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CORREO ELECTRÓNICO [email protected] Pág. 1 de 31 C/ CAMPEZO, 1 – EDIFICIO 8 28022 MADRID TEL: 91 822 54 90 FAX: 91 822 52 89 ANEXO I: Relación de productos no notificados al CPNP, o que no están registrados en esta Agencia (en el caso de productos de cuidado personal). La AEMPS no ha realizado actuaciones. Número de notificación RAPEX Denominación Producto Finalidad Producto Responsable Producto Tipo Incumplimiento Código AEMPS UE-A11-0061/13 Goti Sun Milk Oil Jojoba & Vitamin E- Sun Protection Milk SPF40 Protector solar TG-farm Medico d.o.o. Serbia Presenta un pH inapropiado para este tipo de cosméticos CM-630/2013 UE-A11-0062/13 Goti Sun Milk for Baby Oil Jojoba & Vitamin E- Sun Protection Milk SPF40 Protector solar TG-farm Medico d.o.o. Serbia Presenta un pH inapropiado para este tipo de cosméticos CM-631/2013 UE-A12-1024/13 Dheedhi Hair Care Herbal Shampoo Cosméticos para el cabello Viro Trading Oü Estonia Contaminación microbiológica: Pseudomonas aeruginosa (7,4 x 104 ufc/g) CM-598/2013 UE-A12-1024/13 Roop Amrit Face Cream Cosméticos para el cuidado de la cara Haji and Sons Reino Unido Presencia de sustancia prohibida: 422 mg/Kg de Mercurio Anexo II / 221 CM-599/2013

ANEXO I: Relacin de productos no notificados al CPNP, o que no …+2013... · Roop Amrit Face Cream Cosméticos para el cuidado de la cara Haji and Sons Reino Unido Presencia de sustancia

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CORREO ELECTRÓNICO [email protected] Pág. 1 de 31

C/ CAMPEZO, 1 – EDIFICIO 8 28022 MADRID TEL: 91 822 54 90 FAX: 91 822 52 89

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

Número de notificación

RAPEX Denominación

Producto Finalidad Producto Responsable Producto Tipo Incumplimiento Código

AEMPS

UE-A11-0061/13

Goti Sun Milk Oil Jojoba & Vitamin E- Sun Protection Milk SPF40

Protector solar TG-farm Medico d.o.o. Serbia

Presenta un pH inapropiado para este tipo de cosméticos

CM-630/2013

UE-A11-0062/13

Goti Sun Milk for Baby Oil Jojoba & Vitamin E- Sun Protection Milk SPF40

Protector solar TG-farm Medico d.o.o. Serbia

Presenta un pH inapropiado para este tipo de cosméticos

CM-631/2013

UE-A12-1024/13

Dheedhi Hair Care Herbal Shampoo

Cosméticos para el cabello

Viro Trading Oü Estonia

Contaminación microbiológica: Pseudomonas aeruginosa (7,4 x 104 ufc/g)

CM-598/2013

UE-A12-1024/13

Roop Amrit Face Cream

Cosméticos para el cuidado de la cara

Haji and Sons Reino Unido

Presencia de sustancia prohibida: 422 mg/Kg de Mercurio Anexo II / 221

CM-599/2013

CORREO ELECTRÓNICO [email protected] Pág. 2 de 31

C/ CAMPEZO, 1 – EDIFICIO 8 28022 MADRID TEL: 91 822 54 90 FAX: 91 822 52 89

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

Número de notificación

RAPEX Denominación

Producto Finalidad Producto

Responsable Producto Tipo Incumplimiento Código

AEMPS

UE-A12-1063/13

Art Nails Professional Nail Color & Nail Art System

Cosméticos para el cuidado de las uñas

Thuong Huyen Nguyen República Checa

Presencia de sustancia prohibida: Ftalato de dibutilo Anexo II / 675

CM-600/2013

UE-A12-1064/13 Hin er TOE Nails

Cosméticos para el cuidado de las uñas

Thuong Huyen Nguyen República Checa

Presencia de sustancia prohibida: Ftalato de dibutilo Anexo II / 675

CM-678/2013

UE-A12-1065/13

Xiangnier Design Nails Nail Art

Cosméticos para el cuidado de las uñas

Thuong Huyen Nguyen República Checa

Presencia de sustancia prohibida: Ftalato de dibutilo Anexo II / 675

CM-601/2013

UE-A12-1066/13 Mei jia er Office Girls

Cosméticos para el cuidado de las uñas

Minh Xuan Nguyen República Checa

Presencia de sustancia prohibida: Ftalato de dibutilo Anexo II / 675

CM-679/2013

CORREO ELECTRÓNICO [email protected] Pág. 3 de 31

C/ CAMPEZO, 1 – EDIFICIO 8 28022 MADRID TEL: 91 822 54 90 FAX: 91 822 52 89

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

Número de notificación

RAPEX Denominación

Producto Finalidad Producto

Responsable Producto Tipo Incumplimiento Código

AEMPS

UE-A12-1067/13

Hin er Design nails, Nail art

Cosméticos para el cuidado de las uñas

Duy Hai Ngo República Checa

Presencia de sustancia prohibida: Ftalato de dibutilo Anexo II / 675

CM-602/2013

UE-A12-1068/13

Pearl Face Whitening Beauty Cream

Cosméticos para el cuidado de la cara

Dilkuih distributor Reino Unido

Presencia de sustancia prohibida: 15000 mg/kg de Mercurio Anexo II / 221

CM-603/2013

UE-A12-1069/13

White Gold Whitening Cream with Blackberry extract

Cosméticos para el cuidado de la cara

Dilkuih Distributor Reino Unido

Presencia de sustancia prohibida: 9720 mg/kg de Mercurio Anexo II / 221

CM-604/2013

UE-A12-1103/13 Art Nail

Cosméticos para el cuidado de las uñas

Duy Hai Ngo República Checa

Presencia de sustancia prohibida: Ftalato de dibutilo Anexo II / 675

CM-606/2013

CORREO ELECTRÓNICO [email protected] Pág. 4 de 31

C/ CAMPEZO, 1 – EDIFICIO 8 28022 MADRID TEL: 91 822 54 90 FAX: 91 822 52 89

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

Número de notificación

RAPEX Denominación

Producto Finalidad Producto

Responsable Producto Tipo Incumplimiento Código

AEMPS

UE-A12-1108/13

Sky Soaring Fringed iris art nail

Cosméticos para el cuidado de las uñas

Longevity Group Ltd. República Checa

Presencia de sustancia prohibida: Ftalato de dibutilo Anexo II / 675

CM-680/2013

UE-A12-1109/13 Mei jia er Office Girls

Cosméticos para el cuidado de las uñas

Longevity Group Ltd. República Checa

Presencia de sustancia prohibida: Ftalato de dibutilo Anexo II / 675

CM-607/2013

UE-A12-1110/13 K. nail Art nails

Cosméticos para el cuidado de las uñas

Ngoc Giap Pham República Checa

Presencia de sustancia prohibida: Ftalato de dibutilo Anexo II / 675

CM-608/2013

UE-A12-1118/13 Hair Go Straight Keratin Treatment

Cosméticos para el cuidado del cabello

Hair Go Straight Bélgica

Presencia de sustancia regulada en condiciones distintas de las establecidas: 2,6% de Formaldehído Anexo III / 1128

CM-609/2013

CORREO ELECTRÓNICO [email protected] Pág. 5 de 31

C/ CAMPEZO, 1 – EDIFICIO 8 28022 MADRID TEL: 91 822 54 90 FAX: 91 822 52 89

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

Número de notificación

RAPEX Denominación

Producto Finalidad Producto

Responsable Producto Tipo Incumplimiento Código

AEMPS

UE-A12-1121/13 UNU Bond Nail Glue

Cosméticos para el cuidado de las uñas

Ngoc Giap Pham República Checa

Presencia de sustancia prohibida: Ftalato de dibutilo Anexo II / 675

CM-610/2013

UE-A12-1198/13 Eternal Ink Dark brown

Tintas para tatuaje

Body Cult GMBH Tattoo supplies Alemania

Riesgo químico de acuerdo a la resolución ResAP(2008)1 del Consejo de Europa: 12,3 mg/Kg de Níquel 0,31 mg/Kg de Cadmio 14,0 mg/Kg de Arsenico

CM-632/2013

UE-A12-1236/13

Eternal Ink Lightning Yellow

Tintas para tatuaje

Body Cult GMBH Tattoo supplies Alemania

Riesgo químico de acuerdo a la resolución ResAP(2008)1 del Consejo de Europa: 34,1 mg/Kg de o-Toluidina 6860 mg/Kg de Bario

CM-634/2013

CORREO ELECTRÓNICO [email protected] Pág. 6 de 31

C/ CAMPEZO, 1 – EDIFICIO 8 28022 MADRID TEL: 91 822 54 90 FAX: 91 822 52 89

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

Número de notificación

RAPEX Denominación

Producto Finalidad Producto

Responsable Producto Tipo Incumplimiento Código

AEMPS

UE-A12-1266/13

Miss Patisserie Plum Crunch; Miss Patisserie Sugar Heart Miss Patisserie Rosie; Miss Patisserie La Vie en Rose; Miss Patisserie Very Berry Cherry; Miss Patisserie Sweet Pea; Miss Patisserie Peach Schnapps; Miss Patisserie Sundae Best; Miss Patisserie Wedding Favor.

Cosméticos para la higiene

Miss Patisserie Limited Reino Unido

Estos productos imitan a alimentos, en el color apariencia y tamaño por lo que pueden ser confundidos con comida.

CM-636/2013 CM-637/2013 CM-638/2013 CM-639/2013 CM-640/2013 CM-641/2013 CM-642/2013 CM-643/2013 CM-644/2013

UE-A12-1267/13

Miss Patisserie Miss Mango Miss Patisserie Pom PomMiss Patisserie La La Lime

Cosméticos para la higiene

Miss Patisserie Limited Reino Unido

Estos productos imitan a alimentos, en el color apariencia y tamaño por lo que pueden ser confundidos con comida

CM-645/2013 CM-646/2013 CM-647/2013

CORREO ELECTRÓNICO [email protected] Pág. 7 de 31

C/ CAMPEZO, 1 – EDIFICIO 8 28022 MADRID TEL: 91 822 54 90 FAX: 91 822 52 89

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

Número de notificación

RAPEX Denominación

Producto Finalidad Producto

Responsable Producto Tipo Incumplimiento Código

AEMPS

UE-A12-1290/13 Intenze Zuper Black

Tintas para tatuaje

Planet Clean, Kanka-Bleth GbR Alemania

Riesgo químico de acuerdo a la resolución ResAP(2008)1 del Consejo de Europa: 350 μg/kg de Benzo(a)pireno 10946 μg/kg de Hidrocarburos aromáticos policíclicos (PAH).

CM-669/2013

UE-A12-1308/13

Delkam Group “Hand soap”

Cosméticos para la higiene

Sambro International Ltd. Reino Unido

Contaminación microbiológica: Klebsiella oxytoca (1 x 104 ufc/g)

CM-670/2013

UE-A12-1326/13

Eternal Ink Nuclear Green

Tintas para tatuaje

Premier product GMBH Alemania

Riesgo químico de acuerdo a la resolución ResAP(2008)1 del Consejo de Europa: 562 mg/Kg de Bario

CM-671/2013

UE-A12-1328/13

Electric Ink Light Shadow black tattoo ink

Tintas para tatuaje

Magic Moon Tattoing GMBH Alemania

Riesgo químico de acuerdo a la resolución ResAP(2008)1 del Consejo de Europa: 1420 μg/kg de Hidrocarburos aromáticos policíclicos (PAH).

CM-672/2013

CORREO ELECTRÓNICO [email protected] Pág. 8 de 31

C/ CAMPEZO, 1 – EDIFICIO 8 28022 MADRID TEL: 91 822 54 90 FAX: 91 822 52 89

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

Número de notificación

RAPEX Denominación

Producto Finalidad Producto

Responsable Producto Tipo Incumplimiento Código

AEMPS

UE-A12-1333/13

Incredibile Tattoo Supply Sacred Color- Red Rubens Incredibile

Tintas para tatuaje

Incredibile Tattoo Supply Italia

Riesgo químico de acuerdo a la resolución ResAP(2008)1 del Consejo de Europa: 502 mg/kg de Bario

CM-673/2013

UE-A12-1334/13

Incredibile Tattoo Supply Sacred Color- Pink Warhol Incredibile

Tintas para tatuaje

Incredibile Tattoo Supply Italia

Riesgo químico de acuerdo a la resolución ResAP(2008)1 del Consejo de Europa: 72 mg/kg de Bario

CM-674/2013

CORREO ELECTRÓNICO [email protected] Pág. 9 de 31

C/ CAMPEZO, 1 – EDIFICIO 8 28022 MADRID TEL: 91 822 54 90 FAX: 91 822 52 89

ANEXO II: Relación de productos no notificados al CPNP, 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-A12-1302/13 Mitchell Group Creme Eclaircissante

Cosméticos para el cuidado de la piel

Asia Express Food Holanda

Presencia de sustancia prohibida: Acetato de hidrocortisona

CM-667-2013

Se remitió, por su condición de medicamento, al Departamento de Inspección y Control de esta Agencia

CORREO ELECTRÓNICO [email protected] Pág. 10 de 31

C/ CAMPEZO, 1 – EDIFICIO 8 28022 MADRID TEL: 91 822 54 90 FAX: 91 822 52 89

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

Número de notificación

RAPEX Denominación

Producto Finalidad Producto

Responsable

Producto Tipo Incumplimiento Código AEMPS

INFO-0187/13 Tooth Fairy Teeth whitening product “Tooth-whitening kit”

Blanqueantes dentales

Tooth Fairy Suiza

Presencia de sustancia regulada en condiciones distintas de las establecidas: 7,2g/100g de Peroxido de hidrogeno Anexo III / 12

CM 593/2013/AE

INFO-0211/13 Topline Exim Inc. ROYAL Henna light mahogany (ROYAL Henna Red)

Cosméticos para el cabello

Desconocido

Presencia de sustancia rohibida: 2-Nitro-p-fenilendiamina - Anexo II / 1319

CM 629/2013/AE

INFO-0222/13 Topline Exim Inc. ROYAL Henna light mahogany (ROYAL Henna Black)

Cosméticos para el cabello

Desconocido

Presencia de sustancia regulada en condiciones distintas de las establecidas: 2,2% de-p-fenilendiamina Anexo III / 8 b

CM 677/2013/AE

CORREO ELECTRÓNICO [email protected] Pág. 11 de 31

C/ CAMPEZO, 1 – EDIFICIO 8 28022 MADRID TEL: 91 822 54 90 FAX: 91 822 52 89

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

A11/0061/13 Croatia Category: Cosmetics Product: Sunscreen Brand: Goti Name: Sun milk oil jojoba & vitamin E - sun protection milk SPF 40 Type/number of model: 103365333 MR BK – No 1 Batch number/Barcode: Unknown OECD Portal Category: 53000000 - Beauty / Personal Care / Hygiene Description: Sunscreen protection milk in 200 ml plastic bottle with pump. Country of origin: Serbia

Chemical The label on the product is incomplete and incorrect. Not all ingredients found in the product are listed in the ingredient list. In addition, the pH value is too high. The product does not comply with the Regulation (EC) No 1223/2009 on cosmetic products.

Compulsory measures: Import rejected at border

A11/0062/13 Croatia Category: Cosmetics Product: Sunscreen milk for baby Brand: Goti Name: Sun milk for baby oil jojoba & vitamin E - sun protection milk SPF 40

Chemical The label on the product is incomplete and incorrect. Not all ingredients found in the product are listed in the ingredients list. In addition, the pH value is too high. The product does not comply with

Compulsory measures: Import rejected at border

CORREO ELECTRÓNICO [email protected] Pág. 12 de 31

C/ CAMPEZO, 1 – EDIFICIO 8 28022 MADRID TEL: 91 822 54 90 FAX: 91 822 52 89

Type/number of model: 103365333 MR BK – No 1 Batch number/Barcode: Unknown OECD Portal Category: 53000000 - Beauty / Personal Care / Hygiene Description: Sunscreen milk for babies in 200 ml plastic bottle with pump. Country of origin: Serbia

the Regulation (EC) No 1223/2009 on cosmetic products.

A12/1024/13 Estonia Category: Cosmetics Product: Herbal Shampoo Brand: Dheedhi Name: Hair Care Herbal Shampoo Type/number of model: 76/25D/2005 Batch number/Barcode: SEL 11005 / EAN 8904070900357 OECD Portal Category: 53000000 - Beauty / Personal Care / Hygiene Description: Green coloured herbal shampoo, 200 ml. Country of origin: India

Microbiological The product contains the pathogen Pseudomonas Aeruginosa which can cause severe infections in patients with a damaged skin barrier. The product does not comply with the Cosmetic Products Regulation.

Voluntary measures: Withdrawal of the product from the market

CORREO ELECTRÓNICO [email protected] Pág. 13 de 31

C/ CAMPEZO, 1 – EDIFICIO 8 28022 MADRID TEL: 91 822 54 90 FAX: 91 822 52 89

A12/1062/13 United Kingdom

Category: Cosmetics Product: Skin lightening product Brand: Roop Amrit Name: Face Cream Type/number of model: Unknown Batch number/Barcode: RTM 214105 OECD Portal Category: 53000000 - Beauty / Personal Care / Hygiene Description: Skin lightening face cream in pink plastic pot. Cardboard packaging with information leaflet. Country of origin: Pakistan

Chemical The cream contains mercury (422mg/kg - 0.04%) as a skin lightening substance which can cause damage to internal organs The product does not comply with the Cosmetics Directive.

Voluntary measures: Warning consumers of the risks, Withdrawal of the product from the market

A12/1063/13 Czech Republic

Category: Clothing, textiles and fashion items Product: False nails Brand: Unknown Name: Art Nails Professional Nail Color & Nail Art System Type/number of model: Unknown Batch number/Barcode: Unknown OECD Portal Category: 67000000 - Clothing Description: Set of 12 pieces of plastic nails with different decor and red tube of glue with a white cap. On the back side label is provides the text: DESIGN NAILS. Country of origin: China

Chemical The product poses a chemical risk because the glue contains dibutyl phthalate (DBP).

Compulsory measures: Withdrawal of the product from the market

CORREO ELECTRÓNICO [email protected] Pág. 14 de 31

C/ CAMPEZO, 1 – EDIFICIO 8 28022 MADRID TEL: 91 822 54 90 FAX: 91 822 52 89

A12/1064/13 Czech Republic

Category: Clothing, textiles and fashion items Product: False nails Brand: Hin er Name: TOE Nails Type/number of model: Unknown Batch number/Barcode: Item # 2606 OECD Portal Category: 67000000 - Clothing Description: Set of 12 pieces of plastic nails (on feet) with different decor and red tube of glue with a white cap. on the packaging there is the following inscription: "Professional Quality, Beautiful Nails of Charming Ladies". Country of origin: China

Chemical The product poses a chemical risk because the glue contains dibutyl phthalate (DBP).

Compulsory measures: Withdrawal of the product from the market

CORREO ELECTRÓNICO [email protected] Pág. 15 de 31

C/ CAMPEZO, 1 – EDIFICIO 8 28022 MADRID TEL: 91 822 54 90 FAX: 91 822 52 89

A12/1065/13 Czech Republic

Category: Clothing, textiles and fashion items Product: False nails Brand: Xiangnier Name: DESIGN NAILS NAIL ART Type/number of model: Unknown Batch number/Barcode: #B-001 OECD Portal Category: 67000000 - Clothing Description: Set of 12 pieces of plastic nails with different decor and blue tube of glue with a white cap. On the packaging there is an inscription: 'BEAUTIFUL NAILS OF CHARMING LADIES' Country of origin: China

Chemical The product poses a chemical risk because the glue contains dibutyl phthalate (DBP).

Compulsory measures: Withdrawal of the product from the market

CORREO ELECTRÓNICO [email protected] Pág. 16 de 31

C/ CAMPEZO, 1 – EDIFICIO 8 28022 MADRID TEL: 91 822 54 90 FAX: 91 822 52 89

A12/1066/13 Czech Republic

Category: Clothing, textiles and fashion items Product: False nails Brand: Mei jia er Name: Office Girls Type/number of model: Unknown Batch number/Barcode: MJE-024D OECD Portal Category: 67000000 - Clothing Description: Set of 12 pieces of plastic nails with different decor and red tube of glue with a white cap. The packaging is plastic blister in the outer carton with the following inscriptions: "Meijiaer child boutique fake nails, 12 Designer Nails Set". Country of origin: China

Chemical The product poses a chemical risk because the glue contains dibutyl phthalate (DBP).

Compulsory measures: Withdrawal of the product from the market

CORREO ELECTRÓNICO [email protected] Pág. 17 de 31

C/ CAMPEZO, 1 – EDIFICIO 8 28022 MADRID TEL: 91 822 54 90 FAX: 91 822 52 89

A12/1067/13 Czech Republic

Category: Clothing, textiles and fashion items Product: False nails Brand: Hin er Name: Design nails, Nail art Type/number of model: code: #A-01; The code and text on wholesale packaging: on feet, Item no. JR 1209261 Batch number/Barcode: EAN: 8663326325619 OECD Portal Category: 67000000 - Clothing Description: Set of 12 pieces of plastic nails on feet with milk tinge decor and red tube of glue with a white cap. Wholesale pack contains 27 packs of nails. There is the following inscription on the packaging: 'BEAUTIFUL NAILS OF CHARMING LADIES'. Country of origin: China

Chemical The product poses a chemical risk because the glue contains dibutyl phthalate (DBP).

Compulsory measures: Withdrawal of the product from the market

CORREO ELECTRÓNICO [email protected] Pág. 18 de 31

C/ CAMPEZO, 1 – EDIFICIO 8 28022 MADRID TEL: 91 822 54 90 FAX: 91 822 52 89

A12/1068/13 United Kingdom

Category: Cosmetics Product: Skin-lightening product Brand: Pearl Face Name: Whitening Beauty Cream Type/number of model: Unknown Batch number/Barcode: Batch no : November 2011 OECD Portal Category: 53000000 - Beauty / Personal Care / Hygiene Description: Whitening cream in a white plastic pot, with information leaflet, packaged in pink cardboard box marked 'Beauty Plan 1 Week, Pearl Face Whitening Beauty Cream.' Country of origin: Pakistan

Chemical The product poses a chemical risk because it contains mercury (15000 mg/kg) as a skin lightening substance. The product does not comply with the Cosmetics Directive.

Voluntary measures: Warning consumers of the risks, Withdrawal of the product from the market

A12/1069/13 United Kingdom

Category: Cosmetics Product: Skin-lightening product Brand: White Gold Name: Whitening Cream with Blackberry extract

Chemical The product poses a chemical risk because it contains mercury (9720 mg/kg) as a skin lightening substance, which can cause damage to internal organs. The product does not comply with the

Voluntary measures: Warning consumers of the risks, Withdrawal of the product from the market

CORREO ELECTRÓNICO [email protected] Pág. 19 de 31

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: Unknown OECD Portal Category: 53000000 - Beauty / Personal Care / Hygiene Description: Whitening face cream in a black plastic pot, with information leaflet, packaged in black cardboard box marked ‘White Gold Whitening Cream with Blackberry extract’ Country of origin: Pakistan

Cosmetics Directive.

A12/1103/13 Czech Republic

Category: Clothing, textiles and fashion items Product: False nails Brand: Unknown Name: Art Nails Type/number of model: Item No. JR 1209260 Batch number/Barcode: 8663326325602 OECD Portal Category: 67000000 - Clothing Description: A set of 12 plastic, false fingernails in different colours to be attached with glue contained in a green tube with the inscription MEIJIAMEI. The wholesale pack contains 12 packs of nails. Country of origin: China

Chemical The products pose a chemical risk because they contain dibutyl phthalate (DBP).

Compulsory measures: Withdrawal of the product from the market

CORREO ELECTRÓNICO [email protected] Pág. 20 de 31

C/ CAMPEZO, 1 – EDIFICIO 8 28022 MADRID TEL: 91 822 54 90 FAX: 91 822 52 89

A12/1108/13 Czech Republic

Category: Clothing, textiles and fashion items Product: False nails Brand: Sky Soaring Name: Fringed iris art nail Type/number of model: Item No. XS708 Batch number/Barcode: 6568561654758 OECD Portal Category: 67000000 - Clothing Description: A set of 12 plastic nails with different decoration and a red tube of glue with a white cap. The packaging is a plastic bag inserted into a small box with CE marking. Country of origin: China

Chemical The products pose a chemical risk because the glue contains dibutyl phthalate (DBP).

Compulsory measures: Withdrawal of the product from the market

CORREO ELECTRÓNICO [email protected] Pág. 21 de 31

C/ CAMPEZO, 1 – EDIFICIO 8 28022 MADRID TEL: 91 822 54 90 FAX: 91 822 52 89

A12/1109/13 Czech Republic

Category: Clothing, textiles and fashion items Product: False nails Brand: Mei jia er Name: Office Girls Type/number of model: MJE-030D Batch number/Barcode: Unknown OECD Portal Category: 67000000 - Clothing Description: A set of plastic false nails in the form of a French manicure. Packaging consists of a plastic container with 12/24 false nails and glue in a red tube, inserted into a plastic box. The front of package has text in English ("so natural .. better than your own"). Country of origin: China

Chemical The products pose a chemical risk because the glue contains dibutyl phthalate (DBP).

Compulsory measures: Withdrawal of the product from the market

A12/1110/13 Czech Republic

Category: Clothing, textiles and fashion items Product: False nails Brand: K. nail Name: Art nails Type/number of model: Item No. # KP-818 Batch number/Barcode: Unknown OECD Portal Category: 67000000 - Clothing

Chemical The products pose a chemical risk because the glue contains dibutyl phthalate (DBP).

Compulsory measures: Withdrawal of the product from the market

CORREO ELECTRÓNICO [email protected] Pág. 22 de 31

C/ CAMPEZO, 1 – EDIFICIO 8 28022 MADRID TEL: 91 822 54 90 FAX: 91 822 52 89

Description: A set of plastic, false nails in different colours. Packaging consists of a plastic bag with 10 nails and glue in a red tube. On the front of the package is also the text: BEST QUALITY. Country of origin: China

A12/1118/13 France Category: Cosmetics Product: Hair straightener Brand: Hair Go Straight Name: Keratin Treatment Type/number of model: Unknown Batch number/Barcode: batch A1316D – bar code : 7 29440 30809 4 OECD Portal Category: 53000000 - Beauty / Personal Care / Hygiene Description: Hair straightener in 1-litre clear plastic bottle. Country of origin: United States

Chemical The product contains formaldehyde (2.6 %) which could result in an allergic reaction and skin sensitisation (irritation, itching, tingling and redness). The product does not comply with the Cosmetic Products Regulation.

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

A12/1121/13 Slovenia Category: Clothing, textiles and fashion items Product: Nail glue Brand: UNU Bond Name: Unknown Type/number of model: Art.No.01848 Batch number/Barcode: EAN8026501018483 OECD Portal Category: 53000000 - Beauty / Personal Care / Hygiene Description: Set of 5 little plastic bottles of nail glue, packed in transparent plastic bag. Country of origin: China

Chemical The products pose a chemical risk because the glue contains dibutyl phthalate (DBP).

Voluntary measures: Recall of the product from end users

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C/ CAMPEZO, 1 – EDIFICIO 8 28022 MADRID TEL: 91 822 54 90 FAX: 91 822 52 89

A12/1198/13 Germany Category: Chemical products Product: Tattoo ink Brand: Eternal Ink Name: Dark brown Type/number of model: Dark brown, 30ml Batch number/Barcode: Batch: E25, Lot: 124 OECD Portal Category: 53000000 - Beauty / Personal Care / Hygiene Description: Brown tattoo ink, viscous, 30 ml PET bottle with application nozzle. Country of origin: United States

Chemical The product poses a chemical risk because it contains 12.3 mg/kg of nickel, 0.31 mg/kg cadmium and 14.0 mg/kg arsenic. According to 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. The cadmium content also exceeds the recommended level of 0.2 mg/kg specified in the EU Resolution Res AP (2008) 1. Finally, the arsenic level detected in the sample exceeds the level of 2 mg/kg recommended in Resolution ResAP (2008) 1.

Voluntary measures: Withdrawal of the product from the market

A12/1236/13 Austria Category: Chemical products Product: Tattoo ink Brand: Eternal Ink Name: Lightning yellow Type/number of model: Unknown Batch number/Barcode: LOT 240 OECD Portal Category: 53000000 - Beauty / Personal Care / Hygiene Description: Transparent bottle containing yellow tattoo ink . Country of origin: United States No pictures are available

Chemical The product poses a chemical risk because it contains 34.1 mg/kg of o-toluidine and 6 860 mg/kg of barium. 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 should not be present in tattoo inks and the content of barium should be limited to 50 mg/kg.

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

A12/1266/13 Bulgaria Category: Food-imitating products Product: Bath salts Brand: Miss Patisserie Name: 1. Plum Crunch; 2. Sugar Hear;t 3. Rosie; 4. La Vie en Rose; 5. Very Berry Cherry; 6. Sweet Pea; 7. Peach Schnapps; 8. Sundae Best; 9. Wedding Favor. Type/number of model: Art No. 007027 – 09/14, 011027-08/14, 014023/01/14, 004042-09/14, 006020-09/14, 010020-06/17, 011024-06/14, 307020-09/14 Batch number/Barcode: 2000000005249 OECD Portal Category: 75000000 - Household / Office Furniture / Furnishings Description: Bath salts in the form of scented mini-cakes in 9 varieties. Country of origin: United Kingdom

Choking The product poses a risk of choking because it has detachable small parts and, due to its characteristic form, appearance, colour and size, the product may be mistaken for a foodstuff and placed in the mouth. 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.

Compulsory measures: Ban on the marketing of the product and any accompanying measures

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C/ CAMPEZO, 1 – EDIFICIO 8 28022 MADRID TEL: 91 822 54 90 FAX: 91 822 52 89

A12/1267/13 Bulgaria Category: Food-imitating products Product: Bath salts Brand: Miss Patisserie Name: Miss Mango; Pom Pom; La La Lime Type/number of model: Series "Fizzy Bath Lollipop" Batch number/Barcode: 2000000005263 OECD Portal Category: 75000000 - Household / Office Furniture / Furnishings Description: Bath salts in the form of scented lollipops – in 3 varieties: 1. „Miss Mango” in orange colour with a decorative flower made of synthetic material; 2. „Pom Pom” in pink colour; 3. „La La Lime” in yellow colour with green stripes. Each lollipop has been packed in individual cellophane packaging tied with a blue textile ribbon. On the packaging there are two attached paper stickers: one of them with the following information in English: "Fizzy Bath Lollipop, composition, warning: Do not eat. Keep out of reach of children". Country of origin: United Kingdom

Choking The product poses a risk of choking as, due to its characteristic form, colour and size, it may be mistaken for foodstuff. This may lead children to put pieces in their mouth, suck or ingest them, which could entail the risk of choking. The products do 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

Compulsory measures: Ban on the marketing of the product and any accompanying measures

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C/ CAMPEZO, 1 – EDIFICIO 8 28022 MADRID TEL: 91 822 54 90 FAX: 91 822 52 89

A12/1290/13 Germany Category: Chemical products Product: Tattoo Ink Brand: Intenze Name: Zuper Black Type/number of model: Unknown Batch number/Barcode: Batch: BK72IMX40 OECD Portal Category: 53000000 - Beauty / Personal Care / Hygiene Description: Black liquid sold in plastic bottle with nozzle, best before date 30.06.2017. Country of origin: United States

Chemical The product poses a chemical risk because it contains 350 μg/kg benzo(a)pyrene and 10 946 μg/kg 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 benzo(a)pyrene and PAH should not exceed 5 μg/kg and 500 μg/kg respectively.

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

A12/1302/13 Austria Category: Cosmetics Product: Skin lightening product Brand: Mitchell Group Name: Creme Eclaircissante Type/number of model: Batch: 22003 Batch number/Barcode: 5280130501003 OECD Portal Category: 53000000 - Beauty / Personal Care / Hygiene Description: White and pink metal tube in box; best-before date 10/2014. Country of origin: United States

Chemical The product poses a chemical risk because it contains hydrocortisone acetate. This substance, which belongs to the glucocorticoid class, is prohibited in cosmetic products. The product does not comply with the Cosmetics Directive 76/768/EEC.

Voluntary measures: Warning consumers of the risks, Withdrawal of the product from the market

A12/1308/13 Germany Category: Cosmetics Product: Hand soap Brand: Delkam Group Name: Unknown Type/number of model: Lot 1201127, Model/item: 13330027936 Batch number/Barcode: 73550001531000000150 OECD Portal Category: 53000000 - Beauty / Personal Care / Hygiene Description: Rounded oval liquid soap dispenser with brightly coloured "Sponge Bob"design. On the bottle the name of a well-known TV channel "Nickelodeon" can be found. Country of origin: Greece

Microbiological The product poses a microbiological risk because it has a high concentration of Enterobacteriaceae (Klebsiella oxytoca) which may cause infections.

Voluntary measures: Destruction of the product

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C/ CAMPEZO, 1 – EDIFICIO 8 28022 MADRID TEL: 91 822 54 90 FAX: 91 822 52 89

A12/1326/13 Italy Category: Chemical products Product: Tattoo ink Brand: Eternal Ink Name: Nuclear Green Type/number of model: 3888B Nuclear Green Batch number/Barcode: Batch No.: E39 Lot No.: 207 3888B OECD Portal Category: 53000000 - Beauty / Personal Care / Hygiene Description: Tattoo ink in 60 ml bottle showing the brand, batch, expiry date and producer, text in German. Country of origin: United States

Chemical The product poses a chemical risk because it contains 562 mg/kg of barium. According to the Council of Europe Resolution ResAP (2008)1 on requirements and criteria for the safety of tattoos and permanent make-up' the content of barium should be limited to 50 mg/kg.

Compulsory measures: Ban on the marketing of the product and any accompanying measures

A12/1328/13 Germany Category: Chemical products Product: Tattoo ink Brand: Electric Ink Name: Light Shadow black tattoo ink Type/number of model: Product ref. 400415, use-by date 06/2014, 15 ml bottle Batch number/Barcode: Batch No.:

Chemical The product poses a chemical risk because it contains 1420 μg/kg 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: 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

2485 OECD Portal Category: 53000000 - Beauty / Personal Care / Hygiene Description: Black liquid in small brown bottle. Country of origin: Brazil

A12/1333/13 Italy Category: Chemical products Product: Tattoo ink Brand: Incredibile Tattoo Supply Name: Sacred Color- Red Rubens Incredibile Type/number of model: Red ink Batch number/Barcode: 1730320 11304 OECD Portal Category: 53000000 - Beauty / Personal Care / Hygiene Description: The product is sold in a 30 ml bottle bearing the brand name, batch and expiry date, its packaging and producer. Country of origin: Italy

Chemical The product poses a chemical risk because it contains 502 mg/kg of barium. According to the Council of Europe Resolution ResAP (2008)1 on requirements and criteria for the safety of tattoos and permanent make-up' the content of barium should be limited to 50 mg/kg.

Compulsory measures: Ban on the marketing of the product and any accompanying measures

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C/ CAMPEZO, 1 – EDIFICIO 8 28022 MADRID TEL: 91 822 54 90 FAX: 91 822 52 89

A12/1334/13 Italy Category: Chemical products Product: Tattoo ink Brand: Incredibile Tattoo Supply Name: Sacred Color - Pink Warhol Incredibile Type/number of model: Pink Warhol Incredibile Batch number/Barcode: Batch 1720320, 11719/2012, expiry date 12-2015 OECD Portal Category: 53000000 - Beauty / Personal Care / Hygiene Description: Tattoo ink in a 30 ml bottle showing the brand, batch, expiry date and producer. Country of origin: Italy

Chemical The product poses a chemical risk because it contains 72 mg/kg of barium. According to the Council of Europe Resolution ResAP (2008)1 on requirements and criteria for the safety of tattoos and permanent make-up' the content of barium should be limited to 50 mg/kg.

Compulsory measures: Ban on the marketing of the product and any accompanying measures