CE-0475/13

Número: 0475 Año: 2013

Tipo de notificación:

En aplicación del artículo 12 de la Directiva 2001/95/CE

Categoría: Cosméticos

Nombre de la notificación: TINTA PARA TATUAR, marca FANTASIA, art. nº 3029, lote 1762

Código de barras:

Riesgo: Químico

Motivo: Presencia de Hidrocarburos Aromáticos Policíclicos (HAPs), benzo (a) pireno.

Observaciones del INC:

CCAA a quienes se solicita información:

01. País notificante y persona de contacto:

País: Alemania

País de origen: Estados Unidos

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Section 1: General information

Submission number: MS/1036/13

Case number: A12/0475/13

Creation date: 09/04/2013

Validation/distribution date: 17/04/2013

Notification type: Article 12 GPSD/Article 22 Regulation 765/2008

Version: 1

Notifying country: Germany

Author: Hoffbauer Jan

Organisation/Ministry:

Address:

City:

Phone number:

Fax number:

E-mail: jan.hoffbauer@bvl.bund.de

Validator at MS level: Blume Jochen

Organisation/Ministry: Bundesanstalt für Arbeitsschutz und Arbeitsmedizin - BAuA

Address: Friedrich-Henkel-Weg 1 - 25

City: Dortmund

Phone number:

Fax number:

E-mail: eu-rapex@baua.bund.de

Section 2: Product identification

Product category: Chemical products

Product name: Lining Black

Brand: FantasiaType/number of model: Art.No. 3029Batch number/Bar code: Batch 1762; best-before date 05/2014 Customs code:

Product and packagingdescription:

Glass bottle with screw cap. 125 ml, best-before date 05/2014

Total number of items coveredby the notification:

Unknown

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Photos (products, packaging andlabel):

Foto3.jpgFoto1.jpgFoto2.jpg

Section 3: Regulations and standards applicable

Legal provisions (directive,decision, regulation, etc.):

§ 26 (1) and (2) in conjunction with § 4 (1)(3) LFGB – Criteria as per Council of Europe Resolution ResAP (2008) 1 - BfR statement No 044/2011 of 1.7.2011

Standards: -Proof of conformity (includingexistence of marks):

-

Is the product counterfeit?: Unknown

Certificates: No file(s) attached

Section 4: Traceability

Country of origin: United States

Countries of destination:

Germany

Contact details of the manufacturer(s):

Name: Fantasia Art Supply

Address: 5510 Broadway Blvd.

City: Garland TX, 75043

Country: United States

Contact information:

Contact address: No file(s) attached

Contact details of theexporter(s):

Unknown

Contact details of the importer(s):

Name: Fa.Magic Moon Tattooing GmbH

Address: Karolinger Ring 18-20

City: 41812 Erkelenz

Country: Germany

Contact information:

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Contact address: No file(s) attached

Contact details of the distributor(s):

Name: Tina Bernhard, Fix Ink Tattoo Equipment

Address: Hohenzollernstr. 79

City: 75177 Pforzheim

Country: Germany

Contact information:

Contact address: No file(s) attached

Contact details of the retailer(s):

Name: Mannheim Ink Tattoo Messe Mannheim

Address: Casterfeldstr. 89

City: 68199 Mannheim

Country: Germany

Contact information:

Contact address: No file(s) attached

Section 5: Risk description

Risk category:

Chemical

Summary of test results(description of technical defects):

A sample of the tattoo ink was found to contain 186 µg/kg benzo(a)pyrene.

Legal provisions and standards(with clauses) against which theproduct was tested and did notcomply:

- § 26 (1) and (2) in conjunction with § 4 (1)(3) LFGB – Criteria as per Council of Europe Resolution ResAP (2008) 1 - BfR statement No 044/2011 of 1.7.2011

Risk assessment andconclusions:

In a statement on the health assessment of PAHs in tattoo products, the Federal Institute for Risk Assessment (BfR) concludes that the PAH content of tattoo products should be reduced to a technically unavoidable minimum. The BfR bases its recommendations on the Council of Europe’s criteria on the safety of tattoo inks. The benzo[a]pyrene content should be less than 5 µg/kg, since it is classified as carcinogenic. The benzo[a]pyrene content in the sample is 186 µg/kg, which means that the tattoo ink in question constitutes a health risk (carcinogenic).

Information on known incidentsand accidents:

None.

Tests reports: Probenahmebericht.pdf

Gutachten.pdf

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Section 6: Measures

Type of measures: Voluntary measures

Authority/economic operatortaking notified measures:

Tina Bernhard, Fix Ink Tattoo Equipment

Category of measures: Withdrawal of the product from the market

Date of entry into force: Unknown

Duration: Unknown

Scope: National

Notification sent by a produceror a distributor under Article5(3) of the GPSD:

No file(s) attached

Adopted measures: Rückruf.doc

Section 7: Confidentiality

Is the notification confidential?: No

Section 8: Other

Additional information:

Other attachments: No file(s) attached