CM1183 OECD Portal Category: 75000000 - Household / Office Furniture / Furnishings Description: Whitening spot removing cream in a red and orange cardboard box with a picture of a woman's face. Country of origin: China





A12/0789/13 Norway Category: Cosmetics Product: Skin lightening product Brand: Yimei Name: Whitening spot-removing suit Type/number of model: CM-1068 Batch number/Barcode: 6928286400120 OECD Portal Category: 53000000 - Beauty / Personal Care / Hygiene Description: Green cardboard box with white label. Country of origin: China

Chemical The product poses a chemical risk because it contains mercury compound (5.800 mg/kg). The product does not comply with the Cosmetics Directive 76/768/EEC.


A12/0790/13 Germany Category: Chemical products Product: Tattoo ink Brand: Universal Black Name: Sumi Black Type/number of model: Item Code 13296 Batch number/Barcode: Use-by date: 12/2015 OECD Portal Category: 53000000 - Beauty / Personal Care / Hygiene Description: Small glass bottle with screw cap; black liquid Country of origin: Unknown

Chemical The product poses a chemical risk because it contains polycyclic aromatic hydrocarbons (PAH), with a benzo[a]pyrene content of 1151 µg/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 that level.

Compulsory measures: Recall of the product from end users



No pictures are available

A12/0801/13 Norway Category: Cosmetics Product: Skin-lightening product Brand: Orient Pearl Name: Whitening pearl beauty & spot removing suite Type/number of model: Unknown Batch number/Barcode: 4710589601968 OECD Portal Category: 53000000 - Beauty / Personal Care / Hygiene Description: Skin-lightening product in pink and white cardboard box. Country of origin: Taiwan

Chemical The product poses a chemical risk because it contains a mercury compound (12000 mg/kg) as skin whitening substance. The product does not comply with the Cosmetics Directive 76/768/EEC.


A12/0807/13 The Netherlands

Category: Cosmetics Product: Body paint powder Brand: Paint Glow Products Name: Neon Body Paint Type/number of model: Unknown Batch number/Barcode: Batch 1: 000002 , Batch 2: 000003, Barcode: 5036567 022044 OECD Portal Category: 53000000 - Beauty / Personal Care / Hygiene Description: Plastic bottle of 200 ml, containing body paint powder in 6 different glowing colours.

Microbiological The product poses a microbiological risk because it is contaminated by Pseudomonas aeruginosa, a pathogenic organism. The level of pseudomonas aeruginosa detected is 15000 cfu/g, above the guidance value (1000 cfu/g). The product does not comply with the Cosmetics Directive 76/768/EEC.




Country of origin: United Kingdom

A12/0811/13 Norway Category: Cosmetics Product: Skin-lightening product Brand: E`Yôuth Name: Unknown Type/number of model: QB/T 1857-2004 Batch number/Barcode: 6932511250206 OECD Portal Category: 53000000 - Beauty / Personal Care / Hygiene Description: The whitening spot-removing and cleansing set contains two products in red plastic tube, packaged in a cardboard box. Country of origin: China

Chemical The product poses a chemical risk because it contains a mercury compound (2000mg/kg) as a skin-lightening substance. The product does not comply with the Cosmetics Directive 76/768/EEC.




A12/0812/13 Norway Category: Cosmetics Product: Skin-lightening product Brand: CPHL - Seven Herbal Name: Wrinkle De Crease Type/number of model: Unknown Batch number/Barcode: Unknown OECD Portal Category: 53000000 - Beauty / Personal Care / Hygiene Description: The anti-aging cream is sold in a green cardboard box. Country of origin: Pakistan

Chemical The product poses a chemical risk because it contains a mercury compound (820mg/kg) as a skin-lightening substance. The product does not comply with the Cosmetics Directive 76/768/EEC.



Category: Chemical products Product: Tattoo Ink Brand: Eternal Name: Tangerine - Lime Green - Old Orchid Type/number of model: Tangerine: Lot 07/19/12 Lime Green: Lot 01/03/13 Old Orchid: lot 12/07/12 Batch number/Barcode: Unknown OECD Portal Category: 53000000 - Beauty / Personal Care / Hygiene Description: Plastic bottle (30 ml) in red, black and green colours with yellow label and black top.

Chemical The product poses a chemical risk because it contains azo dyes releasing aromatic amine o-toluidine and 5-nitro-o-toluidine classified as carcinogenic, mutagenic, toxic and sensitising. According to the Council of Europe Resolution ResAP (2008)1 on requirements and criteria for the safety of tattoos and permanent make-up' o-toluidine and 5-nitro-o-toluidine should not be present in tattoo ink.




Country of origin: United States

A12/0867/13 Germany Category: Food-imitating products Product: Beer bath oil Brand: Traditionelle Bierkosmetik Name: Bierbad Type/number of model: Manufactured: 11/2012 Use by: 05/2015 Batch number/Barcode: L502 OECD Portal Category: 53000000 - Beauty / Personal Care / Hygiene Description: Twin-component foaming bath oil with brewer's yeast and hop extracts. Packaging: colourless PET bottle shaped like a disposable beer bottle. The bottle neck is covered with gold-coloured metallic foil and a band (which must be removed when first opened) and has a white plastic screw top. Diameter of bottle neck opening: approx. 2.0 cm. No dosage aperture. Country of origin: Czech Republic

Chemical The product poses a chemical risk because the liquid contains high content of surfactants which, if swallowed, can be toxic. Due to its characteristic form, appearance and packaging, consumers may mistake the product for foodstuffs and therefore swallow the liquid. The product does not comply with the Directive 87/357/EEC on products which, appearing to be other than they are, endanger the health or safety of consumers.

Voluntary measures: Withdrawal of the product from the market Compulsory measures: Ban on the marketing of the product and any accompanying measures



A12/0874/13 Germany Category: Chemical products Product: Tattoo ink Brand: Silverback Ink Name: Unknown Type/number of model: Black 11 Batch number/Barcode: Lot: B498103012 Batch: B498103012S OECD Portal Category: 53000000 - Beauty / Personal Care / Hygiene Description: Black tattoo ink in a plastic bottle of 120 ml with screw top and dispensing nozzle. Country of origin: United States

Chemical The product poses a chemical risk because it contains 7 polycyclic aromatic hydrocarbons (PAH) (25.03 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).



Category: Chemical products Product: Tattoo Ink Brand: Eternal Name: 1.Eternal ink Bright orange 2. Eternal ink Caramel Type/number of model: Eternal ink Bright orange: lot 09/18/12 exp 09/18/2014; Eternal ink Caramel: lot 12/18/12 exp 12/18/2014; Batch number/Barcode: Unknown OECD Portal Category: 53000000 - Beauty / Personal Care / Hygiene Description: Transparent bottle with yellow label and black top. Contains 30 ml. Country of origin: United States

Chemical The products pose a chemical risk because they contain azo dyes releasing 156 mg/kg of the aromatic amine o-toluidine, 135 mg/kg 2,4-toluenediamine and 972 mg/kg o-anisidine which are substances classified as carcinogenic, mutagenic, toxic and sensitizing. According to the Council of Europe Resolution ResAP (2008)1 on requirements and criteria for the safety of tattoos and permanent make-up o-toluidine, 2,4-toluenediamine and o-anisidine should not be released from azo dyes in tattoo inks. The products do not comply with the national legislation




A12/0908/13 Germany Category: Chemical products Product: Tattoo ink Brand: Alla Prima Name: Prima Black Type/number of model: Unknown Batch number/Barcode: LOT 1010 Batch: 0820821016 OECD Portal Category: 53000000 - Beauty / Personal Care / Hygiene Description: Black tattoo ink in a plastic bottle with screw top and dispensing nozzle – 60 ml. Country of origin: United States

Chemical The product poses a chemical risk because it contains 2.2 ppm of polycyclic aromatic hydrocarbons (PAHs). 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.



Category: Cosmetics Product: Skin regenerator cream for permanent make-up and tattoo Brand: Biotek Name: Bioprogram Newgex Type/number of model: Unknown Batch number/Barcode: Lot IB05401 exp. Date 2015-08 OECD Portal Category: 53000000 -

Chemical The product poses a chemical risk because it contains 1% cetrimide (mytrimonium bromide), as declared in the list of ingredients, which exceeds the permitted limit in cosmetics (0.1%). The product does not comply with the Cosmetics Directive 76/768/EEC.




Beauty / Personal Care / Hygiene Description: Skin regenerator cream for permanent make-up and tattoo in white sachet samples containing 4 ml. 50 pieces contained in a white box. Country of origin: Italy

ANEXO I: Relacin de productos no notificados al CPNP, o que no … · 820 mg/Kg de Mercurio Anexo...

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